Fierce Pharma Fierce Biotech Fierce Healthcare Fierce Life Sciences Events Advertise Mailing List ATTEND Show Overview Who Attends Fierce 15 Awards Stay Updated COMMUNITIES Drug Development Clinical BD&L Trial Master File PR & Communications AGENDA Full Agenda Drug Development Clinical BD&L Trial Master File PR & Communications Meet the Speakers Call for Speakers PLAN YOUR VISIT Encore Boston Harbor Hotel & Casino PARTNERS 2025 Partners Partner Resources Floor Plan Become a Sponsor REGISTER ATTEND Show Overview Who Attends Fierce 15 Awards Stay Updated COMMUNITIES Drug Development Clinical BD&L Trial Master File PR & Communications AGENDA Full Agenda Drug Development Clinical BD&L Trial Master File PR & Communications Meet the Speakers Call for Speakers PLAN YOUR VISIT Encore Boston Harbor Hotel & Casino PARTNERS 2025 Partners Partner Resources Floor Plan Become a Sponsor REGISTER Fierce Pharma Fierce Biotech Fierce Healthcare Fierce Life Sciences Events Advertise Mailing List Powerhouse Communities: Drug Development Home Clinical Home BD&L Home Trial Master File Home PR & Comms Home Please check back regularly as we are adding new speakers on a daily basis. Swati Agrawal Senior Director, Global Regulatory Science Moderna Lindsey Allen Vice President, Investor Relations & Communications Amylyx Pharmaceuticals, Inc. Priya Annamalai Director, Inspection Program - Quality Assurance Astellas Pharma Global Development, Inc. Christopher Arendt Chief Science Officer, Head of Research Takeda Amy Atwood Vice President, U.S. and Global Corporate Communications Takeda Ashley Avery Senior Specialist, Quality Documents & Archival AbbVie Marianne Backer CEO Vir Biotechnology Behtash Bahador Director, Health Literacy CISCRP Tuba Bas Senior Director, Clinical Center of Excellence Bristol Myers Squibb Subha Basu Managing Director Converge Advisory Group Natalie Beck Senior Manager, Clinical Trials and RWD Genome Medical Wendy Beeby Head, Clinical Trial Associated Takeda Fritz Bittenbender Senior Vice President and Head of Public Affairs & Access Genentech Joseph Bolster Associate Director, TMF Operations Prothena Biosciences Steffen-Sebastian Bolz Founder & CSO Aphaia Pharma Ariel Bourla Head of Solid Tumor Oncology, Data Science & Digital Health, Research & Development Johnson&Johnson Jared Brooslin Senior Manager, Trial Master File Intellia Therapeutics Karim Budhwani CEO CerFlux. Itziar Canamasas Global Head of Oncology Boehringer Ingelheim Deborah Castellana Former Director, Clinical Trial Documentation & Archival Bristol Myers Squibb Helen Chalk VP, Clinical Operations Mythic Therapeutics Moitreyee Chatterjee-Kishore Head of Oncology Development, Astellas Pharma Inc. Amita Chaudhari Vice President, Head of North America Regulatory Daiichi Sankyo Catherine Cheung Director of Clinical Operations Gilead Science Ivan Cheung CEO NextPoint Therapeutics Peter Clark, PhD VP, Computational Drug Design Novo Nordisk Lee Cooper Managing Director Delos Capital Grace Crawford Head, Clinical Operations Quality & Learning AstraZeneca Maureen Cunningham Senior Director & Head of Clinical Oversight United Therapeutics, Corp. Chris Cutie, M.D. Vice President, Disease Area Leader, Bladder Cancer Johnson & Johnson Innovative Medicine Monique da Silva SVP, Corporate Affairs AnaptysBio Steven Damon CEO Micron Biomedical Ashlyn Deshaies Director, Clinical and TMF Operations TG Therapeutics Meg Dodge Senior Vice President, Investor Relations & Corporate Communications Rocket Pharmaceuticals, Inc. Eleanor Duff Senior Vice President, Global Corporate Communications, BeOne Medicines BeOne Medicines Vinay Edwin Director, Clinical Quality Lead Pharvaris Debbie Etchison Executive Director, Head of Corporate Affairs Alkeus Pharmaceuticals, Inc. Mike Exton Ph.D. CEO Lexicon Pharmaceutical Tom Farrand CEO & Co Founder Delfa Alicia Fiscus SVP, Head of Global Regulatory Affairs & GCP/GLP Quality Assurance Rhythm Pharmaceuticals Melissa Flanagan Sr. Manager, Global TMF & Records Management BeOne