Speakers
Meet Our Speakers
Keynotes
Chief Executive Officer
Lonza
Sr. Vice President, Device & Packaging Operations Manufacturing
Eli Lilly and Company
CEO and President
Pathway for Patient Health LLC
Cancer Survivor & Research Advocate
Motivational Speaker
Digital, Data, and Decision Integrity
Director, Combination Product Development
AbbVie
Head of AI
CIMCON Software Inc
CEO
Valkit.Ai
Operational Technology (OT) Compliance Lead
Takeda Pharmaceuticals International AG
Director, CMC Policy and Advocacy
GSK
Chief Product Officer
Valkit.Ai
CTO
AuraGXP
Engineering Manager - Pharma
Siemens
Managing Director
MH Consulting & Advisory GmbH
Managing Director
QFINITY Quality Management
Senior Executive Consultant
Q-FINITY Quality Management
IT/OT Connected Factory Business Partner
AstraZeneca
Executive Vice President, Managing Partner
Compliance Group Inc
Deputy Director
Head of Statistics and Data Science
Genentech Inc
Vice President - Governance, Risk and Compliance
GSK UK
Director: Automation & OT
Merck
CEO
Infiligence
Director, Validation
Apotex
Global Head, Complex Devices and Drug Delivery Systems, RA CMC and Devices
AbbVie
Founder and Owner
DayOne Pharma Consulting
Executive Industry Advisor
Körber Pharma Software GmbH
Scientist (AI Automation and Statistics)
Apotex Inc.
From Breakthrough to Bedside
Director of Construction & Workplace Experience
Promega Corporation
Manager Technical Services
STERIS
Principal/Planner
Flad Architects
Process Group Lead Engineer and Associate
IPS
Team Lead, Cytogenomics
Astellas
Process Engineering Manager | Vice President of ISPE Midwest Chapter
Burns & McDonnell
Associate Director, Quality Operations
Lonza Biologics Inc
US Director, New Process Technology
Arcadis US
Global Process Science & Regulator Director
Fedegari
Chief Scientific Officer
Multiply Labs Inc
Regulatory Lead, RA CMC
Astellas
Sr. Director of Commercialization and TSMS
Elanco Animal Health
Vice President
Liquidia Corporation
COO
Exubrion Therapeutics
Director, Process Specialist
IPS
Associate Director (Regulatory Policy)
CBER/FDA
Scientific Director
Bristol Myers Squibb
Regulatory Review Scientist
FDA/CBER
Governance, Risk, and Readiness
CMC Regulatory Affairs Manager
Amgen
Analyst
Shabas Solutions LLC
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Director - Engineering Validation
Pfizer
Director Regulatory Affairs - CMC
Amgen Inc.
Executive Director Quality, Regeneron Cell Medicines
Regeneron
CEO
PSC Biotech Corporation
Associate Director Innovation, Regulatory, R&D Quality, Patient Safety
Merck KGaA
Conference Chair
Technology Manager Biotechnology
CRB Group GmbH
Vice President, Quality
PAI Pharma
Director of Data Analytics & Management Review
AbbVie Inc
Associate Director-US & Global Regulatory Affairs
Merck & Co Inc
Senior Associate
Shabas Solutions LLC
Senior Principal Scientist
J&J
Founder
Umk Consulting GmbH
Heads the Regulatory Compliance Solutions
Zifo Technologies
Director of the Office of Quality Surveillance
OPQ/CDER/FDA
Senior QRM Consultant
ValSource
Senior AI Product Manager
Koerber Pharma Software, Inc.
Senior Consultant
Kuatro Group
Team Leader, Drug Shortages Staff
FDA
Vice President, Head of Regulatory Affairs
AbbVie, Inc.
