Skip to main content
RAPS Convergence 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Requires Pre-Registration or Sign-up
Requires Pre-Registration or Sign-up
Additional Registration Fee
Additional Registration Fee
Invitation Only
Invitation Only
Student Program
Student Program
Networking Opportunity
Networking Opportunity
RAPS Focus Area
RAPS Focus Area

Conversation Starters

  1. Home
  2. Conversation Starters
Conversation Starters – New for 2023!
Sessions tagged as “Conversation Starters” are main conference sessions that offer a Solutions Circle (which may occur before or after main session) that takes a deeper dive of its topic. Attendance of the main conference session is not required to attend the Solutions Circle.

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

Conversation Starters

  • Monday, Oct 2nd
    8:30 AM – 4:00 PM EDT
    What are the Requirements for an IND Submission?
    Location/Room: 510B
    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
    Location/Room: 510B
    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”
    Location/Room: 513D
    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
    Location/Room: 511D
    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.
    Location/Room: 513B
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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?
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: 513B
    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
    Location/Room: 513D
    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
    Location/Room: 511D
    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
    Location/Room: 510B
    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
    Location/Room: 511D
    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
    Location/Room: 513D
    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
    Location/Room: 513D
    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
    Location/Room: 513B
    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
    Location/Room: 511D
    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
    Location/Room: 513D
    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!)
    Location/Room: 511D
    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
    Location/Room: 511F
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: Exhibit Hall: Solutions Circles
    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
    Location/Room: 513D
    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
    Location/Room: 513B
    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
    Location/Room: 511D
    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?
    Location/Room: 513D
    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
    Location/Room: 511F
    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
    Location/Room: 510B
    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
    Location/Room: 511D
    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
    Location/Room: 510A
    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
    Location/Room: 511D
    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
    Location/Room: 513D
    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)