Speakers

Karin began her career in the pharmaceutical industry at Bristol-Myers Squibb in their corporate global procurement organization.  She quickly moved from procurement into global supply chain where she focused on business process improvements to enhance performance in areas such as product launch and commercialization. Following an assignment with global quality, Karin moved into manufacturing operations, leading two manufacturing sites. Leading a radiopharmaceutical site in Billerica, MA, Karin significantly improved product cost and site performance. During her tenor in Latina, Italy, where she led a chemical and drug product facility, Karin turned around the site’s performance in cost, quality and supply. After returning to the United States, Karin left BMS to join Becton-Dickenson leading global operations in Pre-Analytical Services, followed by Catalent Pharmaceuticals where she built their global Biologics capabilities while introducing operational excellence across the biologics and sterile operations network.  In 2013 she joined Teva Pharmaceuticals, where she transformed a network of 25 sites in Canada, US, Latin America and Europe; later as COO, Global Operations she led network strategy and global manufacturing science & technology. Prior to rejoining Bristol Myers Squibb in 2023, she held the role SVP, Global Biologics & Sterile Operations at Merck & Co. for 4 years, where she built internal biologics and sterile manufacturing capabilities to supply importance products such as Gardasil and Keytruda as well as the growing biologics pipeline.

In her current role, EVP, Global Product Development & Supply, Karin is a member of the BMS executive committee reporting directly to Chris Boerner, BMS Chairman and CEO. In this role she has responsibility for product development, quality, supply chain, manufacturing operations, global facilities & engineering, and business analytics. Since rejoining BMS she has significantly improved operational performance and is building technical capabilities to deliver an increasingly complex portfolio of products across biologics, small molecule, cell therapy and radiopharmaceuticals.

She has enjoyed growing in her career while also building a family with her husband, Tim.  Together they enjoy three daughters (Amber, Sarah and Kathryn) and their dog, Tucker.

She graduated from Rutgers University with her BA in Political Science/International Relations with a minor in German, and holds a Masters in Pharmaceutical & Device Law from Seton Hall University.

Tina Self is a dynamic leader with over 20 years of experience in the biotech and pharmaceutical industries, specializing in quality and manufacturing. Currently, she serves as the Senior Vice President of Global Biologics Manufacturing and Berkeley Site Head at Bayer. Tina has been with Bayer for over eight years, where she has held several key leadership roles, including Vice President of Manufacturing Operations and Vice President of Quality. She is recognized for her strategic oversight of manufacturing processes, commitment to quality assurance, and her ability to drive continuous improvement. Tina holds an MS in Biotechnology from The Johns Hopkins University and an MBA in International Business from Florida Atlantic University.

She leads a global, multicultural team across North & Latin America, Europe, and Asia responsible for all aspects of Supply Chain Operations and Value Chain Management (Product and Manufacturing strategies) at Merck. Her team is responsible for the supply chain management of Merck’s Human Health portfolio covering Small Molecules, Biologics, and Vaccines.

Bala started her career as an intern at Amazon.com, followed by start-up experiences and pivoting to Pharmaceutical Manufacturing. She began as a shop floor Technical Operations Engineer and, over the last 20 years, held roles of increasing responsibilities across the value chain in Manufacturing, Technical Operations, Engineering, LEAN/Six Sigma, and Supply Chain Management. Having led significant transformation and digital initiatives, she is also a D&I champion in the company and a champion for Merck’s ESG efforts to create sustainable and accessible supply chains.

Bala has a bachelor’s degree from the University of Madras, India, a master’s degree in electrical engineering from Southern Illinois University in Carbondale, and Executive education from Harvard Business School. Bala lives in Doylestown, Pennsylvania, with her husband and three kids (2 humans and a pug).

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.

David Geoghegan is the Head of Quality Assurance and Validation for Spark Therapeutics, Inc, a part of the Roche portfolio of Gene therapy product development.  Since joining Spark in 2021, he’s lead a team of scientists and professionals who are responsible for all aspects of Quality and Validation throughout the development lifecycle of gene therapy products, including non-clinical and clinical development programs as well as the first approved commercial gene therapy product.  Recently, this team successfully hosted inspections of the Luxturna manufacturing facility in Philadelphia by FDA, PMDA, ANVISA, EMA and SFDA.

Prior to joining Spark, David worked for three years at Tmunity Therapeutics, Inc. as the Head of Quality and Validation.  Tmunity worked to develop CAR-T cell therapies to treat solid tumor cancers.  While there, he was a part of the core leadership team that built and validated a new state-of-the-art Viral Vector and Cell Therapy development and manufacturing facility.  The quality systems that David implemented bridged the early development work done at an academic-based advanced therapy CMO to late-stage and commercial-ready in-house manufacturing and analytical operations.

Before joining Tmunity, Geoghegan worked over 30 years in various leadership roles within Operations.  His roles included VP level roles in Manufacturing, Supply Chain as well as Quality, working for small and large Biopharma organizations developing and marketing traditional small molecule products, biologics, and vaccines.  A dual EU/US citizen, he’s worked and lived in global roles and locations.

He holds a BS in Mechanical Engineering from Villanova University and an MBA from Northeastern.

Dr. Heidi Zhang is Chief Development Officer at Tune Therapeutics, where she leads the company’s efforts in developing gene tuning therapies, overseeing clinical development, regulatory strategy, CMC, and manufacturing. Since joining in 2021, she has built and scaled core development functions to enable clinical translation of innovative genetic medicines.

Before joining Tune, Dr. Zhang held leadership roles at BMS/Juno Therapeutics, where she led product and analytical development across a broad portfolio of autologous and allogeneic cell therapies. Her earlier experience includes key roles at Genentech, Novartis, and Amgen, contributing to multiple biologic product approvals. She aspires to improve human health through science and leadership.

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.

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.

Alison Moore brings to Codexis significant experience as a biotechnology and pharmaceutical executive, including an extensive background in biomanufacturing. She is former Chief Technical Officer of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR-T therapies. Prior to Allogene she spent a total of 20 years at Amgen, most recently as Senior Vice President, Process Development, and including roles in Supply Chain and Manufacturing. Dr. Moore also has experience at Genentech as a Director in Chemistry, Manufacturing and Controls, and Regulatory Affairs. Dr. Moore holds a bachelor’s degree in Pharmacology with Honors and a Ph.D. in Cell Biology from Manchester University, England.

Tongtong joined Genentech in 2018 as the head of Pharmaceutical Technical Development for US Biologics, and was named global head of Pharma Technical Development  in April 2021. Prior to her role at Genentech, Tongtong held several scientific, managerial and strategic roles at Eli Lilly, with increasing responsibilities in the Bioproduct Research and Development organisation. Tongtong also worked at Corixa Corporation, a biotech company, where she gained valuable experiences both as a discovery scientist and as a CMC leader in support of therapeutic antibody and cancer vaccine platforms.

