Speakers

2026 Speakers


Eamonn Warren

Group Vice President, Global API & Dry Products Manufacturing

Eli Lilly

Michael Rogers

Principal, Quality and Compliance | Former Associate Commissioner

Canal Row Advisors | Former FDA

Jim Fox

SVP, Americas Supply Operations

AstraZeneca

Anthony Mire-Sluis

Senior Vice President, Global Quality

Gilead Sciences

Jens Vogel

SVP & Head of Global Biologics Operating Unit

Merck

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

Anne Kantardjieff

VP, Head of CMC Development and Regulatory for Biologics and ATMPs

Biogen

Hilary Marston

Principal, Drug & Biological Therapies | Former Chief Medical Officer

Canal Row Advisors | Former FDA

Kevin Trivett

Senior Vice President Manufacturing Operations

Eli Lilly

Sanjay Srivastava

Managing Director, Cell & Gene Therapy CoE Lead

Accenture

Christoph Pistek

VP, Head of Sustainability and Technology, R&D

Takeda

Marian Gindy

Vice President, Small Molecule Science and Technology

Merck

Anders Vinther

Former Chief Quality Officer, Founder & CEO

Quality Business Administration

Jason Martin

SVP, Head of Technical Operations, Hypercon

Halozyme

Harish Santhanam

Vice President Cell Therapy Technical Operations

Bristol Myers Squibb

Justin Burt

Executive Director, Synthetic Product Development

Alexion Pharmaceuticals

Jasmine Riley

Head of Global Quality, Pharma Service Group

Thermo Fisher Scientific

Elizabeth Hewitt

VP, Head of Pharmaceutical Sciences Program Leadership

Takeda

James Flacke

Senior Director, Biotech Production

Regeneron

Moderator: Kim Wolfram

Head of Global Regulatory CMC Biologics & ATMP

Biogen

Julie Ennis

Vice President, Technical Operations Science & Innovation

AstraZeneca

Carlos Candido

Vice President, External Manufacturing, MSAT & Supply Chain

Be Biopharma

Regis Gautier

Executive Director, Product Development & Sustainability Lead

AstraZeneca

Odile Smith

Vice President, Devens Site Head

Bristol Myers Squibb

Yolanda McClean

Senior Director, Quality Strategy & Operations

Alnylam

Brendan Walker

Sr. Director, DS Network Smart Factory Lead

Moderna

Kanti Thirumoorthy

Vice President, Cell Therapy Development and Operations

AstraZeneca

Frank Montgomery

Vice President, CMC Regulatory Affairs

AstraZeneca

Vaishali Shukla

VP, CGT & API Global Expansion Quality

Eli Lilly

Kevin Kerls

Executive Site Director

Lonza

Steve Lexa

Site Quality Lead

Eli Lilly

Stephen Mahoney

Executive Director, Head of Quality Policy & Advocacy

Gilead

Michel Russell

Executive Director, Intercompany Operations, (GLS)  (GSC) (GPS)

Bristol Myers Squibb

Michelle LaFond

Vice President, Preclinical Manufacturing & Process Development

Regeneron Pharmaceuticals

Benjamin Parkhurst

Senior Director, CMC Lead

Flagship Pioneering

Rae Ann Cook

VP, Global Quality

Otsuka Pharmaceuticals

Jonathan Chapman

Executive Director, Global Head of Quality Compliance & Audits

Gilead

Mark Keegan

Global Head of Drug Substance Development, mRNA Center of Excellence

Sanofi

Amanda Lewis

Sr. Director of DNA Operations & Manufacturing Support

Moderna

Pontaah Arbtan

Director, Enterprise Quality Training & Documentation

CSL (Seqirus)

Katie Masterson

Sr. Director Manufacturing Operations

Regenxbio

Katelyn Hahn

Director, Biotherapeutics Site & External Planning

Johnson & Johnson

Joseph Pollarine

Sr Director, Supplier & Vendor Quality

Johnson & Johnson

Brian Curran

SVP Manufacturing Excellence Success

MasterControl

Allison Cacciatore

Vice President of Technical Operations

Project Farma

Lyndsey Young

Executive Director, Head of Quality

Tr1X, Inc.

Amanda Ashcraft

Site Head, VP Norwood Drug Substance Operations

Moderna

Cory Johnson

Director of Quality Assurance

Eli Lilly and Company

Scott May

VP, Chemistry

Eli Lilly and Company

Sue Marrichi

Vice President and Site Head, Gene Therapy Manufacturing Facility

Ultragenyx Pharmaceuticals, Inc.

David Geer

Vice President, CMC

Replimune

Paresma (Pinky) Patel

Director, Regulatory CMC Policy and Advocacy

Gilead Sciences

Vinod Bulusu

Executive Director, Product Stewardship Lead

AstraZeneca

Jacob Greenwood

Vice President

Project Farma

Fabriq

Ignacio Nunez

Former Chief Operations Officer at CellReady

ScaleReady LLC

Andrew Jacon

Head of Sales & Marketing

Körber Pharma Software

Pierrick Lebigre

Vice President Product Management

Körber Pharma Software

Rainer Haemmerle

Executive Director Manufacturing, Fremont

Boehringer Ingelheim

Bart Reitter

VP Sales

Honeywell Life Sciences

Nida Sayed

Senior Manager of Upstream Process Development

Boston Institute of Biotechnology, LLC

Cormac Dalton

Vice President Sterile Manufacturing

AbbVie

Sandra Bennun

Director Biologics Drug Substance Process Development

Merck

Lindsey Daniel

P.E Global Operational Excellence Network Lead, Biologics

Takeda

Anne Marie O’Halloran

Life Sciences Supply Chain & Operations, Americas Lead

Accenture

Kerri Edwards

Associate Director, MSAT

Lonza

Executive to be Announced

McKinsey & Co

Executive to be Announced

eschbach North America, Inc.

2025 Speakers


Loading…