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Introduction
The Golden State played host to some of the sharpest minds in biopharma as the 12th annual American Biomanufacturing Summit unfolded over two powerful days at the Hyatt Regency San Francisco Airport in San Francisco, California. Guided by our exceptional emcees, Kara Renai King (VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development @ Zoetis), Paul Houri (SVP and Chief Quality Officer @ Bristol Myers Squibb), Laura Alquist (SVP and Global Head, Technical Operations @ Kite Pharma), and Blair McNeill, PH.D. (SVP and Head, Cell Therapy @ Sumitomo Pharma)—This year’s summit was filled with impactful sessions, actionable workshops, and invaluable takeaways that attendees, sponsors, and speakers alike will carry with them throughout their careers.
With four session tracks, including Manufacturing & Technology, Quality & Compliance, Supply Chain & Logistics, and Cell and Gene Therapy, attendees were offered a robust selection of sessions, workshops, keynotes, plenaries, and panels to gain knowledge from.
Table of Contents
Day 1 Highlights
Launching the Summit with Visionary Leadership and Industry Insight
The day opened with a compelling keynote from Rao Mantri, Chief Manufacturing Officer at Astellas Pharma, in conversation with Fraiser Kansteiner of Fierce Pharma. Together, they explored how organizations can synchronize multi-modality development with manufacturing excellence—blending agility, quality, and scalable infrastructure into a cohesive, end-to-end strategy. Building on this foundation, Paul Houri, SVP and Chief Quality Officer at Bristol Myers Squibb, delivered a powerful plenary on transforming quality from a regulatory necessity into a true competitive advantage, emphasizing culture, accountability, and innovation at scale.
The conversation then widened into a dynamic, multi-perspective plenary featuring Adam Pfeiffer and Jim Watson of Project Farma, alongside Sarah Hinchin of Gilead Sciences and Oliver Hesse of Bayer. Their discussion tackled the realities of facility strategy in an unpredictable market, from modular design and capital risk mitigation to smarter “make vs. buy” decisions.
Following a lively networking break, the summit transitioned into focused sessions that brought strategy down to execution. Judy Chou, President and CEO of AltruBio, shared insights on scaling clinical-stage biotech operations, while Stelios Tsinontides of Merck & Co., Inc. unpacked how evolving FDA expectations are reshaping quality management systems. In parallel, Thomas Spitznagel of MacroGenics explored the complexities of building resilient supply chains for ADCs, and Harish Santhanam of Bristol Myers Squibb returned the focus to innovation in autologous cell therapy manufacturing.
As the morning progressed into interactive workshops, the emphasis shifted to practical transformation—featuring hands-on perspectives from Havior, Jacobs, Bluecrux, and USDM Life Sciences. From overcoming stalled transformation efforts to accelerating commissioning timelines and embedding AI-driven quality systems, the sessions grounded the morning’s strategic vision in actionable, real-world execution—setting a collaborative and forward-thinking tone for the rest of the summit.
As the morning sessions gave way to lunch, the energy shifted into a more intimate and conversational setting. Over the Lunch & Learn roundtables, attendees gathered for focused discussions, exchanging ideas and real-world challenges with peers across the industry. Conversations were shaped by insights from organizations including Rentschler BioPharma Inc., Afton Scientific, Cytiva, Resilience, PBS Biotech Inc, Bionova Scientific, Singota Solutions, AbbVie, Avid Bioservices, Oxford Biomedica (OXB), Novartis, Honeywell, A-Life - A Google X Moonshot, Mareana, ZS, Katalyze AI, and Boston Institute of Biotechnology.
After a series of powerful sessions, the summit transitioned into an extended break for refreshments and networking. Attendees took the opportunity to engage in pre-arranged 1-2-1 meetings, continue discussions sparked by the plenaries, and connect with partners to explore actionable next steps.
Afternoon Discussions Spotlight the Path from Innovation to Impact
The afternoon resumed with a renewed sense of focus as attendees filtered back into the sessions, ready to translate the morning’s big ideas into tangible execution. Sumitra Angepat, VP of Global Biologic Drug Substance at Bayer, set the tone by sharing a transformation journey rooted in agility—where global teams, dynamic ownership models, and flexible infrastructure are redefining how quickly therapies can reach patients. Alongside this, Farah Fawaz, SVP of Quality and Compliance at Allogene Therapeutics, reinforced the importance of embedding quality across the entire product lifecycle, ensuring that innovation never comes at the expense of consistency or compliance. The conversation extended into supply chain and innovation, where Sheena Behn of AstraZeneca explored how advanced therapies are pushing organizations to rethink global supply strategies, while Andy Lin of Genentech bridged the often complex gap between CMC, clinical development, and commercialization in the rapidly evolving cell and gene therapy space.
