2020 ISPE Biopharmaceutical Manufacturing Virtual Conference

Jun 1, 2020 ‐ Jun 2, 2020


Learning Objectives

  • Explore case studies in process development and equipment design for profitable and sustainable manufacturing. 
  • Gain awareness of the changing landscape of cell and gene therapy development, testing, and commercialization. 
  • Learn about innovations in facility design and operations, and strategies for collaboration between manufacturers and regulators. 
  • Implement best practices used by CDMOs in non-traditional biopharma processes. 
  • Understand the supply chain risks and challenges associated with the production of personalized medicines.


Sessions

Challenges and Opportunities in the Manufacturing of New Treatment Modalities

Jun 1, 2020 9:00am ‐ Jun 1, 2020 10:30am

This year, the 2020 ISPE Biopharmaceutical Manufacturing Conference will focus on advances in manufacturing, facilities, and analytics important to bring new therapies to patients. Now more than ever, manufacturing is on the critical path as many new treatments in the area of personalized medicines and individualized batch production present the challenge to bring these medicines through rapid development, reliable manufacturing, and availability to patients a pace with the advances clinical research is bringing to address unmet needs. At the same time, biosimilars are advancing with the opportunity to provide more access to medicines. In this opening session, we will hear an important regulatory perspective from FDA on gene therapy drug development and a reflection from industry on 10 years on Biosimilars.

Moderator(s):
  • Joseph Famulare, Conference Chair, VP Global Compliance & External Collaboration, Genentech, A Member of the Roche Group
Speaker(s):
  • Tim Howard, PE, CPIP, Interim CEO & President, ISPE
  • Tom Hartman, CEO & President, ISPE
  • Eric Felz, Associate Director Validation, Takeda Pharmaceutical Company
  • Carol Lynch, President, Head-North America, Sandoz US
  • Wilson Bryan, MD, Director, Office of Tissues and Advanced Therapies, FDA/CBER, CBER/FDA

Planning, Building and Operating Cell and Gene Therapy Facilities (Part I)

Jun 1, 2020 10:45am ‐ Jun 1, 2020 12:15pm

Many cell and gene therapy facilities are in different phases of planning, construction, and expansion. Learn from experts in engineering and manufacturing about how these facilities are progressing. This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.

Moderator(s): Speaker(s):

Pharma 4.0: What it is, What it isn’t and How to Implement it

Jun 1, 2020 10:45am ‐ Jun 1, 2020 12:15pm

Trying to figure out what Pharma 4.0 is and what it means to your business? This session will clarify what Pharma 4.0 is and offer practical aspects of how it has been implemented in the plant and what it means to your workforce.

Moderator(s):
  • Eric Felz, Associate Director Validation, Takeda Pharmaceutical Company
Speaker(s):

Planning, Building and Operating Cell and Gene Therapy Facilities (Part II)

Jun 1, 2020 12:45pm ‐ Jun 1, 2020 2:15pm

Many cell and gene therapy facilities are in different phases of planning, construction, and expansion. Learn from experts in engineering and manufacturing about how these facilities are progressing. This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.

Moderator(s): Speaker(s):

Application of ICH Q12 Principles in Modern CMC Submissions

Jun 1, 2020 12:45pm ‐ Jun 1, 2020 2:15pm

This session brings together industry and regulatory agency representatives to discuss case studies involving the implementation of ICH Q12 principles in regulatory submissions to facilitate post-approval CMC changes in an efficient and predictable manner.

Moderator/Speaker(s): Speaker(s):
  • Nina Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen
  • Michael Cohen, PhD, Research Fellow - Global Chemistry, Manufacturing, and Controls, Pfizer Worldwide R&D

Cell and Gene Therapy CMC and Manufacturing: Ensuring the Analysis, Production and Quality

Jun 1, 2020 2:30pm ‐ Jun 1, 2020 4:00pm

Robust and cost-effective viral vector characterization and manufacturing presents a core challenge in the commercialization of gene therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures. Gene Therapy CMC and Manufacturing examines the critical challenges facing the production, characterization and quality control of vector-based gene therapies, with dedicated sessions on rapid CMC development, product and process characterization, upstream and downstream bioprocessing and considerations for large-scale manufacturing.

