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10: RegCMC-Product Quality [clear filter]
Tuesday, June 25
 

10:30am

#244: Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-607-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, panelists will discuss how to define quality on patient relevance rather than on ever-tightening process and analytical capabilities that can reduce efficiency and limit patient access to drugs.

Learning Objectives

Identify purpose-driven as opposed to process-driven approaches to establishing specifications; Define how to apply toxicological concepts to manufacturing process parameters; Describe how to justify more robust design spaces.

Chair

Bowman Cox

Speaker

Panelist
Nina S. Cauchon, PhD, RAC

Panelist
Sarah Pope Miksinski, PhD

Panelist
Eric Jayjock, PhD

Panelist
Geoffrey Wu, PhD

Panelist
Paul Seo, PhD

Panelist
Christine M. V. Moore, PhD



Speakers
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen Inc.
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. She is chair of the AAPS CMC Community, and in addition to AAPS is also active on the ISPE Expedited... Read More →
avatar for Bowman Cox

Bowman Cox

Executive Editor, Manufacturing, Informa Pharma Intelligence
Bowman Cox leads Informa's coverage of pharmaceutical manufacturing. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to manufacturers and their quality organizations. Bowman has followed various energy... Read More →
avatar for Eric Jayjock

Eric Jayjock

Director, Continuous Manufacturing, Patheon, A Part of Thermo Fisher Scientific
Eric Jayjock performed his graduate studies at Rutgers University where he was a part of the NSF Center for Structured Organic Particulate (C-SOPS) systems. During his time at Rutgers, one of his main areas of research was the development of scalable manufacturing processes for oral... Read More →
avatar for Paul Seo

Paul Seo

Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA
Paul has worked for the FDA 15 years, and has gained experience in the Office of Generic Drugs, Office of Pharmaceutical Science, and Office of New Drug Quality Assessment. He currently oversees review processes in the Division of Biopharmaceutics, Office of New Drug Products, as... Read More →
avatar for Geoffrey Wu

Geoffrey Wu

Associate Director for Science and Communication, OLDP, OPQ, CDER, FDA, FDA
Commander Geoffrey Wu is a scientist officer in the United States Public Health Service. He is the Associate Director for Science & Communication in Office of Lifecycle Drug Products (OLDP), OPQ. He has been (co)leading quality assessment and research in controlled correspondence... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Senior Director, AstraZeneca
avatar for Christine Moore

Christine Moore

Global Head and Executive Director, GRACS CMC - Policy, Merck Research Laboratories
Christine Moore is Global Head and Executive Director, CMC Policy at Merck. Christine joined Merck after more than a decade in various positions in the US FDA. Prior to working at FDA, Christine spent 10 years in small and large molecule process development. Throughout her career... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum