State Stem Cell Agency Facilities Working Group Transcript 10/28/05

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California State Stem Cell Agency



REGULAR MEETING 10/28/05

BEFORE THE
SCIENTIFIC AND MEDICAL RESEARCH
FACILITIES WORKING GROUP
OF THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE
ORGANIZED PURSUANT TO THE
CALIFORNIA STEM CELL RESEARCH AND CURES ACT
 
LOCATION:
GRAND HYATT AT UNION SQUARE
345 STOCKTON STREET, BALLROOM EAST
SAN FRANCISCO, CALIFORNIA
DATE:
FRIDAY, OCTOBER 28, 2005
9:04 A.M.
REPORTER:
BETH C. DRAIN, CSR
CSR. NO. 7152
BRS FILE NO:
73792
SAN FRANCISCO, CALIFORNIA, FRIDAY OCTOBER 28, 2005
09:04 A.M.
CHAIRMAN DOMS: OKAY. CAN WE GET STARTED,PLEASE. I'D LIKE TO CALL THE MEETING TO ORDER, AND WE'LL START WITH A ROLL CALL. MELISSA, CAN YOU TAKE CARE OF THAT?
MS. KING: DAVID SERRANO-SEWELL.
MR. SERRANO-SEWELL: PRESENT.
MS. KING: RUSTY DOMS.
CHAIRMAN DOMS: PRESENT.
MS. KING: MARCY FEIT. DEBORAH HYSEN. ED KASHIAN.
MR. KASHIAN: YES.
MS. KING: ROBERT KLEIN.
MR. KLEIN: PRESENT.
MS. KING: SHERRY LANSING. DAVID LICHTENGER.
MR. LICHTENGER: PRESENT.
MS. KING: JEFF SHEEHY.
MR. SHEEHY: HERE.
MS. KING: JANET WRIGHT.
DR. WRIGHT: HERE.
CHAIRMAN DOMS: THANK YOU, MELISSA. WE HAVE ON THE AGENDA THE PLEDGE OF ALLEGIANCE.
MR. KLEIN: RUSTY, I THINK YOU DIDN'T KNOW THAT JOAN WAS GOING TO BE ABLE TO ATTEND, SO SHE WASN'T  ON THE LIST TO BE CALLED. BUT JOAN IS --
MS. SAMUELSON: PRESENT.
MR. KLEIN: WE ARE EXCITED THAT JOAN MADE IT.
CHAIRMAN DOMS: EXCUSE ME. THANKS, BOB.WE HAVE ON THE AGENDA THE PLEDGE OF ALLEGIANCE. SINCE WE DON'T HAVE A FLAG, I THINK WE'LL HAVE TO DISPENSE WITH THAT.
AND I'D LIKE TO WELCOME ALL THE MEMBERS OF THE COMMITTEE AND THOSE PEOPLE THAT ARE HERE IN THE PUBLIC'S INTEREST. I THINK THIS IS AN EXTRAORDINARY OPPORTUNITY FOR ALL OF US TO PARTICIPATE IN A PROJECT AND ENDEAVOR THAT'S CLOSE TO ALL OF OUR HEARTS. AND I'D LIKE TO TALK A LITTLE BIT ABOUT THE COMPOSITION OF THE COMMITTEE, AND THEN I'D LIKE TO ASK PEOPLE TO INTRODUCE THEMSELVES AND GIVE US A VERY BRIEF BACKGROUND.
ON THIS COMMITTEE, WE HAVE FOUR MEMBERS FROM THE REAL ESTATE SECTOR, THREE OF WHICH ARE HERE TODAY, SIX PATIENT ADVOCATES, I BELIEVE WE HAVE FOUR OF THEM HERE TODAY, AND BOB KLEIN, WHO IS OUR ICOC CHAIRMAN.
I'VE HAD THE OPPORTUNITY TO MEET THE REAL ESTATE PARTICIPANTS THIS MORNING. I'VE HAD THE OPPORTUNITY OF VISITING AND MEETING ALL OF THE PATIENT ADVOCATES THAT ARE HERE TODAY. I THINK BOB AND HIS GROUP HOPEFULLY PUT TOGETHER AN OUTSTANDING GROUP PARTICULARLY ON THE -- WE KNOW THAT THE PATIENT ADVOCATES ARE TOTALLY DEDICATED. THEY'RE WONDERFUL PEOPLE. ON THE REAL ESTATE SIDE WE HOPE WE STEP UP TO THE PLATE ON THAT SIDE. I THINK WE'VE GOT A GREAT COMMITTEE, AND I THINK ALL OF US ARE WORKING -- LOOKING FORWARD TO WORKING TOGETHER ON THIS.
SO WHAT I WOULD LIKE TO DO IS HAVE THE PEOPLE INTRODUCE THEMSELVES VERY BRIEFLY, AND I'LL START WITH MYSELF.
I'M FROM SOUTHERN CALIFORNIA, BORN AND RAISED THERE, WENT TO COLLEGE THERE. I'VE BEEN IN THE REAL ESTATE BUSINESS BASICALLY ALL MY LIFE. MY AREAS OF INTEREST AND EXPERTISE ARE IN INVESTMENT MANAGEMENT OF REAL ESTATE DOLLARS AND ALSO PROJECT MANAGEMENT. I HAD A COMPANY THAT PARTICIPATED IN BOTH OF THOSE AREAS, SOLD IT A FEW YEARS AGO, AND I'VE BEEN BASICALLY DOING A LOT OF WORK IN THE NONPROFIT SECTOR. I'M INVOLVED IN THE DEVELOPMENT, PARTICULARLY FROM A SCHEDULE AND BUDGET STANDPOINT, FOR TWO VERY LARGE HOSPITALS IN SOUTHERN CALIFORNIA. WORKING WITH SOME OTHER GROUPS, AND I'M VERY PLEASED TO BE PART OF THE FACILITIES COMMITTEE AND ASSOCIATED WITH THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE.
WITH THAT, I'D LIKE TO INTRODUCE THE VICE WITH THAT, I'D LIKE TO INTRODUCE THE VICE CHAIRMAN OF THIS COMMITTEE, DAVID SERRANO-SEWELL. IT'S ALL YOURS.
MR. SERRANO-SEWELL: THANK YOU, RUSTY. MY NAME IS DAVID SERRANO-SEWELL. I'M A MEMBER OF THE INDEPENDENT CITIZENS' OVERSIGHT COMMITTEE, HAVE THE HONOR OF REPRESENTING THE MS AND THE ALS COMMUNITY AS A PATIENT ADVOCATE. I WAS APPOINTED BY THE ICOC TO THIS WORKING GROUP, AND I'M EXCITED ABOUT SERVING AS VICE CHAIR OF THIS WORKING GROUP AND WITH EVERYONE ELSE.
CHAIRMAN DOMS: I'D LIKE TO ASK OUR WONDERFUL LEADER, BOB KLEIN, TO GO NEXT AS CHAIRMAN OF THE ICOC.
MR. KLEIN: THANK YOU, RUSTY. IT'S EXCITING TO SEE THE FACILITIES GROUP COMMENCE THEIR OPERATIONS. AS WE'LL DISCUSS LATER, THERE'S SOME VERY CRITICAL FUNCTIONS TO PROVIDE SPACE THAT IS CLEAR OF NIH FUNDING SO THE SCIENTISTS IN CALIFORNIA CAN HAVE THE CONFIDENCE THEY'LL BE ABLE TO CARRY OUT THEIR PROGRAM WITHOUT POTENTIAL INTIMIDATION FROM FEDERAL FUNDING SOURCES THROUGH THE NIH.
THE NIH IS AN EXTRAORDINARY MECHANISM OF WHICH WE'RE ALL PROUD NATIONALLY. IT'S UNDER SOME TREMENDOUS BURDENS CURRENTLY BECAUSE OF THE EXECUTIVE ORDER RELATED TO RESTRICTING FUNDS FOR STEM CELL RESEARCH, WHICH WE'LL CERTAINLY, I BELIEVE, ADDRESS UNDER DR. HALL'S COMMENTS.
IN TERMS OF THIS COMMITTEE, WHILE I HAVE A DEVELOPMENT BACKGROUND, A REAL ESTATE DEVELOPMENT BACKGROUND, IN OFFICE, COMMERCIAL, AND RESIDENTIAL, WITH A FOCUS ON INSTITUTIONAL LEVEL APARTMENTS, RESIDENTIAL APARTMENTS, AND A VERY SPECIFIC PUBLIC PURPOSE FOCUS ON APARTMENTS WITH A SIZABLE AFFORDABLE HOUSING COMPONENT, THAT DOES NOT GIVE ME THE VERY SPECIALIZED BACKGROUND THAT'S REPRESENTED BY A NUMBER OF MEMBERS OF THIS COMMITTEE IN DEALING WITH HOSPITAL CONSTRUCTION, IN DEALING WITH THE CONSTRUCTION OF SCIENTIFIC LABS. SO IT'S A GREAT PRIVILEGE TO SERVE WITH MEMBERS OF THIS COMMITTEE WHO BRING TREMENDOUS EXPERTISE FROM THEIR OWN BACKGROUNDS THAT WILL EDUCATE US, LEAD US, AND INFORM US IN A WAY THAT HOPEFULLY ALLOWS US TO MAKE VERY STRATEGIC DECISIONS IN THE FUTURE.
AND IN TERMS OF THE TOTAL SCOPE OF THIS COMMITTEE AS TO WHAT IS BUILT, WHILE THE INITIATIVE ITSELF, AS I WROTE IT, PROVIDES 10 PERCENT OF THE FUNDS OR 300 MILLION FOR CONSTRUCTION, HOPEFULLY WITH AT LEAST A ONE-TO-ONE MATCH, IN MANY CASES IT MAY BE A TWO-TO-ONE MATCH, WE MAY DEVELOP 600 MILLION OR 900 MILLION OF FACILITIES. IN EITHER CASE, IT WOULD BE A FABULOUS CONTRIBUTION TO THE SCIENTISTS AND PHYSICIANS OF CALIFORNIA. THANK YOU.
CHAIRMAN DOMS: DAVID.
MR. LICHTENGER: THANK YOU, RUSTY. I'M DAVID LICHTENGER. FIRST OF ALL, I'VE BEEN INVOLVED IN CONSTRUCTION, REAL ESTATE DEVELOPMENT, AND ON THE BROKERAGE SIDE FOR OVER 20 YEARS, PRIMARILY ON THE EAST COAST, ALTHOUGH THE PAST FIVE YEARS ON THE WEST COAST. I LIVE IN PALO ALTO NOW, AND MY COMPANY'S OFFICES ARE IN SANTA CLARA. MY BACKGROUND HAS IN THE PAST FIVE, SIX YEARS BEEN HEAVILY ON THE TECHNOLOGY AND LIFE SCIENCE SIDE, DOING A LOT OF THE LABS, CLEAN ROOMS, TECHNICAL FACILITIES. ON THE EAST COAST I WAS INVOLVED ALSO IN SOME HOSPITAL AND HEALTHCARE AS WELL.
AND I'M LOOKING FORWARD TO BEING INVOLVED WITH THIS COMMITTEE, AND HOPEFULLY WILL BE ABLE TO ADD SOME VALUE AND HELP THE DOLLARS WE SPEND BEING VERY COST EFFECTIVE.
CHAIRMAN DOMS: THANK YOU, DAVID. JOAN. MS. SAMUELSON: THAT COST-EFFECTIVE PHRASE SEEMS TO ME TO BE ONE OF THE IMPORTANT CRITERION WE'LL HAVE TO PAY ATTENTION TO. JOAN SAMUELSON. I'M FOUNDER AND PRESIDENT OF THE PARKINSON'S ACTION NETWORK, AND THAT'S HOW I CAME TO BE APPOINTED AS A MEMBER OF THE ICOC, A PATIENT REPRESENTATIVE. AND IT'S A WONDERFUL CHALLENGE AND HONOR.
AND I LOOK FORWARD TO WORKING WITH THE OTHER MEMBERS OF THE COMMITTEE AND THE CHAIRMAN. THANK YOU.
CHAIRMAN DOMS: THANKS, JOAN. ED.
MR. KASHIAN: MY NAME IS ED KASHIAN. I WAS BORN IN THE EAST COAST AND EDUCATED AND LIVED IN CALIFORNIA THE BETTER PART OF THE LAST 55 YEARS. I HAVE A SENSE OF EXPERIENCE IN THE REAL ESTATE BUSINESS AND DEVELOPMENT BUSINESS FOR A MEDIUM-SIZED RESIDENTIAL FIRM THAT DEVELOPS FOR ITS OWN ACCOUNT, AND IN RECENT TIME HAD A CONSIDERABLE AMOUNT OF EXPERIENCE WITH OUR UNIVERSITIES AND THE STATE COLLEGES IN THE AREA.
AND I'M HONORED TO BE A PART OF THIS GROUP AND LOOK FORWARD TO WORKING WITH ALL OF US.
CHAIRMAN DOMS: THANK YOU. JANET.
DR. WRIGHT: I'M JANET WRIGHT. I'M A CARDIOLOGIST NORTH OF SACRAMENTO, AND I'M ONE OF THE PATIENT ADVOCATES ON THE ICOC. I HAVE HAD THE PRIVILEGE OF BEING PART OF THE GRANT REVIEW WORKING GROUP, WHICH WAS ABOUT THE SCIENCE. AND I THINK THIS GROUP IS ABOUT GETTING THE SCIENCE A HOME. SO I'M EXCITED TO PARTICIPATE.
CHAIRMAN DOMS: JEFF.
MR. SHEEHY: I'M JEFF SHEEHY. I'M FROM HERE IN SAN FRANCISCO, AND I'M A PATIENT ADVOCATE REPRESENTING PEOPLE WITH HIV AND AIDS.
CHAIRMAN DOMS: OUR ILLUSTRIOUS PRESIDENT,ZACH HALL.
DR. HALL: ZACH HALL. I'M THE PRESIDENT OF CIRM. MOST OF MY CAREER WAS AT UCSF WITH SOME TIME IN WASHINGTON AND SOME TIME IN UNIVERSITY OF SOUTHERN CALIFORNIA. I'M A NEUROBIOLOGIST ONCE UPON A TIME. I'VE BECOME A SCIENCE ADMINISTRATOR.
MR. HARRISON: I'M JAMES HARRISON, OUTSIDE COUNSEL TO THE CIRM. AND IT'S MY JOB TO HELP YOU KEEP IN LINE.
DR. WRIGHT: FULL-TIME JOB.
MR. KLEIN: MR. CHAIRMAN, IT WOULD BE APPROPRIATE TO NOTE THAT JAMES HARRISON WAS ONE OF THE KEY ATTORNEYS THAT HELPED ME WITH THE DRAFTING OF PROPOSITION 71 AND IS EXTRAORDINARILY WELL VERSED IN THE LEGAL ISSUES BEHIND PROPOSITION 71, ITS STRUCTURE, AND ITS IMPLEMENTATION. SO WE'RE VERY PRIVILEGED TO HAVE HIS SERVICES.
CHAIRMAN DOMS: I'M VERY PLEASED. I'VE ALREADY TOLD JAMES TO GIVE ME A TUG OR PULL ME BACK WHEN WE MAY BE HEADING A LITTLE OUTSIDE THE BOUNDARIES. IT'S GREAT TO HAVE YOU, JAMES.
ZACH, DO YOU WANT TO INTRODUCE YOUR STAFF THAT'S HERE TODAY TOO BECAUSE THEY'RE AN IMPORTANT PART OF ALL OF THIS.
DR. HALL: YES. I WOULD LIKE TO INTRODUCE, PARTICULARLY SINCE WE HAVE A SMALL GROUP, I THINK IT WOULD BE USEFUL TO DO SO. DR. ARLENE CHIU JUST STEPPED OUT OF THE ROOM, BUT SHE IS THE DIRECTOR OF SCIENTIFIC PROGRAM AND REVIEW AND HAS WORKED VERY CLOSELY ON THE GRANTS PROGRAM. AND SO MUCH OF -- WE'LL HAVE SOME DISCUSSION TODAY ABOUT HOW THE SCIENTIFIC AND FACILITIES REVIEW WORK TOGETHER, AND SO WE'RE PARTICULARLY GLAD THAT SHE CAN BE HERE.
GIL SOMBRANO HAS RECENTLY JOINED US AND IS IN CHARGE OF -- IS OUR SENIOR REVIEW OFFICER FOR THE -- SCIENTIFIC REVIEW OFFICER FOR THE GRANTS REVIEW PROGRAM. HE'S A PH.D. WHOM WE MANAGED TO PERSUADE TO COME OVER FROM UCSF.
MARY MAXON, DR. MARY MAXON, IS THE DEPUTY TO OUR VICE CHAIR, ED PENHOET. MARY HAS BEEN OUR LEADER PARTICULARLY IN INTELLECTUAL PROPERTY MATTERS.
AND KATE SHREVE IN THE BACK HERE WORKS WITH OUR STANDARDS WORKING GROUP, WHICH IS BUSY PUTTING TOGETHER THE MEDICAL AND ETHICAL STANDARDS BY WHICH THE WORK WILL BE DONE.
AND THIS IS ARLENE CHIU, WHO HAS JUST COME BACK IN THE ROOM. ARLENE CAME TO US FROM NIH WHERE SHE REALLY LED THE PROGRAMS IN STEM CELL BIOLOGY THERE ON THE EXTRAMURAL SIDE.
MELISSA KING EVERYONE KNOWS. AND PROBABLY EVEN MORE THAN THAT IS JENNIFER ROSAIA, WHO IS RESPONSIBLE FOR ALL OF OUR ARRANGEMENTS AND ALL OF THE LOGISTICS IN PUTTING ALL THIS TOGETHER. HAVE WE LEFT ANYBODY OUT? I THINK THAT'S ALL FROM CIRM.
CHAIRMAN DOMS: THANK YOU, ZACH. AND I CAN SAY THAT OVER THE LAST SEVERAL MONTHS, I'VE HAD THE GREAT PLEASURE OF WORKING WITH ZACH AND HIS STAFF. THEY'RE VERY, VERY PROFESSIONAL, THEY'RE VERY TALENTED, THEY'RE COMMITTED AND DEDICATED. AT LEAST FOR ME, AND I THINK YOU WILL ALL FEEL THE SAME WAY, IT'S AN EXTRAORDINARY STAFF. WE'RE LUCKY TO HAVE ALL THOSE PEOPLE.
IN TERMS OF OUR MEETING TODAY, WE HAVE A FULL AGENDA, SO WE NEED TO MOVE ON. I'D LIKE TO MAKE A COUPLE COMMENTS REGARDING THE MEETINGS. I'M VERY INTERESTED IN KEEPING THE DISCUSSION FOCUSED. WE HAVE A TIME SCHEDULE NINE TO TWELVE. I'D LIKE TO ADHERE TO THAT TIME SCHEDULE. THESE PEOPLE ARE ALL AT THIS TABLE, AT LEAST, VOLUNTEERS, AND THEY HAVE COMMITMENTS ELSEWHERE. SO IT'S GOING TO BE ONE OF MY GOALS TO ADHERE TO THE SCHEDULE.
WELCOME ALL COMMENTS, AND ONE OF MY JOBS, ONE OF MY ASSIGNMENTS WILL BE TO FOLLOW UP WITH COMMITTEE MEMBERS ON ASSIGNMENTS.
I'D LIKE TO DIGRESS FOR JUST A SECOND AND GIVE YOU A PERSONAL THOUGHT ON THIS COMMITTEE AND ITS FUNCTIONS. WHEN I WAS FIRST ASKED TO JOIN THIS COMMITTEE AND CHAIR THIS COMMITTEE, I REALLY DID NOT -- I UNDERSTOOD THE CONCEPT OF STEM CELL RESEARCH AND A LITTLE BIT ABOUT THE APPLICATIONS AND THE BENEFITS FROM IT. OVER THE LAST FOUR OR FIVE MONTHS HAVE HAD THE OPPORTUNITY TO BECOME MORE KNOWLEDGEABLE, LONG WAY TO GO, BUT MORE KNOWLEDGEABLE. AND IT'S SORT OF BEEN EXTRAORDINARY, THE LEARNING PROCESS GOING THROUGH ALL THIS.
AND I WAS THINKING -- I WAS TALKING TO SOMEBODY ABOUT THE CONCEPT OF HOPE, AND SHE MENTIONED THAT IN RELATION TO WHAT WE'RE DOING HERE. PEOPLE HOPE FOR A LOT OF THINGS IN LIFE. I WAS THINKING, GEE, I HOPE I WIN THE LOTTO. IT'S PROBABLY TOUGH BECAUSE I NEVER BUY A TICKET; BUT, YOU KNOW, I THINK THIS IS AN OPPORTUNITY FOR US TO REALLY CONVERT HOPE INTO REALITY. THESE PEOPLE AROUND THE TABLE HAVE ALL BEEN AFFECTED IN SOME WAY OR ANOTHER PERSONALLY OR WITH FAMILY, TERRIBLE DISEASES. I HAVE A DAUGHTER THAT HAS SERIOUS LEARNING DISABILITIES.
AND IT'S AN EXTRAORDINARY OPPORTUNITY FOR US TO CONVERT HOPE INTO REALITY. AND I THINK ALL OF US WORKING TOGETHER, IT'S A GREAT CHALLENGE, BUT IT'S A WONDERFUL CHALLENGE. AND I CAN PERSONALLY SAY THAT I AM REALLY, REALLY LOOKING FORWARD TO WORKING WITH EVERYBODY IN THIS COMMITTEE AND THE OTHER PEOPLE THAT ARE ASSOCIATED WITH THE ICOC. AND I THINK ALL OF US WORKING TOGETHER CAN REALLY MAKE ONE VERY SIGNIFICANT DIFFERENCE IN HOW WE LIVE OUR LIVES AND HOW WE LOOK FORWARD TO LIVING OUR LIVES IN THE FUTURE.
SO I WANTED TO SHARE THAT, AND I THINK THAT'S VERY, VERY IMPORTANT.
I WANT TO MAKE A QUICK COMMENT ON THE PUBLIC PARTICIPATION. WE'D LIKE TO INVITE THE PUBLIC TO MAKE COMMENTS DURING THE MEETING. WE HAVE AN AGENDA ITEM AT THE END OF THE MEETING SPECIFICALLY FOR PUBLIC COMMENTS. WE'RE NOT OBLIGATED TO HAVE PUBLIC COMMENTS AS THIS IS A WORKING GROUP AND IS NOT FORMALLY SUBJECT TO THE BAGLEY-KEENE ACT, BUT I THINK, TAKING THE LEAD FROM BOB, WE WILL OPEN THESE MEETINGS UNLESS WE HAVE AGENDA ITEMS THAT WE'LL COVER UNDER THE BYLAWS THAT REQUIRE CLOSED SECTIONS.
AT THE END OF EACH AGENDA ITEM, IF THERE IS PUBLIC COMMENT, WE WILL TAKE IT. I WOULD ASK YOU TO BE BRIEF. I WANT YOU TO LIMIT YOUR COMMENTS TO THREE MINUTES. IF I FEEL THAT WE'RE GETTING OFF TRACK IN TERMS OF PUBLIC COMMENTS REGARDING THE SPECIFIC AGENDA ITEM, I WILL ASK YOU TO HOLD THOSE COMMENTS UNTIL THE END OF THE MEETING.
AT THIS POINT WE'D LIKE TO GO TO AGENDA ITEM NO. 5, WHICH IS THE PRESIDENT'S REPORT, AND I'M GOING TO TURN IT OVER TO ZACH.
DR. HALL: THANK YOU VERY MUCH, RUSTY. LET ME JUST SAY THAT THIS IS MY OPPORTUNITY TO WELCOME YOU ON BEHALF OF THE CALIFORNIA INSTITUTE OF REGENERATIVE MEDICINE, WELCOME YOU TO THIS WORKING GROUP, AND NOT ONLY THIS WORKING GROUP, BUT, AS RUSTY INDICATED, TO THIS VERY DAUNTING AND VERY EXCITING PROJECT THAT ALL OF US ARE WORKING ON.
AS YOU KNOW AND WILL HEAR FURTHER, AN IMPORTANT PART OF OUR MANDATE THROUGH PROPOSITION 71 IS TO PROVIDE FACILITIES THAT CAN BE USED PARTICULARLY FOR HUMAN EMBRYONIC STEM CELL RESEARCH. AND WE WILL BE WORKING WITH YOU OVER A PERIOD OF YEARS TO ACCOMPLISH THAT AIM. AND LET ME JUST SAY PERSONALLY WE ARE DEEPLY GRATEFUL TO YOU FOR GIVING YOUR TIME, YOUR TALENTS, AND YOUR EFFORT TO HELP US PROVIDE CALIFORNIA SCIENTISTS WITH THE BEST POSSIBLE FACILITIES FOR HUMAN EMBRYONIC STEM CELL RESEARCH. AS JANET WRIGHT SAID, TO GIVE THIS RESEARCH A HOME, AND A HOME OF THE QUALITY IT DESERVES.
I APOLOGIZE THAT THIS MATERIAL IS NOT IN YOUR BOOKS, BUT I JUST PUT TOGETHER A SLIDE PRESENTATION FOR THIS PART OF IT. I WOULD LIKE TO JUST TELL YOU A LITTLE BIT AT THE BEGINNING ABOUT WHO WE ARE AND WHERE WE ARE AND WHAT WE'RE DOING AND HOW THE FACILITIES WORKING GROUP FITS INTO OUR OVERALL EFFORT.
I DON'T THINK I HAVE TO EMPHASIZE TO THIS GROUP THE SCIENTIFIC EXCITEMENT AND MEDICAL HOPE THAT STEM CELL RESEARCH HAS GENERATED. IT HAS BEEN QUITE REMARKABLE. BECAUSE STEM CELLS HAVE THE CAPACITY FOR VIRTUALLY UNLIMITED CELL DIVISION AND SELF-RENEWAL AND BECAUSE THEY ALSO HAVE A UNIQUE CAPABILITY TO DIFFERENTIATE INTO ANY ONE OF THE SPECIALIZED CELLS IN OUR BODY, VIRTUALLY ANY ONE, THAT IS, MUSCLE CELL, NERVE CELL, PANCREAS CELL, WHATEVER IT IS, THEY CAN DIFFERENTIATE INTO THAT CELL. THIS HAS GIVEN RISE TO THE IDEA OF SO-CALLED CELL REPLACEMENT THERAPY IN WHICH STEM CELLS OR CELLS DERIVED FROM STEM CELLS ARE USED TO REPLACE DISEASED OR DAMAGED PARTS OF OUR BODY. AND THIS COULD BE IN THE HEART, IN THE PANCREAS, IN THE NERVOUS SYSTEM, WHEREVER IT MIGHT OCCUR.
SO IT'S A TECHNIQUE WITH UNUSUALLY BROAD APPLICABILITY. WE'RE ALSO LEARNING THROUGH A TECHNIQUE CALLED NUCLEAR TRANSFER THAT STEM CELLS MAY BE USED TO PROVIDE HUMAN CELLULAR MODELS OF DISEASES SUCH AS PARKINSON'S DISEASE, ALS, AND CANCER. AND THESE MODELS CAN HELP US LEARN MORE ABOUT THE CAUSES OF THESE DISEASES, AND ALSO WE THINK HELP US FIND DRUGS THAT MIGHT PREVENT OR CURE THE DISEASES. IN THAT SENSE, THEY OFFER THIS DUAL CAPABILITY, THEN, OF CELL REPLACEMENT THERAPY AND ALSO OF THE POSSIBILITY OF BEING A MAJOR SCIENTIFIC TOOL IN LOOKING FOR NEW DISCOVERIES AND NEW THERAPIES.
NOW, UNFORTUNATELY, IN SPITE OF THE TREMENDOUS PROMISE OF THIS WORK, THE UNITED STATES SCIENTISTS HAVE NOT BEEN ABLE TO PARTICIPATE FULLY IN IT BECAUSE THE MAJOR SUPPORTER OF BIOMEDICAL RESEARCH IN THIS COUNTRY, THE NIH, HAS BEEN RESTRICTED BY FEDERAL POLICIES. AND THIS IS THE POLICY THAT WAS ENUNCIATED BY THE WHITE HOUSE IN AUGUST 2001, WHICH IS THAT FEDERAL FUNDS WERE RESTRICTED TO THE USE OF HUMAN EMBRYONIC STEM CELL LINES THAT WERE DERIVED PRIOR TO AUGUST 9, 2001. AND THERE WERE A NUMBER OF FURTHER RESTRICTIONS ON HOW THE LINES MUST BE DERIVED; BUT, IN ESSENCE, THE POLICY REQUIRED THAT THEY BE DERIVED FROM UNUSED EMBRYOS THAT WERE MADE FOR REPRODUCTIVE PURPOSES BY IN VITRO FERTILIZATION.
THERE WERE ORIGINALLY 64 LINES. IT THEN GOT AS HIGH AS 77 LINES, BUT IN ACTUAL FACT MANY OF THESE LINES HAVE PROVED NOT TO BE VERY DURABLE OR NOT TO BE WELL CHARACTERIZED, AND THE NUMBER HAS NOW SHRUNK TO 22. ALL OF THE LINES WERE MADE WITH MOUSE FEEDER CELLS. THEY HAVE MOUSE PROTEINS ASSOCIATED WITH THEM, AND MANY OF THEM, IF NOT ALL, HAVE CHROMOSOMAL ABNORMALITIES. SO THERE IS A TREMENDOUS NEED FOR CREATING NEW CELLS AND FOR LETTING PEOPLE WORK ON THESE THROUGH THE FEDERAL POLICIES.
OF COURSE, THIS WAS THE SOURCE OF PROPOSITION 71. NOW, LET ME JUST POINT OUT THAT THE FEDERAL POLICY HAS SEVERAL IMPLICATIONS THAT ARE DIRECTLY RELATED TO THE WORK THAT THIS WORKING GROUP WILL BE DOING, AND THAT IS WITH RESPECT TO FACILITIES. GIVEN THAT POLICY, PERSONNEL, EQUIPMENT, OR SUPPLIES THAT ARE PAID FOR BY FEDERAL FUNDS CANNOT BE USED FOR RESEARCH OUTSIDE THE FEDERAL GUIDELINES. AND ONE ISSUE THAT HAS BEEN COMPLICATED AND UNCERTAIN, BUT HAS PUT OUR MAJOR RESEARCH INSTITUTIONS IN THE POSSIBILITY OF RISK IS THE QUESTION OF WHETHER SPACE CAN BE SHARED BETWEEN RESEARCH THAT IS FEDERALLY FUNDED AND RESEARCH THAT IS OUTSIDE THE FEDERAL GUIDELINES.
BECAUSE OF THIS UNCERTAINTY, MANY INSTITUTIONS HAVE TAKEN THE POSITION THAT THEY CANNOT DO RESEARCH OUTSIDE THE FEDERAL-FUNDED GUIDELINES IN THE SAME SPACE THAT THEY DO FEDERALLY FUNDED WORK. SO THIS HAS BEEN VERY IMPORTANT, AS BOB INDICATED EARLIER.
AND THEN FINALLY, THE SPACE USED FOR RESEARCH OUTSIDE THESE GUIDELINES CANNOT BE SUPPORTED BY INDIRECT COSTS ON FEDERAL GRANTS. SO ALL OF THIS HAS MEANT THAT MOST OF THE RESEARCH BASE THAT INSTITUTIONS CURRENTLY HAVE FOR RESEARCH, WHICH IS BY AND LARGE FEDERALLY FUNDED, NOT ENTIRELY, BUT BY AND LARGE, IS NOT SUITABLE FOR THIS VERY IMPORTANT WORK THAT WE SEE ON HUMAN EMBRYONIC STEM CELLS.
NOW, IN RESPONSE TO THIS, OF COURSE, UNDER BOB KLEIN'S REMARKABLE LEADERSHIP, CALIFORNIA VOTERS PASSED THE CALIFORNIA STEM CELL RESEARCH AND CURES ACT, PROPOSITION 71. AS I'M SURE ALL OF YOU KNOW, IT AUTHORIZES UP TO 295 MILLION A YEAR FOR TEN YEARS TO FUND STEM CELL RESEARCH AT CALIFORNIA RESEARCH INSTITUTIONS. UP TO 10 PERCENT CAN BE SPENT ON FACILITIES. THE PROPOSITION ASSURES THAT THE RESEARCH IS DONE SAFELY AND ETHICALLY, AND IT PROHIBITS THE USE OF FUNDS FOR REPRODUCTIVE CLONING. AND OVER 59 PERCENT OF THE VOTERS IN THE NOVEMBER 2004 ELECTION SUPPORTED THIS, WHICH I THINK IS A REMARKABLE STATEMENT OF WHAT RUSTY REFERRED TO BEFORE AS THE ENORMOUS WELL OF HOPE THAT I THINK PROPOSITION 71 TAPPED INTO WITH RESPECT TO CALIFORNIA VOTERS.
NOW, PROPOSITION 71 THEN ESTABLISHED THE INDEPENDENT CITIZEN'S OVERSIGHT COMMITTEE, OUR BOARD, CHAIRED BY BOB KLEIN. ED PENHOET IS THE VICE CHAIR. AND, OF COURSE, WE HAVE REPRESENTATIVES, PATIENT ADVOCATE REPRESENTATIVES, FROM THAT BOARD ON THIS WORKING GROUP. IT ALSO ESTABLISHED THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE, OF WHICH I'M THE PRESIDENT, AND IT PROVIDES FOR UP TO A 50-MEMBER STAFF FOR THAT INSTITUTE. AND ALL FUNDING DECISIONS AND ALL POLICY DECISIONS ARE MADE BY THE ICOC, AND CIRM IS CHARGED WITH CARRYING OUT AND IMPLEMENTING THOSE DECISIONS.
