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As part of our Fall Events Season, the team headed to Boston to host our American Pharma Manufacturing & Outsourcing Summit!
Another Year, Another Successful Summit!
The 2024 American Pharma Manufacturing & Outsourcing Summit was held at the prestigious Westin Copley Place in Boston on November 18-19, bringing together over 120 senior executives from some of the world’s leading pharmaceutical companies!
Over two dynamic days, participants discussed the latest trends, emerging technologies, and key opportunities reshaping the pharmaceutical industry. The summit provided valuable networking opportunities and in-depth sessions on current challenges and innovations driving the pharmaceutical sector forward.
The pre-event Happy Hour kicked off the excitement, offering a relaxed setting for guests to network and connect. Sponsored by Emerson, the Happy Hour was the perfect start to build anticipation for the summit ahead.
Did you miss out on this year? Don’t worry—we’ve got you covered!
Here’s a quick recap of the summit's top moments and a sneak peek at what’s in store for next year.
Table of Contents
Day 1 Highlights
The first day started with a warm welcome and opening remarks from Chris Holt, VP of Vector and External Manufacturing Operations at Bristol Myers Squibb, Nicole Wagner, Ph.D., President and CEO of LambdaVision, and Roderico Estanislao, VP of Global Commercial Quality at J&J Innovative Medicine. The emcees set the stage by introducing the key themes of the summit: Pharma manufacturing, outsourcing, and quality.
After the opening remarks, Sandra Rodriguez-Toledo, VP of Site Operations at Amgen, delivered the opening keynote, titled “Reinventing Pharma Manufacturing: Driving Innovation and Operational Excellence.” Sandra’s keynote explored how the pharma manufacturing industry is evolving through advanced automation, data analytics, and continuous improvement strategies.
The summit then featured two insightful plenary sessions. Chris Milano, VP of Global Pharma Quality at Bristol Myers Squibb, and Marina Palumbo, Senior Director and Team Lead for External Supply at Pfizer, led a discussion on Differentiated Quality Oversight of Contract Manufacturing Organizations, focusing on tailored oversight to ensure optimal control and continuous improvement.
Next, Paul Cianciolo, COO at TraceLink, delivered an engaging plenary on Intelligent Orchestration of End-to-End Supply Chain, showcasing how real-time data and AI-driven solutions are enhancing supply chain visibility, resiliency, and risk management in the pharma industry.
After the first plenaries of the day, delegates enjoyed a networking refreshment break and pre-arranged 1-2-1 meetings, offering ample opportunities to discuss key takeaways and forge valuable connections at the summit.
The day continued with a series of three insightful speaking sessions that addressed critical aspects of industry pain points and key themes.
Kathleen Munster, Chief Quality Officer at Biogen, led a session on improving quality and compliance in outsourced manufacturing, focusing on effective collaboration, managing regulations, and maintaining strong relationships with contract manufacturers.
On the topic of outsourcing, Gil Roth, Founder and President of PBOA, addressed challenges in the CDMO sector, including navigating regulatory changes, the rise of onshoring, and improving supply chains and risk management.
Andrew Chang, VP of Quality and Regulatory Compliance, Regulatory Policy and Intelligence, and Global Regulatory Affairs at Novo Nordisk, shared insights on harmonizing policies, integrating innovative quality approaches, and collaborating with regulatory authorities to ensure global standards and industry excellence.
By noon, attendees switched gears by participating in engaging workshops!
Gus Labella, Director of Formulation Development at Mikart, discussed solutions for swallowing and palatability issues, focusing on patient-friendly dosage forms and innovative taste-masking strategies. In another session, Jim Watson, VP of ProjectFarma, Gregory Sukay, VP of Manufacturing & Process Technologies at Arcutis Biotherapeutics, and Brandon King, Director of Site Operations at Sanofi, explored Optimizing Facility Planning for next-gen medicines, covering best practices and emerging technologies. Meanwhile, Mitchell Slade, COO of PL Developments and President of PLD Gummy Co. at Avéma Pharma Solutions, shared insights on Developing Gummy Delivery Systems, highlighting their potential for OTC and Rx drugs, especially for children and seniors.
As the afternoon progressed, it was time for engaging roundtable discussions featuring Adam Baldwin, Manager of Formulation Development at Coating Place, Paul Cianciolo, Chief Operating Officer at TraceLink, William Hermans, Senior Director and General Manager of Large Molecule Development at Curia, Mike Molloy, Director, Technical at BA Sciences, Jeff Barnes, Senior Director of Drug Product BD at Alcami Corp., Bernardo Estupiñán, Senior Director and Managing Partner of the Large Molecule Department at Pyramid Labs, Harshawardhan Ball, President of CDMO Business and Interchem Corp. Contractor at Interchem Corp., Tom Sato, Senior Executive Director of Global Sales and Marketing at Bushu Pharmaceuticals, and William Monteith, Executive Advisor at Kymanox.
