2020 ISPE Biopharmaceutical Manufacturing Virtual Conference

Thank You for Making this Virtual Conference a Huge Success!

The 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference delivered engaging presentations and case studies on cutting-edge topics with many opportunities to gain insights from top industry professionals. Check out the content below to get insights from the conference.


Reflections on the Growing Momentum for Biosimilars in the US

This year marked the ten-year anniversary of the Biologics Price Competition and Innovation Act. Hear from Carol Lynch, President, US and Head North America, Sandoz, as she reflects on the growing momentum for biosimilars in the US during her keynote presentation at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


An Overview of the Design Approach Used to Establish a New Manufacturing Suite to Support Cell and Gene Therapy

Hear from Edward Stevens, Manager of Capital Products, GSK, as he gives an overview of the design approach used to establish a new manufacturing suite to support cell and gene therapy, specifically viral vector manufacturing, during the session "Planning, Building and Operating Cell and Gene Therapy Facilities (Part I)" at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


Manufacturers Are Challenged to Design and Construct Optimal Facilities for the Production of Cell Therapies

Watch now as Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB, shares a simulation of a gowning room to stress the importance of leveraging operational simulations during the session "Planning, Building and Operating Cell and Gene Therapy Facilities (Part I)" at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


Have You Discussed Using Machine Learning Approaches with Any Health Authorities and If So, How Receptive Have They Been?

Hear what Joshua Stauffer, Director, Drug Product Manufacturing System Design & Commercialization, Merck, has to say when he is asked this question by moderator and fellow colleague Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck, during the session “Technology Advancements for Drug Product Manufacturing” at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


What Are Quality and Regulatory Considerations for POD (Portable on Demand) Manufacturing?

Hear from Maria Hoffman, Executive Director, Engineering, Merck, as she discusses quality and regulatory considerations for POD (Portable On Demand) manufacturing during the session “Innovation in Technological Platforms in Biopharmaceutical Manufacturing” at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


How Is Limited Customization a Con for Single-Use Technology at a Commercial Scale?

Hear from Lindsay Smart, Business Development Manager UK, Ireland, North America, ZETA GmbH, and Darren Dasburg, PE, CEO, TreeCo Inc., comment on the view of limited customization being a con for single-use technology at a commercial scale during the "Single-Use Technology Strategies" session at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


Are There Any Good Practices from Regions Such as China or South Korea on How to Gain a Trained Workforce?

Watch Now: Manfred Maeder, PhD, Head Device Development & Commercialization, Novartis, and Lindsey Silva, Ph.D., Senior Manager, Microbiology Global QC Technology, Genentech, answer this question during the session “Preparing for the Workforce Needs in Biopharma Manufacturing” at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference.


A Snapshot of Recent Regulatory Changes across the Global Landscape

Regulatory expectations related to biotechnology and biological products are continually evolving both within mature and emerging regulatory agencies. Watch now to hear from the Conference Chair Joseph Famulare, Vice President, Global Quality Compliance and External Relations, Genentech, as he presents on COVID-19 regulatory responses.


Teaser Talks

  • Regulatory presence at ispe event
  • Annual Meeting & Expo Highlights
  • Breen

Conference Highlights


Program Committee 

Joseph C. Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, A Member of the Roche Group
Chair
Vivianne J. Arencibia
Independent Consultant
Arencibia Quality Compliance Associates
Board Ambassador
Antonio R. Moreira, PhD
Vice Provost, Academic Affairs
University of Maryland, Baltimore County
Andre L. Walker, CPIP
Principal
Walker BioPharm Consulting
Stephen C. Mahoney, JD
Senior Director, Global Quality & Compliance
Genentech, A Member of the Roche Group
Christine M. V. Moore, PhD
Global Head and Executive Director, GRACS CMC Policy
Merck & Co, Inc.
David Doleski
Compliance Head for Biologics Quality Operations
Sanofi
Robert Dream, PE, CPIP
Principal
HDR Company LLC
Eric D. Felz
Associate Director Engineering Quality Systems
Takeda Pharmaceutical Company Limited