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  • Monday, Sep 16th
    8:30 AM – 4:00 PM PDT
    Drug Development in the EU: Regulatory Standards, Supports, and New Approaches
    Location/Room: 104 A
    Workshop Leader: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
    Presenter: Karl-Heinz Huemer – khhconsulting
    Presenter: Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences
    Presenter: Daniela Drago, RAC, FRAPS – NDA Partners
    Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
    Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
    Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)
  • Tuesday, Sep 17th
    8:30 AM – 4:00 PM PDT
    Maximizing Opportunities to Engage With the FDA
    Location/Room: 104 A
    Workshop Leader: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.
    Workshop Leader: Sonday L. Kelly, MS, RAC, PMP – Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration
    Presenter: Angela W. Corona, PhD – BOLDAPPROVALS
    Presenter: Christy Cottrell – FDA/CDER
    Presenter: Ramani Sista, PhD – ORMRR/OTP/CBER/FDA
    Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    9:15 AM – 10:30 AM PDT
    Addressing Medicines Shortages in EU: Prevent, Mitigate, and Ensure Visibility
    Location/Room: 202
    Presenter: Romain Kherrat, PharmD – Clarivate
    Presenter (Remote): Monica Dias, PhD – EMA
    Presenter (Remote): Sofia Zastavnik – European Medicines Agency
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    9:15 AM – 10:30 AM PDT
    Increasing Consumer/Patient Access, Engagement and Health Equity: Innovation Leveraging FDA Proposed/New ACNU NDA Regulatory Pathway
    Location/Room: 201
    Session Leader: Paul A. Wardle, MA, MMath – Klick Health
    Presenter: Erin Oliver, MS, MBA, FRAPS – Haleon
    Presenter: Elisabeth Walther, PharmD, JD – FDA
    Presenter: Danielle Terrell, PharmD, JD, MS, RAC-US – FDA
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    9:15 AM – 10:30 AM PDT
    Using Innovative Regulatory Strategies to Streamline Drug Development – Platform Trials, Model Informed Drug Development, and Real World Evidence
    Location/Room: 203
    Session Leader: Michelle Pernice, Pharm.D. – Fairmount Funds Management
    Presenter: Chelsea O’Connell, MS, RAC – Amgen
    Presenter (Remote): Laura Pioppo – EMA
    Presenter (Remote): Rajanikanth Madabushi – FDA / CDER / OTS / OCP
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    10:35 AM – 11:05 AM PDT
    Solution Circle (D): Maximizing the Potential of Meetings with the FDA
    Location/Room: Exhibit Hall: Solutions Circles Area (D)
    Facilitator: Hagit Marchaim, PhD – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    11:10 AM – 11:40 AM PDT
    Solution Circle (C): The Right Balance Between Business, Science, and Regulation in Managing Supply Chains
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Lopa Bakrania, PhD, RAC – Biohaven Pharmaceuticals
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    11:45 AM – 12:15 PM PDT
    Solution Circle (C): Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and Controls
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Hai Wang, PhD – El Vista Consulting LLC
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    12:20 PM – 12:50 PM PDT
    Solution Circle (B): Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Mark A. Di Cioccio – Team Consulting
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    1:00 PM – 2:00 PM PDT
    CDER’s Product Quality Review of Biologics & Biosimilars: Common Findings, Review Issues and Post-Marketing Recommendations
    Location/Room: 202
    Presenter: Kelly Nolan, MS – Visterra, Inc
    Presenter: William Tubbs – Visterra, Inc
    Presenter: Tulay Kilicdagi, MA, RAC-Drugs – Visterra, Inc
    Presenter (Remote): Leslie A. Rivera Rosado, PhD – FDA / CDER / OPQ / OPQAIII
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    1:00 PM – 2:00 PM PDT
    FDA Forecast: What the FDA has Planned in 2025 for Pharmaceuticals and Biotechnology Products
    Location/Room: 201
    Presenter: Alexander Gaffney, MS, RAC – AgencyIQ
    Presenter: Derrick J. Gingery – Pink Sheet
    Presenter: Kelly Griffin, PhD, RAC – PwC
    Moderator: Ashley Jones-Mitchell, BS – Accumulus Synergy
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    1:00 PM – 2:00 PM PDT
    Regulatory Challenges in New Drug Approval in India and the Way Forward
    Location/Room: 203
    Presenter: Rashmi Kulshrestha, PhD – REGULATORY WISDOM
    Moderator: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    2:15 PM – 3:15 PM PDT
    Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation and Global Perspectives
    Location/Room: 202
    Presenter: Angela N. Johnson, PhD, RAC – Cytiva
    Presenter: Melanie Sorensen – Cytiva
    Presenter: Anabela Marcal – European Medicines Agency
    Presenter (Remote): Manuel Osorio, PhD – CBER/FDA
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    2:15 PM – 3:15 PM PDT
    Clinical Trials in Pregnancy and Lactation: Time for a Paradigm Shift?
