Overview
Is my drug or biologic eligible for one or any of the FDA expedited programs? How do I choose the right process? When do I qualify for a breakthrough? All these questions are answered during this webinar which begins with laying the foundation; first by helping you to understand what’s considered a “serious condition,” available therapies, and what defines an unmet medical need. Speakers will discuss FDA’s four expedited programs: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation, and then walk through which program is best suited to expedite and review a sponsor’s drug development and the different approaches for accelerating regulatory processes.
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Speakers
Jeff Allen, Executive Director, Friends of Cancer Research
Tamy Kim, Director for Regulatory Affairs and Policy, Oncology Center for Excellence; Supervisory Director for Regulatory Affairs, Office of Oncologic Diseases, CDER, FDA
Miranda J. Raggio, Senior Regulatory Program Manager, Expedited Programs, Program Implementation and Development Management Staff, Office of New Drugs, CDER, FDA
Alexander J. Varond, Partner, Goodwin Procter LLP
Kathleen Winson, Executive Group Director, Product Development Regulatory, Roche Genentech
ALEXANDER J. VAROND is a partner in Goodwin & Procter LLP’s Technology & Life Sciences groups and a co-chair of the firm’s FDA Litigation practice. Mr. Varond advises drug, biotech, and device clients on FDA regulatory matters. He has extensive experience in drug and medical device development, Hatch-Waxman patent and exclusivity issues, and regulatory strategy. Mr. Varond also counsels on advertising and promotional issues, defends companies during civil and criminal investigations on a variety of issues, including off-label promotion and GMPs, and regularly advises on corporate transactions. Prior to joining Goodwin in 2017, Mr. Varond was a senior associate at Hyman, Phelps & McNamara, PC. His perspective is reinforced by his in-house counsel experience during a recent six-month secondment to a leading biotech company, where he advised on drug development, compliance, NDA preparation, and exclusivity issues. Mr. Varond’s professional experience includes roles as a medical device engineer, operations manager, and deputy management representative to FDA in the medical device industry. He also served as a law clerk at the US International Trade Commission’s Office of Unfair Import Investigations, and as an intellectual property law clerk at NuVasive, Inc. Mr. Varond received his JD from The George Washington University Law School and a BS in biomedical engineering and management science from UC San Diego.Virtual Learning FAQ
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