Sanat Chattopadhyay

Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $47 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.

Esteban Santos

Esteban Santos serves as executive vice president, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain.

Prior to this role, Santos was senior vice president, Manufacturing, responsible for operations at Amgen’s commercial manufacturing locations in the U.S., Puerto Rico, Ireland, the Netherlands and Singapore. He held various leadership roles, including vice president, Drug Product; vice president, Site Operations; vice president, Manufacturing; and vice president, Engineering. Santos joined Amgen in 2007 as executive director, Manufacturing Technologies.

Before joining Amgen, Santos was site general manager for the Johnson & Johnson (J&J) Cordis operation in Puerto Rico. Prior to J&J, Santos held several management positions in General Electric’s industrial and transportation businesses in Puerto Rico, Connecticut and Pennsylvania.

Santos holds a Bachelor of Science degree in Electrical Engineering from the University of Puerto Rico – Mayagüez, and a Master of Science in Management from the Rensselaer Polytechnic Institute, Hartford, Connecticut.

Azita Saleki-Gerhardt

Dr. Azita Saleki-Gerhardt is Executive Vice President, Operations, at AbbVie, leading a team of scientific, engineering, business, quality, supply chain, security, purchasing and manufacturing professionals responsible for supply and distribution of all AbbVie products, as well as a number of corporate services.

Dr. Saleki-Gerhardt joined Abbott in 1993 as a research scientist. She has worked in key leadership positions of increasing responsibility across a broad range of areas, including science and technology, manufacturing and quality assurance. Following AbbVie’s separation from Abbott, Dr. Saleki-Gerhardt was appointed head of AbbVie Operations.

She has been published in a number of scientific publications and has been awarded several patents related to pharmaceutical sciences.

Dr. Saleki-Gerhardt is a member of the board of directors for Entegris and also serves on the board of directors at the United Way of Lake County. She is a member of the Dean’s Advisory Boards for the School of International Studies and School of Pharmacy at UW-Madison. At AbbVie, she is the executive chair of the Asian Leadership Employee Resource Group.

Dr. Saleki-Gerhardt earned her bachelor’s, master’s and doctorate degrees in pharmaceutics from the University of Wisconsin at Madison.

Wolfram Carius

Prof. Wolfram Carius is the Executive Vice President Pharmaceuticals Product Supply (Chemicals, Pharma, Biotech, Devices) at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior vice president and member of the global leadership team at Sanofi Genzyme for two years. Before that, he worked for Boehringer Ingelheim from 1987 to the end of 2013, eventually becoming responsible for that company’s worldwide chemical, pharmaceutical, and biopharma production network. In his 30 years in the pharmaceutical industry he has worked in Asia, South America and Europe. In 2009, the Biberach University of Applied Sciences awarded him the title of honorary professor in recognition for his long and exceptional service. He also holds a PhD in pharmaceutical biology and analytical phytochemistry from the University of Saarland, Germany.

Juan Andres

As Chief Technical Operations and Quality Officer, Juan Andres is responsible for the supply of product required for Moderna’s preclinical and clinical development programs, as well as scaling the CMC (chemistry, manufacturing and controls) processes across Moderna’s portfolio. Mr. Andres also will lead all CMC late-stage development and future commercialization activities.

Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. In this role, he had responsibility for all of Novartis’ manufacturing sites, and related support functions and technologies worldwide, overseeing small molecules drug substance and drug product, as well as biologics drug substance, drug product and technical development. Mr. Andres’ previous roles at Novartis included Group Novartis Quality Head, Global Head of Technical Research and Development, and Global Pharmaceutical Operations Head. Prior to Novartis, Mr. Andres worked at Eli Lilly & Co. for 18 years in a variety of manufacturing, production and quality roles in the United States, Puerto Rico, UK and Spain, most recently serving as Vice President, Pharmaceutical Manufacturing.

Mr. Andres holds a Master degree in Pharmacy from Alcala de Henares University in Madrid and completed an advanced development program at the London Business School.

Charles L. Cooney (Chairperson)

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Gerard Greco

In September 2014, Dr. Gerard Greco joined Takeda as Global Quality Officer. Dr. Greco has more than 34 years’ experience in quality leadership roles in the pharmaceutical industry.

At Takeda, Dr. Greco has introduced key transformations by creating one Quality Management System and a Global Quality Organization that aligns the quality units and establishes consistent quality systems and programs across the network.

Prior to joining Takeda, Dr. Greco held positions of increasing responsibility at Johnson & Johnson, Wyeth Pharmaceuticals, Pfizer Inc. and Teva Pharmaceuticals, where he served as Senior Vice President of Global Quality Operations.

Dr. Greco holds a doctorate in microbiology and molecular genetics from Rutgers University in the U.S.

Donna Gulbinski

Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history of delivering exceptional quality, compliance and business performance. Donna has a 30-year plus career where she held positions of significant responsibility for Quality and GxP Compliance, including various roles in drug discovery, operations, quality and regulatory affairs. Donna is currently the Chief Quality & Regulatory Affairs Officer at Civica, Inc., a new independent not-for-profit company founded by health care systems to address critical generic drug shortages caused by market failures.

Donna was previously at Lachman Consultant Services, LLC where she was Vice President of the Compliance Practice. Prior to that Donna was the Head of Quality for Bristol-Myers Squibb where she led Quality through 13 NME approvals with flawless pre-approval inspections, built, qualified and approved several biologics facilities and led transformational activities in moving from 34 sites to 12 both from a quality perspective and as the CMC regulatory leader.

Donna’s expertise spans a strong foundation in technical and quality & compliance including basic research at Merck & Co., Inc. across cardiovascular, bone biology, HIV, anti-coagulants and multiple drug resistance.

Brendan O’Callaghan

Brendan O’Callaghan is responsible for over 5000 colleagues across several global manufacturing sites who are committed to bringing life-changing biologics based medicines to help improve the lives of patients everywhere.

In his role, Brendan collaborates transversally with expert teams from across Commercial, R&D and IA to help advance our capabilities and capacities to develop, launch and supply our exciting pipeline of Biologics therapies for SANOFI and the patients we serve. A key focus for Brendan is in supporting our many skilled colleagues as we build the expertise and capabilities we need to achieve our ambition to become a top tier player in Biologics, with a clear focus on Product Technology and Development, Flawless Launch and Reliable, Competitive Commercial Supply, Quality, MSAT, Supply Chain, Engineering, Manufacturing Excellence and other related areas of global support.

Kimberly Lounds Foster

Kimberly Lounds Foster is Senior Vice President, Global Supply Chain at Bristol-Myers Squibb, where she oversees the clinical and commercial supply chain. Bristol develops and manufactures products on multiple technology platforms, including small molecules, biologics and cell therapies. Kimberly joined Bristol through the Celgene acquisition in 2019 after leading Celgene’s Global Technical Operations organization. Prior to Celgene, Ms. Foster was Head of Global Supply Chain at Novartis’ Cell & Gene Therapy unit, where she was responsible for building out the commercial and clinical autologous supply chain for KYMRIAHTM (tisagenlecleucel), the first FDA approved CAR T cell therapy. Ms. Foster held various positions at Sandoz a Novartis company where she built the External Supply Operations functions for the Americas and managed Sandoz US supply chain for in-line products, new products launches and managed the warehouse and distributions network. Prior to Sandoz, Ms. Foster held various roles of increasing responsibilities at Catalent Pharma Solutions, Baxter Healthcare, Accenture and Merck. Ms. Foster’s diverse experience includes business development, mergers & acquisitions, management consulting, strategic planning, process engineering and operational excellence. Ms. Foster holds an M.B.A from The Wharton School, University of Pennsylvania and a B.S. in Chemical Engineering from Northwestern University.

Franco Pieropan

Franco Pieropan is the Senior Vice President of GMS Quality for GlaxoSmithKline based in Research Triangle Park, North Carolina. He provides leadership, direction and focus for Quality ensuring that all products manufactured by Global Manufacturing and Supply meet all Quality standards.

Franco has in-depth knowledge of pharmaceutical manufacturing plant products, processes, markets and regulations. He has over 30 years of management experience and over 20 years of experience within the GSK organization. Franco has held many different roles in GSK managing manufacturing sites, technically complex dose forms, developing and industrializing new products for global supply. He is skilled in innovative technology within a highly regulated environment (FDA, MHRA, EMA, etc.). He has a Master of Science degree in Organic Chemistry from Padova University in Italy.

Al Boyle

Al is Senior Vice President of Technical Operations and Quality for Alnylam Pharmaceuticals. He leads a global organization responsible for all aspects of siRNA process and analytical development, clinical and commercial manufacturing, supply chain operations, engineering, facilities and real estate operations, and quality assurance and quality control oversight for all GxP activities. Prior to joining Alnylam in 2015, Al worked for a number of global biotechnology, chemical and pharmaceutical companies including Alexion, Bristol-Myers Squibb, Hercules, Akzo-Nobel and Celgene. Al holds a PhD in Microbiology from Rutgers University and BS and MS degrees in Environmental and Forest Biology from The State University of New York College of Environmental Science and Forestry.

Uwe Buecheler

Uwe Buecheler, joint Boehringer Ingelheim (formerly Dr. Karl Thomae GmbH) in 1991. During his time at Boehringer Ingelheim he held different positions in Biopharmaceuticals in Regulatory Affairs, Biological Safety and Quality. 2006 he was appointed site head for the Boehringer Ingelheim site in Biberach, Germany and thereafter 2010 got responsible for global Biopharmaceuticals Operations including sites in Germany, Austria, USA and China. In July 2016 he took over the responsibility for the new Biopharma Business Unit responsible for the growing BioXcellenceTM contract manufacturing business as well as supplies of Biopharmaceuticals to Boehinger Ingelheim Human Pharma.
Uwe Buecheler, has conducted his Ph.D. in Molecular Biology at the University of Heidelberg and the Cancer research Center in Heidelberg. Prior joining Boehringer Ingelheim he worked at Roche (former Boehringer Mannheim site in Penzberg). He has been awarded Professor h.c. at the University of Ulm and is member of various Advisory boards and (Bio-) Pharmaceutical Industry Associations

Anders Vinther

Anders Vinther serves as Site Head (Hayward) and VP Global Quality at Intarcia Therapeutics. He joined Intarcia in 2018 as VP Global Quality and Engagement, previous to this Anders was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines worldwide.

Prior to that he worked for Roche and Genentech most recently as the VP of Biologics Quality which included operational quality leadership for 10 Biologics Roche and Genentech manufacturing sites and all outsourced manufacturing for biologics products. Previous to that role he led the Global Quality System and Processes organization in Genentech & Roche. In that role areas of responsibility included developing and overseeing implementation of the Pharmaceutical Quality System (PQS), Quality Risk Management, Operational Excellence, Portfolio Management, Computer Systems and Inspection Management.

Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics, where his responsibilities on the Board of Management included QA, QC, IT, Human Resources and Strategic Planning.

Anders holds a PhD in Chemical Engineering from the Technical University of Denmark and has 20+ years of business and biopharmaceutical experience, including research and development, quality assurance and control, compliance, regulatory affairs and senior management.

In PDA, Anders is currently the Immediate Past Chair of the Board of Directors. Additionally over the past 20 years in PDA he has been Chairman of the Board of Directors, Treasurer, Board of Directors member, task force and conference planning committee leader and member, and author of numerous articles.

Michele D’Alessandro

Michele is Vice President and CIO for the Manufacturing Division with Merck. In this role, she provides strategic leadership, oversight and delivery of information technology and digital solutions for the Merck Manufacturing Division. A change agent with proven track-record of delivering high-impact projects producing outstanding business results broadly across Pharmaceutical Supply Chain and Manufacturing.

Michele and her team have been nationally recognized for the past 5 years in the areas of technical innovation, including next generation data and analytics platforms; supply chain transformation; and modernization/ digitization in manufacturing plants. In Nov 2017, Michele was awarded a Gold Stevie® Award for Women in Business in the Life Sciences and Healthcare Transformation category.

