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:

TimeActivity
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:

TimeActivity
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