Agenda

Day 1 - September 26, 2016

7:00 – 7:45
Breakfast and Registration
7:45 – 8:00
Symposium Introduction
Clive Badman (GSK) / Bernhardt Trout (MIT) 
8:00 – 10:30

CM – Small Molecule Session 1 (Case Studies and Panel discussion)
Chair: Alastair Florence (Univ. of Strathclyde)
Co-Chair: Maurizio Futran (J&J)

 

  • 5 min Introduction - Accomplishments since ISCMP 2014 and Remaining Challenges by Alastair Florence, Ph.D.
  • 25 min Case Study - GMP Continuous Drug Substance Production: Ensuring Quality (Kevin Cole, Ph.D. Lilly) Download Slides
  • 25 min Case Study - Enabling a Higher Assurance of Control for Drug Product Manufacturing (Ian Leavesley, BSE Lilly)
  • 25 min Case Study - Business Case Drivers and Deployment Strategies in the Current Landscape for Continuous Drug Product Manufacturing (Lawrence De Belder, M.Eng J&J) Download Slides
  • 25 min Case Study - Drug Product Continuous Manufacturing: From Business Case to Commercial Manufacturing (Kelly A. Swinney, Ph.D. Vertex)
  • 45 min All Conference Panel Discussion: Panel with Co-chair, Regulator, and Speakers
10:30 – 11:00
Break
11:00 – 1:30

CM – Bioprocessing Session 2 (Case Studies and Panel discussion)
Chair: Konstantin Konstantinov (Codiak Biosciences)
Co-Chair: Nigel Titchener-Hooker (UCL) 

 

  • 5 min Introduction - Accomplishments since ISCMP 2014 and Remaining Challenges by Konstantin Konstantinov, Ph.D.
  • 25 min Case Study - The Shrinking Footprint: Next Generation Technologies in Biomanufacturing; A Case study in the Application of Continuous Manufacturing (Sam Guhan, Ph.D. Amgen)
  • 25 min Case Study - A New Concept for Biopharmaceutical Production and Resulting Regulatory Challenges (Thomas Daszkowski, Ph.D. Bayer AG)
  • 25 min Case Study - Single Use Enabled Automated Continuous Monoclonal Antibody Production with Real Time Release (David Pollard, Ph.D. Merck)
  • 25 min Case Study - End-to-End Continuous Processes Enabling the Implementation of Lean, Flexible and Portable Biomanufacturing (Veena Warikoo, Ph.D. Sanofi)
  • 45 min All Conference Panel Discussion: Panel with Co-chair, Regulator, and Speakers
1:30 – 2:30
Lunch
2:30 – 5:00

CM – Small Molecule Session 3 (Case Studies and Panel discussion)
Chair: Clive Badman (GSK)
Co-Chair: Fernando Muzzio (Rutgers)

 

  • 5 min Introduction - Accomplishments since ISCMP 2014 and Remaining Challenges by Clive Badman, Ph.D. (GSK)
  • 25 min Case Study - The Development of an Integrated Control Strategy for a Continuous Primary Pharmaceutical Process (Hannah Robinson, MEng, GSK) Download Slides
  • 25 min Case Study - Proof of Operations for Continuous Manufacturing and Real Time Release Testing of Film Coated Tablets (Robert Meyer, Ph.D., Merck) Download Slides
  • 25 min Case Study - Control Strategy for Pharmaceutical Continuous Manufacturing  – Overview and Case Study (Mojgan Moshgbar, Ph.D., Pfizer)
  • 25 min Case Study - Considerations on Control Strategies of E2E Pharmaceutical Manufacturing (Markus Krumme, Ph.D., Novartis) Download Slides
  • 45 min All Conference Panel Discussion: Panel with Co-chair, Regulator, and Speakers
5:00 – 5:15
Day 1 Wrap-up Comments
Clive Badman and Bernhardt Trout
5:15 – 6:45
Wine and hors d'oeuvres Reception and Poster Session
6:45 
End of Day 1
 
 
 

Day 2 - September 27, 2016

7:30 – 8:00
Breakfast
8:00 – 8:15
Reflections on Day 1 and Introduction of Day 2
Clive Badman (GSK) /Bernhardt Trout (MIT)
8:15 – 9:15
Keynote Presentation
Keynote Speaker: Janet Woodcock, M.D., FDA (45 min + 15min for Q&A)
9:15 – 10:00

Learning from other industries (1 Case Study with panel discussion)
Chair: Markus Krumme, Ph.D. (Novartis)

 

  • 5 min Introduction - Accomplishments since ISCMP 2014 and Remaining Challenges by Markus Krumme
  • 20 min Case Study - Learnings from Other Industries: "See What is Possible” (Lou Heavner, Emerson Process Management) Download Slides
  • 20 min All Conference Panel Discussion: Panel with Co-chair, Regulator, and Speakers
10:00 – 10:30
Break
10:30 – 12:25

New Technology Session 1: Small Molecule Technologies

Chair: Bernhardt Trout (MIT)
Co-Chair: Michael O’Brien (Pfizer) 

 

  • 5 min Introduction by Bernhardt Trout, Ph.D and Michael O' Brien, Ph.D
  • 15 min Presentation - How Flow Chemistry is Changing Small Molecule Manufacturing by Expanding the Reaction Toolbox (Aaron Beeler, Ph.D., Boston University) Download Slides
  • 15 min Presentation - Status of and Challenges in End-to-End Synthesis of APIs (Klavs Jensen, Ph.D., MIT) Download Slides
  • 15 min Presentation - Continuous Crystallization in Pharmaceutical Manufacturing (Allan Myerson, Ph.D., MIT) Download Slides
  • 15 min Presentation - Innovation in Continuous Filtration, Drying and Formulation of Drugs (Salvatore Mascia, Ph.D., CONTINUUS) Download Slides
  • 3 x (5min) Commentaries from Mark Buswell (GSK), Philip Shering (Astrazeneca) Download Slides and Joel Hawkins (Pfizer) on These New Technologies
  • 35 min All Conference Panel Discussion: Panel with Co-chair, Regulator, and Speakers
12:25 – 1:25
Lunch
1:25 – 3:20

New Technology Session 2: Bio-Processing Technologies
Chair: Charles Cooney (MIT)
Co-Chair: Joanne Beck (Celgene) 

 

  • 5 min Introduction by Charles Cooney, Ph.D.
  • 15 min Presentation - End-to-End Integrated Continuous Manufacture of Monoclonal Antibodies (Massimo Morbidelli, Ph.D., ETH) Download Slides
  • 12 min Presentation - Perfusion Cell Cultures as Prerequisites for Integrated Continuous Bioprocessing (Weichang Zhou, Ph.D., WuXi Biologics)
  • 12 min Presentation - Emerging and Enabling Technologies in Chromatography (Steven Cramer, Ph.D. RPI) Download Slides
  • 12 min Presentation - Emerging and Enabling Technologies in Membrane Separations (Andrew Zydney, Ph.D. Penn State) Download Slides
  • 12 min Presentation - Emerging and Enabling Technologies in Microtechnologies for Bioprocessing (Rajeev Ram, Ph.D. MIT) Download Slides
  • 12 min Presentation - Emerging and Enabling Technologies in Control of Continuous Bioprocesses (Richard Braatz, Ph.D. MIT) Download Slides
  • 35 min All Conference Panel Discussion: Panel with Co-chair, Regulator, and Speakers
3:20 – 3:50
Break
3:50 – 5:30

Regulatory and Quality Session
Chair: Moheb Nasr (GSK)
Co-Chair: Markus Krumme (Novartis)

 

  • 5 min Introduction, Moheb Nasr, Ph.D Download Slides
  • 15 min Presentation - Regulatory and Quality Considerations, an Industry Perspective (Markus Krumme, Ph.D) Download Slides
  • 15 min Presentation - Regulatory and Quality Considerations, a US FDA Perspective [Sau (Larry) Lee, PhD]  Download Slides
  • 15 min Presentation - Regulatory and Quality Considerations, a PMDA Perspective (Yoshihro Matsuda, Ph.D)  Download Slides
  • 50 min All Conference Panel Discussion
5:30 – 5:40
Symposium Conclusion and Proposed next steps
Clive Badman /Bernhardt Trout