Speakers

Edgardo Hernandez (he/him/his) is executive vice president at Eli Lilly and Company and president of manufacturing operations.

Ed served as senior vice president of global parenteral drug product, delivery devices and regional manufacturing from 2018 until 2021. In this role, he was responsible for global parenteral manufacturing, emerging markets manufacturing, drug-product contract manufacturing, packaging, and distribution operations. Ed provided oversight for manufacturing sites in 12 countries across North America, South America, Europe, and Asia; that manufacture the final parenteral product (non-oral) formulations of Lilly medicines.

Previously, Ed was vice president of Fegersheim Operations for Lilly’s manufacturing site located in France. Before that, he served as site head for two other Lilly manufacturing sites: Indianapolis Active Pharmaceutical Ingredient manufacturing from 2014 until 2016, and PR06 in Puerto Rico from 2012 until 2014. Ed joined Lilly in 2005 as an engineering services leader for Lilly del Caribe in Puerto Rico, after working for several years in positions for Pfizer and Pharmacia.

Ed is a native of Puerto Rico and holds bachelor’s and master’s degrees in chemical engineering from the University of Puerto Rico and North Carolina State University, respectively.

Brendan O’Callaghan leads Sanofi’s Manufacturing and Supply organization, a global network of close to 40 internal manufacturing sites, supported by a network of strategic external supply partners. Sanofi’s ambition is to build an Industry leading manufacturing and supply chain capability, based on a future-ready organization and network that will ensure the flawless launch of Sanofi’s rich and diverse late-stage pipeline and the continued, reliable supply of essential, high-quality, affordable and sustainable medicines and vaccines for patients, worldwide. Sanofi will leverage the latest in scientific, digital, technology and workforce solutions to achieve this ambition.

Brendan joined Sanofi in 2015 as Global Head of Biologics, later taking leadership of the integrated Manufacturing and Supply network supporting our Specialty Care portfolio, prior to taking on his current responsibilities in September 2021. He has played a key role in enabling Sanofi’s transformation to a fully integrated BioPharma company and advancing the modernization and digital transformation of our manufacturing teams and network, building capabilities and capacities to support Sanofi’s growth in Biologics, Vaccines and Small Molecule Manufacturing, as highlighted by continued investments into state of the art, digitally advanced and future ready facilities such as the 2020 ISPE Facility of the Year award winning site in Framingham, MA and Sanofi’s agile and industry leading Modulus platforms in Neuville (FR) and Singapore.

Prior to Sanofi, Brendan worked with Merck / MSD, Mallinckrodt and Schering-Plough, where he led Tech Ops organizations of increasing scope and responsibility, across a variety of site and global leadership roles.

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.

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.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.

Susan Abu-Absi, Ph.D. is a strategic operations executive with over 20 years of experience in product development and supply in the biopharmaceutical industry. She joined Be Bio in March 2025 as Chief Operating Officer, responsible for driving all operational aspects of the business to unleash the power of engineered B cell medicines as therapeutics for patients with serious diseases.

Prior to Be Bio, Susan was Chief Technology Officer at 2seventy bio where she led the Technical Development, Supply & Quality organization. Her team provided deep execution capabilities in autologous cell therapy manufacturing resulting in the launch of Abecma and the translation of four novel therapies with complex layered technologies into the clinic.

Prior to 2seventy bio, Susan led technical development & operations at bluebird bio, a pioneer in ex vivo gene therapies, where she played an integral role in the approvals of Zynteglo and Skysona.

Prior to joining bluebird, Susan held leadership roles in the Global Product Development and Supply organization at Bristol Myers Squibb. She started her career in the Process Sciences organization at Bayer Healthcare.

Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota, where she conducted research in the laboratory of Professor Wei-Shou Hu as a National Science Foundation Fellow, and a B.S. in Chemical Engineering, Summa Cum Laude with Honors, from the University of Toledo.

Dr. Advant has served as Savara’s Executive Vice President, Global Technical Operations since March 2024. With approximately three decades of experience in the biopharmaceutical sector, he has considerable expertise in drug substance, drug product, and analytical development with early- and late-stage clinical and commercially approved biologics. Dr. Advant also has extensive expertise in technology transfer, scale-up and cGMP manufacturing (both internal and external) in a highly regulated environment. To date, Dr. Advant has helped launch multiple biologic assets across several therapeutic areas. Prior to joining Savara, he was VP, Manufacturing Operations at GSK, where he was responsible for multi-site drug substance and drug product operations. Previously he held roles of increasing responsibility at Celgene Corporation (acquired by Bristol Myers Squibb), Kemwell BioPharma, ImClone/Lilly, and Diosynth Biotechnology (now FujiFilm Diosynth Biotechnolgy), among others. Dr. Advant holds a Ph.D. in Pharmaceutics from the University of Connecticut.

