2020 has been unprecedented and tumultuous due to simultaneous challenges of a once-in-a-century global pandemic, the resulting socio-economic fallout, and political polarization regarding policy responses to the pandemic, civil rights protests and presidential elections. The FDA has been pressured and challenged and responded with varying degrees of success and now faces an incoming administration that in many ways could not contrast more sharply with its predecessor.

The first annual Wow or Yeow?! Webinar was held on Inauguration Day, January 20, 2017, to discuss whether the outlook for drug development under the new Trump administration might be amazing (Wow!) or unexpectedly painful (Yeow?!). Join the all-star panel of FDA consultants and lawyers in a discussion and Q&A of the 2020 experience and the FDA outlook for 2021 and beyond.

About the Speakers

Alexander Fleming, MD, is Founder and Executive Chairman of Kinexum, a strategic advisory firm specializing in regulatory, clinical, CMC, and other translational aspects of life science product development. Dr. Fleming has carried out pivotal regulatory work during his time at the FDA, where from 1986-98, he was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. He led reviews of landmark approvals, including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. He also helped to shape FDA policies and practices related to therapeutic review and regulatory communication.

David M. Fox advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies, on matters before the FDA and Drug Enforcement Administration (DEA). Known for his collaborative approach to complex regulatory issues, Mr. Fox has successfully resolved numerous disputes between sponsors and staff at FDA on products that raise novel regulatory issues. As a former senior lawyer for FDA and throughout his career in private practice, Mr. Fox has been deeply immersed in the regulatory side of the Hatch-Waxman Act, including pioneer-generic disputes and numerous cases of first impression involving exclusivity issues, Orange Book listings, and patent term extensions. Mr. Fox previously led Hogan Lovells’ Pharmaceutical and Biotechnology practice group and now serves on the firm's global Life Sciences management team.

Timothy Franson, MD, currently serves as a Principal at Faegre Drinker, a firm that provides transactional, litigation and regulatory services to organizations ranging from emerging enterprises to multinational companies. Drawing from extensive clinical and regulatory experience — including five years as VP of global regulatory affairs at Eli Lilly and Company — Dr. Franson guides clients through all pre- and post-approval phases of pharmaceutical development, particularly related to interactions with the FDA and global regulators. Dr. Franson provides clinical and regulatory guidance for drug and biologics development (including strategy, planning, training and issues management), post-approval advice (REM's, labeling and compliance) and due diligence. During his time at Lilly, Dr. Franson was directly responsible for the company’s FDA submissions (NDAs and supplements), which involved more than 20 major submission reviews and approvals.

Steven Grossman is the president of HPS Group LLC, a solution-oriented health policy and public affairs company that specializes strategic counsel that integrates the perspectives of Congress, the Executive Branch, third parties, and the media. From 1989 to 2000, Mr. Grossman was senior managing director and director of health policy in Hill and Knowlton’s Washington office. He developed and implemented public affairs, communications and crisis management programs for health care, pharmaceutical and food clients. In 1985, Mr. Grossman was appointed by President Reagan to serve as a Deputy Assistant Secretary for Health in the U.S. Department of Health and Human Services. Previously, Mr. Grossman was also one of the chief Senate negotiators on the Orphan Drug Act of 1983 and on the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman).

Frank Sasinowski currently serves as the Director of Hyman, Phelps, & McNamara, a law firm that specializes in new drug development, controlled substances, advertising, and health care law. By assisting sponsors and patient organizations in developing new medicines, Mr. Sasinowski has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Mr. Sasinowski was involved in 6 of the most recent 8 drugs FDA approved by way of its accelerated approval process. He is involved in many cell and gene therapies and aided significantly on the first approved systemic gene therapy, Zolgensma. Mr. Sasinowski joined FDA in 1983 as regulatory counsel in the Center for Drugs and Biologics, where he was key to implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. In 1987, he left the FDA as Deputy Director of the health policy staff in the Commissioner’s office and joined Hyman, Phelps & McNamara

Webinar Login Information

Topic: Wow or Yeow?! FDA Outlook for 2021 and Beyond

Time: Jan 29, 2021 11:00 AM Eastern Time (US and Canada)

https://zoom.us/j/98426865160?pwd=R0VDZVZCMFF0K3dOQnBGMDI3OFdidz09

Meeting ID: 984 2686 5160

Passcode: 082985

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For further inquiries, please email elijahabass@kinexum.com or brontejenkins@kinexum.com.