As the day progressed, the summit once again shifted into interactive workshops, where innovation met application. Sessions led by Yokogawa, Rapid Micro Biosystems, FUJIFILM Diosynth Biotechnologies, and Asimov brought forward practical approaches to digital transformation—from autonomous bioprocessing and paperless QC environments to flexible supply chain models and AI-driven biologics production. The energy carried seamlessly into the afternoon networking break, where conversations deepened over shared challenges, new partnerships, and the collective ambition to modernize biomanufacturing.
Returning to the main stage, Brid Rooney of Rentschler BioPharma Inc., delivered a thoughtful plenary on the evolving role of quality, not just as a regulatory function, but as a true client partner.
This set the stage for a dynamic closing panel featuring leaders, including Laura Alquist of Kite Pharma, Maria Brown of Bristol Myers Squibb, Ben Beneski of Allogene Therapeutics, Andy Ramelmeier of Adverum Biotechnologies, Karin Ann Payne of Johnson & Johnson, and Rahul Kaushik of Disc Medicine. Together, they explored how the industry is navigating the path from innovation to execution, balancing agility with standardization, integrating digital tools like AI and digital twins, and building the talent needed to sustain the next generation of biomanufacturing.
As the Chair’s closing remarks brought the day to a close, the afternoon left attendees not only with new ideas but with a clearer vision of how to turn innovation into impact.
Day 2 Highlights
Empowering Leadership and Accelerating Transformation
Day two of the summit began with a sense of purpose that was both reflective and forward-looking, as the early morning Empower Hour brought together an inspiring group of women leaders shaping the future of biomanufacturing. Voices like Jessica Shen of Takeda, Manisha Desai of Bristol Myers Squibb, Kara Renai King of Zoetis, Keñya Edmondson of Pfizer, Karin Ann Payne of Johnson & Johnson, and Stacy Springs of Massachusetts Institute of Technology shared candid reflections on leadership, resilience, and the responsibility of empowering the next generation. Their stories set a powerful and personal tone for the day ahead. This momentum carried into the Chair’s opening remarks, where our emcees framed the day’s themes across manufacturing, quality, supply chain, and cell and gene therapy.
The morning keynote from Daniele Iacovelli, SVP and Global Head of Digital Technology Pharma Medicines at F. Hoffmann-La Roche AG, brought a unifying message around culture as the engine of innovation. He painted a clear picture of how high-performance teams, when aligned with digital transformation and scientific advancement, can unlock scalable operations and sustain competitive advantage. This vision was reinforced in the following plenary, where Bryan Ennis of Sware and Jeff Brittain of Bayer explored how AI and automation are reshaping validation in a digital era.
As attendees moved into the workshop sessions, the focus turned toward applied innovation, with hands-on discussions led by PBS Biotech, Lonza, Bionova Scientific, Mettler-Toledo, and Wacker Biotech. These sessions grounded the morning’s themes in practical execution, from enabling consistent CMC strategies and scaling custom media manufacturing to unlocking new efficiencies through digitalization and advanced measurement technologies.
After a lively networking break, the summit returned to structured sessions where Ben Beneski of Allogene Therapeutics explored next-generation CAR-T manufacturing platforms, while Jessica Shen, M.D. of Takeda, revisited the stage to emphasize the importance of integrating quality, clinical, and regulatory strategy across the lifecycle. The momentum continued across parallel tracks, with Kelley Brna of Merck reframing packaging as a strategic lever for resilience and patient-centric delivery, and Xiling Song of BeOne Medicines highlighting how regulatory CMC alignment can accelerate global development timelines.
The late-morning workshops—featuring insights from Arcwood Environmental, ZS Associates, and Araymondlife SASU—once again brought a practical lens to topics like scalability, AI-enabled workflows, and contamination control, before the final set of sessions carried the conversation into digital transformation and operational excellence.
Following the workshops, leaders, including Lisa McEvoy of Merck, Tiffany Cavallaro of Amgen, Rajiv Mahajan of Exelixis, and Stacy Springs, tied together themes of data-driven manufacturing, supply chain transformation, and the growing importance of analytical readiness. By the time the morning transitioned toward lunch, attendees had not only explored the future of biomanufacturing but also gained a clearer understanding of how to operationalize it at scale.
