OCT 27-29, 2025 | REGISTER

SPEAKERS

ALL SPEAKERS

Scott Biggs

Scott Biggs

Director, Supplier Services
IQVIA
Robert Cerwinski, JD

Robert Cerwinski, JD

Managing Partner
Gemini Law LLP
Shana Christrup

Shana Christrup

Senior Director, Policy
AAM
Jacqueline Corrigan-Curay, JD, M.D.

Jacqueline Corrigan-Curay, JD, M.D.

Principal Deputy Center Director
Center for Drug Evaluation and Research (CDER), FDA
Everett Eissenstat, JD

Everett Eissenstat, JD

Partner
Squire Patton Boggs
Rachel Goode, PhD

Rachel Goode, PhD

Senior Vice President, Head of Legal and Intellectual Property, Biopharmaceutical
Fresenius Kabi USA
Keren Haruvi

Keren Haruvi

Board Chair
Association for Accessible Medicines (AAM)
Vijaya Iyer, MSc

Vijaya Iyer, MSc

Senior Director, Global Regulatory Affairs PLCM & Regulatory Compliance
Apotex Inc.
Kurt Karst

Kurt Karst, JD

Director
Hyman, Phelps & McNamara, P.C.
Johannes Keuschnigg, PhD

Johannes Keuschnigg, PhD

Regulatory Devices Portfolio Head
Sandoz
Sara Koblitz, JD

Sara Koblitz, JD

Director
Hyman, Phelps, & McNamara, P.C.
Scott Kuzner, PhD

Scott Kuzner, PhD

Senior Director, Sciences and Regulatory Affairs
AAM
Chris Lamanna, PhD

Chris Lamanna, PhD

Head Regulatory Devices
Sandoz
Brian McCormick, JD

Brian McCormick, JD

Vice President, Chief Regulatory Counsel & Head, Global Regulatory Policy
Teva Pharmaceuticals
Iilun Murphy, M.D.

Iilun Murphy, M.D.

Director
Office of Generic Drugs (OGD), CDER FDA
John Murphy III

John Murphy III

President and CEO
AAM
Carrie O'Donel, MS

Carrie O’Donel, MS

Senior Principal Device Engineer, Combination Product & Device R&D
Teva Pharmaceuticals
Giuseppe Randazzo

Giuseppe Randazzo

Senior Vice President, Sciences and Regulatory Affairs
AAM
Michael Sargent

Michael Sargent

Senior Director, Policy
AAM
Anand Saxena, M.Sc.

Anand Saxena, M.Sc.

Director, Regulatory Affairs
Cipla LTD
Martin Schiestl, PhD

Martin Schiestl, PhD

Global Head Regulatory Affairs Policy
Sandoz
John Strom, JD

John Strom, JD

Special Counsel
Foley & Lardner LLP
Eva Temkin, JD

Eva Temkin, JD

Partner
Arnold & Porter
Steffen Thirstrup, M.D., PhD

Steffen Thirstrup, M.D., PhD

Chief Medical Officer
European Medicines Agency
Kimberlee Trzeciak

Kimberlee Trzeciak

Senior Vice President
Capitol Hill Consulting Group
Stephanie Trunk, JD

Stephanie Trunk, JD

Partner and Life Sciences Industry Group Co-Leader
Arent Fox Schiff
Cory Wohlbach

Cory Wohlbach

Global Vice President, Biosimilars Regulatory Affairs
Teva Pharmaceuticals
Elena Wolff-Holz, M.D., PhD

Elena Wolff-Holz, M.D., PhD

Global Head Clinical Development
Biocon Biologics Ltd.
Marta Wosińska, PhD

Marta Wosińska, PhD

Senior Fellow, Economic Studies, Center on Health Policy
The Brookings Institution
Sarah Yim, M.D.

Sarah Yim, M.D.

Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs (OND), CDER
FDA