Speakers
Meet Our Speakers
Keynotes
Executive Vice President, Manufacturing and Supply
Sanofi
Global Quality Officer
Takeda
Chief Technical Operations and Quality Officer
Moderna
Director of the Division of Regulation, Guidance and Standards in OPQ/OPPQ
FDA
Chief Quality Officer
Baxter International Inc.
Team Leader, Drug Shortages Staff
FDA
Veteran HR Executive & Author
Retired-First Horizon Bank
Workshop Leaders
Director, Combination Product Development
AbbVie
Associate Principal Scientist in Upstream Process Development
Fujifilm Diosynth Biotechnologies
Founder & CEO
The Sparks Group
Director Regulatory Affairs - CMC
Amgen Inc.
Principle Scientist
Merck
Vice President, Quality
Nivagen Pharmaceuticals, Inc.
Director, Upstream Process Development
Fujifilm Diosynth Biotechnologies
Senior Director, CMC Advisory Office
Pfizer, Inc.
Consultant
The Triality Group, LLC
Senior Executive Consultant
Q-FINITY Quality Management
Principal Consultant
CAI
Associate Director of Digital Support
FUJIFILM
Director - Analytical
Eli Lilly
Practice Leader: ATMPs & Biologics
Genesis AEC
Senior Consultant
Pelleboer Excellence Consultancy
VP, Quality Control
Apogee Therapeutics
Cofounder
Assurea, LLC
President & Founder
Biopharm Services Ltd
Founder | Managing Partner
The Triality Group, LLC
Global Head, Regulatory Affairs
AbbVie, Inc.
Co-founder & President
GessNet
Advanced Therapy Medicinal Products (ATMPs)
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Director Process Facility Engineering
Bristol Myers Squibb
Partner
Barry-Wehmiller Design Group
Principal Quality Engineer
Avobis Bio, LLC
Global Life Sciences Consultant
Rockwell Automation - Marlboro MA
Director of Advanced Therapies and Biologics
PM Group
European Director of Process Technology
Arcadis
Senior Director – BioPartnering Solutions
Bayer
Senior Vice President/Head Cell Therapy
Sumitomo Pharma America, Inc.
President and Chief Scientific Officer
Nanoscope Therapeutics Inc.
Industrial Analyst II: Modeling & Simulation
IPS
Director - Global Engineering
Bristol-Myers Squibb
Co-Founder
Assurea
Technical Director - GMP / Regulatory Compliance
PM Group
Unit Manager Inspectorate Strategy & Innovation
MHRA
Senior Process Specialist
IPS
Global Head, Regulatory Affairs
AbbVie, Inc.
Digital Transformation
Gilead Sciences
Director Systems Architecture, Digital and Execution
Johnson & Johnson Innovative Medicines
Product Owner / Strategic Board
Rommelag ILabs GmbH
GTS Digital Strategy
Bristol Myers Squibb
Projects Technical Manager
AstraZeneca
Group Head of Smart Manufacturing
PM Group
Fellow - Digital Technology, Associate
CRB
Director, Computer Systems Quality and Data Integrity
Syneos Health
Vice President, Global Life Sciences Technical Operations
Capgemini
Founder and Principal
RDG Group LLC
Consultant
The Triality Group, LLC
Senior Executive Consultant
Q-FINITY Quality Management
Managing Director
Q-FINITY Quality Management
CEO
Runtime Verification
IT/OT Connected Factory Business Partner
AstraZeneca
Director, Manufacturing
Takeda Lexington MA
Director Life Sciences & Process Industry
Ing. Punzenberger COPA-DATA GmbH
Smart Manufacturing SME
PM Group
Technical Lead Optical Inspection
Johnson & Johnson Innovative Medicine
Director of Digital Realization for Pharmaceutical Sciences
Pfizer
Managing Director
JLL
Cofounder
Assurea, LLC
Executive Director, IT - Quality and Compliance
Gilead Sciences
Vice President, Corporate Quality
Syneos Health
Founder | Managing Partner
The Triality Group, LLC
Product Manager
Körber Pharma Inspection
Head of Digital Operations
RoslinCT
Head of Quality
Integrity
Manufacturing – Quality Control & Operational Excellence
CMC/Operations Client Service Partner
A-connect
Site Head - Lilly Research Triangle Park
Eli Lilly
Bioprocess Technologies & Engineering
AstraZeneca
Scientific Director, Regulatory Affairs
Novo Nordisk
Discipline Manager, Process Engineering
Arcadis
President
Henlius Biopharmaceutical Ltd
Senior Director, Drug Substance Make, Assess, Release
Genentech
Senior Director, Global Regulatory Affairs-CMC
Merck & Co Inc
Associate Principal Scientist
AstraZeneca
Senior Engineer
Arcadis
Head of General Medicine Engineering & Project Delivery
Sanofi
Technical Services Director
Steris Corporation
Managing Consultant, Compliance Consulting
NNE
President
Guide Star Pharma
Senior Director of Engineering
Nitto Denko Avecia, Inc.
