RAPS Convergence program and speakers are subject to change.
Workshop Leader: Chris Whalley – Seagen Inc.
Speaker: Andrea Laslop, Prof, MD – Austrian Medicines and Medical Devices Agency
Speaker: Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety)
Speaker (Remote): Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices
Speaker: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Speaker: Matthias Dormeyer, MD – MDC RegAffairs GmbH
Speaker: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
Speaker (Remote): Anja E. Schiel, PhD, Senior Advisor – Norwegian Medicines Agency
Workshop Leader: Sundar Ramanan, PhD, MBA – Just-Evotec, Biologics
Workshop Leader (Remote): Sunny Kamlesh Dave, MPharm – Novo Nordisk
Facilitator: Kirsten Messmer, PhD, RAC – Agency IQ
Facilitator: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.
Facilitator: Tina Kim-Hafken, MS – Rain Therapeutics Inc.
Facilitator: Antonella Lozito-Heerschap, PharmD – Moderna, Inc.
Moderator: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.
Speaker: Antonella Lozito-Heerschap, PharmD – Moderna, Inc.
Speaker: Martine Zimmermann, PharmD – Alexion Pharmaceuticals Inc.
Speaker: Tina Kim-Hafken, MS – Rain Therapeutics Inc.
Speaker: Patrick Larcier, PharmD – PharmaLex
Session Leader/Speaker: Kristin Bullok, PhD – Eli Lilly and Company
Speaker: Brett Hauber, PhD – Pfizer, Inc.
Speaker (Remote): Sara Eggers, PhD – U.S. Food and Drug Administration
Speaker (Remote): Francesco Pignatti – European Medicines Agency
Moderator: Kim Quaintance-Lunn – Bayer
Moderator: Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease
Speaker (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration
Speaker (Remote): Marco Cavaleri, PhD – European Medicines Agency
Speaker (Remote): Amy Scott-Billman, MS – AstraZeneca
Speaker (Remote): Phyllis Arthur
Session Leader/Speaker: Ana Sengupta, MS, MBA, RAC – AbbVie
Speaker: Orin Chisholm, GCULT, PhD, SFHEA, FRAPS – University of Sydney
Session Leader/Speaker: Erin Oliver, MS, MBA, FRAPS – Haleon
Speaker: Paul A. Wardle, MA, MMath – Beacon Associates, LLC
Speaker: Alfred Whitehead, MAs, MS, CISSP – Klick Consulting
Speaker: Clark Richardson, MPH – PEGUS Research
Session Leader/Speaker: Kirsten Messmer, PhD, RAC – Agency IQ
Speaker: Anabela Marcal – European Medicines Agency
Speaker (Remote): Shaila Choi, MSc, MTOPRA, CSci – Seagen
Speaker (Remote): Selma Stockner, MA – Zealand Pharma
Speaker (Remote): Bertrand Fournier – Shionogi
Session Leader/Speaker: Aditi Khurana, MBA, PMP, RAC – Asher Biotherapeutics
Speaker: Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE
Speaker: Khushboo Sharma, MBA – Accumulus Synergy
Speaker (Remote): Mary Ann Slack – U.S. FDA Center for Drug Evaluation and Research
Session Leader/Speaker: Kirsten Messmer, PhD, RAC – Agency IQ
Speaker: Kevin Healy, PhD, RAC – Enzyvant Therapeutics, Inc.
Speaker: Mary S. Newman, BS, MS – Taysha Gene Therapies
Session Leader/Speaker: Kerrie Nagrod, MSJ – Bristol-Myers Squibb
Speaker: Michelle P. Pernice, PharmD – Pardes Biosciences
Speaker (Remote): John Concato, MD, MS, MPH – United States Food and Drug Administration, Center for Drug Evaluation and Research
Speaker (Remote): Viashali Popat, MD, MPH – Food and Drug Administration
Speaker (Remote): Andrej Segec, MPharm MSc – European Medicines Agency
Speaker: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Session Leader/Speaker: Michael Craig, BSc Pharm, M.P.S.I – Parexel
Moderator: Mathilda Fienkeng, PharmD, MS, RAC, CDR USPHS – Office of Medical Policy, FDA
Session Leader/Speaker: Monique Carter, MS,RAC – Pfizer
Speaker: Zaida Recinos-Vasquez, MS, MS – Pfizer
Speaker (Remote): Alysha Croker, PhD – Health Canada
Speaker (Remote): Lola Fashoyin-Aje, MD, MPH – Food and Drug Administration
Session Leader/Speaker: James Cross, PhD – Asher Biotherapeutics, Inc.
Speaker: Grace Gao, PharmD – Hoffmann-La Roche Limited
Speaker (Remote): Tamy Kim, PharmD – US Food and Drug Administration
Speaker (Remote): Sarah Bentouati, MA, PharmD – Genentech
Session Leader/Speaker: Martine Zimmermann, PharmD – Alexion Pharmaceuticals Inc.
Speaker: Seema S. Betigeri, PhD – Merck & Co., Inc
Speaker (Remote): Huong Huynh
Session Leader/Speaker: Leslie Harden, PharmD – Biotechnology innovation organization
Speaker: Sumana Biswas, PhD – Bayer Pharma
Speaker: Danielle Friend – Janssen
Session Leader/Speaker: Isabelle Colmagne-Poulard, PhD Pharmacy, MBA – Merck (EMD Serono in the US)
Speaker (Remote): Ashley Boam, BSE, MSBE – FDA/Center for Drug Evaluation and Research
Speaker (Remote): Bruce Randall, B. Sc – Health Canada
Session Leader/Speaker: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.
Speaker: Mark Lane, MS, PhD – PharmaLex
Speaker: Jamie L. Robinson, MBA, RAC – Genentech, a member of the Roche Group
Speaker: Anabela Marcal – European Medicines Agency
Session Leader/Speaker: Andy Papas, PhD, MBA – NSF International, Health Sciences Division
Speaker: Adrienne Lenz, MS, RAC – Hyman, Phelps & McNamara, P.C.
Moderator: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – Quidel
Session Leader/Speaker: Seema S. Betigeri, PhD – Merck & Co., Inc
Speaker: Rob Kalesnik-Orszulak, PharmD – Bristol Myers Squibb
Speaker: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Speaker (Remote): Robyn Bent – FDA
Moderator: Kim Quaintance-Lunn – Bayer
Speaker: Leslie Harden, PharmD – Biotechnology innovation organization
Speaker (Remote): Juan Garcia Burgos, MD – European Medicines Agency
Speaker: Anabela Marcal – European Medicines Agency
Speaker (Remote): Gabrielle Rushing, PhD – TSC Alliance
Session Leader/Speaker: Alex May, M.S. – Biotechnology Innovation Organization
Speaker: Kim Wolfram, MS – Biogen
Speaker: Ben Stevens, PhD, MPH – GSK
Speaker (Remote): Joel Welch, PhD – OBP/OPQ/CDER/FDA
Session Leader/Speaker: Micheline Awad, MBA – Turning Point Therapeutics, Inc.
Speaker: Lisa M. Kelsey, MA LMFT – Genentech, Inc.
Session Leader/Speaker: Erin Oliver, MS, MBA, FRAPS – Haleon
Speaker (Remote): Theresa Michele, MD – FDA
Speaker: Lauren Quinn, JD – Haleon