Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
C
Workshop and Webinar Agendas
WORKSHOP 1: FEBRUARY 27-28, 2020
Workshop on Innovations in Pharmaceutical Manufacturing
Hosted by Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing
AGENDA
THURSDAY, FEBRUARY 27, 2020
The overall goal of this workshop is to identify and discuss potential innovative technologies that could realistically be implemented in the next 5-10 years.
| 8:30 | Welcome |
| Gintaras Reklaitis | |
| Purdue University | |
| 8:40 | Workshop Introduction |
| Janet Woodcock | |
| Director, Center for Drug Evaluation and Research | |
| U.S. Food and Drug Administration |
Session 1: Drug Product
Moderators: Gintaras Reklaitis, Purdue University; Matthew DeLisa, Cornell University
| 9:00 | PCMM and Beyond—Next Gen Innovation for Solid Oral Dosage Forms |
| Dan Blackwood | |
| Pfizer | |
| 9:25 | Disruptive Innovation for Next Generation Biomanufacturing |
| Govind Rao | |
| University of Maryland, Baltimore County | |
| 9:50 | Enabling Technologies for Manufacturing Thermostable and Cost-Effective Biopharmaceuticals |
| Akhilesh Bhambhani | |
| Merck | |
| 10:15 | Challenges for Advanced Drug Delivery |
| Richard Korsmeyer | |
| Consultant | |
| 10:40 | Break/Mingle |
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
| 10:55 | Innovative Drug Products in the Pipeline |
| David Lechuga-Ballesteros | |
| AstraZeneca | |
| 11:20 | Discussion Panel with Morning Speakers and Audience |
| 12:20 | Lunch Break |
Session 2: Control and Analytics
Moderators: Saly Romero-Torres, Biogen; Seongkyu Yoon, University of Massachusetts
| 1:15 | Modeling, Data Analytics, and Machine Learning for Process Development and Verification |
| Richard Braatz | |
| Massachusetts Institute of Technology | |
| 1:40 | Innovative Analytical Technologies and Biopharmaceutical Reference Materials |
| John Schiel | |
| National Institute of Standards and Technology | |
| 2:05 | A Look to the Future: Multi-Attribute Methods and Controls |
| Tiffany Thiel | |
| Amgen | |
| 2:30 | Harnessing the Power of Analytical Sensors in Pharmaceutical Manufacturing: Past, Present, and Future Goals |
| Karin Balss | |
| Janssen | |
| 2:55 | Break/Mingle |
| 3:15 | Emerging Opportunities and Challenges in Biologics Manufacturing Digital Process Data Analytics |
| Jack Prior | |
| Sanofi | |
| 3:40 | Value-Focused Analytics and Digital Technology Roadmap for Advancing Biomanufacturing |
| Jun Huang | |
| Pfizer | |
| 4:05 | Discussion with Afternoon Speakers and Audience |
| 5:00 | Adjourn |
FRIDAY, FEBRUARY 28, 2020
| 8:30 | Welcome to Day 2 |
| Gintaras Reklaitis | |
| Purdue University |
Session 3: Drug Substance Production
Moderators: Timothy Charlebois, Pfizer; Todd Przybycien, Rensselaer Polytechnic Institute
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
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| 8:40 | Compact Factory for Drugs on Demand: Technology, Implementation, and Impact |
| Salvatore Mascia | |
| Continuus | |
| 9:05 | Innovations in Development of Synthetic Small Molecule Drug Substance |
| Jean Tom | |
| Bristol-Myers Squibb | |
| 9:30 | The Biopharmaceutical Industry’s Emerging Continuous and Integrated Platform for Recombinant Protein |
| Jon Coffman | |
| AstraZeneca | |
| 9:55 | Hierarchy of High Impact Improvements in Bio Manufacturing |
| Günter Jagschies | |
| GE Healthcare (Retired), remote | |
| 10:20 | Discussion Panel with Morning Speakers and Audience |
| Additional Panelists: Gregg Nyberg, Merck; Jorg Thommes, Gates; Andy Bommarius, Georgia Tech | |
| 11:20 | Break/Mingle |
Session 4: What’s Missing?