    Location/Room: 203
    Session Leader: Marie Teil, MD – UCB
    Presenter: Anne Lyerly – University of North Carolina at Chapel Hill
    Presenter: Tamara Johnson, MD, MS – FDA Center for Drug Evaluation and Research
    Presenter (Remote): Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    2:15 PM – 3:15 PM PDT
    Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-Centricity
    Location/Room: 201
    Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.
    Presenter: Kathleen Sheridan, MS – PricewaterhouseCoopers (PwC)
    Presenter: Selena Daniels, PharmD, PhD – FDA / CDER
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    4:00 PM – 4:30 PM PDT
    Solution Circle (A): AI's Transformative Impact on CMC in Pharmaceuticals
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Anusha Saripalli – Neuron 23
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    4:00 PM – 4:30 PM PDT
    Solution Circle (C): Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for Transformation
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Gregory L. Palagi, PMP. CSM, DASM, SSM – Integrated Project Management
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    4:30 PM – 5:30 PM PDT
    Failure Is Not An Option: How to Avoid and Recover From an IND Clinical Hold
    Location/Room: 202
    Session Leader: Linda McBride, R.Ph., RAC – IAA Consulting LLC
    Presenter: Tyler C. Vandivort, PhD, RAC, DABT – UCB Biopharma
    Presenter: Ben McLaughlin, MSE – Amylaza Consulting, LLC
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    4:30 PM – 5:30 PM PDT
    Global Tools to Expedite Advanced Therapy Product Development
    Location/Room: 203
    Presenter: Kirsten Messmer, PhD, RAC – KM Intel LLC
    Presenter: Jessica Boehmer, MBA – US Food and Drug Administration
    Presenter (Remote): Caroline Pothet – European Medicines Agency
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Sep 18th
    4:30 PM – 5:30 PM PDT
    Regulatory Excellence: Japan's Type 1 Cartagena Process for Gene Therapy Products
    Location/Room: 201
    Session Leader: Carla Gomes, PharmD, MBA – PPD, a part of Thermo Fisher Scientific
    Presenter: Machiko Goto, MS in agriculture – PPD-SNBL
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    9:15 AM – 10:30 AM PDT
    China Drug Regulatory Pathways
    Location/Room: 201
    Session Leader: Hamish King, RAC, LLB – Cisema
    Presenter: Lisa Huang – PPD Inc
    Presenter: Vincent (Wenbo) Zhou – PPD Inc
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    9:15 AM – 10:30 AM PDT
    The European Pharmaceutical Legislation Revision – Status Update and Ongoing Challenges
    Location/Room: 202
    Session Leader: Kirsten Messmer, PhD, RAC – KM Intel LLC
    Presenter: Martine Zimmermann, PharmD – IPSEN PHARMA
    Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
    Presenter (Remote): Christelle Bouygues, PharmD – EMA
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    9:15 AM – 10:30 AM PDT
    The MLR Ecosystem: Regulatory and Marketing Collaboration for Brand Success
    Location/Room: 203
    Presenter: Margot Arntfield, PhD – Klick Health
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    10:35 AM – 11:05 AM PDT
    Solution Circle (D): The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in Botswana
    Location/Room: Exhibit Hall: Solutions Circles Area (D)
    Facilitator: Tshetsana Senau – Botswana Medicines Regulatory Authority
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    11:10 AM – 11:40 AM PDT
    Solution Circle (A): ADCs CMC – Regulatory Overreach or as Easy as ABC?
