Speakers
Meet Our Speakers
Keynotes
Senior Vice President, Head of Global Quality Compliance and Systems
Takeda
Head of Institute Surveillance
Austrian Agency for Health and Food Safety (AGES)
Vice President, Operations Commercialization
Amgen
Group Vice President, API & Dry Products Manufacturing
Eli Lilly and Company
Accelerating Biopharma with AI & ML: From Discovery to Delivery
Group Manager
RoviSys
Quality & Compliance Manager
Aizon
Founder
BioGrasp GmbH
Regulatory Affairs Specialist
Asahi Intecc USA
Founder & CEO
Theos-CES GmbH
Founder, CEO
Redica Systems
Team Lead II, Quantitative Sciences
Moderna
Process Intensification, Continuous Manufacturing, Sustainability
Process Engineering Department Manager
Arcadis
European Director of Process Technology
Arcadis
Senior Fellow, Purification Bioprocess
CRB
Fellow | Simulation, Modeling & CFD | Associate
CRB
CCO
Sepragen Corporation
Founder and CEO/ CTO
Sepragen Corporation
Senior Engineer
Hitachi, Ltd.
Regional Sales Manager
Stilmas Americas
Implementing Digital Initiatives in the Biopharmaceutical Industry - Where are we on the Road Map?
Computer Systems Validation Director
Trinity Life Sciences - ADVENT Engineering
Leader, Empower Software
Waters Corporation
CTO
InflexionPoint LLC
Senior Automation Engineer
Trinity Life Sciences – Aztec Consulting
Associate Director, Business Development & Licensing Program Manager
Takeda
Senior Director
TCG Digital Solutions LLC
Director of Product Operations
Takeda
Associate Director
Bristol Myers Squibb
Biomanufacturing Facility Lifecycle: Progress, Trends and Challenges
HVAC/Building Service Manager
Wood
Global Pharma Chief Technology Leader
Wood Plc
Process Architecture SME
Barry-Wehmiller Design Group
Vice President of Strategy
Project Farma
Director of Architecture / Process Architect SME
PM Group
Director of Business Development
Syntegon
Director, Process Architecture
CRB
Vice President & Site Head, Gene Therapy Manufacturing Facility
Ultragenyx Pharmaceutical Inc
Architect & Independent Consultant
CGMA, Incorporated
Sr. Manager, Process Engineering
Takeda
Director, Process Architect
IPS
Global Technical Services
Pfizer
Sr. Manager, Manufacturing
Alnylam Pharmaceuticals
Analytical Enhanced Quality
Executive Director, Pharmacokinetics
Merck
Manager Technical Services
STERIS
Senior Technical Services Associate
Steris
Operational Readiness and Cultural Excellence
Dean College of Professional Studies
Northeastern University
Global Project Manager
Moderna
Chief Technical Officer
Sequence Inc
Associate Director
AstraZeneca
Director of MSAT Downstream, Biomanufacturing
Millipore Sigma
Women in Pharma®
Head of Quality Services and Improvement, Takeda MA Biological Operations
Takeda
Director
Merck & Co Inc
Global Head of Operational Excellence, Biologics Network
Takeda
Senior Director of Business Development
Genesis AEC
Business Development Lead
DPR Construction
Business Development Executive
Withum
Director, Manufacturing
Takeda Lexington MA
Chapter President
ISPE Delaware Valley Chapter
Director Project Management
Takeda Pharmaceuticals Inc.
Industry Panel: Global Harmonization of the Drug Approval Process
Global Head of Group Smart Manufacturing
Merck KGaA Darmstadt, Germany
Technology Manager Biotechnology
CRB Group GmbH
Senior Director, US Regulatory Policy
US Pharmacopeia
Site Quality Head, Clinical INT
Moderna Therapeutics
Women in Pharma® Liaison
CEO & Founder
JahvanMed Advisors
Executive Director, Regulatory CMC
Pfizer
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences