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Innovations in Pharmaceutical Manufacturing on the Horizon Technical Challenges, Regulatory Issues, and Recommendations (2021) / Chapter Skim
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Appendix C: Workshop and Webinar Agendas
Pages 77-83

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From page 77...
... 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 77
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From page 78...
... 78 Innovations in Pharmaceutical Manufacturing on the Horizon 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
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From page 79...
... 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
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From page 80...
... 80 Innovations in Pharmaceutical Manufacturing on the Horizon 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
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From page 81...
... 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
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From page 82...
... 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)
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From page 83...
... 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
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Key Terms

  • innovative technologies
  • advance pharmaceutical
  • identify innovative
  • drug evaluation
  • accessible medicines

  • purdue university
  • dosage forms
  • manufacturing webinar
  • matthew delisa
  • drug delivery

  • manufacturing hosted
  • regulatory affairs
  • gintaras reklaitis
  • technology team
  • gen innovation

  • identify innovations
  • regulatory barriers
  • earlier sessions
  • distinguished professor
  • kathryn gedge

  • printing pharmaceutical
  • solid oral
  • administration june
  • emerging technology
  • pharmaceutical dosage

  • workshop introduction
  • oral dosage
  • practical aspects
  • manufacturing agenda
  • gedge distinguished


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