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Michael Craig, BSc Pharm MPSI – Parexel Regulatory Consulting
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    11:10 AM – 11:40 AM PDT
    Solution Circle (C): Health Authority Audit and Inspection 101: Best Practices for Research Organizations
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Olivia A. Seale, PMP, MBA, MS Pharmacology – Integrated Project Management
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    11:45 AM – 12:15 PM PDT
    Solution Circle (A): China Drug Master Files: Latest Points to Know for Pharma Manufacturers
    Location/Room: Exhibit Hall: Solutions Circles Area (A)
    Facilitator: Hamish King, RAC, LLB – Cisema
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    12:20 PM – 12:50 PM PDT
    Solution Circle (B): USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality Strategies
    Location/Room: Exhibit Hall: Solutions Circles Area (B)
    Facilitator: Naiffer Romero, MSc MPH – U.S. Pharmacopeia
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    12:20 PM – 12:50 PM PDT
    Solutions Circle (C): Failure is Not an Option: How to Avoid and Recover from an IND Clinical Hold
    Location/Room: Exhibit Hall: Solutions Circles Area (C)
    Facilitator: Ben McLaughlin, MSE – Amylaza Consulting, LLC
    Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    1:00 PM – 2:00 PM PDT
    Controlling Pharmaceutical Impurities: A Regulatory Perspective
    Location/Room: 203
    Presenter: Alex W. Smith, RAC – Hogan Lovells LLP
    Presenter: Chris T. Middendorf – Paraxel
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    1:00 PM – 2:00 PM PDT
    FDA Efforts to Promote Innovative Medical Product Development
    Location/Room: 202
    Moderator: Ryan Presto – FDA
    Presenter: Wei Liang – FDA/CBER/OTP
    Presenter: Cathryn Lee, MSN CRNP – Office of Program Operations, Office of New Drugs, CDER, FDA
    Presenter (Remote): Ingrid Markovic, PhD – Food and Drug Administration
    Presenter (Remote): Meghana Chalasani – Office of New Drugs, Center for Drug Evaluation and Research, U.S. FDA
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    1:00 PM – 2:00 PM PDT
    Regulatory Convergence of Biologics; APEC, ICH, WHO Efforts for LATAM and Around the World
    Location/Room: 201
    Session Leader: Jared Auclair, PhD – Northeastern University
    Presenter: Michelle Limoli, PharmD – US Food and Drug Administration
    Presenter: Judith Arcidiacono, MS – US Food and Drug Administration
    Presenter: Rominder Singh, PhD – Northeastern University
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    3:15 PM – 4:15 PM PDT
    Expanding Global Access to Complex Generics: It is Time for Regulatory Convergence
    Location/Room: 201
    Presenter: Victor S. Pribluda, PhD – United States Pharmacopeia
    Presenter: Chaitanya K. Koduri – United States Pharmacopeia
    Presenter: Sarah Ibrahim – FDA/CDER/OGD
    Presenter (Remote): Kevin V. Blake, MB BCh BAO PhD – European Medicines Agency
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    3:15 PM – 4:15 PM PDT
    Impact of Public-Private Partnerships in Regulatory Science, Drug Development and Regulatory Decision-Making
    Location/Room: 202
    Moderator: Huong Huynh, PhD – Critical Path Institute
    Presenter: Selena Daniels, PharmD, PhD – FDA / CDER
    Presenter: Robyn Carson, MPH – Abbvie
    Presenter: Cheryl Coon, PhD – Critical Path Institute
    Presenter (Remote): Ralf Herold, PhD – European Medicines Agency
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    3:15 PM – 4:15 PM PDT
    Lessons Learned Since the Implementation of FDA’s Diversity Plans & an Assessment of the 2024 Diversity Action Plans FDA Guidance
    Location/Room: 203
    Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.
    Presenter: Mary Nwaneri (Nwokedi), PharmD – PhRMA
    Presenter: Ashwin Mathew – GSK
    Presenter: Ryan Brown, MPA – H1
    Presenter (Remote): Jamie Gamerman, JD – FDA
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    4:30 PM – 5:30 PM PDT
    Advancing Gene Therapy: A Holistic Approach to Multicomponent Product Development and Delivery Device Lifecycle
    Location/Room: 102
    Session Leader: Mary Speagle – TPIreg, Innomar Strategies Inc
    Presenter: Martin Nemec – Health Cananda
    Presenter: Alyssa Kitchel, PhD – US Food & Drug Administration
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    4:30 PM – 5:30 PM PDT
    Considerations for Global Harmonization and Accelerated Drug Development
    Location/Room: 202
    Presenter: Sue Liu, B.Eng (pharm) MBA RAC – Gilead Sciences
    Presenter: Anabela Marcal – European Medicines Agency
    Presenter: Jessica Boehmer, MBA – US Food and Drug Administration
    Presenter: Michael Rosu-Myles – Health Canada
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Sep 19th
    4:30 PM – 5:30 PM PDT
    Human Factors Development: Navigating Areas of Ambiguity and Insights for Creating Robust Regulatory Strategies
    Location/Room: 203
    Session Leader: Nishchay Gupta – Genentech
    Presenter: Sherri Biondi, PhD – AstraZeneca
    Presenter: Douglass S. Mead, III, RAC – CP Pathways LLC
    Biopharmaceuticals (includes Biologics and Drugs)