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 Regulations and Guidance 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
Managing Director
HDR Company LLC
Director, Upstream Process Development
Fujifilm Diosynth Biotechnologies
Senior Director, CMC Advisory Office
Pfizer, Inc.
Managing Director
MH Consulting & Advisory GmbH
Senior Executive Consultant
Q-FINITY Quality Management
Associate Vice President Technical Excellence & Transformation
CAI
Director - Analytical
Eli Lilly
Practice Leader: ATMPs & Biologics
NCBiosource
Co Chair
Senior Business Developer
Bilthoven Biologicals
VP, Quality Control
Apogee Therapeutics
Women in Pharma Liaison
Cofounder
Assurea
President & Founder
Biopharm Services Ltd
CEO
The Triality Group, LLC
Vice President, Head of 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
BW Design Group
Principal Quality Engineer
Avobis Bio, LLC
Scientific Advisor & Co-Founder
ChemT Biotechnology
Global Life Sciences Consultant
Rockwell Automation - Chelmsford MA
Director of Advanced Therapies and Biologics
PM Group
European Director of Process Technology
Arcadis
Senior Director – BioPartnering Solutions
Bayer
Head, Regulatory Affairs CMC Cell Therapy
Astellas Pharma US
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
Assessor
MHRA
Sr. Process Specialist, GST
IPS - Integrated Project Services LLC
Associate Director (Regulatory Policy)
CBER/FDA
Vice President, Head of 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
Senior Fellow - Digital Technology, Associate
CRB
Director, Computer Systems Quality and Data Integrity
Vice President, Global Life Sciences Technical Operations
Capgemini
Founder and Principal
RDG Group LLC
Managing Director
MH Consulting & Advisory GmbH
Senior Executive Consultant
Q-FINITY Quality Management
Managing Director
QFINITY 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
Technical Lead Optical Inspection
Johnson & Johnson Innovative Medicine
Director of Digital Realization for Pharmaceutical Sciences
Pfizer
Managing Director
JLL
Women in Pharma Liaison
Cofounder
Assurea
Executive Director, IT - Quality and Compliance
Gilead Sciences
Vice President, Corporate Quality
Syneos Health
CEO
The Triality Group, LLC
Product Manager
Körber Pharma Inspection
Head of Digital Operations
RoslinCT
Associate Director, Auditing, Global Development Quality Assurance
Regeneron
Senior Director, Biologics and Cell / Gene Therapies SME
PM Group
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, CMC and Quality Policy
Merck & Co Inc
Associate Principal Scientist
AstraZeneca
Senior Engineer
Arcadis
Head of General Medicine Engineering & Project Delivery
Sanofi
Technical Services Director
STERIS
Senior Consultant
Novo Nordisk
President
Guide Star Pharma
Senior Director of Engineering and Facilities
Nitto Denko Avecia, Inc.
Director QCORe (Quality, Compliance & Operational Readiness)
IPS - Integrated Project Services
Manager of Technology & Engineering
Nitto Denko Avecia
Consultant
Independent
Principal Commissioning, Qualification, and Validation Engineer
AST Inc.
VP of Technical Sales
AST, Inc.
Associate Director, OES Compliance
AbbVie Inc
Principal Process Engineer
Genentech, Inc.
Past Chair
Vice President 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 Sciences, CMC
Pfizer
Director Regulatory Affairs - CMC
Amgen Inc.
VP Engineering Services / Principal Consultant
Project Farma
Founder & Chief Quality Officer
Sware
Professor and Director
University of St.Gallen
Mechanical Engineer, Senior Specialist Quality Assurance
Retired
Software Quality Engineer
Kalleid
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
Senior Director, External Affairs, Regulatory Policy and Intelligence
Novo Nordisk
Principal Consultant
Epista Inc.
Executive Director, Regulatory Affairs-CMC
AstraZeneca
Retired Principal Consultant
Self Employed
Executive Director
Merck
Sustainability & Supply Chain Resiliency
Principal/Planner
Flad Architects
Head of Sustainability Operations
Zoetis
Associate Director, Environmental & Sustainability Lead
AstraZeneca
Global Lead, Site Engineering, Synthetics
Johnson & Johnson
Corporate Director Supply Chain
Endress+Hauser Group Services AG
Director, Environmental Health & Safety
Promega Corporation
Sustainability Services Delivery Lead
Burns & McDonnell
Global Lead Sustainable Design - Life Science and Pharmaceuticals Arcadis
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
Senior Director - Project Management
Project Farma
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
Director
Linesight
Vice President Procurement & Logistics
IPS
Executive Chair
SVP Head of Global Engineering
Takeda Pharmaceuticals International AG
Senior MSAT Scientist
Touchlight Genetics
Program Leader, DP Project
Johnson & Johnson
Senior Vice President
Clayco
Senior Fellow, Pharmaceutical Process| Sr. Associate
CRB
Head, Engineering Operations
Bayer
Director
Linesight
Founder & CEO
Eschbach NA
Project Manager
Bilfinger Life Science GmbH
Prn. Director, Regulatory and Validation Strategy
Cytiva
Board Liason
SVP Global Engineering, EHS & Sustainability
GSK
Associate Director - Biologics
STADA
VP, Global Business Development
Lisure Science
Senior Director Base Fractionation (BMW)
CSL Behring
Senior Principal Architect, Presales - Engineering
AVEVA
Senior Continuous Manufacturing (CM) Manager
USP
Industry Principal- Life Sciences
AVEVA
Segment Director - Life Science
Schneider Electric
Area Sales Director, North America
LOWENCO A/S
AVP, Global Capital Projects
Amgen Inc.
Head of Sustainability Global Engineering
Sanofi
Global Business Development Manager
Siemens Nv
CH & APAC Projects Lead - Engineering, Global Procurement
F. Hoffmann-La Roche AG