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Keynote Speakers

Robert M. Califf, MD
Commissioner of Food and Drugs
FDA
Pam Cheng
Executive VP of Global Operations & IT, Chief Sustainability Officer
AstraZeneca
Flavius Martin
Executive Vice President of Research
Gilead Sciences
Judy Chou
President and CEO
AltruBio, Inc.
Kyle Haraldsen
Chief Technology Officer
Lyndra Therapeutics
Celia Lourenco
Associate Assistant Deputy Minister
Health Canada
David Churchward
Global Head Sterility Assurance, Cell and Gene Technologies
Lonza Biologics

Global Regulatory Town Hall Speakers

David Churchward
Global Head Sterility Assurance, Cell and Gene Technologies
Lonza Biologics
Paul A. Gustafson
2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor
Regulatory Operations and Enforcement Branch (ROEB), Health Canada
Evdokia Korakianiti
Head of Quality and Safety of Medicines
EMA
Celia Lourenco
Associate Assistant Deputy Minister
Health Canada
Mahesh R. Ramanadham, Pharm.D./M.B.A.
Deputy Director
FDA/CDER/OPQ/OPPQ
Vimal Sachdeva
GMP Inspector (Technical Officer)
World Health Organization
Varley Dias Sousa
Directorate Senior Adviser
Anvisa

Advanced Therapies - Advanced Manufacturing Speakers

Nino Adamo
Vice President and General Manager
Turner Construction Co
Dominic Baca
Manager, Global Manufacturing Science & Technology
Genetech
Adam J. Barlow
Rincipal and Founder
Baseline Controls, Inc
Sal Ceja
Principal, Architect, AIA, LEED AP
EwingCole
Nissan Cohen
Owner
Biopharmaceutical Water Doc
Roderick T. Freeman
Associate Director, Quality Engineering
Kite Pharma, Inc.
Gregory R. Gara
Vice President of Pharmaceutical Engineering
Sarepta Therapeutics
Giacomo Girotto
Product Owner - Vision Inspection Systems
Stevanato Group
James V. Green
Director Platform Engineering
Bayer
Emily Heffernan, PE
US Director, New Process Technology
Arcadis DPS Group
Drew Johnston
Vice President Site Engineering
Bayer
Austin G. Lock
Technical Director, Group Head of Technology
PM Group
Placeholder Person Graphic
Mark R. Melilli
Cell & Gene Therapy Advanced Manufacturing Lead
Vertex Pharmaceuticals
Nima Payan
Chief Operating Officer
SPIN Biotech Consulting LLC
Chad M. Salisbury, MBA
Senior Vice President
Project Farma
Gene Russell
Senior Director, Head of Engineering
WuXi Biologics
Andrew Slusser
Senior Director of Architecture/ Process Architecture SME
PM Group
Tyler C. Underhill
Biologics & Cell / Gene Therapies SME
PM Group
Laura Whelan
Executive Vice President, Project Management Services
Savills North America
Anders Widov, M Sc Chem Eng
Sales Director
BWT Pharma & Biotech AB
Aaron Allen
Director, Global Quality
Moderna Therapeutics
Melisa Arslantepe
QA Specialist
Bachem AG
Erich H. Bozenhardt
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Peter W. Cramer
Principle Process Architect/SME
Jacobs Engineering
Zhimei Du
Vice President
Landmark Bio
John Easson
MS&T Process Science Leader
Spark Therapeutics, Inc.
Charles A. Heffernan
Director of Advanced Therapies and Biologics
PM Group
Mao-shih Liang
MS&T Process Science Principal
Spark Therapeutics, Inc.
Francesca A. McBride
Director, Regulatory Compliance
Jacobs , Life Sciences
Todd A. Rumsey
Senior Process Engineer
Jacobs Engineering Group Inc
George Todorov
Senior Process Specialist
IPS
Julie Vickers
Process Subject Matter Expert
Jacobs Engineering Group Inc

Digital Transformation Speakers

John Brezovec
Analytics Engineer
Seeq Corporation
Vincent Gerber
Digital Strategy Delivery Lead
F. Hoffmann-La Roche
Daniele Iacovelli
CDO/Global Head of Digital, Analytics & Operational Excellence
F. Hoffmann-La Roche
Philipp Kläsle
VP MES & Process Management
Körber Pharma Switzerland GmbH
Laura Kuger
PhD Candidate
Karlsruhe Institute of Technology (KIT)
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Tatum O'Kennedy
Analytics Engineer
Seeq Corporation
Christian Woelbeling
Executive Industry Advisor
Körber Pharma Software GmbH
Chris Clark
Director
TenTenTen Consulting Limited
Rene-Pascal Fischer
Scientist & Software Architect
Fraunhofer IESE
Rod Hoffman
IT/OT Connected Factory Business Partner
AstraZeneca
Khaled Moussally
Executive Vice President Clients & Regulatory Relations
Compliance Group Inc
Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
NNE
Veronika Nindl
Senior MS&T Engineer
VTU Engineering GmbH
Andrew Palm
Director, Integrated Process Analytics
Pfizer
Hubertus Rehbaum
Managing Director
Dr. Rehbaum Technology Consulting GmbH
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences
Jason Spiegler
SVP Strategy, Sales & Marketing
Compliance Group
Josef Trapl
Head of Innovation in Life Science
Heather D. Watson
Director
TenTenTen Consulting Ltd
Christian Woelbeling
Executive Industry Advisor
Körber Pharma Software GmbH
Sion Wyn
Director
Conformity Ltd.
Matthew Ryan Beu
Senior Project Engineer
Datamura Solutions Llc
Kevin Hynes
Head: Business Intelligence & Digitalization
AstraZeneca
Paige E. Kane, PhD, CPIP
Director Knowledge Management
MERCK & CO (US)
Chad Kellner
Sr. Director - Site Operations
AstraZeneca
Bruce Klopfenstein
CQV SME
MMR Engineering
Mehron Mirian
Director, Project Services
MMR Consulting
Tatum O'Kennedy
Analytics Engineer
Seeq Corporation
Eric J. Staib
Head of Quality
Validated Cloud
David M.W. Staunton
Director, Global Managed Services
Cognizant (Zenith Technologies)
Brandi M. Stockton
Co-Founder and Principal Consultant
The Triality Group LLC

Manufacturing - Quality Control - Operational Excellence Speakers

Jose A. Caraballo
VP Quality Systems, Compliance, and Quality Engineering
Kite Pharma, Inc.
Placeholder Person Graphic
Jennifer Eichenberg
Instructional Designer
The Sparks Group
Norman A. Goldschmidt
President
Genesis AEC
Stephen M. Hall
Chief Process Engineer
Genesis AEC
Christine Holbrook
Senior Process Engineer
Center for Breakthrough Medicines
Timothy W. Lisle
Sr. Director of Process Architecture
Precis Engineering, Inc.
Jeffery N. Odum, CPIP
Practice Leader: ATMPs & Biologics
Genesis AEC
Martin Orcoyen
President | ISPE Argentina Affiliate (2021-2025) ||| Director De Operaciones
Qualipharma
Kristina Pumphrey
Chapter President
ISPE Delaware Valley Chapter
David Raab
Senior Process Engineer
Genesis AEC
Matthew H. Snyder
Director, Engineering & Facilities
Center for Breakthrough Medicines
Omair Ahmed
Chief Operating Officer
Nexus Pharmaceuticals LLC
Pär O. Almhem
President
ModWave
Dante Amatangelo
Executive Consultant
PQE Group
Keith E. Bader
Vice President, Cleaning Science & Laboratory Services
Hyde Engineering + Consulting Inc
Joanne R. Barrick, RPh
Sr. Director TS/MS Validation
Eli Lilly and Company
Robert A. Brady
Director, Engineering Project Management WP MMD
Merck & Co
Andrew J. Brewer
Principal Engineer, MSAT
Genentech Inc
Daniel L. D'Aquila, PE
Sr. Director, Mfg Operations
GlaxoSmithKline
Leslie M. Edwards, MSE
Vice President, Technology & Business Development
Skan US
Harald Erös
Lead of Refrigeration, Cooling and Heat-Pump Technologies
Takeda
Gregory Groberman
Sr. Facilities Engineer
Takeda
Babak Haghiri
Vice President of Manufacturing - Site Head Los Angeles
Takeda Pharmaceutical
Placeholder Person Graphic
Kenneth M. Hamilton, PhD
Director Process Engineering
Genentech Inc
Daisuke Hirasawa
Digital & Engineering Dept.
Chugai Pharmaceutical Co Ltd
Richard Sanderson
Regional Operations Director
IPS - Integrated Project Services
Brian K. Smith
Director, Project Management
SKAN US, Inc.
Nathan W. Temple
CQV Business Area Leader
CAI
Behzad Torabifar
Sr. Dir Head of Sustainable Operations
Genentech
Paul F. Valerio
Director of Process Technology / Senior Associate
IPS - Integrated Project Services, LLC
Placeholder Person Graphic
Geoffrey Wing
Principal Mechanical Engineer
Genentech, Inc.
Shermeen Abbas
Director, Process Development
Amgen Inc.
Stephen Crowley
Associate Principal Scientist, Oral Formulation Sciences
Merck
 
Rachelle Howard, PhD
Director of Manufacturing Automation and Digital Strategy
Vertex Pharmaceuticals, Inc.
Amanat Kaur
Bioprocess Engineer
Hyde Engineering & Consulting
Justin McGarvey
BMS Team Lead Engineer
AstraZeneca
Geoffrey Pot
General Manager Operations - Site Head
Takeda
Richard Steiner
Senior Manager Business Strategy
Pharmatech Associates
Anthony S. Tantuccio
Fellow Scientist
Hovione (Formerly With Merck & Co Inc.)
Hamid Teimourian
Energy Program (Sustainability) Lead
AstraZeneca