The goal of this session is to identify innovations that might not have been discussed in earlier sessions. That is, this session provides the opportunity for “free” discussion.
| 11:45 | Discussion Session with Speakers and Audience |
| 12:45 | Closing Remarks |
| Gintaras Reklaitis | |
| Purdue University | |
| 1:00 | Adjourn Workshop |
WORKSHOP 2: JUNE 2-3, 2020
VIRTUAL WORKSHOP ON TECHNICAL AND REGULATORY BARRIERS TO INNOVATIONS IN PHARMACEUTICAL MANUFACTURING
HOSTED BY COMMITTEE TO IDENTIFY INNOVATIVE TECHNOLOGIES TO ADVANCE PHARMACEUTICAL MANUFACTURING
AGENDA
June 2, 2020
| 9:00 | Welcome and Workshop Introduction |
| Gintaras Reklaitis | |
| Purdue University | |
| 9:05 | Perspective from the Office of Pharmaceutical Quality on Barriers to Innovation |
| Michael Kopcha | |
| Director, Office of Pharmaceutical Quality | |
| Center for Drug Evaluation and Research | |
| U.S. Food and Drug Administration |
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Session 1: Delivering on Manufacturing Innovation: Challenges and Opportunities
Committee Moderator: Matthew DeLisa, Cornell University
Secondary Moderator: Timothy Charlebois, Pfizer
| 9:25 | Regulatory Challenges to Pharmaceutical Innovation |
| Roger Nosal | |
| Pfizer | |
| 9:50 | Innovative Strategies to Control Product Quality Attributes and Reduce Commercialization Timelines |
| Patrick Swann | |
| Amgen | |
| 10:15 | Break |
| 10:25 | The Need for Regulatory Flexibility to Support Flexible Manufacturing |
| Christine Moore | |
| Merck | |
| 10:50 | A Role for Public-Private Partnerships in Advancing Biopharmaceutical Manufacturing Innovation |
| Kelvin Lee | |
| University of Delaware | |
| 11:15 | Discussion Panel with Morning Speakers and Audience |
| Moderator will ask questions submitted by committee or audience members. | |
| 12:00 | Lunch Break |
Session 2: Blurring the Boundaries: Integration, Intensification, and Control
Committee Moderator: Stephen Hadley, Bill & Melinda Gates Foundation
Secondary Moderator: Todd Przybycien, Rensselaer Polytechnic Institute
| 12:30 | Opening the Door to the Future – Why Continuous Manufacturing Was the Key |
| Paul Collins | |
| Lilly | |
| 12:55 | Considerations for the Design and Construction of Next Generation Biologics Manufacturing Facilities |
| Jim Thomas | |
| Just – Evotec Biologics | |
| 1:20 | Janssen’s Journey Toward Improved, More Agile Manufacturing through Deployment of Sensor and Model Based Advanced Process Control: Barriers and Opportunities |
| Mauricio Futran | |
| Janssen | |
| 1:45 | “Right-sized” Efficient Multi-Product Manufacturing |
| Kerry Love | |
| Sunflower Therapeutics | |
| 2:10 | Break |
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
| 2:25 | The Alchemy of Process Control: Regulatory Flexibility and Supply Robustness |
| Kim Wolfram | |
| Biogen | |
| 2:50 | Control Strategy as a Critical Aspect of Manufacturing Innovation: Opportunities and Challenges on the Path to Implementation |
| Jason Starkey | |
| Pfizer | |
| 3:15 | Discussion Panel with Afternoon Speakers and Audience |
| Moderator will ask questions submitted by committee or audience members. | |
| 4:00 | Adjourn |
JUNE 3, 2020
| 9:00 | Welcome to Day 2 |
| Gintaras Reklaitis | |
| Purdue University |
Session 3: Innovative Processing Technologies
Committee Moderator: Kelley Rogers, National Institute of Standards and Technology
Secondary Moderator: Timothy Charlebois, Pfizer
| 9:05 | Addressing Technical and Regulatory Challenges in the Development of Innovative Drug Delivery Technologies to Increase Access in Global Health Settings |
| Susan Hershenson and Ping Zhao | |
| Bill & Melinda Gates Foundation | |
| 9:30 | Modern Aseptic Processing – What Are You Validating and Why? |
| Brent Lieffers | |
| Singota Solutions | |
| 9:55 | Novel Formulations to Improve Biologics Stability |
| Patricia Seymour | |
| BDO | |
| 10:20 | Break |
| 10:30 | Innovative Formulations and Delivery Technologies: Practical Aspects from Development to FDA Approvals |
| Mansoor Khan | |
| Texas A&M | |
| 10:55 | 3D Printing Pharmaceutical Dosage Forms at Commercial Scale: Aprecia’s Journey |
| Jae Yoo | |
| Aprecia | |
| 11:20 | Innovations in Freeze Drying |
| Steve Nail | |
| Baxter |
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
| 11:45 | Discussion Panel with Morning Speakers and Audience |
| Moderator will ask questions submitted by committee or audience members. | |
| 12:30 | Lunch Break |
Session 4: Disruptive Technologies and Convergent Innovations
Committee Moderator: Todd Przybycien, Rensselaer Polytechnic Institute
Secondary Moderator: Christopher Earnhart, JPEO-CBRND
| 1:00 | Perspectives from an Investor in Start-Up Life Science Industrials that Provide Fundamental Technologies and Services to Biopharma |
| Gustavo Mahler | |
| Dynamk Capital | |
| 1:25 | Novel Approaches to Manufacturing to Enable Rapid Response |
| Amy Jenkins | |
| Defense Advanced Research Projects Agency | |
| 1:50 | Perspectives from an Institutional Innovation Firm on Pioneering Life Science Platforms and Their Challenges |
| Noubar Afeyan | |
| Flagship Pioneering | |
| 2:15 | Discussion Panel with Afternoon Speakers and Audience |
| Moderator will ask questions submitted by committee or audience members. | |
| 3:00 | Closing Remarks |
| Gintaras Reklaitis | |
| Purdue University | |
| 3:15 | Adjourn Workshop |
WEBINAR 1: JUNE 29, 2020
COMMITTEE TO IDENTIFY INNOVATIVE TECHNOLOGIES TO ADVANCE PHARMACEUTICAL MANUFACTURING
WEBINAR WITH CENTER FOR DRUG EVALUATION AND RESEARCH, US FOOD AND DRUG ADMINISTRATION
JUNE 29, 2020
AGENDA
| 10:30 | Purpose of Open Session |
| G.V. Rex Reklaitis | |
| Chair, Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing | |
| Burton and Kathryn Gedge Distinguished Professor, Purdue University | |
| 10:35 | Conversation with Study Sponsor on Regulatory Requirements, Scope of Responsibility, and Preparedness for Innovative Technologies |
| Sau (Larry) Lee | |
| Director, Emerging Technology Team Chair |
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
| OTR, OPQ, FDA | |
| Katherine Tyner | |
| Associate Director for Science (acting) | |
| CDER, OPQ, FDA | |
| 11:50 | Opportunity for Public Comment |
| 12:00 | END OF OPEN SESSION |
WEBINAR 2: AUGUST 11, 2020
COMMITTEE TO IDENTIFY INNOVATIVE TECHNOLOGIES TO ADVANCE PHARMACEUTICAL MANUFACTURING
WEBINAR WITH THE ASSOCIATION FOR ACCESSIBLE MEDICINES
AUGUST 11, 2020
AGENDA
| 11:00 | Purpose of Open Session |
| G.V. Rex Reklaitis | |
| Chair, Committee to Identify Innovative Technologies to Advance Pharmaceutical Manufacturing | |
| Burton and Kathryn Gedge Distinguished Professor, Purdue University | |
| 11:05 | Conversation with the Association for Accessible Medicines on Innovations in the Manufacture of Generics Drugs and Barriers to Innovations |
| David Gaugh | |
| Senior Vice President, Sciences & Regulatory Affairs | |
| Association for Accessible Medicines | |
| Lisa Parks | |
| Vice President, Sciences & Regulatory Affairs | |
| Association for Accessible Medicines | |
| 12:20 | Opportunity for Public Comment |
| 12:30 | END OF OPEN SESSION |
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
Suggested Citation:"Appendix C: Workshop and Webinar Agendas." National Academies of Sciences, Engineering, and Medicine. 2021. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations. Washington, DC: The National Academies Press. doi: 10.17226/26009.
×