Moderator(s): Speaker(s):
  • James Warren, VP, Pharmaceutical Development, Ultragenyx Pharmaceutical Inc.
  • Kathleen Francissen, PhD, Senior Director, Pharma Technical Regulatory, Genentech, A Member of the Roche Group
  • Monica Commerford, PhD, Manager of Regulatory Affairs, Brammer Bio

Technology Advancements for Drug Product Manufacturing

Jun 1, 2020 2:30pm ‐ Jun 1, 2020 4:00pm

This session will discuss technology advances related to the manufacturing of biologic drug products of different dosage forms. Technologies and case studies to be discussed include low temperature sealing of container closures and continuous aseptic spray freeze-drying.

Moderator(s):
  • Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.
Speaker(s):
  • Qingyu Zeng, PhD, Fellow & Technical Director, West Pharmaceutical Services
  • Laura Moody, PhD, Product Manager - Primary Packaging, Pharma Liquid Packaging, Syntegon Pharma Technology
  • Joshua Stauffer, Director, Drug Product Manufacturing System Design & Commercialization, Merck & Co., Inc.

Increased Automation and Digitalization in Manufacturing

Jun 1, 2020 4:15pm ‐ Jun 1, 2020 5:45pm

Computer systems have continued to help manage complexity involved in biopharmaceutical manufacturing. Such systems have evolved in ways previously not anticipated. This session will explore some of the evolving uses of computer systems to allow a greater focus on product quality.

Moderator(s):
  • David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
Speaker(s):
  • Bruce Kane, PE, Life Science Industry Consultant, Rockwell Automation
  • Michael Shanno, Head of Digital, Biologics Corporate Quality, Sanofi
  • Martin Mayer, Business Development Smart Engineering Services & Digitalization, ZETA GmbH

Practical Challenges with Quality System Management in Cell and Gene Therapies

Jun 1, 2020 4:15pm ‐ Jun 1, 2020 5:45pm

This session will focus on the challenges with the establishment of quality oversight and systems from the initial patient interface through manufacturing and supply for cell and gene therapies. Experience with the application of cGMPs in the hospital setting will be discussed as well as the conflicting priorities when multiple companies are imposing different demands on the same institutions, notably as these controls are part of the approved applications. The efforts to harmonize standards globally, as well as the regulator experience in determining true compliance risks will be addressed.

Moderator(s): Speaker(s):
  • Ekaterina Allen, PhD, Regulatory Project Manager and CMC Facilities Reviewer, CBER/FDA
  • Luciana Mansolelli, Director, Operations & Strategic Planning, Novartis
  • Lina Ertle, Head of External Relations EMEA and Japan, F. Hoffmann-La Roche Ltd.

Regulatory Updates on Biotechnological and Biologic Products

Jun 2, 2020 9:00am ‐ Jun 2, 2020 10:30am

Regulatory expectations related to biotechnology and biological products are continually evolving both within mature and emerging regulatory agencies. This session will provide a snapshot of recent regulatory changes across the global landscape. Invited speakers will provide a sampling of some of the recent regulatory responses related to the ongoing COVID-19 pandemic, discuss the rapidly evolving regulatory landscape in China, and highlight some of the recent trends related to sterile products in the United States.

Moderator(s):
  • Christine Moore, PhD, Global Head and Executive Director, GRACS CMC Policy, Merck & Co., Inc.
Speaker(s):
  • Joseph Famulare, Conference Chair, VP Global Compliance & External Collaboration, Genentech, A Member of the Roche Group
  • Richard Friedman, Deputy Director, Science & Regulatory Policy, CDER/FDA
  • Lawrence Hill, PharmD, CEO, Gan & Lee Pharmaceuticals USA
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