FDA/PQRI Workshop on the Regulatory Framework for DM and POC Manufacturing – Day 1

Glenn Wright, Chair – PQRI Board of Directors; Chief Operating Officer, Parenteral Drug Association (PDA)

Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA)

Future drug manufacturing may be more distributed, flexible, and portable than it is today. Distributed manufacturing (DM) platforms may even enable localized point-of-care (POC) manufacturing, which could allow for better response to patient demand but also challenge the current approach for regulating pharmaceutical quality. Appreciating the potential benefits of these advanced technologies for U.S. patients, FDA started an initiative of collaborative engagement to proactively develop a regulatory framework for DM and POC technologies.

Session 1 will provide an introduction to DM and POC technologies, summarize critical areas for consideration as FDA evaluates a potential framework to regulate these technologies, and discuss DM/POC terminology harmonization among all stakeholders.

Thomas O’Connor, Ph.D., Deputy Director, Office of Testing and Research, OPQ/CDER/FDA

Riley Myers, Ph.D., Emerging Technology Team, OPQ and Lead Biologist, Office of Biotechnology Products (OBP), CDER/FDA

• • Thomas O’Connor, Ph.D.
  • Riley Myers, Ph.D.
  • Carolyn Yong, Ph.D., Associate Director for Policy, Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER)/FDA

Session 2 will explore potential operating/business models between a DM/POC applicant and DM/POC sites, discuss the roles and responsibilities of the applicant and the site user(s) based on various operating/business models, and identify regulatory challenges associated with these models.

John J. Lewin III, Pharm.D., MBA, Chief Medical Officer, On Demand Pharmaceuticals, Inc.

We will explore various potential models for distributed/point-of-care manufacturing operations.  In addition to evaluating the potential benefits to patients, we will discuss implications for different approaches as it relates to the applicant and the site user(s) as well as regulatory challenges and opportunities.   

Alvaro Goyanes, Ph.D., Co-Founder and CEO, FabRx; Honorary Lecturer, UCL School of Pharmacy

• • John J. Lewin III, Pharm.D, MBA
  • Alvaro Goyanes, Ph.D.
  • Joel Welch, Ph.D., Chair, Emerging Technology Program, Associate Director for Science & Biosimilar Strategy, OBP/OPQ/CDER/ FDA

Registrants will breakout into several concurrent breakout sessions to facilitate small group discussions