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Ten Remarkable Years: Celebrating the 10th anniversary of the American Biomanufacturing Summit [Summit Recap]

  • April 24, 2024

For our second summit of the season, we headed to "Golden Gate City" for our 10th annual American Biomanufacturing Summit!

Next stop, San Francisco!

From April 10-11, 2024 at the Hyatt Regency San Francisco Airport, we celebrated the 10th anniversary of our American Biomanufacturing Summit! We want to extend our sincerest thanks and deep appreciation to everyone who played a part in making this incredible event possible.

Suppose you missed out on this year's American Biomanufacturing Summit, or would like to reminisce on the event?

In that case, we've put together a recap of key moments and highlights from the 2-day summit. From insightful presentations to productive 1-2-1 meetings and energetic networking, to lively roundtable discussions and panels, we can confidently say that it was an exceptional experience.

Table of Contents

Day 1 Highlights

Day 2 Highlights

Conclusion

Testimonials

 

Day 1 Highlights

Day 1 of the 10th annual American Biomanufacturing Summit started with an energetic welcome from our Room 1 chair, Andrew Wirths, SVP, Supply Americas at AstraZeneca. His opening remarks set the tone for an event filled with excitement, engagement, and right insights! A special thank you goes out to our emcees for the breakout rooms, including Jackie Elbonne, Chief Quality Officer and SVP, Global Quality at Amgen, Robert Bottome, VP, Global Supply Chain at BioMarin Pharmaceuticals, and Chris Holt, VP and State Head, Cell Therapy Manufacturing at Bristol Myers Squibb.


We launched the event with a dynamic opening keynote from Pam Cheng, EVP, Global Operations and IT, Chief Sustainability Officer at AstraZeneca. Pam took to the stage and discussed optimizing biomanufacturing processes. She highlighted the key advantages of strengthening supply chain resiliency through innovating, collaborating, and adapting. 

Following the keynote was Thomas Potgieter, PH.D., SVP, Cell Therapy Development and Operations at Bristol Myers Squibb, who led a plenary on revolutionizing cell therapy manufacturing through innovating, scaling, and optimizing. He also touched on key points in exploring methods for increasing cell therapy production rates, implementing efficient, end-to-end processes, and more. 

Next up was a plenary session featuring Greg Gara, SVP, and Adam Pfeiffer, VP from ProjectFarma, accompanied by Antinea Chair, VP, Technical Operations at Cellares, and Thomas Potgieter, PH.D., SVP, Cell Therapy Development and Operations at Bristol Myers Squibb. They discussed redefining technical operations for transformative medicines, opportunities and innovations in technical operations to optimize manufacturing, and additional insights into best-in-class practices.

Following the captivating speaking sessions, we took a break to enjoy refreshments, network, and engage in pre-arranged 1-to-1 meetings. This intermission provided the opportunity for all participants to foster new connections and explore innovative business solutions.

 

 

Day 1 continued with engaging sessions from Andrew Skibo, Chief Manufacturing Officer at FluGen Inc., Peter Marks, PH.D., Director, Center for Biologics Evaluation and Research at the FDA, Kevin Brower, PH.D., Global Head, Purification Development, Mammalian Platform at Sanofi, and Dominique De Jaeger, VP, CAR-T Supply Chain at Johnson & Johnson. They addressed career growth and development in biomanufacturing, accelerating innovative manufacturing growth, streamlining the industry's manufacturing future, and the art and science of scaling a commercial CAR-T therapy.

Next up were some insightful workshops! On the main stage, David Shenberger, VP, Strategic Development at CAI, led an engaging workshop about the importance of early planning in speed to patient. Meanwhile, Julie Pacheco, VP, Service, and Bishoy Labib, Senior Architect at Integrant led a captivating workshop on data-driven biotech manufacturing and building a comprehensive platform.

Across the hall were two additional workshops, one led by Bob Lenich, Business Director, Process and Knowledge Management at Emerson, and the other led by Sara Miller, Associate Director, Cell Therapy Business at FUJIFILM Diosynth Biotechnologies. In Bob's workshop, he discussed getting the most from digital recipe management lifecycle transformation. Sara's workshop provided insights into an allogeneic commercial journey.

Afterward, we transitioned into Lunch & Learn Roundtable Discussions, where industry experts engaged in moderated discussions about pressing issues in the field. These engaging conversations were led by executives from Rapid Micro Biosystems, Curia, Adlib, Biovia, Samsung Biologics, Azzur Group, Singota Solutions, Aragen, Cytiva, BA Sciences, Smart Labs, and Resilience.

