Moderator:
Alison Moore
CMC Executive
Panelists:
Tim Moore
EVP, Chief Technical Officer
Allogene Therapeutics
Wolfram Carius
EVP Pharmaceuticals
Bayer AG
Dr. Pascal Bécotte
Managing Director
Russell Reynolds Associates
Snehal Patel
SVP, Head Technical Operations
Sana Biotechnology
Alison Moore
CMC Executive
Per Alfredsson
SVP, Global Biologics Operations AstraZeneca and President AstraZeneca AB
AstraZeneca
Ralf Altenburger
Global Head, Cell and Gene Therapy, Genentech/Roche
Roche
Alison Moore
CMC Executive
Jack Garvey
CEO/ Managing Partner
Compliance Architects LLC
Judith Koliwer, PhD
Sr. Industry Advisor and Principal Consultant Advanced Therapies
Körber Business Area Pharma
Robert Zamboldi
Site Head – US Cell & Gene Therapy, Morris Plains
Novartis
Jennifer McCafferty
SVP, CMC-Regulatory and Quality
Merck
Heidi Zhang
EVP, Head of Technical Operations
Tune Therapeutics, Inc.
Kevin Sharp
SVP, Head of Samsung Biologics America Sales
Samsung Biologics
mRNA manufacturing offers great benefits and potential for infectious diseases and personalized medicines due to the advantages in flexibility, cost, and speed of development, but there are still challenges to overcome to fully realize the potential, especially when addressing small batch manufacturing. Considering manufacturability and scale-up from the beginning will help to deliver process efficiency and scalability along the spectrum of mRNA products. In this presentation, we’ll discuss how digital technology can help accelerate therapeutic development and strategies to adopt a paper free approach at all stages of development.
Katarina Stenklo
Enterprise End-to End Solutions Leader
Cytiva
Judith Koliwer, PhD
Sr. Industry Advisor and Principal Consultant Advanced Therapies
Körber Business Area Pharma
Michael Thien
Head & SVP, Pharmaceutical Sciences
Takeda Pharmaceuticals
Federico A Feldstein, JD
VP, Global Head of Supply Chain Quality
Johnson & Johnson Innovative Medicines
This discussion will focus on the scientific, technical and cultural transformations required to drive towards true industrialization of cell therapies, including:
Jens Vogel
SVP & Global Head of Biotech
Bayer Pharmaceuticals
Amy Doucette
Head of Business Operations – Automation Product Group Pharma
Applied Materials
Michael Kraich
VP of Global Project & Product Management
Boehringer Ingelheim Biopharmaceuticals GmbH
Seshu Tyagarajan
Chief Technical and Development Officer
Candel Therapeutics
Dr. Larry R. Fiegland
Discoverant Product Manager
Dassault Systèmes
Brad Wynja
VP of Business Development
INCOG BioPharma Services, Inc.
Giuseppe Mauro
VP, Head of Large Molecule Manufacturing
Incyte Biosciences Technical Operations Sarl
Ben Castro
SVP Manufacturing Operations
Just – Evotec Biologics
Eric Hacherl
Chief Operating Officer
Kyttaro Therapeutics
Kacey Fetcho-Phillips
AVP, Site Head
Merck
Heather Erickson
VP, Supply Chain Management & Business Operations
Sangamo
Mike Nuzzolo
Head of Quality Operations
Spark Therapeutics
Georgeta Puscalau
Senior Vice President Quality
Tune Therapeutics, Inc.
Lars Petersen
President and CEO
FUJIFILM Diosynth Biotechnologies
Rahul Singhvi
Co-Founder & CEO
Resilience, Inc.
David Y. H. Chang
President and Chief Technology Officer
WuXi Advanced Therapies
Moderator:
Adam Pfeiffer
VP
Project Farma
Panelists:
Doug Alleavitch
VP Quality
Arcellx
John Khoury
EVP
Project Farma
Paul Jorjorian
VP Biologics
Thermo Fischer
Sarah Stevens, Ph.D.