Medicines USA Inc. (Formerly BeiGene USA, Inc.) Bradford Flint Partner Ropes & Gray Stephen Framil Corporate Global Head of Accessibility Merck & Co., Inc. Robert Gabbay Former Chief Scientific & Medical Officer American Diabetes Association Margo Georgiadis Co-founder & CEO Montai Therapeutics; Flagship Pioneering Kristen Giessler Senior Manager, Risk Based Quality Management Operations Takeda Pharmaceuticals International Co. Gregory Goldmacher Associate VP, Clinical Research Merck Linda Goodman Co Founder Fauna Bio Olga Granaturova Managing Partner & CoFounder ANAMAX Innovation & PriveBio Gabriela Graterol Associate Director of Clinical Quality Assurance Astellas Abigail Gregor Partner Ropes & Gray Rahul Gupta President GATC Health Rebecca Halbur Associate Director, TMF Records Mangement, Cinical Trial Systems & Operations Moderna Janet Hammond Chief Development Officer Atea Pharmaceuticals Jamie Harrop Vice President Clinical Operations Beam therapeutics Paul Hastings CEO Nkarta, Inc.; Ex-Chair, Biotechnology Innovation Organization Devora Henderson President Elevate Clinical Research Karrie Hilsinger Head of Clinical Operations UroGen Pharma Etienne Hinton TMF System Specialist Duke University Health System Tom Hopkins Vice President, Head, ExploR&D Eli Lily & Company Eric Hughes Global R&D head and Chief Medical Officer Teva Gary Hughes CEO Teckro Troy Ignelzi Chief Financial Officer Rapport Therapeutics & Sofinnova Investments Darren Incorvaia Staff Writer Fierce Biotech Laura Indolfi Co-founder & CEO PanTher Therapeutics Erik Ingelsson, MD, PhD Chief Scientific Officer Wave Life Sciences Ramya Iyer Sr. Manager, TMF Development Records Management | Development Operations & Portfolio Management Regeneron Anthony Jarkowski Vice President, Head of Search & Evaluation, Business Development Bristol Myers Squibb O'Tika Jones Senior Specialist, Business Ops Management – TMF Daiichi Sankyo, Inc. Jose Juves SVP, Corporate and Patient Affairs Dyne Therapeutics Chiedza Kaitano Vice President and Global Program Head for Obesity Regeneron Dawn Kalmar Chief Communications Officer Stoke Therapeutics Daniel Karlin Chief Medical Officer MindMed Lindsay Kehoe Senior Project Manager and Lead Emerging Programs Clinical Trials Transformation Initiative Maren Killackey VP, Head of Investor Relations & Communication Generation Bio Carter King Executive Vice President, Business Development Protagonist Therapeutics Jim Koers Associate Vice President, Head of Due Diligence Eli Lilly and Company Jennifer Krohn Associate Director, Clinical Operations, RBQM Gilead Sciences John Lacey Lead, Corporate R&D and Science Communications Takeda Andrew Lam Managing Director, Head of Biotech Private Equity Ally Bridge Group Mankit Law Senior Director, Business Development, Search & Evaluation GSK Erin Leckrone Vice President, Clinical trials National Marrow Donor Program (NMDP) John Lepore CEO ProFound Therapeutics Jeremy Levin Chairman and CEO Ovid Therapeutics Scott Lohr Senior Vice President, Informatics. Program Director of Chronos, Alkahest, A Grifols Company Richard Lowenthal Co-Founder, President, and CEO ARS Pharmaceuticals Matt Lowery Clinical Research & Site Expert Caitlin Lowie VP, Corporate Communications and Investor Relations Ardelyx Dawn Lundin Vice President of Global Quality Lykos Therapeutics Karla MacDonald Chief Corporate Affairs Officer Entrada Therapeutics Micah Mackison CEO Vico Therapeutics Edoardo Madussi Senior Director, Business Development & Strategic Initiatives Intelligencia Harish Manmathan Director, Data Engineering for Clinical Trials RemeGen Biosciences Rao V. Mantri Chief Manufacturing officer Astellas Paula Markos Director II, RDQA Inspection Management Abbvie Jim Martineau CEO & CoFounder Nosis Bio Gabrielle Masson Senior Editor Fierce Biotech Lindsay Mateo CCO Weave Matt McKendrick Manager GCP Excellence in Clinical Trials Takeda Jeffery Meckler CEO Indaptus Therapeutics Lauren Merrill Director of TMF and R&D Records Management Biogen