Agenda | International Consortium for Advanced Medicines Manufacturing

Introduction

The International Symposium of Continuous Manufacturing of Pharmaceutical (ISCMP) was established in 2012 and has organized three successful meetings bringing together leading scientist and technical experts from industry, academia, and global regulatory authorities. These symposia helped lay the foundation for future industry adoption and regulatory policies.

Building on the success of ISCMP with an eye toward accelerated adoption of advance manufacturing technologies for small molecules, biologics, vaccines, and other modalities, ICAMM (International Consortium of Advance Medicine manufacturing) was established in 2021. ICAMM’s 2023 meeting will bring together the leading scientists and experts from academia, industry, global regulatory authorities, and policy makers to access progress to date, celebrates implementation success, evaluate remaining challenges and put together a joint future vision that will benefit patients globally by delivering needed medicines and overcoming technology and supply chain challenges.

Day 1 Morning Session – Celebrating Success

8:00 – 8:30 AM	Networking Breakfast and Check-in
8:30 – 8:45 AM	Symposium Chairs Opening Remarks Clive Badman and Bernhardt Trout
8:45 – 9:30 AM	Keynote: Celebrating Success in Advanced Manufacturing Janet Woodcock, Principal Deputy Commissioner, FDA
9:30 – 10 AM	Celebrating Success: Advanced Manufacturing of Biologics Kripa Ram, Senior VP and Global Head of CMC, Sanofi
10 – 10:30 AM	Celebrating Succes: Advanced Manufacturing of Small Molecules Patricia Hurter, CEO, Lyndra Therapeutics
10:30 – 11 AM	Morning Coffee Break
11 – 11:30 AM	Celebrating Success: Advanced Manufacturing of Vaccines/mRNA Margaret Ruesch, Vice President, Biotherapeutics Pharmaceutical Sciences, Pfizer R&D
11:30 – 12:15 PM	Morning Panel: Celebrating Success in Advanced Manufacturing Morning Speakers
12:15 – 1:15 PM	Lunch

Day 1 Afternoon Session – The Future of Healthcare and Supply Chains

1:15 - 1:50 PM	Keynote: The Role of Advanced Manufacturing for Supply Chains and Lessons Learned from the Pandemic John Polowczyk, Managing Director at EY, former White House Supply Chain lead on the Coronavirus Task Force
1:50 – 2:25 PM	(Re)Imagining the Future of Pharmaceutical Manufacturing Sarah O’Keeffe, SVP Synthetic Molecule Design & Development, Eli Lilly Arup Roy, Senior Vice President, BioProduct Research and Development, Eli Lilly
2:25 – 3 PM	Initiatives Enabling the Future of Healthcare Alastair Florence, Director, Future Continuous Manufacturing and Advanced Crystallisation (CMAC) Jon-Paul Sherlock, Head of Innovative Manufacturing Technology, AstraZeneca
3 – 3:30 PM	Afternoon Break
3:30 – 4:05 PM	Implementing Advanced Manufacturing Technologies Konstantin Konstantinov, CTO, Codiak Biosciences
4:05 – 4:55 PM	Afternoon Panel: The Future of Healthcare and Supply Chains Afternoon Speakers
4:55 – 5 PM	Symposium Chairs Day 1 Closing Remarks Clive Badman and Bernhardt Trout
5 – 6:30 PM	Poster and Wine Reception Posters by technology vendors and researchers

Day 2 Morning Session – Addressing Future Challenges

8:00 – 8:30 AM	Networking Breakfast
8:30 – 8:45 AM	Symposium Chairs Opening Remarks Day 2 Clive Badman and Bernhardt Trout
8:45 – 9:30 AM	Keynote: Addressing Future Challenges Peter Marks, Director of CBER, FDA
9:30 – 10 AM	The role of CDMOs in Addressing Future Challenges through the use of Advanced Manufacturing Technologies Rahul Singhvi, CEO, Resilience
10-10:30 AM	Morning Coffee Break
10:30 – 10:50 AM	The Role a CDMO Takes in Accelerating Pharmaceutical Innovation Today Through the Use of Advanced Manufacturing Julien Meissonnier, CSO, Catalent
10:50 – 11:10 AM	Thermo Fisher’s Current and Future Advanced Manufacturing Technology Douglas B. Hausner, Senior Manager, Continuous Manufacturing, Thermo Fisher Scientific
11:10 – 11:30 AM	Manufacturing of Cell and Gene Therapies: Current State, Challenges, and Best Practices from a CDMO Perspective Behnam Ahmadian Baghbaderani, Global Head of Process Development, Lonza
11:30 – 12:30 PM	Lunch

Day 2 Afternoon Session – The Future of Regulatory

The regulatory and quality session speakers will provide updates on implementation progress and remaining challenges. Dr. Lee, ICH Q13 Rapporteur, will lead the session by outlining the main content of ICH Q13. This will be followed by five leading regulators sharing their perspectives and summarizing current efforts to facilitate the implementation of advanced manufacturing platforms. In addition, Dr. Montgomery will share an industry perspective on regulatory and GMP lessons learned to date. A panel discussion will follow. Dr. Pieropan will join the panel with all regulatory and quality speakers.

12:30 –12:35 PM	Session Introduction Moheb Nasr, NPRC
12:35 – 12:55 PM	A Review of ICH Q13 Sau Lee, Deputy Director of Science, FDA
12:55 – 1:15 PM	Regulators’ Perspective on Advanced Manufacturing – FDA Manuel Osorio, Senior Scientist for Emerging Technologies and Medical Countermeasures, CBER/FDA Joel Welch, AD Science and Biosimilar Strategy, FDA
1:15 – 1:35 PM	Regulators’ Perspective on Advanced Manufacturing – EMA Dolores Hernán, Senior Quality Specialist, EMA
1:35 – 1:55 PM	Regulators’ Perspective on Advanced Manufacturing - PMDA Yoshihiro Matsuda, Senior Scientist (Quality), PMDA
1:55 – 2:15 PM	Regulatory and GMP Lessons Learned to Date, an industry Perspective Frank Montgomery, Vice President CMC Regulatory Affairs, AstraZeneca
2:15 – 3:00 PM	Afternoon Panel: The Future of Regulatory Afternoon Speakers and Franco Pieropan, Executive Director, FPP Consulting
3:00 – 3:05 PM	Symposium Chairs Closing Remarks Clive Badman and Bernhardt Trout