Tongtong received her B. Sc. in Molecular Biology from University of Science and Technology of China, a doctorate in Biology from Syracuse University, and completed her postdoctoral training in cell biology and yeast genetics at Cornell University.  

As Chief Global Supply Officer, Executive Vice President, Mike McDermott leads Pfizer’s internal and external manufacturing and supply chain activities.

Mike and the Pfizer Global Supply (PGS) team work to ensure uninterrupted supply for Pfizer’s entire product portfolio. This includes hundreds of medicines and vaccines provided to more than 185 countries worldwide. The PGS network, which includes more than 30 global manufacturing sites and approximately 31,000 colleagues, also works with more than 300 contract manufacturers to produce 50 billion doses of medicines and vaccines each year.

Mike has more than 30 years of industry experience, having joined Pfizer in 1989, by way of Wyeth, after starting as a Project Engineer in Pearl River, New York. He has held many roles, including Plant Manager and Operational Vice President of multiple divisions, including Consumer Healthcare, Biotechnology and Supply Chain, as well as roles in Finance and Marketing.

He was named President of PGS in 2018 and assumed his current role in January 2022.

A passionate advocate for Diversity, Equity and Inclusion, Mike has enacted impactful changes to increase diversity within PGS and was recently named Executive Sponsor of Pfizer’s Women’s Resource Group, the company’s largest Colleague Resource Group.

In addition to ambitious goals related to product supply at launch and manufacturing cycle times, Mike and PGS support Pfizer’s Net Zero strategy, which includes delivering Greenhouse Gas reductions.

Mike, his wife Katie and their five daughters – of whom he is incredibly proud – are committed to community engagement and social action. An active volunteer himself, Mike was a Board Member for People to People, a non-profit organization which helps under-served communities, for 10 years.

Mike holds Bachelor of Science and Master of Science degrees in Industrial Engineering from the New Jersey Institute of Technology (NJIT), where he has been an adjunct professor. He was named an NJIT Distinguished Alumnus and is the recipient of the 2023 Newark College of Engineering Outstanding Alumnus Award.

Mike serves on the Executive Committee of the National Association of Manufacturers and is a member of the Pharmaceutical Manufacturers Forum.

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.

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Jerry Murry, is Senior Vice President of Process Development at Amgen. Jerry started his career at Amgen in 2006 as Executive Director, Process Development within the Translational Sciences organization in R&D, and was promoted to Vice President, Process Development in 2010. In 2012, Jerry joined the Amgen Full Potential Transformation team as lead of the initiative “Transforming Process Development at Amgen”(AFP3).

In 2014, as part of the integration and reorganization of a new single, global process development team, Jerry was named the head of CMC Lifecycle management with responsibility for Operations Commercialization activities including regulatory filings and launches.

In 2016, Jerry became head of Drug Product Technologies with responsibility for all formulation and product and process development.
In 2018, Jerry was promoted to Senior Vice President Process Development at Amgen with responsibilities for all global Process Development activities.

Prior to joining Amgen, Jerry spent 8 years at Pfizer Central Research and 6 years at Merck Research Laboratories in Process Development.

Jerry earned BA/BS in Biology and Chemistry at Texas Lutheran University, a PhD in Chemistry from University of Utah and was an NIGMS NIH Fellow at Harvard University.

Tina Self is a dynamic leader with over 20 years of experience in the biotech and pharmaceutical industries, specializing in quality and manufacturing. Currently, she serves as the Senior Vice President of Global Biologics Manufacturing and Berkeley Site Head at Bayer. Tina has been with Bayer for over eight years, where she has held several key leadership roles, including Vice President of Manufacturing Operations and Vice President of Quality. She is recognized for her strategic oversight of manufacturing processes, commitment to quality assurance, and her ability to drive continuous improvement. Tina holds an MS in Biotechnology from The Johns Hopkins University and an MBA in International Business from Florida Atlantic University.

Mike has 35 years of experience in the BioPharma industry, having spent 16 years in R&D and 17 years in manufacturing; retiring as a senior vice president from Merck & Co. (MSD) in March of 2022 and recently becoming Head, Pharmaceutical Sciences in R&D at Takeda Pharmaceuticals in September 2022.  During his 33 years at Merck, Mike led process development/new product introduction, operations, facility construction/start-up and divisional strategy/transformation/culture.  Under his leadership, Mike’s areas have introduced manufacturing products which have changed medical paradigms for treatment.  This includes the medically significant CRIXIVAN (the first effective AIDS therapy) and ERVEBO (the only vaccine for ebola), as well as large market drugs like JANUVIA (for Type II diabetes – $6BB/yr in revenue) and KEYTRUDA (for cancer – ~$20BB/yr in revenue) and has overseen more than 50 new product introductions.

In addition, he has led the timely delivery and start-up of over $8 BB in new manufacturing facilities for vaccines and biologics.  He has successfully led 3 major transformation projects and large segments of 2 company integrations.  Mike now heads the Pharm Sciences group in Takeda R&D and is responsible for product definition and process and method development and characterization from the Research interface through introduction to manufacturing.

Mike received his PhD from MIT, his BS from Caltech.  He chairs a hospital board, sits on two Boards of Directors (including the board of Ireland’s NIBRT), and has been a member or chaired academic visiting committees for MIT, UTexas, Tufts, Johns Hopkins and U Delaware.  He currently lives in Westfield, New Jersey.

C. Greg Guyer, Ph.D, joined BioMarin in May 2020 and currently serves as Chief Technical Officer and Executive Vice President of Global Manufacturing and Technical Operations, responsible for overseeing our manufacturing, process development, quality, supply chain, engineering and analytical chemistry departments. From 2015 to 2019, Dr. Guyer served in a number of increasingly responsible positions at Bristol Myers Squibb (BMS), primarily leading all of operations and biologic development. Prior to BMS, Dr. Guyer worked for Merck & Co., Inc., from 1994 to 2015, leading various global organizations in biologic and pharmaceutical operations, quality, regulatory, emerging markets strategy and enterprise systems. He currently serves on the Board of Directors for the University of Georgia Research Foundation.

Dr. Guyer earned his Ph.D. in analytical chemistry from American University, Bachelor of Science degree in chemistry from the University of Georgia and Master of Business Administration degree from Lehigh University

John Pinion has over 30 years of global biotech leadership experience across multiple modalities, including gene therapy, and spanning multiple functions across CMC and translational sciences.

John joined Ultragenyx in July 2015 and provides leadership for Quality, Compliance and Translational Sciences to include Pharmacology, Toxicology, Research and Bioanalytical Development.  As an executive leader, he contributes to corporate strategy and portfolio management.  

