Speakers
Meet Our Speakers
Keynote Speakers
President and CEO
ISPE
Senior Director and Group Manager, Project and Product Leadership
AstraZeneca
SVP Head of Global Engineering
Takeda Pharmaceuticals International AG
Sr. Auditor, Computer Systems Quality
Syneos Health
Head of Operations Quality, Compliance and External Affairs
AstraZeneca
Executive Director
EMA
Manager, Biotherapeutic Quality Division
Health Canada
Executive Director, CMC Regulatory Affairs
Gilead Sciences, Inc.
Vice President & General Manager, Life Sciences
Jacobs
Head of Global Regulatory Strategy and Submissions
NGT Biopharma
Chief Patient Supply Officer
Spark Therapeutics, Inc.
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences
Group Vice President, Global Parenteral Products and Devices
Eli Lilly
Advanced Therapy Medicinal Products Speakers
Process Engineer
Fujifilm Diosynth Biotechnologies
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Process Engineer
Clark, Richardson, Biskup
Managing Director for Quality
Catapult Cell and Gene Therapy
Director, Process Architect
IPS
Senior Expert Aseptic Processing
KyooBe Tech GmbH
Senior Director, Manufacturing Science and Technology
Johnson & Johnson
Senior Project Manager
Catalent Pharma Solutions
Valsource Inc
CQV Lead
Core Services Group
Technical Director - GMP / Regulatory Compliance
PM Group
Principal Engineer
Pharmatech Associates
Senior Vice President Manufacturing/Site Head
Advanced Medicine Partners
Senior Process Specialist
IPS
Senior Director, Quality Assurance
Encoded Therapeutics
Global Head, Regulatory Affairs
AbbVie, Inc.
Global Lead Business Development
Bausch+Ströbel SE + Co. KG
Digital Transformation Speakers
Gilead Sciences
Associate Director
Gilead Sciences Inc
Fellow - Digital Technology, Associate
CRB
Kindeva Drug Delivery
Senior Director
Gilead Sciences
Senior Executive Consultant
QFINITY
Gilead Sciences
Director, Manufacturing Analytics
Bristol Myers Squibb
CSO & Co-Founder
Aizon
Manager
Sanofi Pasteur
Spark Therapeutics, Inc.
Commissioning & Qualification Lead, Specialty Care GBU
Sanofi
Director Q & C Validation
Sanofi-Aventis
Head, Digital Quality Operations for R&D
Sanofi
Executive Director, IT - Quality and Compliance
Gilead Sciences
Vice President, Corporate Quality
Syneos
Founder | Managing Partner
The Triality Group, LLC
Head of Quality
Tulip Interfaces
Executive Director, Engineering
Amgen
CEO
No Deviation Pte Ltd
Manufacturing - Quality Control - Operational Excellence Speakers
Director, Combination Product Development
AbbVie
Lead Process Engineer
CRB
Engineering Data Strategist
Eli Lilly And Company
Principal/Planner
Flad Architects
VP of Plasma Engineering
Takeda Pharmaceuticals Inc.
Chief Manufacturing Officer
Wheeler Bio
Director Technology Management
Exyte Central Europe GmbH
Executive Director
Boehringer Ingelheim
Senior Director and the Head of Strategy and Programs
Sequoia Biotech Consulting
Oligonucleotide/Peptide Market Leader
CRB
Executive Director - Data & Analytics
Eli Lilly
Vice President - Quality & Regulatory Compliance
STAQ Pharma Inc
Manager
Sanofi Pasteur
Director, Nonclinical Biostatistics
Genentech Inc
Distinguished Engineer, Global Engineering & Facilities
Biogen Inc.
Assistant Director
Ionis Pharmaceuticals
Global Head, Complex Devices and Drug Delivery Systems, RA CMC and Devices
AbbVie
President and COO
Datamura Solutions, LLC
Regulatory - Compliance - Quality Speakers
CMC Regulatory Affairs Manager
Amgen
Consultant
Valsource Inc
Northeastern University
Senior Director & Group Manager, CMC Regulatory Affairs
AstraZeneca Ltd
Zifo Technologies
The Cooper Union for the Advancement of Science and Art
Executive Director, Regulatory Affairs-CMC
AstraZeneca
Global Head, Regulatory Affairs
AbbVie, Inc.
Bristol-Myers Squibb
Senior Director
GlaxoSmithKline
Sustainability - Supply Chain Resiliency Speakers
Assistant Research Director
Duke-Margolis Center for Health Policy
Sr. Safety, Health & Environmental Specialist
AstraZeneca
Senior Process Engineer
Burns & McDonnell
Owner
Biopharmaceutical Water Doc
Engineering Director
Amgen Inc
Process Engineer
AbbVie
Associate Director-US & Global Regulatory Affairs
Merck & Co Inc
Branch Chief, CDMO Network
PCI/BARDA/ASPR/HHS
PM Group
Senior Project Manager
PCI (A Salas O'Brien Company)
Global Lead for Energy & Sustainable Operations
Johnson & Johnson
Global Lead of Environmental Sustainability & Life Cycle Assessment
Takeda
Director CMC Global Regulatory Affairs Strategic Projects & Innovation
Gsk
Head of Sustainability
Belimed Life Science
Senior Consultant
L.E.K. Consulting
Workshops
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Director, Computer Systems Quality and Data Integrity
Syneos Health
Senior Director, Corporate Quality Systems & Cultural Excellence
Perrigo
Professor and Director
University of St.Gallen
Director, Integrated Process Analytics
Pfizer
Head of Business Development for North America
COMECER