After enjoying some delicious food and sharing lots of valuable insights, we returned to more speaking sessions.
Manda Pasarkar, Director of Global Regulatory Affairs, CMC at Sanofi shared strategies for integrating global CMC regulatory requirements to ensure product quality and compliance. Luiz Alberto Barberini, Latin America's Head of External Manufacturing at Bayer Consumer Care discussed building strong supplier relationships and governance models for reliable manufacturing compliance. Colin Baker, SVP of Quality Assurance of Bimeda focused on enhancing quality assurance in pharma manufacturing.
In a series of insightful workshops, Arul Ramadurai, Chief Commercial Officer at Axplora, explored new approaches to API partnerships, focusing on faster delivery of GLP-1s and ADCs through agile CDMO collaborations.
Paul Cianciolo, Chief Operating Officer at TraceLink, and Bharath Sundararaman, General Manager at TraceLink, demonstrated how digital integration improves supply chain resiliency by leveraging business-to-network integration for real-time intelligence, better inventory control, and reduced operational costs.
Finally, Bob Lenich, Director of Process and Knowledge Management Business at Emerson discussed managing tech transfer data as a product, showcasing its potential to revolutionize digital processes in the industry.
Women in Leadership Panel
The Women in Leadership panel was one of the day's most impactful sessions, with an inspiring discussion from top leaders in the pharmaceutical industry. Sandra Moreira, VP of Quality Head, NA at Bayer, Nicole Wagner, Ph.D., President and CEO of LambdaVision, Sandra Rodriguez-Toledo, VP of Site Operations at Amgen, Odile Smith, VP and Site Head of Devens Campus at Bristol Myers Squibb, and Manda Pasarkar, Director of Global Regulatory Affairs, CMC at Sanofi, shared valuable insights on career and leadership. They discussed overcoming career barriers, adapting leadership approaches during times of disruption, and the best advice they’ve received in their career.
The panelists also reflected on the importance of resilience, collaboration, and mentorship in their leadership journeys. Their personal stories inspired the attendees, emphasizing the significance of empowering women in decision-making roles to drive change in the pharmaceutical industry.
The following panel on Transforming Global Pharmaceutical Manufacturing Operations featured leaders: Heath Christie, Executive Director of AstraZeneca, Ian Neal, Director of Supply Chain and Global External Operations at BioMarin Pharmaceuticals, Judd Taylor, Director and Head of Tech Transfer and Process Validation at Takeda, Jacob Greenwood, VP of ProjectFarma, and Nikolai Makaranka, Director of Manufacturing Analytics at Bristol Myers Squibb.
They discussed industry trends, agile strategies, and the role of digital technologies in driving improvement. Key topics included managing risks in 24/7 manufacturing and expanding site capacity, with an emphasis on leadership and operational excellence.
The day concluded with closing remarks and a Networking Drinks Reception, sponsored by Bionova Scientific.
Day 2 Highlights
Day 2 kicked off with a delicious networking breakfast, setting the stage for the exciting program ahead!
Chris Holt, VP of Vector and External Manufacturing Operations at Bristol Myers Squibb welcomed everyone with engaging opening remarks, highlighting the exciting agenda of the day.
Roderico Estanislao's opening keynote provided an in-depth exploration of the critical role last-mile delivery and commercial quality management play. This was followed by an engaging plenary session from Brian Fahie, VP and Global Head of Quality Control at Biogen, who shared insights into how Biogen is leading the way in analytical development to revolutionize global manufacturing.
After a networking break with refreshments and pre-arranged 1-2-1 meetings, the sessions continued with a strong focus on emerging technologies.
Nikolai Makaranka, Director of Manufacturing Analytics at Bristol Myers Squibb, led an insightful session in Room 1 on AI adoption in manufacturing, while Krishna Kotha, Director of Technical Quality Assurance at Organon, explored in Room 2 how to drive continuous improvement and a culture of excellence in quality. Adriana Sardella, Director of Global External Operations at Apotex, shared strategies for enhancing supply chain resilience, and Rao Tatapudy, Director of Technical Services Operations at Mallinckrodt, along with Dave Livingston, Head of Quality at Mallinckrodt, covered strategic product development and tech transfers in both generic and branded pharmaceuticals.
