Regulatory Sciences Community

 

Please join us for an engaging panel discussion on Acceleration of New Medicines: CMC Lessons Learned from Emergency Use Authorizations.

Despite numerous scientific and medical advancements in the last twenty years, there remains a need for safe and efficacious medicines for the treatment of serious unmet medical conditions.  Health agencies worldwide have developed innovative regulatory approaches for accelerating the development of new medicines and the regulatory review of the marketing applications in an effort to bring these important new medicines to patients faster.

The SARS-Cov-2 (Covid-19) pandemic, which triggered a public health emergency declaration in the US, highlighted the need for close collaboration between industry and regulators to rapidly bring new products to the frontlines for the diagnosis and treatment of patients with Covid-19. This close collaboration between the FDA and industry and innovative approaches taken had led to unprecedented speed at which products were authorized under Emergency Use Authorization as treatments for patients with Covid-19 and their subsequent approval following the NDA/sNDA and BLA/sBLA pathways.

This session will provide an overview of Emergency Use Authorization and how it differs from normal drug approval pathways.  Industry and FDA experts will share their experiences and lessons learned from their collaborative work on Covid-19 treatments that were made available to patients in record time under an EUA and how some of these could be applied to the acceleration of important new medicines for the treatment of patients with unmet medical need under non-EUA setting.  Additionally, industry members will share their experiences in bringing new medicines to patients in the US under an EUA versus ex-US.

The following experts will share their experiences and views on this topic:

• Jessica Ursin, R.A.C., Genentech, Inc.
• Reza Oliyai, Ph.D. Gilead Inc.
• Thomas Oliver, Ph.D., FDA OPQ/OND
• Patrick Lynch, Ph.D., FDA OPQ/OBP

Pre-meeting work: The following FDA guidelines and readings may be useful for those participants who would like to have a baseline understanding of Emergency Use Authorizations/expedited Programs prior to joining the virtual panel discussion.

• FDA's webpage on Emergency Use Authorization: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
• FDA Guidance for Industry Expedited Programs for Serious Conditions––Drugs and Biologics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics

 

About the Panelists and Moderators

Jessica Ursin, R.A.C. is an Associate Regulatory Program Director in Pharma Technical Regulatory at Genentech, Inc., a member of the Roche Group.  She has worked on all stages of the biologics product lifecycle from early development to initial market applications to marketed activities.  She has been a regulatory lead on multiple accelerated development programs including products with Breakthrough Designation, PRIME, and Emergency Use Authorization.  As the Global Submission Lead for a COVID-19 treatment program, she developed strategies and led many emergency use authorization and marketing authorization applications globally.  Jessica holds a B.S. in Chemistry from Colorado State University and an EU Regulatory Affairs Certification (R.A.C.). 

Reza Oliyai, Ph.D. is. the Senior Vice President of Pharmaceutical and Biologics Operations at Gilead Sciences. He provides executive and strategic leadership to over 1400 personnel responsible for global development and commercial manufacturing. His organization has three main functions: pharmaceutical development for small molecules, end-to-end development for biologics, and worldwide commercial manufacturing of all drug products. These functions include strategic sourcing to establish and maintain the global supply chain for all clinical and commercial programs. Oversee all internal and external manufacturing of clinical and commercial supplies of drug products for small molecules and of all intermediates and products end to end for biologics and ADCs.

 Dr. Oliyai received a B.S. in Pharmacy from the Oregon State University and a Ph.D. in Pharmaceutical Chemistry from the University of Kansas. He is an inventor on multiple U.S. and international patents, and has contributed to the development, commercialization, and approval of over 27 products including Biktarvy®, Genvoya®, Harvoni®, Epclusa®, Vemlidy®, Cayston®, and Veklury®.