Jennifer Michaelson Chief Scientific Officer Cullinan Therapeutics David Moller Chief Scientific Officer Variant Bio Melissa Moody Director, Corporate Communications, Executive Communications Merck P K Morrow Senior Vice President and Head of Oncology Therapeutic Area Unit Takeda Christopher Mortko Vice President, Head Search and Evaluation, Business Development & Licensing Merck Curran Murphy Senior Director Clinical Operations / Head of Clinical Business Operations Blueprint Medicines John Murphy Chief Scientific Officer Arbor Biotechnologies John Murray VP Global Business Development & Country Head UK SanaClis Mike Nally CEO Generate Biomedicines Sahm Nasseri SVP Business Development & Strategy Generate Biomedicines Michael Palladinetti Global Head of Immunology & Inflammation Business Development Sanofi Dinesh Patel CEO Protagonist Therapeutics Masoom Patel Process Capability Manager, Clinical Documentation Management Boehringer Ingelheim :Pharmaceuticals, Inc Rita Pease Head of Quality Assurance Harbor Clinical Jacob Petersen Senior Vice President, Diabetes, Obesity and MASH Therapeutic Area Novo Nordisk Oksana Petrushyna Sr. Data Scientist - Metrics, Analytics & Performance (MAP) Merck Stephanie Pfister Vice President, Clinical Operations Biohaven Christine Purcell Senior Specialist, Business Ops Management-TMF, Global Development Information Management, R&D Strategy & Operations Daiichi Sankyo, Inc. Cameron Pye Co Founder Unnatural Products Inc. Adrian Quartel Chief Medical Officer Zevra Therapeutics Maha Radhakrishnan Executive Partner, Private Equity Sofinnova Simmi Rana Associate Director, Records Management Viridian Therapeutics Bhaskar Rege Senior Vice President, Pharmaceutical and Early-Stage Development Alkermes Jorge Reis Filho Chief AI and Data Scientist AstraZeneca Maria Restrepo Program Director, Diversity in Cliical Trials Medtronic Sara Riordan Vice President, Strategy Genome Medical Jackie Roberts Manager, GCP Excellence in Clinical Trials Takeda Michael Rossi CEO and Chairman of the Board Y-mAbs Carsten Rudolph Co-Founder & CEO Ethris Sarah Ruiz Clinical Strategist Kivo David Schaffer Professor; Director of QB3; Director of Bakar BioEnginuity Hub UC Berkeley Rich Segal Partner Cooley, LLP Christy Shaffer General Partner Hatteras Venture Partners Mridula Shukla Sr. Director, Regulatory Affairs Roche - Genentech Andres Sirulnik Senior Vice President, Clinical Development Unit Head, Hematology Regeneron Hunter Smith CFO Rhythm Pharmaceuticals Jeremy Springhorn CEO Nido Biosciences Brad Stefanovic Head of Clinical Innovation Simulations Plus Tadaaki Taniguchi Chief R&D Officer Astellas Jasmine Thangaraj eTMF Manager, TMF Records Management Moderna Helen Torley President and CEO Halozyme Therapeutics Jamie Marie Toth Global Head, TMF Management & Records BeOne Medicines USA Inc. (Formerly BeiGene USA, Inc.) John Truesdell Chief Business Officer Foresight Diagnostics Vinoo Urity Director, Global Clinical Operations RemeGen Biosciences Yaming Wang Managing Director Alphabet Consulting Kym White SVP and Chief Corporate Affairs Officer Generate:Biomedicines Laura Whitmore Senior Director, Business Operations and Clinical Outsourcing Kailera Therapeutics Rochelle Williams-Belizaire, MPH, CPH US Oncology Strategy Lead, Diversity in Clinical Trials Boehringer Ingelheim Pharmaceuticals Melisa Williamson Director, GCP Quality Operations Lead PharPoint Research Sam Windsor CEO Ignota Labs Heather Wolff Vice President, Development Operations Sionna Therapeutics Kelli Wright Director, Patient Advocacy Day One Biopharmaceuticals Diyong Xu Principal OrbiMed Advisors Sandeep Yadav VP, Technical Development Sangamo Ben Yerxa President Opus Genetics Hanadie Yousef Co-Founder and CEO Juvena Therapeutics Nisha Zaidi Vice President, Head of Global Alliances, Business Development Bristol Myers Squibb Alex Zhavoronkov CEO Insilico Medicine Jimmy Zhuang Assistant General Council, Business Development Novo Nordisk Toban Zolman CEO Kivo VIEW THE FULL AGENDA