Agenda

A schedule of events for Co-Processed API is provided below for the convenience of conference attendees.

This multi-day workshop was held July 13-14, 2022, at the University of Maryland School of Pharmacy.

For a printable version of the conference agenda, please download this document‌.

Wednesday, July 13, 2022:

Time	Activity
8:20-8:30 a.m.	Welcome Remarks Stephen Hoag, PhD Department of Pharmaceutical Sciences University of Maryland School of Pharmacy
8:30-8:40 a.m.	Conference Introduction and Workshop Intent Ramesh Sood, PhD Senior Scientific Advisor, ONDP, OPQ, CDER, FDA
Session 1: Why Does the Development Pipeline Need Technology Options
8:35-8:45 a.m.	Opening Remarks Lawrence Yu, PhD Deputy Office Director CDER/FDA
8:40-9:20 a.m.	Keynote Presentation: The Present and Future of Pharmaceutical Quality Larry Lee, PhD Deputy Super Office Director of Science, OPQ, FDA
9:20-10:00 a.m.	Keynote Presentation: Need for New Paths to Accelerated Technology Implementation Timothy Watson, PhD Executive Director and Team Leader for CMC Advisory Office, Pfizer
10:00-10:15 a.m.	Coffee Break
10:15-10:35 a.m.	Case Studies Emerging Modalities and Compound Developability Assessment in Small Molecule Early Development Ahmad Sheikh, PhD Senior Research Fellow and Head of Solid-State and Computational Chemistry, AbbVie
10:35-10:55 a.m.	Case Studies Persistent Needle Challenges: A Class of Compounds Preventing Crystallization Routes to Modulate Bulk Powder Properties Patrick McArdle, PhD Professor, National University of Ireland, Galway
10:55-11:15 a.m.	Case Studies Overview of Particle Engineering Routes and Pipeline Needs Alastair Florence, PhD Distinguished Professor and Director of CMAC, University of Strathclyde
11:15 a.m. - 12:00 p.m.	Breakout Sessions 1A Discussion Leaders (Room 306) Paresma (Pinky) Patel, PhD Branch Chief of Division of New Drug API, ONDP, OPQ, CDER, FDA Luke Schenck Principal Scientist, Merck & Co., Inc. Timothy Watson, PhD Executive Director and Team Leader for CMC Advisory Office, Pfizer 2A Discussion Leaders (Room 310) Ramesh Sood, PhD Senior Scientific Advisor, ONDP, OPQ, CDER, FDA Jeremy Merritt, PhD Director in SMDD, Eli Lilly & Co. Deniz Erdemir, PhD Associate Scientific Director, Bristol-Myers Squibb 3A Discussion Leaders (Room 314) Mohan Sapru, PhD Branch Chief, New Drug Products Division III, Branch V, ONDP, OPQ, CDER, FDA Steven Ferguson, PhD Assistant Professor School of Chemical and Bioprocess Engineering, University of College Dublin; Adjunct Assistant Professor School of Pharmacy and Pharmaceutical S Sciences, Trinity College Dublin; Principal investigator, NIBRT
12:00-1:00 p.m.	Lunch Break
Session 2: Technical Considerations for Designation of Co-Processed API as Drug Substance or Drug Product Intermediate
1:00-1:30 p.m.	Keynote Presentation: Co-Processed APIs-Scientific and Regulatory Considerations Rapti Madurawe, PhD Division Director, OPMA, OPQ, CDER, FDA
1:30-2:05 p.m.	Keynote Presentation: Cobicistat on Silicon Dioxide: Utilizing a Carrier Particle Technology to Solve an API’s Physical Property Limitations Jared Evans, PhD Senior Director, Drug Substance Regulatory Strategy, Gilead Sciences
2:05-2:25 p.m.	Case Studies Integrated Processing for Co-Processed API Steven Ferguson, PhD Assistant Professor School of Chemical and Bioprocess Engineering, University of College Dublin; Adjunct Assistant Professor School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin; Principal investigator, NIBRT
2:25-2:40 p.m.	Case Studies Precipitation Processes to Control Material and Powder Properties of Amorphous Solid Dispersions Derek Frank, PhD Senior Scientist in Particle Engineering Lab in Process R&D, Merck & Co., Inc.
2:40-2:55 p.m.	Case Studies Co-Processed API Product and Process Development, Optimization, and Scale-up Nima Yazdanpanah, PhD Consultant on Advanced Manufacturing and Modeling and Simulation Applications, Procegence
2:55-3:15 p.m.	Case Studies Strategic Considerations in Choosing a Co-Processing Approach San Kiang, PhD Chief Technology Officer Drug Product, J-Star Research/Porton
3:15-3:30 p.m.	Case Studies Dry Coating Approach to Enhance API Physical Properties Raimundo Ho, PhD Principal Research Scientist, Materials Science Center of Excellence Lead, AbbVie, Inc.
3:30-3:45 p.m.	Coffee Break
3:45-4:30 p.m.	Breakout Sessions 1B Discussion Leaders (Room 306) Ramesh Sood, PhD Senior Scientific Advisor, ONDP, OPQ, CDER, FDA Deniz Erdemir, PhD Associate Scientific Director, Bristol-Myers Squibb Luke Schenck Principal Scientist, Merck & Co., Inc. 2B Discussion Leaders (Room 310) Rapti Madurawe, PhD Divisional Director, OPMA, OPQ, CDER, FDA Jeremy Merritt, PhD Director in SMDD, Eli Lilly & Co. Raimundo Ho, PhD Principal Research Scientist, AbbVie, Inc. 3B Discussion Leaders (Room 314) Paresma (Pinky) Patel, PhD Branch Chief of Division of New Drug API, ONDP, OPQ, CDER, FDA Billie Kline, PhD Chemical Engineering Senior Fellow, Vertex Pharmaceuticals Haitao Zhang, PhD Associate Research Fellow in Chemical Process R&D, Sunovion Pharmaceuticals Inc.