NOW, CIRM IS AIDED IN ITS WORK BY THREE WORKING GROUPS. AND YOU WILL HEAR MORE ABOUT THESE AS WE GO ON. BUT THE FIRST IS THE STANDARDS AND ETHICS WORKING GROUP, WHICH IS COMPOSED OF ETHICISTS, SCIENTISTS, AND CLINICIANS, AND PATIENT ADVOCATES FROM OUR BOARD, 19 MEMBERS. THE SCIENTISTS AND ETHICISTS ARE CHOSEN FROM ALL OVER THE COUNTRY. THESE ARE NATIONALLY PROMINENT PEOPLE, AND THEY ARE IN THE PROCESS OF, UNDER THE LEADERSHIP OF SHERRY LANSING FROM OUR BOARD, WHO'S NOT WITH US TODAY, AND DR. BERNIE LO, FROM UCSF, THEY'RE IN THE PROCESS OF FORMULATING THE ETHICAL AND MEDICAL STANDARDS BY WHICH THE WORK THAT WE DO WILL BE CARRIED OUT.
THE SECOND WORKING GROUP IS THE GRANTS REVIEW WORKING GROUP, WHICH IS COMPOSED OF 15 SCIENTISTS, NATIONALLY PROMINENT, ALL FROM OUTSIDE OF CALIFORNIA, TO AVOID CONFLICT OF INTEREST. THERE ARE SEVEN PATIENT ADVOCATE MEMBERS ON THAT WORKING GROUP, AND AT LEAST FOUR, I THINK, OF THE PATIENT ADVOCATES ON THIS GROUP ARE ALSO ON THAT GROUP. SO THERE IS USEFUL OVERLAP THERE. AND PLUS BOB KLEIN, OUR CHAIR, IS ON THAT GROUP.
AND THEN FINALLY, THE FACILITIES WORKING GROUP, WHICH YOU KNOW ABOUT.
NOW, LET ME JUST TELL YOU A LITTLE BIT, AND I WON'T DWELL ON THIS AT ANY LENGTH, BUT WE HAVE BEEN VERY MUCH OCCUPIED IN THE FIRST SIX MONTHS OF OUR EXISTENCE, EIGHT MONTHS OF OUR EXISTENCE WITH ADMINISTRATIVE MATTERS. AND I THINK GIVEN THE VARIOUS CHALLENGES THAT WE'VE FACED, MY OWN VIEW IS THAT WE'VE DONE A REMARKABLE JOB IN DOING ALL THIS. THE BOARD HAS BEEN FANTASTIC. WE HAVE CHOSEN THE WORKING GROUP MEMBERS, WE HAVE A HEADQUARTERS SITE SELECTED, AND WE'RE GOING TO MOVE INTO THAT IN A COUPLE OF WEEKS. RIBBON CUTTING NEXT WEEK. WE HAVE HIRED SCIENTIFIC STAFF, AT LEAST MADE A BEGINNING, WITH DRS. CHIU AND SOMBRANO. WE'VE ESTABLISHED CONFLICT OF INTEREST AND MEETING POLICIES, AND THEN WITH THE STANDARDS WORKING GROUP, WE HAVE ADOPTED GUIDELINES FORMULATED BY THE NATIONAL ACADEMY FOR RESEARCH ON HUMAN EMBRYONIC STEM CELLS AS OUR INTERIM REGULATIONS UNTIL WE FORMULATE OUR OWN FINAL REGULATIONS. AND THE POINT OF THE INTERIM REGULATIONS IS THAT IT LET'S US GO AHEAD WITH OUR WORK WHILE WE ARE FORMULATING THE FINAL REGULATIONS, WHICH IS, AS IT TURNS OUT, QUITE A LONG PROCESS.
SCIENTIFICALLY WE HAVE ISSUED OUR -- WE HAVE APPROVED OUR FIRST SERIES OF GRANTS. WE ISSUED A REQUEST FOR APPLICATIONS, AND I'LL TALK MORE ABOUT THAT PROCESS IN A MOMENT. IN MAY THE GRANTS WORKING GROUP REVIEWED 26 APPLICATIONS FOR OUR CIRM TRAINING GRANT PROGRAM, AND THE PURPOSE OF THIS PROGRAM IS TO TRAIN YOUNG SCIENTISTS, BOTH BASIC AND CLINICAL, TO PROVIDE THE WORKFORCE THAT THIS WORK WILL REQUIRE, AND TO GET STARTED THE PIPELINE THAT WILL PROVIDE THE HIGHLY TRAINED WORKERS IN STEM CELL RESEARCH THAT WE WILL NEED.
THIS WAS REVIEWED IN AUGUST AND IN SEPTEMBER THE ICOC APPROVED 16 APPLICATIONS FOR AWARDS. AND WE ARE AWAITING OUR FUNDING, WHICH I THINK YOU'LL HEAR MORE ABOUT FROM BOB IN JUST A MOMENT, BUT WE ARE VERY HOPEFUL THAT WE WILL HAVE THAT SECURED SOON AND CAN ACTUALLY MAKE THOSE AWARDS.
WE ALSO HAD A SCIENTIFIC MEETING ON OCTOBER 1ST AND 2D TO HELP US SET OUR PRIORITIES. THIS WAS A FIRST STEP OF A SCIENTIFIC STRATEGIC PLAN, AT LEAST INFORMATION GATHERING FOR THAT, AND I'LL SAY JUST A WORD ABOUT THAT LATER, BUT I WANTED TO LET YOU KNOW ABOUT IT.
NOW, LET ME END BY THEN TALKING ABOUT THE FACILITIES WORKING GROUP. AND WHAT I'M GOING TO TELL YOU IN THIS SLIDE AND THE NEXT SLIDE IS DERIVED DIRECTLY FROM PROPOSITION 71. AS YOU'VE HEARD, UP TO 10 PERCENT OF THE BOND PROCEEDS ARE ALLOCATED TO BUILD SCIENTIFIC AND MEDICAL RESEARCH FACILITIES OF NONPROFIT ENTITIES. THE FACILITIES WORKING GROUP, IN ADDITION, SHALL "MAKE RECOMMENDATIONS TO THE ICOC ON CRITERIA REQUIREMENTS AND STANDARDS FOR GRANTS AND LOANS FOR BUILDINGS, BUILDING LEASES, AND CAPITAL EQUIPMENT." IN OTHER WORDS, YOU WILL RECOMMEND TO THE ICOC THE CRITERIA THAT YOU WILL USE IN JUDGING THE APPLICATION AND ALSO, AS WE'LL TALK ABOUT LATER, YOU WILL MAKE RECOMMENDATIONS TO THE ICOC FOR THE PROCEDURES THAT YOU WILL USE IN GOING ABOUT THIS BUSINESS, YOUR BUSINESS.
THE PROPOSITION FURTHER SPECIFIES THE STANDARDS THAT THE WORKING GROUP ADOPTS SHOULD INCLUDE FACILITY MILESTONES AND TIMETABLES, PRIORITY FOR FACILITIES AVAILABLE WITHIN TWO YEARS AFTER AWARD. ALL FACILITIES AND EQUIPMENT MUST BE LOCATED IN CALIFORNIA. MATCHING FUNDS OF 20 PERCENT BY THE INSTITUTION ARE REQUIRED. CONSTRUCTION AND LABOR STANDARDS MUST BE MET. AND YOU ARE CHARGED WITH RECOMMENDING PROCEDURES TO ENSURE COMPLIANCE WITH THESE STANDARDS.
SO I THINK I WILL THEN LEAVE IT AT THIS POINT. WE WILL TALK LATER ABOUT HOW THE WORKING GROUP WILL WORK IN THE CONTEXT OF OUR OVERALL GRANTS PROGRAM, BUT FIRST, I'D LIKE TO TURN IT OVER TO OUR CHAIR, BOB KLEIN, TO GIVE YOU A REPORT ON THE ICOC.
CHAIRMAN DOMS: ZACH, BEFORE YOU DO THAT, THANK YOU VERY MUCH. ARE THERE ANY QUESTIONS?
DR. HALL: I'D BE HAPPY TO ANSWER ANY QUESTIONS YOU MAY HAVE.
CHAIRMAN DOMS: THANK YOU.
MR. KLEIN: AS ZACH'S BACKGROUND PRESENTATION SUGGESTS, WE'VE COME A LONG WAYS IN THE FIRST TEN MONTHS WHEN WE REALLY HAD STAFF. ACTUALLY STAFF CAME ABOARD ON JANUARY THE 14TH OF THIS YEAR. AND IN TERMS OF THE TRANSPARENCY OF THIS ORGANIZATION, I'D LIKE TO SPECIFICALLY ACKNOWLEDGE THAT JEFF SHEEHY AND DAVID SERRANO-SEWELL, I THINK, EARLY ON IN ONE OF THE MEETINGS IN APRIL INTRODUCED A RESOLUTION TO REALLY OPEN UP THE HEARINGS WHENEVER WE COULD TO HAVE PUBLIC HEARINGS AND RESTRICT ANY CONFIDENTIAL HEARINGS TO THE VERY NARROW CATEGORY OF CONSIDERATION THAT REQUIRES THOSE TYPES OF HEARINGS. FOR EXAMPLE, FOR THIS COMMITTEE, REAL ESTATE NEGOTIATIONS ON ACQUIRING PROPERTY OR CONSTRUCTION CONTRACTS, VERY SPECIFIC KINDS OF CONSIDERATIONS WOULD BE CONFIDENTIAL HEARINGS.
BUT THE BOARD AND ITS COMMITTEES HAVE HAD OVER 50 PUBLIC HEARINGS SINCE JANUARY THE 15TH, WHICH IS A RECORD FOR THE ESTABLISHMENT OF ANY PUBLIC AGENCY IN CALIFORNIA. THE PATIENT ADVOCATES ON THIS BOARD ONLY TOO WELL KNOW THE TREMENDOUS EFFORT THAT'S GONE INTO HAVING THOSE HEARINGS BECAUSE MANY OF THE PATIENT ADVOCATES HERE SIT ON TWO OR THREE WORKING GROUPS IN ADDITION TO THE BOARD.
IN ACCOMPLISHING THE GOALS OF THIS COMMITTEE, IT'S IMPORTANT TO NOTE THAT DR. ZACH HALL AND DR. ARLENE CHIU WITH MARY MAXON'S HELP AND OTHER STAFF MEMBERS' HELP WHO ARE HERE, GIL'S ASSISTANCE, WE'VE GONE THROUGH A TREMENDOUS GRANT APPLICATION PROCESS AS A MODEL. WE HAD OUR FIRST APPLICATIONS DUE ON JUNE -- THE FIRST APPLICATIONS WERE AVAILABLE FOR OUR INFRASTRUCTURE TRAINING GRANT PROGRAM ON JUNE 1ST. THEY WERE DUE JULY 1ST. PEER REVIEW WAS AUGUST 4TH, AND BOARD APPROVAL WAS SEPTEMBER 9TH.
NOW, AS CERTAINLY EVERYONE KNOWS WHO DEALS WITH THE NIH, THIS IS A GREAT MODEL. WE WILL BE UNDER GREATER CHALLENGES AS WE GO FORWARD TO KEEP UP WITH THAT MODEL, BUT IT WAS A PHENOMENAL PERFORMANCE. AND JOAN SAMUELSON PARTICULARLY SHOULD TAKE GREAT PRIDE IN THAT AS THE CO-CHAIR OF THE GRANTS WORKING GROUP.
WHAT WE HAVE BEFORE US IS A TREMENDOUS CHALLENGE IN TIMING AS WELL BECAUSE, AS DR. HALL MENTIONED, NOT ONLY IS IT INTENDED THAT THE FACILITIES THAT ARE CONSTRUCTED BE CONSTRUCTED IN THE FIRST FIVE YEARS IN ORDER TO GET ONLINE AS SOON AS POSSIBLE THE FACILITIES INDEPENDENCE THAT'S NECESSARY BY OUR RESEARCH INSTITUTIONS TO PROTECT THEM BY CHANGING FEDERAL REGULATIONS, BUT THERE IS BURIED INTO THE INITIATIVE'S CENTRAL DIRECTIVE, AS DR. HALL MENTIONED, A PRIORITY FOR FACILITIES THAT CAN BE BUILT WITHIN TWO YEARS OF A GRANT AWARD.
NOW, AS MEMBERS OF THIS COMMITTEE KNOW AND AS, IN PARTICULAR, OUR CHAIR AND ED KASHIAN KNOW BECAUSE HE WAS, OF COURSE, ON THE UC REGENTS, THAT'S A TREMENDOUS CHALLENGE. AND WE'LL PROBABLY NEED TO HAVE A PARTNERSHIP WITH CITIES TO ACCOMPLISH THAT CHALLENGE. WE'RE JUST COMPLETING OUR FACILITIES HEADQUARTERS, WHICH IS BUILT OUT UNDER A CUSTOMIZED DESIGN, VERY QUICKLY AND WILL BE AVAILABLE FOR US HERE ON NOVEMBER 2D. WE COULDN'T HAVE ACHIEVED THAT TIMETABLE WITHOUT THE TOTAL COOPERATION, LEADERSHIP OF CITY AND COUNTY OF SAN FRANCISCO.
THE COMPETITION THAT WE SPONSORED FOR OUR HEADQUARTERS FORMED A PARTNERSHIP BETWEEN THE CITIES, THEIR CIVIC DONORS, AND THE RESEARCH INSTITUTIONS IN THEIR AREAS TO PUT TOGETHER THE BEST APPLICATION POSSIBLE WITH THE INTENT THAT THERE WOULD BE A FAST TRACK TO IMPLEMENT THOSE HEADQUARTERS PLANS. THAT IS A GOOD MODEL OF THE KIND OF AGGRESSIVE CITY COOPERATION THAT CAN HELP OUR RESEARCH INSTITUTIONS AND OUR UNIVERSITIES GET PAST YEARS OF ZONING DELAYS, ENTITLEMENT ISSUES, TO GET PAST REAL OBSTACLES THAT CAN BE CREATED IF THERE'S NOT A SEPARATE TRACK DESIGNATED TO FAST-TRACK THESE FACILITIES.
AND SO HOPEFULLY WE CAN FOLLOW THAT MODEL BY FORMING COMPETITIVE PARTNERSHIPS WITH THE LOCAL CITIES AND ZONING JURISDICTIONAL GROUPS SO THAT WHEN WE GET AN APPLICATION, WE KNOW THAT THE LOCAL JURISDICTION HAS SIGNED OFF ON THE TIMETABLE AND COMPETITIVELY WE KNOW THEY'RE GOING TO BE ABLE TO PERFORM BECAUSE THEY HAVE THE BACKING OF THE LOCAL JURISDICTION. THEY'RE NOT GOING TO FIGHT THEIR WAY THROUGH BECAUSE OTHERWISE THE TIMETABLES WILL NEVER BE ACHIEVED.
I WOULD REMIND EVERYONE IN THE CONTEXT IN WHICH PROPOSITION 71 WAS WRITTEN THAT 2006 IS AN ELECTION YEAR FEDERALLY. AND THE NIH IS UNDER, AS I REFERENCED EARLIER, AN EXECUTIVE ORDER FROM THE PRESIDENT. THERE IS NO LAW, FEDERAL LAW, THAT PASSED THE HOUSE AND THE SENATE PREVENTING THE NIH FROM PUTTING FUNDS OUT FOR EMBRYONIC STEM CELL RESEARCH ON UNLIMITED LINES. IT'S PURELY AN EXECUTIVE ORDER; AND BECAUSE IT IS AN EXECUTIVE ORDER, IT CAN BE CHANGED OVERNIGHT.
THAT EXECUTIVE ORDER IS BEING IMPLEMENTED THROUGH AN OFFICE OF MANAGEMENT AND BUDGET CLARIFYING MEMORANDA THAT CAN BE CHANGED BY A PHONE CALL FROM THE WHITE HOUSE.
SO IT IS -- WE HAVE AN IMPERATIVE MISSION, PARTICULARLY IN AN ELECTION YEAR WHERE THERE MAY BE SUBSTANTIAL PRESSURE ON THE WHITE HOUSE FROM GROUPS THAT ARE NOT NECESSARILY SUPPORTIVE OF THIS RESEARCH TO PROVIDE SPACE. AS OUR CHAIR AND VICE CHAIR, RUSTY DOMS AND DAVID SERRANO-SEWELL AND THE PRESIDENT ZACH HALL HAVE COMMENTED ON THE POTENTIAL OF AN IMMEDIATE PLAN TO IMPLEMENT A SHARED SPACE PROGRAM, IT IS IMPERATIVE WE PROTECT OUR INSTITUTIONS AND OUR RESEARCHERS FROM PRESSURES THAT MAY EVOLVE VERY QUICKLY, PRECIPITOUSLY WITHOUT ANY LEAD-TIME NOTICE. THIS CAN COME UPON US IN A BLINK OF AN EYE, AND WE NEED TO AGGRESSIVELY FIND A WAY TO PROTECT OUR INSTITUTIONS AND OUR RESEARCHERS TO PUT THEM IN A POSITION WHERE THEY HAVE AN INDEPENDENT BASE TO CONDUCT THE RESEARCH.
BUT IT IS WITH GREAT OPTIMISM THAT I LOOK AT THE GROUP ASSEMBLED HERE. I KNOW THEY ARE UP TO THE TASK. AND CERTAINLY THE LEADERSHIP TO DATE HAS BEEN VERY INSPIRING AS A MODEL. I WOULD ALSO SAY THAT WE ARE OPERATING WITHIN THE CONTEXT OF A RESOLUTION BY THE BOARD ON MAY 23D OF THIS YEAR WHICH SUGGESTED THAT, AS A STRATEGIC CONCERN, IT WOULD BE IMPORTANT TO FIND OUT WHAT THE VARIOUS INSTITUTIONS WERE CONTEMPLATING, WHAT THEY HAD PLANS FOR, WHAT THEY HAD IN CONSTRUCTION BIDDING SO THAT WE CAN MOVE FORWARD WITH A KNOWLEDGE THAT OUR TACTICAL ACTIONS ARE WORKING WITHIN A COMPREHENSIVE SET OF INFORMATION WE UNDERSTAND AS TO WHERE THESE INSTITUTIONS ARE.
NOW, THAT HAS NOT BEEN IMPLEMENTED BECAUSE THE SMALL STAFF OF THE INSTITUTE HAS BEEN WORKING ON THESE 50 PUBLIC MEETINGS, ON SUPPORTING DR. HALL'S INITIATIVE TO CREATE THIS TREMENDOUS MODEL OF A GRANT PROCESS, AND THE STANDARDS PROGRAM. THE OFFICE OF THE CHAIR HAS, AS A COMMITMENT TO THIS, TRIED TO ALLOCATE ALL OF THE CHAIR'S STAFF, TO THE EXTENT REASONABLE AND TO THE EXTENT NEEDED, TO AUGMENT THE STAFF OF THE CIRM TO ACCOMPLISH THESE VARIOUS MISSIONS. AND I THINK THAT THE CHAIR'S STAFF CAN PICK UP THE RESPONSIBILITY TO AT LEAST GET THAT LETTER OUT TO THE INSTITUTIONS, GET THE INFORMATION IN, TURN IT OVER TO THIS COMMITTEE AND DR. HALL SO THEY HAVE AN INFORMATIONAL BASE OF WHAT'S GOING ON IN THE STATE AS WE TRY AND MOVE FORWARD VERY QUICKLY.
I THANK YOU VERY MUCH FOR YOUR SERVICE TO THIS COMMITTEE. I WOULD LET YOU KNOW THAT THE BOARD IS TREMENDOUSLY APPRECIATIVE OF THE EXPERTISE REPRESENTED HERE.
CHAIRMAN DOMS: THANK YOU, BOB. I'D LIKE TO FOLLOW -- ZACH HALL.
DR. HALL: BOB, COULD I ASK YOU, WOULD YOU BE WILLING TO SAY JUST A WORD ABOUT THE LITIGATION AND ITS EFFECT ON OUR FUNDING AND WHEN THE FUNDING SCHEDULE MIGHT BE, WHAT OUR ASPIRATIONS ARE BECAUSE THAT, I THINK, PLAYS INTO WHAT I'M GOING TO BE SAYING LATER. YOU ARE THE ONE WHO SHOULD SPEAK TO THAT.
MR. KLEIN: THERE ARE -- THERE WERE THREE PIECES OF LITIGATION FILED AGAINST THE CIRM. ONE FEDERAL PIECE OF LITIGATION ALLEGING THAT THE MICROSCOPIC EMBRYOS THAT ARE IN IN VITRO FERTILIZATION CLINICS THAT, WHEN DECLARED TO BE EXCESS AND DONATED BY A FAMILY WITH INFORMED CONSENT TO RESEARCH, THAT THEY HAVE CIVIL RIGHTS EVEN THOUGH THEY ARE MICROSCOPIC AND LIMITED TO LESS THAN 14 DAYS OF CELL DIVISION. THAT CASE WAS DISMISSED AS OF APPROXIMATELY MONDAY OF THIS WEEK.
SO WE'RE NOW LEFT WITH TWO CASES THAT ARE STATE-BASED CASES. AND IN AUGUST, THANKS TO THE LEADERSHIP OF JAMES HARRISON AND THE ATTORNEY GENERAL'S OFFICE, WE WERE ABLE TO CONSOLIDATE THOSE TWO CASES INTO ONE CASE IN ALAMEDA COUNTY WITH EXPEDITED TREATMENT UNDER THE CASE. NEVERTHELESS, IT MAY BE A YEAR BEFORE WE'RE THROUGH ALL OF THE APPEALS, PARTICULARLY NOTING THAT THE OPPOSING COUNSEL WAS ACTIVE IN THE TERRY SCHIAVO CASES. THEY'RE RELIGIOUSLY BASED OPPOSITION COUNSEL. AND THEY ARE IDEOLOGICALLY COMMITTED TO THE OPPOSITION.
WITH THAT IN MIND, WE HAVE A BOND ANTICIPATION NOTE PROGRAM WHICH HAS TWO-YEAR BOND ANTICIPATION NOTES THAT SPECIFICALLY CARRY A LITIGATION DISCLOSURE. THAT LITIGATION DISCLOSURE EFFECTIVELY SAYS THAT IF, IN FACT, WE WERE NOT TO WIN THESE CASES, YOU WOULD NOT BE REPAID ON THESE BOND ANTICIPATION NOTES. SO EFFECTIVELY THE PARTIES WHO WE'RE DISCUSSING THE PURCHASE OF THESE BOND ANTICIPATION NOTES ARE INDIVIDUALS WITH SUBSTANTIAL RESOURCES, WHO HAVE A CHARITABLE HISTORY OF DONATING TO MEDICAL AND SCIENTIFIC MISSIONS, AND PHILANTHROPIC FOUNDATIONS THAT HAVE A CHARITABLE HISTORY BECAUSE THEY KNOW THAT ONCE THEY BUY THESE BOND ANTICIPATION NOTES, THEY WILL HAVE ACCOMPLISHED THEIR PRIMARY MISSION, AND THEY HAVE THE UNPRECEDENTED CHARITABLE OPPORTUNITY OF GETTING THEIR MONEY BACK SO THEY CAN DO ADDITIONAL GREAT GOODS ON A CHARITABLE BASIS.
IT IS OUR HOPE THAT IN DECEMBER WE COULD GO OUT WITH THE FIRST BOND ANTICIPATION NOTE OFFERING, BUT IT IS SIZED CURRENTLY TO DEAL WITH THE INFRASTRUCTURE TRAINING GRANTS AND THE POTENTIAL OF A PROGRAM STILL TO BE CONSIDERED BY THE BOARD FOR SEED MONEY INNOVATION GRANTS OR SOME OTHER PURPOSE THE BOARD SO DESIGNATES. WE WOULD HAVE TO GO TO A SECOND FUNDING ROUND TO FUND FACILITIES. AND OBVIOUSLY THESE ARE PLACED ON A CUSTOMIZED BASIS. UNTIL ABOUT 30 DAYS AGO, WE THOUGHT WE WERE GOING TO FUND JUST THE FIRST 18 MILLION, WHICH WAS A SIMPLER TASK. WE'VE TAKEN ON THIS TASK OF FUNDING THE FIRST TWO PROGRAMS WITH THE FIRST BAN OFFERING IN ORDER TO MAKE IT A CLEAR MESSAGE TO THE IDEOLOGICAL RIGHT THAT WHEN THE PUBLIC IN CALIFORNIA MANDATES A PROGRAM OF VITAL SIGNIFICANCE TO THE PATIENTS AND FAMILIES OF THIS STATE, THAT THE LEGAL SYSTEM CANNOT BE ABUSED TO SHUT DOWN MEDICAL AND SCIENTIFIC FUNDING.
CERTAINLY WITH A $50 MILLION MESSAGE, SOME OF OUR SUPPORTERS AND THE PUBLIC BELIEVE WE WILL HAVE COMMUNICATED MORE THOROUGHLY TO THE IDEOLOGICAL RIGHT THAT THIS WILL NOT BE A SUCCESSFUL APPROACH FOR THEM TO GO AGAINST THE STATE OR OUR UNIVERSITIES OR RESEARCH INSTITUTIONS TO TRY AND STOP VITALLY NEEDED PROGRAMS.
THE OTHER OPTION, OF COURSE, FOR THE FACILITIES GROUP, WHICH HAS BEEN BROUGHT UP PREVIOUSLY BY INSTITUTIONS IN THE STATE, IS THERE APPEARS TO BE INSTITUTIONS THAT ARE DOWNSTREAM ON DEVELOPING PLANS WHERE THEIR TRUSTEES OR BOARD MEMBERS OF THOSE INSTITUTIONS WOULD POTENTIALLY BE WILLING, IF THEY HAD A CONDITIONAL COMMITMENT FOR FACILITIES, TO GO OUT AND ISSUE BONDS AND GET GAP LOANS TO COVER POTENTIAL CHARITABLE CONTRIBUTIONS BECAUSE THEY FEEL THEY HAVE SUCH AN OUTSTANDING INSTITUTIONAL PROPOSAL, THEY'RE WILLING TO TAKE A RISK ON WHETHER THEY WOULD EVER GET A GRANT FROM THIS BOARD ON A PURELY COMPETITIVE BASIS.
NOW, CERTAINLY THAT'S AN AREA THAT NEEDS TO BE EXAMINED THOROUGHLY BY THIS COMMITTEE, BUT THERE IS THE POTENTIAL THAT THERE CAN BE FACILITIES BUILT WHERE RESEARCH INSTITUTIONS ARE TAKING A PURE RISK ON WHETHER OR NOT THEY WOULD BE ABLE TO QUALIFY. I THINK THAT THE PROCESS THAT THEY'VE COMMUNICATED WITH THE BOARD ABOUT IS THAT THEY'D LIKE TO KNOW IF THERE CAN BE A ROUND OF GRANT REVIEWS WHERE WE CAN GIVE THEM A CONDITIONAL COMMITMENT WHICH SAYS IF WE WIN OUR LITIGATION, WE WOULD THEN PROVIDE A GRANT FOR YOU. AND THEY WOULD TAKE THE RISK OF WHETHER OR NOT WE WOULD WIN THE LITIGATION.
MR. SERRANO-SEWELL: ON THE FACILITIES SIDE?
MR. KLEIN: ON THE FACILITIES SIDE. I WILL POINT OUT TO YOU THAT AN AMICUS BRIEF WAS JUST FILED IN THE LITIGATION. MUNGER, TOLLS & OLSON, WHICH IS THE LAW FIRM THAT'S FAMOUS BECAUSE CHARLIE MUNGER REPRESENTS WARREN BUFFET, AMONG MANY CLIENTS, HAS VOLUNTEERED FIVE ATTORNEYS, PARTNERS, TO REPRESENT THE AMICUS PARTIES, AND THE AMICUS PARTIES REPRESENT 15 PATIENT ADVOCACY ORGANIZATIONS, AS WELL AS ABOUT 15 INSTITUTIONS IN THE STATE, FROM THE SALK INSTITUTE TO THE CITY OF HOPE TO CHILDREN'S HOSPITAL OF L.A. TO STANFORD TO USC.
AND ALL OF THEIR ATTORNEYS, ALL OF THESE INSTITUTIONS' ATTORNEYS, HAVE LOOKED AT THE LITIGATION IN-DEPTH. SO THEY'VE REACHED A CONCLUSION THAT THEY HAVE ENOUGH CONFIDENCE IN THIS LITIGATION, THEY WANT TO JOIN US AS AMICUS PARTIES. THAT ALSO WOULD TEND TO INDICATE THAT POTENTIALLY THEIR COUNSEL BELIEVE ENOUGH ABOUT THE OUTCOME, THAT THEY MIGHT BE WILLING TO ADVISE THEIR CLIENTS THAT IF THEY WERE TO GET A CONDITIONAL COMMITMENT FOR A FACILITIES GRANT FROM THIS GROUP, THEY MIGHT BE WILLING TO PROCEED AT THEIR RISK, SOLELY AT THEIR RISK, WITH BOND ISSUES TO FINANCE THEIR FACILITIES, POTENTIALLY HAVING SOME BACKUP COMMITMENTS FOR ADDITIONAL EQUITY FROM THEIR DONORS IF, IN FACT, WE WERE NOT SUCCESSFUL.
WE, OF COURSE, BELIEVE WE WILL BE SUCCESSFUL. THEIR ATTORNEYS BELIEVE WE WILL BE SUCCESSFUL AND HAVE AUTHORIZED THEIR ORGANIZATIONS TO JOIN AN AMICUS BRIEF, BUT WE WILL AT THIS POINT JUST SAY WE'RE HIGHLY COMMITTED TO A POSITIVE OUTCOME IN THE LITIGATION. AND WE ARE VERY OPTIMISTIC, BUT NOTHING IN LIFE CAN BE GUARANTEED. THANK YOU.
CHAIRMAN DOMS: THANK YOU, BOB.
MR. LICHTENGER: I JUST WANTED TO MAKE TWO COMMENTS, MAYBE A LITTLE PREMATURE, BUT I WOULD AGREE WITH BOB, THAT IT WOULD BE A VERY HIGH PRIORITY TO HAVE THAT SURVEY CONDUCTED ABOUT WHAT IS OUT THERE IN THE PIPELINE.
AND IN TERMS OF FACILITATING THE BUILDING OF THESE FACILITIES, I WOULD MAKE MENTION THAT TWO YEARS WOULD ACTUALLY BE GENEROUS IF WE WERE ABLE TO FIND LOCATIONS WHERE THERE ARE EXISTING BUILDINGS AND THEY JUST NEEDED TO BE RETROFITTED. SO THAT IT'S QUITE POSSIBLE IT CAN BE DONE WELL UNDER A YEAR DEPENDING ON WHAT LOCATION AND THE CONDITION OF THE EXISTING BUILDING.
AND ALSO JUST MAKING MENTION AND TOUCHING BASE ON WHAT BOB MENTIONED, IF SOME OF THESE FACILITIES AND THE LOCATIONS HAVE THE RIGHT TO BUILD WITHOUT HAVING ZONING CHANGES, OBVIOUSLY THAT'S A LARGE PART OF THE DELAYS THAT WILL OCCUR, ESPECIALLY IF THERE'S NEW BUILDING CONSTRUCTION.
CHAIRMAN DOMS: THANK YOU, DAVID. BOB, I'VE ALSO HEARD THAT SENATOR BROWNBACK HAD SOME LEGISLATION THAT COULD IMPACT US. ONE, IF THAT'S TRUE, COULD YOU GIVE US --
MR. KLEIN: CERTAINLY. IN THE HOUSE IT'S CONGRESSMAN WELDON, IN THE SENATE IT'S SENATOR BROWNBACK WHO HAVE COMPLEMENTARY LEGISLATION WHICH WOULD CRIMINALIZE THIS AREA OF RESEARCH. IN ADDITION, THE HOUSE BILL REALLY SHOWS MORE ON A MORE TRANSPARENT BASIS THE FULL INTENTIONS. IT WOULD NOT ONLY CRIMINALIZE EMBRYONIC STEM CELL RESEARCH, BUT THE WELDON BILL, WHICH PASSED THE HOUSE IN 2002 AND 2003, SAYS THAT IF I WERE TO TAKE MY 15-YEAR OLD SON WHO HAS JUVENILE DIABETES, FOR EXAMPLE, TO CANADA OR ENGLAND OR NOW MAYBE SOUTH KOREA FOR TREATMENTS, AND IF I WERE TO THEN COME BACK INTO THE UNITED STATES, BECAUSE OF ENCODED LANGUAGE, WHICH AS A LAWYER, I CAN READ FAIRLY WELL, I HAD PARTICIPATED IN THAT TREATMENT, I WOULD BE SUBJECT TO ARREST AT THE BORDER.
ADDITIONALLY, THE PATIENT WOULD BE IN A SITUATION WHERE IF THEY HAD PAID ANYONE TO ADVISE THEM IN THE PROCESS, MEANING A DOCTOR, THE DOCTOR WOULD BE SUBJECT TO A MILLION-DOLLAR FINE MINIMUM AND IMPRISONMENT.
