2025 Speakers

Pam Cheng

Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. Under her leadership, AstraZeneca Global Operations has transformed significantly driving top performance across the business while delivering value back to the enterprise.  The next phase of transformation includes the convergence of operational excellence and digital innovation, building the ‘Factory of the Future’.

Before AstraZeneca she spent 18 years in global manufacturing, supply chain, and commercial roles at Merck/MSD. As president of MSD China, she was responsible for MSD’s entire business in China—sales and marketing, commercial operations, and oversight of manufacturing and research and development. Prior to that, she was head of Global Supply Chain Management and Logistics for Merck and led the transformation of Merck supply chains across the global supply network.  Before joining the Biopharmaceutical industry, she worked in engineering and project management roles at Universal Oil Products, Union Carbide Corporation, and GAF Chemicals.

In addition to her executive role at AstraZeneca, Pam is a nonexecutive director for the board at Smiths Group plc.

Ms. Cheng holds bachelor’s and master’s degrees in chemical engineering from Stevens Institute of Technology and an MBA in marketing from Pace University.

Pam Cheng

Executive Vice President, Global Operations & Information Technology

AstraZeneca

Melissa Seymour

Melissa Seymour is executive vice president, Global Quality for Eli Lilly and Company.

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.

Melissa Seymour

Executive Vice President, Global Quality

Eli Lilly

Catalina Vargas

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 team of more than 800 employees working to seamlessly plan and deliver medicines to patients in more than 50 countries around the world, from clinical through commercial for all modalities.

Prior to her current role, Catalina was Chief of Staff to the CEO of BMS where she led important strategic enterprise-wide initiatives. Catalina has an exceptional record of building high performing and agile global teams, and she is a passionate advocate for diversity and inclusion. In her Chief of Staff role, she led BMS’ diversity and inclusion commitments, which included areas such as clinical trial diversity, health equity, workforce representation, employee giving and supplier diversity.

Catalina joined BMS in 2018 as Vice President, Strategic Sourcing and Procurement, Global Product Development and Supply, where she managed a complex supply chain of external suppliers to bring critical medicines to patients. During her time in this role, she successfully integrated the Celgene and BMS sourcing and procurement groups.

Prior to joining BMS, Catalina was with Pfizer for 18 years, where she was tapped for progressive leadership positions across strategic sourcing, global procurement and external manufacturing.

Born and educated in Colombia, Catalina has a bachelor’s degree in industrial engineering and a graduate degree in finance and capital markets. She currently serves as an associate board member for the Congressional Hispanic Caucus Institute (CHCI).

Catalina Vargas

Senior Vice President, Global Supply Chain

Bristol Myers Squibb

Jerh Collins

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.

Jerh Collins

Chief Technical Operations & Quality Officer

Moderna

Charles L. Cooney

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

Joanne Beck

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.

Joanne Beck

Chief Technical Officer

Abata Therapeutics

Ingrid Markovic

Ingrid Markovic, Ph.D. serves as Senior Science Advisor and CMC Policy Lead at the Center for Biologics, US FDA where she is responsible for providing leadership, strategic direction, and oversight for development, implementation, and integration of CMC policies for complex biologics.

In the international arena, Ingrid serves as CBER ICH Quality Lead, and is/was FDA Topic Lead for M4Q, (co)Lead for QDG and Q12. She also had an opportunity to serve as Q3E Rapporteur briefly.

Ingrid previously worked in the industry sector leading US & EU CMC Regulatory Policy efforts with focus on Technological Innovation and Cell & Gene Therapies collaborating with Trades Associations to support continual improvement and innovation in the Biopharmaceutical sector.

Ingrid completed her Ph.D. at University of Wisconsin, Madison and Post-Doctoral Training at the Laboratory of Cellular and Molecular Biophysics at the National Institutes of Health, Bethesda, MD.

Ingrid Markovic

Senior Science Advisor/CMC Lead

FDA

Bilal Arif

Bilal Arif joined Sarepta in 2019 as senior vice president, head of strategy and technical operations where he was central in helping grow the technical operations team and building the Company’s manufacturing capabilities. He was named chief technical operations officer in December 2022. As head of technical operations, Bilal is responsible for the Company’s CMC strategy and global supply chain management for its RNA and gene therapy portfolio.

