Speakers
Meet Our Speakers
Keynotes
CEO and President
Pathway for Patient Health LLC
Sr. Vice President, Device & Packaging Operations Manufacturing
Eli Lilly and Company
Cancer Survivor & Research Advocate
Motivational Speaker
Chief Executive Officer
Lonza
Workshops
Head of Regulatory Compliance
Johnson & Johnson
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Vice President of Innovation
Marquis Energy
Director
Energy Efficiency Consultancy Ltd.
Senior Manager
Deloitte
Chief Product Officer
Valkit.Ai
Senior Director, CMC and Quality Policy
Merck & Co Inc
Founder and CEO
ProcellaRX
Board Liason
President
Genesis AEC
Manager CQV and Digital Validation EU
No Deviation
Past Chair
Senior Consultant
Novo Nordisk
Environmental Sustainability Strategy Manager
Pfizer
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
Digital, Data, and Decision Integrity
Director, Combination Product Development
AbbVie
Head of AI
CIMCON Software Inc
Operational Technology (OT) Compliance Lead
Takeda Pharmaceuticals International AG
Director, CMC Policy and Advocacy
Gsk
Chief Product Officer
Valkit.Ai
Director of Architecture and Innovation
Intuitive Surgical Inc
Engineering Manager - Pharma
Siemens
Managing Director
MH Consulting & Advisory GmbH
Managing Director
Q-FINITY Quality Management
Senior Executive Consultant
Q-FINITY Quality Management
IT/OT Connected Factory Business Partner
AstraZeneca
Executive Vice President, Managing Partner
Compliance Group Inc
Head of Statistics and Data Science
Genentech Inc
Vice President - Governance, Risk and Compliance
GSK UK
CEO
Infiligence
Director, Validation
Apotex
Global Head, Complex Devices and Drug Delivery Systems, RA CMC and Devices
AbbVie
CQV and Operational Readiness Lead
Alliance BIO
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
Principal/Planner
Flad Architects
Team Lead, Cytogenomics
Astellas
Process Engineering Manager | Vice President of ISPE Midwest Chapter
Burns & McDonnell
US Director, New Process Technology
Arcadis US
Global Process Science & Regulator Director
Fedegari
Chief Scientific Officer
Multiply Labs Inc
Emerging Leader
RA CMC Specialist
Astellas
Associate Principal Process Engineer
Lonza
Manufacturing Engineer
Micro Tube Fabricators
Vice President
Liquidia Corporation
Exubrion Therapeutics
CQV and Compliance Engineer III
IPS - Integrated Project Services
Director, Process Specialist
IPS
Sr. Process Specialist, GST
IPS - Integrated Project Services LLC
Scientific Director
Bristol Myers Squibb
Regulatory Review Scientist
FDA/CBER
Governance, Risk, and Readiness
Analyst
Shabas Solutions LLC
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Vice President, Compliance Operations
ProQuality Network
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
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
Partner
GXP-CC GmbH
Heads the Regulatory Compliance Solutions
Zifo Technologies
Senior QRM Consultant
ValSource
Senior AI Product Manager
Koerber Pharma Software, Inc.
Senior Consultant
Kuatro Group
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
Manufacturing Allstream Manager
AstraZeneca - 4601 IN-62 MOUNT VERNON, IN 47620 UNITED STATES
Vice President, Compliance Operations
ProQuality Network
Associate Director, Engineering
Merck & Co Inc
Senior Project Engineer
CRB
Head of Quality Compliance
BlueRock Therapeutics
Associate Director
Gilead Sciences Inc
CEO
PSC Biotech Corporation
Senior R&D Manager, Global Product Labeling
Beckton, Dickinson, and Company
Director Allstream Manufacturing
AstraZeneca
Vice President and Global People Director
Arcadis
Program Director, Strategy & Transformation
Syner-G
Senior Director of Education, Outreach and Digital Experience
Open Biopharma Research and Training Institute
Principal Process Engineer
Fluor Life Sciences
Business Development Manager
National Institute for Bioprocessing Research and Training (NIBRT)
Fellow Scientist of Continuous Tableting
Hovione L.L.C.
VP of CSV/CSA/DI & Digital Governance, Head of Chicago, & Local Equity Partner
PQE Group
Past Chair
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
Managing Director, Life Sciences
JLL
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
Process Engineer
Takeda
Senior Process Engineer
PM Group
Director of Business Development
Syntegon
Director Process/Specialty Engineer
Fluor
Associate Director - Safety, Health, Environment
AstraZeneca
Sector Development Manager - Pharmaceuticals
Spirax-Sarco Limited
Facilities Manager
Solvias
Vice President | Industrial Water Treatment & Optimization
Arcadis US, Inc.
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