Speakers
Meet Our Speakers
Keynote Speakers
Director, Office of Strategic Programs
FDA
Group Vice President, Global Parenteral Products and Devices
Eli Lilly and Company
Sr. Liaison, Patient Advocacy & Industry Relations Central Area
Acadia
Validation and Information Technology Principal Auditor, Quality Assurance
CTI Clinical Trial and Consulting Services
Executive Director
EMA
Chief Patient Supply Officer
Spark Therapeutics, Inc.
SVP Head of Global Engineering
Takeda Pharmaceuticals International AG
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 Science Advisor and CMC Policy Lead At the Center for Biologics
FDA
Senior Director, Manufacturing Science and Technology
Johnson & Johnson
Senior Project Manager
Catalent Pharma Solutions
Senior Consultant
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 Director Business Development
Bausch+Ströbel SE + Co. KG
Digital Transformation Speakers
Gilead Sciences
Associate Director
Gilead Sciences Inc
Fellow - Digital Technology, Associate
CRB
Vice President of Quality
Kindeva Drug Delivery
Senior Director
Gilead Sciences
Senior Executive Consultant
Q-FINITY Quality Management
Associate Director
Gilead Sciences
Director, Manufacturing Analytics
Bristol Myers Squibb
CSO & Co-Founder
Aizon
Head External Liaison, Global Quality
Sanofi Aventis
Head of Digital Systems, Automation and Metrology Spark Therapeutics, Inc.
Commissioning & Qualification Lead, Specialty Care GBU
Sanofi
Head, Digital Risk & Compliance – Data and SaMD
Sanofi
Head, Digital Risk & Compliance, Strategy & Governance
Sanofi
Executive Director, IT - Quality and Compliance
Gilead Sciences
Vice President, Corporate Quality
Syneos Health
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
Director, Combination Product Development
AbbVie
Fellow, BioProcess Design
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
Head External Liaison, Global Quality
Sanofi Aventis
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
CMC Regulatory Affairs Manager
Amgen
Consultant
Valsource Inc
Northeastern University
Senior Director, Regulatory Affairs CMC
AstraZeneca
Global Quality Manager & Policy Lead
F. Hoffmann-La Roche Ltd
Heads the Scientific Informatics and Regulatory Compliance Solutions
Zifo Technologies
Student / Founder
The Cooper Union for the Advancement of Science and Art
Executive Director, Regulatory Affairs-CMC
AstraZeneca
Senior Scientific Evaluator
Health Canada
Global Head, Regulatory Affairs
AbbVie, Inc.
Director of Chemical Process Development
Bristol-Myers Squibb
Senior Director
GlaxoSmithKline
Sustainability - Supply Chain Resiliency
Assistant Research Director
Duke-Margolis Center for Health Policy
Environmental & Sustainability Lead
AstraZeneca
Senior Process Engineer
Burns & McDonnell
Owner
Biopharmaceutical Water Doc
Sr. Dir. Global Engineering - Env. Sustainability
Amgen, Inc. - Thousand Oaks, CA
Associate Director-US & Global Regulatory Affairs
Merck & Co Inc
Deputy Assistant Secretary, Cent for Industrial Base Management and Supply Chain
HHS/ASPR/IBMSC
PM Group
Senior Project Manager
Salas O'Brien
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
Engagement Manager
L.E.K. Consulting
Workshops
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Director, Computer Systems Quality and Data Integrity
Syneos Health
Chief Process Engineer
Genesis AEC
Senior Consultant, Global BioPharm Center of Excellence
Merck Chemicals GmbH
Director, Integrated Process Analytics
Pfizer
Head of Business Development for North America
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