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LIFE SCIENCES

Supporting AZ’s Bold Ambition: Scaling Advanced Therapies for Success
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Supporting AZ’s Bold Ambition: Scaling Advanced Therapies for Success

June 3, 2025

Sheena Behn is an established global leader in the Pharmaceutical Industry with significant supply chain, manufacturing and development experience and expertise. She has worked at AstraZeneca for 25 years.

Sheena is currently VP Vaccine and Immune Therapies Supply Chain and VP for Oncology Supply, based in Cambridge, UK.

She was previously based in Gothenburg as VP R&D Supply Chain (2012-2014) running the global group for Clinical Supply at AZ; and before that VP for Wuxi Manufacturing site for 3 years, based in China (2010-2012).

Sheena is a Pharmacist who started her career working in London hospitals, before working in pharmaceutical development with GSK and then AZ before joining Operations in 2007.

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Managing Pharma Supply Chains to Navigate Tariffs
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Managing Pharma Supply Chains to Navigate Tariffs

June 3, 2025

Allyson Nicholson is a seasoned biopharmaceutical executive with 29 years of experience in end-to-end supply chain management, business reengineering, and digitalization, across a wide range of industries including banking, airline, food, public sector, consulting, and pharmaceutical. Allyson has a proven track record in process improvement, large systems implementations, and mergers and acquisitions. With extensive experience in clinical and commercial supply chains, Allyson has successfully led product commercialization and in-market execution, ensuring supply reliability.

Currently, Allyson serves as the Head of Global Supply Chain at BioMarin Pharmaceutical, where she is responsible for the successful execution and services of all global supply functions ensuring supply to patients for their commercial portfolio and pipeline candidates.

Outside of work she enjoys cooking, learning about wine, skiing and walking in a beach somewhere. She currently lives in Boston with her husband, two young-adult children, and their two dogs.

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Transforming Global Operations: Accelerating Production and Innovation at BMS
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Transforming Global Operations: Accelerating Production and Innovation at BMS

June 3, 2025

Catalina Vargas is Senior Vice President and Global Supply Chain (GSC) Lead at Bristol Myers Squibb (BMS). A global pharmaceutical executive with more than 20 years of experience, Catalina currently leads a talented team, working to seamlessly deliver medicines to patients in more than 50 countries around the world. Under her leadership, Catalina has built a highly synchronized, transparent and sustainable supply chain organization.

Catalina joined BMS in 2018 as Vice President, Strategic Sourcing and Procurement, Global Product Development and Supply, where she managed a complex supply chain to bring critical medicines to patients. During her time in this role, BMS acquired Celgene, which at the time was the largest deal in biopharma history, and Catalina successfully integrated the Celgene and BMS sourcing and procurement groups.

Immediately prior to her current role leading GSC, Catalina was Chief of Staff to the CEO of BMS where she led strategic enterprise-wide initiatives and advanced the leadership team’s governance and decision-making model. With an exceptional record of building high performing and agile global teams, Catalina is a passionate advocate for inclusion.

Prior to joining BMS, Catalina was with Pfizer for 17 years, where she was tapped for leadership positions across strategic sourcing, operations, and external manufacturing.

Catalina has a bachelor’s degree in industrial engineering and a graduate degree in finance and capital markets.

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Resilient Operations in a Changing World: Innovation with Purpose
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Resilient Operations in a Changing World: Innovation with Purpose

May 29, 2025

Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing and technology transfer, as well as plant manager for the cell culture facility.

Paulino holds a Bachelor of Science degree in Biochemistry from Marquette University.

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From Platform Excellence to Personalized Oncology: Shaping the Next Era of mRNA Science and Manufacturing at Moderna
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From Platform Excellence to Personalized Oncology: Shaping the Next Era of mRNA Science and Manufacturing at Moderna

May 29, 2025

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible for the technical development, quality, and supply of preclinical, clinical and commercial programs within Moderna’s portfolio.

Dr. Collins joined Moderna from Novartis, where he held roles of increasing responsibility over the last nearly 30 years, focused on pharmaceutical production and manufacturing, including roles serving as Head of Global Chemical Operations and Anti-Infectives and as Head of Global Chemical Operations.

Dr. Collins received his Bachelor of Science in Chemistry and his Ph.D. in Organic Chemistry from University College Cork, Ireland. He also conducted post-doctoral cancer research at Arizona State University.

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Regulatory Instability’s Impact on Drug and Biologics Manufacturing

May 29, 2025

Alexander Gaffney is a regulatory and media executive responsible for founding and leading the research division of AgencyIQ, the regulatory analysis division of the media company POLITICO. As the Vice President of Regulatory Policy and Intelligence, Alexander directs the division’s analysis of regulatory issues affecting pharmaceutical, biotechnology, medical device, chemical and food companies.

Before joining AgencyIQ, Alexander analyzed life sciences regulations as part of PricewaterhouseCoopers’s Health Research Institute and was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also served as Managing Editor for the company’s flagship publication, Regulatory Focus.

Alexander is regularly asked to speak to executive audiences about life science regulatory policy developments and his analysis and work (including his daily newsletter, FDA Today) is relied upon by many of the country’s top life sciences companies, law firms, trade associations, regulatory professionals, legislative staffers and public health officials. He has a master’s degree in Regulatory Science from the University of Maryland and his Regulatory Affairs Certification (RAC) in US regulation. He also serves as the co-chair of the Drug Information Association’s (DIA) Regulatory Policy and Intelligence Community and the Chair of RAPS’ Regulatory Intelligence Conference.

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Bold and Unafraid: Lessons in Leadership and the Value of Manufacturing in Building the Next Great Biotech
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Bold and Unafraid: Lessons in Leadership and the Value of Manufacturing in Building the Next Great Biotech

May 29, 2025

Tim Maines joined Alnylam in August 2017 as the Global Head of Quality Assurance and Quality Control and was promoted to Chief Technical Operations and Quality Officer in April of 2023, holding over 35 years of experience. Prior to joining Alnylam, Tim was a member of the senior leadership teams at Ariad Pharmaceuticals, Omthera Pharmaceuticals, Astra Zeneca/MedImmune, GTC Biotherapeutics (formerly Genzyme Transgenics) and Stryker Biotech where he provided strategic input and independent quality and technical oversight of each company’s global GxP operations. In total, these experiences resulted with the commercialization and market expansion of thirteen novel medicines, including four FDA-approved therapies at Alnylam.

Tim holds a Bachelor of Science in Biology/Microbiology from Gannon University.

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Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine
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Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine

May 29, 2025

Evaluating which production platforms will be most effective for emerging modalities, such as rAAV gene therapies
Considering the next steps for established platforms like mAbs, ADCs, and mRNA: How can we efficiently address significant markets, such as treatments for Alzheimer’s
Examining the changes within the CMC ecosystem and assessing whether we are once again overextending our capacity
Addressing the risks of fragmentation: How can we improve communication, collaboration, and the consolidation of our best ideas to ensure collective success?
Discussing the motivations for launching new companies today and envisioning the future growth and evolution of our business ecosystem

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Fireside Chat: Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership and Cell Therapy Success
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Fireside Chat: Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership and Cell Therapy Success

May 30, 2025

Dr. Joanne Beck is currently Chief Technology Officer at Abata Therapeutics. Prior to this, she served as Chief Technology Officer at Aerium Therapeutics and COO at Boston Pharmaceuticals, a private company developing candidates across multiple indications in cardiometabolic, oncology, and immune/inflammatory diseases. Prior to joining Boston Pharmaceuticals, she was Executive Vice President of Global Pharmaceutical Development and Operations at Celgene where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics and Astria Therapeutics.

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Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing
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Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing

May 30, 2025

Dr. Jack Prior leads MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he spearheads global initiatives in process monitoring and AI-driven yield improvement for biologics manufacturing. Previously as Head of MSAT Digital, he led teams working to develop global process data analytics systems and to digitize laboratory operations for Industrial Affairs Specialty Care drug substance and drug product manufacturing.

His leadership spans nearly three decades at Sanofi-Genzyme, where he has led manufacturing science organizations supporting process characterization, modeling, technology transfer, and manufacturing operations for critical therapies treating rare genetic disorders. Throughout his career, he has focused on integrating process modeling and advanced analytics with manufacturing science to enhance biologics production across US and European operations. He has led manufacturing science teams supporting multiple tech transfers across the Sanofi network, including the team supporting transfer to a new continuous single-use digital facility, while advancing approaches to process modeling and scale-up.

Dr. Prior holds a Doctor of Science in Chemical Engineering from MIT, where his research in data reconciliation for bioprocess development laid the foundation for his work in process monitoring and control. His current work continues to advance manufacturing science through the integration of digital technologies, process modeling, and AI in biologics manufacturing.