President of Azzur Labs & Azzur Cleanrooms on Demand™
Azzur Group
Brian Curran
SVP Manufacturing Excellence Success
MasterControl, Inc.
Peter Marks
Director – Center for Biologics Evaluation and Research (CBER)
FDA
Over the last few decades we have all witnessed the industrialization of biologics manufacturing, as well as continuous progress in complex medicines such as Cell and Gene Therapy. In this panel we will reflect on where we started, where we are now, and what our future holds. We dedicate this conversation to Mike Kamarck, an exceptional leader of our era whose legacy includes everything we plan to discuss:
Alison Moore
CMC Executive
Wolfram Carius
EVP Pharmaceuticals
Bayer AG
Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus,
and Faculty Director, Emeritus Deshpande Center for Technological Innovation
MIT (Massachusetts Institute of Technology)
Sanat Chattopadhyay
EVP, President, Merck Manufacturing Division
Merck
Mike McDermott
EVP, Chief Global Supply Officer
Pfizer
Pat Yang
Vice Chairman & Co-Founder
Resilience, Inc.
Brendan O’Callaghan
EVP, Manufacturing and Supply
Sanofi
Aine Hanly
Chief Technology Officer
Vir Biotechnology
Michael Kamarck (In Memoriam)
BioPharma Advisor & Board of Directors: Passage Bio, VaxCyte
Alison Moore
CMC Executive
John Tomtishen
VP Operations
Cellares
Alison Moore
CMC Executive
Stacey Ma
EVP, Pharmaceutical Development and Manufacturing
Gilead
Roberto Silveira
Global Technology & Engineering
Pfizer
Alison Moore
CMC Executive
Jack Garvey
CEO/ Managing Partner
Compliance Architects LLC
Judith Koliwer, PhD
Sr. Industry Advisor and Principal Consultant Advanced Therapies
Körber Business Area Pharma
Luis Mustafa Perez
VP Innovation & Operational Excellence
Moderna
It is time for Quality leaders to transition from a traditional compliance driven role to that of a Quality Business Leader making quality a competitive advantage for companies rather than seen as a cost. To become a successful Quality Business Leader requires mastering the following skills
Anders Vinther
SVP Pharmaceutical Development & Manufacturing
Kronos Bio
Chris Stevens
Chief Patient Supply Officer
Spark Therapeutics
Eric Hacherl
Co-Lead, NIIMBL Viral Vector Program
NIIMBL
Chris McDonald
SVP & Global Head of Technical Operations
Kite, a Gilead Company
Amrit Chaudhuri
CEO/Cofounder
SmartLabs
Dave Stewart
SVP, Operational and Process Technology, Large Scale Business Unit
FUJIFILM Diosynth Biotechnologies
Martin Rabel
Sr. Field Application Scientist
Precision NanoSystems Inc.
Greg Sukay
VP Manufacturing and Process Technologies
Arcutis Biotherapeutics
Vinod Bulusu
Executive Director, Head Global Biologics CMC Product Stewardship
AstraZeneca
John Tomtishen
VP Operations
Cellares
Shahid Rameez
Director, Global Vaccines and Biologics Commercialization
Merck
Tariq Warsi
Sr. Executive Technical Operations
Christine Sheaffer
Head of Manufacturing and Supply
Spark Therapeutics
Annette Hillebrand
Executive Director Global Regulatory Affairs CMC
Ultragenyx
Glen Campbell
Head of External Manufacturing
Vir Biotechnology
Thomas Potgieter
SVP, Global Cell Therapy Development & Operations
Bristol-Myers Squibb
Amy Gamber
VP, Manufacturing
Atara Biotherapeutics
Dr. Pascal Bécotte
Managing Director
Russell Reynolds Associates
Shannon Knott
Executive Director
Russell Reynolds Associates
Alison Moore
CMC Executive