USP Workshop on Identifying and Addressing Barriers to Continuous Manufacturing Adoption

USP Workshop on Identifying and Addressing Barriers to Continuous Manufacturing Adoption

Registration Agenda Speaker Biographies

Continuous manufacturing is an advanced manufacturing technology gaining increased attention from industry and policymakers for its potential to enable production efficiencies for many drugs and their ingredients. Such efficiencies can help achieve geographic diversity in sourcing and supply chain resilience. Obstacles to continuous manufacturing adoption remain, however. These include knowledge gaps and uncertainties about regulations, resource requirements, the business case and return on investment. Taking center stage at this two-day workshop will be actionable insights, strategies and potential solutions as part of a holistic approach to identifying and addressing the barriers to continuous manufacturing adoption. Co-sponsored with the Regulatory Affairs Professionals Society, event presentations and discussions will be led by FDA, industry, academia, U.S. Pharmacopeia (USP), and other stakeholders.

The workshop will feature perspectives from across the pharma supply chain, including generics manufacturers, innovators, and contract development and manufacturing organizations (CDMOs). 

Potential benefits of pharmaceutical continuous manufacturing (PCM) can include opportunities to:

  • Enhance flexibility and efficiency in manufacturing
  • Lower production costs
  • Cut environmental footprints
  • Accelerate production and scale-up in response to emergencies
  • Reduce quality issues through real-time monitoring

Challenges to PCM adoption can include:

  • Knowledge gaps (e.g., areas where PCM may be most impactful and how best to implement it)
  • Workforce capacity challenges 
  • Start-up costs 
  • Lack of clarity on the return on investment
  • Navigating global regulatory uncertainties

USP is pleased to present this engaging and interactive workshop to explore successes and challenges in developing and implementing PCM, including both in-person and virtual participation. 

The workshop will consist of formal presentations, case studies, discussions, and working sessions with opportunities for attendees to ask questions and dig deeper into presented content. 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 to share experiences, gain insights, and address the unique challenges of PCM adoption. 

Key topics

  • FDA’s perspective and updates on the PCM regulatory landscape
  • The business case for PCM: Demonstrating value and return on investment
  • Industry case studies of successful PCM implementation
  • Implementation of a novel approach to flow chemistry manufacturing
  • Leading and navigating disruptive manufacturing technology innovation
  • Overcoming technical challenges and organizational barriers to PCM adoption
  • Ensuring quality PCM processes

Types of presentations

  • Case studies
  • Success stories
  • Working sessions
  • Sharing pitfalls/learnings
  • Implementation strategies (mitigating risks)
  • Networking reception

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 and quality control analysts/staff interested in process analytical technology
  • Regulatory officials
  • Contract research and manufacturing organizations
  • Vendors developing novel technologies for PCM
  • Data acquisition and analytics specialists
  • Policy professionals
  • Students and junior scientists

Featured speakers

  • 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
  • Eric Jayjock, Director, Process Engineering, Vertex Pharmaceuticals
  • Todd Maloney, Executive Director, Eli Lilly
  • Srividya Ramakrishnan, Vice President and Head - API Process Engineering, Dr. Reddy’s
  • Frank Witulski, Director of Engineering, Merck


  • Information sharing and discussion among industry leaders, regulators, experts, and stakeholders at different stages of PCM interest or adoption
  • Examination of existing and emerging challenges and strategies for PCM adoption
  • Assessment of resource requirements and potential return on investment of PCM
  • Capability building to overcome technical challenges and organizational barriers to PCM
  • Increased understanding of the current PCM regulatory landscape and regulators’ perspective
  • Active engagement and networking among workshop attendees and presenters

The venue
In-person participation will take place at USP’s Rockville, MD headquarters. There will also be a virtual option for those who cannot attend in person. If you have any questions about registration, travel or local accommodations, please email

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