VP of CSV/CSA/DI & Digital Governance, Head of Chicago, & Local Equity Partner
PQE Group
Co-founder & President
GessNet
People, Capability, and the Workforce of Delivery
Area Sales Manager
Burkert Fluid Control Systems
Vice President, Compliance Operations
ProQuality Network
Associate Director, Engineering
Merck & Co Inc
Global Director, Operational Readiness & Excellence
CAI
Senior Project Engineer
CRB
Head of Quality Compliance
BlueRock Therapeutics
Associate Director
Gilead Sciences Inc
CEO
PSC Biotech Corporation
Vice President and Global People Director
Arcadis
Sr. Director, AI & Digital Innovation
Vera Therapeutics
Program Director, Strategy & Transformation
Syner-G
Senior Director of Education, Outreach and Digital Experience
Open Biopharma Research and Training Institute
Consultant
Global Light Enterprise LLC
Senior Architect
Fluor Life Sciences
VP Operations
Real Estate Vertex Pharmaceuticals
Business Development Manager
National Institute for Bioprocessing Research and Training (NIBRT)
Fellow Scientist of Continuous Tableting
Hovione LLC
VP of CSV/CSA/DI & Digital Governance, Head of Chicago, & Local Equity Partner
PQE Group
Vice President of Engineering
Daichi Mechanical
AI/ML Compliance Team Lead
Hoffmann-La Roche Limited
Vice President External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Systems That Deliver Reliably – Carbon, Sustainability & Business Case
Sr Strategic Account Manager - Pharmaceuticals
Spirax Sarco
Site Sustainability Lead & Site Energy Manager
Bayer U.S., LLC
Managing Principal, Science & Technology
WB Engineers+Consultants
Director, CMC Policy and Advocacy
GSK
Associate Director Program Management
Lonza
Process/Specialty Engineer
Fluor Enterprises
Senior Process & Specialty Engineer
Fluor
Director, QC Design Lead
Eli Lilly and Co
Process Engineer
Takeda
Senior Principal Scientist
J&J
Senior Process Engineer
PM Group
Director of Business Development
Syntegon
Director Process/Specialty Engineer
Fluor
Chief Platform Architect
Blue Mountain
Associate Director - Safety, Health, Environment
AstraZeneca
Sector Development Manager - Pharmaceuticals
Spirax-Sarco Limited
Facilities Manager
Solvias North America LLC
Global Sustainability Manager
Fluor Life Sciences
Fellow and Lead Process Utilities Engineer
CRB Group GmbH
Lab Planner
Flad Architects
Site Sustainability Lead
AstraZeneca
Project Architect
Flad Architects
Global CapEx Procurement Manager
AstraZeneca
Senior Project Manager, Mechanical
WB Engineers + Consultants
Facility of the Year Awards (FOYA) Category Winners Showcase
SVP Head of Global Engineering
Takeda Pharmaceuticals International AG
Project Director
AstraZeneca
Engineering Project Manager
AstraZeneca
Senior Fellow, Pharmaceutical Process| Sr. Associate
CRB
SVP Global Pharma Engineering & Maintenance Excellence Lead
Bayer AG
Vice President Global Engineering
Pfizer Inc
Sustainability Manager
Takeda Manufacturing Austria AG
Head of Sales - Technical Business Development
BSP Pharmaceuticals
AVP, Global Capital Projects
Amgen Inc.
Senior Vice President
Shenzhen Hepalink Pharmaceutical Co., Ltd.
Interactive Workshops
Head of Regulatory Compliance
Johnson & Johnson
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Director
Energy Efficiency Consultancy Ltd.
Senior Vice President, Quality and Compliance Practice
ELIQUENT Life Sciences
Operational Technology (OT) Compliance Lead
Takeda Pharmaceuticals International AG
Chief Product Officer
Valkit.Ai
Director, Enterprise Project Staff
CDER/OPQ/OQA/PMS - FDA
Senior Director, CMC and Quality Policy
Merck & Co Inc
Founder and CEO
ProcellaRX
Board Liaison
President
Genesis AEC
Scientific Director, Regulatory Affairs
Novo Nordisk
Technical Evangelist
Perforce
Manager CQV and Digital Validation EU
No Deviation
Global Director, Quality
CAI
Senior Consultant
Novo Nordisk
CEO & Founder
JahvanMed Advisors
Associate Director - Global Engineering Assurance
AbbVie, Inc.
CEO and President
Pathway for Patient Health LLC
US Strategic Operation Director
PQE Group
Founder and Owner
DayOne Pharma Consulting
Senior Solution Validation Engineer
Kneat
Sponsored Sessions
Senior Business Development Executive
Autodesk
Associate, Manufacturing Operations Technology Solutions
Pfizer
Principal, Computational Design
Arcadis
Director of Operations, Life Sciences
ARCO Design/Build
Industry Principal- Life Sciences
AVEVA
Client Relations Manager
Area Sales Director, North America
Lowenco A/S
Area Sales Director, North America
LOWENCO A/S
Industry Manager - Life Science
Endress+Hauser
Segment President, Consumer Packaged Goods
Schneider Electric
US Director Process Architecture
Arcadis