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Biopharmaceuticals Sessions

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  2. Biopharmaceuticals Sessions
Browse Biopharmaceuticals (includes Biologics and Drugs) Sessions*

*Program and presenters subject to change. Please check back frequently for updates.

Biopharmaceuticals Sessions

  • Monday, Oct 2nd
    8:30 AM - 4:00 PM EDT
    What are the Requirements for an IND Submission?
    Workshop Leader: Hagit Marchaim, PhD MBA – HMC-Regulation
    Presenter: Lina Jamis, MS – Synthego Corporation
    Presenter: Tyler C. Vandivort, PhD, RAC, DABT – Amplicore Inc
    Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)
  • Tuesday, Oct 3rd
    8:30 AM - 4:00 PM EDT
    Drug Development in EU: Regulatory Standards, Support and New Approaches
    Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
    Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting
    Presenter: Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices
    Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
    Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
    Presenter (Remote): Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH
    Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
    Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    Decoding Orphan Drug development: Bridging Boundaries and Thinking “Outside the Box”
    Session Leader: Luis Rocha, PhD – Allucent
    Presenter (Remote): Kristina Larsson, MSc – European Medicines Agency
    Presenter: Punam Sandhu, PhD – Jazz Pharmaceuticals
    Presenter: Rivka Zaibel – ADRES, Advanced Regulatory Services Israel Ltd.
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    Drug-Led Combination Products - Submission Guidance and Contents
    Presenter: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
    Presenter: Courtney Evans
    Presenter: Douglass S. Mead, III, RAC – CP Pathways LLC
    Q&A Presenter: Nishchay Gupta – Genentech
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Wednesday, Oct 4th
    8:00 AM - 9:15 AM EDT
    Maximizing the Impact of Patient-centric Data: Meaningful Interactions Informing Regulatory Decision-making.
    Moderator: Maria A. Apostolaros, JD, PharmD, MS, BSc, RPh, CCEP – PhRMA
    Presenter: Robyn Bent, RN, MS – FDA
    Presenter: Josh Coulter, MA – Pfizer
    Presenter (Remote): Claire Espinasse
    Presenter: Nicholas Langevin – Sumitomo Pharma America, Inc.
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: A Roadmap of Expedited Pathways in Europe - The Fast for the Curious
    Facilitator: Farhad Amiri, PhD, FAHA – Parexel International
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: Biosimilar Regulations in Middle East - Challenges and Proposed Solutions
    Facilitator: Guriqbal Singh – Regweb Consulting Services Inc.
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: eCTD Module 3, How Much Detail Do I Submit?
    Facilitator: Robert L. Waterland, PhD – Certara Drug Development Solutions
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: How Soon Can I Implement This? "Navigating FDA Submissions and Review Logistics: A One-Stop Guide
    Facilitator: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
    Facilitator: Myriam Triest, PhD – CMC-RX Consulting
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: 5 Ways that an RA Department Will be Impacted by IDMP Data Standards
    Facilitator: Niels B. Leander, PhD – NNIT
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: Enabling Earlier Access to Medicines in Latin America by Rationalizing Legalization Requirements
    Facilitator: Cammilla Gomes – Roche
    Facilitator: Pedro Franco, PhD, MSc, PharmD. – Merck KGaA
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    12:05 PM - 12:35 PM EDT
    Solutions Circle: Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource Augmentation
    Facilitator: Cham Williams, MS – IQVIA
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    Drug Marketing Approval Pathways in China: 2023 Latest Updates, Accelerated Pathways & Market Challenges
    Session Leader: Hamish King, RAC, LLB – Cisema
    Presenter: Helen Ye, n/a – Accestra Consulting
    Presenter: Veena CHORGHADE – PTC Therapeutics, Inc.
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    FDA Expectations for using Digital Tools in Decentralized Clinical Trials
    Session Leader: Junyang Wang – EMD Serono
    Presenter: Jill Lee, JD – Novo Nordisk
    Presenter (Remote): Elizabeth Kunkoski, MS – FDA
    Presenter (Remote): Andrew Potter, PhD – US FDA
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Wednesday, Oct 4th
    2:00 PM - 3:00 PM EDT
    FDA Forecast 2024: What Pharmaceutical and Biotech Regulatory Professionals can Expect from FDA Next Year
    Session Leader: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
    Moderator: Khushboo Sharma, MBA – Accumulus Synergy
    Presenter: Derrick Gingery – The Pink Sheet
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    Ensuring Patient Registries Support Regulatory Decision-Making
    Presenter: David Hinds, MHS – BioMarin Pharmaceutical Inc.
    Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
    Presenter: Mayss Naccache, MSc – World Federation of Hemophilia
    Presenter (Remote): Kelly Plueschke – European Medicines Agency (EMA)
    Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    Industry Experience with Implementing ICH Q12 in US and Canada
    Presenter: Jamie L. Robinson, RAC, MBA – Genentech, Inc.
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    3:30 PM - 4:30 PM EDT
    Navigating Global Regulatory Frameworks for Cell and Gene Therapy Development
    Session Leader: Kimberly Benton, PhD – Dark Horse Consulting Group
    Presenter: Kirsten Messmer, PhD, RAC – POLITICO’s AgencyIQ
    Presenter (Remote): Caroline Pothet – European Medicines Agency
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    4:45 PM - 5:45 PM EDT
    FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle Management
    Session Leader: Paul A. Wardle, MA, MMath – Beacon Associates, LLC
    Presenter: Danielle Terrell, PharmD, JD, MS, RAC U.S. – Food and Drug Administration
    Presenter (Remote): Elisabeth Walther, PharmD, JD – US Food and Drug Administration
    Presenter: Alfred Whitehead, MAs, MS – Klick Consulting
    Moderator: Erin Oliver, MS, MBA, FRAPS – Haleon
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    4:45 PM - 5:45 PM EDT
    Making an Impact to Bring Further Diversity and Inclusion in Clinical Research
    Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Presenter: Sarah Bly – Worldwide Clinical Trials
    Biopharmaceuticals (includes Biologics and Drugs)
  • Wednesday, Oct 4th
    4:45 PM - 5:45 PM EDT
    Regulatory Opportunities and Challenges with mRNA Technology – Lessons Learned from the COVID-19 Pandemic
    Presenter: Antonella Lozito, PharmD – Moderna
    Presenter: Immo Zdrojewski – Moderna
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Actionable Steps to Meeting Regulatory and Ethical Considerations in Clinical Trial Diversity
    Session Leader: Brittany Gerald – Moderna
    Presenter (Remote): Jamie Gamerman, JD – FDA
    Presenter: Mary Nwokedi, PharmD – PhRMA
    Presenter: Immo Zdrojewski – Moderna
    Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Get the 411 on 1.14 (It's More Than Just Compliant Labeling!)
    Session Leader: Mona Desai – Desai RA Consultants, LLC
    Presenter: Free Peay, RAC, Global – Peay Regulatory Affairs Consulting, LLC
    Presenter: Tabitha Elmore – Pharming Healthcare, Inc.
