Pharma Manufacturing World Summit

Eamonn Warren serves as Group Vice President of API and Dry Products Manufacturing at Eli Lilly and Company, where he leads the global network of internal and external manufacturing sites responsible for active pharmaceutical ingredients and dry-product production. He assumed this role in 2024 and is a member of Lilly’s Manufacturing Leadership Team.

Eamonn began his career with Lilly in 1995 at the Kinsale manufacturing site in Ireland as an automation engineer. Over the course of nearly three decades, he has held roles of increasing responsibility across engineering, operations, Six Sigma, human resources, and site leadership. His international experience includes assignments in Puerto Rico, Indianapolis, Augusta in the state of Georgia, and the Fegersheim manufacturing site in France.

Prior to his current position, Eamonn served as the global lead for Lilly’s Parenteral Manufacturing Network, where he oversaw strategy, performance, and modernization across Lilly’s sterile manufacturing capabilities. He is recognized for championing advanced and innovative manufacturing approaches as well as for his focus on operational excellence, talent development, and regulatory rigor.

A native of Ireland, Eamonn holds a degree in Chemical Engineering from University College Dublin and a degree in Management and Marketing from University College Cork.

Dr Mire-Sluis is currently Head of Quality for Gilead Sciences. He was Head of Global Quality for AstraZeneca and Vice President, North America, Singapore, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland.

He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

Anne Kantardjieff, PhD, is Vice President and Head of CMC Development and Regulatory for Biologics and Advanced Therapies at Biogen. She is a seasoned biopharmaceutical executive with over 15 years of experience advancing complex biologics and cell and gene therapies from early development through global commercialization.

Anne is recognized across the industry for her expertise in CMC strategy, manufacturing scalability, and regulatory integration for advanced modalities. She leads global teams responsible for development, technical transfer, and regulatory CMC strategy across a diverse portfolio of biologics and ATMP programs, partnering closely with R&D, Quality, and Commercial Operations to enable reliable, inspection-ready supply and accelerated patient access.

Prior to Biogen, Anne served as Vice President of Manufacturing and MSAT at bluebird bio, where she led end-to-end supply and technical operations for four commercially approved autologous gene therapies—Zynteglo, Skysona, Abecma, and Lyfgenia. In this role, she oversaw external manufacturing partnerships, process validation, regulatory inspections, and commercial launch execution across multiple global markets.

Earlier in her career at bluebird bio, Anne drove strategic process improvements, expanded manufacturing capacity, and played a pivotal role in successful product approvals. She previously held leadership roles at Alexion Pharmaceuticals, where she led early- and late-stage process development teams and contributed to the commercialization of Strensiq, Kanuma, and Ultomiris.

Anne is known for building high-performing, collaborative organizations and integrating technical rigor with strategic decision-making to modernize manufacturing platforms and enable modality agility.

She holds a PhD in Chemical Engineering from the University of Minnesota and a Bachelor of Engineering in Chemical Engineering from McGill University. She is widely published and has held leadership roles within the American Chemical Society’s Biochemical Technology Division.

Hilary Marston, M.D., M.P.H., served for more than a decade as a leader and strategic advisor on national public health policy and is a recognized expert in the clinical and regulatory aspects of medical product and vaccine development. She brings this expertise to her work with biotechnology and drug companies and investors at Canal Row, and prior to this, at Marston Health, LLC, which she founded after her tenure in FDA leadership. 

Dr. Marston was FDA’s inaugural Chief Medical Officer, serving as the primary clinical advisor to the Commissioner and leading the office that oversees clinical matters involving multiple FDA product development centers, including financial incentives (e.g., for rare disease product development), targeted grantmaking, and research participant protection policy. She also led the Agency’s response to health crises, including epidemics and medical product shortages.

Dr. Marston previously served as Senior Advisor for Global COVID-19 Response on the White House COVID-19 Response Team, as Director for Medical Biopreparedness and Response at the U.S. National Security Council, and as Policy Advisor for Pandemic Preparedness at the National Institute of Allergy and Infectious Diseases. She also worked at McKinsey & Company and the Bill & Melinda Gates Foundation.

Dr. Marston trained in Internal Medicine and Global Health Equity at Brigham & Women’s Hospital. She completed her M.P.H. at the Harvard School of Public Health.

Joanne is a seasoned biotech executive with over 30 years of experience across large pharma and early-stage biotech in the areas of operations, leadership, product development, process development, clinical & commercial manufacturing, and supply chain. Over the course of her career, she has contributed to the licensure and commercialization of numerous medicines across different modalities and therapeutic areas. She has fostered high-performing, empowered individuals and teams and mutually beneficial partnerships with both internal and external stakeholders.

Before Halozyme, Joanne most recently served as the Chief Technical Officer at Abata Therapeutics, a company developing Treg cell therapies for serious autoimmune and inflammatory diseases.  Prior to Abata, she served as the Chief Technical Officer at Aerium Therapeutics, Inc. and as the Chief Operating Officer and interim CEO at Boston Pharmaceuticals. Previously, Joanne served as the Executive Vice President of Global Pharmaceutical Development and Operations at Celgene Corporation where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality functions. Joanne also served in leadership positions at other pharmaceutical and biotech companies, including Shire, Abbott Laboratories, Amgen, and Genentech. She has served as a member of the Board of Directors of public biopharmaceutical companies, including Orchard Therapeutics and Astria Therapeutics.

Joanne holds a Ph.D. in Biochemistry and Molecular Biology from Oregon Health and Science University and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.

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.