AND FINALLY, THERE'S AN IMPORTATION CLAUSE THAT SAYS THAT YOU CANNOT IMPORT THE TREATMENT, INCLUDING IMPORTING IT IN ANY BODY. THAT MEANS I CAN'T BRING MY CHILD BACK INTO THE UNITED STATES BECAUSE THEY WOULD HAVE THE TREATMENT IN THEIR BODY. SO IT'S A VERY DRACONIAN BILL, VERY MUCH OUTSIDE OF THE TRADITION OF THE UNITED STATES OF RESPECTING THE RIGHTS OF FAMILIES TO SEARCH OUT AND OBTAIN THE BEST TREATMENT FOR THEIR CHILDREN OR THEIR PARENTS OR THEIR SPOUSES, WHETHER IT'S IN THIS COUNTRY OR OUTSIDE THIS COUNTRY.
AND IN THE HOUSE THIS YEAR, WE WERE ABLE TO STOP THAT BILL IN COMMITTEE. THE WELDON BILL WAS KILLED ON A 36 TO 29 VOTE. LAST YEAR WE WERE ONLY ABLE TO STOP IT BECAUSE NANCY REAGAN SPOKE OUT AND REALLY LED THE HOUSE TO REEXAMINE WHAT THE BILL SAID.
IN THE SENATE, IN ORDER TO BRING THE CASTLE/DEGETTE BILL TO A VOTE, THE CASTLE/DEGETTE BILL AUTHORIZED MORE EMBRYONIC STEM CELL RESEARCH, IT NEEDS A UNANIMOUS CONSENT RESOLUTION IN THE SENATE IN ORDER TO AVOID FILIBUSTERS OR OTHER PROBLEMS IN THE SENATE. AND SENATOR BROWNBACK HAS SAID HE WILL NOT AGREE TO THE UNANIMOUS CONSENT RESOLUTION UNLESS HIS BILL IS THE ONLY BILL THAT WOULD BE CONSIDERED TO PROHIBIT HUMAN REPRODUCTIVE CLONING.
NOW, THAT MEANS IF YOU WANT TO VOTE AGAINST HUMAN REPRODUCTIVE CLONING IN THE UNITED STATES, HE WANTS YOU TO ONLY HAVE THE CHOICE OF VOTING AGAINST HUMAN REPRODUCTIVE CLONING IF YOU WOULD ALSO OUTLAW SOMATIC CELL NUCLEAR TRANSFER, WHICH IS WHAT IN THE BROWNBACK BILL.
IT'S OUR UNDERSTANDING THAT, BECAUSE OF HIS POSITION, THAT WILL NOT COME UP FOR A VOTE THIS YEAR. BUT IT DOES EMPHASIZE THE PRESSURE WE'RE UNDER TO MOVE FORWARD VERY QUICKLY. IF THEY WERE TO OUTLAW SOMATIC CELL NUCLEAR TRANSFER, IT WOULD CUT OFF A CRITICAL ELEMENT OF THE TECHNOLOGY JUST RECENTLY ADVANCED BY SOUTH KOREA THAT HELPS IMPLEMENT THE KNOWLEDGE WE GAIN FROM EMBRYONIC STEM CELL RESEARCH. IT WOULD NOT ITSELF STOP THE EMBRYONIC STEM CELL RESEARCH, BUT WOULD CRITICALLY IMPACT WHAT THE INSTITUTIONS COULD CARRY OUT IN TRANSLATIONAL MEDICINE TO ADVANCE THERAPIES.
CHAIRMAN DOMS: WE DO HAVE SOME CHALLENGES. DAVID.
MR. SERRANO-SEWELL: I THOUGHT YOU GAVE AN ABRIDGED VERSION OF WHAT WE'VE DONE SO FAR, BOB. THERE'BEEN A LOT MORE, AND THE ONLY OTHER THING I WANTED TO MENTION WAS, AND YOU MAY HAVE TOUCHED ON THIS, BUT WE APPOINTED MEMBERS TO OUR WORKING GROUPS, WHICH TOOK A LOT OF WORK. IT'S AN INCREDIBLE AMOUNT OF RESEARCH AND SEARCH THAT WENT ON. BEFORE OUR MEETINGS WE HAVE THE DISEASE SPOTLIGHTS, WHICH TAKES A LOT OF STAFF TIME TO DO A GOOD JOB. I THINK THOSE ARE IMPORTANT AS WELL.
YOU MENTIONED THAT WE'VE LOCATED OUR HEADQUARTERS HERE IN SAN FRANCISCO. THAT WAS A BIG BUILDUP AND PROCESS, HIGHLY COMPETITIVE, WE REALLY GOT A GOOD DEAL, WE'RE OPENING IT NEXT WEEK OR HAVING OPEN HOUSE. WENT THROUGH A PRESIDENTIAL SEARCH, HIRED ZACH. IN THIS PAST 11 MONTHS, WE'VE ACCOMPLISHED A GREAT DEAL. AND I ALSO WANTED TO TOUCH ON THOSE OTHER THINGS AS WELL.
MR. KLEIN: I WAS TRYING TO BE CAREFUL ABOUT RESPECTING THE TIME, BUT I WOULD ALSO SAY THAT THROUGH THE WORK OF JOAN SAMUELSON, JEFF SHEEHY, JANET WRIGHT, YOURSELF, THERE'S BEEN A TREMENDOUS OUTREACH TO THE STATE LEGISLATURE TO TRY AND HELP THEM UNDERSTAND OUR MISSION, OUR DEDICATION, AND SOME OF THE THINGS THAT ARE CRITICAL TO OUR PROCESS, LIKE PEER REVIEW. AND WE THINK WE MADE SOME MAJOR STRIDES IN WORKING OUT A GOOD EFFECTIVE PARTNERSHIP WITH THE LEGISLATURE, THANKS TO THE PATIENT ADVOCATES ON THIS GROUP IN PARTICULAR.
CHAIRMAN DOMS: THANK YOU, DAVID. THANK YOU, BOB. OUR NEXT AGENDA ITEM IS AN INFORMATIONAL OVERVIEW OF THE CIRM GRANTS FACILITIES WORKING GROUP AND SHARED SPACE RFA'S. TURN THAT OVER TO ZACH.
DR. HALL: THANK YOU, RUSTY. WHAT I WANTED TO DO IN THIS PART OF THE MEETING IS TO GIVE YOU AN OVERALL PERSPECTIVE OF OUR GRANTS PROGRAM AND TO BEGIN THE DISCUSSION OF HOW THE FACILITIES WORKING GROUP WILL FUNCTION WITHIN THAT PROGRAM.
AS YOU HEARD EARLIER, ONE OF YOUR TASKS WILL BE TO DISCUSS WHAT CRITERIA AND STANDARDS THAT YOU WILL USE IN YOUR WORK AND THEN TO MAKE RECOMMENDATIONS TO THE ICOC FOR THOSE. YOU WILL ALSO NEED TO MAKE RECOMMENDATIONS THE ICOC ON THE PROCEDURES THAT YOU WILL USE AND THE BYLAWS BY WHICH YOU GOVERN YOURSELVES IN THIS MEETING. THIS WORKING GROUP HAS THE ADVANTAGE THAT IT IS THE THIRD OF OUR WORKING GROUPS TO GET STARTED; AND SO ON SOME OF THESE MATTERS, YOU HAVE TWO EXAMPLES OF WORKING GROUPS ALREADY THAT HAVE GONE THROUGH THESE EXERCISES SO THAT YOU CAN USE SOME OF THIS MATERIAL AS A BEGINNING TEMPLATE FOR YOUR DISCUSSIONS. IT'S NOT MEANT TO PRESCRIBE OR LIMIT YOU IN ANY WAY, BUT SIMPLY TO HELP YOU AND GET STARTED.
AS I MENTIONED BEFORE, THE PATIENT ADVOCATE MEMBERS, IN PARTICULAR, ON THE GRANTS COMMITTEE, AND JOAN IS THE VICE CHAIR OF THAT COMMITTEE, SO WE HAVE THAT SORT OF EXPERTISE BEHIND US. AND WE DO WANT WHEREVER POSSIBLE TO MAKE OUR PROCEDURES UNIFORM ACROSS. IF THERE ARE GOOD REASONS TO CHANGE THEM, WE'RE HAPPY TO DO THAT.
LET ME BEGIN, HOWEVER, BY JUST EXPLAINING FOR THOSE WHO MAY BE NEW TO THE WORLD OF SCIENTIFIC GRANT-MAKING HOW WE, IN PARTICULAR, ALSO REPRESENTATIVES OF OTHER INSTITUTIONS IN MANY WAYS, HOW WE DO OUR BUSINESS IN TERMS OF MAKING GRANTS. AND THE FACILITIES GRANTS WILL BE ONE ASPECT OF THIS.
FOR ANY GRANTS PROGRAM, WE START WITH A DECISION THAT WE WANT TO INVITE GRANTS FOR A PARTICULAR PURPOSE. AND USUALLY THAT MAY BE FOR A RESEARCH PURPOSE, BUT IT MAY HAVE A FACILITIES COMPONENT OR IT MAY BE FOR A FACILITIES GRANT, BUT WE SPECIFY IN THE RFA WHAT WE WANT. FOR EXAMPLE, THE TRAINING GRANT RFA SAID WE WANT APPLICATIONS FOR TRAINING GRANT PROGRAMS.
THE CIRM THEN BRINGS A PROPOSAL TO THE ICOC FOR ITS APPROVAL FOR THE RFA; AND IF THE ICOC APPROVES, THE CIRM THEN ISSUES AN RFA TO CALIFORNIA INSTITUTIONS AND ON ITS WEB SITE.
WHAT'S IN THE RFA? THE RFA SPECIFIES THE PURPOSE FOR WHICH WE'RE SEEKING APPLICATIONS, HOW WE INTEND TO STRUCTURE THE GRANTS; THAT IS, WHAT KINDS OF BUDGET CATEGORIES WE WOULD RECOMMEND, WHAT WE WANT IN THE APPLICATION FOR THE TRAINING GRANTS. FOR EXAMPLE, WE SPECIFIED THAT AT LEAST TWO DIFFERENT KINDS OF COURSES MUST BE GIVEN IN THE APPLICATION, ONE ON THE SCIENCE AND ONE ON THE ETHICAL ISSUES INVOLVED. WE TELL THEM IN THE RFA WHAT INFORMATION THEY NEED TO PROVIDE, HOW THE APPLICATIONS WILL BE EVALUATED, WHAT WE WILL REQUIRE OF THE GRANTEES, AND WHAT RESTRICTIONS, INCLUDING THE BUDGET, THERE MAY BE ON WHAT IS OFFERED. WE MAY SAY YOU MAY APPLY FOR GRANTS UP TO THIS AMOUNT OF MONEY FOR THIS PARTICULAR PURPOSE. IF IT WERE A FACILITIES GRANT, WE MIGHT PUT A LIMIT ON THE SIZE OR OTHER RESTRICTIONS ABOUT HOW THE SPACE WOULD BE USED AS PART OF THE RFA.
IN GENERAL, THEN, WE ASK ALSO ANYBODY WHO WANTS TO SEND IN AN APPLICATION TO SUBMIT A SO-CALLED LETTER OF INTENT. THAT IS TO LET US KNOW BY A CERTAIN DATE IF THEY INTEND TO SUBMIT AN APPLICATION. THIS IS VERY HELPFUL TO US BECAUSE, FIRST OF ALL, IT TELLS US HOW MANY APPLICATIONS WE'RE LIKELY TO HAVE. AND SECONDLY, IT ALSO SOMETIMES WARNS US AHEAD OF TIME IF THERE ARE COMPLICATIONS THAT WE CAN HEAD OFF AT AN EARLY STAGE.
THE APPLICATIONS ARE THEN RECEIVED AT A DEADLINE DATE. THEY'RE EXAMINED BY CIRM STAFF TO BE SURE THAT THEY MEET THE REQUIREMENTS THAT WE SPECIFIED. AND THEN THEY'RE DISTRIBUTED TO THE WORKING GROUP FOR REVIEW. AND THAT IS DONE EITHER BY CIRM STAFF WITH HELP FROM THE CHAIR, IN THIS CASE, I EXPECT, BECAUSE YOU ARE MORE EXPERIENCED THAN WE ARE IN THESE MATTERS, THAT THAT DISTRIBUTION WOULD BE MADE BY THE CHAIR WITH THE ASSISTANCE OF CIRM AS NEEDED.
THE WORKING GROUP THEN MEETS AND, ACCORDING TO PROCEDURES THAT WE WILL DISCUSS IN DETAIL LATER, UNDER DISCUSSION LED BY RUSTY AND DAVID, THE APPLICATION IS GIVEN A SCORE, AND THEN THE WORKING GROUP MAKES A RECOMMENDATION TO THE ICOC. AND THEN AS I INDICATED, THE ICOC MAKES ANY FINAL DECISION ABOUT APPROVAL FOR GRANT AWARDS.
NOW, YOU MIGHT ASK AT THIS POINT HOW DO WE DECIDE WHAT THE TOPIC OF THE RFA IS AND WHEN WE ISSUE THEM. THE RFA'S ARE EXTREMELY IMPORTANT BECAUSE THEY'RE THE PRINCIPAL WAY IN WHICH WE SHAPE OUR RESEARCH PROGRAM IN ORDER TO ATTAIN THE GOAL WHICH WE ALL SHARE OF USING STEM CELL RESEARCH TO DEVELOP THERAPIES FOR DISEASE. AND SO WE WANT THE RFA'S IN GENERAL TO BE PART OF A LARGER SPECIFIC PLAN, STRATEGIC PLAN, THAT WE HAVE.
SO WE ARE NOW ABOUT TO BEGIN AND HAVE BEGUN IN ONE SENSE A PROCESS FOR FORMULATING A LONG-TERM SCIENTIFIC STRATEGIC PLAN. AND THIS WILL BE A JOINT PROJECT BETWEEN THE CIRM AND THE ICOC. WE HAVE HAD A FIRST STEP IN OUR INFORMATION GATHERING WITH THE SCIENTIFIC MEETING THAT WAS HELD ON OCTOBER 1ST AND 2D. AND I KNOW RUSTY WAS IN ATTENDANCE AT THAT MEETING, WHICH WE APPRECIATED VERY, VERY MUCH. WE EXPECT TO DEVELOP THE PLAN OVER THE NEXT SIX MONTHS OR SO.
NOW, IN THE MEANTIME, WHILE WE ARE DEVELOPING THAT SORT OF OVERARCHING AND LARGE-SCALE PLAN, WHICH WILL SPECIFY OVER A PERIOD OF TIME HOW WE INTEND TO DEVELOP OUR PROGRAM, THERE ARE A NUMBER OF STRATEGIC NEEDS THAT SHOULD BE MET FAIRLY IMMEDIATELY. AND WE HAVE NOT TAKEN THESE FORMALLY TO THE ICOC, ALTHOUGH WE HAVE HAD INFORMATION -- WE HAVE GIVEN INFORMATION TO THE ICOC ABOUT THE THOUGHT THAT WE HAVE BEEN THINKING ABOUT THIS, BUT LET ME POINT OUT AT THE BEGINNING THEY HAVE NOT BEEN APPROVED, SO WHAT I'M GOING TO PRESENT TO YOU IS THE PROPOSAL AND THE DISCUSSION THAT WE HAVE HAD AND WHAT WE PRESENTED FOR INFORMATIONAL PURPOSES TO ICOC, BUT NO DECISIONS HAVE BEEN MADE FINALLY.
AND SO WE SEE -- BOB KLEIN, I SHOULD SAY, WAS VERY INSTRUMENTAL IN HELPING US TO FORMULATE THESE. IN FACT, THEY WERE, IN FACT, IN SOME CASES HIS IDEAS, QUITE CLEARLY, BUT THERE ARE TWO CLEAR AND IMMEDIATE NEEDS THAT I THINK ARE VERY IMPORTANT, AND WE ARE ALL AGREED.
ONE ARE SO-CALLED INNOVATION OR STARTER GRANTS THAT WOULD GET THE WORK GOING WITH AN EMPHASIS ON GIVING PEOPLE GRANTS THAT THEY COULD GET PRELIMINARY EVIDENCE FOR PARTICULAR IDEAS, GRANTS THAT MIGHT LET PEOPLE ESTABLISH INVESTIGATORS OUTSIDE THE FIELD GET A START, BUT AT ANY RATE, SOMETHING TO GET IT GOING WITH A SMALL AMOUNT OF MONEY OVER A SHORT PERIOD OF TIME, SORT OF LIKE IGNITING AN ENGINE. WE GIVE A LITTLE SPARK HERE AT THE BEGINNING TO SET THINGS OFF.
AND THEN BOB MENTIONED THAT WE HAVE A REAL CHALLENGE IN THAT WE NEED, PARTICULARLY FOR HUMAN EMBRYONIC STEM CELL WORK OUTSIDE THE FEDERAL GUIDELINES, WHICH WE HAVE A PARTICULAR INTEREST BECAUSE OF THE DEFECTION BASICALLY OF THE FEDERAL GOVERNMENT FROM THIS AREA, THIS PROMISING AREA, WE NEED TO PROVIDE SPACE TO LET SOME OF THIS WORK GO ON.
SO WHAT WE HAVE PROPOSED, THEN, OR WILL PROPOSE, WHAT WE'VE BEEN DISCUSSING ARE THREE RFA'S. AND LET ME DESCRIBE TO YOU HOW THEY WOULD BE PHASED. FIRST OF ALL, WE WOULD HAVE AN RFA FOR INNOVATION GRANTS. AND AS I SAY, THESE WOULD BE RELATIVELY SMALL AMOUNTS OF MONEY. WE ARE IMAGINING RIGHT NOW ON THE ORDER OF A COUPLE HUNDRED THOUSAND DOLLARS. THEY WOULD BE FOR TWO YEARS, AND THEY WOULD BE FOR STEM CELL RESEARCH OUTSIDE THE FEDERAL GUIDELINES. AND THIS COULD START IMMEDIATELY, AND THERE ARE SOME INVESTIGATORS WHO ARE ALREADY DOING WORK OUTSIDE THE FEDERAL GUIDELINES THAT IS SUPPORTED EITHER BY PRIVATE DISEASE FOUNDATIONS OR SUPPORTED BY THE HOWARD HUGHES. SO THEY HAVE AVAILABLE TO THEM SPACE IN THEIR OWN LABS THAT THEY'VE SET ASIDE AS NONFEDERAL RESEARCH SPACE.
AND WE THINK THERE ARE ENOUGH OF THEM OUT THERE THAT WE COULD ASK FOR INNOVATION GRANTS AND GET THOSE STARTED WITHOUT ANY OTHER EFFORT ON OUR PART.
DO YOU HAVE A QUESTION, DAVID?
MR. SERRANO-SEWELL: JUST A CLARIFICATION, ZACH. FOR THE INNOVATION, YOU MAY HAVE ALREADY SAID THIS, BUT FOR INNOVATION 1 RFA, INNOVATION 2 RFA, THOSE WILL BE THE GRANTS WORKING GROUP?
DR. HALL: YES. YES. ABSOLUTELY.
MR. SERRANO-SEWELL: SHARED SPACE WILL BE THE FACILITIES GROUP.
DR. HALL: I PRESENT THIS BECAUSE I WANT YOU TO UNDERSTAND HOW YOUR SHARED SPACE RFA THAT WE HOPE WE WILL BE ABLE TO CARRY FORWARD FITS INTO AN OVERALL PLAN THAT WE HAVE. IT'S NOT OUT THERE ON ITS OWN.
SO WE GET INNOVATION 1 OFF RIGHT AWAY. THEN WE SEE THE NEXT NEED IS TO HAVE WHAT WE CALL AN RFA FOR SHARED SPACE; THAT IS, TO SUGGEST THAT WE WOULD ACCEPT APPLICATIONS FROM INSTITUTIONS WHO WISH TO DEVELOP SOMETHING ON THE ORDER OF 2,000 TO 4,000 SQUARE FEET OF SPACE THAT WOULD BE DEDICATED TO HUMAN EMBRYONIC STEM CELL WORK. I'M SORRY. I LEFT OUT THE EMBRYONIC. THAT WOULD BE A SPACE IN WHICH WORK OUTSIDE THE FEDERAL GUIDELINES COULD GO ON. AND BECAUSE THAT'S A RELATIVELY SMALL AMOUNT OF SPACE, IT WOULD NEED TO BE SHARED. WE WOULD NOT WANT IT TO BELONG JUST TO ONE PERSON. AND THERE MAY EVEN BE A NEED, WHICH WE CAN DISCUSS LATER, FOR INSTITUTIONAL SHARING WITHIN A PARTICULAR REGION THAT WE COULD WRITE INTO THE RFA. THAT IS, IF WE GET A GRANT LIKE THIS, YOU'RE REQUIRED NOT ONLY TO MAKE IT AVAILABLE TO PEOPLE WITHIN YOUR INSTITUTION, BUT WITH OTHER SMALL INSTITUTIONS IN YOUR AREA SO THAT PEOPLE WHO WANT TO DO THIS WORK COULD COME AND DO IT.
LET ME JUST SAY THAT THIS WORK IS QUITE -- IT'S NOT ROUTINE TO WORK ON HUMAN EMBRYONIC STEM CELLS. THEY'RE HARD TO CULTURE. THERE'S A CONSIDERABLE TECHNICAL ART INVOLVED. AND WHAT WE ENVISAGE WOULD BE HAVING SPACE WITH NECESSARY BASIC EQUIPMENT; THAT IS, INCUBATORS, HOODS, STERILE HOODS, FREEZERS, MICROSCOPES, THE BASIC KIND OF SPACE TO LET YOU DO THAT WORK. AND WE PROBABLY WOULD PROVIDE FUNDS TO STAFF THAT FOR A PERIOD OF SEVERAL YEARS. THAT IS, WE WOULD HAVE A HIGH LEVEL TECHNICIAN THERE WHO COULD TEACH PEOPLE HOW TO HANDLE THESE CELLS AND WHO WOULD BE AVAILABLE FOR TECHNICAL WORK.
AND WE IMAGINE THAT THEY WOULD BE USED IN THE FOLLOWING WAYS. LET'S SUPPOSE A VERY WELL-ESTABLISHED AND EXCELLENT INVESTIGATOR WHO IS A DEVELOPMENTAL BIOLOGIST OR WHO MIGHT BE A CELL BIOLOGIST OR MIGHT EVEN BE MORE FAR AFIELD, A TISSUE ENGINEER NOT WORKING WITH HUMAN EMBRYONIC STEM CELLS MIGHT SAY, GEE, THIS LOOKS PROMISING. AND I HAVEN'T GONE INTO THIS BECAUSE THERE'S NO FEDERAL MONEY AND I DON'T REALLY HAVE SPACE IN MY LAB, BUT I HAVE A GREAT IDEA FOR THIS. WHAT I'D LIKE TO DO IS TO GET A GRANT, AND THEN HAVE A TECHNICIAN OR POSTDOCTORAL FELLOW DO THAT WORK IN THE SHARED SPACE UNDER THE EYE OF THE TECHNICIAN. AND THEN IF THIS PANS OUT, THEN I WOULD LIKE TO COME BACK FOR A MAJOR GRANT TO THE INSTITUTE. AND THAT IS, OF COURSE, THE SORT OF THING WE WOULD LOVE TO HAVE HAPPEN TO ATTRACT TALENTED PEOPLE TO THIS FIELD. AND PARTICULARLY IF THEY HAVEN'T BEEN WORKING IN IT, THEY DON'T HAVE NONFEDERAL SPACE BECAUSE THIS IS VERY UNUSUAL THAT YOU HAVE TO HAVE SPACE THAT CAN'T BE USED FOR FEDERAL FUNDS.
SO WE WOULD THEN HAVE AN RFA TO DEVELOP THAT SPACE. WE THINK THAT COULD BE DONE FAIRLY QUICKLY. AND THEN WITH THAT IN THE PIPELINE, WE COULD THEN GO OUT FOR A SECOND ROUND OF INNOVATION GRANTS THAT WOULD SAY, OKAY, YOU DON'T HAVE SPACE OF YOUR OWN TO DO THIS; BUT IF YOU HAVE AVAILABLE SHARED SPACE THAT WE'VE ALREADY DEVELOPED HERE, THEN THIS WOULD PROVIDE AN OPPORTUNITY FOR YOU TO GO OUT AND DO THIS WORK.
SO I'M SORRY THIS IS A LITTLE BIT
COMPLICATED, BUT I'M WALKING YOU THROUGH IT. I WELCOME QUESTIONS.
MR. LICHTENGER: ZACH, ON THE SHARED SPACE RFA, IS THERE ANY THOUGHT ABOUT TRYING TO FIND PRIVATELY AVAILABLE SPACE OUT THERE THAT COULD BE SUBLEASED?
DR. HALL: WE WOULD LET THE INSTITUTION DO THAT. AND WHETHER IT REQUIRES RENOVATION OR LEASING NEW SPACE OR RENTING, WHATEVER THEY PROPOSED, WE WOULD WRITE THE RFA SO THAT COULD BE INCLUDED, AND THEN THEY COULD COME BACK TO US AND MAKE A PROPOSAL, AND YOU WOULD EVALUATE WHETHER THIS WAS A REALISTIC OPTION OR NOT.
MR. LICHTENGER: I WAS REFERRING TO THE FACT THAT POTENTIALLY THAT THE CIRM COULD LEASE SOME SPACE THAT THEN COULD BE USED BY GROUPS THAT MIGHT BE FUNDED LATER ON.
DR. HALL: WELL, I THINK WHAT WE WOULD PREFER WOULD BE TO HAVE THE INSTITUTIONS DEVELOP THE PLAN. THEY LEASE THE SPACE AND THEN WE WOULD PROVIDE MONEY FOR THAT LEASE IF IT WERE DONE DIRECTLY. WE DON'T WANT TO BE THE DIRECT HOLDER OF THE LEASE IN THAT REGARD. BECAUSE THE SCIENTISTS AREN'T OURS, THEN WE GET INTO A WHOLE COMPLICATION. THEN WE'LL MAKE SURE THAT, FOR EXAMPLE, THE INSTITUTION IS RESPONSIBLE FOR THE USE OF ANY RADIOACTIVE MATERIAL IN THAT SPACE, FOR ANY BIOMATERIALS, THE WHOLE FEDERAL LICENSING THE INSTITUTION IS RESPONSIBLE FOR AND WE'RE NOT. BUT WE WOULD LEAVE OPEN ALL THOSE POSSIBILITIES.
JEFF.
MR. SHEEHY: I HAD A SERIES OF QUESTIONS. FIRST, WHAT'S YOUR GENERAL TIME? IS THERE A TIMELINE ATTACHED TO THIS?
DR. HALL: YES. I WILL COME TO THAT IN JUST A MOMENT. CAN I DO THAT?
MR. SHEEHY: WE CAN COME BACK TO THAT.
A CLARIFICATION ON FACILITIES GRANTS RELATED, I THINK, TO DAVID'S QUESTION. BOB MAY HAVE AN ANSWER. JAMES. WE'RE LIMITED TO ONLY MAKING GRANTS IN NONPROFIT INSTITUTIONS FOR FACILITIES GRANTS?
MR. KLEIN: YES.
MR. SHEEHY: MY THIRD QUESTION IS ON THE INNOVATION GRANTS. THOSE WILL BE AVAILABLE TO FOR-PROFIT INSTITUTIONS?
DR. HALL: IF THEY CAN TAKE CARE OF THEIR OWN SPACES AND IF WE HAVE OUR IP POLICY WORKED OUT FOR FOR-PROFIT INSTITUTIONS, IN PRINCIPLE THAT COULD BE DONE AS FAR AS I KNOW.
CHAIRMAN DOMS: WOULD YOU REPEAT THAT QUESTION, JEFF?
MR. SHEEHY: WILL THE INNOVATION GRANTS BE AVAILABLE TO FOR-PROFIT?
DR. HALL: BY THE WAY, I DON'T MEAN TO SAY THAT INNOVATION 2, THAT PEOPLE WHO HAVE THEIR OWN SPACE CAN'T APPLY FOR IT.
MR. SHEEHY: NO. I MEAN EVEN IN INNOVATION 1, WE WOULD BE INVITING RFA'S FROM FOR-PROFIT INSTITUTIONS.
MR. KLEIN: JEFF, I'D LIKE TO COMMENT. JEFF, AS YOU KNOW, TO DATE THE BOARD HAS DEFERRED FOR-PROFIT APPLICATIONS TO MAKE SURE THAT WE CAN REALLY HAVE THE TIME TO LOOK AND SEE WHETHER THERE'S ADDITIONAL CONSIDERATIONS THAT NEED TO BE TAKEN INTO ACCOUNT. AT THE TIME THE BOARD DISCUSSES WHETHER TO GO AHEAD WITH THE INNOVATION PROGRAM, THAT'S A DECISION THAT YOU AND THE OTHER BOARD MEMBERS WILL HAVE TO DECIDE, WHETHER WE HAVE SUCH ADDITIONAL ETHICAL GUIDELINES IN PLACE THAT WE'RE PREPARED TIMEWISE TO PROCEED WITH FOR-PROFIT INSTITUTIONS AS A PART OF THAT ROUND. SO THAT'S REALLY YOUR DECISION.
MR. SHEEHY: WE DECIDED NOT-FOR-PROFIT FOR THE TRAINING GRANTS, BUT INNOVATION -- FROM A PATIENT ADVOCATE POINT OF VIEW, AND NOT TO SHOW A FOR-PROFIT BIAS, BUT FOR-PROFIT IS USUALLY CLOSER TO PUTTING SOMETHING INTO SOMEBODY. AND I WAS JUST ASKING.
DR. HALL: IN PRINCIPLE, YES.
MR. SHEEHY: IN THE SHARED SPACE, WOULD WE ACCEPT SOME SORT OF PARTNERSHIP BETWEEN A FOR-PROFIT AND NON-FOR-PROFIT ENTITY? I MEAN HOW BRIGHT IS THAT LINE?
DR. HALL: WELL, SOMEBODY HAS TO TAKE RESPONSIBILITY FOR THE SPACE. RIGHT? SO YOU CAN HAVE -- THE ISSUE IS WHETHER AN INSTITUTION WOULD BE WILLING TO HAVE PEOPLE FROM A FOR-PROFIT COME IN AND USE THE SPACE OR NOT, AND I THINK THAT'S AN ISSUE WE JUST HAVE TO SORT OUT. BUT --
MR. SHEEHY: JOINTLY OPERATED.
DR. HALL: WE WOULD HAVE TO MAKE THE GRANT TO A NONPROFIT INSTITUTION, AND I THINK WE WOULD HAVE TO BE, JAMES, YOU CORRECT ME ON THIS, BUT WE'D HAVE TO BE VERY SURE THAT WASN'T JUST ACTING AS A FRONT, THAT WE WEREN'T DOING SOMETHING THAT WOULD VIOLATE THE LAW USING THE NONPROFIT AS A -- THESE ARE TECHNICAL QUESTIONS THAT WE CAN GET INTO AS WE DEVELOP THIS, BUT THEY ARE VERY IMPORTANT. WE DON'T HAVE COMPLETE ANSWERS TO THEM OBVIOUSLY.
MR. SHEEHY: NO. BUT IT SEEMED TO ME, AT LEAST FROM THE TRAINING GRANTS, THAT THERE WERE TWO INSTITUTIONS I REMEMBER THAT HAD VERY INTIMATE RELATIONSHIPS WITH FOR-PROFIT ENTITIES. AND IT SEEMS THAT THEY MAY HAVE -- MAY BE A LITTLE BIT CLOSER TO GETTING SOMETHING DONE, AND I JUST WANTED TO MAKE SURE -- I JUST WANTED TO GET SOME CLARIFICATION THAT THEY'RE NOT, THAT THAT MIGHT BE SOMETHING -- I WANT TO GET A SENSE OF WHETHER THAT'S SOMETHING WE WANT TO ENCOURAGE OR DISCOURAGE OR WE'RE NEUTRAL ON, AT LEAST FROM A LEGAL STANDPOINT.
DR. HALL: I THINK IT'S COMPLICATED, AND WE'D HAVE TO LOOK INTO IT. BUT IN PRINCIPLE, IF THERE'S A GOOD IDEA -- I THINK ACTUALLY WE WOULD EXPECT THE NONPROFITS -- I MEAN THE FOR-PROFITS, THEY DON'T RUN OFF NIH MONEY IN GENERAL. SO THERE'S NO REASON, OFF THE TOP OF YOUR HEAD, THAT THEY SHOULDN'T HAVE SPACE TO DO THIS WORK. AND I THINK WE JUST HAVE TO BE VERY SURE ABOUT UNDER WHAT CONDITIONS IT WAS DONE.
MR. SHEEHY: I THINK OF THREE EXAMPLES. ONE IS AN INSTITUTION THAT HAD A VERY DEFINED INTIMATE RELATIONSHIP WITH A MAJOR PHARMACEUTICAL, ANOTHER INSTITUTION, THEIR LEAD INVESTIGATOR HAD A VERY TIGHT RELATIONSHIP WITH A START-UP FROM THE EAST COAST, AND THEN A THIRD INSTITUTION ACTUALLY WAS USING AS PART -- HAD A FLOOR OF THEIR BUILDING THAT WAS OPERATED THAT WAS LEASED TO A FOR-PROFIT ENTITY, AND THEY PLANNED ON DOING ALL THEIR STEM CELL RESEARCH ON THAT FLOOR.
DR. HALL: THAT'S AN ARRANGEMENT BETWEEN THEM AND THE COMPANY. I THINK IF THEY ASK US TO PAY FOR THAT, FOR EXAMPLE, WE WOULD HAVE TO LOOK AT THAT VERY CAREFULLY AND SEE IF IT MET OUR STANDARDS. AND IF IT MET OUR REQUIREMENTS AND IF IT DID, PRESUMABLY WE COULD DO THAT. I MEAN THEY WOULD BE JUST LIKE ANY OTHER RENTER.
NOW, THE ISSUE WITH THE FIRST TWO EXAMPLES IS YOU DON'T HAVE COMPANY SCIENTISTS DOING THE WORK ON UNIVERSITY SPACE. AND THAT'S RELATIVELY, CERTAINLY WITHIN THE UNIVERSITY OF CALIFORNIA -- MR. KASHIAN MIGHT BE ABLE TO TELL US MORE ABOUT THAT -- BUT IN GENERAL THAT'S NOT ALLOWED.
LET ME SUGGEST THAT THESE ARE IMPORTANT QUESTIONS AND COMPLICATED ONES WE DON'T HAVE READY ANSWERS.
MR. SHEEHY: YOU DON'T HAVE TO HAVE ANSWERS. JUST RAISING THAT.
DR. HALL: I APPRECIATE YOUR RAISING THEM BECAUSE THEY WILL BE THINGS WE'LL HAVE TO DEAL WITH AS WE GO FORWARD.
CHAIRMAN DOMS: ZACH, DAVID HAD A QUESTION.
MR. LICHTENGER: FIRST OF ALL, JEFF, THANKS FOR PICKING UP ON MY POINT. I THINK WHERE I WAS GOING, ZACH, WAS THAT I THINK THERE IS SPACE AVAILABLE OUT THERE THAT IS FOR SHARING OR SUBLEASING BY FOR-PROFIT COMPANIES. AND JUST, YOU KNOW, I KNOW OUR GOAL IS TO GET RESEARCH GOING AS QUICKLY AS POSSIBLE, SO I THINK THAT'S CERTAINLY AN AVENUE, IF IT CAN LEGALLY BE DONE WHERE THERE'S NO CONFLICT, THAT YOU CAN HAVE OPERATIONAL FACILITIES VERY, VERY QUICKLY.
DR. HALL: THAT WOULD BE GREAT. MY OWN VIEW IS IF IT MEETS INSTITUTIONAL NEEDS, THAT WOULD BE TERRIFIC. BUT IN SOME CASES THERE MAY BE INSTITUTIONS WHERE THERE IS NO SPACE IMMEDIATELY AROUND, AND THEIR RESEARCHERS WOULD HAVE TO GO SEVERAL MILES OR SOMETHING.
MR. KLEIN: I WOULD ALSO LIKE TO PUT THIS IN THE CONTEXT THAT IF THE BOARD DECIDES TO GO FORWARD ON THE INNOVATION GRANTS, ONE OF THE THOUGHTS THAT PREVIOUSLY HAD BEEN DISCUSSED AS A JUSTIFICATION FOR A PRIORITY FOR THIS PROGRAM IS THAT IN NONPROFIT INSTITUTIONS, THESE RESEARCHERS WHO ARE SUBJECT TO NIH FUNDING CANNOT USE ANY OF THE NIH EQUIPMENT, ANY NIH SUPPLIES, OR SPACE FOR THEIR WORK. SO THEY ARE UNDER A VERY BRIGHT LINE DISCIPLINE WHERE UNLESS WE GIVE THEM SEED MONEY TO CONDUCT THEIR PRELIMINARY WORK, THEY CAN'T POINT TO NON-NIH FUNDS TO SHOW HOW THEY FINANCED THEIR EQUIPMENT AND SUPPLIES AND SALARIES TO DO THE WORK, AND THEY'RE SUBJECT TO VERY SEVERE PENALTIES, INCLUDING THE FACT THAT INSPECTORS WERE SENT TO DOUG MELTON'S LAB AT HARVARD TO ESSENTIALLY CONVEY AN INTIMIDATION, THAT THE NIH INTENDED TO REALLY IN A VERY DISCIPLINED WAY ENFORCE THIS VERY STRICT DIVISION.
SO THAT THERE'S A PARTICULAR NEED IN THE NONPROFIT SECTOR TO HAVE CLEAN FUNDS TO SHOW HOW THEY DID THEIR PRELIMINARY WORK AS A BASIS FOR THEN LATER DEVELOPING A LARGER PI GRANT.
MR. SHEEHY: I JUST HAD --
DR. WRIGHT: MY QUESTION IS, BOB, YOU TALKED ABOUT EARLIER SURVEYING THE INSTITUTIONS IN THE STATE ABOUT THEIR POTENTIAL PLANS, AND THEN DAVID'S QUESTION ABOUT SPACE. IS IT POSSIBLE -- I DON'T UNDERSTAND WHAT -- THERE'S PROBABLY A REASON WHY THIS WOULDN'T WORK, BUT ALSO ASKING THE QUESTION ABOUT POTENTIAL AVAILABLE SPACE CURRENTLY TO SOMEHOW BUILD A CLEARINGHOUSE MECHANISM. I'M NOT SURE THAT THIS GROUP WANTS TO SERVE IN THAT CAPACITY, BUT SOMEWHERE TO BUILD A DATABASE OF POTENTIAL SPACE IN THE STATE THAT THEN COLLABORATORS CAN TAP INTO, WORK TOGETHER. THAT'S WHAT WE WANT TO ENCOURAGE.
CHAIRMAN DOMS: ARE YOU TALKING ABOUT AN INVENTORY OF SPACE THAT'S NOT ASSOCIATED WITH, FOR EXAMPLE, A UNIVERSITY?
DR. WRIGHT: WELL, I THINK I WOULD INCLUDE UNIVERSITIES.
CHAIRMAN DOMS: NO. IT WOULD INCLUDE UNIVERSITIES, BUT I THOUGHT YOU WERE GOING INTO A MORE BROADER INVENTORY OF SPACE THAT MIGHT HOUSE RESEARCH FACILITIES THAT ARE OWNED BY EITHER INVESTORS OR FOR-PROFIT ENTITIES.
DR. WRIGHT: YES.
MR. LICHTENGER: THAT WAS WHERE I WAS GOING.
MS. SAMUELSON: I HAVE A CLARIFICATION QUESTION, I THINK.
CHAIRMAN DOMS: PLEASE. I'M SORRY.
MS. SAMUELSON: AND IT'S A LITTLE MORE FOUNDATIONAL. AS I UNDERSTAND IT, UNDER THE CURRENT PRESIDENT'S EXECUTIVE ORDER AND NIH REGULATIONS, FUNDING OF PERSONNEL AND EQUIPMENT AND SUPPLIES IS NOT PERMITTED THROUGH NIH FUNDS, BUT THAT THERE'S AN UNCERTAINTY ABOUT WHETHER SPACE CAN BE FUNDED. AND SO MY QUESTION IS, AND I THINK IT'S IMPORTANT WE UNDERSTAND THIS, AND IT'S A BIT CONFUSING IN MY MIND, AND I ALSO THINK IT'S IMPORTANT TO MAKE A CLEAR RECORD FOR THE PUBLIC ABOUT THAT BECAUSE THE PEOPLE CAME UP TO ME ON THE STREET AND NEIGHBORS WHEN THEY FOUND OUT I WAS APPOINTED TO THIS, EVERYBODY HAS A STRONG FEELING ABOUT PROP 71, AS WE ALL DO. WE WANT TO GET THOSE CURES FAST.
BUT THE SECOND THING PEOPLE WERE HITTING ME ON WAS LET'S NOT WASTE ANY MONEY. AND EVERY NOW AND THEN, PEOPLE WOULD SAY, WELL, DON'T GO BUILDING A BUNCH OF BUILDINGS. YOU'RE NOT GOING TO BUILD A BUNCH OF BUILDINGS, ARE YOU? SO I THINK IT NEEDS TO BE CLEAR THAT WE'RE DOING THAT, FUNDING CAPITAL INVESTMENTS WHERE WE HAVE TO AND ONLY WHERE WE HAVE.
SO CAN THAT BE CLARIFIED TO THE POINT WHERE SOME OF THIS SPACE CAN BE MADE AVAILABLE UNDER FUNDING SOURCES OR IT CAN BE AVAILABLE WITHOUT US HAVING TO FUND THE PERSONNEL AND THE SCIENTIFIC WORK WITHOUT HAVING TO BUILD THE BUILDING AS WELL?
MR. KLEIN: FIRST OF ALL, I THINK THAT'S ONE OF THE FIRST THINGS THEY'RE FOCUSING ON IS HOW TO TRY AND GET SOME SPACE WHERE THEY'RE LEASED, AS DAVID HAS SUGGESTED, OR RENOVATION OF SPACE OR OTHER SHARED SPACE ACCOMMODATIONS THAT THEY'RE GOING TO ADDRESS IN GREATER DETAIL LATER. THAT'S, OF COURSE, WHY WE LIMITED FACILITIES TO 10 PERCENT. BUT PERHAPS IT WOULD BE BENEFICIAL, JAMES, TO GET THE OMB CIRCULAR TO ALL MEMBERS OF THIS BOARD.
AND IN ADDITION TO THE OMB CIRCULAR THAT DEFINES WHAT IS APPROPRIATE AND ACCEPTABLE, IN MAY OF THIS YEAR THERE WAS AN ADDITIONAL TIGHTENING OF WHAT THE NIH INTERPRETATION WAS ON WHAT YOU COULD DO.
MY UNDERSTANDING IS THAT SOME OF THE INFORMAL COMMUNICATION HAS BEEN VERY STRICT. MAYBE DR. HALL CAN COMMENT ON THAT AS TO WHAT WOULD BE PERMITTED, INCLUDING A PURE EXCLUSION FROM ANY NIH SPACE, THAT NIH SPACE CANNOT BE USED. BUT WE CAN GET YOU A MEMO, I THINK, THAT WOULD BE GOOD TO PREPARE BEFORE THE NEXT MEETING DIRECTLY ADDRESSING THE FORMAL AND INFORMAL COMMUNICATIONS.
AND, OF COURSE, AGAIN, WE'RE IN THE MIDDLE OF A POLITICAL YEAR. WE'VE SEEN, IN ADDITION TO THESE RESTRICTIONS, WE'VE SEEN THE STATE DEPARTMENT, AT THE WHITE HOUSE DIRECTION, GO TO THE UNITED NATIONS TO GET A RESOLUTION PASSED BY THE UNITED NATIONS CONDEMNING SOMATIC CELL NUCLEAR TRANSFER. SO VERY CLEAR WHAT DIRECTION THAT THE PART OF THE FEDERAL GOVERNMENT IS MOVING IN AS VERSUS THE CONGRESS, WHICH APPEARS TO BE MOVING VERY AGGRESSIVELY TO TRY AND SUPPORT THIS NEW AREA OF MEDICAL TECHNOLOGY AND SCIENTIFIC DISCOVERY.
DR. HALL: LET ME JUST SAY TO THAT I THINK THE SITUATION IS VERY MURKY. AND I THINK NEITHER SIDE WANTS TO CLARIFY IT. THAT IS, I THINK THE RIGHT WING WOULD LIKE TO KEEP THE THREAT OF AN AUDIT OPEN, AND I THINK THOSE IN FAVOR OF STEM CELL RESEARCH ARE ALMOST AFRAID TO ASK BECAUSE THEY DON'T WANT TO HEAR A FIRM ANSWER. SO WHAT'S HAPPENING IS, AS BOB INDICATED, THERE HAVE BEEN INSTANCES OF INTIMIDATION.
ON THE OTHER HAND, HARVARD APPARENTLY, AFTER SPENDING HALF A MILLION DOLLARS IN LEGAL FEES TO RESEARCH THIS, DECIDED THAT, IN FACT, IT WAS AN ACCOUNTING PROBLEM. AND THEY ARE DISCUSSING WITH SEVERAL OTHER UNIVERSITIES THE POSSIBILITY OF JUST KEEPING TABS ON ALL OF THIS STUFF. AND AS I UNDERSTAND IT, THEY WILL NOT HAVE A SHARP DIVISION OF SPACE INTO FEDERAL AND NONFEDERAL.
BUT THE PROBLEM IS OTHER INSTITUTIONS DON'T WANT TO TAKE THAT AGGRESSIVE A POSITION. AND I THINK THE PROBLEM IS WE CAN'T GET A CLEAR-CUT ANSWER ON IT THAT'S GOING TO SATISFY EVERYBODY. WE DON'T TAKE THE RISK. THE INSTITUTIONS HAVE TO. I THINK IT'S THE RIGHT THING FOR US TO DO IS TO SAY WE WANT TO GET THE WORK DONE. AND WHILE THERE'S A DANGER THAT YOU WILL BE AUDITED OR THAT THE GOVERNMENT WILL COME DOWN HARD ON YOU, WE DON'T WANT TO PUT YOU IN THAT SITUATION OF RISK AT ALL. WE WANT TO GIVE SPACE THAT WILL LET THE WORK GO ON. OTHERWISE I THINK IT'S GOING TO BE VERY COMPLICATED FOR EACH INSTITUTION TO MAKE THIS DECISION. AND AS I SAY, SOME OF THEM APPEAR TO BE NOT AS AGGRESSIVE AS I'M TOLD THAT HARVARD IS. I DON'T HAVE ANYTHING OFFICIAL ON THAT. I'VE BEEN TOLD THAT BY PEOPLE INVOLVED.
MR. SHEEHY: ACTUALLY I HAVE A COUPLE OF QUESTIONS. SO FIRST, THE FUNDING FOR THE SHARED SPACE RFA, IS THIS GOING TO BE A BOND ANTICIPATION NOTE FUNDED, OR IS IT GOING TO BE SOMETHING THAT WE'RE ANTICIPATING, THAT BOB IS ANTICIPATING THAT THEY MIGHT FUND ON THE -- REMEMBER YOU WERE DISCUSSING THAT ENTITIES MIGHT BE WILLING TO GO AHEAD WITH SOME FACILITIES FUNDING. LIKE WE MADE THE GRANT, THAT THEY COULD TAKE THAT THEIR OWN. DO WE KNOW RIGHT NOW WHETHER THIS --
MR. KLEIN: WHEN WE ASK ON THE INVENTORY, WE COULD ASK THEM WHAT THEY'RE WILLING TO DO AS A QUESTION, JEFF, TO RESPOND TO YOUR QUESTION, AND GIVE THAT INFORMATION TO THIS COMMITTEE.
MR. SHEEHY: THEN THE SECOND PART IS WHERE WOULD A STEM CELL BANK, WHICH SEEMED TO BE THE ONE STRONG FACILITY RECOMMENDATION THAT CAME OUT OF THE SCIENTIFIC MEETING, WHERE DOES THAT FIT?
DR. HALL: THAT'S A GOOD POINT, AND IT'S A POINT I FAILED TO MAKE. IN THE PREVIOUS SLIDE, I TALKED ABOUT THE OVERALL STRATEGIC PLAN. OUT OF THAT STRATEGIC PLAN WILL, I'M SURE, COME A STRONG RECOMMENDATION THAT WE HAVE BOTH RESOURCE CENTERS, SUCH AS THE STEM CELL BANK, PERHAPS A CENTRALIZED GNP FACILITY, ALTHOUGH THERE WAS A LOT OF DISCUSSION ABOUT THAT, AND THAT THERE WOULD ALSO BE MAJOR RESEARCH CENTERS IN WHICH WE WOULD BE TALKING ABOUT NOT 2 TO 4,000 SQUARE FEET, BUT WHAT WE'D BE TALKING ABOUT IS 50,000 SQUARE FEET OR A HUNDRED THOUSAND SQUARE FEET OR MAYBE EVEN A WHOLE BUILDING FOR STEM CELL RESEARCH AT A FEW MAJOR CENTERS. THAT WILL BE, OVER THE LONG TERM, THE IMPORTANT WORK THAT THIS COMMITTEE WILL BE DOING.
BECAUSE OF THE EXPENSE OF A STEM CELL BANK, I THINK WE ARE NOT YET, AND WE WOULD LIKE IT TO BE PART OF AN OVERALL PLAN, WE ARE NOT YET READY TO MOVE ON THAT; WHEREAS, THIS IS SOMETHING THAT, AS SOON AS WE HAVE THE MONEY, WE COULD GO ON VERY QUICKLY AND WE SEE AS SHORT TERM.
MR. SHEEHY: DO YOU ANTICIPATE THE STEM CELL BANK BEING OPERATED BY CIRM OR SOMETHING THAT WE'D PUT OUT AN RFA FOR?
DR. HALL: NO. WE WOULD PUT OUT AN RFP AND SAY THAT WE WOULD HAVE A CONTRACT FOR ONE OR MORE STEM CELL BANKS, AND WE WOULD SPECIFY UNDER WHAT CONDITIONS AND SO FORTH AND SO FORTH. ACTUALLY IT'S QUITE COMPLICATED. WE ARE BEING VISITED -- STEVE LYNN IS IN THE AUDIENCE FROM THE BRITISH CONSULATE. AND THE UK HAS SET UP A STEM CELL BANK, AND THE HEAD OF THAT STEM CELL BANK WILL BE VISITING IN NOVEMBER. AND WE WILL BE IN TOUCH WITH HIM AND BE VERY INTERESTED TO UNDERSTAND HOW THEY DO IT, WHAT PROBLEMS THEY'VE RUN INTO. BUT IT'S QUITE A BIG PROJECT, AND IT'S NOT ONLY JUST THE BUILDING, IT IS STAFF, IT IS TREMENDOUS AMOUNT OF EQUIPMENT. THIS WILL BE MAJOR, MAJOR IN TERMS OF FINANCIAL IMPACT.
IN TERMS OF OVERALL -- IN TERMS OF $3 BILLION, IT'S SOMETHING WE COULD AND SHOULD DO; BUT IN TERMS OF WHAT WE CAN REASONABLY EXPECT IN THE BRIDGE FUNDING, I THINK THAT'S PROBABLY NOT ON THE BOOKS.
MR. SHEEHY: BUT IF WE WERE TO GET, ESPECIALLY SINCE WE'RE TALKING ABOUT THE NORTHERN AND SOUTHERN CALIFORNIA REGIONAL, IT MIGHT BE A PRESTIGE ISSUE UP THERE WITH THE HEADQUARTERS, THAT WE MIGHT BE ABLE TO GET SOME OF THESE ADVANCE COMMITMENTS BASED ON EXPECTATIONS, ESPECIALLY IF WE CAN MAKE SOME, JUST SOME MINIMAL FUNDS UP FRONT AVAILABLE. I JUST WANT TO PUT THAT OUT THERE.
DR. HALL: BOTH OF THOSE REMARKS, JEFF, I THINK IT'S A VERY IMPORTANT ISSUE. IT'S SOMETHING THAT WE ARE ACTIVELY THINKING ABOUT WORKING ON. AS YOU KNOW, IT'S COME UP IN THE STANDARDS WORKING GROUP.
I JUST ALSO WANT TO REINFORCE WHAT JOAN SAID BECAUSE I THINK IT IS VERY IMPORTANT THAT WE MAKE CLEAR THAT THE REASON WE'RE DOING THIS IS TO GET THE WORK GOING, IS TO GET IT STARTED. AND IT'S NOT ANY SORT OF GIVE-AWAY PROGRAM. WE WOULD HOPE THAT WE WOULD BE ABLE TO HAVE ENOUGH SHARED SPACE FACILITIES THROUGHOUT THE STATE, THAT, YOU KNOW, ANYBODY WOULD BE WITHIN REACH. WE WON'T HAVE ONE FOR EVERY INSTITUTION. I DON'T THINK WE CAN DO THAT, BUT THAT WE WOULD HAVE ALL THE MAJOR INSTITUTIONS COVERED. AND THAT PEOPLE WOULD BE, IF THERE WERE AN INSTITUTION WITH A SINGLE STEM CELL RESEARCHER OR SOMEBODY WAS INTERESTED, WE PROBABLY WOULD NOT PUT A FACILITY THERE, BUT WE WOULD HOPE THAT THEY WOULD BE WITHIN REACH OF ONE THAT THEY COULD USE.
THE IDEA IS JUST TO PROVIDE THE RESOURCES NECESSARY TO GET PEOPLE STARTED AND TO GIVE PEOPLE THE OPPORTUNITY TO BE ABLE TO GET THEIR IDEAS GOING, WHICH I THINK THERE'S A LOT OF PEOPLE NOW HAVE BEEN EXCITED ABOUT THIS, THEY'VE BEEN THINKING ABOUT IT, THEY'RE RARING TO GO. AND THE CRYING NEED THAT WE HEAR FROM THE SCIENTIFIC COMMUNITY IS WE DON'T HAVE A PLACE TO DO THESE EXPERIMENTS. SO THAT'S THE INTENT.
MAYBE I SHOULD MOVE ON, RUSTY, BECAUSE WE HAVE A LOT OF WORK TO DO HERE.
CHAIRMAN DOMS: DAVID HAD ONE QUICK QUESTION.
MR. LICHTENGER: I JUST WANTED TO ADD THE COMMENT ABOUT POTENTIALLY SHARED OR LEASED SPACE WITH PRIVATE FOR-PROFIT ENTITIES, THAT I THINK THAT THERE ARE SPACES AVAILABLE THROUGHOUT CALIFORNIA, PROBABLY IN THE GREATER BAY AREA AND SAN DIEGO, THAT ARE AVAILABLE WITH MINIMAL CAPITAL IMPROVEMENTS THAT COULD BE SET UP IN A MATTER OF MONTHS. SO I JUST WANT TO ADD THAT I THINK THAT'S SOMETHING THAT COULD BE DONE VERY, VERY QUICKLY AND VERY, VERY COST EFFECTIVELY.
CHAIRMAN DOMS: I'D JUST LIKE TO -- I'M SORRY, ZACH. I HAD TWO COMMENTS, BUT I'LL JUST MAKE ONE. WHEN WE TALK ABOUT SHARED SPACE, SAY, OFF OF A MAJOR CAMPUS IN A FOR-PROFIT, ONE OF THE ISSUES THAT WE HAVE TO CONSIDER AS WELL AS THE ACTUAL PHYSICAL SPACE IS THE EQUIPMENT, SUPPLIES, AND STAFF BECAUSE YOU CAN HAVE A NICE SPACE, BUT ONE OF THE THINGS IN TERMS OF TRYING TO MAXIMIZE THE USE OF OUR DOLLARS, WE'D LIKE TO SHARE EQUIPMENT ALSO. AND SO EQUIPMENT AND SUPPLIES AND SUPPORT FACILITIES ARE ALSO VERY, VERY IMPORTANT IN LOOKING AT SPACE, SAY, OFF CAMPUS IN TERMS OF, AS I SAID, TO GET THE MOST WE CAN FOR OUR DOLLAR. I'M SORRY, ZACH, GO AHEAD.
DR. HALL: THAT'S GREAT. I APPRECIATE THOSE COMMENTS.
LET ME JUST GO ON QUICKLY. I THINK I'VE MADE THESE POINTS, BUT JUST TO SHOW YOU THAT THE AIMS OF THE INNOVATION RFA'S ARE PILOT PROJECTS, NEW IDEAS, RECRUIT ESTABLISHED SCIENTISTS INTO STEM CELL RESEARCH, AND ALLOW A QUICK RAMP-UP OF STEM CELL RESEARCH THAT HAS BEEN CURTAILED BY FEDERAL RESTRICTIONS ON FUNDING. AS I THINK JEFF OR DAVID, SOMEBODY POINTED OUT EARLIER, THESE INNOVATIONS GRANTS WOULD HAVE A SCIENTIFIC REVIEW THROUGH THE GRANTS WORKING GROUP, BUT WOULD NOT HAVE A FACILITIES REVIEW. BUT WE WANTED TO DISCUSS IT HERE AS PART OF THE OVERALL PROGRAM.
FOR THE SHARED SPACE RFA, THE IDEA WOULD BE TO CREATE A SAFE HAVEN FOR WORK OUTSIDE THE FEDERAL GUIDELINES AND PROVIDE SPACE FOR SEED PROJECTS, PARTICULARLY THESE INVESTIGATORS. AND WE FORESEE THESE AS OPTIMALLY HAVING BOTH SCIENTIFIC AND FACILITIES REVIEW. AND THE REASON IS IF AN INSTITUTION APPLIES FOR 5,000 SQUARE FEET OF SPACE AND IT TURNS OUT THEY DON'T HAVE ANYBODY THAT -- THEY DON'T HAVE ANY STRENGTH IN THIS AREA, THEN I THINK IT'S NOT A GOOD INVESTMENT ON OUR PART TO PUT A MAJOR FACILITY IN A PLACE WHERE THERE'S NOT GOOD SCIENCE GOING ON. AND SO WE WOULD LIKE SOME ASSESSMENT ON THE SCIENTIFIC SIDE OF WHETHER THE SPACE WOULD BE PUT TO GOOD USE, AND THEN AN ASSESSMENT BY YOU ABOUT WHETHER THE PLANS FOR THE SPACE ARE REASONABLE.
AND LET ME TALK ABOUT THAT A LITTLE BIT FURTHER. JEFF BROUGHT UP THE ISSUE OF TIMING. AS BOB SAID, WE ARE LOOKING FOR -- AND I USE THE TERM WE GENEROUSLY. BOB IS REALLY DOING THE LION'S SHARE OF THE WORK ON THIS -- BUT LOOKING FOR TWO PIECES OF FUNDING, ONE, A FIRST SLICE OF 50 MILLION, WE HOPE. AND UNDER THAT WE WOULD FUND OUR TRAINING GRANTS, AS BOB SAID, AND WE WOULD PLAN THAT WE COULD DO SOME INNOVATION 1 GRANT WITHOUT NEW SPACE.
IN THAT CASE, IF THESE ARE APPROVED BY THE ICOC, WHICH IS A PREREQUISITE TO ANY OF THIS, THEN AS SOON AS THE BRIDGE FUNDING WAS SECURED, WE COULD IMMEDIATELY PUT OUT AN RFA. I WOULD SAY WE COULD REVIEW ROUGHLY THREE MONTHS LATER AND WITH AN AWARD SIX MONTHS AFTER THAT. THESE ARE APPROXIMATE FIGURES, AND IT MAY BE UNDER TIME PRESSURE WE COULD DO BETTER THAN THAT, OR THERE MAY BE EVENTS THAT SLOW THEM DOWN A LITTLE BIT, BUT THAT IS ROUGHLY A TIME SCALE.
SO LET'S THINK ABOUT THAT, AND LET'S ASSUME THAT WE WERE ABLE TO GET SOME FUNDING SO THAT WE COULD GET THOSE OUT EVEN BY THE EARLY PART OF THE YEAR. THEN IF WE WERE ABLE TO BE FORTUNATE AND GET $100 MILLION IN BRIDGE FUNDING, THEN WE WOULD BE ABLE TO GO AHEAD WITH SHARED SPACE AND INNOVATION 2. AND WE THINK THAT THE SHARED SPACE COULD FOLLOW INNOVATION 1 AS QUICKLY AS WE HAVE THE STAFF TO GET IT OUT.
THESE ARE COMPLICATED RFA'S, MUCH MORE SO THAN JUST THE INNOVATION RFA, BUT LET'S SAY WE COULD GET IT OUT WITHIN THREE MONTHS. AND THEN THREE MONTHS AFTER THAT -- I'M SORRY. THERE'S A MISPRINT -- INNOVATION 2 FOLLOWS INNOVATION 1 BY ABOUT SIX MONTHS. WE COULD PUT THOSE OUT. LET ME GO BACK OVER THAT.
LET'S SUPPOSE WE WERE ABLE TO PUT OUT -- SECURE OUR FUNDING, WE COULD PUT OUT AN EARLY, LET'S SAY, JANUARY WE COULD PUT OUT AN RFA FOR INNOVATION 1. THEN SHORTLY AFTER THAT, LET'S SAY, FIRST OF MARCH, APRIL, WE COULD GET OUT AN RFA FOR SHARED SPACE, ASSUMING WE HAVE A HUNDRED MILLION. AND FOR YOUR PURPOSES, THAT MEANS IT WOULD BE REVIEWED IN THE SUMMER. SO THAT'S THE KEY POINT I WANT TO MAKE HERE. I DON'T SEE THAT WE COULD DO IT MUCH MORE QUICKLY THAN THAT, ALTHOUGH WE MIGHT BE ABLE TO.
AND THEN INNOVATION 2 WOULD BE, IF WE WERE ABLE TO AWARD THE SHARED SPACE GRANTS BY THE LATE SUMMER, THEN WE COULD HAVE INNOVATION 2 BY THE END OF THE YEAR. AND THAT WAY WE'D HAVE THAT SPACE IN THE WORKS BY THE TIME THE INNOVATION 2 CAME AROUND.
SO THAT IS A TIMETABLE. AS WE SEE IT, THERE'S NOT A DECISION HERE ON ANYBODY'S PART. IT'S JUST AN ESTIMATE OF WHAT WE THINK IT MIGHT BE. AND IT ROUGHLY COULD FOLLOW THAT. AND AS I SAY, WE MIGHT BE ABLE TO BEND THIS SCHEDULE IN VARIOUS WAYS UNDER PARTICULAR CONSTRAINTS OR URGENCIES.
NOW, LET ME JUST MENTION A LITTLE BIT. I'VE SAID BEFORE THAT WE HAVE THREE KINDS OF COSTS. AND, RUSTY, YOUR REMARK LED RIGHT INTO THIS. WE HAVE THE COST OF RENOVATING OR ACQUIRING THE SPACE. DAVID, THE SECOND BEING ACQUIRING OR LEASING, I SHOULD HAVE PUT, BUT HOWEVER IT'S PROVIDED FOR. THEN WE HAVE THE COST OF CAPITAL EQUIPMENT, AND THAT HAS TO COME OUT OF THE FACILITIES BUDGET. WE ARE TRYING TO GET A READING AND SEEING IF THERE IS A STATE POLICY ON WHAT CONSTITUTES CAPITAL EQUIPMENT; THAT IS, OVER HOW MUCH IS IT CAPITAL. THAT FIGURE MIGHT BE $100,000. IF YOU HAVE A SINGLE PIECE OF EQUIPMENT THAT'S OVER $100,000, IT CONSTITUTES CAPITAL EQUIPMENT. WE JUST DON'T KNOW WHAT THE STATE WOULD SAY ABOUT THAT.
AND THEN WE HAVE THE COST OF SMALL EQUIPMENT, SUPPLIES, AND STAFFING. AND THAT WOULD COME OUT OF THE SCIENTIFIC BUDGET, NOT OUT OF YOUR BUDGET.
AND WE DON'T REALLY KNOW. WE HAVE DONE A ROUGH ESTIMATE. IT COULD BE UP TO THREE MILLION FOR EACH FACILITY. AND DEPENDING ON HOW WE CONSTRAIN THAT AND HOW MUCH MONEY WE HAD, WE COULD BE AS HIGH AS 20 DIFFERENT PLACES. THAT WOULD GIVE US CERTAINLY GOOD COVERAGE ACROSS THE STATE AND WOULD NOT ONLY HAVE OUR MAJOR INSTITUTIONS, BUT QUITE A NUMBER OF IMPORTANT SMALLER INSTITUTIONS AS WELL. AND SO, AGAIN, I'M PROJECTING THIS ON THE BASIS OF ALMOST NO INFORMATION, BUT TO GIVE YOU SOME IDEA OF WHERE WE ARE IN THE SCALING OF IT.
CHAIRMAN DOMS: RIGHT. I THINK, DAVID, YOU HAVE A QUESTION?
MR. LICHTENGER: ZACH, THOSE NUMBERS THAT YOU HAVE, THESE BUDGETS, THEY'RE BASED ON WHAT SQUARE FOOTAGE?
DR. HALL: $100 A SQUARE FOOT.
MR. LICHTENGER: OKAY. TO ARRIVE AT THE THREE --
DR. HALL: WELL, THE THREE MILLION, THE HOOKER IN THIS THE QUESTION IS HOW MUCH EQUIPMENT DO YOU PUT IN THESE. AND THERE I DON'T WANT TO GET OFF INTO A TECHNICAL THING, BUT AN ISSUE HERE IS YOU CAN PROVIDE BASIC EQUIPMENT FOR THIS RESEARCH; BUT IF YOU SAY THAT EVERY PIECE OF EQUIPMENT THAT TOUCHES A STEM CELL OR A STEM CELL PRODUCT HAS TO BE SEPARATE FROM NONFEDERALLY FUNDED, THAT CAN BE -- THAT CAN BE A BIG MESS. THAT IS, IF YOU ISOLATE A PROTEIN FROM A HUMAN EMBRYONIC STEM CELL, YOU RUN IT OUT ON A GEL AND NOW YOU WANT TO DO MASS SPECTROSCOPY ON IT, DO YOU HAVE TO HAVE A SEPARATE MASS SPECTROSCOPY FACILITY FOR THAT? THAT DOESN'T MAKE ANY SENSE.
SO HOW WE TITRATE THAT WILL MORE THAN ANYTHING ELSE DETERMINE THE TOTAL COST OF THESE GRANTS.
CHAIRMAN DOMS: I THINK MAYBE WHERE YOU WERE GOING, DAVID, IS WE'RE TALKING ABOUT 250 TO $500,000. YOU CAN'T BUILD SPACE.
DR. HALL: THIS WOULDN'T BE NEW CONSTRUCTION. I THINK THIS WOULD BE EITHER RENOVATION OR LEASE OR RENT, SOMETHING LIKE THAT. IF THESE FIGURES ARE OFF, BY THE WAY, WE'RE PLEASED TO HEAR FROM YOU. WE DON'T HAVE ANY EXPERTISE IN THIS AREA. I CAN'T QUITE SEE DAVID'S FACE. HE MAY FIND THESE FIGURES LAUGHABLE.
DR. WRIGHT: HE'S SMILING.