Prior to joining Ultragenyx, Mr. Pinion held senior leadership roles at Roche and Genentech departing the organization as Senior Vice President, Global Head of Quality and Compliance. Prior to Genentech, Mr. Pinion spent 17 years in operational and global senior leadership roles at Baxter International.

In addition to his position at Ultragenyx, John is currently COO of Amlogenyx, a subsidiary of Ultragenyx and is a member of the Board of Directors of Aroa Biosurgery Ltd.

He holds a B.S. in Mechanical Engineering from West Virginia University.

Thomas has been serving as the Senior Vice President of Cell Therapy Development and Operations at BMS since August 2023. Before joining BMS, he held multiple roles with Merck & Co, where he gained experience in basic research, early and late-stage process development, capital project management, site-based technical operations, commercialization, manufacturing science and technology, and supply chain. Before that, Thomas worked for startup, GlycoFi, founded at Dartmouth College, where he conducted post-doctoral research after receiving his PhD in Bioprocess Engineering from the University of Cape Town in South Africa.

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca.  He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc.  Prior to working at Amgen, he was 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.

Jamie Moore is currently Senior Vice President of Technical Development responsible for the CMC development of drug substance and drug product for Gilead’s pharmaceutical and biologic product portfolio. She has over 20 years of experience as a chemist and pharmaceutical scientist working in both large and small Biopharmaceutical companies including CytomX and Roche. At CytomX, she was Senior Vice President on the executive team leading the Protein and Process Sciences, and Manufacturing organizations. Previously she spent a significant portion of her career at Genentech/Roche where she held multiple technical and managerial leadership roles within Pharma Technical Operations including Head of Pharmaceutical Development and Global Head of Manufacturing Science and Technology for Commercial Products. Externally, Jamie is serving as the President- for the Board of Directors for CASSS, an organization that brings together industry, academic and regulatory leaders to resolve scientific challenges impacting CMC development and regulation. She has a B.S. in Chemistry and received her doctoral degree in Chemistry and Chemical Biology from UCSF.

Koustuv Chatterjee is the Senior Vice President of External Manufacturing & Supply, in the Manufacturing & Supply division of Sanofi. Prior to joining Sanofi in 2023, Koustuv has held several leadership positions in Merck & Co, Teva Biopharmaceuticals USA, and Amgen Inc. Koustuv’s career started in process development and has spanned across manufacturing operations, network strategy, product and device development, Manufacturing Science & Technology, internal and external manufacturing operations. Koustuv obtained his Bachelor’s degree in Pharmaceutical Technology from Jadavpur University, Kolkata, India, Masters. in Industrial Pharmacy from University of Toledo Ohio, and Ph.D. in Pharmaceutics from University of Minnesota.

Eliana Clark, PhD is Executive Vice President and Chief Technical Officer at Intellia Therapeutics, where she is responsible for Internal and External Manufacturing, Supply Chain, CMC Strategy and Operations, Process and Analytical Development, Genomics Operations, and Quality, for novel gene editing-based products, both ex-vivo cell-based therapies and in vivo therapies.  Eliana joined Intellia in January of 2020.  Prior to Intellia, Eliana spent nearly eight years in leadership roles at Biogen, including vice president of International Manufacturing Operations and vice president of Global Manufacturing Sciences.  In her most recent role at Biogen, she led the team responsible for the CMC product strategy and lifecycle management for Biogen’s entire product portfolio including clinical and commercial products. Before Biogen, Eliana spent many years at Sanofi/Genzyme, where she held leadership roles in CMC Regulatory, Manufacturing Sciences, and Technology Development.  Prior to working in industry, Eliana was a professor of Chemical and Biological Engineering at Tufts University for 14 years. She holds a B.E. and Ph.D. in Chemical Engineering from the Universidad Nacional de Litoral in Santa Fe, Argentina, and is a graduate of the Greater Boston Executive Program at MIT Sloan School of Management and the WIB Boardroom Ready Program at George Washington University.

Chris McDonald joined Kite in 2018 and currently serves as Global Head of Technical Operations.

Prior to joining Kite, Chris was with AstraZeneca, where he was VP & Site Head of Operations for their monoclonal antibody site. Previously, Chris spent 10 years at Novartis Vaccines in positions of increased responsibility, including VP & Site Head of Vaccines Operations, and VP & Global Head of Technical Operations Strategy. In this role Chris was responsible for product life cycle management, long range production planning and manufacturing network strategy for a network operating in eight countries. Prior to his time at Novartis, Chris held various manufacturing and engineering leadership roles at Amgen.

Chris holds a bachelor’s degree in computer science from Eastern Michigan University and master’s degree in business from the Fuqua School of Business at Duke University.

Andrew “Andy” Ramelmeier, Ph.D. is Adverum’s chief technology officer responsible for leading the company’s technology and operations organization, including process development and manufacturing. Dr. Ramelmeier has more than 30 years of experience in the development and manufacturing of biopharmaceuticals, including monoclonal antibodies, vaccines, gene and cell therapy products and therapeutic proteins. Most recently, Dr. Ramelmeier served as executive vice president, head of technical operations at Sangamo Therapeutics, where he was responsible for quality, process and analytical development, manufacturing and supply chain of viral vector and cell therapy pipeline products, as well as the oversight of two internal GMP facilities and multiple contract manufacturing organizations (CMOs)/contract research organizations (CROs) for manufacturing and quality control (QC) activities. Prior to Sangamo, Dr. Ramelmeier served as senior vice president, technical operations at Portola Pharmaceuticals, responsible for the process development, technology transfer, manufacturing, and supply chain of small and large molecule pipeline products. Before that, Dr. Ramelmeier held positions of increasing responsibility at several companies, including BioMarin Pharmaceuticals, Johnson & Johnson and Merck Research Laboratories.

Dr. Ramelmeier earned his B.E.S. in Chemical Engineering from Johns Hopkins University and a Ph.D. in Chemical Engineering from University of California, Berkeley. He conducted post-doctoral work at The Institute of Enzyme Technology affiliated with the Heinrich-Heine-University of Dusseldorf.

