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BioProcess International US West
March 16-18, 2027
San Diego Convention CenterSan Diego, CA, USA
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Key Sessions
Chairperson's Opening Remark
Thomas Seewoester, Ph.D.
Speed Without Shortcuts: How AI is Transforming CMC and Validation at Amgen
Amgen
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Agenda March 16, 2027: Pre-Conference Workshop & Plenary - PT (Pacific Time, GMT-08:00)

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Agenda March 16, 2027: Pre-Conference Workshop & Plenary - PT (Pacific Time, GMT-08:00)
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Showing 1 of 1 Streams
8:00am - 8:55am
Pre-Conference Workshop Registration
Showing 3 of 3 Streams
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 10:30am
Tech transfer continues to be one of the most persistent bottlenecks in bioprocess development and manufacturing. Whether teams are transferring internally, moving programs across global networks, onboarding new partners, or shifting supply chains in response to geopolitical and onshoring pressures, the process remains too slow, too manual, and too vulnerable to rework. Comparability requirements, documentation gaps, site-fit issues, and misalignment between sending and receiving teams continue to add risk and delay. This half-day workshop will bring together development, MSAT, CMC, and manufacturing leaders to explore how companies are improving transfer readiness, reducing friction, and building more effective handoffs across sites and organizations. Through practical presentations and case studies, attendees will learn what strong transfer packages look like, how leading teams approach comparability and readiness by phase, and where digital tools can make transfer faster and more reliable.
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
Presentation Title: TBD
  • Nikita Tatwadhia - Scientist, AstraZeneca
9:30am - 10:00am
Challenges and Emerging Approaches in Upstream Process Development: Productivity, Product Quality, and Modeling
  • Gregory Keil - Scientific Director, Global Upstream and Cell Line Development, Bristol-Myers Squibb
10:00am - 10:30am
Presentation Title: TBD
  • Michael Coolbaugh - Head of Advanced Manufacturing Implementation, Sanofi
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
Organizations across bioprocess development and manufacturing are under pressure to act, but many are still wrestling with the same questions: Which use cases are actually delivering value? Why do so many digital initiatives stall? What data infrastructure is required before AI can work at scale? And how can companies move forward without investing in tools that become obsolete before they are fully deployed? This half-day workshop will focus on practical, presentation-based examples of where AI and digital workflows are improving productivity, reducing documentation burden, enhancing process understanding, and enabling faster decisions. It will also address the less glamorous but essential foundations of digital transformation, including data access, standards, governance, and workflow integration across development and manufacturing environments. As tools mature, the workshop will also address the workforce side of this shift: how organizations are upskilling staff, retaining institutional knowledge from an aging workforce nearing retirement, and building "human-in-the-loop" workflows rather than simply automating around people.
Showing 1 of 1 Streams
10:30am - 11:00am
Morning Refreshment Break
Showing 3 of 3 Streams
11:00am - 12:00pm
Tech transfer continues to be one of the most persistent bottlenecks in bioprocess development and manufacturing. Whether teams are transferring internally, moving programs across global networks, onboarding new partners, or shifting supply chains in response to geopolitical and onshoring pressures, the process remains too slow, too manual, and too vulnerable to rework. Comparability requirements, documentation gaps, site-fit issues, and misalignment between sending and receiving teams continue to add risk and delay. This half-day workshop will bring together development, MSAT, CMC, and manufacturing leaders to explore how companies are improving transfer readiness, reducing friction, and building more effective handoffs across sites and organizations. Through practical presentations and case studies, attendees will learn what strong transfer packages look like, how leading teams approach comparability and readiness by phase, and where digital tools can make transfer faster and more reliable.
12:00pm - 12:30pm
Panel Discussion - Intangible, Non-Technical Aspects of Transfers
11:00am - 11:30am
Smart Continuous Manufacturing of Biotherapeutics: Modeling, Analytics, and Control
  • Richard Braatz, Ph.D. - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
11:30am - 12:00pm
Orchestrating Continuous Purification Processes – Pilot Plant Case Studies
  • Chad Varner, Ph.D. - Associate Director, Sanofi
12:00pm - 12:30pm
Panel Discussion: Intensified Today, End-to-End Tomorrow? What's Really Standing in the Way?
11:00am - 12:00pm
Organizations across bioprocess development and manufacturing are under pressure to act, but many are still wrestling with the same questions: Which use cases are actually delivering value? Why do so many digital initiatives stall? What data infrastructure is required before AI can work at scale? And how can companies move forward without investing in tools that become obsolete before they are fully deployed? This half-day workshop will focus on practical, presentation-based examples of where AI and digital workflows are improving productivity, reducing documentation burden, enhancing process understanding, and enabling faster decisions. It will also address the less glamorous but essential foundations of digital transformation, including data access, standards, governance, and workflow integration across development and manufacturing environments. As tools mature, the workshop will also address the workforce side of this shift: how organizations are upskilling staff, retaining institutional knowledge from an aging workforce nearing retirement, and building "human-in-the-loop" workflows rather than simply automating around people.
12:00pm - 12:30pm
Panel Discussion - How do we make the AI advancements more accessible to the industry?
Showing 2 of 2 Streams
12:30pm - 1:00pm
Transition to Lunch Presentations
1:00pm - 1:45pm
Lunch 'n' Learn Presentations
1:45pm - 1:55pm
Networking Break
12:30pm - 1:55pm
BPI West Main Conference Registration
Showing 1 of 1 Streams
1:55pm - 2:00pm
Chairperson's Opening Remark
2:00pm - 2:45pm
Speed Without Shortcuts: How AI is Transforming CMC and Validation at Amgen
  • Thomas Seewoester, Ph.D. - Vice President, Site Operations, Amgen
2:45pm - 3:30pm
Keynote Plenary Session 2 - To Be Announced
3:30pm - 3:40pm
End of BPI WEST Plenary Session
NextAgenda March 17, 2027: Main Conference Day One
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