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Using Innovation to Accelerate & Optimize Your Drug Manufacturing Scale-Up Strategy
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Using Innovation to Accelerate & Optimize Your Drug Manufacturing Scale-Up Strategy

May 30, 2025

Joe Goodman is the General Manager of the Americas region for Honeywell Life Sciences, where his team partners strategically with the company’s global clients and prospects, identifying the quality and manufacturing system solutions that best fits their needs. Joe is recognized as a thought leader in the fields of quality systems, regulatory compliance, and the implementation of enterprise software within the Life Sciences manufacturing industry. Before joining Honeywell, Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black Belt. He owes much of his penchant for process and solution design to his time spent in that role. Joe also speaks internationally at Compliance and Manufacturing events.

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Building Audit-Ready Facilities: Quality Leadership from Design to Commercial Launch
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Building Audit-Ready Facilities: Quality Leadership from Design to Commercial Launch

May 30, 2025

LeeAnn Chrisco is an accomplished Quality Assurance executive with over 20 years of leadership in GMP manufacturing and compliance. As Director of Quality Assurance at INCOG Biopharma Services, she provides strategic QA oversight across manufacturing, packaging, and quality control, ensuring global regulatory compliance. LeeAnn has led audit readiness, regulatory agency interactions, and facility startups for clinical and commercial operations. Her expertise spans technical transfer, aseptic processing, and quality systems innovation. A contributing author to ISPE and BioPhorum publications, LeeAnn brings deep industry insight and a passion for building high-performing quality cultures in fast-paced, regulated environments.

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Performance Management Beyond Limits: Elevating Operations Excellence Globally
LIFE SCIENCES

Performance Management Beyond Limits: Elevating Operations Excellence Globally

March 3, 2025

Chester Zelaya is the Senior Vice President of Implant Network Global Operations at Edwards Lifesciences, overseeing global facilities that support both Surgical Heart Valve and Trans-Catheter Divisions. With over 30 years of leadership experience in the biopharmaceutical and medical device industries, Chester has a proven track record of driving operational excellence across diverse, multi-plant environments. Prior to joining Edwards, he held senior roles at Shire and Baxter, where he managed large-scale plasma manufacturing operations and led significant global initiatives. Chester also serves as a board member for Heart to Heart Global Cardiac Care, helping to expand access to life-saving cardiac treatments in underserved regions. His strategic vision, technical expertise, and commitment to building high-performing teams contribute to his success as a leader in the healthcare industry.

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How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better

January 23, 2025

In the run-up to the 2025 edition of the Medical Device Manufacturing Excellence Summit series we spoke with Shawn McCarthy, Jessica Swanson, and Peggy Hansen of Regenity Biosciences about exciting developments in the Medical Device space, with a particular emphasis on both the power of collaboration and the importance of a regulatory strategy. Regenity is an industry-leading CDMO working with 120 different industry partners and offering special expertise in regenerative devices. In this wide-ranging conversation we talk about industry trends, how medical device manufacturers are evolving to continue to meet the needs of patients, and also about some of the big ideas Regenity wants to share with the executives attending MDMES25. For all this and more, give this episode a listen!

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The Speaker Roundtable from BMWS24 — A Conversation About Biopharmaceutical Manufacturing Issues and Ideas
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST, ROUNDTABLES

The Speaker Roundtable from BMWS24 — A Conversation About Biopharmaceutical Manufacturing Issues and Ideas

December 13, 2024

For this special episode of Executive Platforms’ bluEPrint Podcast series we had some of the most senior speakers and delegates from the 2024 edition of the long-running Biomanufacturing World Summit series sit down and speak to the challenges and opportunities submitted by attendees of the event as they filled out their delegate profiles, weighted by popularity.

With topics ranging from leadership and culture, to talent attraction, development and retention, to supply chain issues, to commercializing CGTs and other ATMPs, change and disruption throughout the business landscape, and how to serve patients better now and in the future, this wide-ranging conversation sees five senior executives from five very different companies speaking to the issues, ideas, innovations, and inspirations that matter to all of them as guided by a moderator who knows the industry inside and out. It is a fantastic deep dive into what is most relevant to biopharma technical operations leaders today. Give it a listen!

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Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances
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Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances

November 27, 2024

Sanat Chattopadhyay is responsible for the company’s (approx. $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

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