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Monday, June 24 • 3:30pm - 4:30pm
#168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-569-L04-P; CME 1.00; IACET 1.00; RN 1.00

The pace of innovation in the pharmaceutical industry has accelerated tremendously. Future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization and industry efforts. This session will present an overview of the landscape for innovative modalities and emerging technologies in the field of human therapeutics, and the regulatory CMC challenges associated with their product development and approval.

Learning Objectives

Discuss the landscape for innovative modalities and emerging technologies in the field of human therapeutics; Describe the regulatory CMC challenges associated with their product development and approval.

Chair

Nina S. Cauchon, PhD, RAC

Speaker

Regulating Innovation in CMC – A Perspective from Industry
Nina S. Cauchon, PhD, RAC

Integrated Manufacturing and its Opportunities to Low Cost Vaccine Manufacture
J. Christopher Love, PhD, MA

Regulating Advanced Therapy: Gene and Cell Therapy Products
Raj K. Puri, MD, 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 J. Christopher Love

J. Christopher Love

Professor; Member, Koch Institute for Integrative Cancer Research, Koch Institute At MIT
J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering and member of the Koch Institute for Integrative Cancer Research at MIT. Dr. Love received his Ph.D. in 2004 in physical chemistry at Harvard University. His research centers on... Read More →
avatar for Raj Puri

Raj Puri

Director, Division of Cellular and Gene Therapies, OTAT, CBER, FDA
Raj K. Puri, M.D., Ph.D. is a director of the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) at FDA’s Center for Biologics Evaluation and Research (CBER). He has been directing this division for more than16 years. He is also... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session