CIRM Appoints National Expert on Drug Development and Regulation as Vice President, Research and Development
San Francisco, Calif., January 20, 2011 — The California Institute for Regenerative Medicine (CIRM), the state stem cell agency created by Proposition 71, has named Ellen Feigal, M.D., as its first Vice President for Research and Development effective January 31. Feigal currently serves as Executive Medical Director for Global Development at Amgen, Inc.
Feigal distinguished herself in many positions in academia, the federal government, non-profit research organizations, small pharma and large biotech companies. She has focused on assessing novel therapies, training young investigators in how to assess novel therapies, and in building partnerships and coalitions to enhance translational research. In her position at Amgen she also led the scientific/clinical interface with patient advocacy organizations and formalized the company’s policy on expanded access to therapies for those with limited or no treatment options.
“As CIRM matured and moved more of its resources into translational and clinical science, we saw the need to formalize a role for a vice president for research and development, and Ellen’s career trajectory and experience fill our vision for that role perfectly,” said CIRM President Alan Trounson. “We are delighted she has agreed to make CIRM the next stage of her very distinguished career.”
Feigal will report to Trounson and will work closely with other CIRM executives to build and manage the pre-clinical and clinical programs, both within California and with CIRM’s international collaborators, as well as interactions with the NIH, FDA and other regulatory bodies. She will also manage the assembly and oversight of CIRM’s clinical advisory committee that will assess project progress, milestones and go/no-go decisions. A key aspect of her portfolio will be working with the biotechnology, pharmaceutical and investment sectors as well as academia to enable and enhance development of clinical applications from CIRM’s science portfolio.
“I am very excited about the opportunities and the challenges as stem cell research crosses the threshold into clinical trials with patients with many different conditions of high clinical need,” said Feigal. “These programs need to be designed to support the advance of more widespread application of successful results.”
In addition to her work at Amgen, Feigal currently serves as Adjunct Professor and Director of the American Course on Drug Development and Regulatory Sciences at the University of California, San Francisco. The course, developed under her leadership in collaboration with the FDA, UCSF’s Department of Bioengineering and Therapeutic Sciences, its Center for Drug Development Sciences and the European Center of Pharmaceutical Medicine at the University of Basel, was launched in 2007. It is taught over two years, with six sessions, each four days in length in Washington, D.C. and a separate parallel course in San Francisco. Feigal will step down as course director and adjunct professor as she takes on this new position at CIRM.
“Ellen Feigal has the knowledge and breadth of experience to assure that the stem cell agency meets its promised goals of delivering stem cell-based therapies to the millions of patients suffering from chronic disease and injury,” said CIRM Governing Board Chair, Robert Klein. “The agency has already committed more than $300 million to translational research and Ellen’s guiding hand will make sure those and future investments in clinical pursuits provide a substantial return to the voters of California in the form of significantly reduced costs of care for many diseases and injuries.”
After getting her medical degree at UC Davis, completing residency there and at Stanford, and her hematology/oncology fellowship at UCSF, Feigal began her academic career at UCSF looking at the development of AIDS-associated lymphoma. She moved on to a faculty position at UC San Diego where she began assessing novel therapies for AIDS-associated lymphoma. In 1992, she joined the Cancer Therapy Evaluation Program at the National Cancer Institute. While there she developed new programs including a multidisciplinary AIDS Malignancy Working Group, a multi-center specimen bank for AIDS malignancy specimens, and a training program for clinical investigators. She became Deputy Director of the Division of Cancer Treatment and Diagnosis in 1997 and became its acting Director in 2001.
In 2004 she was recruited to Phoenix to become Vice President of Clinical Sciences and Deputy Scientific Director of the newly created non-profit Translational Genomics Research Institute (TGen). There she developed clinical research partnerships with hospitals and clinics and major research universities across the state. She also served on the Governor’s committee to establish a new medical school in Phoenix.
On a TGen-supported sabbatical during 2006, Feigal opened a Phoenix satellite facility for C-Path, an independent, non-profit organization dedicated to implementing the Food and Drug Administration’s Critical Path Initiative, which aims to accelerate the development of more effective treatments and diagnostics. She also directed C-Path’s orphan disease program.
In February 2007, she was recruited to become the Chief Medical Officer of Insys Therapeutics in Phoenix. There she oversaw the development and analysis of early phase trials and designed and launched Phase III trials. Then in April 2008 she was recruited to her current position at Amgen.
About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding