Beyond the Pill: Inside the American Pharma Manufacturing & Outsourcing Summit [Summit Recap]

Introduction

The 9th Annual American Pharma Manufacturing & Outsourcing Summit brought together more than 150 senior pharmaceutical leaders for two days of learning, collaboration, and productive dialogue. Guided by our exceptional emcees—Becca Ford, VP, Project Delivery, Global Fill and Finish Expansions (Novo Nordisk), Luiz Alberto Barberini, Head, External Manufacturing, LATAM (Bayer), and Shawn Brueggemeier, Senior Director and Head, Drug Substance Operations and Supply (Bristol Myers Squibb)—the summit unpacked the most urgent challenges and emerging opportunities shaping the future of pharma manufacturing and external partnerships.

Across three core streams—Manufacturing, Outsourcing, and Supply Chain—attendees engaged in a wide range of sessions, panels, workshops, lunch-and-learns, 1-to-1 meetings, and networking receptions that fueled meaningful conversations and actionable insight. From AI-enabled production and advanced analytics to CDMO collaboration models, end-to-end visibility, and resilient supply strategies, the summit offered a comprehensive look at how the industry is advancing efficiency, ensuring compliance, and strengthening global capacity.

What followed was two days of candid discussion, shared challenges, and real-world solutions, where attendees left with fresh perspectives, actionable ideas, and a stronger network to support the next wave of pharma manufacturing and outsourcing transformation.

A Morning of Vision: Keynotes & Plenaries

The day began with a powerful keynote from Daniel VonDielingen, SVP, Global Parenteral Network Expansion at Eli Lilly, who set the tone by laying out what it truly takes to scale manufacturing across a global network. Through stories of digital transformation, automation, and culture-building, Daniel grounded attendees in a shared understanding: the future of pharma manufacturing isn’t on the horizon; it’s already here.

From there, the summit moved into a plenary session led by Koustuv Chatterjee, SVP and Head, External Manufacturing and Supply at Sanofi, who explored how global supply networks and external manufacturing partnerships are evolving into strategic engines of resilience.

Closing the morning’s starter sessions was Dan Walles of TraceLink, whose plenary demonstrated how digital networks are redefining commercial and logistics orchestration.

With that, attendees stepped into the first networking break. A chance to exchange cards, reconnect with colleagues, and dive into pre-arranged 1-2-1 meetings that would continue throughout the day.

Breakout Sessions and Workshops: The Core Streams in Full Force

After refreshments, attendees dispersed into three breakout rooms focusing on the summit’s three streams: Manufacturing, Outsourcing, and Supply Chain.

In Manufacturing, Becca Ford (Novo Nordisk) walked through the one-model approach to delivering global capital projects. Her pragmatic insights into scalable facility design and cross-functional collaboration offered a roadmap for future-ready sites. In Outsourcing, Colin Baker (Bimeda) shared a global perspective on FDA inspection readiness, emphasizing team coordination and lean processes. Meanwhile, the Supply Chain room welcomed Jagy Patel (Johnson & Johnson Innovative Medicine), who broke down the journey from reactive planning to fully orchestrated digital decision-making.

The themes aligned across rooms: better data, smarter oversight, and systems built for speed and flexibility.

Workshops brought groups together for practical exploration of some of the industry’s biggest challenges. In Room 1, experts from ProjectFarma, Eli Lilly, Novo Nordisk, Lonza, and Alnylam Pharmaceuticals teamed up for a dynamic session on optimizing facility planning and start-up. Across the hall, PLD Pharma Services led a deep dive into launching OTC and Rx gummies, sparking discussion around stability, taste masking, dosage accuracy, and commercialization strategy. And in the third workshop room, Emerson explored the transformative value of digitizing tech transfer, illustrating how reusable specifications and seamless integration can substantially accelerate scale-up.

Over lunch, attendees joined roundtable discussions hosted by Coating Place, ECI, Process Alliance, Bushu Pharma, System Loco, Systech, and TraceLink. Conversations ranged from serialization challenges to contract manufacturing expectations, offering an informal but impactful exchange of ideas across the external network landscape.

Afternoon Conversations: Data, CDMO Strategy & Seamless Scale-Up

Following lunch, three more breakout sessions pulled attendees back into focused learning. In Room 1, Imara Charles, PH.D. (Bristol Myers Squibb) explored the growing power of command centers—spaces where real-time data can drive sharper, faster decisions. In Room 2, Gil Roth (Pharma & Biopharma Outsourcing Association) shed light on the shifting CDMO landscape and how legislative and regulatory changes are reshaping partnership models. While in Room 3, Amlan Dutta (Sanofi) walked through the complexity of scaling from clinical to commercial manufacturing, reinforcing the importance of quality frameworks, tech transfer readiness, and digital modernization.

After sessions came the workshop block, which kept the momentum going. TraceLink led a workshop on integrating manufacturing and logistics processes into a digitally orchestrated control tower, highlighting the value of real-time visibility from order to shipment. At the same time, Bluecrux explored how AI, transparency, and supplier collaboration can fundamentally transform outsourcing success. Meanwhile, Genesis AEC brought architectural and engineering expertise to a workshop on designing future-ready pharmaceutical facilities

As glasses clinked and conversations flowed into the early evening, the summit transitioned to its most anticipated discussions.

Featuring our first panel discussion, Shaping the Future of U.S. Pharma Manufacturing in a Changing Regulatory Landscape. A powerhouse lineup took the stage, including: Andy Ramelmeier (Adverum Biotechnologies), Amlan Dutta (Sanofi), Lori Canzanese (Merck), Colin Baker (Bimeda), Cedric Dubois (Teva Pharmaceuticals), and Laks Pernenkil (Deloitte). Together, they explored reshoring, regulatory shifts, domestic competitiveness, and the technologies reshaping U.S. manufacturing. Attendees leaned in as panelists debated incentives, global risk, and how policy is shaping long-term strategy.

Following the panel, Dave Miller of AustinPx provided a compelling plenary on the role CDMOs play in simplifying processes to reduce costs without compromising quality. His case comparison of KinetiSol® versus spray drying sparked discussion throughout the room. 

The final panel of the day brought together leaders, including Karin Shanahan (Bristol Myers Squibb), Jack Prior (Sanofi), Joseph Horvath, Ph.D. (Takeda), Zaher Shabani (Incyte), and Becca Ford (Novo Nordisk), to unpack digital tools, AI, automation, and predictive operations. Their vision of flexible, tech-enabled manufacturing systems left attendees energized about what comes next.

The day wrapped with closing remarks from the summit chairs, offering gratitude to speakers and attendees before opening the doors to the evening networking drinks reception, sponsored by ProjectFarma.

Kicking Off Day 2: Breakfast & Empower Hour

The morning opened with an energy that was equal parts warmth and ambition. The Empower Hour brought together an exceptional group of women leaders:

• Goldi Kaul, Ph.D., VP and Head, External Alternative CMC Development, Boehringer Ingelheim
• Denise Powell, VP, External Manufacturing Operations, Merck
• Leslie Wolfe, SVP, CMC, Orca Bio
• Manda Pasarkar, Director, Global Regulatory Affairs, CMC, Sanofi
• Kara Renai King, Ph.D., VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development, Zoetis
• Heather Preu, CEO, Intellect

The group shared personal anecdotes of overcoming industry challenges, mentorship experiences that shaped their confidence, and the importance of advocating not only for oneself but for the next generation. Their message was clear: impactful leadership is built through community, courage, and consistent visibility.

Following the day 2 opening remarks, Patrick Hinojosa, SVP, Pharma Supply Chain Management (Bayer), delivered a concise yet compelling keynote on people-centered supply chain transformation, highlighting the need for integrated teams, flexible talent models, and purpose-driven leadership to increase responsiveness and accelerate enterprise-wide alignment.

The day 2 plenaries first featured Andy Ramelmeier, Ph.D., Chief Technology Officer (Adverum Biotechnologies), who shared a focused look at how the industry can shift from profit-driven to patient-centric by designing scalable, cost-effective treatments, supported by strong CMC strategy and trust-building measures across R&D and commercialization. Then followed Aaron Bazal, Executive Director (Vibraclean), who emphasized the strategic value of robust contamination control, demonstrating how harmonized cleaning practices and proactive environmental monitoring can significantly strengthen operational resilience in sterile manufacturing environments.

Attendees moved into informal discussions, reconnecting with peers, partners, and solution providers to deepen conversations sparked throughout the summit.

Late Morning Sessions and Discussions

As the break concluded, participants dispersed into concurrent breakout rooms, each offering a more tactical, hands-on look at the operational challenges and innovations shaping pharma manufacturing. 

In the Manufacturing room, Lori Canzanese of Merck shared how her team is advancing global digital manufacturing by more tightly integrating automation and IT systems, building scalable digital infrastructures that support analytics and AI, and strengthening global collaboration through standardized platforms and workflows. Meanwhile, the Outsourcing stream featured Steven Cray of Takeda, who emphasized the importance of drawing talent and diverse perspectives from across the organization to build a truly multifaceted supplier relationship management team. In the Supply Chain room, Kara Renai King of Zoetis offered a compelling look at navigating operational disruptions caused by natural disasters.