The conversations continued naturally into the Lunch & Learn Roundtables, where attendees joined company-hosted discussions from Myrtelle, Amgen, BioMarin Pharmaceutical, Moderna, Bristol Myers Squibb, Genentech, AstraZeneca, BeOne Medicines, Gilead, and Disc Medicine.
By the final stretch of the afternoon, the summit’s energy shifted once again as attendees moved back into session rooms for the last round of content-rich discussions. Fabian Gerlinghaus, Co-Founder & CEO of Cellares, led a session on delivering commercial-ready cell therapies and standardizing automation-native facility design across the US, EU, and Japan.
As the summit came to a close, a special thanks to the dedicated chairs who helped guide and shape the conversations throughout both days. Kara Renai King of Zoetis, Keñya Edmondson of Pfizer, Laura Alquist of Kite Pharma, and Blair McNeill, PH.D., of Sumitomo Pharma. As the final chair’s remarks concluded and the survey prize was awarded, the event then transitioned into the Thank You Reception, where attendees gathered for one final opportunity to network, reconnect, and continue the conversations sparked throughout the summit.
Conclusion
As the American Biomanufacturing Summit came to a close, one message stood above the rest: the future of biomanufacturing will belong to organizations bold enough to embrace transformation. From AI-driven quality systems and digitally connected manufacturing to scalable cell and gene therapy platforms and resilient global supply chains, the discussions throughout the summit made it clear that the industry is entering a new era—one defined by agility, collaboration, and accelerated innovation.
Whether it was leaders sharing how they are scaling next-generation therapies, modernizing validation and compliance, or rethinking operational models to meet growing patient demand, the summit showcased an industry actively building the future in real time. The conversations were not just about what’s possible—they were about what’s already happening across the biomanufacturing landscape today.
If you missed this year’s American Biomanufacturing Summit, you missed more than a conference. You missed a front-row seat to the ideas, partnerships, and technologies shaping the next generation of biopharmaceutical manufacturing.
The good news? The conversation is only just beginning. Learn more about future events and what’s ahead at biomanamerica.com
Until next time — keep innovating, keep scaling, and keep pushing the future of biomanufacturing forward.
Testimonials
“It was a great conference with just the right balance of vendors and speakers. The content was pertinent to the challenges that we all face in the industry.”
- John Ruesch, Chief Technical Operations Officer @ Biocryst
“It was a great experience! I really enjoyed meeting with all these companies and seeing the latest technologies and solutions. The speakers' transparency and the opportunity to benchmark were incredible! I especially loved the Women in Leadership panel.”
- Fatou Diagne, Director of Operations @ Sanofi
“Excellent conference with very talented speakers. Presentations were practical, informative, and provided real examples and guidance vs a high-level overview. Will plan to attend again!”
- Jounal Shaikh, Exec Director Cell Therapy Global Supply Chain @ Bristol Myers Squibb
“This is my first time attending this conference. The agenda items are packed with up-to-date trends and new technology. I really enjoyed my time spent here.”
- Ming Aquila, Quality Director @ Ionis Pharmaceuticals
“The Summit was exceptionally well-organized, featuring a thoughtful selection of relevant topics. The high energy levels kept attendees fully engaged throughout the event. Most importantly, I found the networking opportunities invaluable and successfully established connections with several new suppliers.”
- Lewis Tsai, Director, Value Chain Management @ Merck
“Good experience overall. I really enjoyed the talks and found them engaging and insightful. They provided valuable exposure to current industry trends and helped deepen my understanding of where the field is heading.”
- Yunzhi (Sophie) Xiao, Director @ 89bio/Genentech
“Great experience as it was informative from the speaker sharing their knowledge and productive from the one-to-one network meetings.”
- George Shi, Associate Director, External Manufacturing @ Disc Medicine
“This experience has proven to be highly informative and insightful. It is particularly valuable to gain an understanding of our industry partners and their strategies for integrating advanced technologies.”
- Zarna Patel, Director, Quality System @ Abcuro
Learn more about our upcoming 2026 North American events, and secure your spot today:
- American CIO & Cybersecurity Summit | June 9-10, 2026
- American Electronics & High-Tech Manufacturing Summit | June 16-17, 2026
- American Automotive Summit | September 15-16, 2026
- American Medical Device Summit | October 26-27, 2026
- American Food Manufacturing Summit | November 2-3, 2026
- American Aerospace & Defense Summit | December 3-4, 2026
- American Chemical Manufacturing Summit | December 9-10, 2026
- ...and more 2027 events!
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