Biotech Breakthroughs & Big Ideas: 2025 American Biomanufacturing Summit Recap

Shaping the Next Era of Biomanufacturing

The 11th annual American Biomanufacturing Summit took place April 15-16, 2025 at the Hyatt Regency San Francisco Airport! The event brought together 250+ top minds in the pharmaceutical and biotech industries for two days of strategic insights, collaborative discussions, and forward-thinking innovation. As one of the premier events in the biomanufacturing space, the summit served as a platform for senior executives, scientists, and solution providers to tackle the most pressing challenges in biologics production, digital transformation, regulatory compliance, and supply chain optimization.

In this recap, we’ll take you inside the keynotes, panels, and networking sessions that defined this year’s summit, highlighting the trends, takeaways, and transformative ideas that are driving biomanufacturing forward.

Table of Contents

Day 1 Highlights

Day 1 of the American Biomanufacturing Summit kick started with a Networking Breakfast sponsored by Navigate Biopharma.

We then had our opening remarks delivered by Andrew Wirths of AstraZeneca. Additionally, he introduced Hennie Frick of GSK, Tom Cheslock of Pfizer and Joshua Zibit of Astellas as our breakout room emcees.

We were fortunate to have Peter Stevenson, Mayor of Burlingame join us to deliver an inspiring welcome address that was sure to leave our attendees excited for the two days ahead.

The opening keynote was delivered by Daniela Ottini of Sanofi. This dynamic session highlighted bold strategies for accelerating digital transformation to enhance manufacturing agility and responsiveness. The keynote empowered leaders to drive forward-thinking innovation and shape the future of biomanufacturing with confidence, adaptability, and vision.

Following the keynote, Wolfram Carius of Bayer led a plenary session titled Navigating Opportunities and Challenges in Cell and Gene Therapy within a Multimodal Landscape. The discussion explored current opportunities and challenges in the biopharma industry, including the impact of economic conditions, rapid technological advancements, sustainability initiatives, and talent acquisition hurdles.

Following that, a Fireside Chat united three prominent voices in the field to explore how cell therapy is being transformed through scalable automation. Chris Mcdonald of Kite Pharma, Narinder Singh of Arcellx, and John Khoury of Project Farma joined forces to discuss key challenges and solutions in scaling automated processes from R&D to commercial production, while showcasing the latest advancements in automation technologies. The discussion emphasized the critical role of integrating digitalization and automation to boost scalability, reduce costs, enhance product consistency, and ensure regulatory compliance.

Next, attendees enjoyed refreshments, networking, and pre-arranged 1-2-1 meetings sponsored by Bionova Scientific. This is a dedicated time and space designed to facilitate impactful networking and the development of new business relationships.

The summit continued with dynamic speaker sessions spotlighting the industry's most pressing topics—including manufacturing & technology, quality & compliance, supply chain & logistics, and cell & gene therapy.

Harish Santhanam of Bristol Myers Squibb tackled scalability and robustness in autologous cell therapy. He dove into process robustness to
deliver on-time, in-specification therapies to patients. We then had RJ Doornbos of Amgen deliver a session titled "Regulatory Framework and AI Integration: Transforming Quality Assurance". She discussed generative AI optionality and the impact it has on organizational operations.

Room 3 had Tom Cheslock of Pfizer address the complexity of global supply chains to streamline operations and improve efficiency. Joshua Zibit also gave a thought-provoking talk on advancing AAV vector technologies for next-generation gene therapy applications, and finished with a case study highlighting milestones achieved by Astellas Gene Therapy Research.

Following the sessions, attendees participated in interactive and hands-on workshops led by industry experts focused on driving innovation and practical solutions within biomanufacturing operations.

In Room 1, Bryan Holmes of Andelyn Biosciences and Bryan Ennis of Sware led a workshop titled Validation Excellence for CDMOs – From Regulatory Burden to Business Driver. This session tackled the evolving landscape of validation in CDMO environments, reframing it from a compliance-heavy obligation to a catalyst for operational and business performance.

Vega Finucan of USDM Life Sciences delivered an immersing session, Agentic AI Shaping the Future of Intelligent Automation in Biomanufacturing in Room 2. Finucan clarified the complementary role of Agentic AI, not as a replacement for human talent but as an augmentation that bolsters governance and compliance.

In Room 3, Bob Lenich of Emerson walked through the current state of recipe and tech transfer processes and laid out a vision for how digital transformation can enhance traceability, repeatability, and cross-functional collaboration.

Additionally, we had Imroz Ghangas of Asimov addressed the inefficiencies of traditional, empirical bioprocess development and proposed a forward-thinking model-driven approach.

The momentum continued into the afternoon with more breakout sessions:

Christopher Grail shared Bayer’s strategic blueprint for marrying operational performance with environmental stewardship. The session began by addressing the urgent need for energy-efficient manufacturing systems, and Grail detailed how Bayer is redesigning its engineering approaches to reduce the carbon footprint across global operations.

Next, Frank Seibel of Roche emphasized that compliance excellence isn’t just about checking boxes—it’s about cultivating a mindset and infrastructure where quality is proactive, not reactive. He delivered key insights including the adoption of lean tools to eliminate waste, simplify workflows, and reduce deviations across biomanufacturing sites.

In Room 3, Imara Charles of Bristol Myers Squibb brought the audience into the nerve center of BMS’s global supply chain—its real-time command center. Designed for agility and resilience, this digital hub enables smarter, faster decision-making across complex manufacturing and distribution networks.

Finally, in Room 4 Birk Vanderweeën delivered a strategic overview of how Legend Biotech is building a scalable and efficient global manufacturing network for autologous CAR-T therapies. As demand for cell and gene therapies grows, so does the challenge of producing personalized treatments at scale.

The afternoon workshops offered attendees practical insights into leadership, AI, workforce agility, and operational excellence.

In Room 1, Ken Forman of IDBS kicked things off with a thought-provoking session on how large language models (LLMs) are shaping the future of biomanufacturing.

We then had Josh Russell of AST outline how modular manufacturing is becoming the go-to solution for companies seeking speed, compliance, and flexibility in ATMP production.

Bill Bressler of Navigate BioPharma Services Inc. tackled the regulatory elephant in the room—how to integrate the European Union's In Vitro Diagnostic Regulation (IVDR) and design control into long-standing quality systems without disruption.

In Room 4, Dane Grismer of KBI Biopharma closed out the track with a high-impact session on streamlining biologic development by combining digital tools, proven platforms, and agile workflows.

After a refreshing networking and Happy Hour break, Joydeep Ganguly took the stage with a bold proposition: AI and machine learning aren’t just a trend—they’re delivering results at scale when integrated with purpose and precision. His session centered around Gilead’s Lighthouse Program, an enterprise-wide initiative showcasing how AI can transform everything from supply chain logistics to sustainability goals.

In a dynamic fireside chat, three of AstraZeneca’s top executives (Jim Fox, Arun Krishnan, and Andrew Wirths) shared how they are building a resilient, agile, and digitally empowered supply network to handle uncertainty and scale for the future.

This was followed by a plenary delivered by Richard Kilmer of Cargosense, where he touched on accelerating the identification of supply chain disruptions to minimize operational impact.

The day concluded with a high-level panel discussion on Advancing Digital Transformation and Manufacturing Excellence in Biomanufacturing. This session featured Imara Charles of Bristol Myers Squibb, Daniela Ottini of Sanofi, Judy Chou of Altrubio, Narinder Singh of Arcellx, and John Hearty of IDA Ireland. They explored how digital technologies are reshaping biomanufacturing by improving process efficiency, scalability, and operational consistency.

To finish off the day, we invited all Summit attendees to a Networking Drinks Reception sponsored by Ajinomoto.

Day 2 Highlights

Empower Hour

The morning of Day 2 kicked off with an inspirational Empower Hour and Networking Breakfast in Room 1.

We had Anita Chu Li of AWIS join us as a moderator for the two morning sessions. We started with a fireside chat including Marina Hong of Bayer on fostering an inclusive operating model through dynamic shared ownership. We then had Colette Ranucci of Merck, Adriana Fernandez of Eli Lilly, Kenya Edmonson of Pfizer, and Maricarmen Szendrey of Amgen take the stage to discuss leadership lessons, significant barriers, and best pieces of advice during the Women in Leadership Panel.

Empower Hour set the tone for the day, equipping attendees with the tools to lead boldly and effectively.

The morning continued with a keynote by Karin Shanahan of Bristol Myers Squibb. She drew from the organization's cross-functional expertise—offering valuable insights and best practices from manufacturing, supply chain, and quality teams across various therapeutic modalities. Their integrated approach demonstrated how operational excellence can drive both efficiency and innovation.

Following the keynote, the day continued with an insightful plenary session featuring David Connolly of Rentschler. A major theme of the session was the importance of scalable, flexible facility design. Connolly emphasized the need for facilities that can adapt to evolving technologies, regulatory requirements, and shifting production demands—ensuring long-term readiness and sustainability.

Post-keynote, attendees engaged in a range of insightful workshops focused on transformative techniques in manufacturing and operations.

In Room 1, Virovek's Haifeng Chen and Peter Hoang presented groundbreaking insights into how BAC-to-AAV technology is redefining the potential of AAV vectors in cancer therapeutics.

Concurrently, in Room 3, Scott Barnard of Bluecrux delivered a compelling session on the transformative role of artificial intelligence in planning and scheduling within the biomanufacturing landscape.

In Room 4, Mahalia Corrales of FUJIFILM Diosynth Biotechnologies introduced the KojoX™ strategy, a bold and innovative approach to redefining supply chain flexibility and scalability in biomanufacturing.

Following the dynamic series of workshops, attendees welcomed a refreshment break—courtesy of Bionova Scientific—offering time to recharge and engage in their scheduled 1-2-1 meetings.

The Summit continued with several insightful sessions across different tracks:

James Rider explored how Amgen is integrating AI and digital intelligence to automate biomanufacturing processes and boost operational efficiency. Through fully automated, AI-enabled facilities and digital platforms, the company is expanding capacity while improving speed and accuracy.

In Room 2, Jason Dowd of Bayer discussed the development of robust 2D and 3D technology platforms that allow for more precise quality assessments in cell therapy. He emphasized how automation and modeling help monitor critical quality attributes, ultimately increasing data utilization and reducing yield variability.

Down the hall, Kara Renai King of Zoetis addressed the increasing threat of natural disasters to global manufacturing operations. She outlined the organization's comprehensive strategy for risk assessment, facility hardening, and rapid response.

In Room 4, Ben Beneski shared Allogene Therapeutics’ vision for the future of cell therapy through the development of allogeneic, “off-the-shelf” CAR-T treatments.

The morning continued with more dynamic workshops. Kim Huggins and Brian Crowley-Koch of Alula delivered an engaging workshop focused on the human side of manufacturing leadership. They tackled the persistent challenges leaders face in high-pressure environments and provided strategies rooted in behavioral science to drive meaningful performance improvements.

In Room 3, Kenneth Gibbons of C&F LLC examined the power of agentic AI platforms in uncovering new insights and enhancing operational efficiency within manufacturing.

Also, in Room 4, Fabian Gerlinghaus of Cellares addressed the complex challenges surrounding cell therapy production, emphasizing the importance of automation and scalability.

Following the workshops, we had Jason Arcediano of BioCina deliver a meaningful discussion on the evolution of non-viral gene transfer technologies.

As the day continued, the Lunch & Learn roundtable discussions and Open Seating Lunch provided attendees with the unique opportunity to enrich knowledge and engage in thought-provoking exchanges with leaders from top companies such as Disc Medicine, Genentech, AstraZeneca, Bayer, Gilead, Sanofi, Pfizer and Poseida Therapeutics.

In a forward-looking panel discussion, industry leaders came together to explore the rapidly changing landscape of contract development and manufacturing organizations (CDMOs) and their pivotal role in advancing biomanufacturing. This included Jenny Banh of Lonza Vacaville, Dipesh Lad of Flex BioCulture, Molly Morse of Mango Materials, Gordon Zagar of ZCI, and Gabriel Youtzey of University of California.