 

Following the roundtables, we heard from more industry executives during their insightful speaking sessions. Thomas Spitznagel, PH.D., SVP, Technical Operations at MacroGenics, spoke on strategies in biomanufacturing to build resilient and robust operations. Leading the next room was Scott Goodberlet, VP and Head, Quality Americas Region and Device Quality at AstraZeneca. He highlighted advancing proactive quality operations and nurturing a culture of excellence.

Lee Spach, VP, Cell Therapy Global Supply Chain at Bristol Myers Squibb, simultaneously led a session on unveiling the future and revolutionizing pharmaceutical supply chains for cell therapy success. Meanwhile, Phillip Ramsey, SVP, Technical Operations at Sangamo Therapeutics, Inc., led a stream covering the evolving and emerging CAR-T therapy supply chain, in addition to the current challenges and developments.

Later in the afternoon, we dove into some workshops from our solution providers. Josh Russell, VP, Sales and Marketing at AST, discussed a case study in flexibility with modular, automated fill-finish solutions. Erik Nordwald, Associate Director, Process Technology and Innovation at KBI Biopharma hosted a workshop that revolved around fast, cheap drug development with purecoli.

Concurrently, another workshop hosted by Kunal Bargotra, Product Manager at Adlib, explored "the new way" and modernizing document management for more efficient operations. Meanwhile, Jesse Cugliotta, Global Industry Lead, Healthcare and Life Sciences at Snowflake, led their workshop on a unified data platform with built-in AI and Snowflake's solution for life sciences supply chains. 

Following these engaging sessions, we prepared for our next round of one-on-one meetings and a Networking Happy Hour.

 

 

After the break, we moved to an empowering panel discussion surrounding Women in Leadership. The panel brought together Aine Hanly, EVP and Chief Technology Officer at Vir Biotechnology, Katherine Miller, VP and Global Head, Biologics Development Analytics and Quality at Bayer, Dafni Bika, SVP, Global Head Pharmaceutical Technology and Development at AstraZeneca, Evelyn Marchany Garcia, SVP and Chief Quality Officer at BioMarin Pharmaceuticals, and Kara Renai King, VP and Site Lead at Pfizer. The panelist shared their inspiring leadership journeys, challenges they had to overcome, and lessons learned along the way. 

We then moved to an insightful plenary about Discovery to Delivery™, an integrated model for the acceleration of ATMP development which was led by Dan Dernbach, SVP, Global Operations, Azzur Cleanrooms on Demand™ at Azzur Group.

Concluding Day 1 of the conference, we heard from a panel comprised of Lauren Smith, Chief Quality Officer at Orca Bio, Scott Bradley, VP, PSS Platform Strategy and Delivery at Novartis, Cenk Ündey, PH.D., VP, and Global Head, PTD Data and Digital at Roche, Jim Fries, CEO at Rx-360, Katharine Miller, VP, Head, Biologics Analytical Development and Quality - Global at Bayer, and Dave Watrous, VP, Sales, Customer Success, and Marketing at IDBS. The industry executives shared their expertise and strategies for defining and supporting digital maturity in biomanufacturing operations

We wrapped up the day with closing remarks, followed by a vibrant Networking Drinks Reception, bringing together our valued delegates, sponsors, and speakers for enjoyable networking. A special thank you to Black & Veatch for sponsoring the featured cocktail of the evening, the Blue Venture!

A special appreciation goes out to our emcees, Andrew Wirths, Jackie Elbonne, Robert Bottome, and Chris Holt, for their insightful contributions and support throughout the day!

 

Day 2 Highlights

Day 2 of the American Biomanufacturing Summit kicked off bright and early with a Networking Breakfast, followed by our emcee, Andrew Wirths, providing their opening remarks to set the tone for the day ahead.

The morning commenced with an opening keynote led by Joydeep Ganguly, Chief Sustainability Officer and SVP, Corporate Operations at Gilead Sciences. Joydeep shared some insights on the topic of sustainability transformation and a practitioner playbook. 

Immediately preceding Joydeep's insightful session, Jens Vogel, SVP and Global Head, Biotech at Bayer, led a plenary. Their presentation delved into delivering on multi-modality portfolios, and touched on innovation and flexible global networks.

Following Jens' engaging session, Kevin Sharp, SVP and Head, Global Sales at Samsung Biologics wrapped up our morning plenaries with his captivating session. Kevin spoke on enhancing CDMO capabilities for collaborative success and embracing sustainable growth initiatives. 

After our initial Day 2 morning plenaries, we enjoyed our final networking break of the summit with more engaging 1-2-1 meetings and refreshments!

Workshops were then hosted in separate rooms for the delegates to attend. In Room 1, Brad Wynja, VP of Business Development at INCOG BioPharma Services, hosted a workshop on better partnerships and building a CDMO to accommodate the evolving manufacturing complexities and increasing supply chain challenges for drug developers. Concurrently in Room 2, Pete Genest, Director, Business Development at Smart Labs, hosted a workshop next door. Pete spoke on enabling your process from the bench to the clinic and a hybrid resourcing solution for your manufacturing needs.

Across the hall in Room 3, Ken Forman, Lead Product Manager, Manufacturing at IDBS and Abhi Ray, Co-Founder and CTO at Aventior, led a workshop demonstrated how and why data is the asset you need for your manufacturing AI initiatives. Meanwhile in Room 4, Marc Hummersone, Senior Director, R&D at Astrea Bioseparation, led a workshop about the downstream process intensification for challenging cell and gene therapy bioprocessing.
 

 

The lively workshops was followed by a series of captivating sessions. On the main stage, Thomas Potgieter, SVP, Cell Therapy Development and Operations, and Imara Charles, VP, Process and Digital Excellence, Global Supply Chain at Bristol Myers Squibb, led a session about building resilience and combating supply risk with effective and efficient contingency planning solutions. Next door, a session was led by Mitch Lwandowski, VP and Head, Quality at GRAIL Inc. Mitch led the lively session on maintaining a balance of innovation change and quality risks.

Across the hall, another session was hosted by Bolette Bjerregaard, Director and Team Lead, Project Management, Late Stage Manufacturing Development at Genmab, where he shared some great insights on elevating CMC operations, alongside innovating, optimizing, and excelling in biomanufacturing. Simultaneously, an additional session was led by Leela Paris, VP, Process Engineering and Manufacturing, Cell Therapy, and Stacy Veysey, Senior Director, Talent Acquisition, Research, Manufacturing and Technology at Vertex Pharmaceuticals. Leela and Stacey focused their discussion on unlocking professional potential in the cell and gene therapy space.

Following the engaging sessions, we kicked off noon with our final set of workshops. In Room 1, Sun Chau Siu, Executive Director and Head, Technology at Altruist, hosted a workshop on accessing the China marketing using a localization strategy, and shed light on the opportunities and challenges. Concurrently in Room 2, Jon Gunther, VP, Business Development at Just-Evotec Biologics, hosted a workshop next door. Jon spoke on continuous manufacturing and the current paradigm shift in biologics.

Across the hall in Room 3, Dennis J. Yoon, Senior Director, Manufacturing Science and Technology at Abzena, led a workshop regarding navigating a complex downstream manufacturing strategy to ensure clinical and commercial success.

Then, it was time for lunch with some engaging roundtable discussions featuring Snehal Patel, EVP and Head, Technical Operations at Sana BiotechnologyBolette Bjerregaard, Director and Team Lead, Project Management, Late Stage Manufacturing Development at Genmab, Alyssa Mesa, Director and Head, Learning and Operational Excellence, Clinical Supply Center at GenentechRobert Bottome, VP, Global Supply Chain at BioMarin PharmaceuticalsDerrell Porter, CEO at cTRL Therapeutics, and Jim Dekloe, Director and Founder, Industrial Biotechnology Program at Solano College.

Having enjoyed some delicious food and lots of valuable insights, we returned to the main stage with a thought-provoking Diversity Equity and Inclusion Panel, where we had the honor of hosting Colette Jue, Senior Director, Site Compliance at Genentech, Thomas Spitznagel, SVP, Technical Operations at MacroGenics Inc., and Meredith Gibson, CEO at Associate of Women in Science. The panelists discussed how they define diversity and inclusion in an ever-changing work environment, how and where the conversation is headed, how their organizations build D&I into its structure, and provided more key insights. As we concluded the discussion, the experts generously provided actionable advice for fellow leaders, offering concrete steps towards building and growing current diversity, equity, and inclusion initiatives in their organizations, driving tangible progress for the future.

Next door, we had an intriguing session led by Mark Piskadlo, VP, Cell Therapy Manufacturing, NJ Site Leader at Bristol Myers Squibb. During this session, Mark covered manufacturing excellence and provided insights on leveraging Opex to advance autologous cell therapy manufacturing.