Having dedicated his entire career to the strategic and operational aspects of manufacturing, Bilal is a well-regarded and recognized leader with over 20 years of relevant biotech, pharma and management experience, including serving as vice president, product strategy & planning, technical operations at Shire. During his tenure at Shire, Bilal served as a member of the technical operations leadership team. His experience spans across supporting early clinical-stage programs through to market authorization. At Shire, Bilal was also responsible for leading the TechOps team responsible for conducting due diligence/integration of new technologies and M&A assets.

“My interest in manufacturing and technical operations is matched by my desire to be a part of the most exciting and promising areas of scientific innovation, which was the primary driver for joining Sarepta. I love the pace, which supports the idea that we are truly dragging tomorrow into today for patients. For these reasons and many more, being at Sarepta in this role and at this time, has been and continues to be a real highlight of my career.”

In touching upon his vision for Sarepta’s CMC strategy, Bilal cited proactive management, preparedness, quick decision making, and recognizing the importance of teamwork as being a promising formula for success.

“Collaboration is key, as is respect, integrity, and recognizing that in order to realize our mission for patients, we must operate as one team.”

Bilal received his Bachelor of Engineering degree in chemical engineering from McGill University, a Master of Science in Biotechnology from Tufts University, and an MBA from Brown University’/Instituto de Empresa (IE) Business School.

Bilal Arif

Executive Vice President, Chief Technical Operations Officer

Sarepta Therapeutics

Brendan O’Callaghan

Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of Sanofi’s diverse pipeline, to build world-class standards of manufacturing and supply chain excellence and to future proof Sanofi’s manufacturing network, leveraging the latest digital, process and technology solutions, to ensure the continued reliable supply of essential, high-quality medicines to patients worldwide.

Brendan joined Sanofi in 2015 and was previously our Global Head of Biologics and Manufacturing and Supply head of the Specialty Care portfolio. He has played a key role in supporting our transformation to a fully integrated BioPharma company and advancing the digital transformation of our manufacturing network, notably the Framingham site in the US, which was awarded the prestigious International Society for Pharmaceutical Engineering Factory of the Future and Facility of the Year Awards in 2020.

Prior to Sanofi, Brendan worked at Schering-Plough before moving to Merck / MSD as Head of Biologics and later Vice President of its Europe, Middle East and Africa Operations.

Brendan graduated in chemical engineering from the University College of Dublin, where he currently serves as an honorary adjunct Professor of Chemical and Biochemical Engineering.

He is married with four sons. A keen sports enthusiast, Brendan is a UEFA qualified soccer coach, with a specialization in Goalkeepers.

Brendan O’Callaghan

Executive Vice President, Head of Manufacturing & Supply

Sanofi

Kathleen Munster

Kathleen is a Biopharmaceutical leader with experience in small biotech and global Fortune 500 companies including bluebird bio, Intercept, BMS, Catalent, and now Biogen. She has developed and led site and HQ-based teams spanning Quality, IT, Product Development, and Supply Chain functions. She has deep expertise in managing Health Authority inspections and has tackled strategic and operational challenges, from global business process implementation to managing day-to-day operations. Kathleen enjoys solving complex problems, managing large organizations, and aligning teams on the most effective path forward that ensures compliance and enables the business.

Kathleen Munster

Chief Quality Officer

Biogen

Arleen Paulino

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.

Arleen Paulino

Senior Vice President Global Manufacturing

Amgen

Timothy Maines

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.

Timothy Maines

Chief Technical Operations & Quality Officer

Alnylam Pharmaceuticals

Steve Johnson

Steve Johnson

Vice President Quality Assurance

Ultragenyx

Erica Olson

Erica Olson

Senior Vice President, Global Supply Chain

Gilead Sciences

Chris Stevens

As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team of dedicated professionals working together in manufacturing and technical operations, supply chain, quality and compliance to deliver transformational therapies for patients globally. Chris is also responsible for capital investments, engineering, EHS, real estate and facilities management across the enterprise.

