Speakers
Meet Our Speakers
Keynotes
International Board Liaison/Foundation Board Liaison
Vice President, Head of Quality Auditing and Risk Management
Lonza AG
Deputy Director, Office of Manufacturing Quality
FDA/CDER
Senior Vice President for Regulatory Compliance
Eliquent Life Sciences
Advanced Therapy Medicinal Products (ATMPs)
Biopharma Executive
Senior Industry Advisor and Principal Consultant for Advanced Therapies
Koerber Pharma Software Inc
Head of Engineering
Andelyn Biosciences
Senior Director of Manufacturing Operations
Rengenxbio
Head of IT
NecstGen
Principal Consultant, Technical Services
Steris Corp.
Manager Manufacturing Operations
REGENXBIO
Associate Director QA Microbiology
Regeneron Pharmaceuticals, Inc.
Annex 1 – Case Studies & Misc.
Environmental QA Senior Technical Manager
Genentech/Roche
Director of Business Development
GBA Life Sciences
Director Tech Ops and Bridgeton MFG
Kindeva Drug Delivery
Head of Technical Services
Jubilant HollisterStier
Executive Director US Sales
SKAN US, Inc.
CEO & Founder
Steed MicroBio LLC / JYA
Product Manager
Tema Sinergie
Director
C&E Solutions BV
Process Expert
Siegfried Hameln
Isolator Design
Digital Solutions Manager
SKAN AG
Director of Product Management Pharma, North America
Syntegon Pharma Technology
Senior Scientist GMP Compliance
Franz Ziel GmbH
CEO
Afton Scientific
Associate Director- Aseptic Processing
Terumo Pharmaceutical Services GmbH
Component Quality
R&D Manager and Process Specialist
De Lama SpA
Director, Technical Product Development
West Pharmaceutical Services
Strategy and Technical Affairs
Gerresheimer AG
Project Manager
Stevanato Group
Manager of MSAT (Manager of Manufacturing Science and Technology)
Grand River Aseptic Manufacturing
Facility Design
Sr Director - Facilities, Utilities, and Capital Projects
Eli Lilly Italia SpA
VP Quality and Regulatory
Argonaut Manufacturing Services
Assoc Dir Mfg
Genzyme
Director Sales Turnkey
Optima Pharma GmbH
Radiopharma High Potent
Process Engineer
CRB
Senior Process Engineering Manager
Pharmascience
Business Development Manager
Koerber Pharma
Sr VP of Technical Sales
Custom Powder Systems
Senior Business Development Manager
University of Iowa Pharmaceuticals
Airflow Testing
MSc
Bausch+Ströbel SE + Co. KG
R&D Engineer
Bausch+Ströbel SE + Co. KG
Associate Director, Drug Product Manufacturing Department
Kyowa Kirin Co., Ltd.
QA Manager
Chugai Pharma Manufacturing Co., Ltd.
Scientist and Modeling & Simulation Lead
Johnson & Johnson
Expert
JGC JAPAN Corporation
Manager
DAIICHI SANKYO CO., LTD.
Sen. Director Pharma Excellence
Syntegon Technology GmbH
Sterile Processing
Sr. Director of Process Technology
IPS - Integrated Project Services, LLC
Misc. Case Studies
General Management - Head of Engineering
Siegfried Hameln
Sr. Sterility Assurance Adviser
Cytiva
Co-founder & CEO
White Raven