MR. LICHTENGER: IT DEPENDS. IT DEPENDS. THOSE NUMBERS, IF THE FACILITY WAS IN PRETTY GOOD SHAPE AND IT NEEDED RELATIVELY MINOR MODIFICATIONS, AND IT DEPENDS WHAT KIND OF LABS, CLEAN ROOMS. WE'RE NOT TALKING ABOUT VIVARIUMS HERE, SO IT'S CERTAINLY POSSIBLE TO SPEND THAT LITTLE.
DR. HALL: WHAT WE'RE THINKING ABOUT, AND THOSE WERE BASED ON MY EXPERIENCES, I ADMIT, OVER FIVE YEARS AGO AT UCSF, BUT THAT'S SORT OF THE ASSUMPTION, THAT YOU HAVE LABS THAT ARE THERE, THEY'RE BEING USED, YOU'RE GOING TO TAKE THEM OUT OF THE FEDERAL POOL, YOU'RE GOING TO PUT UP A FEW PLASTERBOARD WALLS, REARRANGE THE SPACE IN IT A LITTLE BIT, BUT THAT THEY WOULD HAVE THE PLUMBING AND THE VAC AND ALL THE REST THAT'S NECESSARY TO DO THAT. SO IT WOULDN'T BE CONVERTING OFFICE SPACE INTO A LAB.
MR. KLEIN: I WOULD ASK JAMES. IN TERMS OF THIS DEFINITION OF CAPITAL EQUIPMENT, OUR INTENTION WAS CERTAINLY TO CREATE THE ESSENTIAL DECISION-MAKING BODY AT THE CIRM AND ICOC LEVEL TO CARRY OUT OUR MISSION. SO INDEPENDENT OF WHAT OTHER STATE AGENCIES ARE DOING IN TERMS OF THEIR DEFINITIONS OF CAPITAL EQUIPMENT, AND IT MAY VARY QUITE A BIT BETWEEN AGENCIES, WHAT IS YOUR GENERAL SENSE ABOUT OUR ABILITY TO SET OUR OWN DEFINITIONS ABOUT CAPITAL EQUIPMENT AND WHAT CONSTITUTES CAPITAL EQUIPMENT?
MR. HARRISON: YOU ARE CORRECT, THAT UNDER PROP 71 THE CIRM IS THE AGENCY THAT HAS THE RESPONSIBILITY TO IMPLEMENT THE ACT. AND PART OF THAT INVOLVES DETERMINING WHAT EXACTLY CONSTITUTES CAPITAL EQUIPMENT. EXISTING STATE LAWS AND REGULATION WITH RESPECT TO CAPITAL EQUIPMENT MIGHT OFFER SOME GUIDANCE, BUT ULTIMATELY THE DISCRETION RESTS IN YOUR HANDS. I THINK, NONETHELESS, THE STATE REGULATION AND GUIDELINES WOULD BE A BENCHMARK AGAINST WHICH TO MEASURE WHETHER YOU'VE EXCEEDED YOUR DISCRETION. BUT THE JUDGMENT IN THE FIRST INSTANCE IS IN YOUR HANDS.
CHAIRMAN DOMS: I THINK THAT'S AN IMPORTANT ISSUE AND ONE THAT HAS CONCERNED ME, AS ZACH AND I TALKED ABOUT THIS SLIDE, BECAUSE IF YOU LOOK AT TAKING EXISTING SPACE AND RENOVATING IT OR GOING OUT AND LEASING SPACE AND THEN RENOVATING THAT SPACE OR PAYING, I'M NOT SAYING WE LEASE SPACE, BUT THE SPACE IS LEASED, AND THAT WOULD BE PART OF THE FACILITIES COST. IF YOU ARE LOOKING AT THOSE KINDS OF NUMBERS AND YOU LOOK AT A $3 MILLION AVERAGE COST FOR SHARED SPACE RFA, YOU HAVE IN THE RANGE OF TWO TO TWO AND A HALF MILLION DOLLARS FOR CAPITAL EQUIPMENT. AND THAT SOUNDS LIKE A LOT OF MONEY FOR EQUIPMENT. WHEN YOU'RE TALKING ABOUT A FACILITIES WORKING GROUP LOOKING AT FACILITIES, THE MAJORITY OF THAT IS EQUIPMENT. AND SO I THINK A DEFINITION OF EQUIPMENT IS REALLY, REALLY IMPORTANT TO UNDERSTAND WHERE WE ARE IN TERMS OF NUMBERS AND ALLOCATION OF DOLLARS BETWEEN THE SCIENCE AND THE FACILITIES SIDE OF THE 90/10 EQUATION.
DR. HALL: I THINK WE'RE GOING TO NEED TO KEEP THAT FIGURE AS HIGH AS WE CAN. OTHERWISE, WE'RE GOING TO RUN THROUGH OUR BUDGET FAIRLY QUICKLY. EVEN ON THE SCIENCE SIDE, WE WILL END UP -- IT DEPENDS IF IT'S A 100,000, IT MIGHT BE TOO LOW.
CHAIRMAN DOMS: I JUST THINK IT NEEDS CLARIFICATION.
DR. HALL: I THINK WHAT WAS ENVISAGED, AND, BOB, I WASN'T AROUND WHEN THIS WAS BEING WRITTEN, BUT WHAT WAS ENVISAGED, I IMAGINE, WAS THAT YOU MIGHT DECIDE YOU WANT TO SET UP A CORE FACILITY FOR A LARGE CENTER IN WHICH YOU WOULD HAVE A VERY EXPENSIVE PIECE OF EQUIPMENT, LIKE A MASS SPEC FACILITY, THAT WOULD BE SHARED OR LIKE A HIGH THROUGHPUT FACILITY FOR SCREENING FACILITY OR SOMETHING THAT WOULD BE A ROBOTICS FACILITY THAT WOULD BE USED BY A LOT OF PEOPLE. THAT MIGHT BE PART OF THAT. AND THERE YOU'RE REALLY TALKING HUNDREDS OF THOUSANDS OF DOLLARS, NOT A FEW THOUSAND.
LET ME JUST ASK. MARY MAXON, EARLIER IN THE YEAR WHEN WE WERE LOOKING AT THIS, AND IT SEEMS LIKE A HUNDRED YEARS AGO, BUT IT WAS ACTUALLY ONLY ABOUT FOUR OR FIVE MONTHS AGO, AND MARY DID SOME RESEARCH ON THIS, AND SHE SAID SHE JUST WANTED TO MAKE A POINT.
DR. MAXON: SO IN JANUARY AND FEBRUARY, ED PENHOET AND I DID AN INFORMAL SURVEY OF BOTH NONPROFIT AND FOR-PROFIT NEEDS AND AVAILABILITIES IN THE LATTER CASE. THE FOR-PROFIT NEED IS MINIMAL, BUT THERE ARE, DUE TO THE BIOTECH WINTER OF 2002 AND 2003, THERE'S LOTS OF INCUBATOR SPACE AROUND IN BOTH NORTHERN AND SOUTHERN CALIFORNIA. THERE ARE ALSO FOR-PROFIT ENTITIES THAT ARE BEGINNING BUSINESS MODELS NOW WHERE THEY ARE ACTUALLY STRUCTURING ENTIRE LABORATORIES, INCLUDING PEOPLE AND EQUIPMENT, FOR NONPROFIT INDIVIDUALS TO USE TO RELIEVE THIS BURDEN IN THE EARLY DAYS. SO I THINK THAT'S A VERY GOOD SIGN.
AND JUST ONE MORE PIECE ABOUT EQUIPMENT. WE ALSO DID A SURVEY FOR EQUIPMENT USES THAT MINIMALLY WOULD BE REQUIRED AND A MAXIMAL WISH LIST, SO WE'RE AHEAD OF THE GAME ON THINGS THAT WE THINK WE MIGHT NEED. BUT WITH, FOR EXAMPLE, AN EIGHT-CHANNEL CONFOCAL MICROSCOPE RINGING IN BETWEEN HALF MILLION AND A MILLION BUCKS, YOU GO THROUGH THAT MONEY PRETTY FAST. SO THAT WOULD BE SOMETHING TYPICALLY THAT MANY LABORATORIES WOULD CHIP IN ON TO BUY SO THAT THEY WOULD USE IN A CENTRAL UNIVERSITY FACILITY. THESE ARE VERY REAL NEEDS, AND WE HAVE A LITTLE BIT OF AN IDEA WHAT WE THINK WE MIGHT NEED.
CHAIRMAN DOMS: THANK YOU, MARY.
MR. SHEEHY: CAN I JUST ASK A QUESTION ABOUT THE EXPENSIVE PIECES OF EQUIPMENT? WHEN THEY HAVE THESE MULTIUSES, AREN'T THERE USUALLY CHARGE-BACKS THAT THE INSTITUTION GETS FROM OTHER USERS OF THESE THINGS SO THAT THE CHARGES -- WE MAY MAKE AN UP-FRONT CHARGE, BUT OUR RESEARCH MAY NOT EVEN NECESSARILY BE THE BIGGEST CONSUMER OF THAT.
DR. HALL: COULD BE. AND I THINK THERE YOU HAVE THE QUESTION OF WHETHER YOU CAN SHARE EQUIPMENT BETWEEN FEDERAL AND NONFEDERAL. THAT WILL BE THE ISSUE. AND IF YOU CANNOT, THEN WE WOULD BE PAYING, IN ESSENCE, WE MIGHT END UP PAYING RECHARGE EXPENSES TO OURSELVES. THAT IS, CIRM MIGHT PAY FOR IT IN ANY CASE.
MS. SAMUELSON: A FOLLOW-UP QUESTION. ON THOSE BIG EXPENSIVE PIECES OF EQUIPMENT, MIGHT NOT THEY ALREADY HAVE SOME KIND OF -- MORE LIKELY HAVE SOME KIND OF ACCOUNTING SYSTEM CHARGING THE USES SUCH THAT YOU COULD DIFFERENTIATE AND SATISFY?
DR. HALL: AGAIN, IT'S THE FEDERAL, NONFEDERAL PROBLEM.
MS. SAMUELSON: COULDN'T YOU DIFFERENTIATE BETWEEN THE TWO IN THIS AND SEPARATE OUT THE FEDERAL?
DR. HALL: IF A UNIVERSITY IS WILLING TO KEEP THE BOOKS ON IT AND DO IT THAT WAY, THEN YES. IF NOT, NO. I THINK THAT'S --
MS. SAMUELSON: I GUESS IT WOULD BE NICE TO REALLY BUILD A RECORD ON THIS AND DRILL DOWN A BIT ON THE FEASIBILITY OF THAT. OF COURSE, WE DON'T WANT THE STIGMA OF THIS RESEARCH TO DAMPEN IT TO SLOW THE SPEED.
DR. HALL: I HAVE PASSED ON THE INFORMATION THAT I HAD ABOUT HARVARD. I HAVE PASSED ON WITHIN THE STATE.
MS. SAMUELSON: BUT HARVARD HAS SET UP AN ACCOUNTING SYSTEM AND IS PROCEEDING WITH IT, RIGHT?
DR. HALL: YES, BUT OTHER INSTITUTIONS HAVE DECIDED NOT TO GO THAT ROUTE. I THINK IT'S A VERY -- IT'S NOT AS IF IT'S A MAGIC SOLUTION, THAT HARVARD HAS SOLVED SOME PROBLEM THAT NOW EVERYBODY CAN DO. PART OF IT IS I THINK HARVARD'S DECIDED TO DO IT THIS WAY, AND THAT'S GOOD FOR THE REST US BECAUSE HARVARD IS BIG ENOUGH. MOST INSTITUTIONS ARE NOT GOING TO SPEND OVER HALF MILLION DOLLARS ON LEGAL FEES TO RESEARCH THIS PROBLEM. AND SO I THINK -- SO IT WILL BE INTERESTING TO SEE HOW IT WORKS OUT, BUT I THINK WE CAN'T WAIT FOR IT TO WORK OUT. IT WON'T BE AUTOMATIC OR SIMPLE, AND I THINK WE NEED TO GO AHEAD AND JUST WORK WITH THE INSTITUTIONS AS CLOSELY AS POSSIBLE TO MAKE SURE THAT OUR MONEY IS SPENT WISELY AND THAT WE, ON THE OTHER HAND, LEAVE THEM SOME FREEDOM TO LIVE WITH THEIR OWN POLICIES.
MR. KLEIN: I'D LIKE TO SAY THAT BOTH JEFF AND JOAN'S INSTINCTS ARE GOOD HERE BECAUSE UNDER THE SECTION 125290.65 THAT DEFINES THAT THE FACILITIES WORKING GROUP, UNDER (G)(II), IT SPECIFICALLY CALLS OUT THAT THE CAPITAL EQUIPMENT COST AND CAPITAL EQUIPMENT LOANS BE ALLOCATED WHEN EQUIPMENT CAN BE RECOVERED IN PART BY THE GRANTEE FROM OTHER USERS OF THE EQUIPMENT. SO FROM THIS PERSPECTIVE, IF WE PAY FOR EQUIPMENT, IT'S POSSIBLE THAT THE GRANTEE CAN KNOW UP FRONT THAT THEY CAN CHARGE OFF PART OF THOSE COSTS TO OTHER GRANTS -- OTHER USES THAT ARE NONSTEM CELL USES THAT CAN HELP RECOVER PART OF THAT.
SO WE MIGHT NOT PAY FOR, FOR EXAMPLE, A HUNDRED PERCENT OF THE COST OF THE EQUIPMENT OR SET UP A SYSTEM WHERE IT'S, IN FACT, PART OF A GRANT, PART OF A LOAN, AND AS THESE CHARGES COME IN, THEY REPAY THE LOAN PORTION, COMES BACK TO THE FACILITIES COMMITTEE THAT CAN PUT THE MONEY OUT AGAIN. SO THERE IS SOME ABILITY FOR THIS COMMITTEE TO INNOVATE, AS ZACH SAYS, AS LONG AS THE COST IS LARGE ENOUGH TO JUSTIFY THIS KIND OF ACCOUNTING BY THE INSTITUTION.
CHAIRMAN DOMS: I THINK THAT IN THE DISCUSSIONS, AT LEAST, THAT I'VE HAD WITH STAFF, THAT'S A PRIORITY IN TERMS OF EQUIPMENT, TO ALLOCATE WHATEVER PORTION THEY CAN. IF THEY PURCHASE IT, TO ALLOCATE AS MUCH AS THEY CAN; OR IF THEY'RE SHARING IT, TO MAKE SURE THAT THE ALLOCATION IS CORRECT. BUT IT'S TO SPREAD THE COST AMONG AS MANY PEOPLE OR MANY ENTITIES AS POSSIBLE.
MR. SHEEHY: I JUST NOTE THAT IT IS ROUTINE. I MEAN WE HAVE A CORE IMMUNOLOGY LAB AND A CORE VIROLOGY LAB THAT ROUTINELY DO THE ACCOUNTING AND CHARGE INDIVIDUAL PI'S FOR USING THEIR FACILITIES. SO THIS IS KIND OF ROUTINE.
DR. HALL: THEY HAVE TO DO IT IN ORDER TO COVER THEIR OPERATING COSTS.
MR. SHEEHY: AND I GUESS THE QUESTION THAT JOAN WAS KIND OF ASKING IS IF WE PAY FOR IT, DOES THAT MEAN THAT NIH GRANTEES WOULD BE UNWILLING TO PAY US TO USE OUR EQUIPMENT? IT'S THE OPPOSITE SIDE OF THE QUESTION. WE WOULD BE USING NIH FUNDS. NIH WOULD BE KIND OF GOING OFF OUR CAPITAL.
DR. HALL: IT'S INTERESTING. I DON'T KNOW THE ANSWER TO THAT QUESTION.
MS. SAMUELSON: AND IT MAY BE THAT WITH THE SIZE GRANTS THAT WE CAN GIVE FOR RESEARCH, THAT THERE WILL BE ENOUGH OF AN INCENTIVE TO GET THEM, THAT LABS WILL BE WILLING TO TAKE THE RISK TO SET UP THE ACCOUNTING SYSTEMS AND MAYBE PUT SOME PRESSURE ON THE NIH.
MR. SHEEHY: WELL, THE ACCOUNTING SYSTEM, WHAT WE'RE TALKING ABOUT IS THAT WE GET A GIANT MICROSCOPE AND SOMEBODY GETS FUNDED FOR NIH AND USE PART OF THEIR NIH GRANT TO BORROW THE USE OF THE MICROSCOPE THAT WE BOUGHT.
DR. HALL: IF WE BUY IT, THEN THE NIH PEOPLE --
MR. SHEEHY: I DON'T THINK THE NIH WOULD FORBID THAT, AND THAT WOULD BE A CHARGE-BACK THAT WE COULD RECOVER IN TERMS OF WHAT BOB WAS TALKING ABOUT THAT COULD HELP TO FINANCE THE COST OF THIS CAPITAL EQUIPMENT.
CHAIRMAN DOMS: OKAY. WE HAVE ONE MORE QUESTION, AND I'D LIKE TO KEEP IT MOVING, IF WE CAN. WE'VE GOT A COUPLE MORE AGENDA ITEMS THAT WE NEED TO COVER. DAVID.
MR. LICHTENGER: I WAS JUST CURIOUS ABOUT HOW YOU DEFINE CAPITAL EQUIPMENT ON THE FACILITIES BUDGET AND CAPITAL EQUIPMENT FOR THE SCIENTIFIC BUDGET BECAUSE IT KIND OF SOUNDED AS THOUGH THE EXPENSIVE ITEMS WERE REALLY SCIENCE THINGS THAT THE SCIENTISTS ARE USING VERSUS, FOR EXAMPLE, A CAGE WASHER WHICH MIGHT BE USED IN A VIVARIUM WOULD BE MORE OF A FACILITIES CAPITAL EQUIPMENT.
CHAIRMAN DOMS: I THINK THAT'S BEEN THE --
DR. HALL: WE WILL WORK ON THAT.
CHAIRMAN DOMS: -- FOCUS OF OUR QUESTION, AND I THINK THAT'S UP TO ZACH AND STAFF TO COME BACK TO US WITH FURTHER INFORMATION OR A RECOMMENDATION TO US. ZACH, PLEASE GO AHEAD.
DR. HALL: LET ME JUST MOVE ON BECAUSE WHAT I'D LIKE TO DO IS JUST TO WALK YOU THROUGH A WAY IN WHICH THIS MIGHT WORK. I WANT TO EMPHASIZE THAT WHAT WE'RE TALKING ABOUT WHERE WE HAVE BOTH SCIENTIFIC AND FACILITIES REVIEW IS A NEW CHALLENGE FOR US. WE HAVEN'T DONE ANYTHING LIKE THIS, AND I THINK IT'S UNUSUAL EVEN IN OTHER AGENCIES.
SO I WANTED, HOWEVER, JUST SO THAT YOU WOULD HAVE SOME IDEA OF HOW IT MIGHT WORK. THIS IS NOT -- WE'RE NOT TRYING TO TELL YOU HOW TO DO YOUR BUSINESS, BUT JUST TO GIVE AN ILLUSTRATION SO THAT YOU CAN THINK ABOUT IT. SO I'VE JUST TALKED ABOUT THIS BEFORE. WE WOULD HAVE A LETTER OF INTENT BEFORE THE APPLICATION IS SUBMITTED. THE APPLICATIONS WOULD THEN GO THROUGH THE GRANTS WORKING GROUP TO REVIEW THE SCIENTIFIC CONTENT AND THE FACILITIES WORKING GROUP TO REVIEW PLANS FOR SPACE.
AND BASED ON THE DISCUSSION WITH RUSTY AND DAVID, WE THINK THAT THE PROPER THING IS FOR THE FACILITIES WORKING GROUP IN THE END TO HAVE ALL THIS INFORMATION AND TO MAKE THE FINAL RECOMMENDATION TO THE ICOC, WHICH THEN MAKES THE FINAL DECISION.
SO WHAT WE WOULD SAY IN THE RFA THAT WOULD BE IMPORTANT FOR INSTITUTIONS TO ANSWER? WHAT ARE THE KINDS OF CONSIDERATIONS WE MIGHT ASK FOR? AGAIN, WE DON'T -- I JUST PUT THESE OUT FOR ILLUSTRATIVE PURPOSES. IF YOU DON'T AGREE WITH THEM, I'M NOT GOING TO DEFEND THEM ONE WAY OR THE OTHER. I'M JUST TRYING TO PROVIDE AN IDEA.
WHAT SPACE AND FACILITIES DO THEY PRESENTLY HAVE FOR HUMAN STEM CELL RESEARCH? ARE THERE CORE FACILITIES SHARED SPACE AVAILABLE NOW FOR HUMAN STEM CELL RESEARCH OUTSIDE THE FEDERAL GUIDELINES? HOW LARGE WOULD A PROPOSED NEW FACILITY BE? WE WOULD SET LIMITS ON THAT. WHERE WOULD IT BE LOCATED? DO THEY PLAN TO EXPAND AN EXISTING FACILITY OR TO RENOVATE SPACE THAT THEY HAVE NOT COMMITTED TO THIS BEFORE? SOME INSTITUTIONS MAY HAVE SOME OF THIS ALREADY, BUT THEY NOW NEED TO EXPAND IT. IS IT GOING TO BE DONE IN THE INSTITUTION SPACE? DAVID, YOUR QUESTION. OR WILL SPACE BE RENTED OR LEASED FROM SOMEBODY ELSE? IF EXISTING SPACE, WILL THERE BE RENOVATION? WHAT IS THE BUDGET AND TIMETABLE FOR COMPLETION?
AND THEN WE IMAGINE THAT THE KINDS OF QUESTIONS YOU MIGHT ASK IN YOUR DISCUSSIONS ARE: IS THIS A REASONABLE COST? ARE THE TIMELINES AND MILESTONES SATISFACTORY? CONSTRUCTION AND RENOVATION PLANS? ARE THE RATES COMPETITIVE? IS THERE ADEQUATE OVERSIGHT TO BE SURE THAT CONSTRUCTION WORK IS GOING TO BE DONE TO A HIGH STANDARD? IS THERE GOOD INSTITUTIONAL CAPABILITY FOR RENOVATION AND MAINTENANCE OF SPACE? THIS WON'T BE A PROBLEM IN THE LARGE INSTITUTIONS, BUT WE CAN IMAGINE PLACES APPLYING THAT DO NOT HAVE STRONG FACILITIES EXPERTISE. AND WHAT IS THE LEVEL OF INSTITUTIONAL COMMITMENT, WHICH IS WHAT WE MENTIONED BEFORE.
CHAIRMAN DOMS: LET ME MAKE A COMMENT ON THESE LAST TWO SLIDES. IN TERMS OF THE NEXT AGENDA ITEM, WE'RE GOING TO TALK ABOUT THE PROCESS FOR REVIEWING THE GRANTS. IT'S NOT ON THE AGENDA, AND IT'S SOMETHING THAT WE WILL UNDERTAKE FOR THE NEXT MEETING, IS THE CRITERIA. I THINK ZACH HAS A VERY GOOD START HERE, AND THESE ARE THE ISSUES. I THINK THEY'RE ALL RELEVANT ISSUES, BUT I THINK IT HAS TO BE EXPANDED. AND THAT WOULD BE THE RESPONSIBILITY OF MEMBERS OF THIS COMMITTEE, PARTICULARLY THE REAL ESTATE PEOPLE ON THIS COMMITTEE, WORKING WITH STAFF. AND AT THE NEXT MEETING, WE WOULD TALK ABOUT THE CRITERIA THAT WE WOULD EVALUATE THESE GRANT APPLICATIONS ON. BUT TODAY WE'RE GOING TO FOCUS ON THE REVIEW PROCESS, VERY RELEVANT, BUT --
DR. HALL: JUST TO ORIENT EVERYBODY IS ALL IT'S MEANT TO DO.
CHAIRMAN DOMS: I APPRECIATE THAT, BUT IT'S GOING TO BE PART OF WHAT WE DISCUSS AT OUR NEXT MEETING.
DR. HALL: LET ME JUST REPEAT THESE LAST TWO SLIDES ON THE SCIENCE SIDE SO THAT YOU HAVE SOME IDEA THE WAY IT WOULD WORK THERE. WE WOULD ASK IN THE RFA, FOR EXAMPLE, HOW MANY SCIENTISTS DO YOU ANTICIPATE MIGHT WANT TO USE THIS SPACE? HOW MANY SCIENTISTS ARE NOW DOING HUMAN STEM CELL WORK AT THE INSTITUTION? OR WE WOULD MAKE SOME EVALUATION OF THE QUALITY OF THE WORK OF THE SCIENTISTS. IF IT'S SOMEBODY WHO HASN'T HAD A GRANT FOR TEN YEARS, IT'S NOT CLEAR WE'D WANT TO BUILD A FACILITY FOR THEM. WILL THE PROPOSED FACILITY BE AVAILABLE TO THOSE FROM OTHER INSTITUTIONS IN THE AREA? AND WE MIGHT WANT TO SET REQUIREMENTS FOR THIS. WHAT EQUIPMENT AND STAFFING DO THEY PROPOSE? AND, AGAIN, WE WOULD PUT SOME REQUIREMENTS ON THIS. WHO WILL SUPERVISE THE SPACE? VERY, VERY IMPORTANT.
JEFF, YOU MENTIONED CORE FACILITIES. EVERYBODY WHO'S HAD ANYTHING TO DO WITH CORE FACILITIES KNOWS THAT UNLESS YOU HAVE SOMEBODY RUN IT WHO'S THERE AND HAS SCIENTIFIC OVERSIGHT, IT WILL NOT BE A SUCCESS. YOU CAN'T HAVE A MACHINE SHOP AND SAY ANYBODY WANTS TO CAN COME IN. OTHERWISE YOUR TOOLS ARE BANGED UP. AND IT'S THE SAME WITH BIOLOGICAL EXPERIMENTS.
HOW WILL PRIORITIES FOR SHARED USE BE DETERMINED? WHO DECIDES WHO GETS TO USE THE SPACE AND IN WHAT PRIORITY? SO ALL OF THESE WOULD BE THINGS THAT THE SCIENTISTS WOULD MAKE SOME EVALUATION OF.
SO THEN WHEN IT CAME TO BE REVIEWED, THEN I THINK THE REVIEWERS WOULD SAY HOW MANY USERS ARE ANTICIPATED? WHAT ARE THEIR SCIENTIFIC QUALIFICATIONS? IS THE AMOUNT OF SPACE JUSTIFIED BY THE PROPOSED NEED? VERY IMPORTANT TO COORDINATE THOSE TWO. WILL THERE BE EXPERTISE? AND JUST TO ASK THE QUESTIONS ON OUT.
I THINK THAT'S ALL -- LET ME THEN TAKE THAT OUT. THAT BASICALLY CONCLUDES MY PRESENTATION AT THIS POINT, AND I WOULD TURN IT OVER TO --
CHAIRMAN DOMS: ARE THERE ANY QUESTIONS?
MR. SHEEHY: COULD I JUST ASK ONE? AND THIS IS JUST FOR THE FUTURE. COULD WE GET -- COULD WE REALLY DIG DOWN ON HOW THE ACCOUNTING IS DONE WITHIN INTRAINSTITUTIONAL? I CAN SEE A SCENARIO WHERE WE GET A SHARED FACILITY AND WHERE WE GET DOUBLE POPPED. WE PUT THE FACILITY IN, AND THEN THEY CHARGE SOMEBODY THAT WE FINANCED TO DO RESEARCH TO HAVE THEIR SPECIMENS PUT THROUGH A HIGH INPUT, HIGH THROUGHPUT, SO I WOULD NOT --
DR. HALL: WE WILL HAVE ADMINISTRATIVE SAFEGUARDS.
MR. SHEEHY: IT WOULD BE GREAT TO KIND OF UNDERSTAND. AND MAYBE TO SEE IF THERE IS AN INTEREST WHEN WE DO START TO TALK ABOUT BUYING THESE VERY EXPENSIVE PIECES OF EQUIPMENT OF RECOUPING BECAUSE I'M CERTAIN THAT -- DOESN'T SEEM LIKE -- WE OUGHT TO BE ENCOURAGING THEM TO MAKE THESE MORE WIDELY AVAILABLE TO OTHER RESEARCHERS IN ORDER TO RECOUP COSTS. I HAVE A FEELING THAT THAT WILL HAPPEN ANYWAY; BUT IF WE FRONT-END, WE MIGHT GET SOME OF THAT MONEY BACK.
CHAIRMAN DOMS: THAT'S AN EXCELLENT POINT, JEFF.
MS. SAMUELSON: I HAVE A SOMEWHAT RELATED QUESTION. I'M STILL FOCUSED ON BUILDING THE RECORD FOR THE NECESSITY OF INVESTING IN THE SPACE. AND I WONDER IF THAT MAYBE AT THE NEXT MEETING WE COULD IN PERHAPS A CLOSED SESSION HAVE SOME SCIENTISTS COME TO US WHO HAVE HAD EXPERIENCE WITH INTIMIDATION, PROPOSED AUDITS THEY DON'T THINK THEY OTHERWISE WOULD HAVE GOTTEN, OR USING AN ACCOUNTING SYSTEM THAT WORKS SO THAT WE WOULD HAVE AN EXPERTISE OURSELVES AND CAN EFFECTIVELY DEFEND SPENDING MONEY ON SPACE WHEN WE KNOW THAT SOME LABS ARE ABLE TO GET FEDERAL FUNDING AND USE THE SAME SPACE THROUGH AN ACCOUNTING SYSTEM.
CHAIRMAN DOMS: ZACH, IS THAT SOMETHING YOU THINK WE COULD TAKE A STAB AT? LET ME JUST SAY I HAVE TALKED TO TWO INSTITUTIONS THAT HAVE CONSIDERABLE RESEARCH ACTIVITIES. AND THE ATTITUDE OF ONE OF THOSE INSTITUTIONS IS I'M NOT GOING TO DO ANYTHING TO JEOPARDIZE MY RELATIONSHIP WITH NIH. THE OTHER ONE SAID I'M PREPARED TO DEVELOP A SET OF ACCOUNTING STANDARDS WITH ALLOCATIONS, AND I CAN LIVE BY THEM, AND I'LL BE PREPARED TO DEFEND THEM IF SUBJECT TO AN NIH AUDIT. I THINK IT'S THAT IMPORTANT. THEY THINK IT'S THAT IMPORTANT, AND THEY'RE PREPARED TO REALLY WORK. THEY THINK THEY'RE A LONG WAY TOWARDS THAT, OF SEGREGATING NIH SPACE VERSUS NON-NIH SPACE WITH THE HOPE OF, OBVIOUSLY, GETTING SOME GRANTS FROM US. AND THEY'RE ONLINE AND THEY'RE WORKING ON THAT, AND THEY'RE PREPARED -- THEY SAY AT THIS POINT THEY'RE PREPARED TO DO THAT. SO THERE IS SOME WORK BEING DONE. IT'S SORT OF A PHILOSOPHY AND A COMMITMENT OF THE INSTITUTION AS TO WHERE THEY WANT TO DRAW THIS LINE.
DR. HALL: YOU KNOW, I THINK WE -- I WOULD JUST SAY THAT IF THE SITUATION WERE -- LET ME PUT IT ANOTHER WAY. I THINK THAT WHAT WE SHOULD FOCUS ON IS THE FACT THAT THIS SPACE IS NEEDED ALMOST NO MATTER WHAT THE POLICY IS AT THE UNIVERSITY. IT IS MURKY. IT MAY CHANGE. BOB HAS MADE THIS POINT A NUMBER OF TIMES. THESE POLICIES CAN BE CHANGED IN A MINUTE, BETTER OR FOR WORSE; AND THAT BECAUSE THIS PARTICULARLY HUMAN EMBRYONIC STEM CELL RESEARCH HAS BEEN RELATIVELY TRUNCATED BECAUSE IT TAKES -- BY THE FEDERAL RESTRICTIONS BECAUSE IT TAKES SOME SPECIALIZED EQUIPMENT AND KNOWLEDGE, ALMOST EVERYBODY SAYS THEY NEED, NOT HUGE WINGS OF BUILDINGS, YES, MAYBE EVENTUALLY, BUT RIGHT NOW THEY JUST NEED SPACE TO GET STARTED IN.
SO I THINK THE SITUATION IS SUFFICIENTLY MURKY. MY OWN FEELING IS THERE'S STRONG JUSTIFICATION AND THAT EVEN IF AN INSTITUTION HAS DECIDED, AS RUSTY SAID, IN A SECOND THAT THEY'RE GOING TO FIGHT IT, THAT WE SHOULD BE WILLING TO GO IN AND PUT SPACE IN THERE FOR THEM TO GET THEIR WORK GOING. I REALLY FIRMLY BELIEVE THAT WHAT WE SHOULD KEEP OUR EYE ON HERE IS PROVIDING SPACE TO GET THIS WORK STARTED.
MR. KLEIN: I WOULD ABSOLUTELY REINFORCE THAT COMMENT BY SAYING, REMEMBER, THAT IN 1994 WHEN THERE WAS FUNDING TO THE NIH FOR EMBRYONIC STEM CELL RESEARCH THAT WAS TO BE TRIGGERED BY THE PRESIDENT'S COMMISSION ISSUING MEDICAL AND ETHICAL STANDARDS REGULATIONS FOR THAT RESEARCH, THAT PRESIDENT CLINTON SET UP A COMMISSION. AND AS YOU KNOW, I REFERENCED BEFORE, THE COMMISSION WORKED AN ENTIRE YEAR. AND YET THE HISTORICAL RECORD SHOWS THAT SINCE THE CONGRESSIONAL ELECTIONS WENT AGAINST CLINTON, THAT ON THE VERY DAY HIS COMMISSION ISSUED THE REGULATIONS THAT WOULD HAVE TRIGGERED THE RELEASE OF THE FUNDING FROM NIH FOR EMBRYONIC STEM CELL RESEARCH, IN ORDER TO BE ABLE TO HAVE IN THE HOUSE OF REPRESENTATIVES THE SUPPORT FOR HIS NIH FUNDING BILL, CLINTON HAD TO ISSUE A LETTER SUSPENDING HIS OWN COMMISSION'S REGULATIONS SO THAT NO FUNDING WAS EVER RELEASED.
AND IT'S A VERY STRONG DEMONSTRATION TO RESEARCH INSTITUTIONS THAT IF THE HOUSE ELECTIONS, FOR EXAMPLE, IN 2006 GO MORE CONSERVATIVELY, BECAUSE THAT'S, OF COURSE, THE RELIGIOUS RIGHT -- THE FRINGES OF THE RELIGIOUS RIGHT ARE PUTTING OUT A LOT OF MONEY TO MAKE SURE THAT HAPPENS. AND STEM CELL RESEARCH IS ONE OF THEIR PRINCIPAL TARGETS. THAT WHOEVER IS IN OFFICE CAN BE IN A POSITION WHERE THERE IS PRESSURE ON THE NIH, IF THEY'RE GOING TO RECEIVE THEIR FUNDING, TO, IN FACT, BE EVEN TO THE EXTENT OF BEING PUNITIVE IN TERMS OF THEIR INTERPRETATION OF REGULATIONS.
STANFORD WENT THROUGH AN AUDIT SOME YEARS AGO WHERE THEY THOUGHT THEY HAD REPRESENTATIONS ON WHAT WAS ACCEPTABLE COST ALLOCATION PRACTICES. IN FACT, AT THE END OF THAT AUDIT, THERE WAS LESS THAN 2 PERCENT OF THE COSTS OF WHICH THERE WAS A DISAGREEMENT, BUT STANFORD WAS UNDER TREMENDOUS CRITICISM AND NEGATIVE PUBLICITY THROUGH THAT AUDIT. SO THERE ARE A LOT OF INSTITUTIONS THAT WATCHED THAT HISTORY, REALIZING THE SENSITIVITY OF THIS ISSUE, THEY WON'T CREATE A WHOLE NEW DEPARTMENT. THEY WON'T HIRE PEOPLE AND RECRUIT CHAIRS AND PUT THEM INTO A POSITION WHERE THE VERY SPACE THEY'RE WORKING UNDER CAN BE PULLED OUT FROM UNDER THEM. WE HAVE TO PROVIDE, IF PEOPLE ARE GOING TO DEDICATE THEIR LIVES TO THIS AREA, SOME SENSE OF STABILITY AND REMOVE AT LEAST THAT RISK.
MR. SHEEHY: COULD I JUST ADD TO THAT, HAVING TALKED TO STEM CELL SCIENTISTS AT THE STANDARDS WORKING GROUP WHO HAD BEEN THROUGH AN NIH AUDIT, AND EVEN THOUGH HE PASSED, I MEAN THESE ARE TRAUMATIZING EXPERIENCES. AND THERE ARE COSTS ASSOCIATED WITH GOING THROUGH THESE AUDITS THAT WE MAY NOT SEE, BUT THEY DO. THEIR ENTIRE STAFF, EVERYTHING COMES TO A GRINDING HALT WHEN AN NIH AUDIT TAKES PLACE. AND EVERY PIECE OF PAPER HAS TO BE ACCOUNTED FOR. SO THERE IS A STRONG RATIONALE FOR TRYING TO SEGREGATE THIS.
MS. SAMUELSON: OF COURSE. I THINK THIS IS A DISCUSSION THAT WILL CONTINUE OFFLINE AND SHOULD BECAUSE IT'S IMPORTANT THAT WE BE CAUTIOUS IN HOW WE USE OUR MONEY. $3 BILLION IS NOT MUCH MONEY WHEN YOU'RE TALKING ABOUT ACTUALLY GETTING EFFECTIVE THERAPIES AND CURES, AND SO WE HAVE TO BE JUDICIOUS ABOUT IT.
CHAIRMAN DOMS: THANK YOU. THANK YOU, ZACH. OUR NEXT AGENDA ITEM IS AGENDA ITEM NO. 8, CONSIDERATION OF ALL REVIEW PROCEDURES FOR FACILITIES GRANTS. WHAT I'D LIKE YOU TO DO IS TAKE A COUPLE MINUTES, I THINK IT'S IN TAB 3, AND READ THAT. AND THEN WE'LL TALK ABOUT IT.
MR. SERRANO-SEWELL: CAN WE HAVE A FIVE-MINUTE BREAK?
CHAIRMAN DOMS: WE CAN TAKE A FIVE-MINUTE BREAK. FIVE MINUTES ONLY, PLEASE.  

 

(A RECESS WAS TAKEN.) 
CHAIRMAN DOMS: BOB, CAN WE -- LET'S GET STARTED BECAUSE WE'RE SORT OF RUNNING UP AGAINST IT. I THOUGHT WE HAD PLENTY OF TIME ON THE AGENDA. I THINK WE'VE HAD A GREAT DISCUSSION. WE HAVE TWO AGENDA ITEMS LEFT TO COVER. ONE IS THE REVIEW PROCESS, AND THE OTHER ONE IS THE BYLAWS.
AND THEN CAN I ASK A QUESTION NOW. IS THERE ANYBODY FROM THE PUBLIC THAT WANTS TO COMMENT? I'M NOT ASKING YOU TO DO IT NOW. I'M SORRY. I'M TRYING TO GET A SENSE OF THE TIMING HERE. MR. REED, YOU WILL COMMENT. IS THERE ANYBODY ELSE THAT HAS A COMMENT? THANK YOU VERY MUCH.
THE NEXT AGENDA ITEM IS THE REVIEW PROCESS FOR FACILITIES GRANT APPLICATIONS. YOU'VE ALL HAD A CHANCE TO READ THAT, AND I WANT TO MAKE THE DISTINCTION. THIS IS THE PROCESS FOR REVIEWING THE GRANTS. IT'S NOT HOW WE EVALUATE THE GRANTS. THE EVALUATION OF THE GRANTS WILL BE DISCUSSED AT THE NEXT BOARD MEETING.
LET ME JUST SUMMARIZE IT, AND THEN I'LL OPEN IT UP FOR DISCUSSION, BUT I WANT TO SAY THAT THIS FOLLOWS SIMILAR GUIDELINES TO THE PROCESS FOLLOWED IN THE STANDARDS GROUP AND THE SCIENTIFIC GRANTS GROUP. THEY SPENT A LOT OF TIME WORKING ON IT. STAFF HAS REVIEWED IT. AND FROM MY THINKING ABOUT IT AND REVIEWING IT, I THINK IT MAKES A LOT OF SENSE. BUT LET ME GO IT THROUGH IT BRIEFLY, AND THEN WE'LL OPEN IT UP FOR QUESTIONS.
AS I SAY, THE JOB OF -- ONE OF THE JOBS OF THIS COMMITTEE IS TO REVIEW THE MERIT OF THE GRANT APPLICATIONS. AND ALL MEMBERS PARTICIPATE IN THIS. AND I WANT TO MAKE IT VERY CLEAR THAT THIS COMMITTEE IS A WORKING GROUP AND DOES NOT APPROVE THESE GRANTS. THIS GROUP MAKES A RECOMMENDATION TO THE ICOC. THE ICOC THEN HAS THE AUTHORITY, IT'S BASICALLY THEIR DECISION TO APPROVE THEM, TO REJECT THEM, TO MODIFY THEM. SO OUR FUNCTION IS TO MAKE RECOMMENDATIONS TO THE ICOC, AND THEN THEY TAKE IT FROM THERE.
SO AFTER WE RECEIVE THE GRANT APPLICATION, THE STAFF, IN CONSULTATION WITH ME AND PROBABLY DAVID, WILL ASSIGN THE APPLICATION TO A PRIMARY REVIEWER AND A SECONDARY REVIEWER. AND I'M PROPOSING THAT THE PRIMARY REVIEWERS IN THIS SITUATION BE MEMBERS OF THE REAL ESTATE -- REPRESENTING THE REAL ESTATE SIDE OF THINGS WITH THE SECONDARY REVIEWER BEING A PATIENT ADVOCATE. AND THEY'LL BE ASSIGNED BASED ON THEIR EXPERIENCE. ANY POTENTIAL CONFLICTS OF INTEREST, I THINK WE'VE GONE THROUGH THAT ALREADY, AND I DON'T THINK THERE WILL BE ANY, BUT WE'LL TAKE A LOOK AT IT.
AND THEN THE PRIMARY REVIEWER IS ASKED TO WRITE A DESCRIPTION OF THE GRANT BASED ON THE MATERIAL SUBMITTED BY THE APPLICANT. AND THEN THE PRIMARY AND THE SECONDARY REVIEWER WILL BE ASKED TO WRITE A ONE- OR TWO-PAGE SUMMARY ADDRESSING THE APPLICATION STRENGTHS AND WEAKNESSES AND EVALUATE IT BASED ON IN THE LIGHT OF THIS SPECIFIED CRITERIA, WHICH AT THIS POINT WE DON'T HAVE.
AND BASED ON THOSE WRITTEN PRESENTATIONS, AND WE WILL GET THEM TO YOU THREE DAYS PRIOR TO THE MEETING, AND I'LL TALK ABOUT MATERIAL FOR MEETINGS AT THE CONCLUSION OF THE MEETING BECAUSE I DO WANT TO ADDRESS THAT ISSUE. YOU WILL GET THE REVIEWS, THEN WE'LL ALL SIT DOWN AND WE WILL DISCUSS EACH OF THE INDIVIDUAL GRANT APPLICATIONS. AT THAT POINT WE WILL ASK THE MEMBERS TO SUBMIT -- I'M SORRY -- WE WILL ASK THE MEMBERS TO EVALUATE IT, AND WE'LL ASK THEM TO GIVE US A SCORE. AND THAT SCORE WILL RANGE FROM ONE TO A HUNDRED. AND THAT WILL BE DONE SEPARATELY ON A SECRET BALLOT BASIS. EACH OF THE MEMBERS OF THIS COMMITTEE WILL GIVE THAT A GRADE, AND THEY WILL BE GIVEN TO THE STAFF. THE STAFF WILL THEN CALCULATE THE SCORE FOR EACH OF THE APPLICATIONS, AND THEN THEY WILL COME BACK TO US WITH THAT SCORE.
SO AT THAT POINT, WE'VE REVIEWED THEM, WE'VE DISCUSSED THEM, THEY HAVE A SCORE, AND THEN AT THAT POINT DAVID WILL TAKE OVER SINCE WE'RE LOOKING FOR A RECOMMENDATION AT THAT POINT. DAVID, AS THE VICE CHAIR OF THIS COMMITTEE, WILL TAKE OVER, AND HE'LL PRESIDE OVER A DISCUSSION THAT PUTS THESE GRANTS INTO BASICALLY THREE CATEGORIES: RECOMMENDED FOR FUNDING, WHICH IS HIGHLY MERITORIOUS; AND WE'RE GOING TO RECOMMEND IN THAT GROUP, AND I THINK IN THE BYLAWS IT'S SPELLED OUT, IN THE DRAFT OF THE BYLAWS IT IS A TIER ONE GRANT. WE'RE GOING TO RECOMMEND THOSE FOR FUNDING. AGAIN, WE'LL RECOMMEND THEM TO THE ICOC FOR FUNDING. AND THEN WE HAVE RECOMMENDED FOR FUNDING PENDING AVAILABLE FUNDS. THE AMOUNT OF FUNDS IS A SEPARATE ISSUE NOT FOR DISCUSSION TODAY. IT DEPENDS ON WHAT KIND OF FUNDING WE HAVE AVAILABLE. AND ASSUMING THAT WE HAVE FUNDS, WE THINK THESE GRANTS ARE QUALIFIED FOR FUNDING. AND THEN WE HAVE THE THIRD CATEGORY, WHICH IS NOT RECOMMENDED FOR FUNDING AT THIS TIME.
NOW, THERE'S A PROVISION IN THERE THAT SAYS IF 35 PERCENT OF THE MEMBERS HAVE A MINORITY POSITION, THEN THAT GRANT WILL BE SUBMITTED TO THE ICOC WITH THE QUALIFICATION THAT IT WAS NOT RECOMMENDED FOR FUNDING, BUT THERE'S A 35 PERCENT PERCENTAGE, IF YOU WILL, THAT DO FEEL THAT THAT SHOULD BE CONSIDERED FOR FUNDING.
THAT'S HOW THE PROCESS BASICALLY WORKS FOR, I KNOW, SCIENTIFIC GRANTS GROUP WITH SOME MODIFICATIONS. THE MODIFICATION BEING THAT I THINK THE PRIMARY REVIEWER SHOULD BE A MEMBER OF THE REAL ESTATE FIELD ON THIS COMMITTEE. THEY HAVE TWO REVIEWERS. WE HAVE A MUCH SMALLER GROUP, SO WE'LL ONLY HAVE ONE SECONDARY REVIEWER. IT'S A PROCESS THAT THE SCIENTIFIC GROUP IS COMFORTABLE WITH. I THINK MEMBERS OF THE PATIENT ADVOCATE GROUP HERE ARE MEMBERS OF THE SCIENTIFIC GROUP COMMITTEE. IF THEY CARE TO COMMENT, I'D APPRECIATE THEIR COMMENTS. BUT IT'S FAIRLY SIMPLE. IT'S FAIRLY STRAIGHTFORWARD. AND I THINK IT'S ONE THAT WILL WORK BASED ON WHAT WE'VE SEEN WITH THE OTHER GROUPS. AT THIS POINT OPEN IT UP FOR QUESTIONS.
DR. HALL: THERE WAS ONE THING THAT I DON'T KNOW IF IT WAS INADVERTENT OR NOT, BUT ONE LITTLE ADDITION THERE WAS WE HAD TALKED ABOUT AFTER YOUR GROUP GIVES IT A SCORE AND YOU TURN IT OVER TO DAVID, AT THAT POINT THEN ALSO THE STAFF GIVES YOU THE SCIENTIFIC SCORE.
CHAIRMAN DOMS: YOU'RE RIGHT. I'M SORRY. YOU'RE ABSOLUTELY RIGHT. YOU WANT TO COMMENT ON THAT? I DON'T THINK WE'VE QUITE DETERMINED HOW THAT SCIENTIFIC SCORE IS GOING TO BE INCORPORATED. IS IT A SEPARATE SCORE? IS IT INCORPORATED INTO THE FACILITIES SCORE? AND I THINK THAT'S SOMETHING THAT WE NEED TO GIVE MORE THOUGHT TO, AND WE'LL GET BACK TO THIS GROUP.
DR. HALL: I JUST WANT TO MAKE SURE IT WAS ON THE TABLE WHATEVER YOU DECIDE.
MR. SHEEHY: OKAY. SO I'M JUST GOING TO BASICALLY TAKE APART THIS PROCESS REALLY QUICKLY. AND JUST TO PUT IT IN BALANCE, THE STANDARDS WORKING GROUP ACTUALLY HAS A COMPLETELY DIFFERENT PROCESS FROM THE GRANTS WORKING GROUP. SO HAVING SAT ON BOTH, THERE ARE VIRTUES TO EACH. ONE IS THAT IT WOULD SEEM TO ME THAT THE SCIENTIFIC REVIEW SHOULD TAKE PLACE FIRST BECAUSE WE SHOULD NOT EVALUATE SOMETHING THAT HASN'T HAD THE SCIENTIFIC REVIEW. SO THAT WILL WEED OUT A LOT OF STUFF THAT WE SHOULDN'T EVEN WORRY ABOUT LOOKING AT. IF THE SCIENTISTS THINK IT'S NOT WORTHY, THEN WHY SHOULD WE EVEN REVIEW IT?
I THINK SENDING IT TO A TEAM TO EVALUATE IS A GOOD IDEA, BUT IT SHOULD NOT BE A SEPARATED PROCESS. IT SHOULD BE A COLLABORATIVE PROCESS.
I DON'T LIKE THE SECRET SCORING. I THINK WE SHOULD BE MORE OPEN, AND I ALSO THINK -- NOT TO DISPLAY TOO INTIMATE OF A KNOWLEDGE OF THE REAL ESTATE INDUSTRY, BUT MY PARTNER IS A RESIDENTIAL REALTOR, AND IT SEEMS LIKE WHAT YOU GUYS DO BEST IS NEGOTIATE. THERE'S NOT A NEGOTIATION LOOP IN HERE. WHERE IS OUR COUNTER? I THINK THAT WE SHOULD BUILD -- THIS VERY CLOSELY MIRRORS THE SCIENTIFIC REVIEW, AND THIS IS NOT A SCIENTIFIC REVIEW. THIS IS FACILITIES NEGOTIATION IS HOW I SEE IT. AND I WOULD LOVE TO BE ABLE TO TAKE ADVANTAGE OF THE FOLKS WHO HAVE VOLUNTEERED BASICALLY. I'M SURE WE'RE DOING SOMETHING, BUT IT NOWHERE COMES NEAR TO WHAT YOU GUYS GET FOR DOING YOUR DAY JOBS, TO REALLY SEE IF WE COULD TAP INTO YOUR ABILITY TO CUT REALLY GOOD, HARD BARGAINS WITH THE PEOPLE THAT WE'RE WORKING WITH AND SOMEHOW TO BUILD A PROCESS THAT WILL ALLOW THAT TO HAPPEN.
CHAIRMAN DOMS: ANY OTHER COMMENTS?
MS. SAMUELSON: JUST TO SUPPLEMENT WHAT JEFF HAD TO SAY. I SEE THE SCIENTIFIC REVIEW PROCESS OR THE RESEARCH FUNDING WORKING GROUP'S PROCESS AS EVOLVING. WE HAVE A PROCESS THAT WAS SET IN PLACE FOR THE FIRST TRAINING GRANTS, BUT I THINK NOW WE'RE GOING TO BE ABLE TO REVIEW THAT AND SEE WHERE IT SHOULD BE TWEAKED, AND I'M SURE IT SHOULD BE IN SOME RESPECTS, SO I WOULDN'T THINK TOO MUCH ABOUT NEEDING TO FOLLOW THAT.
IN ADDITION, THE STANDARDS GROUP HAS ANOTHER PROCESS THAT'S DIFFERENT. SO IT SEEMS TO ME IT SHOULD BE ONE THAT'S REALLY FOCUSED ON WHAT WE'RE TRYING TO ACCOMPLISH WITHIN THIS WORKING GROUP AND, AS JEFF SAID, REALLY BENEFITING FROM YOUR EXPERTISE.
MR. LICHTENGER: THANK YOU. JEFF MADE A LOT OF GOOD POINTS, AND THE FIRST THOUGHT I HAD ABOUT THIS IS THAT I'M NOT A SCIENTIST. AND I NEED -- WE NEED THE SCIENTIFIC ANALYSIS AND EVALUATION TO OCCUR FIRST BECAUSE I DON'T THINK WE NEED TO ANALYZE THOSE PROPOSALS THAT REALLY AREN'T UNDER CONSIDERATION FOR SCIENTIFIC MERIT. SO I THINK THAT MAKES A LOT THE SENSE, AND I AGREE WITH JEFF ON THAT.
THE OTHER THING IS THAT I CAN SEE THAT THERE MIGHT BE, LET'S SAY, YOU KNOW, SEVERAL PROPOSALS THAT HAVE GOOD SCIENTIFIC MERIT, BUT HAVE SIGNIFICANT, HOW SHALL I SAY, FACILITIES CHALLENGES, AND THAT THERE MIGHT BE STIPULATIONS, AND AS JEFF IS PUTTING IT, NEGOTIATIONS THAT MIGHT OCCUR ABOUT, WELL, WE REALLY LIKE YOUR PROPOSAL FROM A SCIENTIFIC PERSPECTIVE, BUT WE SEE MAJOR FLAWS FROM A FACILITIES AND REAL ESTATE SIDE, BUT, YOU KNOW, COULD YOU STRUCTURE IT THIS WAY AND LOOK AT TAKING -- INSTEAD OF BUILDING A WHOLE NEW BUILDING, LOOKING AT SPACE NEAR POTENTIALLY A UNIVERSITY TO LEASE AND OTHER SUGGESTIONS.
MR. SERRANO-SEWELL: I APOLOGIZE FOR MISSING THE FRONT END OF THIS CONVERSATION, BUT I THINK WHAT YOU, CORRECT, JEFF, IF I'M WRONG, YOU WANT TO ALLOW THE EXPERTS -- WELL, THE MEMBERS OF THIS COMMITTEE AND THE COMMITTEE ITSELF SOME ABILITY TO NEGOTIATE WITH THOSE INSTITUTIONS THAT HAVE SUBMITTED PROPOSALS FOR CONSIDERATION?
MR. SHEEHY: I WOULD LEAVE IT TO THE EXPERTS TO FIGURE OUT HOW EXACTLY WE DO THAT, BUT IT SEEMS LIKE, AS DAVID SUGGESTED, WE GET THE SCIENTIFICALLY REVIEWED PROPOSALS AND WE SOMEHOW MAKE SOME EVALUATION OF THOSE. AND THEN WE CAN SIT AROUND AND HAVE SOME SORT OF DISCUSSION AND THEN HAVE A FEEDBACK THAT WE GIVE TO THE INSTITUTIONS. AND MAYBE OUR MEETINGS -- MAYBE WE NEED TO THINK ABOUT, WHEN WE SCHEDULE OUR SCIENTIFIC REVIEW MEETINGS, TO ACTUALLY HAVE TWO MEETINGS SET UP WITHIN A RELATIVELY NARROW TIME FRAME SO THAT WE HAVE THE ABILITY TO SEND IT BACK TO THE INSTITUTIONS WITH THE DEFICIENCIES, THAT THEY CAN GET AN OPPORTUNITY TO ADDRESS THE DEFICIENCIES, AND THEN WE CAN MEET AGAIN AND THEN DO A FINAL RANKING. THAT JUST SEEMS TO ME --
MR. SERRANO-SEWELL: JUST AS A FOLLOW-UP, AND I WANT TO ASK JAMES THIS QUESTION, CAN WE BUILD THAT IN OUR RFA? I KNOW WITH THE CITY, WE SEND OUT AN RFA. THERE'S VERY STRICT DEADLINES, THE SUBMITTAL DATES, LETTER OF INTENT. IT'S VERY HARD AND WITH GOOD REASON. WE DON'T WANT TO EXPOSE THE CITY TO ANY KIND OF LIABILITY DOWN THE ROAD, AND WE WANT TO GIVE AN EVEN PLAYING FIELD FOR EVERYONE.
MR. HARRISON: THIS WORKING GROUP CAN ESTABLISH WHATEVER PROCEDURES IT WANTS TO IN ORDER TO REVIEW THE APPLICATIONS. THERE ARE DUE PROCESS CONSIDERATIONS THAT MAY ARISE IF ONE APPLICANT IS TREATED DIFFERENTLY THAN ANOTHER AND THAT LEADS TO A COMPLAINT. BUT YOU CAN STRUCTURE IT AT YOUR DISCRETION PROVIDED THAT YOU COMPLY WITH DUE PROCESS REQUIREMENTS AND TREAT ALL THE APPLICANTS FAIRLY.
CHAIRMAN DOMS: THANK YOU. JEFF, IN RESPONSE TO YOUR COMMENTS, I'M GLAD TO HEAR YOU THINK THAT THE SCIENTIFIC REVIEW -- WE'VE HAD SOME DISCUSSIONS ON THAT, AND WE'VE BEEN CONCERNED ABOUT FAIRNESS IN TERMS OF REVIEWING ALL THE FACILITIES GRANTS THAT COME IN AS A -- UNDER THE SHARED RFA, WHICH IS A FACILITIES RESPONSIBILITY. AND WE HAD SOME CONCERN THAT IF IT'S A FACILITIES GRANT AND YOU HAVE THE SCIENTIFIC COMMITTEE -- THE SCIENTIFIC GRANTS COMMITTEE REVIEW IT FIRST AND THEY KNOCK OUT SOME. IF IT'S A FACILITIES GROUP, THE FACILITIES GROUP HASN'T HAD THE OPPORTUNITY TO REVIEW ALL OF THE GRANTS.
I'M COMFORTABLE WITH, AND QUITE HONESTLY IT'S GOING TO SAVE THIS COMMITTEE SOME WORK, IF THE SCIENTIFIC GRANTS REVIEW COMMITTEE REVIEWS IT AND SAYS THIS APPLICATION OR THIS PROPOSAL JUST DOESN'T MAKE ANY SENSE WHATSOEVER. HAVING SAID THAT, I'M CONCERNED THAT THE FACILITIES GROUP HAS MET ITS OBLIGATIONS TO REVIEW ALL THE APPLICATIONS FOR SHARED SPACE FACILITIES GRANTS.
MR. KLEIN: COUPLE OF POINTS. ONE, I THINK, STARTING WITH THE MINOR POINT, RATHER THAN CALL IT A SECRET BALLOT, IF WE CALL IT A CONFIDENTIAL BALLOT BECAUSE CERTAINLY WE'LL KEEP RECORDS OF THE BALLOT, AND THEY'RE AVAILABLE FOR INTERNAL AUDIT PURPOSES AND REVIEW TO BE CONSISTENT TO MAKE SURE WE CAN SHOW IN THE FUTURE THAT WE MET OUR CONFLICT STANDARDS AND OTHER STANDARDS. SO I THINK A CONFIDENTIAL BALLOT WOULD BE VALUABLE.
SECONDLY, WITH JEFF'S POINT, I THINK IT'S A VERY GOOD ONE, THAT AFTER THE PRELIMINARY REVIEWS, POTENTIALLY WE COULD JUST INSERT HERE IN OUR PROCESS THAT THE CHAIR AND THE VICE CHAIR JOINTLY COULD DESIGNATE A SINGLE MEMBER OR TWO-MEMBER TEAMS OF THIS COMMITTEE TO POTENTIALLY MEET WITH APPLICANTS. A, WE MAY HAVE SOME PROBLEMS THAT CAME UP IN THE REVIEW WHERE WE DON'T UNDERSTAND THE ISSUES, OR THERE'S A POTENTIAL WITH THIS EXPERTISE ON THIS COMMITTEE TO NEGOTIATE AND CHANGE THIS, WHICH COULD MATERIALLY CHANGE HOW THE SCORING WOULD HAPPEN IN THE NEXT PHASE. SO THAT BY GIVING US THAT OPTION TO HAVE THAT NEGOTIATION PHASE AND CLARIFICATION PHASE, IT COULD BE VERY VALUABLE, AS JEFF POINTS OUT.
I THINK THE THIRD MAJOR POINT IS THAT THERE MAY BE SITUATIONS WHERE A SCIENTIFIC SCORE -- FIRST OF ALL, I DO BELIEVE THE SCIENTIFIC SCORE WOULD BE BETTER IF IT'S AVAILABLE TO US BEFORE WE OURSELVES CREATE A FACILITIES SCORE BECAUSE IT'S VALUABLE INFORMATION. BUT THERE MAY BE A NUMBER OF CASES WHERE THERE'S NO APPROPRIATE SCIENTIFIC SCORE. THE REASON IS THAT IN TRYING TO CREATE SOME INITIAL NIH-FREE SPACE, WE MIGHT WANT TO GEOGRAPHICALLY LOCATE SOME SMALL FACILITIES GRANTS OF 2 TO 4,000 FEET JUST TO CREATE SOME SPACE WHICH COULD BE USED BY NUMEROUS DIFFERENT APPLICANTS OVER A PERIOD OF THE NEXT FOLLOWING TEN YEARS OR EVEN TWO YEARS SO THAT THERE WILL BE A WIDE RANGE IN THE SCIENTIFIC CLIENTS THAT USE THE SPACE.
IT'S NOT THAT WE'RE APPROVING SOMETHING FOR ONE SCIENTIFIC USER OR ANOTHER, BUT, IN FACT, NUMEROUS SCIENTIFIC USERS. SO IT'S DIFFICULT TO KNOW HOW TO GRADE THAT SPACE. WHEREAS, IF WE ARE DOING A MAJOR FACILITY APPROVAL FOR A PARTICULAR UNIVERSITY OR RESEARCH INSTITUTION, THE SCIENTIFIC GROUP HAS CRITICAL INFORMATION FOR US TO EVALUATING THE EXPERTISE AT THAT COMMUNITY. BUT AT LEAST WHEN WE'RE INITIALLY TRYING TO PUT SOME SURVIVAL SPACE IN PLACE, WE MIGHT WANT TO ALLOW OURSELVES THE OPTION OF NOT HAVING A SCIENTIFIC SCORE, BUT POTENTIALLY HAVING SOME INFORMATION, DIRECTION FROM THE SCIENTIFIC STAFF, THE PRESIDENT'S OFFICE AS TO THEIR SUGGESTIONS THAT THEY MIGHT CLEAR WITH THE GRANT REVIEW COMMITTEE CHAIR, FOR EXAMPLE, AND VICE CHAIR, BUT WOULDN'T LEAD TO A FORMAL SCORE.
DR. HALL: LET ME MAKE TWO POINTS, IF I MAY.
CHAIRMAN DOMS: PLEASE.
DR. HALL: FIRST IS WE RAN INTO A SIMILAR SITUATION IN THE GRANTS REVIEW COMMITTEE. IT'S WORRYING ABOUT THE NUMBER OF GRANTS WE WOULD HAVE. AND NIH NOW USES WHAT'S CALLED A TRIAGE SYSTEM WHERE YOU TAKE THE -- YOU MAKE A PRELIMINARY JUDGMENT AND YOU TAKE THE BOTTOM THIRD OF THE GRANTS AND YOU SAY WE'RE NOT GOING TO REVIEW THESE, PERIOD. WE JUST DON'T THINK THEY HAVE A CHANCE NO MATTER WHAT HAPPENS. IT WAS POINTED OUT TO US THAT SINCE IT IS THE ICOC THAT MAKES ALL FINAL DECISIONS, THAT WE HAVE TO BE VERY CAREFUL BECAUSE IF THERE'S A SENSE THAT THE WORKING GROUP HAS DISQUALIFIED SOME GROUP OF GRANTS THAT AREN'T BROUGHT TO THE ICOC, THEN WE'RE OPEN FOR LITIGATION, AS I UNDERSTAND IT.
AND I THINK ONLY THING ONE HAS TO BE CAREFUL OF IS THAT ALL GRANTS WOULD HAVE TO COME, AND I WOULD SUGGEST THAT ALL GRANTS SHOULD THEN HAVE, IF ANY GRANTS HAVE THEM, ALL GRANTS SHOULD HAVE BOTH SCIENTIFIC AND FACILITIES SCORES. AND THEN I THINK YOU CAN ARRANGE IT SO YOU DON'T SPEND MUCH TIME IN YOUR WORKING GROUP ON THE ONES THAT YOU DON'T THINK ARE GOING TO DO WELL. I THINK, JAMES CAN CORRECT ME, THAT WE'RE GOING TO BE FORMALLY OBLIGATED TO BRING ALL APPLICATIONS TO THE ICOC. THEY MAKE THE FINAL DECISION. AND WE GIVE THEM OR THIS GROUP GIVES THEM, I DON'T GIVE THEM, THE BEST --
CHAIRMAN DOMS: THAT WAS MY UNDERSTANDING, AND THAT'S WHY WE HAVE TO REVIEW. IT WOULD BE --
DR. HALL: YOU MAY CHOOSE TO GIVE IT A QUICK DISCUSSION AND A QUICK VOTE, BUT I THINK YOU HAVE TO GIVE IT A NUMBER.
LET ME MAKE ONE OTHER POINT, IF I MIGHT, RUSTY. AND THAT IS THAT ALTHOUGH THE IDEA OF NEGOTIATION IS AN ATTRACTIVE ONE, AGAIN, I THINK THERE'S A DANGER, A LITTLE TRAP HERE. MEMBERS OF THIS COMMITTEE CAN'T BOTH NEGOTIATE A DEAL AND THEN VOTE ON WHETHER THE DEAL IS A GOOD ONE OR NOT. I THINK THAT'S CALLED A CONFLICT OF INTEREST.
MR. KLEIN: I DON'T THINK THAT'S TRUE.
MR. SERRANO-SEWELL: IT'S AN INTERESTING CONCEPT, ZACH, BUT ON ITS FACE, I DON'T SEE A CONFLICT.
DR. HALL: WELL, YOU BASICALLY SET UP THE DEAL YOURSELF, AND THEN YOU GO AND VOTE FOR IT.
CHAIRMAN DOMS: I DON'T MEAN TO PUT YOU ON THE SPOT, JAMES, BUT I AM.
DR. HALL: THAT WOULD BE MY SENSE.
MR. HARRISON: IT'S NOT A TECHNICAL CONFLICT OF INTEREST UNDER STATE LAW, BUT I THINK, AS ZACH SUGGESTS, IT COULD CREATE AN APPEARANCE THAT THE PERSON WHO NEGOTIATED THE DEAL AND THEN IS BRINGING IT TO THE COMMITTEE FOR ITS REVIEW AND APPROVAL MAY HAVE PRECONCEIVED BIAS TOWARDS THAT APPLICATION, BUT IT'S NOT A TECHNICAL CONFLICT.
