2024 Speakers

Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada.

Sanat oversees a network of 50 pharmaceuticals, vaccines, biologics/therapeutic proteins and animal health manufacturing, commercialization and distribution sites with approximately 20,000 staff in over 20 countries around the world producing annually 17.5 billion tablets, 700M injectables, 1 billion packs, and 90 billion animal health vaccines doses in 22,000 product finishes. He also serves on Merck’s Executive Committee.

In his current role, he has successfully launched a new strategy for the manufacturing and supply organization, restructured the organization into four independent, interconnected business units, and further integrated supply planning and operations across the company.

He has a 30-year track record of success in commercialization, manufacturing and supply chain excellence in therapeutic proteins, vaccines and pharmaceuticals for Hoechst, Aventis, Wyeth and Merck.

Before joining Merck in November 2009, Sanat worked for Wyeth Pharmaceuticals as Senior Vice President, New Products & Process Development. A graduate Chemical Engineer and a post-graduate Industrial Engineer from India, Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments in 5 countries across 3 continents, rising to the level of Senior Vice President, Product Development & Supply at Aventis where he led global supply chain, including new product commercialization, technology and engineering.

Outside Merck, Sanat serves on the Board of Directors of Hilleman Laboratories, an equal joint-venture partnership formed between Merck and the Wellcome Trust, a global charitable foundation dedicated to human and animal health. He is also a member of the Advisory Board of the USA-India Chamber of Commerce.

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.

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.

Dr. Alison Moore is a CMC Executive who most recently served as the Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.

Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization where she is responsible for all internal and external manufacturing operations and strategic supplier relationships to deliver reliable supply for patients across the globe. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing, technology transfer, and plant management.

In her career Paulino has developed extensive experience in operations and end to end value chain management. She has focused heavily on applied process engineering and technology advancement and has advanced CMC commercialization of numerous biologics and complex small molecules. She has a proven ability to develop and sustain organizations that deliver results.

Paulino has been a champion for change and innovation, an avid supporter in advancing science causes, and an advocate for empowering women in the STEM field. Her passion is to create cultures where diversity brings strength, inclusion is celebrated, and everyone feels a sense of belonging. She contributes actively to the community and sits on various committees including serving on the Board of Directors of Senior Concerns. She previously was on the Board of Directors for the Pacific Science Center. Paulino was presented the Healthcare Businesswomen’s Association (HBA) Rising Stars Award for Amgen in 2015.

Paulino holds a Bachelor of Science degree in Biochemistry from Marquette 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.

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.

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.  

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.

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.

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

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.

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.

Eliana Clark brings to Intellia more than 20 years of experience in the biopharmaceutical industry. Prior to Intellia, Eliana spent eight years in many leadership roles at Biogen, including vice president of Product Development and Portfolio Management, vice president of International Manufacturing Operations and vice president of Global Manufacturing Sciences. In her most recent role, she led the team responsible for CMC strategy, product supply and life cycle management for Biogen’s entire portfolio of clinical and commercial products. Before Biogen, Eliana spent many years at Sanofi/Genzyme, where she held leadership roles in formulation development, technical services and CMC regulatory. Prior to working in industry, Eliana was a professor at Tufts University in the Chemical and Biological Engineering Department for nearly 15 years.

As chief technical officer at Intellia, Eliana is responsible for manufacturing, supply chain, CMC strategy, process and analytical development, genomics operations and quality. She holds a B.E. and Ph.D. in Chemical Engineering from the Universidad Nacional del Litoral, Argentina, and has graduated from the Greater Boston Executive Program at MIT Sloan School of Management.

Mr. Pinion joined Ultragenyx in July 2015 as CQOO and EVP, where he provides leadership for the company’s translational sciences functions, including Pharmacology and Toxicology, Research and Bioanalytical Development, as well as GxP Quality and Compliance, Validation and CMC Analytical Development and QC.

Prior to joining Ultragenyx, Mr. Pinion spent 10 years at Genentech (subsequently Roche), most recently as Senior Vice President and Global Head of Quality and Compliance for Pharma Technical Operations based in Basel, Switzerland. Before Genentech, Mr. Pinion spent 17 years in operational and senior leadership roles in Baxter International’s Renal, Bioscience, Parenterals and Device divisions.

Mr. Pinion serves on the Board of Directors and as Chair of the Audit and Risk Committee of Aroa Biosurgery Ltd.

He received a B.S. in mechanical engineering from West Virginia 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.

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.

Jamie Moore is the Senior Vice President of Technical Development responsible for all aspects of 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 Global Head of Pharmaceutical Development and Head of Manufacturing Science and Technology for Commercial Products. Externally, Jamie serves as the President-elect 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.