Head of Procurement - R&D, Manufacturing and Supply Chain
Astellas
Chief Technology Officer & VP of Customer Service
AST Inc
Manager of Technology & Engineering
Nitto Denko Avecia
Director of Strategic Partnerships
Performance Validation, Inc.
Principal Commissioning, Qualification, and Validation Engineer
AST Inc.
Associate Director, OES Compliance
AbbVie Inc
Principal Process Engineer
Genentech, Inc.
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Regulatory, Compliance & Quality
Vice President, Compliance Operations
ProQuality Network
Senior Data Scientist
AbbVie
Senior Director, Global Regulatory Affairs, CMC
Pfizer
Director Regulatory Affairs - CMC
Amgen Inc.
Senior Director, Global Quality Engineering
CSL Behring
Founder & Chief Quality Officer
Sware
Professor and Director
University of St.Gallen
Mechanical Engineer, Senior Specialist Quality Assurance
Retired
Software Quality Engineer
Takeda Pharmaceuticals Inc.
Sr. Manager, Technical Services
STERIS Life Sciences
Regulatory and Quality Co-Op
Access Vascular Inc
Associate Director, Statistics
Pfizer
Senior Director of Data Strategy and Analytics
Redica Systems
Principal Consultant
Epista Inc.
Executive Director, Regulatory Affairs-CMC
AstraZeneca
CAI Retired Principal Consultant
Senior Director
GlaxoSmithKline
Sustainability & Supply Chain Resiliency
Principal/Planner
Flad Architects
Head of Sustainability Operations
Zoetis
Associate Director, Environmental & Sustainability Lead
AstraZeneca
Senior Director, Global Engineering & Technology
Johnson & Johnson
Corporate Director Supply Chain
Endress+Hauser Group Services AG
Director, Environmental Health & Safety
Promega Corporation
Sustainability Services Delivery Lead
Burns & McDonnell
Sustainable Design Lead - Life Science and Pharmaceuticals
Arcadis
CEO
CoolPlanet
Director of Business Development
Syntegon
Vice President of Operations – Americas
Baxter
Head of Customer and Industry Advocacy Strategy
Sartorius Bioprocess Solutions
Head of Procurement - R&D, Manufacturing and Supply Chain
Astellas
Project Manager
Amgen
Associate Director and Global Category Leader for Raw Materials
BioMarin Pharmaceutical
Technical Director - GMP / Regulatory Compliance
PM Group
Head of Sustainability Global Engineering
Sanofi
Director of Sustainable Design and Delivery
CRB Group
Vice President
Century 3 (Shanghai) Inc.
Co-founder
Century 3 Shanghai Inc
Sponsored Sessions
Vice President Procurement & Logistics
IPS
Director
Linesight
Founder & CEO
Eschbach NA
Prn. Director, Regulatory and Validation Strategy
Cytiva
Strategy & Marketing Lead – Life Science
Schneider Electric
Pharma Industry Principle
Eschbach GmbH