2020 ISPE Biopharmaceutical Manufacturing Conference

The 2020 Biopharmaceutical Manufacturing Conference will focus on innovation in facilities, production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply for the future.  This conference will bring together experts that are developing, implementing, and operating advanced supply chains providing high quality medicines to global markets. 

Program presentations will address challenges of new modalities, process, operational and facility innovations, and supply chain strategies bringing reliability, efficiency, and modernization for today's manufacturing and tomorrow's new therapies.  The conference will feature views and case studies by biopharmaceutical industry professionals, in additional to perspectives from regulatory officials.  Regulators will provide insights on CMC approaches, and CGMP developments for emerging technologies and individualized treatments.

Whether you are producing biologic drug substance, conducting sterile fill-finish operations, or entering into cell and gene therapy, this conference will provide the latest information to help your organization have the knowledge and agility needed to meet the needs of the patients we serve. 


Topics

  • Cell and Gene Therapies from Research to Clinical to Production
  • Emerging Technologies to Deliver Cell and Gene Therapies
  • Supply Chain Challenges and How the Industry is Meeting Them (including facility design & operations)
  • Monoclonal Antibodies (including ADCs) and Oligonucleotides
  • Harmonization: Regulatory, CMC, GMP
Women in Pharma Event

Join the conversation! This Women in Pharma® panel of biopharmaceutical leaders will share their insights on achieving and the value of gender balance in biopharmaceutical manufacturing. In addition, the event will include audience participation in breakout group discussions.

Note: This session is included with full conference registration.

Who Should Attend

  • Emerging Technologies Scientists and Professionals 
  • Bio Site Directors and above 
  • Operations managers 
  • Manufacturing, Quality Control and Quality Assurance heads 
  • Procurement professionals 
  • Engineering and Facility management heads 
  • Contract Manufacturing interface heads 
  • Key supply chain interfaces 
  • Process sciences, process development heads 
  • Global Regulatory Authorities involved in BLA, PAI, New Technologies 
  • Construction services, engineering services 
  • Suppliers (resins, media, etc.) 

All levels of experience will benefit from the presentations and opportunities for engagement to continue to shape the direction of the pharmaceutical industry


Learning Objectives

  • Explore the 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 production of personalized medicines. 

Program Committee 

Joseph C. Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, Inc.
Co-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
Darren M. Dasburg
Bio Executive
Self Employed
Christine M. V. Moore, PhD
Global Head and Executive Director, GRACS CMC Policy
Merck & Co.
David Doleski
Compliance Head for Biologics Quality Operations
Sanofi
Robert Dream, PE, CPIP
Principal
HDR Company LLC
Eric D. Felz
Associate Director Validation
Takeda Pharmaceutical Company Limited