Thomas Oliver, Ph.D. is Director of the Division of New Drug Products I (ONDP/OPQ/FDA) and has over 24 years of experience at the FDA.  The Division works on the CMC drug product assessments (INDs, NDAs, associated meeting packages) for seven clinical divisions (the five divisions in the Oncology Center of Excellence (OCE), Division of Antiviral Products and the Division of Anti-infective Products).  The Division also provides support with CBER and CDRH clinically related applications that need CMC small molecule support.  Tom has previous experience with many of the clinical areas at the FDA and has both pre-approval and post-approval experience (CMC, labeling and efficacy supplements). He received his B.S. in Chemistry from Pennsylvania State University, his Ph.D in Organic Chemistry from the University of Rochester, and did his post-doctoral studies at Duke University.

Patrick Lynch, Ph.D. is a Review Chief in Division of Biotechnology Review and Research II (DBRR2) of the Office of Biotechnology Products (OBP), located in the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) at FDA. OBP is responsible for review of product quality information submitted in regulatory applications for biotechnology biological products. He first joined FDA in 2009, where he has served as a research fellow, product quality reviewer, and team leader for assessment biological products. He served as application team lead for assessment of Emergency Use Authorizations (EUA) for monoclonal antibodies that target and neutralize SARS-CoV-2. He received his Ph.D. in Biochemistry from Duke University in Durham, North Carolina, and his Bachelor of Science from the University of Georgia in Athens, Georgia.

Kin Tang, Ph.D. is a Senior Director in Global Pharma Technical Regulatory at Genentech, a member of the Roche Group, where he leads a Technical Regulatory Group responsible for Regulatory CMC strategies for small molecule development products from entry into human to NDA/MAA. Prior to his current role in CMC Regulatory affairs, Kin held scientific and leadership roles at Roche and Warner-Lambert Company in early and late-stage CMC development from pre-EIH to NDA. His areas of focus include regulatory scientific CMC strategies for drug substance and drug products and biopharmaceutics. Kin is past chair of the AAPS Chemistry and Manufacturing Community. Kin holds a B.S. in Pharmacy and M.Sc. and Ph.D. in Pharmaceutical Sciences from Rutgers, the State University, under the mentorship of Dr. Thomas Medwick. 

James Bernstein, Ph.D. leads the Live Oak Pharmaceutical Consulting practice, which provides consultants for all CMC functions for early to late-phase drug development projects. Prior to founding Live Oak in 2007, he worked at GSK and heritage companies for 24 years in both drug substance and drug product support. His contributions to client projects typically include CMC strategy, regulatory documents and meetings, and analytical science. His formal education includes a B.S. in Chemistry and Physics from Centenary College of Louisiana and a Ph.D. in Physical Chemistry from the University of North Carolina at Chapel Hill.

 

Organizing Team:
Kin Tang (Genentech), James Bernstein (Live Oak Pharmaceutical Consulting), Kim Huynh-Ba (Pharmalytik), Andrea Schirmer (Boehringer Ingelheim), David Schwinke (AbbVie), Scott Roberts (Novo-Nordisk)

DISCLAIMER
The views and opinions expressed in this discussion are the participants' own and do not necessarily reflect the views or policies of their respective employers.

PLEASE READ THESE NOTES CAREFULLY:

1. No Registration is necessary – log in will be accepted on first come first served basis. The number of participants is limited to 250.

(Please make sure you have a reliable internet connection as there is no warranty if you can reconnect once logged out.)

2. The link will be available 10 min before the discussion start for attendees to sign on. The discussion will begin promptly at 1pm EST.

Link to connect: See below

3. You will be in a listening only mode. Questions for the panel during the discussion can be entered in the chat area and will be addressed as time allows.

 

Link for Joining the Project Orbis Virtual Panel Discussion

Please join my meeting from your computer, tablet or smartphone.
https://www.gotomeet.me/AAPS-CMC_Community

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Kin Tang Ph.D.
Director, Regulatory
Genentech
South San Francisco CA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.Director, Regulatory
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