As the program progressed into the next round of sessions, the Manufacturing track welcomed Joseph Horvath of Takeda, who unpacked developments in quality risk management. In the Outsourcing room, Robert Newell of BioMarin walked attendees through the strategy and structure behind scaling global external operations. Across the hall in the Supply Chain stream, Leslie Wolfe of Orca Bio discussed strengthening quality, enhancing compliance, and improving validation practices across manufacturing.

The conversations continued naturally into the Lunch & Learn Roundtables, where attendees joined company-hosted discussions from Teva Pharmaceuticals, Pfizer, Incyte, Elanco, Bristol Myers Squibb, Biogen, Amgen, and Bayer. Each table delivered a concentrated exchange of ideas that blended real-world experience with forward-looking strategy, giving attendees actionable takeaways for their organizations.

Final Afternoon Conversations

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. In Room 1, the conversation was led by Bayer’s Luiz Alberto Barberini, who emphasized how strengthening supplier relationships has become inseparable from advancing digital transformation. Across the hall in Room 2, Sanofi’s Manda Pasarkar walked participants through what it truly means to align and integrate CMC functions within modern pharma operations.

The afternoon then brought everyone together for a highly anticipated panel discussion featuring Jenelle Sweet of CSL, David Kolwyk of Biogen, Steven Cray of Takeda, Shane Kelly of BioMarin, and Grace Festa of the Virginia Economic Development Partnership. Together, they tackled one of the industry’s most pressing challenges: cultivating the next-generation workforce. The panelists explored practical strategies for building stronger talent pipelines, from targeted upskilling programs to structured early-career pathways that prepare employees for advanced technical roles. Their discussion offered attendees a realistic and forward-looking view of how biotech and pharma companies can strengthen their teams to meet evolving industry demands.

As the final sessions wrapped and participants filtered back into the main hall, the summit drew to a close with warm closing remarks and the much-anticipated survey prize giveaway.

Conclusion

Over two days at the American Pharma Manufacturing & Outsourcing Summit, leaders from across manufacturing, outsourcing, and supply chain came together to share hard-earned lessons, exchange new ideas, and collectively shape the future of pharmaceutical operations. The insights, connections, and momentum built here will continue to inform decisions long after the summit’s close, proof that this community remains committed to elevating standards across the industry.

A heartfelt thank you to everyone who joined us, contributed to the discussions, and helped make this year’s gathering such a success. 
We invite you to stay engaged and join us again next year—whether at the American Pharma Manufacturing & Outsourcing Summit, taking place November 19-20, 2026, in Boston, MA, or our European affiliate, the European Pharma Outsourcing Summit, taking place June 17–18, 2026, in Düsseldorf, Germany. We look forward to continuing the journey together.

For those who missed this year’s incredible summit, the time is now to register for next year: posummit.com

Testimonials

“A diverse section of contemporary, impactful, exciting topics related to pharma manufacturing and outsourcing.”

Mara Ketchum, Senior Director Product Quality Lead @ Bristol Myers Squibb

“The summit delivered meaningful insights into emerging trends in pharmaceutical manufacturing and outsourcing. The sessions (keynotes, panels, and roundtables) were well-structured, and the speakers provided thought-provoking, practical, and relevant perspectives for both industry and regulatory stakeholders.”

Zaher Shabani, Director, Global Regulatory Affairs CMC @ Incyte Corporation

“This summit was an excellent opportunity to learn about critical topics in this space, while expanding my network of peers and suppliers.“

Samuel Lopez de Victoria, Director - External Manufacturing @ Johnson & Johnson

“I am beyond pleased with the diverse topics and speakers present. The event was very well organized, and I definitely recommend it.”

Bilen Gebremariam, Associate Director, QA @ Tarsus Pharmaceuticals

“Fantastic!! Great opportunity to interact and get to benchmark with peers and suppliers.”

          Luiz Barberini, Head, External Manufacturing, Latin America @ Bayer

"Super engaging. Great setup for networking and lunch & learns. Lectures and panel discussions are tailored carefully, focusing on current trends and upcoming challenges."

Komal Hingu, QA Manager @ Galderma

Learn more about our upcoming 2026 North American events, and secure your spot today:

• American Manufacturing Summit | March 17-18, 2026
• American Biomanufacturing Summit | April 14-15, 2026
• American Supply Chain Summit | April 27-28, 2026
• American Packaging Summit | May 14-15, 2026
• American CIO & Cybersecurity Summit | June 9-10, 2026
• American Electronics & High-Tech Manufacturing Summit | June 16-17, 2026
• ...and more 2027 events!

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