Tim Moore is Executive Vice President, Chief Technical Officer for Allogene, overseeing product sciences, supply chain, manufacturing, quality and technical operations. Tim has more than three decades of leadership experience in biopharmaceutical manufacturing and operations and was responsible for the global development of two of the most successful autologous CAR T manufacturing processes in the industry. Prior to roles as Chief Operating Officer of Instil Bio, and President and Chief Operating Officer of PACT Pharma, Tim was Executive Vice President, Technical Operations at Kite Pharma (now a Gilead company) from 2016 to 2019, where he was responsible for the process development, manufacturing, quality and supply chain for Yescarta®, the first FDA approved CAR T therapy for the treatment of non-Hodgkin lymphoma. He and his team also developed the manufacturing process for Kite’s second FDA approved autologous CAR T therapy, Tecartus®. Tim previously served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee where he oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Tim serves as a Board member for Cerus and BioLife Solutions. He received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

Steven Barash is a dynamic manufacturing information systems thought leader spearheading digital manufacturing initiatives at L7 Informatics. Steven holds an established software implementation portfolio of regulated technology solutions in the cell and gene therapy manufacturing industry. Steven is committed to end-to-end automation of complex cell gene manufacturing operations to deliver personalized treatments to patients. He is focused on delivering unified enterprise data solutions to ease operational complexities, improve product quality, and digitally scale GMP commercial operations. Before L7 Informatics, Steven held various leadership and engineering roles at Charles River Labs, Cognate BioServices, TRC, Juno Therapeutics, Regeneron Pharmaceuticals, and AxoGen. Steven has a B.S. in Chemical Engineering from the University of Florida where he focused on translational research in immunomodulatory drug efficacy in preclinical animal models.

Mike Cody is the Director of Digital Life Science at ZAETHER, where he works with digital leaders and executives at global life science companies to reimagine process development and manufacturing while building a digitally enabled enterprise. Mike orchestrates his team of industry experts, consultants, and analysts to support visioning, designing, and execution of novel digital and IT/OT solutions to meet the evolving needs of life sciences clients.

Søren Thuesen Pedersen is Senior Director, External Affairs, Regulatory Policy and Intelligence at Novo Nordisk. He is a Chemical Engineer by education and has been working 30 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratory and CMC Manufacturing Development. He has been one of the founding fathers of the Novo Nordisk External Requirements’ Process; How does Novo Nordisk ensure compliance of new external requirements? Mr. Pedersen is currently responsible for the External Representation and Advocacy strategy out of Novo Nordisk’s GMP&Q area and represents Novo Nordisk in various associations ISPE, EFPIA, IFPMA and BIO. Specifically, Mr. Pedersen is a member of the EFPIA Manufacturing Quality Expert Group (MQEG) since 2019 and member of the Board of Directors in IQ Consortium.

He has furthermore been member of the Novo Nordisk Board of Directors for 12 years as an elected employee representative.

His spare time interests include Danish and EU Politics.

Martin P. Müller joined Novo Nordisk in 2014 and currently directs development projects for innovative technologies within Aseptic Manufacturing, with particular focus on formulation, filling, wash & sterilization, and environmental monitoring.

Before moving to production in Novo Nordisk, Mr. Müller has served 10 years in Device R&D, driving the digital agenda of the area, external affairs and QMS-processes and project management, among others.

Mr. Müller earned his Master of Arts from Humboldt University Berlin, Germany, and his Master of Business Administration from Copenhagen Business School, Denmark.

Karin Ann Payne is the Vice President of Corporate Quality in BMS.

In this role, Karin provides strategic quality and compliance leadership in the GxP development and implementation of an integrated QMS across the Enterprise including Research and Early development, Global Drug Development, Global Product and Supply and Medical Affairs and in support of the product lifecycle.

Prior to joining BMS she was the VP of NA Quality for Bayer where she was responsible for ensuring that Bayer remained committed to the highest standards of quality, which is paramount to the patients and customers it serves every day. She joins Bayer from Reckitt Benckiser, where she most recently held the role of Head of Global Corporate Quality Compliance. In this role, she was responsible for managing the company’s Global Quality Management System, Corporate Quality audits, and its Global metrics and Computer System Validations teams. She also managed the Europe and North America Commercial Quality teams, responsible for managing market quality. Prior to that, she held a variety of roles in Quality Assurance and Compliance including positions at Actavis and Pfizer, managing the unique challenges and opportunities of both the consumer health and pharmaceutical industries.

She holds an MLS in Pharmaceutical law (High Honors) from Seton Hall, MBA in Financial Management (High Honors) with a Certificate in International Finance from Iona University and a Bachelor’s in Biological Sciences from Rutgers University.

Dr. David Chang is a seasoned leader with over three decades of experience in the biopharmaceutical and biotechnology sectors, specializing in cell therapy and biologics manufacturing. As CEO of TBMC, Dr. Chang brings a wealth of expertise in leading advanced therapeutic development and operations on a global scale.

Prior to joining TBMC, Dr. Chang served as President and CEO of WuXi Advanced Therapy Unit from June 2020 to February 2024. He also held key leadership positions at renowned organizations, including Corporate Vice President and Head of Cell Therapy Manufacturing at Celgene (now Bristol Myers Squibb), Corporate VP and Global Head of Technical Operations at Roche, and Senior Director of Biologics Manufacturing Science and Technology at Genentech. His strategic vision and deep technical knowledge were pivotal in advancing therapeutic manufacturing capabilities across these roles.

Earlier in his career, Dr. Chang led cell culture process development at Biogen and contributed to groundbreaking research as Senior Scientist of Cell Culture at BASF Research and Senior Chemical Engineer at Schering-Plough Research Institute.

Dr. Chang holds a PhD in Biochemical Engineering from MIT (1992) and a B.S. in Chemical Engineering from National Taiwan University (1985).

Kawa Chiu is the Chief Technical Officer at Abdera Therapeutics, a biopharmaceutical company leveraging antibody engineering to design and develop next-generation precision radiopharmaceuticals for cancer.  Kawa joined Abdera in 2022 and built out Technical Operations organization and CMC capabilities.  During her tenure, Kawa and her team developed Abdera’s lead program, ABD-147, a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac) to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity.  The FDA cleared the IND for the treatment of SCLC and LCNEC in May 2024 and recognized the potential of ABD-147 to become a transformative treatment option in areas of high unmet medical need by granting fast track designation in extensive-stage SCLC in June 2024, and an orphan drug designation for the treatment of neuroendocrine carcinoma in August 2024.

Prior to Abdera, Kawa served as the vice president of CMC supply chain at Lyell Immunopharma, a cell therapy company focused on solid tumors.  At Lyell, 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.

Brian Riley, an experienced leader in operations, quality and manufacturing, is Chief Manufacturing Officer at Beam. Prior to Beam, Mr. Riley spent five years at Catalent Pharma Solutions, initially as General Manager, Biologics and most recently as the Vice President of Operations. There, he helped to cultivate the company’s biologics business, managing five biologics plants supporting the company’s drug substance and products across North America and Europe. Prior to Catalent, Mr. Riley served as the Site Director of Durham, NC operations at bioMerieux, where he led both the company’s compliance remediation effort and global growth platform. Before bioMerieux, Mr. Riley held progressive roles through quality and operations at Biogen Idec, Amgen and Diosynth Biotechnology.

Mr. Riley holds an MBA from Campbell University and a B.S. from North Carolina State University.

Rainer Müller, Ph.D., is Senior Vice President Global Technical Development at BioNTech, a position he has held since May 2024. Together with his team, he is providing BioNTech’s Technical & Chemistry, Manufacturing, and Controls (“CMC”) Development strategy across its portfolio.

Rainer joined BioNTech in May 2022 as Vice President Operations Projects, where he led key initiatives to optimize operations and development processes. He was later promoted to Vice President Global Technical Development & Operations Projects, further expanding his responsibilities to support BioNTech’s internationalization. Prior to joining BioNTech, Rainer spent 17 years at Roche, where he held roles of increasing responsibility within Technical Operations and Development. Most recently, he served as their Global Technical Development Head for Individualized and Cell Therapies.

Rainer started his career in the biopharmaceutical industry in 1998 at Medigene AG after completing his Ph.D. in Biochemistry and Cell Biology at the Max-Planck Society and the University of Tübingen, Germany.

Harish Santhanam brings over 25 years of invaluable experience in Pharmaceutical Development and Manufacturing with a career spanning various leadership positions in renowned pharmaceutical companies, Harish has demonstrated exceptional expertise in driving innovation, spearheading manufacturing initiatives, and ensuring quality in drug product delivery.

Before joining BMS, Harish served as the Site Head of Manufacturing Science and Technology at Kite Pharma, where he led the establishment of a Greenfield Manufacturing facility in Frederick, MD. His leadership was instrumental in taking the project from conceptualization through commercialization, ensuring the delivery of quality autologous cell therapy products to patients.

Prior to his tenure at Kite, Harish’s career journey included his time at Merck, where he contributed significantly to the startup of a manufacturing facility in Dublin, Ireland, specifically for Keytruda. At Merck, he also led digitization and data management efforts, implementing state-of-the-art digital solutions across biologics manufacturing processes.

Throughout his career, Harish has held various leadership positions, including his time at Eli Lilly, where he served as Director of Engineering in Biologics Manufacturing and Corporate Engineering. His responsibilities included technology transfer, process improvement initiatives, and due diligence for in-licensing molecules.

Harish began his illustrious career in pharmaceuticals at Pfizer, where he gained invaluable experience in Small Molecule Development.

Harish Santhanam is a visionary leader in the pharmaceutical industry. He continuously pushes the boundaries of innovation to make significant contributions to global healthcare through his expertise in manufacturing sciences and technology.

Harish holds a Master of Science in Chemical Engineering from the University of Illinois, an MBA from the University of Chicago, and a Bachelor of Science in Chemical Engineering from the University of Madras in India, underpinning his strong academic foundation in pharmaceutical sciences. Beyond his professional endeavors, Harish resides in New Jersey with his wife Vidya and finds solace in spending leisure time with his beloved Golden Retriever, Milo.

A biotechnology leader with 25 years’ experience in developmental, clinical and commercial biologics manufacturing, Christine Sheaffer joined Spark in 2018 and now serves as the Head of Manufacturing & Supply. In this role she leads both internal and external manufacturing, supply chain and operational excellence; she also has functional responsibility for operational readiness of Spark’s Gene Therapy Innovation Center, which is currently under construction in University City, Philadelphia.

While at Spark Christine has built a strong manufacturing team and played a pivotal role in the manufacturing and supply of LUXTURNA™, the first gene therapy for a genetic disease approved in the U.S. She and her team are also responsible for clinical supply of the assets in Spark’s pipeline for Fabry disease, Hemophilia A and others.

A proven leader with deep technical skills, Christine is highly experienced in technical transfer, commercialization, CMC submissions, and successfully preparing facilities and teams for regulatory inspections. At the same time, she has extensive experience working with cell culture and purification operations, stainless steel and single use bioreactors, and in general GMP manufacturing operations.

Prior to joining Spark, Christine served as Senior Director of Manufacturing at Endo Pharmaceuticals where she led the tech transfer and commercialization of Xiaflex™.

Christine earned a BS in Biology from Bloomsburg University.

Laurent Rossi serves as a senior advisor to the Renault Group and is the former Chief Executive Officer of Alpine Racing SAS and chairman of Alpine Racing Ltd. Rossi previously served as Renault’s Chief Strategy Officer and was appointed CEO in 2021 with the Alpine name joining the Formula 1 grid ahead of the 2021 FIA Formula 1 World Championship season.

He began his career at Renault in Paris before earning his MBA from Harvard Business School and joining Boston Consulting Group, where he worked in the New York office. As an automotive expert, he was a consultant on several strategic and operational assignments, working with major global automakers and parts suppliers. He covered the entire value chain from design to sales, including powertrain strategy, manufacturing, and supply chain.

In 2012, he moved to Google, taking charge of developing commercial relations with major automotive industry companies, initially based in Paris for the Europe region, then in New York for the Americas region. Rossi eventually served as the head of Google’s Global Auto Practice, before returning to Renault in February 2018. After a short period heading the Organization Department, he was appointed as VP of Corporate Strategy and Business Development.

Rossi holds a Master of Science in Fluid Mechanics from ENSEEIHT (Toulouse) and a Master of Science in Mechanical Engineering / Automotive Engines & Petroleum Products from IFP School.

John Tomtishen is a cell therapy industry veteran and recognized CMC leader within biopharmaceutical manufacturing having served in diverse business and technical roles throughout his career. John is currently the SVP & General Manager of Cellares’ IDMO business where he is facilitating Cell Shuttle market adoption with various partners to transform the cell therapy manufacturing paradigm. Earlier in his career, John played pivotal roles in the filing and approval of the first CAR-T cell therapy, Kymriah™ while at Novartis, and the clinical development and BLA filing of Carvykti™ at Legend Biotech. John serves as the CMC Committee Chair with the American Society of Gene and Cell Therapy (ASGCT), the Manufacturing Advisory Committee Co-Chair with BioNJ, and is a member of the Cell Therapy Advisory Committee with the Alliance for Regenerative Medicine (ARM).

Jack Garvey, founder of Compliance Architects®, is a seasoned FDA compliance expert with nearly 30 years of leadership experience at industry giants like Johnson & Johnson and C.R. Bard. Combining his chemical engineering and law background, Jack provides practical solutions to minimize FDA enforcement risk. His firm specializes in hands-on GMP consulting, quality, and compliance. Jack is celebrated for his straightforward FDA compliance approach, showcased through blogs, webinars, and public speaking. He’s committed to reducing enforcement risk through diligence, investment, and innovation.

Justin is a leader in Accenture’s Life Sciences Supply Chain practice and has led business and technology transformation projects across Manufacturing, Quality, Planning and Fulfilment in the UK and US. Justin’s passion is product launch, helping clients to optimize strategy and planning for complex new molecule launches. As well as driving development, transfer and scale up of manufacturing and technology capabilities. Originally from London, Justin lives in Brooklyn, NYC with his wife and 2 daughters and enjoys soccer and cycling.

Alex Cooke is the founder & CEO of Phase 3 Search- a boutique executive search firm driven by their mission to accelerate drug development through building and supporting the world’s life sciences leadership teams.

Alex’s expertise lies in building out executive teams in early stage companies, working with PE & VC backed biotechs to accelerate their growth and development. He provides much more than placement, acting as a trusted advisor to his clients.

With 11 years industry expertise placing biotech executives at home and abroad in Europe, Alex is a visionary and active member of the FORBES Business Council.

Patricia Turney is currently the Chief Technical Officer at ACELYRIN, INC a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology and ophthalmology. Ms. Turney is a member of the Executive Team and is responsible for overseeing Operations which consists of Clinical Operations, CMC regulatory, Manufacturing, Product Development, Product Development & Devices, Supply Chain, Corporate Quality, and Facilities / Real Estate.

Ms. Turney has a distinguished career and proven track record across both large and small biopharma with extensive expertise in delivering transformative medicines to patients across Therapeutic areas. Prior to ACELYRIN, Ms. Turney served as Senior Vice President, Operations at Arcutis Biotherapeutics, she built-out the Technical Operations organization to successfully execute on their product development milestones including several filings and their first Commercial launch of Zoryve™ in the U.S. and Canada. Over a 24-year span, Ms. Turney held roles of increasing responsibility with Amgen, most recently as Vice President, External Manufacturing & Supply and was responsible for a worldwide network of almost 50 contract manufacturing sites. She has managed early-to-late-stage programs across numerous technologies and delivery platforms. Her scope included several commercial products supporting more than $4B in revenue (Enbrel™, Kyprolis™, Otezla™). As an expat, Ms. Turney led operations at Amgen’s Manufacturing Site in the Netherlands, serving over 50 countries, which earned the company’s “Best Plant Award.” Ms. Turney developed a new function to enable Amgen to commercialize several combination product programs from auto-injectors to on-body injectors from development through to regulatory approval: Nuelasta™ OnPro™, Aimovig™, Repatha™ SureClick, Enbrel™AutoTouch®. Also at Amgen, Ms. Turney led R&D strategic initiatives including product portfolio analysis & planning and clinical operations expansion to Asia for denosumab clinical trials.

Earlier in her career, Ms. Turney was a Federal Aviation Administration Certified Flight Instructor, Airline Transport Pilot, and a Naval Aviator in the United States Navy. Ms. Turney has been recognized with The HBA Luminary Award for her commitment to healthcare and advancing others’ careers as a role model and mentor. She currently serves as the Board Chair of Exceptional Minds.

She holds a Bachelor of Science in Mathematics and Engineering from the United States Naval Academy and a Master of Business Administration from the Anderson School at the University of California, Los Angeles.

Chris Campbell has over 25 years of experience in both small biotechnology companies and large pharmaceutical organizations with much of that time spend in the development of biological products. Those companies include Eden biosciences, Genetics Institute, EMD Pharmaceuticals, Xcellerex and prior to joining Sarepta, 14 years with Millennium / Takeda. Chris has been privileged to support development and commercialization activities for a number of large molecule programs, such as antibodies, ADCs, cell therapy, microbiome and gene therapy assets. Chris has been a part of Sarepta Therapeutics for over 6 years and is accountable for CMC development at Sarepta, which includes process development for Sarepta’s gene therapy and RNA assets and CMC management.

Katie Chaddock is a creative and agile supply chain leader whose career extends over 25 years in pharmaceutical and biotech operations. Katie has experience with generic and brand medications, large and small molecules and cell therapies. Katie was employed with Johnson & Johnson for the past 10 years and had the ambitious task of establishing a world-wide manufacturing network for the delivery of lifesaving Covid-19 vaccines. She recently transitioned to the Site Head of Commercial Manufacturing at Orca Bio, a late-stage start-up company focused on cell therapies. She holds a degree in Chemical Engineering from West Virginia University.

Sarah Barkow, PhD is Director of External Engagement with Bristol Myers Squibb Company. She drives BMS’ strategy for External Engagement in the GxPs, with a key focus on integrating predictive insights from regulatory intelligence to reduce risk. This includes working closely with PhRMA, BIO, IFPMA and other trade organizations and tracking regulatory and policy developments across the GxP realm. Sarah joined BMS from FDA, where she held multiple roles in CDER’s Office of Compliance, including as Acting Director, Manufacturing Quality Guidance and Policy Staff. At FDA, Sarah was instrumental in drafting multiple guidance and policy documents, particularly around data integrity and medical gas. Prior to joining FDA, Sarah served as a Project Lead in Immunoassay Development working on thyroid assays at Beckman Coulter.

Sarah has her PhD in Physical Chemistry from MIT.

Michael Boychyn is the Executive Director of Manufacturing Process & Analytical Science within AstraZeneca’s Biologics Global Technical Operations team, covering drug substance, product, combination products (devices), packaging & serialization, and analytical methods. He has more than 20 years of experience in each phase of the product development continuum (pre/GLP tox, phase 1-3 process development, characterization, PPQ (validation), BLA authoring, pre-approval inspections and commercial manufacturing) for numerous modalities (mabs, proteins, peptides, AAVs, adjuvanted vaccines, MSCs) at various companies from big pharma (Amgen, Eli Lilly, Novartis) to small biotechs. He has an interest in the adoption of digital tools to increase the efficiency of work (right the first time as fast as possible) and manufacturing processes.

Mike Nuzzolo is the Head of Quality Operations at Spark Therapeutics where he leads an organization responsible for assuring the consistent quality of commercial and clinical gene therapy products. With over thirty years of quality-related experience in commercial manufacturing of vaccine, pharmaceutical and biotech products, Mike has developed extensive knowledge and experience in quality control testing, critical reagent qualification and management, analytical method validation, analytical method transfer, rapid method implementation, lean operational laboratory design, regulatory compliance, and product release while operating within quality management systems that include deviation management, product complaints, change control, batch disposition, and medical devices.

Prior to joining Spark Therapeutics, Mike was at Merck for over 27 years where he held a variety of different roles of increasing responsibility including the Director of Laboratory Operations and Quality Operations supporting the global distribution of vaccine products.

As Vice Present Quality, Head of Operations Central Quality, Anthony leads global teams with accountability for driving the Quality strategy, systems and performance across the internal and external supply and distribution network.

In addition to Corporate Quality functions and strategy, his role includes leadership for global teams accountable for the Quality Management System, Product and Supply Issue Management, Global Marketing Company Affiliate Quality, Alexion Rare Disease Unit Central Quality, Quality Learning & Development, Operations/Commercial GxP training and Quality Digital strategy and enterprise systems and solutions.

