Speakers
Meet Our Speakers
Keynotes
Executive Vice President, Manufacturing and Supply
Sanofi
Global Quality Officer
Takeda
Chief Technical Operations and Quality Officer
Moderna
Chief Quality Officer
Baxter International Inc.
Veteran HR Executive & Author
Workshop Leaders
Director, Combination Product Development
AbbVie
Founder & CEO
The Sparks Group
Director Regulatory Affairs - CMC
Amgen Inc.
Principle Scientist
Merck
Managing Director
HDR COMPANY LLC
Director, Upstream Process Development
Fujifilm Diosynth Biotechnologies
Senior Director, CMC Advisory Office
Pfizer, Inc.
Senior Executive Consultant
Q-FINITY Quality Management
Senior Director, Manufacturing R&D
Charles River Laboratories Inc
Director - Analytical
Eli Lilly
Practice Leader: ATMPs & Biologics
Genesis AEC
VP, Quality Control
Apogee Therapeutics
President & Founder
Biopharm Services Ltd
Global Head, Regulatory Affairs
AbbVie, Inc.
Co-founder & President
GessNet
Advanced Therapy Medicinal Products (ATMPs)
Principal Scientist in Process Science and Modeling
Johnson & Johnson Innovative Medicine
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.
Head of Automation & Innovation
Legend Biotech
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
Product Owner Visual Inspection Software
Körber Pharma Inspection GmbH
Gilead Sciences
Director, Systems Architecture, Digital and Execution
Johnson & Johnson Innovative Medicines
Product Owner / Strategic Board
Rommelag ILabs GmbH
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
Head of Data Science Pharm Sciences
Pfizer
Senior Executive Consultant
Q-FINITY Quality Management
Managing Director
Q-FINITY Quality Management
CEO
Runtime Verification
IT/OT Connected Factory Business Partner
AstraZeneca
Head of Digital Operations
RoslinCT
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
Managing Director
JLL
Cofounder
Assurea, LLC
Executive Director, IT - Quality and Compliance
Gilead Sciences
Founder | Managing Partner
The Triality Group, LLC
Vice President, Corporate Quality
Syneos Health
Head of Quality
Integrity
Manufacturing – Quality Control & Operational Excellence
CMC/Operations Client Service Partner
A-connect
Site Head - Lilly Research Triangle Park
Eli Lilly
Student
Jefferson University
Scientific Director, Regulatory Affairs
Novo Nordisk
Discipline Manager, Process Engineering
Arcadis
COO
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.
Chief Technology Officer & VP of Customer Service
AST Inc
Manager of Technology & Engineering
Nitto Denko Avecia
Director of Strategic Partnerships
Performance Validation, Inc.
Owner/CEO
Independent Consultant
Principal Commissioning, Qualification, and Validation Engineer
AST Inc.
Associate Director, OES Compliance
AbbVie 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
Operations Director
Kite Pharma, Inc.
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, Sterilization
STERIS Life Sciences
Regulatory and Quality Co-Op
Access Vascular Inc
Associate Director, Statistics
Pfizer
Senior Director of Data Strategy & 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
Sr. Safety, Health & Environmental Specialist
AstraZeneca
Senior Director, Global Engineering & Technology
Johnson & Johnson
Corporate Director Supply Chain
Endress+Hauser Group Services AG
Director, Environmental Health & Safety
Promega Corporation
Sustainable Design Lead - Life Science and Pharmaceuticals
Arcadis
CEO
CoolPlanet
Director of Business Development
Syntegon
Head of Customer and Industry Advocacy Strategy
Sartorius Bioprocess Solutions
Project Manager
Amgen
Senior Consultant
SEI
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.
Student