Finally, we had a dynamic panel discussion, leaders from emerging biotech companies shared valuable insights on how small and medium-sized enterprises (SMEs) can successfully navigate the complex world of biomanufacturing and compete with larger pharmaceutical players. This included Renuka Sivendran of Agenus, Justin Skoble of Caribou Biosciences, Rahul Kaushik of Disc Medicine, John Herberger of Eledon, and Melanie Juba of IDBS.

As we wrap up another impactful American Biomanufacturing Summit, we’re thrilled to recognize the exceptional engagement and enthusiasm of our attendees. A special congratulations to Michael Ong, named our survey prize standout, and EJ Brandreth, named our networking standout —thank you both for bringing an extra spark to the summit experience!

Throughout the two days, attendees exchanged breakthrough ideas, explored emerging technologies, and built meaningful relationships that will help shape the future of biomanufacturing. The conversations were dynamic, the insights actionable, and the spirit of collaboration stronger than ever.

We’re energized by the passion and progress this community continues to bring to the table. Thank you to everyone who joined us—we can’t wait to connect again at our next summit and keep advancing biomanufacturing together.

Conclusion

We’re excited to share that the 2025 American Biomanufacturing Summit was a tremendous success!

A huge thank you to all the delegates, speakers, and sponsors who brought incredible energy, insight, and innovation to this year’s event. Your passion and participation made this Summit truly unforgettable.

📅 SAVE THE DATE:

April 14-15, 2026
Hyatt Regency San Francisco Airport – San Francisco, CA

Couldn’t attend this year? Don’t worry—registration is now open for next year’s Summit! Seats are already filling up, so be sure to reserve your spot soon.

👉 Visit biomanamerica.com to register and learn more.

To stay updated on all our upcoming events, visit generisgp.com/events.

We can’t wait to welcome you back in 2026!

Testimonials

"Great networking and learning experience; very applicable and targeted."
Doug Alleeavitch, Vice President, Quality, Arcellx

"Very good, organized and very informative. Excellent presenters with on-point topics."
Julie Brown, Director, QC Microbiology, BioMarin

"I’m impressed by the excellent roster of speakers and curated content here at the American Biomanufacturing Summit. The event itself was very well organized and the conference app is an easy way to navigate the schedule and customize the experience."
Anne Koehler, Director, Business & Operations, BlueRock Therapeutics

"This summit is one of the best. The intimate environment and senior leader peers make it easy for networking and learning."
Kara King, VP, Platform Lead for Pharma Americas and China, Zoetis

"Well-organized event, great Generis Team, great content, enough time for networking, great speakers. Vendors were excellent to discuss new technologies and platforms with."
Rakesh Kakkar, VP/Head of Manufacturing & Supply Vaccines, US, Sanofi

"The American Biomanufacturing Summit provided a great opportunity to meet with prospective new clients and to have meaningful discussions with colleagues across the industry. The Generis staff has been excellent!"
Jessica Feldman, Director, Process Science, Rentschler Biopharma

"Informative, interactive and well designed. Expertise on demand for cutting edge concerns."
Jim Gagnon, Director of Quality, Amgen

"It was energizing and exciting! New networks were created and old ones were rekindled. Full days with appropriate breaks and connecting opportunities."
Keñya Edmondson, VP, Sterile Injectables Operations, Pfizer

"Presentations were relevant to the challenges facing the industry. It is also a great opportunity to connect with peers to understand how others are addressing common issues."
Amy Gamber, VP, End to End Supply, Atara

"Productive meeting. I was able to access a lot of information and vendors that will be helpful for making future manufacturing decisions."
Michael Ong, Sr. Director, Manufacturing, Candid Therapeutics

"Very interactive. I really enjoyed the pre-arranged 1:1 meetings and the roundtable discussions!"
Erica Welker, Director Western Region, BA Sciences

"Very well organized! Great app with easy to refer to scheduling, attendees, and navigation around the venue, with a lot of help available from Generis staff on site."
Sunny Motwani, Senior Operations Manager, Amgen

"This was well organized and facilitated. I enjoyed the size of the event. It was conducive to more discussions compared to other events. I truly appreciated the many Generis facilitators of the one-to-one meetings. On many occasions, I felt like I was a VIP with my own handlers."
John Kumer, Director of Process Development, Aptevo Therapeutics LLC

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