DR. HALL: I WOULD SUGGEST AN ALTERNATE PROCEDURE, WHICH WOULD AVOID THAT, AND THAT IS IF YOU SAY WHAT YOU WANT, AND WE'D HAVE TO THINK THIS THROUGH, YOU WOULD SAY THAT THIS IS DEFICIENT IN THESE WAYS. AND THEN THE STAFF CONVEYS THAT TO THE VARIOUS APPLICANTS. THEY THEN CAN AMEND OR CHANGE IT AND THEN BRING IT BACK. BUT WE WOULDN'T NEGOTIATE WITH THEM. I THINK THE DANGER IS THAT YOU'RE IN POSITION OF SAYING IF YOU DO THIS, THEN YOU WILL GET -- I CAN TELL YOU YOU WILL GET THIS, AND SO YOU END UP SORT OF STRUCTURING THE APPLICATION. TO ME, I THINK IT OPENS US UP FOR SOME CRITICISM. AGAIN, THAT WOULD BE MY ADVICE.
MR. KLEIN: I WAS JUST GOING TO SAY THAT I THINK JEFF IS FOCUSED ON THE MISSION, WHICH IS TO USE OUR RESOURCES AS WISELY AS POSSIBLE AND TO USE THE EXPERTISE OF THIS COMMITTEE AS WISELY AS POSSIBLE. AND CERTAINLY I THINK, QUITE PROPERLY, ZACH, YOU POINT OUT THAT NO ONE IN NEGOTIATING CAN SAY THAT YOU ARE GOING TO GET THIS OR WHAT YOUR SCORE IS GOING TO BE BECAUSE THEY DON'T KNOW. ALL THEY CAN SAY IS, YOU KNOW, ON A COMPARATIVE BASIS, BASED ON WHAT WE'VE SEEN, IT WOULD BE BETTER IF YOU WERE TO RESTRUCTURE THIS BECAUSE THIS IS NOT VERY COMPETITIVE OR OTHER AREAS OF THE STATE HAVE COVERED THIS SPECIFIC NEED. HAVE YOU CONSIDERED EMPHASIZING THIS NEED IN YOUR APPLICATION, FOR WHICH WE DON'T HAVE ANY OTHER APPLICATIONS.
SO THERE IS A NEGOTIATION PROCESS, I THINK JEFF IS SUGGESTING, THAT CAN PROVIDE VERY USEFUL FEEDBACK. WHEN THE GRANT THEN COMES TO THE FULL COMMITTEE, OTHER MEMBERS MAY SEE IT VERY DIFFERENTLY, BUT AT LEAST IT PROVIDES SOME INFORMATION FOR THE APPLICANT THAT MAY BE HELPFUL IN MAKING THE APPLICATION MORE EFFICIENT AND EFFECTIVE IN TERMS OF THE FUNDS REQUESTED.
MR. KASHIAN: I'D LIKE TO SUPPORT JEFF'S POINT OF VIEW. IT SEEMS TO ME THAT OUR OBLIGATION TO THE PEOPLE OF CALIFORNIA, WHO ARE FURNISHING THE MONEY, IS TO PUT THE MOST AMOUNT OF MONEY POSSIBLE INTO THE RESEARCH AND THE LEAST AMOUNT POSSIBLE INTO THE REAL ESTATE. UNDER THOSE CONDITIONS, IT WOULD IT SEEM TO ME UNWISE NOT TO USE THE EXPERTISE OF THE REAL ESTATE PEOPLE IN DEALING WITH AN APPLICATION THAT HAS GREAT SCIENTIFIC MERIT, BUT COULD USE SOME HELP FROM THE REAL ESTATE POINT OF VIEW IN TERMS OF FINANCING. AND I DON'T SEE WHERE THAT WOULD BE A CONFLICT AT ALL.
DR. HALL: LET ME JUST SAY I ABSOLUTELY AGREE WITH THE AIMS OF THIS. I HAVE NO PROBLEMS WITH IT. I'M CONCERNED ABOUT THE MECHANISM. AND IT'S GOING TO BE VERY LARGE AMOUNTS OF MONEY INVOLVED HERE, MORE MONEY THAN ANY OTHER GRANT WE DO. AND THIS IS A POLITICAL PROCESS. THERE'S GOING TO BE INTENSE COMPETITION. SUPPOSE WE DECIDE TO AWARD LATER ON THREE $50 MILLION GRANTS OR 60 OR $75 MILLION GRANTS FOR A BUILDING AT MAJOR CENTERS. WHAT HAPPENED WITH THE SITES WILL BE NOTHING COMPARED TO THE COMPETITION THAT WILL GO ON OVER THOSE CENTERS. THERE WILL BE TREMENDOUS INTENSE COMPETITION.
I THINK IT'S GOING TO BEHOOVE US WHEN THAT HAPPENS TO HAVE A PROCESS. I THINK IT'S FINE FOR THE COMMITTEE TO MAKE ITS CRITICISMS AND THEN TO DISCUSS, BUT I'M JUST CONCERNED THAT THERE BE A PROCESS THAT BE ABSOLUTELY -- WHAT IS THE PHRASE? -- MORE PURE THAN CAESAR'S WIFE, OR WHATEVER IT IS. IT WOULD BE CLEAN AS CLEAN CAN BE SO THAT ANYBODY COMES IN.
JAMES AND I WERE JUST TALKING. IN THE SITE COMPETITION, FOR EXAMPLE, WHERE THERE WAS A LOT OF PUBLICITY ON THIS, IF IT HAD BEEN POSSIBLE TO GO BACK AFTER THE APPLICATIONS AND IF MEMBERS OF THE SITE SELECTION COMMITTEE HAD THEN GONE BACK AND HAD PRIVATE DISCUSSIONS WITH PEOPLE ABOUT WHAT THEY COULD DO TO THEIR GRANT APPLICATIONS, I THINK ALL HELL WOULD HAVE BROKEN LOOSE. I MAY BE WRONG ABOUT THAT, BUT JUST AM VERY CONCERNED ABOUT THAT.
MR. SHEEHY: THE FIRST POINT, THE IDEA OF HAVING THE SCIENTIFIC REVIEW TAKE PLACE FIRST, DID NOT PRESUPPOSE THAT WE WOULD NOT REVIEW ALL GRANTS APPLICATIONS.
THE SECOND POINT IS THAT, YOU KNOW, THERE IS A BAGLEY-KEENE EXCLUSION FOR REAL ESTATE NEGOTIATIONS. WHY IS THAT? BECAUSE THE PUBLIC EXPECTS REAL ESTATE NEGOTIATIONS TO TAKE PLACE WHEN REAL ESTATE DEALS ARE MADE BY THE STATE OF CALIFORNIA. AND TO PUT IN PLACE A PROCESS THAT DOES NOT INCLUDE THE POTENTIAL FOR A REAL ESTATE NEGOTIATION SEEMS ON THE FACE ALMOST ABSURD.
NOW, I AM AGNOSTIC ABOUT WHETHER OR NOT A PATIENT ADVOCATE IS INVOLVED IN NEGOTIATIONS. REALLY IT'S THE EXPERTISE OF SOME OF THE PEOPLE WE HAVE SITTING AROUND THIS TABLE THAT I'D LIKE TO BRING TO BEAR ON THAT PROBLEM. AND I THINK IF WE DO OUR CONFLICTS OF INTEREST POLICY APPROPRIATELY, I DON'T THINK A CONFLICT WOULD BE A PROBLEM. AND I THINK THAT IT COULD BE A VERY DEFENSIBLE PROCESS MYSELF. AND I KNOW THE SITE SELECTION WAS SOMETHING, BUT IT MIGHT NOT HAVE HURT THE SITE SELECTION TO HAVE ANOTHER ROUND, TO BE HONEST. IT MIGHT HAVE NEGATED SOME OF THE NEGATIVE FEEDBACK WE HAVE.
CHAIRMAN DOMS: JAMES.
MR. HARRISON: LET ME JUST ELABORATE FOR A MINUTE. I THINK THAT IT'S A PROCESS THAT WE HAVE TO GIVE SOME CONSIDERATION TO IF IT'S ONE THAT YOU ARE INCLINED TO ADOPT. AND WHAT I CAN FORESEE AS A POTENTIAL PROBLEM, FOR EXAMPLE, WOULD BE A SITUATION WHERE YOU WOULD UNDERTAKE NEGOTIATIONS WITH ONE APPLICANT AND SAY THESE ARE THE PARTS OF YOUR APPLICATION THAT WE THINK ARE REALLY DEFICIENT. YOU KNOW, IF YOU FIX THIS AND YOU FIX THIS, WE THINK THAT'S VERY IMPORTANT. AND THERE'S ANOTHER APPLICANT WHOSE APPLICATION YOU THINK IS JUST SO DEFICIENT, YOU DON'T EVEN WANT TO SPEND THE TIME DEALING WITH THEM. AND THEN LO AND BEHOLD, YOU AWARD A LOAN OR A GRANT TO THE APPLICANT WHOM YOU HAVE NEGOTIATED WITH AND YOU DON'T TO THE APPLICANT WHO YOU HAVEN'T DISCUSSED THE MATTER WITH. THAT'S WHERE WE HAVE THE POTENTIAL FOR CRITICISM AND POTENTIALLY FOR LITIGATION ARISING OVER WHETHER THE APPLICANTS WERE TREATED FAIRLY DURING THE REVIEW PROCESS.
SO WHILE I THINK IT'S SOMETHING WE CAN EXPLORE, IT'S JUST SOMETHING THAT I THINK WE NEED TO GIVE MORE STUDY TO.
MR. KASHIAN: COUNSEL, DON'T YOU BELIEVE THE GO/NO-GO ISSUE DEALS WITH THE SCIENTIFIC ISSUES? IT SHOULDN'T DEAL -- WITH THE REAL ESTATE IS SUCH A MINOR PORTION OF THIS THING AND THE PEOPLE THAT ARE SCIENTIFIC REALLY DON'T HAVE A COMPREHENSION OF FINANCE OR REAL ESTATE AND THE CONSTRUCTION OF IT. WHY IS IT THAT WE CAN'T HELP THOSE APPLICANTS THAT HAVE MERIT TO BE ABLE TO STRUCTURE THE REAL ESTATE PORTION THAT WOULD APPLY TO THE SCIENTIFIC PORTION?
MR. HARRISON: I DON'T MEAN TO PREJUDGE IT AND TO SAY THAT YOU CAN'T DO IT. I JUST WANTED TO FLAG A POTENTIAL PROBLEM THAT COULD ARISE DEPENDING UPON HOW IT'S CARRIED OUT. YOU ALL WILL EVENTUALLY RECOMMEND CRITERIA BY WHICH YOU'RE GOING TO EVALUATE THESE APPLICATIONS. SOME OF THESE CRITERIA ARE SET FORTH IN SOME DETAIL IN PROPOSITION 71 ITSELF. OTHERS YOU WILL COME UP WITH.
SO IF AN APPLICANT IS DEFICIENT IN MEETING ONE OF THOSE CRITERIA AND YOU'RE TO NEGOTIATE OR DURING THE GRANT APPLICATION PROCESS ALERT THAT APPLICANT TO THAT DEFICIENCY AND HAVE THAT APPLICANT COME BACK, BUT YOU HAVEN'T AFFORDED THE SAME CONSIDERATION TO ANOTHER APPLICANT, REGARDLESS OF THE SCIENTIFIC MERIT, THAT'S WHERE YOU ARE GOING TO RUN INTO POTENTIAL PROBLEMS FROM A PROCESS STANDPOINT.
MR. KLEIN: I DON'T AGREE WITH THAT.
CHAIRMAN DOMS: LET ME JUST MAKE A COUPLE COMMENTS, IF I MIGHT. I'VE SORT OF ALREADY FAILED IN ONE OF MY FIRST RESPONSIBILITIES I SAID I WOULD TRY TO ACHIEVE, WHICH IS GETTING US OUT OF HERE ON TIME. SO I'M A LITTLE EMBARRASSED ON THAT, BUT THIS IS IMPORTANT. AND CAN MEMBERS OF THE COMMITTEE GIVE US ANOTHER HALF HOUR OR 45 MINUTES? SORRY ABOUT THAT. BUT I THINK -- GO AHEAD.
MR. KLEIN: VERY QUICKLY. YOU KNOW, THE STATE OF CALIFORNIA NEGOTIATES, GOES IN REAL ESTATE NEGOTIATIONS WITH APPLICANTS, PROPONENTS, FOR LEASES AND FACILITIES ALL OVER THIS STATE. AND THE NEGOTIATION EVERY DAY THAT OCCURS IN ONE MEETING IS NOT THE SAME AS IN THE NEXT. BUT THEY NEGOTIATE TO GET THE BEST DEAL FOR THE PEOPLE OF THE STATE OF CALIFORNIA. SO IT'S INHERENT IN THAT PROCESS THAT THERE WILL BE DIFFERENT THINGS SAID IN DIFFERENT MEETINGS, AND THAT SYSTEM HAS STOOD UNDER FIRE AND EXAMINATION FOR DECADES, IF NOT MAYBE A HUNDRED YEARS.
SO I THINK WE HAVE TO FACE OUR RESPONSIBILITY. THE REASON IN WRITING THIS INITIATIVE THAT I PUT PEOPLE WITH REAL ESTATE CAPACITY AND KNOWLEDGE ON THIS COMMITTEE WAS TO DO EXACTLY WHAT JEFF IS TALKING ABOUT. SO WHILE IT IS VERY IMPORTANT, AS POINTED OUT BY JAMES AND ZACH, TO BE SENSITIVE AND TO HAVE A GOOD PROCESS AND PERHAPS OUT OF SOME NEGOTIATIONS WE'LL COME OUT WITH SOME INFORMATION THAT WE DISTRIBUTE TO EVERYONE THAT HAS AN APPLICATION PENDING TO TRY AND HAVE A MORE LEVEL PLAYING FIELD. BUT AS WE LEARN ABOUT THE PROBLEMS IN THE APPLICATIONS THEMSELVES, IT'S IMPORTANT THAT WE HAVE THIS OPTION.
SO I'D LIKE TO MAKE A MOTION THAT THE CHAIR AND VICE CHAIR JOINTLY, WHEN THEY FEEL IT IS IN THE INTEREST OF THE PEOPLE OF CALIFORNIA TO CREATE A MORE EFFECTIVE APPLICATION, CAN DESIGNATE MEMBERS OF THIS COMMITTEE TO MEET TO NEGOTIATE WITH APPLICANTS TO TRY AND ENHANCE THOSE APPLICATIONS FOR THE PROCESS. THE PROCESS UNDER THIS MOTION WILL BE DEVELOPED BY THIS COMMITTEE IN CONJUNCTION WITH THE STAFF'S RECOMMENDATIONS AND THE COUNSEL'S RECOMMENDATIONS, BUT I'D LIKE TO MAKE THIS MOTION TO AMEND WHAT'S PROPOSED SO THAT WE HAVE THE OPTION TO DO IT, WHEN APPROPRIATE, WITH A PROCESS TO BE DEVELOPED. AND SO I DON'T KNOW IF THERE'S A SECOND, BUT THAT'S THE MOTION.
MR. SERRANO-SEWELL: THERE'S A SECOND.
MR. LICHTENGER: I'LL SECOND.
CHAIRMAN DOMS: ANY DISCUSSION?
MR. LICHTENGER: I WANT TO MAKE ONE POINT. I THINK THIS GOES ALONG WITH WHAT JEFF AND BOB HAVE BEEN SAYING. ONE THOUGHT I HAD WAS THAT FOR EVERY FACILITIES WORKING GROUP PROPOSAL THAT WE ACTUALLY REVIEW, WE HAVE COMMENTS TO ALL OF THEM. I'M SURE WE WILL HAVE COMMENTS TO ALL OF THEM. AND THAT CAN BE DISTRIBUTED TO ALL THE PROPOSALS. AND THAT WAY POTENTIALLY WE AVOID SOME OF THE LEGAL CONFLICTS TO BE LATER ON, AND HOW THOSE APPLICANTS RESPOND TO THOSE 1 COMMENTS COULD THEN PUT US IN A POSITION WHERE WE COULD GO THAT NEXT STEP, IF WE THINK APPROPRIATE, IN TERMS OF SOME KIND OF NEGOTIATION OR DISCUSSION WITH THOSE APPLICANTS. THAT WAY IF EVERYONE HAS COMMENTS -- I DON'T KNOW IF ANYONE HAS DONE ANY KIND OF INDIVIDUAL REVIEW PROCESS IN ANY MUNICIPALITIES, THEY ALWAYS HAVE COMMENTS TO EVERYTHING. SO THAT WAY EVERYONE IS TREATED EQUALLY BECAUSE EVERYONE WILL HAVE COMMENTS TO THEIR PROPOSAL.
MS. SAMUELSON: I GUESS I'M THINKING THAT THE PROCESS MAYBE CAN BE SIMPLIFIED A LITTLE BIT WITH PERHAPS THE ASSIGNMENT OUT TO A COUPLE PEOPLE OF EACH PROPOSAL SO THAT SOMEONE IS -- WE'RE SHARING THE HOMEWORK OF THE READING AND SO ON WITH THE SCIENTIFIC MERIT SCORING AVAILABLE AT THE OUTSET. AND THEN THERE'S A DISCUSSION. IT SEEMS TO ME THE ASSESSMENT IS TYPICALLY GOING TO BE THIS IS A GREAT IDEA. IF IT'S NOT A GREAT IDEA, WE WOULDN'T WASTE OUR TIME SCIENTIFICALLY, BUT IT'S A LITTLE RICH OR THERE'S SPACE AVAILABLE BY SOME OTHER -- SOMEWHERE ELSE THAT MIGHT BE CHEAPER OR IN THE BIG PICTURE MORE EFFECTIVE. AND WHY NOT HAVE THAT GROUP DISCUSSION, AND THEN NEGOTIATION COULD BE A PART OF THAT IF IT SEEMED TO BE USEFUL.
MR. SERRANO-SEWELL: I'M TRYING TO FIT THIS EXPERIENCE INTO WHAT I DO AT WORK, AND IT'S NOT REALLY APPLICABLE ALL THE TIME. BUT I KNOW THAT WHAT WE TRY TO DO SOMETIMES AT THE CITY IS WE ISSUE AN RFA FOR AN EXCLUSIVE RIGHT TO NEGOTIATE. THAT'S WHAT YOU GET. YOU DON'T GET THE CONTRACT, YOU DON'T GET THE AWARD. WHAT YOU DO IS YOU GET THE RIGHT TO NEGOTIATE WITH US, AND THEN EITHER THE NEGOTIATIONS ARE SUCCESSFUL OR THEY'RE NOT. MAYBE THAT MIGHT BE ONE WAY TO APPROACH. AND DURING THAT NEGOTIATION PROCESS, JEFF, YOU'RE RIGHT, OFTEN THESE DISCUSSIONS TAKE PLACE IN PRIVATE AND THEY ARE EXEMPT FROM THE CITY'S BROWN ACT, WHICH IS THE BAGLEY-KEENE ACT.
DR. HALL: I THINK THAT'S A VERY INTERESTING IDEA, AND I'M JUST TRYING TO SORT OUT IN MY MIND AS I HEAR THE DISCUSSION HERE. I DON'T KNOW HOW MUCH FREEDOM WE HAVE WITHIN PROPOSITION 71 TO RESTRUCTURE THIS, BUT WHAT IF -- YOU CAN ALMOST IMAGINE A SEQUENTIAL REVIEW THROUGH THE ICOC SO THAT THE SCIENTIFIC REVIEW COMMITTEE REVIEWS, MAKES ITS RECOMMENDATIONS TO THE ICOC FOR WHICH ONES TO PURSUE. AND THEN ALMOST YOU SAY -- THEN THE ICOC SAYS, OKAY, WE THEN DIRECT THESE TO THE FACILITIES WORKING GROUP TO GET THE BEST DEAL POSSIBLE ON THESE GRANTS. AND IT'S ALMOST LIKE, AS DAVID WAS SAYING, YOU DON'T GUARANTEE THAT YOU GET IT. IT'S ALMOST LIKE AN EXCLUSIVE RIGHT TO NEGOTIATE, BUT YOU THEN -- BECAUSE WHAT I HEAR IS THAT YOU'RE SAYING THE PRIMARY JUDGMENT IN SOME WAYS SHOULD BE SCIENTIFIC. AND IF IT'S WORTHWHILE SCIENTIFICALLY, THEN WE SHOULD KNOCK OURSELVES OUT TO GET WHAT IS A GOOD DEAL IN WHICH THE MONEY IS SPENT IN THE MOST ECONOMICAL WAY TO GET THAT SCIENTIFIC OBJECTIVE. I DON'T KNOW IF THAT'S POSSIBLE.
MR. KASHIAN: NOBEL PRIZE WINNERS ARE A LOT RARER THAN REAL ESTATE.
DR. HALL: YOU WOULDN'T WASTE YOUR TIME, AND I'M CONCERNED BY THE THING THAT JAMES SAYS, THAT YOU HAVE A GRANT THAT'S HOPELESS, AND IT'S GOING TO BE VERY HARD TO GO OUT AND NEGOTIATE WITH PEOPLE AND SAY, WELL, YOU GOT A TEN ON THE SCIENTIFIC SCORE, BUT WE WANT TO TELL YOU THAT YOU HAVE A CHANCE IF YOU CAN RESTRUCTURE IN THIS WAY. I THINK IT OPENS UP A LOT OF COMPLICATED ISSUES, BUT I THINK THE IDEA OF SAYING THAT HERE ARE ONES THAT WE THINK SCIENTIFICALLY ARE THE FIVE BEST AND WE TURN THAT OVER. THEN THROUGH THE ICOC, I THINK THAT WOULD HAVE TO BE THE CASE. OTHERWISE, YOU RUN THE RISK OF HAVING THE SCIENTIFIC WORKING GROUP AS HAVING TAKEN SOME OUT. BUT THEN YOU SAY, OKAY, HERE ARE THE ONES TO DO. AND NOW WE WANT THE FACILITIES WORKING GROUP TO MAKE SURE THAT WE GET THE BEST POSSIBLE DEAL ON DOING THAT. THAT'S JUST AN IDEA.
MR. KLEIN: THAT'S A SEPARATE PROCESS. IT'S VERY INTRIGUING. MAY I SUGGEST THAT GIVEN TIME BETWEEN NOW AND THE NEXT MEETING WE MIGHT INVESTIGATE THAT PROCESS. BUT IF WE COULD, SUBJECT TO THE PUBLIC'S COMMENT, I WOULD LIKE TO ASK THAT WE CALL THE QUESTION BECAUSE REALLY THE QUESTION AT THIS LEVEL IS JUST ONCE IT GETS HERE, USING THE EXPERTISE HERE FOR NEGOTIATION, AND SO WHAT I AM SUGGESTING DOESN'T PREEMPT THE POSSIBILITY OF FOLLOWING SOME OF THESE VERY CREATIVE IDEAS THAT HAVE BEEN PUT FOR OTHER PARTS OF THE PROCESS.
CHAIRMAN DOMS: LET ME ASK JAMES. WE'RE NOT PASSING ANYTHING, WE'RE NOT ASKING FOR APPROVAL. IS THE -- I THINK THE MOTION SHOULD -- YOU MIGHT -- IT'S PART OF THE PROCESS AND WILL BE INCORPORATED, BUT I'M NOT SURE THE MOTION IS APPROPRIATE SINCE WE'RE NOT APPROVING ANYTHING AT THIS POINT.
MR. HARRISON: AS I UNDERSTOOD THE MOTION, IT WAS A MOTION TO DIRECT STAFF, ALONG WITH COUNSEL, TO CONSIDER THIS ISSUE AND COME BACK WITH A FURTHER PROPOSAL.
MR. KLEIN: NO, IT'S NOT ACTUALLY THAT. IT'S TO MODIFY THE SPECIFIC PROCESS THAT IS UNDER DISCUSSION FOR REVIEWING GRANTS.
DR. HALL: AS A RECOMMENDATION TO THE ICOC?
MR. KLEIN: YES. SO THAT WHEN WE VOTE TO FORWARD TO THE ICOC OUR FORMAL PROCESS, WE WOULD INCORPORATE THIS OPTION IN OUR OWN INTERNAL PROCESS. SO I AM SUGGESTING AN APPROVAL TO AMEND THE DRAFT PROCESS UNDER CONSIDERATION.
CHAIRMAN DOMS: IS THAT APPROPRIATE? MR. HARRISON: THAT'S APPROPRIATE. SO IT'S AN AMENDMENT TO THIS PROPOSAL PRIOR TO THE PROPOSAL ITSELF BEING ADOPTED.
MR. KLEIN: THAT'S RIGHT.
MR. KASHIAN: I'LL SECOND THE MOTION AS AMENDED.
MS. SAMUELSON: QUESTION. WHAT IS THE TIME URGENCY TO APPROVING A PROCESS? BECAUSE IT SEEMS TO ME IT WOULD REALLY MAKE SENSE TO JUST SEND THIS BACK TO THE DRAFTING BOARD WITH --
CHAIRMAN DOMS: I THINK THAT'S WHAT WE'RE PLANNING TO DO. I THINK IT'S COMING UP ON THIS COMMITTEE AND TO WORK WITH STAFF TO COME BACK WITH A REVISED PROPOSAL TAKING INTO ACCOUNT THE COMMENTS THAT WE'VE HEARD TODAY. AND I THINK, JEFF, YOU MADE SOME GREAT COMMENTS. AS I SAID, THIS IS JUST A DRAFT, AND WE'RE NOT CLOSE AT THIS POINT.
MR. SHEEHY: SHOULD WE JUST GO AHEAD AND VOTE ON THIS?
MR. KLEIN: WE HAVE TO GET PUBLIC COMMENT.
CHAIRMAN DOMS: PUBLIC COMMENT.
MR. REED: DON REED. IT JUST SEEMS TO ME LOGICAL THAT SINCE WE HAVE THE STRENGTH OF THE FOUR NEW PEOPLE WHO ARE EXPERTS IN THIS AREA, IT WOULD BE A MISTAKE NOT TO UTILIZE THAT STRENGTH. WE MUST NOT DENY OURSELVES THE POWER THAT YOU BRING TO US.
CHAIRMAN DOMS: THANK YOU VERY MUCH. CALL FOR THE QUESTION. ALL IN FAVOR. OPPOSED? PASSED UNANIMOUSLY.
ON THIS SUBJECT, THEN, I THINK AT OUR NEXT MEETING, WORKING WITH STAFF, WE'LL COME BACK WITH A REVISED PROPOSAL ON THE REVIEW PROCESS. I THINK THIS WAS A VERY, VERY GOOD AND VALUABLE DISCUSSION. WE MADE A LOT OF PROGRESS. SO WE WILL HAVE SOMETHING TO PRESENT AT THE NEXT MEETING.
LAST AGENDA ITEM BEFORE PUBLIC COMMENT IS DISCUSSION OF THE BYLAWS. AGAIN, I WANT TO STRESS THAT THIS IS FOR DRAFT. THIS IS A DRAFT. LET ME ASK JAMES TO COVER THOSE.
MR. HARRISON: PROPOSITION 71 REQUIRES EACH OF THE THREE WORKING GROUPS TO --
CHAIRMAN DOMS: COULD I JUST SAY ONE THING? THE DRAFT IS IN YOUR MATERIALS BEHIND TAB 4. IF WE HAD MORE TIME, I'D ASK YOU TO READ THEM. I'LL ADDRESS THAT WHEN WE'RE CONCLUDING.
MR. HARRISON: AS I WAS SAYING, PROPOSITION 71 REQUIRES EACH OF THE THREE WORKING GROUPS TO PROPOSE RULES AND PROCEDURES FOR ITS OPERATIONS TO THE ICOC. STAFF HAS DRAFTED BYLAWS, WHICH ARE AT TAB 4, TO ACCOMPLISH THAT PURPOSE FOR YOUR CONSIDERATION. WE'RE NOT ASKING TO YOU APPROVE THEM TODAY. SO PLEASE READ THEM AT YOUR LEISURE AND THINK ABOUT ANY MODIFICATIONS YOU MAY WISH TO MAKE.
LET ME JUST BRIEFLY TAKE YOU THROUGH THEM AND KIND OF HIT THE HIGHLIGHTS. THE BYLAWS DEFINE THE FUNCTIONS OF THE WORKING GROUP, AND THEY'RE MODELED, AS ZACH AND RUSTY SAID EARLIER, ON THE BYLAWS BOTH OF THE STANDARDS WORKING GROUP AND THE RESEARCH FUNDING WORKING GROUP. THEY SET FORTH IN SPECIFIC TERMS THE FUNCTIONS OF THE WORKING GROUP, WHICH ARE BROADLY DEFINED AS PROPOSING STANDARDS AND REQUIREMENTS FOR THE EVALUATION OF GRANTS AND LOANS, AND THEN MAKING RECOMMENDATIONS FOR PROCEDURES TO ENSURE THE PROPER OVERSIGHT OF THE RECIPIENTS OF GRANTS AND LOANS.
THE BYLAWS ALSO DEFINE THE MEMBERSHIP OF THE WORKING GROUP, WHICH, OF COURSE, HAS BEEN ESTABLISHED BY STATUTE. ONE WRINKLE TO THAT IS THE BYLAWS PROVIDE FOR THIS COMMITTEE TO RELY ON THE EXPERTISE OF ALTERNATE OR AD HOC MEMBERS WHEN ADDITIONAL EXPERTISE IS REQUIRED IN THE REVIEW OF GRANTS. THESE MEMBERS ARE NONVOTING MEMBERS, BUT WOULD BE CALLED UPON TO ATTEND MEETINGS TO PROVIDE EXPERTISE RELATED TO A SPECIFIC SUBJECT.
THE BYLAWS, ALSO FOLLOWING THE ICOC'S LEAD, PROVIDE FOR THE CHAIR OF THIS WORKING GROUP TO BE DRAWN FROM AMONG THE FOUR REAL ESTATE MEMBERS AND THE VICE CHAIR TO BE DRAWN FROM AMONG THE PATIENT ADVOCATE MEMBERS OF THE WORKING GROUP, WITH A DIVISION OF LABOR THAT IS SIMILAR TO THE DIVISION OF LABOR FOR THE RESEARCH FUNDING GROUP, WHICH RUSTY HAS ALREADY DESCRIBED TODAY.
THE BYLAWS ALSO PROVIDE THAT THIS GROUP IS COVERED BY CONFLICT OF INTEREST POLICIES. FOR THE ICOC MEMBERS, OF COURSE, THEY'RE COVERED BY CALIFORNIA CONFLICT OF INTEREST LAWS. THE NON-ICOC MEMBERS OF THE WORKING GROUP ARE COVERED BY A CONFLICT OF INTEREST POLICY, WHICH HOPEFULLY YOU ALL HAVE, THAT WAS ADOPTED BY THE ICOC.
AS WE DISCUSSED BRIEFLY EARLIER, THE BYLAWS REQUIRE THAT THIS GROUP MEET IN OPEN SESSION EXCEPT WHEN NECESSARY TO DISCUSS CERTAIN ITEMS. AND THOSE INCLUDE CONFIDENTIAL REAL ESTATE NEGOTIATIONS, WHICH, AS JEFF POINTED OUT, IS ALSO PERMISSIBLE UNDER THE BAGLEY-KEENE ACT; CONFIDENTIAL INPUT REGARDING THE SCIENTIFIC MERIT OF AN APPLICATION, AS WELL AS THE SCIENTIFIC STRENGTH OF THE STEM CELL PROGRAM AT THE INSTITUTION THAT'S APPLYING FOR A FACILITIES GRANT; AND ANY OTHER MATTERS THAT ARE PERMISSIBLE TO BE DISCUSSED IN CLOSED SESSION UNDER THE BAGLEY-KEENE OPEN MEETING ACT, WHICH INCLUDES, FOR EXAMPLE, THE IDENTITY OF A DONOR WHO WISHES TO REMAIN ANONYMOUS.
AND, FINALLY, THE BYLAWS PROVIDE THAT THIS WORKING GROUP MAY RECOMMEND ADDITIONAL EXCEPTIONS TO THE OPEN MEETING POLICY THAT YOU DETERMINE ARE NECESSARY IN ORDER TO ACHIEVE YOUR OBJECTIVES. THAT RECOMMENDATION FOR AN ADDITIONAL EXCEPTION WOULD HAVE TO GO TO THE ICOC, AND THE ICOC WOULD HAVE TO PROVIDE NOTICE TO THE PUBLIC AND THE LEGISLATURE, AND AGREE TO THAT EXCEPTION BY A 70-PERCENT VOTE BASED ON AN AGREEMENT THAT THE ICOC REACHED WITH THE LEGISLATURE ABOUT ENSURING TRANSPARENCY.
WE'VE ALREADY DISCUSSED AT SOME LENGTH THE PROCEDURES FOR RECOMMENDING GRANTS AND LOANS. SO I'M NOT GOING TO COVER THOSE. AND OBVIOUSLY WE WILL MEET AGAIN NEXT TIME TO CONSIDER REFINEMENTS TO THOSE PROCEDURES. AND AS OUR CHAIR DESCRIBED EARLIER, THERE ARE THREE CATEGORIES OF RECOMMENDATIONS THAT YOU CAN MAKE: A RECOMMENDATION FOR FUNDING, A RECOMMENDATION FOR FUNDING PENDING THE AVAILABILITY OF FUNDS, AND A RECOMMENDATION THAT THE APPLICATION IS NOT SUFFICIENTLY MERITORIOUS AT THIS TIME FOR FUNDING. WE'VE ALSO INCLUDED A PROVISION WHICH AUTHORIZES YOU TO RECOMMEND PARTIAL FUNDING OF AN APPLICATION.
