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Karen Walker, Chief Technology Officer at Kyverna Therapeutics, shares insights into the groundbreaking potential of CAR T-cell therapy to transform the treatment of autoimmune diseases. In this fireside chat, she explores emerging science, early clinical progress, and what this next frontier could mean for long-term disease remission and patient outcomes.
Continue readingChris Crowell, VP and Global Head of Manufacturing at Kite, a Gilead Company, shares strategies for advancing manufacturing and innovation to drive productivity and reduce cost of goods. He explores how process improvements, modern technologies, and flexible, future-ready capabilities are reshaping biomanufacturing—illustrated through real-world examples of measurable impact.
Continue readingBirk Vanderweeën, Senior Vice President of Global Manufacturing & Supply at Legend Biotech, shares key lessons from launching commercial manufacturing for CARVYKTI™. He highlights the challenges that shaped critical decisions along the way and the insights now guiding the next phase of CAR-T production, scaling, and delivery.
Continue readingModerator Michael Thien, former SVP & Head of Pharmaceutical Sciences, R&D at Takeda, leads a discussion with Pat Yang, Chairman of Taiwan BioManufacturing Corp, and Ran Zheng, CEO of Landmark Bio, on fostering innovation in today’s rapidly shifting healthcare landscape. The panel explores innovative approaches to developing therapies for rare and ultra-rare diseases, integrating digital tools and automation into biomanufacturing, and driving cross-functional innovation amid evolving regulatory and supply chain pressures.
Continue readingMichalle Adkins, Director of Life Sciences Strategy at Emerson, shares how digital-first workflows, automation, and AI are transforming tech transfer from a bottleneck into a competitive advantage. She explores how connected platforms streamline recipe translation, optimize scheduling, and accelerate pipeline throughput by combining intelligent technology with human expertise.
Continue readingPascal Bécotte, Managing Director at Russell Reynolds, and Marie-Noëlle Gagnon, Chief Talent Officer at Cirque du Soleil Entertainment Group, share how Cirque’s creative heritage inspires leadership through ambiguity and change. They explore how open communication, trust, and a strong sense of purpose empower teams to stay resilient and adaptable in high-pressure environments.
Continue readingAdam Pfeiffer, Senior Vice President at Project Farma; Angela Goodenough, Executive Director of CMC, Analytical Development & Quality Control and Interim Head of Clinical Supply Chain at AnaptysBio; Jeff Davis, VP of Clinical Manufacturing at Gilead; and George Skillin, VP of Client Engagement at Project Farma, share how to build adaptive technical operations that can keep pace with the future of biomanufacturing. They explore how to strengthen internal and external partnerships, maximize innovation and efficiency, and balance quality with speed to market in an increasingly dynamic environment.
Continue readingRainer Haemmerle, Executive Director of Manufacturing at Boehringer Ingelheim Biopharmaceuticals GmbH, shares how strategic partnerships fuel agility and excellence in biomanufacturing. He explores how collaborative models accelerate new capabilities, strengthen responsiveness from development to commercial scale, and help biopharma companies navigate evolving market and regulatory pressures.
Continue readingHow will agentic AI reshape biopharma manufacturing by 2030? In this BMWS 2025 keynote, Merck EVP Sanat Chattopadhyay explores the future of cost-effective, intelligent process innovation across global manufacturing networks.
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Melissa previously served as the chief quality officer for Bristol Myers Squibb. In this role, she led the GPS Quality organization in setting the quality compliance strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality and compliance. Before joining Bristol Myers Squibb, Melissa was also the chief quality officer at Biogen. She has had prior roles providing oversight for QC laboratories and spent several years as the vice president of Corporate Quality, with responsibility for global compliance and quality systems as well as in-market Quality.
Melissa earned a Bachelor of Science degree in Biological Sciences and Biochemistry from North Carolina State University and an Executive Master of Business Administration degree from Duke University. She has over 25 years of experience in the quality arena, including quality positions at Novo Nordisk and Glaxo Smith Kline.
Melissa has been involved in influencing regulatory guidance through her participation on non-profit Boards of the Parenteral Drug Association since 2016, currently serving as chair-elect; as well as Rx-360 consortium focused on supply chain security vis-à-vis public health concerns and patient safety. She has been an advocate for simplification of post approval change processes, participating in industry forums, writing articles and interacting with regulators. She holds certifications from ASQ as a Certified Quality Auditor, Quality Engineer and Quality Manager.
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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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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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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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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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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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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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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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