Gail M. Farfel
CAREER SUMMARY
With 19 years experience in Clinical Development, Regulatory Strategy and Medical Affairs, Dr. Farfel advises companies on asset evaluation, clinical development program planning and regulatory strategy for new chemical entities, new indications, and new formulations. Formerly Vice President of US Neuroscience at Novartis Pharmaceuticals and a member of the PhRMA Clinical Research Subcommittee, her expertise spans many indications in Psychiatry and Neurology including affective disorders, substance abuse, neurodegenerative diseases and pain. Dr. Farfel has a proven track record in US, EU and Japanese regulatory approvals and new product/new indication launches during her career and is the author of over 50 publications and presentations.
KEY ACCOMPLISHMENTS
- Led or participated in clinical development of 19 NCEs, including 11 commercialized products such as Zoloft, Zyrtec, and Lyrica
- Expertise in depression and dysthymia, panic disorder, GAD, PTSD, sleep disorders, schizophrenia, substance abuse liability, multiple sclerosis, Alzheimer's disease and other dementias, epilepsy, Parkinson's disease, ADHD, neuropathic pain and other pain syndromes, TBI and SCI
- Experienced in global regulatory submissions including INDs, CTDs, NDAs, sNDAs, MAAs, and 505(b)(2), with formulations for capsules, tablets, chewable tablets, sprinkles, oral solutions, IV and patch
- Multiple successful FDA Advisory Committee Meeting outcomes including two first indications: Zoloft for Posttraumatic Stress Disorder and Exelon for Parkinson's Disease Dementia
- Successful leader of collaborations between large multinational companies; between large pharma and biotech; and public-private partnerships
EDUCATION
Dr. Farfel trained as a biochemist and behavioral pharmacologist, receiving a BA in Biochemistry from The University of Virgina and a PhD in Neuropsychopharmacology from The University of Chicago.