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Monday, June 25 • 3:00pm - 4:15pm
#153: New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-550-L04-P; CME 1.25; IACET 1.25; RN 1.25

The session is intended to have a broad look at technology innovations and interactions with regulatory authorities in this area. The two key themes of continuous manufacturing and advanced therapy medicinal products are chosen to illustrate recent innovations. Topics included are: quality attributes, control strategy and advanced analytical methods, including PAT applications.The session will address both small and large molecules and give examples of complex biologicals, e.g. Gene and Cell therapy and CAR-T cells applications. Regulatory challenges for implementation of new technologies will be addressed, including possibilities for effective interaction with regulatory authorities.

Learning Objectives

Identify recent technological developments and regulatory challenges in their implementation; Describe continuous manufacturing and how complex biological products are characterized and control strategies are developed; Discuss possibilities for interaction with regulatory authorities on development of innovative products


Peter Richardson, PhD


Global Approval and Acceptance of Continuous Manufacturing: Regulatory Opportunities
Leslie Weiss, MBA, RPh

Regulatory Challenges and Solutions for New Technology Development
Lucy Chang, PhD

Innovative Manufacturing for Cell and Gene Therapies
Michael Havert, PhD

avatar for Lucy Chang

Lucy Chang

Exceutive Director, Merck & Co., Inc.
Dr. Chang received her Ph.D. from University of Connecticut and has worked in various biopharm companies including Sanofi, GSK, Pfizer and Teva. She is currently the Executive Director of Global Regulatory CMC, providing regulatory leadership, oversight and strategy to a team of Regulatory... Read More →
avatar for Michael Havert

Michael Havert

Biologist/CMC Reviewer, Gene Therapy Branch, OTAT, CBER, FDA
Mike has been a CMC Reviewer in the Gene Therapy Branch since 2004. Gene Therapies are a diverse group of new technologies that include genetically modified viruses and cells. Mike’s recent accomplishments include serving as BLA Chair for a genetically modified autologous T-cell... Read More →
avatar for Peter Richardson

Peter Richardson

Head of Quality, Specialised Scientific Disciplines Department, European Medicines Agency (EMA)
Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical... Read More →
avatar for Leslie Weiss

Leslie Weiss

Director, CMC Regulatory Affairs, Janssen Research and Development LLC
Leslie Weiss, Director of CMC RA at Janssen R&D, leads a team responsible for managing new registrations and post approval changes for a diverse product portfolio. Leslie’s team received the first FDA approval for a batch to CM process switch. She continues to partner with global... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session