ISPE 2017 Biopharmaceutical Manufacturing Conference

Education Program

Taking capacity expansion to the next level

Operationalize your investments with innovative strategies and technologies designed to speed time to launch.

Why attend? High-value topics to implement right away:

  • Benchmarking strategies for improving time to market
  • Effective approaches for managing multi-product production
  • Latest Developments in Biopharmaceutical Research
  • Balancing CMO vs. internal capabilities
  • Developing & Commercializing Biosimilars
  • Supply chain risk mitigation
  • Considerations for implementing new technologies
  • Updates on advanced therapeutics - CAR T and Personalized Cancer Vaccines
  • Insights into innovative company cultures and strategies for engineering human competency
  • New approaches in control strategy, continuous manufacturing, and managing contamination risks

Agenda Expand all

Monday 4 December

Keynote Presentation: Facility Engineering Capacity Challenge - Taking Capacity to the Next Level
Joydeep Ganguly, Vice President - Engineering, Facilities & Operations, Gilead Sciences

Keynote Presentation: The Journey from Start-up
Timothy Moore, Executive Vice President, Technical Operations, Kite Pharma

Engineering Human Competency – A Key Factor in Operational Agility
Richard Tree, Vice President, Commissioning Agents, Inc.

Tech Transfer Excellence and Efficiency
Ben Hughes, Director Clinical Operations, Patheon

Cold Chain Infrastructure and Risk Mitigation: Facing the Wall
Bill Collingwood, Head of Supply Chain, Biologics, MedImmune/AstraZeneca

Moving to Single-Use: The Impact on Agility (Singapore Project)
Robert Bader, Senior Manager, Jacobs Engineering

Addressing Flexible, Multi-product Manufacturing of Biopharmaceuticals
Jeffrey Odum, Global Technology Partner, Strategic Manufacturing, NNE

Lessons Learned and Current Strategies in Bio Manufacturing
Sally Dyer, Head of Manufacturing, Boulder Manufacturing Center, MedImmune

Five Products in Six Months at 15K
Miriam Anderson, Biogen

Integrity is Insufficient - Proving Process Equipment Closure is Complicated
Andre Walker, Principal, Andre Walker Consulting

 


Tuesday 5 December

Keynote Presentation: Working with CMOs to Maximize Operational Agility
Timothy Tyson, CEO, Avara

Overcoming Barriers to Innovation: Risks and Rewards Festo
Strategies to Speed Post Approval Changes – ICH Q12
Kowid Ho, PhD, Pharma Technical Regulatory Policy, Roche-Genentech

Control Strategy, CPV, and Licensure
Sharif Ahmed, PhD, Associate Director, Bayer HealthCare, Invited

Leveraging Platform Knowledge to Streamline and Improve Process Parameter Classification and Control
Kristi Griffiths, PhD, Sr Research Advisor, Statistics, Eli Lilly

Tech Transfer Challenges Unique to CMO Relationships
Paul Jorjorian, Global Director, Technology Transfer, Patheon

Continuous Biopharmaceutical Manufacturing
Christoph Herwig, PhD, Institute of Chemical Engineering, Austria

Addressing Production and QC Challenges for Bioactive Protein Domains and Multi-Protein Complexes
James R. Swartz, PhD, Professor of Chemical Engineering and of Bioengineering, Stanford University

Process Strategies for Rapid Response and Highly Resource-Constrained Scenarios
Karen McDonald, Professor of Chemical Engineering, University of California-Davis Towards Engineering

Scalable and Defined Systems for Stem Cell Manufacturing
David Schaffer, Professor of Chemical and Biomolecular Engineering, Bioengineering, and Neuroscience, University of California-Berkeley

The Importance of Analytics in Determining Similarity
Florian Wolschin, Head of Physicochemical Characterization/ Technical Development Biosimilars, Novartis BTDM/ Hexal AG

Biosimilars Analytics
Xu-Rong Jiang, PhD, MD, Director, MedImmune, Invited

USP Standards
Fouad Atouf, PhD, Vice President, Science-Global Biologics , United States Pharmacopeial Convention, Invited
Earl Dye, Director of CMC Regulatory Policy, Genentech (A Member of the Roche Group)


Wednesday 6 December

Keynote Presentation: Manufacturing Advanced Therapeutics
Robert Baffi, PhD, Executive Vice President of Technical Operations, BioMarin

Keynote Presentation: FDA Perspective: Developing a Safe Efficacious and Quality Product
Thomas Finn, PhD, Office of Tissues and Advanced Therapies, FDA/CBER/OTAT/DCGT/CTB

Unique Aspects in Commercializing CAR T Therapy
Spencer Fisk, VP & Global Head Cell & Gene Technical Development & Manufacturing, Novartis

Industry Perspective: Regulatory Aspects in Developing Personalized Cancer Vaccines
Kathleen Francissen, PhD, Senior Director, CMC Regulatory, Genentech (A Member of the Roche Group)

Regulatory and Industry Panel

Moderator: Stuart E. Builder, PhD

  • Spencer Fisk, VP & Global Head Cell & Gene Technical Development & Manufacturing, Novartis
  • Robert Baffi, PhD, Executive Vice President of Technical Operations, BioMarin
  • Thomas Finn, PhD, Associate Director for Regulatory Policy, Office of Vaccines Research and Review, FDA/CBER
  • Kathleen Francissen, PhD, Senior Director, CMC Regulatory, Genentech (A Member of the Roche Group)
  • David Schaffer, PhD, Professor of Chemical and Biomolecular Engineering, Bioengineering, and Neuroscience, University of California-Berkeley

Who should attend?

  • Bio Site Director 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 such as GE, Fisher et al
  • Process sciences, process development heads
  • Global Regulatory Authorities involved in (BLA, PAI, New Technologies)
  • Construction services, engineering services
  • Suppliers (resins, media, etc.)

Event Sponsors

Register Early!

Register before 1 October to take advantage of the early bird rate and save!


Keynote Speakers

Joydeep Ganguly Photograph
Facility Engineering Capacity Challenge - Taking Capacity to the Next Level
Joydeep Ganguly
Vice President, Engineering, Facilities & Operations
Gilead Sciences
Timothy Moore Photograph
The Journey from Start-up
Timothy Moore
Executive Vice President, Technical Operations
Kite Pharma
Timothy Tyson Photograph
Working with CMOs to Maximize Operational Agility
Timothy Tyson
CEO, Avara
Robert Baffi Photograph
Manufacturing Advanced Therapeutics
Robert Baffi, PhD
Executive Vice President Technical Operations
BioMarin Pharmaceutical
Thomas Finn Photograph
FDA Perspective: Developing a Safe Efficacious and Quality Product
Thomas Finn, PhD
Office of Tissues and Advanced Therapies FDA/CBER/OTAT/DCGT/CTB

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Presentations & Attendee Roster

Conference Attendees: