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Special thanks to the ISPE San Francisco Bay Area Chapter for serving as Host Chapter for this event.

Launch Readiness: Operational Agility for Today’s Challenges

Speed time to launch with innovative operational and process development approaches. Learn from and network with biopharmaceutical colleagues from C-suite executives to academic experts and production professionals.

3 Comprehensive Education Tracks:

  • Launch Readiness
  • Operational Agility
  • Advanced Therapeutics

View Education Agenda

Biopharmaceutical Leadership ForumAdd the Biopharmaceutical Leadership Forum, Sunday 3 December, to your registration for even more savings!

Your Bio Experience Includes:

  • Two and a half days of Regulatory and Industry Interaction
  • Keynote Thought Leaders from Kite Pharma, Gilead Sciences, BioMarin, Avara, and FDA
  • Experts from industry pharma and device, academic research, and regulatory agencies
  • Amgen
  • Astra Zeneca
  • Avara
  • Bayer
  • Biogen
  • BioMarin
  • Eli Lilly and Company
  • Commissioning Agents, Inc.
  • FDA - CBER and CDER
  • Festo
  • Genentech (A Member of the Roche Group)
  • Gilead Sciences
  • Institute of Chemical Engineering, Austria
  • Jacobs Engineering
  • Kite Pharma
  • Massachusetts Institute of Technology (MIT)
  • M+W Central Europe GmbH
  • MedImmune/AstraZeneca
  • NNE
  • Novartis
  • Patheon part of Thermo Fisher Scientific
  • Public Health England
  • Roche-Genentech
  • Stanford University
  • Takeda
  • United States Pharmacopeia
  • University of California – Berkeley
  • University of California – Davis
  • University of Maryland – Baltimore County

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

Tour Just Added! BioMarin Research Center

BioMarin Research CenterWednesday, December 6 1245 - 1730  

The BioMarin Research Center opened in 2016, and is the newest research laboratory located at the company’s San Rafael, CA headquarters. The 85,000 square-foot facility is central to the fast-growing company's pipeline of treatments for rare diseases and disorders. While on the tour, guests can see several pre-clinical labs ranging from Bioanalytical development to the general research functions and research stage bioprocess.

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Group Discount

Discounted rates apply for groups of 3 or more. See Registration page for more information.

Program Committee

Conference Co-Chairs

Jennifer Lauria Clark photograph

Jennifer Lauria Clark, CPIP
Executive Director, Strategic Development
Commissioning Agents, Inc.

Andre Walker photograph

Andre Walker, CPIP
Andre Walker Consulting

Program Committee Members

Joseph Famulare photograph

Joseph Famulare
Vice President, Global Compliance
Genentech (A member of the Roche group)

Andrew Skibo photograph

Andrew Skibo
Head of Global Biologics Operations & Engineering

Antonio Moreira photograph

Antonio Moreira, PhD,
Vice Provost
University of Maryland, Baltimore County

Darren Dasburg photograph

Darren Dasburg
Vice President and Site Head, Boulder Manufacturing Center

Britt Petty photograph

Britt Petty
Senior Director of Site Operations

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