Since joining Spark in 2017, Chris has effectively led teams in several key areas, initially serving as Head of Manufacturing where he led the development of Spark’s manufacturing network through the filing and launch of Luxturna, the first approved gene therapy for genetic disease in both the US and EU. Later, Chris held the role of Asset General Manager, Hemophilia A where he had end to end responsibility for Spark’s Hem A program before being promoted to Head of Product Strategy where he led the team responsible for all programs in Spark’s portfolio. Chris was appointed Chief Patient Supply Officer for Spark in the fall of 2022.

With more than 25 years’ end to end leadership experience in gene therapy, biotech, pharmaceutical and consumer products industries, Chris is an industry veteran with deep expertise in designing and operating supply chains in complex regulatory environments, manufacturing science and technology, technology transfer, quality, compliance, product strategy and P&L management.

Prior to Spark, Chris led teams at GlaxoSmithKline (GSK) focused on strategy, operations and planning, as well as GMP clinical manufacturing operations including process transfer and cell banking. Earlier in his career he held roles of increasing responsibility at Bristol-Myers Squibb (BMS) in process engineering, manufacturing and supply chain in Massachusetts, Indiana and Puerto Rico.

Beyond his role with Spark, Chris currently serves as President of the Board at A Haven – a non-profit family grief center in Chester County, Pennsylvania. He received his M.S. in Industrial Management from the University of Southern Indiana and a B.S. in Chemical Engineering from Purdue University.

Chris Stevens

Chief Patient Supply Officer

Spark Therapeutics

Paul Testa

Paul Testa

Executive Vice President Supply Chain & Operations

Kyowa Kirin

Magaly Aham

Magaly Aham

Senior Vice President, Head Global Quality Compliance & Systems

Takeda

Allyson Nicholson

Allyson Nicholson

Vice President Global Supply Chain

BioMarin

Vijay Raju

Vijay Raju joined Pioneering Medicines / Flagship Pioneering as Vice President, CMC in 2022. He is responsible for the technical development of the therapeutic portfolio across modalities in collaboration with internal project teams, Flagship platform companies and biopharma partners.

Prior to Flagship, Vijay was with Novartis for more than 14 years in various roles including Vice President, NCE Analytical R&D where his team contributed to an industry leading portfolio resulting in multiple marketing approvals. He was the sponsor of an industry top-tier CMC digital transformation program that enabled new ways of working and operational efficiencies. Earlier, he contributed to CMC strategy that included acquisitions / divestitures, building new capabilities and evolution of sites across the globe (in US, Europe & Asia). Before Novartis, Vijay was with Boehringer Ingelheim where he was responsible for commercialization of oral and inhalation products.

Vijay Raju

VP CMC

Pioneering Medicines / Flagship Pioneering

Inna Ben-Anat

Inna Ben-Anat is the Global Head of Smart Factories at Sanofi Manufacturing and Supply. In this role, Inna defines the vision and roadmap for Smart Factories, partnering with Digital and Business Units to achieve best-in-class performance through smart and sustainable manufacturing and digitization. Leveraging advanced technologies and AI throughout simplified and standardized industrial processes enables affordability and robustness of medicines and vaccines supply for the patients.

Previously, Inna served as the Head of Global Manufacturing Strategies and Technologies at Amgen. Before that, Inna was the Global QMS Technology Transfer and Commercialization Head at Merck, following 11 years at Teva in various leadership roles, including Head of the MS&T organization within the Americas operation, Head of Product Robustness, and Global QBD Strategy.

Inna holds an M.Sc. in Quality Assurance and Reliability and a B.Sc. in Chemical Engineering, both from Technion, Israel Institute of Technology.

Inna Ben-Anat

AVP, Global Head Connected Smart Factories, Manufacturing & Supply

Sanofi

Sunny Patel

Sunny Patel

Director, Global Supplier Quality Management

Gilead

Christine Goldschneider

Christine Goldschneider

Vice President of Manufacturing & Supply Specialty Care Head of Alliances and Dupixent Franchise Leader

Sanofi

Executive to be Announced

Executive to be Announced

Project Farma

Executive to be Announced

Executive to be Announced

Boehringer Ingelheim

Executive to be Announced

Executive to be Announced

MasterControl

Executive to be Announced

Executive to be Announced

Redaptive Sustainability Services LLC

Executive to be Announced

Executive to be Announced

Axplora

Executive to be Announced

Executive to be Announced

INCOG BioPharma Services, Inc.

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