Regulatory - Compliance - Quality Speakers

John G. Groskoph
Executive Director, Global CMC
Pfizer
Diane L. Hustead
Executive Director, Regulatory Affairs
Merck & Co., Inc.
Christine M. V. Moore, PhD
Executive Director, Quality Systems & Compliance
Organon LLC
Kevin O'Donnell, PhD
Market Compliance Manager
Health Products Regulatory Authority (HPRA)
Ciby Abraham, PhD
Senior Director and Group Manager, Project and Product Leadership
AstraZeneca
Marquerita Algorri, PhD
Manager - Global Regulatory Affairs CMC
Amgen Inc
Lori-Anne Boville
Group Director, Pharma Technical Regulatory, Device and Combination Products
Genentech Inc.
Nina S. Cauchon, PhD
Director Regulatory Affairs - CMC
Amgen Inc.
Sheetal Gaiki
Associate Director
Janssen RND
Paul A. Gustafson
2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor
Regulatory Operations and Enforcement Branch (ROEB), Health Canada
Steven Hertz, MBA, PE
Consumer Safety Officer, Office of Pharmaceutical Quality
CDER/FDA
Robert L. Iser, M.S.
Vice President, Quality Policy and Advocacy (VP)
Pharma Technical Quality & Compliance (PTQ), Genentech/Roche
Christine M. V. Moore, PhD
Executive Director, Quality Systems & Compliance
Organon LLC
Susan W. Neadle, FRAPS, FAAO
President
Combination Products Consulting Services LLC
Roger Nosal
Head of Global Regulatory Strategy and Submissions
NGT Biopharma
Susan E. Polifko, Commander
PharmD, RAC-US
USFDA- FDA/CDER/OPQ/OPMA
James Wabby
Global Head, Regulatory Affairs
AbbVie, Inc.
Maotang Zhou
Branch Chief
FDA
Maria Amaya
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Sherri Boucher
Senior Scientific Evaluator, Vaccine Quality Division 2
Health Canada
Andrew Denny
Senior Director, Governance & Performance Management
Bristol-Myers Squibb
Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence
Perrigo
Michael Grischeau
Director of Data Analytics & Management Review
AbbVie Inc
Connie Langer
Director, CMC - Global Regulatory
Pfizer
Sarah C. Pope Miksinski, PhD
Executive Director, CMC Regulatory Affairs
Gilead Sciences, Inc.
Christine M. V. Moore, PhD
Executive Director, Quality Systems & Compliance
Organon LLC
Tara Scherder
Principal
SynoloStats
Benjamin Stevens
Director of CMC Policy and Advocacy
GlaxoSmithKline
Mahesh R. Ramanadham, Pharm.D./M.B.A.
Deputy Director
FDA/CDER/OPQ/OPPQ
Marcus Yambot
Senior Consumer Safety Officer
FDA/CDER/OPQ/OQS
Eli Zavialov, PhD
Senior Director
GlaxoSmithKline

Supply Chain Resiliency Speakers

Robert Battista
BLA Filing Transport Validation Expert
Modality Solutions
Jie Chen, Ph.D.
Principle Research Scientist
AbbVie
Chelsea Coffey, MSc, MBA, PMP
Clinical Drug Supply
Biogen
Monica Dias, PhD
Head of Supply and Availability of Medicines and Medical Devices
EMA
Ylva Ek
Founder
Robur Life Science Advisory AB
Lynne Ensor
SVP, Head of Global Strategic Compliance Consulting
PAREXEL International
Kedar Gokhale
Director
Serum Institute of Idia PVT, Ltd.
Luis Hernandez
Associate Director of Logitics
Vertex Pharmaceuticals
Diane L. Hustead
Executive Director, Regulatory Affairs
Merck & Co., Inc.
Philip R. Lyman, PhD
Director of Process Simulation
Arcadis DPS Group
Patricia M. Melton, PhD
Managing Director
Mime Solutions Ltd.
Wolfgang PHILIPP
Head of Unit Intelligence and Innovation
EUROPEAN COMMISSION
Gregory Rullo
Senior Director, Regulatory Affairs-CMC
AstraZeneca
Henal Shah
Head of the European Lab Centre of Excellence (CoE) Practice
Cognizant Technology Solutions
Emily Thakur, CDR
Team Leader, Drug Shortages Staff
FDA
John D. Wass, CPIP
Head, Engineering Operations - Pharma
Baxter Healthcare Corporation
Aaron Weinstein
Senior Director, Compliance Consulting
IPS – Integrated Project Services, LLC
Andy Wilkinson
Aseptic Fill Finish SME
Carina Dolan
Associate Vice President
Vizient
Lindsey E. Daniel, PE
Product Operations Program Manager
Takeda
Jeff Davis
Executive Director & Site Head
Genentech
James Michael Fries
CEO
Rx-360
Michael J. Greening
Head of Project Delivery US
Genentech Inc
Steven Lucio
Senior Principal
Vizient
Mittal Sutaria
Senior Vice President
Vizient
Erica Torres
Head of Global Launch Excellence
Takeda