The U.S. Pharmacopeia (USP) is pleased to present this interactive and engaging two-day workshop on identifying and addressing the barriers to adoption of pharmaceutical continuous manufacturing (PCM).

Featuring informative presentations and discussions led by FDA, industry, academia, USP, and other key stakeholders, our robust agenda is designed to provide actionable insights, strategies, and potential solutions you can take home to share with peers and colleagues at your company.

Information sharing and discussion will take center stage, including perspectives from regulators, industry leaders, experts, and others implementing or actively considering PCM applications, which have the potential to facilitate efficiencies, lower costs, increase manufacturing flexibility, and bolster supply chain resilience.

The workshop will take a holistic approach to identifying and addressing the barriers to adoption of continuous manufacturing, which include knowledge gaps and uncertainties about regulations, resource requirements, the business case and return on investment. A key feature will be perspectives from across the pharma supply chain, including generics manufacturers, innovators, and contract development and manufacturing organizations (CDMOs). Day two will include working sessions where all participants are invited to contribute. An informal networking reception will also provide additional opportunities to connect with colleagues and experts in the field.

Key topics:

• FDA’s perspective and updates on the PCM regulatory landscape
• Demonstrating value and return on investment
• Case studies of successful PCM implementation
• Overcoming technical challenges and organizational barriers to PCM adoption
• Ensuring quality PCM processes

Objectives

• Increased understanding of the PCM regulatory landscape and regulators’ perspectives
• Capability building to overcome technical challenges and organizational barriers to PCM
• Examination of existing and emerging challenges and strategies for PCM adoption
• Active engagement and networking among workshop attendees and presenters

Who should participate

• Lab directors, executives, and decision makers for manufacturing platforms (generics, innovators, CDMOs)
• Scientists and engineers from industry and academia who are developing/implementing PCM
• Quality assurance directors
• Regulatory affairs and policy professionals

Speakers:

Rajeev Rehani Budhdev, Executive Vice President and Head - API R&D, Dr. Reddy’s

Greg Connelly, Senior Director of Continuous Manufacturing, Vertex Pharmaceuticals

Olivier Dapremont, Executive Director, Process Technologies, Ampac Fine Chemicals

Adam Fisher, Director, Science Staff - Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA

Judy Frels, Senior Fellow, Executive Development Programs, University of Maryland – Robert H. Smith School of Business

Dennis Hall, Vice President, Advanced Manufacturing Technologies, U.S. Pharmacopeia

Todd Maloney, Executive Director, Eli Lilly

Frank Witulski, Director of Engineering, Merck