Prior to AstraZeneca, Anthony has held Operations leadership positions in global strategic, overseas and regional/site roles in Manufacturing, Quality and Compliance at Amgen, Biogen, Catalent and Johnson & Johnson.

In his current role as the Senior Director of Validation at Spark, John leverages over 24 years of expertise in the compliance and validation of enterprise computer systems, applications, and equipment regulated by the FDA and EU. John is a compliance and validation thought leader and has a deep understanding of 21 CFR Parts 210, 211, 606, 820, 11, and Annex 11. John’s experience spans a variety of analytical systems, including HPLCs and spectrophotometers, as well as computer systems such as ERP, LIMS, EDMS, EMS, PCS, and DCS, serving major pharmaceutical, medical device, and blood management companies. Before joining Spark in May of 2015, his career included roles at Pfizer, AstraZeneca, TEVA, Smith & Nephew, GE Healthcare, DSM, Haemonetics, and the American Red Cross, where he has consistently ensured compliance with predicate rules, 21 CFR Part 11, and GAMP 5 guidance. John holds a Bachelor of Science degree in Computer Information Systems from the Florida Institute of Technology.

Amy has been at Atara Biotherapeutics for 5 years. She is currently the Vice President of Manufacturing, which includes External Manufacturing, Material Sciences, and Manufacturing Science and Technology functions. Prior to her current role, she led the joint team that transitioned the commercialization of the first approved allogeneic T-cell therapy to Atara’s strategic partner, Pierre Fabre. Amy has broad operations experience across multiple regulated industries, including biopharmaceutical, petrochemical, and oil and gas. She specializes in business systems design and implementation and program and project management. Prior to Atara, Amy held a variety of roles at companies such as Seqirus and Amgen. She has also worked in Operations Management Consulting for companies such as KBC Advanced Technologies and Plant Leadership Systems. She earned her BS in Chemical Engineering from Arizona State University.

Brad Lambert is a seasoned IT leader with over 20 years of experience in the biotechnology industry. He has driven innovation and IT strategies across various functions, including Manufacturing, QC, QA, PMO, Supply Chain, HR, Safety, Security, Facilities, Engineering, and Process Sciences. Brad excels in budgeting, procurement, organizational restructuring, and global resourcing. He has successfully led complex IT programs, developed strategic roadmaps, and managed global strategies to advance business digitization and deliver application effectiveness, reliability, and cybersecurity control.

Joe Goodman is the Global Vice President of Customer Transformation at Honeywell Life Sciences where he leads efforts to strategically partner with global clients and prospects to achieve their business goals.  Joe is recognized as a thought leader in the fields of life sciences quality and manufacturing.  Prior to joining Sparta Systems which subsequently became Honeywell Life Sciences through acquisition, Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black Belt.  He owes much of his penchant for process and solution design to his time spent in that role.  Joe also speaks internationally at Compliance and Manufacturing events.

Brad Matanin is the Global Network Strategy Director for Biologics at AstraZeneca. In this role, Brad is responsible for AZ’s global network strategy to supply biologics drug substance, parenteral drug product, and new modality manufacturing platforms including ADCs and Cell Therapy. Brad partners across global operations, commercial, and R&D to shape long term supply strategies to deliver the right capacity, in the right location, and at the right time to meet AZ’s bold ambition. Brad is based in Gaithersburg, MD.

Caitlin Masterman is an Associate Director of Technical Operations within Gilead Sciences’ Biologics Technical Development Organization, where she supports technical transfer of a diverse portfolio of early-phase biologics assets. She completed undergraduate studies at Virginia Tech and holds an MS in Biotechnology from Johns Hopkins University.

Lisa Winstead is currently the Site Quality Head at Resilience Inc in Durham, NC. Lisa has acted as a leader of the sterility assurance and quality programs. Lisa has experience in building and managing large teams, developing and deploying standard operating procedures and guidelines, and expertly maintaining businesses processes. She had supported GMP manufacturing, Sterility Assurance initiatives and has ensured compliance by managing the release of bulk and filled product. Prior to her current role at the Resilience Durham site, Lisa held various leadership positions at Hospira, Pfizer, Wyeth and Human Genome Sciences.

Lisa has more than 25 years of industry experience which expands to quality management, GMP auditing, root cause analysis, CAPA verification, Quality Risk Management, GMP operations, and batch disposition. She has made significant contributions in driving operational excellence and achieving superior results regarding batch manufacturing cycle times. Lisa has consistently turned around organizations with compliance challenges. Lisa has demonstrated success in implementing Quality Shop Floor programs, improving lead times and implementing remediation activities that meet regulatory requirements.

Lisa holds a B.S. degree in Biology from Saint Paul’s College, a MBA in Management from Iona College and a Master in Regulatory Science from the University of Maryland. She is also a certified Quality Auditor by the American Society of Quality and a Certified Qualified Person Liaison by David Begg & Associates.

Lisa Winstead is currently the Site Quality Head at Resilience Inc in Durham, NC. Lisa has acted as a leader of the sterility assurance and quality programs. Lisa has experience in building and managing large teams, developing and deploying standard operating procedures and guidelines, and expertly maintaining businesses processes. She had supported GMP manufacturing, Sterility Assurance initiatives and has ensured compliance by managing the release of bulk and filled product. Prior to her current role at the Resilience Durham site, Lisa held various leadership positions at Hospira, Pfizer, Wyeth and Human Genome Sciences.

Lisa has more than 25 years of industry experience which expands to quality management, GMP auditing, root cause analysis, CAPA verification, Quality Risk Management, GMP operations, Inspection Readiness, Product Approvals, and batch disposition. She has made significant contributions in driving operational excellence and achieving superior results regarding batch manufacturing cycle times. Lisa has consistently turned around organizations with compliance challenges. Lisa has demonstrated success in implementing Quality Management programs, Data Integrity Remediation, Product Licensure Approvals, Maturity Modeling, improving lead times and implementing remediation activities that meet regulatory requirements.

Lisa holds a B.S. degree in Biology from Saint Paul’s College, an MBA in Management from Iona College and a Master in Regulatory Science from the University of Maryland. She is also a certified Quality Auditor by the American Society of Quality and a Certified Qualified Person Liaison by David Begg & Associates.

