Biomanufacturing World Summit

The Biomanufacturing World Summit is a premier gathering of industry leaders, biomanufacturing executives, and experts dedicated to exploring innovative strategies, emerging trends, and best practices in the dynamic world of biomanufacturing. 

November 19 - November 21, 2024

Hilton San Diego Bayfront | San Diego, CA

Attendees
+
of attendees are Director level and above
%
Global Organizations
+
Renowned Speakers
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Join This Year's Conversation

BMWS gathers Senior Manufacturing Executives, Technical Operations Quality Executives, and Biomanufacturing Executives to share insights, foster innovation, and build invaluable connections. Dive into a thoughtfully curated environment that brings together thought leaders, allowing you to explore new ideas and engage in meaningful discussions. Join the conversation at BMWS and be part of a community dedicated to pushing the limits of biomanufacturing success.

Featured Speakers This Year

Year after year, we bring to the stage today's thought leaders and innovators

Sanat Chattopadhyay

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.

Sanat Chattopadhyay

EVP, President Merck Manufacturing Division

Merck

Peter Marks

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.

Peter Marks

Director – Center for Biologics Evaluation and Research (CBER

FDA

Pat Yang

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.

Pat Yang

Vice Chairman & Co-Founder

Resilience, Inc.

Alison Moore

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.

Alison Moore

CMC Executive, Board Member

Arleen Paulino

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.

Arleen Paulino

SVP Global Manufacturing

Amgen

Tim Moore

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.

Tim Moore

EVP, Chief Technical Officer

Allogene

Michael Thien

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.

Michael Thien

SVP & Head, Pharmaceutical Sciences Takeda R&D

Takeda

Greg Guyer

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

Greg Guyer

EVP and Chief Technical Officer

BioMarin Pharmaceutical Inc.

Chris McDonald

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.

Chris McDonald

Global Head of Technical Operations

Kite, a Gilead Company

John Pinion

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

John Pinion

EVP Translational Sciences, Chief Quality Operations Officer

Ultragenyx

Anthony Mire-Sluis

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.

Anthony Mire-Sluis

SVP Head of Global Quality

AstraZeneca

Magaly Aham

Magaly currently works at Takeda as a Senior Director Quality Compliance for the Global Oncology & Biologics Division. Prior to joining Takeda she worked in consulting for Pharma-BioServ US Inc., MedImmune, Pfizer, Wyeth and Schering Plough in positions of increased responsibility. She holds a Bachelors Degree in Chemistry from the University of Puerto Rico and a Master Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in Maryland, US. She has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. Magaly has participated as a lead in companies undergoing remediation efforts such as Consent Decrees and Warning letter environments in which she has developed expertise in quality systems design and implementation and Risk Management. She is Kepner-Tregoe Problem Solving Decision Making(PSDM) Certified Trainer, former ASQ Quality Auditor (CQA), US-RAC, and a PR Licensed Chemist. She was the PDA QRM IG Coordinator for the past couple of years and recently was appointed Co-Lead of this QRM IG.

Magaly Aham

SVP, Head Global Quality Compliance & Systems

Takeda

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Highlights From Last Year

Highlights from last year

The Biomanufacturing World Summit 2023 gathered top biomanufacturing leaders to share new ideas and collaborate on solutions that inspired a collective vision for change, shaping the future of the industry. 

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