ISPE 2016 Biopharmaceutical Manufacturing Conference

Biotech therapies are comprising a greater portion of the pipelines and approvals of New Molecular Entities by global health authorities – adding to this are the approvals of biosimilars and programs to access these medicines in developing countries.  This unprecedented growth makes the 2016 Biopharmaceutical Manufacturing Conference a must-attend conference for anyone who is addressing the challenges and opportunities facing the biopharmaceutical manufacturing sector.

Sessions will explore:

  • How will development, licensing, and manufacturing of biotech therapies from a global regulation and industry perspective be impacted?
  • What are the expectations as the industry has not only matured but now is embarking on a large growth curve?
  • Will global regulatory authorities align on regulatory expectations that encourage sustainable innovations in biotherapeutic manufacturing?
  • What are the emerging health authority expectations as new treatments with unique supply chain and manufacturing needs emerge?
  • Are efforts on regulatory harmonization in ICH, WHO, PIC/s working to support the approval and lifecycle management of biotech therapies?

In addition to addressing the questions above, the 2016 Biopharmaceutical Manufacturing Conference will explore:

  • Regulatory expectations for preapproval inspections
  • Licensing
  • New technologies
  • Lifecycle management
  • Ongoing expectations
  • Emerging trends

Session Highlight:

Join us for a two-part panel discussion on addressing the lifecycle management of biopharmaceutical manufacturing featuring a regulatory perspective in part one and a view from pharmaceutical companies who are embarking on the challenges and opportunities by forging forward with biopharmaceutical manufacturing.

Part 1

  • Wednesday, 7 December 8:30 – 10:00
  • Leader: Joseph Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
  • Speakers:
    • FDA Perspective on Pre-Approval Inspection, New Developments in Biotech PAI Inspections, Common Findings and Factors leading to Success
      David Doleski, Deputy Director (Acting), OPF, FDA/CDER/OPQ/OPF, USA
    • FDA Perspective on Implementing Emerging Technologies in Biopharma, How to Best Approach the Agency, Factors for Success
      Joslyn Brunelle, PhD, Product Quality Team Leader (Lead Biologist), FDA/CDER/OPQ/OBP/DBRRIV, USA

Part 2

  • Wednesday, 7 December 10:30 – 12:30
  • Leader: Joseph Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
  • Speakers:
    • Licensing Biosimilars vs New Molecular Entities: A Regulatory Introduction
      Jonathan Harris, Director Regulatory MedI BioVentures, MedImmune/AstraZeneca, USA
    • From CMC to GMP, Manufacturing for Multiple Markets and the Challenge Meeting the Various Requirements
      Jennifer Cheung, Director, Head of GMP Compliance Audit, Americas and Asia Pacific, Global Quality Compliance and External Collaboration (PTQG), Genentech/Roche, USA
    • Enabling Global Lifecycle Innovation for Biopharmaceutical Manufacturing, Regulatory Convergence Efforts, and Unique Considerations for Biosimilars
      Roger Nosal, PhD, Vice President & Head, Global Chemistry, Manufacturing & Controls, Pfizer Inc., USA
  • Rounding out this session will be an interactive panel discussion featuring the speakers from part one and two addressing questions from the audience.

Don’t miss out the 2016 Biopharmaceutical Manufacturing Conference 5 -7 December 2016 in San Francisco, CA USA.

Register - ISPE 2016 Facilities of the Future Conference

By:  Joe Famulare, Chair, ISPE Board of Directors