BTC Webinars

• 2022 Webinar Series:

  • May 24, 2022: – Approaches to Establishing Bioequivalence Safe Space for Orally Administered Drug Products: Applications and Case Studies
  • Click here to view a recording of the webinar.  Moderator/Speaker bios are available here.
  • Moderator: Andreas Abend, Ph.D., Senior Principal Scientist, Merck & Co., Inc.
    Speakers:
  • Approaches to establishing Bioequivalence safe space for orally administered drug products: Application and case studies
    • Xavier Pepin, Pharm.D, Ph.D., Associate VP Regulatory Strategy, SimulationsPlus
  • Non-PBBM Safe Space Approaches
    • Filippos Kesisoglou, Ph.D., Distinguished Scientist, Merck & Co., Inc.

• 2021 Webinar Series:

  • October 27, 2021 – Exploring the Development and Utility of an Inhalation-based Biopharmaceutics Classification System (iBCS)
  • Click here to view a recording of the webinar.  PDFs of the presentations are not currently available.
  • Moderator:  Wenlei Jiang, Ph.D., Senior Science Advisor, Office of Research and Standards, Office of Generic Drugs, FDA
  • Speakers:

What is an iBCS? Principles and Framework

• • • • Jayne E. Hastedt, Ph.D., Managing Director, JDP Pharma Consulting, LLC

A Modeling Approach to Identify the iBCS Class Boundaries

• • • • Per Bäckman, Ph.D., Senior Adviser, Inhalation Science, Emmace Consulting AB

Panel Discussion

• • • • Jayne E. Hastedt, Ph.D.
      • Per Bäckman, Ph.D.
      • Barbara Schug, Ph.D., SocraTec R&D GmbH
      • Ajit Narang, Ph.D., ORIC Pharmaceuticals Inc.
      • Bing Cai, Ph.D., Office of Life-cycle Drug Products (OLDP/OPQ/CDER) US FDA
      • Ross Walenga, Ph.D., Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), OGD/CDER, US FDA
      • Bryan Newman, Ph.D., Pharmacologist, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), CDER, US FDA
      • Bhagwant Rege, Ph.D., Division Director, Division of Immediate and Modified Release Products III, OLDP/OPQ/CDER, US FDA
      • Renishkumar Delvadia, Ph.D., Drug Product Reviewer
        Office of New Drug Products\OPQ\CDER, US FDA

Click here to view the bios for the speakers and panelists.

• • April 8, 2021 – BTC/DTC Webinar – Development and Biopharmaceutics of Long-Acting Injectables
    • Moderators: Ajit Narang, Ph.D., Genentech and Diane Paskiet, West Pharmaceutical Services

Click to view the webinar recording.

PDFs of the presentations are available below:

• • Introduction slides
  • Application of Quantitative Clinical Pharmacology in the Development of Long Acting Injectable (LAI) Drug Products – Liang Zhao, Ph.D.
  • Physiologically Based Pharmacokinetic (PBPK) Modeling of Long Acting Injectables (LAI): Challenges and Opportunities -Viera Lukacova, Ph.D.
    • Viera Lukacova’s presentation is available upon request, please contact the PQRI Secretariat.

Click for Speaker Bios.

• 2020 Webinar Series:  

  • April 28, 2020 – The Challenge and the Promise: Developing Complex Drug Products
    • Click here to view the webinar recording.
  • July 29, 2020 (BTC/PQTC webinar) – Excipient Considerations for Parenteral Drug Development
    • Click here to view the webinar recording.
  • September 16, 2020 – Regulatory Requirements and Technical Considerations for Biosimilar Products
    • Click here to view the webinar recording
  • December 9, 2020 – Biopharmaceutics of mAbs: Fundamentals and Pharmaceutical Development Aspect
    • Click here to view the webinar recording.

• 2019 Webinar Series:

  • October 10, 2019 – Holistic QbD to Enable Product Quality Webinar – presented by: Ajit Narang, Ph.D., Genentech; Rakhi Shah, Ph.D., FDA; Xavier Pepin, Pharm.D, Ph.D; Divyakant Desai, Ph.D., BMS; Xavier Pepin, Pharm.D, Ph.D., AstraZeneca
    • Click to view the webinar recording.
    • Click to view a pdf of the webinar slides.
    • Moderator and Speaker bios
    • Q&A Session from Webinar
  • June 7, 2019 – The Expanding IVIVC Toolbox to Enable Drug Product Quality and Clinical Pharmacology – Complementary Traditional and PBPK Based Approaches – Presented by Filippos Kesisoglou, Ph.D., Merck and Xinyan (Susie) Zhang, Ph.D., FDA
    • To view the webinar recording, click here.
    • PDFs of the presentations are available here:
      • Introduction
      • Filippos Kesisoglou, Ph.D., Merck
      • Xinyuan (Susie) Zhang, Ph.D., FDA

• 2018 Webinar Series:

  • April 9, 2018 – A Science Based Approach to Simplifying the Regulatory Pathway for Topical Drugs – (TCS); presented by: Vinod P. Shah, Ph.D., FAAPS, FFIP and Flavian Radulescu, Ph.D.
    • Click here to view a recording of the webinar.
  • June 19, 2018 –Questions about the Proposed Topical Classification System (TCS), and What to Do with It; presented by: Sam Raney, Ph.D, FDA
    • Click here to view the recording.
  • October 23, 2018 – Performance Testing in Quality Control and Product Development, Where are We?;  presented by: Raimar Löbenberg, University of Alberta
    • Click here to view the recording.  Click presentation for a pdf of the slides.
  • December 6, 2018 –  Biowaiver Approaches for Solid Oral Dosage Forms in New Drug Applications; presented by: Poonam Delvadia, Ph.D., FDA
    • Click here to view the recording.  Click presentation for a pdf of the slides.