THIS IS MODELED ON A PROVISION THAT'S ALSO INCLUDED IN THE RESEARCH FUNDING WORKING GROUP'S BYLAWS. AND AS RUSTY SAID, A MAJORITY OF A QUORUM OF YOU MUST RECOMMEND FUNDING DECISIONS. IF THERE IS A MINORITY GROUP OF 35 PERCENT OR MORE, THEIR RECOMMENDATION ON A PARTICULAR APPLICATION WILL BE FORWARDED TO THE ICOC.
FINALLY, TO THE EXTENT THERE ARE THINGS IN THESE BYLAWS THAT OVER TIME YOU GROW TO DISLIKE, YOU MAY RECOMMEND THAT THEY BE MODIFIED. AND THE ICOC WILL TAKE THAT UNDER CONSIDERATION.
CHAIRMAN DOMS: OKAY. THANK YOU, JAMES. QUESTIONS?
MS. SAMUELSON: I'VE GOT A COUPLE. I GUESS THE FIRST ON THE LAST PAGE, FUNDING RECOMMENDATIONS, A COMMENT. I'M WONDERING RATHER THAN HAVING IT STRUCTURED AS IT IS WHERE THE WORKING GROUP MAY RECOMMEND PARTIAL FUNDING OF AN APPLICATION, WHY NOT JUST SEPARATE OUT THE BUDGET AND HAVE THIS COMMITTEE RECOMMEND AN AMOUNT THAT IT MAKES SENSE TO FUND BECAUSE WOULDN'T THAT BE THE NORMAL WAY THAT YOU WOULD DO YOUR WORK? RATHER THAN HAVING THE --
CHAIRMAN DOMS: WE DON'T KNOW THE BUDGET. THAT'S ONE OF THE -- WHAT WE'RE DOING IS SETTING THEM UP IN TERMS OF PRIORITIES. AND IF WE KNEW HOW MUCH MONEY WE HAD, THAT WOULD BE GREAT, AND MAYBE WE WILL AT THAT TIME. WE CAN EVALUATE THEM ON THAT BASIS.
DR. HALL: I THINK IT'S INTENDED TO DO, JOAN, WHAT YOU INDICATE; THAT IS, A FACILITIES GRANT WILL COME IN AND SAY -- LET'S JUST SAY WE LOOK AT ONE WHERE SOMEBODY COMES IN FOR 4,000 SQUARE FEET OF SPACE AND HAS A RENOVATIONS COST FOR IT. AND I THINK WHAT THAT GIVES YOU THE OPTION TO DO IS TO SAY, LOOK, YOU'VE ONLY GOT X NUMBER OF PEOPLE THERE. AND JUDGED AGAINST THE OTHER GRANTS, WE THINK -- AND YOU DON'T HAVE PLANS TO GET MORE, WE THINK HALF THE SPACE WOULD BE FINE. AND SO WE WILL SUGGEST THAT THE BUDGET BE REDUCED ACCORDINGLY. AND WE SEND IT THE STAFF TO DO THE FIGURES TO DO THAT. THAT'S OUR INTENT IS TO SAY WE ONLY WANT TO FUND HALF OF THIS, AND WE'RE GOING TO GIVE YOU LESS AMOUNT OF MONEY.
AND THE POINT IS THE REASON THAT'S IN THERE, OTHERWISE IT'S AN UP-OR-DOWN VOTE, AND YOU MAY SAY THIS IS VERY WORTHWHILE. IT JUST NEEDS TO BE SHRUNK A LITTLE BIT. THAT'S THE IDEA IN THE TRAINING GRANTS.
MS. SAMUELSON: THAT'S ALL I'M SAYING.
CHAIRMAN DOMS: ANY OTHER COMMENTS?
MS. SAMUELSON: I GUESS ONE IS A QUESTION ABOUT WHETHER THIS TRACKS THE INITIATIVE IN REIMBURSEMENT AND PER DIEMS FOR THE PATIENT ADVOCATE MEMBERS. THE TERMINOLOGY IS DIFFERENT, AND IT SEEMS TO BE MORE NARROW THAN IN THE INITIATIVE. AND THAT'S OF GREAT IMPORTANCE TO ME AND THE OTHER PATIENT ADVOCATES. I DON'T KNOW THAT WE NEED TO TAKE THIS WORKING GROUP'S TIME WITH THAT RIGHT NOW. I JUST WANTED TO POINT THAT OUT.
CHAIRMAN DOMS: OKAY. THESE ARE, AGAIN, A DRAFT. AND I THINK IF YOU MAKE ME AWARE OF THOSE COMMENTS, I'LL WORK TO TRY TO STRAIGHTEN THEM OUT.
MS. SAMUELSON: AND THE FINAL ONE IS TO CONSIDER ADHERING MORE TO THE INITIATIVE ON BAGLEY-KEENE BECAUSE THERE MIGHT BE A PROCESS THAT REALLY WORKS FOR THE WORK OF THIS WORKING GROUP THAT USES THAT CLOSED SESSION CAPACITY WITHOUT HAVING TO BE SO SPECIFIC ABOUT WHICH RATIONALE FOR THAT WE'RE USING ON A GIVEN DAY. WE CAN PASS THOSE ALONG.
CHAIRMAN DOMS: OKAY. THANK YOU.
MR. KLEIN: I'D SPECIFICALLY LIKE TO DRAW OUR COUNSEL'S ATTENTION TO THE POINT THAT WE HAVE ITEM NO. 6 AS CONFIDENTIAL FINANCIAL INFORMATION ABOUT THE INSTITUTION. I THINK THAT THAT SHOULD BE A LITTLE MORE BROADLY STATED BECAUSE WE CAN HAVE CONFIDENTIAL FINANCING DISCUSSIONS THAT MAY BE NECESSARY BECAUSE AN INSTITUTION, WE MAY THINK THAT IT NEEDS TO FINANCE MORE AND GET LESS OF A GRANT FROM US, BUT WE DON'T KNOW THAT THEY HAVE A COVENANT BASED ON SOME BANK LINE OR OTHER PRIVATE FINANCIAL ARRANGEMENT IN INSTITUTIONS THAT LIMITS THE AMOUNT OF OTHER FINANCING THEY CAN DO. AND THEY MAY HAVE CONSTRAINTS WHERE THEY MAY NEED TO USE CONTRIBUTIONS TO FUND CERTAIN RESERVES THAT THEY'VE COMMITTED TO IN TERMS OF THEIR OVERALL FINANCIAL PLAN.
SO THERE'S -- I THINK THAT THERE IS A POTENTIAL FOR HAVING TO HAVE CONFIDENTIAL FINANCING DISCUSSIONS ABOUT THEIR APPLICATIONS. NOW, WHENEVER WE HAVE A DISCUSSION OF THE ACTUAL APPLICATION FOR APPROVAL, WHATEVER OUR FINANCING PLAN AND EQUITY ARRANGEMENTS WILL BE COMPLETELY PUBLIC DISCUSSIONS, BUT WE NEED TO BE ABLE TO HAVE DISCUSSIONS TO GET THE RIGHT INFORMATION SO WE'RE NOT ASKING FOR SOMETHING THAT'S TECHNICALLY IMPOSSIBLE OR OTHER COMMITMENTS MAY NOT BE SOMETHING THEY CAN DO.
CHAIRMAN DOMS: I THINK THAT'S AN EXCELLENT POINT, PARTICULARLY IF WE'RE GOING TO MOVE TOWARDS THE NEGOTIATION STANCE WITH THESE INSTITUTIONS. THEY MAY BE REQUIRED TO GIVE US SOME INFORMATION THAT WE CERTAINLY WOULDN'T WANT IN THE PUBLIC RECORD. AND I THINK WITHOUT DOING THAT, BOB, IT WOULD SORT OF -- IT COULD TIE OUR HANDS IN OUR DISCUSSIONS WITH THESE APPLICANTS.
ANY OTHER QUESTIONS? WE WILL TAKE ANOTHER CRACK AT THE BYLAWS AND PRESENT THEM AT THE NEXT MEETING.
AT THIS POINT, I'D LIKE TO ASK FOR ANY PUBLIC COMMENT.
MR. REED: I HAVE TWO POINTS. NO. 1, SCNT WAS MENTIONED EARLIER, SOMATIC CELL NUCLEAR TRANSFER. I THINK IT'S IMPORTANT TO REMEMBER THAT THIS IS NOT SOMETHING WHICH IS PERIPHERAL. IT'S CENTRAL TO OUR ENDEAVOR. WE HAVE MUST HAVE IT.
SECONDLY, IT IS BACKED UP BY EVERYBODY WHO KNOWS ANYTHING ABOUT THE SUBJECT. SOMATIC CELL NUCLEAR TRANSFER IS SUPPORTED BY THE AMERICAN MEDICAL ASSOCIATION, NATIONAL ACADEMY OF SCIENCE, THE ASSOCIATION OF AMERICAN UNIVERSITIES, AND EVERY MAJOR SCIENTIFIC, EDUCATIONAL, AND MEDICAL ORGANIZATION WHICH HAS TAKEN A POSITION ON IT. THE OPPOSITION IS PURELY POLITICAL AND RELIGIOUS.
SECONDLY, WE'D LIKE TO, JUST ON BEHALF OF PEOPLE WHO ARE SUFFERING, THANK YOU SO MUCH FOR YOUR INVOLVEMENT IN THIS GROUP. I THINK YOU WILL FIND AS YOU GO THROUGH THE INCREDIBLE AMOUNTS OF WORK THAT WILL BE DEMANDED OF YOU FOR ALMOST NO MONEY, THAT AT LEAST YOU HAVE THE CONSOLATION KNOWING THAT YOU'RE NOT FIGHTING ALONE. IT'S BEEN A JOY TO WATCH THE PEOPLE THAT WORK ON THESE COMMITTEES. THEY ARE AT THE TOPS OF THEIR FIELD.
I HAVE TO TELL A STORY ABOUT SHERRY LANSING SINCE SHE'S NOT HERE TO DEFEND HERSELF. I AM MOVIE STRUCK. I LOVE MOVIES. AND, OF COURSE, I KNEW WHO SHERRY LANSING WAS. AND SHE WAS THE PRESIDENT OF PARAMOUNT MOTION PICTURE STUDIOS. I HAD TO ASK HOW CAN YOU, THE HEAD OF THIS POWERFUL BUSY ORGANIZATION, SHE DID THE MOVIE TITANIC, FOR INSTANCE, HOW CAN YOU JUSTIFY THE TIME TO WORK ON THIS PARTICULAR ASSIGNMENT? AND SHE SAID, "IT IS THE MOST IMPORTANT THING IN MY LIFE." I BELIEVE YOU ALL FEEL THAT WAY. THANK YOU VERY MUCH.
CHAIRMAN DOMS: THANK YOU. I'VE HAD THE OPPORTUNITY OF LISTENING TO YOU SPEAK AT THE SCIENTIFIC CONFERENCE WITH YOUR COMMENTS AND APPRECIATE THEM VERY MUCH. TOO BAD THERE ARE NOT A LOT MORE PEOPLE LIKE YOU WHO SUPPORT US AND HELP US WITH WHAT WE'RE TRYING TO ACHIEVE HERE. SO THANK YOU VERY MUCH.
MR. REED: THERE'S A LOT. I'M JUST NOISY.
CHAIRMAN DOMS: BEFORE WE WRAP UP, I'D LIKE TO SUMMARIZE A FEW POINTS AS TO WHERE THIS COMMITTEE IS GOING. BOB MENTIONED THE INVENTORY OF SPACE AT VARIOUS INSTITUTIONS. I THINK THAT IS SOMETHING THAT WE COULD WORK WITH ON STAFF AND WORK TO GET THAT OUT AS QUICKLY AS WE CAN, BOB. AND WE'LL BE GLAD TO DO ANYTHING WE CAN TO HELP. I DO THINK THAT'S IMPORTANT, AND IT'S TIMELY.
WE'VE TALKED ABOUT THE REVIEW PROCEDURES IN SOME DETAIL, AND I APPRECIATE ALL THE COMMENTS FROM MEMBERS OF THE COMMITTEE, AND WE'LL COME BACK WITH SOMETHING THAT CERTAINLY WON'T BE PERFECT, BUT WILL BE HOPEFULLY MUCH BETTER STRUCTURED IN TERMS OF MEETING THE DESIRES OF THE COMMITTEE FOR DISCUSSION AT THE NEXT MEETING.
THE CRITERIA, WE'LL BEGIN TO WORK ON THAT. WE'VE TALKED ABOUT THE PROCESS. NOW WE NEED TO WORK ON WHAT ARE WE GOING TO ASK THESE PEOPLE IN TERMS OF THE APPLICATION, AND THAT'S GOING TO BE, I THINK, A COLLABORATIVE EFFORT BETWEEN -- WE NEED ARLENE'S INPUT ON THE SCIENTIFIC SIDE. AND SO WE'LL WORK ON DEVELOPING THAT. WE'LL HAVE A FIRST DRAFT AT OUR NEXT MEETING ON THAT SUBJECT.
THE WHOLE ACCOUNTING ISSUE IS SOMETHING THAT WE'LL TALK ABOUT WITH STAFF, THE ALLOCATION ISSUE, THE NIH AND --
DR. HALL: I HEAR A LOT OF THE STAFF WORK COMING UP HERE, RUSTY. I JUST WANT TO CHECK WITH YOU. I THINK UNTIL WE GET OUR NEW FUNDS, I THINK WE'RE GOING TO BE VERY STRAPPED FOR STAFF WORK. I THINK WE'RE GOING TO HAVE TO BE VERY CAREFUL ABOUT THE OBLIGATIONS. WE CAN WORK AT A CERTAIN SPEED, BUT WE JUST NEED TO BE VERY CLEAR --
CHAIRMAN DOMS: YOU KNOW, I APPRECIATE THAT, ZACH. I KNOW MELISSA WILL HAVE SOME WORDS FOR ME AFTER THIS MEETING.
LET ME PRIORITIZE IT THEN. I THINK THE INVENTORY OF SPACE IS --
DR. HALL: NOW, WE HAD TALKED BEFORE ABOUT THAT BEING PART OF -- ESSENTIALLY PART OF THE RFA, THAT WE ASK WHAT SPACE THEY HAVE AVAILABLE.
CHAIRMAN DOMS: I THINK BOB WAS SAYING HE THINKS --
MR. KLEIN: IN ORDER TO GET OUT THERE BEFORE WE SEND OUT AN RFA SO WE KNOW WHERE WE'RE AT ON THE PLANET, UNDERSTANDING THE CONSTRAINTS ON ZACH'S STAFF, A BOARD RESOLUTION, I CAN USE BOARD STAFF TO GET THAT OUT AND GET THE INFORMATION BACK TO THE SCIENTIFIC STAFF AND TO THIS COMMITTEE.
DR. HALL: BOB, I THINK WE'RE GOING TO NEED TO DISCUSS THAT.
MR. KLEIN: OKAY.
CHAIRMAN DOMS: IT WILL BE DISCUSSED BETWEEN ZACH AND BOB. THESE ARE THE REVIEW PROCEDURES, I'LL SPEND SOME TIME ON THAT. AND TO THE EXTENT STAFF HAS TIME, I WOULD LIKE TO TRY TO HAVE SOMETHING NEXT TIME.
THE CRITERIA, WE CAN BEGIN TO DEVELOP THAT. I CAN WORK WITH THE REAL ESTATE COMMITTEE -- MEMBERS OF THE -- REAL ESTATE MEMBERS OF THE FACILITIES COMMITTEE ON THAT.
IN TERMS OF MEETINGS, WE'LL TRY TO PUT AS MUCH MATERIAL AS POSSIBLE, GIVE THAT TO YOU PRIOR TO THE MEETING.
DR. HALL: LET ME JUST ASK A SCHEDULE QUESTION. WE COULD HAVE OUT -- WE COULD HAVE, IF WE ARE ABLE TO GET $100 MILLION IN JANUARY, BY JANUARY, WE COULD HAVE AN RFA OUT FOR THE SHARED SPACE FACILITY, I THINK, SOMETIME IN MARCH. DOES THAT GIVE US TIME NOW TO HAVE A SURVEY TO WRITE UP AND PREPARE SOMETHING, SEND IT OUT, GET IT BACK, HAVE IT DIGESTED THROUGH THIS COMMITTEE, HAVE IT INFORM WHAT WE ASK? I'M JUST NOT CLEAR THAT'S IT -- IN FACT, I'M CONCERNED THAT IT MAY HAVE THE UNINTENDED EFFECT OF DELAYING THE RFA.
MR. SERRANO-SEWELL: ZACH, LET ME SEE IF I UNDERSTAND THIS. WE'RE GOING TO SEND OUT THIS LETTER. EVERYBODY UNDERSTANDS IT'S AN INVENTORY. THERE'S BEEN DISCUSSIONS. WE HAVE NOTES. THERE'S A BOARD RESOLUTION TO THAT EFFECT, SO IT'S SOMETHING THAT WE NEED TO DO.
DR. HALL: IT'S NOT A BOARD RESOLUTION.
MR. KLEIN: YES, THERE IS.
DR. HALL: NO, I'M SORRY, BOB. THERE'S A BOARD RESOLUTION FOR CASE STUDIES.
MR. KLEIN: THERE'S A BOARD RESOLUTION FOR AN INVENTORY THAT MIGHT LEAD TO A CASE STUDY. IN THIS CASE, WE CAN EASILY AND QUICKLY IMPLEMENT THE PORTION THAT IS AN INVENTORY OF SPACE AND ASK QUESTIONS ON PROJECTS THAT ARE IN PROCESS. SINCE I SPONSORED THE RESOLUTION, I'M WELL INFORMED ON ITS CONTENT.
WE DON'T NEED TO IMPLEMENT THE CASE STUDY PORTION OF THAT AT THIS TIME.
DR. HALL: WELL, THE QUESTION IS WHEN IT HAPPENS, AND I GUESS WE HAD DISCUSSIONS BEFORE, DISCUSSED AT LEAST THE POSSIBILITY OF HAVING IT AS PART OF THE RFA.
CHAIRMAN DOMS: WE DID HAVE THOSE DISCUSSIONS. YOU'RE RIGHT, ZACH.
DR. HALL: WHICH SAY IF YOU ARE INTERESTED IN THIS, WE NEED TO KNOW WHAT OTHER SPACE YOU HAVE. AND THE ADVANTAGE OF THAT IS THERE'S SOME INCENTIVE FOR THE INSTITUTIONS IN DOING THIS. I'M CONCERNED -- I DON'T KNOW -- JUST AS WE PLAY IT, IT SEEMS TO ME I'M AFRAID BY THE TIME WE SEND THIS OUT, PEOPLE ARE THEN GOING TO SAY ARE WE REQUIRED TO DO THIS? ON WHAT TIME SCALE? HOW LONG DOES IT TAKE? WHAT ARE THE REASONS FOR DOING THIS? I THINK WITH OUR INSTITUTIONS, WE'RE GOING TO HAVE A LOT OF EXPLAINING TO DO. AND THEN IT COMES -- ALL THE STUFF COMES BACK IN, AND THEN IF WE'RE GOING TO WAIT ON THE RFA TO DIGEST ALL THAT INFORMATION, THEN I THINK IT'S NOT CLEAR TO ME. IT SEEMS TO ME IT WOULD BE CONSISTENT WITH THE BOARD RESOLUTION, IF IT WAS PART OF IT, THAT THIS WOULD BE AS PART OF THE RFA.
MR. SERRANO-SEWELL: ZACH, MY OWN THOUGHT IS I DIDN'T SEE THIS LETTER CONTINGENT ON THE SHARED SPACE RFA. YOU'VE GIVEN US A REALLY EXCELLENT STARTING POINT FOR THE SHARED SPACE RFA. WHAT THOSE ISSUES ARE, YOU'VE NARROWED THEM VERY WELL, SO WE HAVE A SENSE OF WHAT THE CRITERIA EMBODIED IN THE RFA MIGHT LOOK LIKE ALREADY WITH SOME REFINEMENTS, OF COURSE. SO I DON'T SEE THIS LETTER, THIS INVENTORY LETTER, WHATEVER, BEING CONTINGENT ON ONE ANOTHER. WE CAN DO THE LETTER AND WE CAN DO THE RFA.
DR. HALL: INDEPENDENTLY?
MR. SERRANO-SEWELL: YES. THAT'S HOW I SEE IT.
MR. KLEIN: I'D LIKE TO ALSO POINT OUT I'M NOT AWARE OF A SOURCE OF $100 MILLION BY JANUARY. SO THE INTENT HERE IS WITH THE INVENTORY, WE HAVE INFORMATION THAT THIS COMMITTEE AND THE STAFF CAN MAKE STRATEGIC DECISIONS THAT MAY HELP IN FORMULATING THE RFA. IT'S ALWAYS BETTER TO OPERATE IN THE CONTEXT OF AS MUCH INFORMATION AS POSSIBLE, BUT I HAVE NO INTENTION THAT THIS INVENTORY PREVIOUSLY APPROVED BY BOARD RESOLUTION SHOULD SLOW DOWN ANYTHING YOU WANT TO DO WITH AN RFA.
DR. HALL: IF WE HAVE SOME DIRECTION THEN FROM THE WORKING GROUP ABOUT WHAT INSTITUTIONS THAT THIS SHOULD BE DIRECTED TO, ABOUT WHETHER IT SHOULD INCLUDE PRIVATE SPACE AS WELL, WHAT THE SCOPE OF IT SHOULD BE, HOW THIS SHOULD WORK OUT?
CHAIRMAN DOMS: YOU'RE --
DR. HALL: IF WE'RE REALLY GOING TO HAVE A SURVEY, I'M SORRY, I CAME TO THIS MEETING UNPREPARED THAT THEY WERE GOING TO DO IT IN THIS WAY. IF WE HAVE A CHARGE, I NEED TO KNOW WHAT IT IS, AND I NEED TO GET SOME DIRECTION FROM THE SUBCOMMITTEE THEN ABOUT HOW COMPREHENSIVE? WHAT EXACTLY DO WE ASK FOR? IS IT THE NIH-FREE SPACE? IS IT FREE SPACE FOR STEM CELL WORK? DOES IT INCLUDE CAPITAL EQUIPMENT? DOES IT INCLUDE SPACE? EXACTLY WHAT ARE WE BEING ASKED? I JUST NEED TO KNOW THAT.
MR. KLEIN: THIS WAS DISCUSSION WITH THE BOARD SUBCOMMITTEE THAT CREATED THIS FACILITIES GROUP, AND CERTAINLY I CAN GO OVER AND GIVE YOU THAT INFORMATION. WHAT HAS BEEN SUGGESTED HERE TODAY, WHICH IS VERY HELPFUL, AND I THINK THE BOARD SUBCOMMITTEE, NOR THE BOARD HAD REALLY THOUGHT THROUGH, WAS THAT THAT SURVEY SHOULD INCLUDE PRIVATE SPACE. AS DAVID SAYS, THERE COULD BE SOME SIGNIFICANT POSSIBILITIES THERE, THAT IN COLLECTING INFORMATION THAT'S AVAILABLE.
BUT MY SUGGESTION IS THAT A DRAFT CAN BE DONE, AND IT COULD BE CIRCULARIZED BY JUST FOR COMMENT ON THE DRAFT TO IMPLEMENT THIS, MAKING SURE NOTHING IS FORGOTTEN, NOT ONLY WITH THE STAFF'S REVIEW OF THIS DRAFT, BUT THIS COMMITTEE'S REVIEW OF THAT DRAFT TO MAKE SURE WE INCORPORATE WHAT WAS IN THE RESOLUTION AS WELL AS THE GREAT IDEAS THAT CAME OUT OF THIS MEETING.
CHAIRMAN DOMS: I THINK ZACH'S POINT IS WHO'S GOING TO DO THE DRAFT.
DR. HALL: MY SUGGESTION WOULD BE IF WE WANT TO DO THIS, IT'S REALLY UNCLEAR TO ME, I WOULD SUGGEST THAT THERE BE A DRAFT THAT COMES BACK TO A SECOND COMMITTEE OF THIS SUBCOMMITTEE, WHICH THEN DISCUSSES EXACTLY WHAT YOU WANT TO GET OUT OF IT, WHAT INFORMATION YOU WANT, REALLY HAVE A DISCUSSION BECAUSE IT WILL BE A LOT OF WORK FOR UNIVERSITIES. IF IT ALL COMES IN, IT'S GOT TO BE COLLATED IN SOME WAY. YOU MAY HAVE REPORTS FROM, DEPENDING ON HOW YOU DO IT, AS MANY AS 50 DIFFERENT INSTITUTIONS. AND I JUST WANT TO BE SURE BEFORE WE COMMIT TO THIS AND ASK US TO DO THE WORK THAT WE KNOW WHAT EXACTLY WHAT WE'RE DOING AND IT'S BEEN DISCUSSED IN THE SUBCOMMITTEE SO THAT WE KNOW WHAT THE PURPOSE IS, WHAT THE LIMITS ARE. AND I WOULD SUGGEST A DRAFT THAT COMES BACK TO THE SUBCOMMITTEE THEN TO DISCUSS.
MR. SHEEHY: I WONDER IF THE CHAIR MIGHT BE WILLING TO SEE IF THERE MIGHT BE SOME VOLUNTEERS ON THIS COMMITTEE TO MAKE A SUBCOMMITTEE THAT WOULD WORK WITH ZACH ON THIS ISSUE SO THAT WE DON'T HAVE TO CONVENE A WHOLE OTHER MEETING FOR THIS. IF THERE'S SOME WILLINGNESS FOR SOME FOLKS HERE TO WORK WITH ZACH ON THIS, AND THEN WE CAN KIND OF PUT THIS ISSUE TO REST.
CHAIRMAN DOMS: THAT'S A GOOD POINT.
MR. LICHTENGER: I'D BE WILLING TO VOLUNTEER TO WORK ON THE SUBCOMMITTEE WITH ZACH ON THIS ISSUE.
CHAIRMAN DOMS: I'M ASSUMING YOU WOULD, JEFF.
MR. SHEEHY: I WAS TRYING NOT TO BE ON. THAT'S WHY I SAID VOLUNTEERS, BUT IF NEED BE. MR. KLEIN: SINCE IT'S A BOARD RESOLUTION AND SINCE THE ORIGINAL CONTENT OF THE LETTER I WORKED OUT WITH DR. FRIEDMAN FROM CITY OF HOPE, I'LL SERVE ON THIS COMMITTEE AND COMMIT BOARD STAFF TO IMPLEMENT THIS AFTER WE'VE GOTTEN SOME CONCURRENCE ON IT.
MR. SHEEHY: I'D BE HAPPY TO PARTICIPATE, IF YOU DON'T ASK TOO MUCH.
CHAIRMAN DOMS: I WILL BE HAPPY TO WORK ON IT.
MR. SERRANO-SEWELL: WE'LL DELEGATE TO THE CHAIR OF THIS WORKING GROUP THE ASSIGNMENT OF POLLING THE MEMBERS, GETTING THE VOLUNTEERS TOGETHER, AND WORKING WITH ZACH. YOU GET TO DO THAT.
CHAIRMAN DOMS: THANK YOU, DAVID. OKAY. WE'LL BRING THIS TO A CONCLUSION. AND, ZACH, I WANT TO COMMENT THAT NOW THAT I LOOK AT MY LIST, THERE WERE A LOT OF THINGS THERE. AND I KNOW VERY WELL HOW HARD YOUR STAFF WORKS. AND MELISSA IS JUST -- I'M SURE OTHER PEOPLE HAVE GONE ABOVE AND BEYOND THE CALL OF DUTY JUST TO GET READY FOR THIS MEETING, SO WE'LL WORK ON THE INVENTORY LETTER. I'D ALSO -- I'LL TAKE THE RESPONSIBILITY OF TRYING TO PUT TOGETHER THE OUTLINE OF REVIEW PROCEDURES AND CRITERIA AND THOSE OTHER ISSUES.
DR. HALL: LET ME MAKE A LONG-TERM REMARK, IF I MAY, RUSTY, AND THAT IS WE DIDN'T TALK ABOUT IT AT THE MEETING. IT CAME UP IN SEVERAL OF OUR PHONE CALLS. AND THAT IS, OUR OBJECT IN THE LONG RUN IS TO HAVE A STAFF PERSON FOR THIS COMMITTEE THAT WOULD BE EXPERIENCED IN CONSTRUCTION AND SPACE AND THESE MATTERS THAT COULD WORK ON THINGS LIKE THIS. AND WE ARE CONSTRAINED FROM HAVING A PERSON WITH SUCH EXPERTISE ON OUR STAFF BECAUSE OF OUR BUDGET CONSTRAINTS.
MELISSA, BOB HAS VERY GENEROUSLY LET MELISSA HAVE SOME OF HER TIME WORKING ON THIS COMMITTEE, WHICH HAS BEEN VERY GOOD. AND AS YOU KNOW, SHE'S DONE A TERRIFIC JOB. IN ACTUAL FACT, WE DON'T HAVE ANYBODY ON OUR STAFF NOW THAT HAS THE KIND OF EXPERTISE. I HOPE WE WILL HAVE AT SOME POINT.
ONE OF THE POINTS HAS BEEN TO WAIT AND SEE, AS THIS COMMITTEE HAS DEVELOPED, WHAT KIND OF PERSON WE NEED AND WHAT KIND OF EXPERTISE WE NEED. I HOPE AS SOON AS WE ARE ABLE TO GET OUR FINANCIAL AFFAIRS IN ORDER, THAT WE WILL BE ABLE TO HIRE A PERSON WHO WILL GIVE FIRST-RATE TECHNICAL EXPERTISE TO THE COMMITTEE AS WELL AS THE VERY GOOD ORGANIZATIONAL EXPERTISE THAT MELISSA HAS GIVEN.
CHAIRMAN DOMS: I HOPE SO TOO. OKAY. ANY OTHER QUESTIONS, COMMENTS?
MR. KASHIAN: I HAVE AN UNRELATED QUESTION. ASK COUNSEL HIS GUESS, IF YOU WILL, ABOUT THE LENGTH OF TIME IT WOULD TAKE TO GO THROUGH THE JUDICIAL VALIDATION PROCESS. COUNSEL, I'D LIKE TO KNOW YOUR GUESS AS TO THE LENGTH OF TIME IT WOULD TAKE TO GET THROUGH THIS JUDICIAL VALIDATION PROCESS THAT WE'RE IN. AND IF IT'S REQUIRED TO GO INTO THE FEDERAL COURTS AS WELL AS THE STATE COURTS.
MR. HARRISON: LET ME ANSWER THAT IN TWO DIFFERENT WAYS. THE ONLY ACTION PENDING CURRENTLY, AS BOB POINTED OUT, IS THE CONSOLIDATED STATE COURT ACTION. ON NOVEMBER 17TH THE ALAMEDA SUPERIOR COURT WILL HEAR A MOTION THAT WE'VE BROUGHT ON BEHALF OF THE STATE DEFENDANTS TO DISMISS THE CASE. IF WE ARE SUCCESSFUL IN CONVINCING THE COURT THAT THERE'S NO NEED FOR DISCOVERY AND A LENGTHY EVIDENTIARY TRIAL AND THAT SHE CAN RULE ON THE LEGAL ISSUES NOW, THEN UNDER OUR BEST-CASE SCENARIO, IT WOULD PROBABLY TAKE AT LEAST A YEAR FROM THEN TO GET THROUGH THE APPELLATE COURT PROCESS AND COME TO A FINAL CONCLUSION.
IF ON NOVEMBER 17TH THE COURT DETERMINES THAT IT'S NECESSARY TO UNDERTAKE DISCOVERY AND TO HOLD A TRIAL PRIOR TO REACHING A CONCLUSION ON THE MERITS, THEN IT COULD BE A SIGNIFICANTLY LONGER PERIOD OF TIME.
WITH RESPECT TO THE FEDERAL COURT LITIGATION, IT WILL IN ALL LIKELIHOOD BE REFILED, BUT IT DOESN'T PREVENT THE STATE FROM ISSUING BONDS. SO THOUGH WE'RE CONCERNED ABOUT IT ON THE MERITS, WE'RE NOT CONCERNED ABOUT IT FROM THE STANDPOINT OF IT HOLDING UP THE FUNDING OF THE PROGRAM.
MR. KASHIAN: THANK YOU.
CHAIRMAN DOMS: COMMENTS OR QUESTIONS? THANK YOU ALL VERY MUCH.
(THE MEETING WAS THEN CONCLUDED AT 12:40 P.M.)
 
REPORTER'S CERTIFICATE
 
I, BETH C. DRAIN, A CERTIFIED SHORTHAND REPORTER IN AND FOR THE STATE OF CALIFORNIA, HEREBY CERTIFY THAT THE FOREGOING TRANSCRIPT OF THE PROCEEDINGS BEFORE THE SCIENTIFIC AND MEDICAL RESEARCH FACILITIES WORKING GROUP OF THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE IN THE MATTER OF ITS REGULAR MEETING HELD AT THE LOCATION INDICATED BELOW
GRAND HYATT AT UNION SQUARE
345 STOCKTON STREET, BALLROOM EAST
SAN FRANCISCO, CALIFORNIA
ON
FRIDAY, OCTOBER 28, 2005
WAS HELD AS HEREIN APPEARS AND THAT THIS IS THE ORIGINAL TRANSCRIPT THEREOF AND THAT THE STATEMENTS THAT APPEAR IN THIS TRANSCRIPT WERE REPORTED STENOGRAPHICALLY BY ME AND TRANSCRIBED BY ME. I ALSO CERTIFY THAT THIS TRANSCRIPT IS A TRUE AND ACCURATE RECORD OF THE PROCEEDING.