Attendees then enjoyed lively lunch & learn roundtable discussions, led by top experts: Judd Taylor, Director and Head of Tech Transfer and Process Validation at Takeda, Marina Palumbo, Senior Director and Team Lead of External Supply Operations, Quality at Pfizer, Ian Neal, Director of Supply Chain and Global External Operations at BioMarin Pharmaceuticals, Manda Pasarkar, Director of Global Regulatory Affairs, CMC at Sanofi, Marcus von Rechenberg-Paulsson, Senior Manager of Global Supply Chain at Takeda, Sandra Moreira, VP of Quality Head, NA at Bayer, Julia Zhou, VP of Quality Assurance at Bristol Myers Squibb, Brian Gregory, Director of QC Cell and Gene Therapy at Vertex, and Anna Jenks, Director of Pharmaceutical Operations and Clinical Supply at Merck.
These roundtables covered key topics, including streamlining tech transfer to enhance efficiency while maintaining quality, leveraging digital tools for quality monitoring, and optimizing supply chains using AI and machine learning. Experts also discussed navigating FDA inspections, building high-performing quality control teams, and optimizing oral solid dosage production in clinical manufacturing.
The afternoon agenda continued with an engaging panel discussion with Judd Taylor, Director and Head of Tech Transfer and Process Validation from Takeda, Ian Neal, Director of Supply Chain and Global External Operations of BioMarin Pharmaceuticals, Manda Pasarkar, Director of Global Regulatory Affairs, CMC from Sanofi, Marcus von Rechenberg-Paulsson, Senior Manager of Global Supply Chain at Takeda, Sandra Moreira, VP and Quality Head, NA from Bayer, and Marina Palumbo, Senior Director and Team Lead of External Supply Operations, Quality from Pfizer, who shared insights from the roundtable discussions and offered valuable takeaways on streamlining tech transfer, integrating AI, and improving quality culture.
What followed was an inspiring Diversity, Equity, Inclusion and Belonging panel, featuring Suki Toguchi, Chief of Staff at Gilead Sciences, and Nidhi Chaudhary, Global Head of DEI, Culture, and Community at CSL. They discussed actionable strategies for fostering diversity in the workplace and how leaders can drive meaningful DEI initiatives within their organizations.
The event concluded with closing remarks from our incredible emcee, Chris Holt, who also announced the winners of our survey prize giveaway. Congratulations to Brian Gregory and Randall Sookoo on their well-deserved wins!
We also want to express a special thank you to Nicole Wagner, Ph.D. and Roderico Estanislao for their remarkable support throughout the day emceeing the breakout rooms.
Conclusion
We are thrilled to celebrate the success of this year's event!
A huge thank you to all the esteemed experts, delegates, and sponsors who made this Summit an extraordinary experience. Your unwavering support and enthusiasm have been the driving forces behind the success of this event, and we’re excited to carry this momentum into the 9th Annual American Pharma Manufacturing & Outsourcing Summit.
We hope these two days of insight and innovation left a lasting impact on you, as it certainly did for us. If you couldn’t join us this year, we invite you to express your interest in participating next year—it's never too early to get excited about what’s to come!
SEE YOU NEXT YEAR: American Pharma Manufacturing & Outsourcing Summit | November 17-18, 2025, Boston
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Visit the Summit’s website to learn more and secure your pass today!
Don’t miss out on next year—early registration is now open for attendees, solution providers, and speakers! Stay connected by checking out our event calendar at generisgp.com/events.
Testimonials
“This conference was a great way to connect individually with industry leaders and solve business solutions in a laid-back comfortable environment.”
Randall Sookoo, Senior Global Data Analytics Lead, Johnson & Johnson
“I enjoyed the interesting talks, especially as they were from senior leaders.”
Brian Gregory, Director, QC Cell and Gene Therapy, Vertex
“It’s a great opportunity to connect with industry peers and get a chance to meet CMOs!”
Johnny Zhang, Director, Clinical Supply, CEREVEL/Abbvie
“Wonderful networking!”
Julia Zhou, VP Quality Assurance, Bristol Myers Squibb
“Overall a good experience! The topics are relevant within the industry and there are good opportunities to network.”
Rishabh Sachdeva, Director of Business Development, Coating Place
“Generis’ meetings are among the top ones in the Pharmaceuticals industry based on high-level presenters and the networking provided.”
Luiz Alberto Barberini, Operations Manager, Bayer
“Great networking. Insightful talks!”
Julie Hilton, Business Development, Pyramid Labs
“Very good, well-curated pre-arranged meetings and a well-targeted audience of attendees.”
Chris Adkins, Business Development Manager, Kymanox
Learn more about our upcoming North American events and secure your spot today:
- 11th annual American Manufacturing Summit | March 19-20, 2025
- 11th annual American Biomanufacturing Summit | April 15-16, 2025
- 9th annual American Supply Chain Summit | May 1-2, 2025
- ...and more 2025 events!
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