    Presenter: Kamana Singh, DVM, MMB, MBA, RAC(US) – APS Pharma Solutions, LLC
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    8:00 AM - 9:15 AM EDT
    Lessons on the EU-Clinical Trials Regulation
    Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Presenter: Sarah Bly – Worldwide Clinical Trials
    Presenter: Anabela Marcal – European Medicines Agency
    Presenter: Ben Kaspar – MMS Holdings
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: Pediatric Drug Development:  Failure is not an Option
    Facilitator: Linda McBride, R.PH, RAC – IAA Consulting LLC
    Facilitator: Karl-Heinz Huemer, MD, PhD – khhconsulting
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: Regulatory Trends and Opportunities for Drug Delivery Combination Products
    Facilitator: Chin-Wei Soo, DRSc, FRAPS – Genentech and Roche
    Facilitator: Nishchay Gupta – Genentech
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    10:45 AM - 11:15 AM EDT
    Solutions Circle: What you need to know about the EU-Clinical Trials Regulation
    Facilitator: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials
    Facilitator: Sarah Bly – Worldwide Clinical Trials
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: Deep Dive into Labeling Operations
    Facilitator: Mona Desai – Desai RA Consultants, LLC
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    11:25 AM - 11:55 AM EDT
    Solutions Circle: FDA Expectations for Digital Health Tools in Decentralized Clinical Trials
    Facilitator: Junyang Wang – EMD Serono
    Facilitator: Jill Lee, JD – Novo Nordisk
    Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    Biosimilar Regulatory Standards in the ICH Regions: Implications for Global Biosimilar Development
    Presenter: Antonina G. Nikolova, PhD – Allucent
    Presenter: Leah Christl, PhD – Amgen
    Presenter: Marcus S. Delatte, PhD – Allucent
    Presenter (Remote): Peter Richardson, Ph. D. – European Medicines Agency (EMA)
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    Pediatric Drug Development: Failure is not an Option
    Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting
    Presenter: Linda McBride, R.PH, RAC – IAA Consulting LLC
    Presenter: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023
    Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters
  • Thursday, Oct 5th
    2:00 PM - 3:00 PM EDT
    Strategies to Leverage Patient Preference and Perspective to Support Development of New Drugs and Indications
    Session Leader: Priyanka Ingle, MD (Intl), MSc, PhD – Bayer Pharmaceuticals
    Presenter: Shefali Goyal, MS, MSc – Organon
    Presenter: Sandra V. Cron, MS – Organon
    Moderator: Kathleen O'Sullivan, MS, MSL, RAC – Bayer
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    Is Animal Testing Really No Longer Needed for Drug Development?
    Session Leader: Kamali G. Chance, PhD, MPH, RAC – KC Biopharmaceutical Consulting
    Presenter (Remote): Paul Brown, PhD – Food and Drug Administration
    Presenter (Remote): Thibault Honegger – NETRI
    Presenter: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    Navigating the Unique Complexities of CMC Challenges for Cell Therapies
    Session Leader: Olivia Ziolkowski, J.D., M.P.H. – Takeda Pharmaceuticals
    Presenter: Sanika Inamdar – Obsidian Therapuetics
    Presenter: Yoko Momonoi, M.S. – Takeda Pharmaceuticals
    Presenter: Antonina G. Nikolova, PhD – Allucent
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    Overview of Select PDUFA VII Innovative Meeting Programs
    Session Leader: CHRISTOPHER EGELEBO, DHSc, MBA, MS, RAC, PMP, RN – US Food and Drug Administration
    Presenter: Yvonne Knight, MS – US Food and Drug Administration
    Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration
    Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    3:30 PM - 4:30 PM EDT
    The Inflation Reduction Act and Beyond: Impacts of the Evolving Reimbursement Landscape on Drug Development
    Session Leader: Mallory O'Connor, MPH – Mallinckrodt
    Presenter: Jesse D. Mendelsohn – Model N
    Moderator: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Challenges & Potential Global Convergence of the Regulatory Approval Process for Complex Generic Drugs
    Session Leader: Janet Vaughn – Teva Pharmaceuticals
    Presenter: Victor S. Pribluda, PhD – United States Pharmacopeia
    Presenter: Chaitanya Koduri, MTech – United States Pharmacopeia
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Enabling Global Regulatory Environments to Deliver Better Self Care Interventions
    Presenter: Jay E. Sirois, PhD – Consumer Health Products Association
    Presenter: Joseph Chan, RPh – Bayer
    Presenter: Gerry Harrington
    Presenter: Amanda Wong, RAC – Haleon Canada
    Biopharmaceuticals (includes Biologics and Drugs)
  • Thursday, Oct 5th
    4:45 PM - 5:45 PM EDT
    Regulatory Collaboration Through Cloud Platforms
    Session Leader: Vada A. Perkins, MSc, MS, DRSc (c) – Bayer Pharmaceuticals
    Presenter: Danielle Friend – Janssen
    Presenter (Remote): Virginia Hussong – FDA Center for Biologics Evaluation and Research
    Presenter: Khushboo Sharma, MBA – Accumulus Synergy
    Biopharmaceuticals (includes Biologics and Drugs)