Andrea (Andi) Goddard serves as Chief Technical Officer at CatalYm. She brings three decades of global biotechnology experience, spanning all levels of operations — from the manufacturing floor to the C-suite. Andi joined CatalYm from Roche Pharma and Genentech, Inc. where she most recently was the Chief Quality Officer for Roche Pharma Technical Operations. In this role, she led a global team delivering end-to-end quality and compliance for Roche’s pharmaceutical commercial products and clinical pipeline. During this time, Andi was also a member of the Genentech, Inc. Executive Committee. Previously, Andi held various operational and executive roles in manufacturing, technology, and quality across Roche and Genentech. Andi holds a BA in Human Biology from Stanford University.

Manisha Desai, a seasoned pharmaceutical executive and strategic leader, currently serves as the Senior Vice President of Product Development within Global Product Development and Supply (GPS) at Bristol Myers Squibb (BMS).  Throughout her 25-plus-year career at BMS, Manisha has developed extensive expertise in the biopharma industry, with a focus on end-to-end CMC development. This includes the design & development, scale-up, and technology transfer for both oral and parenteral drug products for BMS’s small and large molecule portfolio, as well as combination products, to manufacturing sites. In addition to her technical expertise, Manisha has excelled in developing and executing organizational strategy, leading strategic partnerships, building high-performing teams, managing large global organizations, shaping organizational culture, and guiding teams through change.

Manisha earned her bachelor’s and Masters degree in Pharmaceutical Sciences from the University of Mumbai, India; her Ph.D. in Pharmaceutical Sciences from the University of Michigan; and her MBA from the NYU Stern School of Business.

Outside of work, Manisha enjoys spending time with her family and friends, traveling, engaging in charity work, and watching shows on Broadway.

Stephen Hill is the Chief Operating Officer at Lyell. He is responsible for research and end-to-end development and supply of cell therapies to support Lyell’s clinical and commercial aspirations.

Hill was formerly Head of Biologic Operations at AstraZeneca where he was responsible for end-to-end supply of the commercial and late-stage clinical portfolio for Biologics that included oversight of six manufacturing sites across the US and Europe and five commercial products.

As Vice President Operations, Site Head at the AstraZeneca Frederick Manufacturing Center, Hill was responsible for the largest biologics manufacturing facility within the company’s global network. The site consists of a licensed, large-scale cell culture facility and recently commissioned small-scale facility.

Prior to AstraZeneca Hill served as Vice President Bulk Manufacturing at Amgen’s Puerto Rico facility and as Executive Director leading commercial formulation and filling and commercial drug substance operations.

Hill also served prior roles as Executive Director, Manufacturing Technologies leading manufacturing global networks and as Executive Director, Plant Manager leading clinical drug substance operations. In his corporate role he led manufacturing of the future, operations strategy, high reliability performance and manufacturing global network initiatives. In his plant manager role he was an effective change agent driving productivity improvement to deliver multiple pipeline new product introductions annually.

Hill joined Amgen from ICOS Corporation where he executed GMP clinical plant start-up and led manufacturing, ultimately transitioning the operation into a contract manufacturing business. Hill started his career at Immunex Corporation as an operator manufacturing Enbrel.

Hill holds a Master in Business Administration (MBA) and Bachelor’s in Microbiology (BS) and Political Science (BA) from the University of Washington.

Aine’s career in the biomanufacturing sector spans roles in the UK, Ireland, and the US, with a strong focus on developing innovative solutions to expedite the delivery of medicines to patients. Aine Hanly has recently rejoined Amgen as Vice President, Quality. In this role, Aine will lead a global team accountable for all aspects of quality oversight for Amgen’s products, from early product and process design to manufacturing and product supply to ensure that quality standards are met and in compliance with applicable regulatory requirements.

Prior to her return to Amgen, Aine spent the past 4 years with Vir Biotechnology, an immunology-based biopharmaceutical company developing medicines for infectious diseases and other serious conditions. Aine was the Chief Technology Officer (CTO) and EVP Technical Operations, leading the company’s technical operations function, which included responsibility for end-to end GxP Quality and Data Strategy.

Prior to Vir, in her almost decade-long tenure at Amgen, Aine led teams across several Amgen sites (ACO, AML, AMA and ATO) including oversight of clinical manufacturing and clinical supply (MCS). Her leadership roles in Process development supported the commercialization of Amgen’s pipeline products and technical support for ongoing manufacturing operations. As the site head at Amgen’s Cambridge facility, Aine also led the site’s transformation and staff expansion.

Prior to joining Amgen in 2012, Aine held roles of increasing responsibility in Pfizer (formerly Wyeth) Process Development, Product Supply and Quality including site head of Quality for Pfizer’s Grange Castle Manufacturing site in Ireland.

Aine earned her bachelor’s degree in biological chemistry and her Ph.D. in physical organic chemistry from the University of Ulster in Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining Yale University and CuraGen Corporation as a lead scientist, where she focused on gene isolation and validation using various molecular biology techniques.

Pascal leads Russell Reynolds’ operations in New York and Canada. He works closely with our healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives.

Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He also earned master’s and doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.

A chemical engineer by training with a Ph.D. in Chemical Engineering from The Technical University of Denmark, Hanne Bak started at Regeneron in 2004 as a Research Engineer in Preclinical Manufacturing and Process Development (PMPD). First, Hanne enjoyed increasing levels of responsibility within PMPD while also developing an Analytical team providing high throughput analytical support to PMPD. In 2015, Hanne transitioned into overall leadership of the PMPD department. In this role, she was responsible for all aspects of process development ranging from
molecule and cell line assessment and selection through technology transfer and post launch process optimization activities. Since joining Regeneron, Hanne and her team have been involved in the development and technology transfer of well over 100 novel manufacturing processes for mAbs, bispecifics, Adeno Associated Virus (AAV), Antibody Drug Conjugates (ADC), and Antibody Tethered Ligand (ALT) to eleven different Regeneron manufacturing suites, provided subject matter expertise for technology transfers to external contract manufacturing and partner sites, and contributed to or fully developed manufacturing processes for all of Regeneron’s thirteen (13) approved pharmaceutical drugs. Hanne has also overseen the digital transformation of PMPD, including extensive laboratory, process and data automation efforts and data architecture. In 2025, Hanne expanded her role to lead a newly formed function named Product, Analytical, and Process Development (PAPD), encompassing all aspects of process development through drug product, including extended analytical characterization, assay and reagent development supporting Regeneron from research through commercial manufacturing. Hanne is also the executive sponsor for Regeneron’s LGBTQ+ employee user group and serves on Regeneron’s Responsibility Committee.

Nick Warne is currently Vice President of Pharmaceutical Research and Development at Pfizer.  Nick has 36 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development.  He and his team have been fortunate to have contributed to the licensure of 25 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs.  Nick holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals.  Prior to his position at Pfizer, Nick had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts.  Nick received his PhD in Chemistry from Purdue University under the guidance of Professor Michael Laskowski Jr. He received his BS in Biochemistry, with Distinction in Research, from the University of Rochester.

Kawa Chiu is the Chief Technical Officer of Abdera Therapeutics Inc. Kawa joined Abdera in 2022. She brings to Abdera more than 25 years of global manufacturing, supply chain and CMC experience across broad modalities.

Prior to Abdera, Kawa served as the vice president of CMC supply chain at Lyell Immunopharma, a cell therapy company focused on solid tumors. During her tenure, Kawa oversaw CMC programs that enabled three IND approvals, established the company’s autologous patient supply chain, and implemented a progressive cloud based, integrated manufacturing systems. Prior to Lyell, Kawa spent 14 years at Genentech in South San Francisco and at Roche in Basel, Switzerland in roles including head of Oceanside drug substance manufacturing, global head of technical operation strategy, global head of biologics operational excellence and global head of supply planning. Kawa started her career and held a number of manufacturing positions at Merck & Co., Inc.

Kawa holds a B.S. in operations from The Ohio State University, a M.Sc. in Engineering from University of Pennsylvania, an MBA from New York University, and a Master in Public Health from U.C. Berkeley.

Siegfried Hackl, PhD, is Senior Vice President of Product Supply at Ultragenyx, where he has led External Manufacturing and Global Supply Chain Management since February 2017. He is responsible
for clinical and commercial supply across gene therapy, small molecules, biologics, and nucleotide
modalities. In this role, Dr. Hackl develops and executes manufacturing strategies and oversees a
global CMO and distribution network to ensure a robust, responsive, and financially accountable
supply system. He also contributes significantly to CMC development across Ultragenyx’s diverse and
innovative product pipeline and plays a key role in shaping the company’s quality mindset and continuous improvement culture, while actively supporting talent development, workforce agility, and
inclusion and diversity.

Prior to joining Ultragenyx, Dr. Hackl spent more than two decades at Boehringer Ingelheim (1993–
2017), holding a variety of senior leadership roles across Europe and the Americas. His positions included Head of Microbial Fermentation (Austria), Head of a European Manufacturing Alliance Project
(Germany), Vice President of Fill & Finish for all biotech molecules (Germany), Plant Manager and
Vice President of the BI manufacturing site in Mexico, Head of Systems Quality Assurance for BI Germany, Global Head of Biotech Performance Management and Lean Transformation, and Head of
Lifecycle Management for a blockbuster respiratory device platform.