Thursday, July 14, 2022:

Time	Activity
8:30-8:40 a.m.	Day 2 Overview and Introduction Luke Schenck Principal Scientist, Merck & Co., Inc. Stephen Hoag, PhD Professor, University of Maryland, Baltimore Ramesh Sood, PhD Senior Scientific Advisor, ONDP, OPQ, CDER, FDA
Session 3: Regulatory & Scientific Considerations for Designation of Co-Processed API as Drug Substance or Drug Product Intermediate
8:40-9:10 a.m.	Keynote Presentation: An FDA Perspective on Regulatory Considerations for Co-Processed APIs Laurie Graham-Eure, PhD Director, Division of Internal Policies and Programs, OPPQ, OPQ, FDA
9:10-9:40 a.m.	Keynote Presentation: Motivation to Define Co-Processed API as a Drug Substance and Overview of Current Regulatory Landscape Sharon Page, BSc (Hons) Director, Global Chemistry, Manufacturing and Controls (GCMC), Pfizer R&D UK Ltd Lindsey Saunders Gorka, PhD Director and Team Leader, Global Regulatory CMC, Pfizer, Inc.
9:40-10:10 a.m.	Case Studies Excellent CU of Low Dose Direct Compression Tablets Achieved Using Co-Processed API Changquan Calvin Sun, PhD Professor and Associate Department Head, University of Minnesota
10:10-10:25 a.m.	Coffee Break
10:25-10:45 a.m.	Case Studies Treatment of Non-active Components in Co-Processed API: Do Excipients Obscure GMP DS Method Ability to Detect Chemical/Phase Purity Frank Bernardoni, PhD Principal Scientist, Analytical R&D, Merck & Co.
10:45-11:15 a.m.	Case Studies Considerations in Regard to Designation of Active Substance for mRNA Therapeutics Don Parsons, PhD Vice President, Early Technical Development and Lipid Nanoparticle Process Development, Moderna
11:15 a.m. - 12:00 p.m.	Breakout Sessions 1C Discussion Leaders (Room 306) Peter Capella, PhD Director, Div. of Immediate and Modified Release Drug Products, OLDP, OPQ, CDER, FDA Luke Schenck Principal Scientist, Merck & Co., Inc. 2C Discussion Leaders (Room 310) Laurie Graham-Eure, PhD Director, Division of Internal Policies and Programs, OPPQ, OPQ, FDA Jeremy Merritt, PhD Director in SMDD, Eli Lilly & Co. Deniz Erdemir, PhD Associate Scientific Director, Bristol-Myers Squibb 3C Discussion Leaders (Room 314) Mohan Sapru, PhD Branch Chief, New Drug Products Division III, Branch V, ONDP, OPQ, CDER, FDA Ben Stevens, PhD, MPH Director CMC Policy and Advocacy, GSK Llorente Bonaga, PhD Director, Regulatory Affairs, CMC, Global Regulatory Affairs and Clinical Safety, Merck & Co. USA
12:00-1:00 p.m.	Lunch Break
Session 4: How Might We Advance Global Harmonization
