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General Session Speakers

Sharmista Chatterjee, PhD
Division Director
FDA, OPMA
Francesco Cicirello
Senior Director, Quality Compliance BioNTainer
BioNTech US Inc.
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Rene-Pascal Fischer
Scientist & Software Architect
Fraunhofer IESE
Robert S. Langer, PhD
Institute Professor
Massachusetts Institute of Technology
Piper Trelstad, PhD
Head of Chemistry, Manufacturing & Controls
Bill & Melinda Gates Medical Research Institute

Track 1: Lean & Green: Innovation & Technologies in Sustainability

Alexander Mitropoulos, Ph.D., MBA
Director, Franchise Portfolio Management, PFAS Focus
MilliporeSigma
Robin Newman
CQV Lead
Core Services Group
Thomas Page, PhD
Vice President, Engineering and Asset Development
Fujifilm Diosynth Biotechnologies
Alexis Parrillo
Investigator, Biopharmaceutical Process Development
GSK
Marc P. Pelletier, PhD
Director
CRB
Jeffery N. Odum, CPIP
Practice Leader: ATMPs & Biologics
Genesis AEC
Todd L. Troutman
Director - Engineering
AstraZeneca

Track 2: Quality Culture within the Quality Management Maturity (QMM) Framework

Matteo BERNASCONI
Research Associate & PhD Student
University of St.Gallen
Thomas Friedli, PhD
Professor and Director
University of St.Gallen
Bright S. Gnanaselvam
HEAD QUALITY ASSURANCE
Quest NUTRA/PHARMA
Jahanvi Miller
Amgen Inc
Marla A. Phillips, PhD
CEO and President
Pathway for Patient Health LLC
Christine Teipen Smith
Executive Director - Global Quality Systems
Eli Lilly And Company
John Spenn
Director
Dorset Quality Services (DQS) Ltd
Hugo Ta
Gilead Sciences

Track 3: Data Science-Assisted Biopharmaceutical Tech Transfer & Process Characterization

Christoph Herwig, PhD
Senior Scientific Advisor
Körber Pharma Austria
Scott Tran
Boehringer Ingelheim
Ted Webb
Digital Enablement of Clinical Bioprocessing
GSK

Track 4: Novel Technology Innovations in Advanced Manufacturing

Daniel Becker
Head of Business Development INACTIVATE
KyooBe Tech GmbH
Robert Dream, PE, CPIP, PhD
Managing Director
HDR COMPANY LLC
Zhimei Du
Vice President
Landmark Bio
Komal Hatti
Director, Process Architect
IPS
David C. O'Connell
Project Manager
Verista, Inc
Julian Petersen
Head of Business Development and Product Management
Groninger & Co GmbH
Robert Reefe, PhD
Chief Development Officer
BlueSphere Bio

Track 5: Lifecycle Strategies for Acceleration of Commercialization

Peter Blennerhassett
CEO
Blynksolve
Lenora Dieyi
Process Engineer - Investigator
GSK
Sebastian Scheler
Managing Director
Innerspace GmbH
Mihaela C. Simianu, PhD
VP of R&D and Operations
Singota Solutions
Thomas Zahel, PhD
Head of Innovation
Körber Pharma Austria GmbH

 

Track 6: Challenges and Trends in Biopharmaceutical Facility Design

Steve Chapman
Partner
Barry-Wehmiller Design Group
Sydney Hamilton
Strategic Facility Planner
CRB
John Hatzis
Global Life Sciences Consultant
Rockwell Automation - Marlboro MA
Emily Heffernan, PE
US Director, New Process Technology
Arcadis US
Scott McNallan
Director of Architectural Design
CRB
Robert O'Keeffe
Director (Engineering Tech Centre)
Eli Lilly
Marc P. Pelletier, PhD
Director
CRB
Gil Stevens
Executive Director, Global Engineering
Ultragenyx Pharmaceutical Inc
William G. Whitford
Strategic Solutions Leader
Arcadis