Praveen Prasanna is the Sr. Director, External Manufacturing at Verve Therapeutics.  Praveen has nearly 20 years in the pharma/biotech industry, developing biologic and peptide products for rare diseases.  He held various roles of increasing responsibility within process development and external manufacturing at RTP Pharma, Genetics Institute/Wyeth, Shire, and ImmunoGen.  Praveen was most recently at AVEO Oncology, where he was Senior Director and Head of Biologics Development and Manufacturing.  Praveen is active in the Parenteral Drug Association and was a co-author of the first edition of PDA Technical Report 60 (2012).  His interests are phase-appropriate QbD implementation, digital CMC, and external manufacturing best practices.  Praveen earned a Bachelor’s and Master of Chemical Engineering from McGill University and a Ph.D. in Chemical Engineering from Tufts University.

Kevin has over 20 years of biologics manufacturing experience for both innovators and CDMOs in all phases of molecule lifecycles.  He currently leads Just’s innovative J.POD continuous manufacturing site in Redmond, WA.

Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.

With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies to the market, with an emphasis on engineering and qualification in the advanced therapy and large-molecule biologics space. He has a degree in Chemical Engineering from Colorado State University

Greg Gara has over 30 years of experience designing and constructing large- and small-scale manufacturing facilities from beginning to end, for multiple biotech and gene therapy companies across the globe.  Prior to joining Project Farma, he served as Senior Vice President of Manufacturing at Taysha Gene Therapy, responsible for leading the design, construction, and startup of their new large-scale manufacturing facility located in North Carolina.  Before Taysha, Mr. Gara served as Vice President of Pharmaceutical Engineering at Sarepta, where he led and managed their manufacturing operations for all gene therapy products. Prior to Sarepta, he served as Vice President of Technical Operations and Engineering at AveXis, a Novartis company, where he led the design, construction, and startup of the Libertyville facility, the new facilities in Research Triangle Park and Colorado. Mr. Gara led project teams responsible for expanding both lab and manufacturing space in North Carolina and Colorado locations in support of on-going operations.  Prior to AveXis, he led the facilities and engineering organization at Hospira prior to the company’s acquisition by Pfizer. Before joining Hospira, he spent 15 years at Amgen, holding positions of increasing responsibility, and was part of the Cork, Ireland, construction project. Mr. Gara received a B.A. in Biology and Environmental Science from Augustana College.

John Lee is an accomplished CAR-T immunobiologist with over 20 years of cancer cell biology expertise spanning small and large molecules, as well as cell-based therapeutics. He possesses more than 15 years of clinical research and cell therapy experience including positions at The Wistar Institute, Janssen Pharmaceuticals, and GlaxoSmithKline. Lee previously built the Cell Therapy Platform team at Janssen Pharmaceuticals. The group led and supported end-to-end therapy discovery and development across nearly a dozen CAR-T programs, including the recently approved cilta-cel (Carvykti). Lee holds a PhD from the Brody School of Medicine, an MBA from Penn State University, and a BSc from Indiana University of Pennsylvania.

Stefan Lutz joined Codexis in 2020 as Senior Vice President of Research to lead the company’s research team advancing the discovery of proteins. Previously, he was a Professor and Chair of the Chemistry Department at Emory University, joining the university in 2002 and ascending to Department Chair in 2014. Stefan has co-authored over 65 peer-reviewed articles and six technical books and journals, holds six patents and is a frequent industry speaker. Dr. Lutz received a B.Sc. in chemistry/chemical engineering from Zurich University of Applied Sciences, an M.Sc. in Biotechnology from the University of Teesside and a Ph.D. in chemistry from the University of Florida.

Ken has spent over 30 years in product, project and IT operations leadership focused in the software and life science industries. Prior to joining IDBS where he focuses on software to manage biopharma manufacturing process data, Ken served as Director, Project Management at BIOVIA. Previously, he was Director of Commercial Operations at Fischer Imaging and Director of IT at Allos Therapeutics and Genomica. 

Ken holds a BSc in Computer Science from Cal Poly and an MBA from the University of Colorado, Denver.

Fabian Gerlinghaus is Co-Founder and Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about meeting total patient demand for cell therapies globally. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honors degree in technology management from the Center for Digital Technology and Management, Munich.

John Stewart, Vice President KojoX Strategy, serves as part of the Global Strategic Business Services group at FUJIFILM Diosynth Biotechnologies.  His responsibilities include the execution of the Company’s novel KojoX^TM Strategy. John is an executive with 30 years tenure in the pharmaceuticals industry with a background in international multi-site leadership of both small molecule and biologics manufacture and supply networks and with responsibility for internal and external manufacturing of clinical and commercial stage biologics.

Robert W. Beall -Vice President, ProPharma Group has 35+ years of industry experience. Robert has supported the development and commercialization of multiple cell therapy products and processes including decentralization of CD19+ CAR T therapies, development of hospital cellular therapy labs, including expansion of the NIH Center for Cellular Engineering, as well as the expansion of the first commercialized CAR-T therapy process capabilities. Other Cell therapy programs included remediation support for cellular and media manufacturing programs, and guidance for multiple CAR-T manufacturing automation advancements. Robert supported the COVID-19 response by establishing global safety systems for three major vaccines.  He has led hundreds of international product transfers utilizing both internal transfers and CMO’s at multiple top 10 Pharmaceutical companies. He is a graduate of the Rochester Institute of Technology (RIT) with a BS in Engineering and has completed advanced degree studies as well as completing his PMP certification.  He is an international speaker and author.

Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.

Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year postmarket clinical study for orthopedic devices.Lowe has a bachelor’s degree in mechanical engineering from the University of Utah and an MBA from Indiana University.

With three decades in the pharma, biopharm, and cell and gene therapy, Andrew has been on the bench through executive leadership. With eight (8) successful BLAs including a recent approval for TIL therapy while at Iovance, Andrew has found a niche in late stage development and commercialization. From CMC sections to inspections, he has been fortunate to be on the forefront of such products as Simponi, Stellara, Tanzeum, Nucala, Benlysta Subcutaneous admin, Nucala at Home, Blenrep, and most recently Amttagvi. Most recently he started a company, CMC & Quality Partners, aimed at helping companies achieve their submission, inspection, and commercial launch readiness goals.

See more at LinkedIn: (1) Andrew Jones | LinkedIn and (2) website: https://www.cmcquality.com/

A Manufacturing Leader with over 26 years of experience in the Pharmaceutical, Biotech, and Contract Development and Manufacturing Organizations (CDMO), Karen currently serves as the Director of External Manufacturing at Spark Therapeutics in Philadelphia, PA.  In this role, Karen manages Spark’s network of external partners providing the essential services for drug substance and drug product formulation, fill and finish ensuring the successful distribution of commercial and clinical gene therapy products.

A robust background in heavily regulated manufacturing operations, client relationship management, business development, and Lean Six Sigma methodologies has been fundamental in enabling Karen to successfully implement meaningful change across multiple esteemed organizations such as WuXi Advanced Therapies, Shire, Amgen, and Wyeth where she has overseen large teams responsible for complex manufacturing operations.