Dr. Hackl holds an MSc in Biotechnology from the University of Vienna and a PhD in Pharmaceutical
Technology from the University of Berlin.

Craig Beasley is the Chief Technical Officer at BlueRock Therapeutics. Prior to joining BlueRock, Craig was the Vice President, Cell Therapy Supply Chain at BMS, where he oversaw supply chain for BMS’s clinical and commercial stage cell therapy assets. Previously, Craig was Head of Manufacturing and Supply Chain at Juno Therapeutics and Vice President of Next Generation Manufacturing at Biogen. Prior to working in biotechnology, Craig worked for Union Carbide in process development. Craig holds a B.S. in Chemical Engineering from Purdue University.

Jose Torres-Vorshirm is Senior Vice President of Global Technical Operations at BioNTech, where he oversees the end-to-end technical operations supporting the company’s pipeline and operations. His responsibilities encompass advancing a broad range of modalities—including antibodies and mRNA-based therapeutics—through development, manufacturing scale-up, and commercialization.

With more than 25 years of leadership experience in biopharmaceutical technical operations, global supply chain, and manufacturing, Jose has built expertise in delivering complex biologics and advanced therapies at commercial scale. Prior to his current role at BioNTech, he served in leadership roles at AstraZeneca, Eli Lilly and Company, and Novavax.

Jose holds a Master’s degree in Technical Management from Johns Hopkins University, a Postgraduate degree in Business Management and Supply Chain from the University of Warwick in England, and a Bachelor’s degree from the University of Puerto Rico-Mayaguez. He is a recognized leader in driving technical operations strategy and execution to bring innovative therapies to patients.

Angela Jung specializes in recruiting transformational technology executives for global Fortune 500, private equity, venture capital, and growth-stage firms.

Based in New York, Angela is a leader in our global cybersecurity team and a member of our Technology Practice. She excels at recruiting Chief Information Officers, Chief Information Security Officers, Chief Technology Officers, Technology Operating Partners, and board directors. During her career, Angela has proven herself as a trusted advisor, delivering tailored leadership solutions to ensure her clients succeed in a rapidly evolving technology landscape.

Prior to joining Russell Reynolds Associates, Angela served in the US Army as a Military Intelligence Officer and was one of the first women assigned to an Infantry Battalion. She rose through the ranks from Lieutenant to Captain and held multiple leadership positions across information security, operational security, and anti-terrorism in support of a Brigade Combat Team’s operations in the Pacific Theater.
Angela received her BS in biology from the University of Miami and her MBA from Columbia Business School. She also speaks fluent Korean.

Satarupa Das leads commercial product CMC teams, providing end-to-end technical CMC leadership for regulatory submissions and approvals, yield and CoGm improvements, and strategies that support uninterrupted supply, business continuity, and risk mitigation. She also serves as the Operations representative for pipeline products, helping drive operations readiness for new product launches. In her current role, she leads a team focused on agile CMC approaches for accelerated approvals, as well as the implementation of alternative raw materials to improve cost of goods, sustainability, and supply resilience across the product lifecycle. Before joining AstraZeneca, Satarupa worked at Novavax in Manufacturing Quality Control and technology transfers and at Covance as a Lead Scientist in clinical studies. She holds a PhD in Biochemistry and completed her postdoctoral training at the National Cancer Institute, NIH.

Eric is the Executive Director of Supply Chain Business Performance & Transformation within Bristol Myers Squibb. Eric leads the digital and process programs across Supply Planning horizons. His team champions innovation by leveraging data and technology to enhance operational excellence and drive the digital-first strategy within Global Supply Chain. Prior to his current role, Eric successfully integrated long-term strategic planning into global supply chain.

Prior to joining BMS, Eric spent 17 years at Merck including roles within Network Strategy & Execution and Supply Chain Management, where he led significant projects across supply planning, new product launch and manufacturing.

He holds Bachelor degrees in Chemical Engineering and Business from Lehigh University, and a Masters in Operations Research from Columbia University.

Alec Nielsen is co-founder and CEO of Asimov, a Boston-based mammalian synthetic biology company. He holds a B.S. in Bioengineering and Electrical Engineering from the University of Washington, and a Ph.D. from MIT Biological Engineering, where he researched foundational biochemistries for synthetic biology, computer-aided genetic circuit design, and machine learning applications in biosecurity. Alec’s mission is to advance humanity’s ability to design living systems, enabling biotechnologies with outsized benefit to civilization.