Kawa Chiu brings to Abdera more than 26 years of global manufacturing, supply chain and CMC experience across broad modalities. Most recently, 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 built out and oversaw CMC programs that enabled three IND approvals in two years. In addition, Kawa established the company’s autologous patient supply chain and implemented a progressive cloud based, integrated manufacturing systems.

Prior to Lyell, Kawa served in multiple senior management positions at Genentech in South San Francisco and at Roche in Basel, Switzerland 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. As the global head of supply planning, Kawa oversaw the company’s $46 billion biologics product supply with a complex network of 35+ internal and external manufacturing sites. Her team led the effort that reduced 20% of global inventory while eliminating chronic stockouts. As the head of Oceanside manufacturing, Kawa transformed the manufacturing operations from a chaotic startup to the most reliable supplier while introducing three new products: Avastin, Rituxan and Actemra.

Kawa started her career as a manufacturing supervisor at Merck & Co., Inc. She held several leadership positions including global quality auditor, automation engineer for a vaccine facility startup, and a program lead that transformed Merck’s distribution strategy in North America, Brazil and Europe, which resulted in $100M revenue enhancement.

Kawa holds a B.S. in operations from the Ohio State University, a M.Sc. in engineering from University of Pennsylvania and an MBA from New York University.

Fun Fact:

Kawa is an avid runner and completed 15 half-marathons and 3 full marathons including the beautiful Jungfrau Marathon running up the Swiss Alps with a 6400 feet elevation.

John Tomtishen is SVP Operations & GM at Cellares. At Cellares John is responsible for supporting partnership activities and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm. He has more than 10 years of experience in cell and gene therapies, biologics, and vaccines, with diverse roles in Business Operations, CMC/Technical Operations, Supply Chain, Engineering/Facilities, and Operational Excellence. John served as the Site Managing Director at Legend Biotech’s corporate headquarters. At Legend, John had an integral role in the clinical development and BLA filing of Carvykti™ (ciltacabtagene autoleucel) in collaboration with Janssen Pharmaceuticals. John also worked for Novartis Pharmaceuticals within Cell and Gene Technical Development & Manufacturing where he had an integral role in the filing and approval of the first CAR T-cell BLA, Kymriah™ (tisagenlecleucel).

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.

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.

Dr. Gargi Seth is a Director in Global Technical Development Project and Portfolio Management group. In this role, Dr. Seth and her team partner with TDTs and stakeholders to drive the progression of CMC projects to deliver the pipeline, develop tools to support decision making, support continuous improvement of TDT business processes, define methodologies for cross-project learning and generate insights for strategy development and implementation. In her current role, Dr. Seth has been leading cross-functional efforts at an organizational level within Roche Pharma Technical (PT) to assess readiness to deliver on future demand scenarios of patient-centric flexible care solutions, has served as Technical Development Lead for a late stage large molecule and has successfully implemented strategic innovation experiments to improve governance and decision-making effectiveness.

Through her experiences in both established biotech, and emerging market start-up companies, Dr. Seth brings business and strategic acumen, in-depth scientific knowledge, product and process development expertise, direct people management and cross-functional team leadership experience.

Prior to Genentech, Dr. Seth was part of the Senior Management Team as Head of Technology Management at Cipla Biotec in India where she was responsible for building and leading a technical management department to identify, develop, implement and transfer bioprocess and analytical technologies.  Prior to Cipla, Dr. Seth was Senior General Manager and Associate Vice President of R&D at Intas Pharmaceuticals in India, leading process and product development functions to develop recombinant therapeutics.

Dr. Seth was formerly a group leader at Genentech in Technical Development function where she led several cross-functional teams to gain fundamental insights into protein production processes.

Dr. Seth earned her Ph.D. in Chemical Engineering from the University of Minnesota and is an active member of the biotechnology community.

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.

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.

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.

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.

Dr. Pascal Bécotte leads the firm’s Canadian operations and leads the firm’s global Corporate Officers practice which includes the Finance, Human Resources, Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs practices. Pascal is also a member of the firm’s Global Executive Committee as well as a member of the Healthcare and Industrial teams, where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. He splits his time between the Toronto and New York offices.

Pascal has more than 18 years of executive search experience, most recently with a leading global executive search firm where he was Managing Partner for the Montreal office. Immediately prior to joining Russell Reynolds Associates, Pascal worked for Target, where he was Group Vice President for Stores and Officers in Canada. Earlier in his career, he was President of a boutique recruiting and consulting firm specialized in sales and marketing. Pascal began his career as National Sales Manager for a sportswear manufacturing company.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and was 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 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.

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.

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.

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.