Pharma Manufacturing World Summit

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.

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.

Karin Shanahan oversees worldwide product development, manufacturing and supply for Bristol Myers Squibb as executive vice president, Global Product Development & Supply (GPS). GPS develops and produces active ingredients and drug products and delivers the company’s medicines throughout the world. The GPS team achieves this mission through a relentless focus on innovation, quality, safety and agility.

“I’m excited to return to Bristol Myers Squibb, where I began my career in the pharmaceutical industry. Though I’ve worn many hats in the industry since then, I was drawn back to Bristol Myers Squibb because of its unwavering dedication to quality and delivering innovative medicines to patients in need,” says Karin. “I am honored to help lead the integral GPS team as we navigate an everchanging landscape.”

Karin began her career in the pharmaceutical industry at Bristol Myers Squibb in corporate procurement, global supply chain, and global quality. Karin moved into manufacturing operations, leading two manufacturing sites in Billerica, MA, and Latina, Italy. After almost 14 years with Bristol Myers Squibb, Karin joined Becton-Dickenson as a leader of global operations, followed by Catalent Pharmaceuticals where she led global Biologics operations. In 2013, Karin joined Teva Pharmaceuticals as senior vice president and chief operating officer of global operations, where she led global Manufacturing Science & Technology (MS&T) and Network Strategy and a network of 25 sites across Europe and the Americas. Most recently, Karin served as senior vice president of Global Biologics & Sterile Operations at Merck.

Karin earned a bachelor’s degree in political science and international relations from Rutgers University and a master’s degree in jurisprudence (MSJ), pharmaceutical and device law, from Seton Hall Law School.

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.

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.

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.

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.

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.

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.

Nicole Murphy is Executive Vice President, Pharmaceutical Operations and Technology of Biogen and joined the Executive Committee in 2022. Ms. Murphy joined Biogen in 2015 and has held senior executive positions, including most recently as Senior Vice President, Head of Global Manufacturing & Technical Operations (GMTO).  In 2017, Ms. Murphy played a critical role during the successful spin-off of Biogen’s hemophilia franchise, as the Vice President and Head of Technical Operations of Bioverativ and prior to the spin-off was the General Manager and Head of Cambridge Site Operations at Biogen. Ms. Murphy has extensive experience in leading Supply Chain, Quality, Process Development, Manufacturing and Engineering functions. Prior to joining Biogen Ms. Murphy spent over 15 years at Amgen.

Ms. Murphy holds an MS in Chemical Engineering, an MBA from Rensselaer Polytechnic Institute, and a BS in Engineering from the University of Massachusetts at Amherst. Ms. Murphy serves on a variety of industry councils and committees.

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.

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.