Industry Consultant December 2019 – Present
Sunovion Pharmaceuticals, Marlborough, MA
Vice President & Head, Office of Strategic Planning & Global Head of R&D Center of Excellence, September 2019 - Present
Maximize clinical development and portfolio performance based on corporate strategy and resource allocations. Execute compliant clinical activities to develop great medicines for patients. Implement, guide, and communicate R&D strategy through productive relationships, strategic decision-making, and resource allocation.
- Contribute to four corporate-level committees serving as the trusted and ‘Go-To’ R&D link to Portfolio Planning, Clinical Development, and Corporate Governance leading working groups and management of clinical, regulatory, and commercial business strategies.
- Led Office of Strategic Planning guiding resource allocation of $100M+ direct costs annually and study conduct. Implemented improved methods to capture executive perspectives on strategic direction and include valuation in planning activities of over twenty-seven development programs in over thirteen assets;
- Chaired group that reviewed all study related documentation, including a total of over fifty-six protocols and informed consents. Implemented method to automate reviews making the process significantly more efficient, cutting review time in half while improving quality;
- Initiated company-wide evaluation of pharmacovigilance and governance with over eighteen initiatives to enhance patient safety and compliance;
- Performed a comprehensive R&D review of four late phase programs to capture Lessons Learned in the development processes and improve regulatory interactions.
Food and Drug Administration, Silver Spring, MD, April 2009 - August 2019
Medical Officer, Division of Neurology Products & Team Leader, Anesthesiology Drug Products
- As Senior Medical Reviewer, led evaluations for the most challenging rare disease (e.g., Exondys51, Radicava, and Tegsedi) and sleep drug (Intermezzo and Nuvigil (post-marketing) applications; As Lead Medical Officer for Anesthesiology products, led all NDA and IND review teams (e.g., Bridion, neostigmine, phenylephrine) for review and postmarketing activity.
- Designed and facilitated training for over 360 fellow Medical Officers and safety staff to improve analytical skills and regulatory reviews;
- Participated in the authoring of the current, Guidance for Industry on IND Safety reporting, which streamlined and clarified safety reporting procedures;
- Represented FDA as a Topic Expert in the International Conference for Harmonization M1 group bringing standardization and innovation to the regulatory documentation and reporting arena. Originated two major safety initiatives adopted by the FDA and MedDRA/ICH organizations.
- Helped optimize FDA internal safety analysis techniques using the MedDRA Standardised Query Methodology, resulting in New Reviewer Award from Commissioner
- Represented the Office of New Drugs to the Working Group that authored the Guidance for Industry on the certification process that brought the commercialization of medical gases into regulation;
- Organized and led the Agency’s Symposium and Workshops on Pediatric Sedation and Development of Insomnia Drugs resulting in more informed drug development and improved Investigator / Regulator relations.
- Additional experience as Adjunct Faculty, National Institute of Health Clinical Center, Department of Health and Human Services, Department of Clinical Pharmacology & Johns Hopkins University; Vice President, Clinical Development with Supernus Pharmaceuticals; Director / Group Director at Bristol Myers Squibb, Department of Neuroscience.
Doctor of Philosophy in Neurobiology and Doctor of Medicine
The University of Chicago, Chicago, IL
- Thesis - Endogenous Pyrogens in the Mammalian Central Nervous System
Bachelor of Science in Chemistry
The American University, Washington, DC
- Summa cum Laude, Valedictorian, President of ODK Senior Honor Society
- Medical License: New York #216099-1
- Certificate Program in Pharmacoepidemiology, FDA CDER/University of Pennsylvania (2010)
Training & Development
- Leading Strategy Growth, Columbia University School of Business/ExecOnline (2020)
- Excellence in Government Fellow, Partnership for Public Service, Washington, DC (2013)
- The Program on Negotiation for Senior Executives, Harvard Law School, Cambridge, MA (2005)
Professional & Community Involvement
- Eagle Scout Advisor, Troop 214 , Bethesda MD (2012 - 2016)
- Regulatory Science & Review Enhancement Award – Grant for $35K funding research on novel algorithmic SMQ methodology; renewed for $100K (2017 - 2018)
- Friend of MedDRA Award, MedDRA Maintenance & Support Services Organization (2015)
- Dr. Francis O. Kelsey Drug Safety Excellence Award, MedDRA Adverse Event Diagnostics Development Team (2012)
- Scientific Achievement Award for Outstanding New Reviewer, FDA (2011)