1:00-1:30 p.m.	Keynote Presentation: Global Regulatory Harmonization Challenges and Opportunities Mahesh Ramanadham, PharmD, MBA Deputy Director, OPPQ, OPQ, CDER, FDA
1:30-2:00 p.m.	Keynote Presentation: The Zelboraf Story: Sharing Experience with Different Drug Substance Designations Cinzia Gazziola, PhD Pharma Technical Drug Regulatory Affairs Manager, F. Hoffman-La Roche, Switzerland
2:00-2:20 p.m.	Case Studies A Strategy for Co-Processed API as Drug Substance in Early Clinical Studies to Rapidly Inform Tech Feasibility with Critical In Vivo Data Llorente Bonaga, PhD Director, Regulatory Affairs, CMC, Global Regulatory Affairs and Clinical Safety, Merck & Co. USA
2:20-2:40 p.m.	Case Studies Metformin Premix: Challenges Encountered During Reclassification from Co-Processed API Use to Resolve Severe Metformin Agglomeration to Pharmaceutical Intermediate Dirk Wandscheider, PhD Laboratory Manager Particle Characterization, EMD Serono/Central Analytical Services Merck KGaA, Darmstadt, Germany Sandra Masanes Marza CMC Leader Diabetes, Manufacturing Science & Technology, EMD Serono/Merck KGaA, Darmstadt, Germany
2:40-3:00 p.m.	Case Studies Opportunities and Challenges to Innovation and Harmonization for Pharmaceutical Quality Manufacturing from Industry Perspective Timothy Watson, PhD Executive Director and Team Leader for CMC Advisory Office, Pfizer
3:00-3:15 p.m.	Coffee Break
3:15-3:45 p.m.	Breakout Sessions 1C Discussion Leaders (Room 306) Mohan Sapru, PhD Branch Chief, New Drug Products Division III, Branch V, ONDP, OPQ, CDER, FDA Luke Schenck Principal Scientist, Merck & Co., Inc. Ben Stevens, PhD, MPH Director CMC Policy and Advocacy, GSK 2C Discussion Leaders (Room 310) Peter Capella, PhD Director, Div. of Immediate and Modified Release Drug Products, OLDP, OPQ, CDER, FDA Jeremy Merritt, PhD Director in SMDD, Eli Lilly & Co. Timothy Watson, PhD Executive Director and Team Leader for CMC Advisory Office, Pfizer 3C Discussion Leaders (Room 314) Mahesh Ramanadham, PharmD, MBA Deputy Director, OPPQ, OPQ, CDER, FDA Llorente Bonaga, PhD Director, Regulatory Affairs, CMC, Global Regulatory Affairs and Clinical Safety, Merck & Co. USA Cinzia Gazziola, PhD Pharma Technical Drug Regulatory Affairs Manager, F. Hoffman-La Roche Switzerland
3:45-4:30 p.m.	Workshop Summation, Review of Breakout Sessions 1-4 for Draft Workshop Proceedings Publication Luke Schenck Principal Scientist, Merck & Co., Inc. Stephen Hoag, PhD Professor, University of Maryland, Baltimore Ramesh Sood, PhD Senior Scientific Advisor, ONDP, OPQ, CDER, FDA