Our Fireside Chat commenced shortly after the insightful DE&I panel on the main stage. Jackie Elbonne, Chief Quality Officer and SVP, Global Quality at Amgen, and John Hearty, VP, Life Sciences at IDA Ireland took the stage and led the discussion on defying imagination to drive quality. In this chat, they delved into the pillars of quality and compliance at Amgen, utilizing quality as a differentiator of superior patient and customer outcomes and business performance, and building a culture of excellence that engages and empowers cross-functional teams.

To wrap up two days of thought-provoking discussions, our final plenary was led in Room 1 by Matt Gardner, Chairman of the Board at California Biomanufacturing Center, Jim Dekloe, Director and Founder, Industrial Biotechnology Program at Solano College, and Peter Conte, National Director, Laboratory and Life Sciences at Trans Western. The speakers led the discussion on the biomanufacturing landscape today and exchanged insights into cell and gene therapy talent, space requirements for 21st-century biomanufacturing, manufacturing operations, and speed to market.


As the Summit drew to a close, concluding two days filled with learning, networking, and knowledge exchange, our incredible emcee Andrew Wirths for delivered their closing remarks and announced the winners of our survey prize giveaway. A special thank you again to Jackie Elbonne, Robert Bottome, and Chris Holt for their remarkable support throughout the day emceeing the breakout rooms.

In celebration of our attendees' outstanding participation, we're delighted to unveil our prize champions, who've brought an extra dash of vibrancy to our event! A big congratulations to Natira Matthews, Senior Director, Manufacturing at Sutro Biopharma, our survey winner, and Pinghua Chua, Director at Chinook Therapeutics, Inc., the networking superstar!

As an additional thank you to wrap up the successful event, we invited all attendees to the Grove for the closing Thank You Reception. Looking forward to seeing you back here next year!

 

Conclusion

We are delighted by the achievements of our 10th Anniversary of the American Biomanufacturing Summit! Our heartfelt appreciation goes out to the esteemed experts mentioned earlier, as well as every delegate and sponsor company who contributed to making this Summit an extraordinary experience. Our summits flourish on your dedicated support and enthusiasm!

It's been a remarkable journey towards this event's 10th anniversary, and we're excited to replicate the success in the 11th annual American Biomanufacturing Summit!

We genuinely hope the Summit left an impressionable and lasting impact on you, just as it has on us. If you couldn't join us this time but are eager to be part of this exceptional gathering next year, don't hesitate to express your interest. It's never too early to get excited about what's to come next!

SEE YOU NEXT YEAR: 11th annual American Biomanufacturing Summit | Spring 2025 in San Francisco, CA

Visit the summit's website to learn more and secure your pass today!

Save your spot at next year's discussion as an attendee, solution provider, or speaker with early registration opening now! To keep yourself in the loop about upcoming Summits, explore our event calendar at generisgp.com/events

 


Testimonials

The summit is a great networking opportunity! If you want to gain access and learn from the executive leaders of top biopharma, this is your chance...

Elia Sanchez, QC Director, Biomarin

 

Robust with learning, networking and collaboration. Great seeing old colleagues and meeting new colleagues.

Kara King, Vice President, Operations, Pfizer

 

Absolutely a must-attend summit! Second year in a row attending this event.  The topics, focus, interactions, and format are top-notch!

Charles Reichel, Executive Director- Drug Product and Supply Chain, Xencor, Inc.

 

I thoroughly enjoyed the plenary speakers and networking! I advanced my understanding of the critical challenges the industry is facing, and vendor capabilities I can leverage in the future. “This was my first time at the summit. I would highly recommend it! The presentations and all discussions were very insightful. It was great to network and connect in an informal setting...

Natalie Christian, Executive Director, Merck

 

This was my first time at the summit. I would highly recommend it! The presentations and all discussions were very insightful. It was great to network and connect in an informal setting...

Sargam Kaur Arora, Associate Director Quality and Compliance, Gilead Sciences

 

Very well-organized event, great selection of speakers and topics. Very insightful of the commonality of issues our peers are experiencing.

Gerardo Rivera, Supply Chain Lead, AstraZeneca

This was my first time at the summit. I would highly recommend it! The presentations and all discussions were very insightful. It was great to network and connect in an informal setting... The American Biomanufacturing Summit has been excellent. I especially appreciate the effort the Generis team puts into generating meaningful scheduled conversations.

Jake Callis, Head of Project Management, New Business, Simtra BioPharma

 

Excellent for networking and 1:1 meetings with executive-level decision-makers.

Shawn Olsen, NA Sales Director, Rapid Micro Biosystems


 

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