Michele holds a Bachelors’ double major degree in Math and Computer Science from Rutgers University and an M.B.A. in Information Sciences from Rutgers Graduate School of Management.

Michele serves on the National Association of Manufacturer’s Manufacturing Leadership Council Board of Governors, CNBC’s Technology Executive Council, the Strategic Advisory Board for enigma.io, and the Big Data Advisory Board for Rutgers University.

Ariel Alon

Ariel Alon is Vice President Technical Operations at Novartis. He is responsible for the Americas and special technology manufacturing and supply organization at Novartis Technical Operations. He provides clear vision, long-range strategic planning and a culture of continues improvement to his organization. Ariel led significant initiatives in network optimizations, quality and supply. He received Novartis CEO award twice for excellence in performance. He has over 20 years of experience in various executive leadership roles in the pharmaceutical industry mainly in Manufacturing, Quality and Supply Chain. Ariel holds a Master degree in Engineering and Management. He is a member of the manufacturing advisory committee of BioNJ.

Remo Colarusso

Remo Colarusso is Vice President, Janssen Supply Chain (JSC) at Johnson & Johnson. In this capacity, Remo is responsible for the global manufacturing and supply management of all J&J pharmaceutical brands. He is a member of the Pharmaceutical Global Operating Committee (GOC) and the Johnson & Johnson Supply Chain (JJSC) Leadership Team.

Remo has more than 30 years of biotech and pharmaceutical experience with Johnson & Johnson in the areas of manufacturing, pharmaceutical development, planning, strategy, engineering, project management and process improvement (Lean/Six Sigma). Over the course of his career at Johnson & Johnson, he has held a variety of diverse, strategic leadership roles in the Pharmaceuticals (Janssen) sector, including Vice President, Manufacturing and Technical Operations (MTO), Vice President of Pharmaceutical Development & Manufacturing Sciences (PDMS) in the Research & Development Operations organization, and Vice-President, Product Management, where he was responsible for planning, new product introduction and product lifecycle management. Prior to joining Johnson & Johnson, Remo held roles in engineering at JM Huber Corporation and in process development at the Colgate Palmolive Company.

Over the course of his distinguished career, Remo has been recognized for his tireless commitment to driving supply chain innovation and continuous improvement to deliver maximum value for customers and patients. Personally, he is a strong advocate for diversity and inclusion and focuses a lot of his time mentoring the next generation of industry leaders.

Remo is an active member of numerous organizations designed to support the leadership development and advancement of our industry. He is an active member in the Global Pharmaceutical Manufacturing Leaders Forum Committee of the International Society of Pharmaceutical Engineers (ISPE) and a member of the Pharmaceutical Manufacturers Forum with other supply chain senior leaders from across the pharmaceutical industry. He also participates in the National Association of Manufacturers to further manufacturing excellence in the United States.

Remo holds a Bachelor of Science in Chemical Engineering and an MBA in Operations Research, both from Rutgers University.

Daniel Couto

Daniel Couto is the Chief Operating Officer of Vedanta Biosciences, a leading Microbiome company. Mr. Couto is an Operations Management Executive with over 25 years of experience starting and advancing Biopharmaceutical Development and Manufacturing organizations to higher levels of capability, growth and productivity. Mr. Couto has a comprehensive knowledge and hands-on experience leading organizations through improvement initiatives and developing new therapeutic modalities. Mr. Couto is the former SVP of Manufacturing and Operations of ContraFect Corporation, a public company developing new Lysin enzymes for MRSA infections. His previous employment was with Merck Sharp Dohme Biologics UK Ltd. (former Avecia Biologics) where he served as Vice President of Commercial Manufacturing Operations responsible for all late stage and commercial product. Prior to this he was responsible for 7 World Wide Contract Manufacturing sites including API/BDS and Final Fill Finish as he served as Director of Manufacturing for Nuvelo Inc. (San Francisco Bay area). He has been instrumental in 2 BLA submissions for drug approvals, 2 major Pre-Approval Inspection (PAI), and several IND submissions. Mr. Couto holds patents for several novel separation technologies such as Bulk Protein Crystallization, HPTFF, SMB, and Bacterial formulation and Lyophilization. Prior to this he served in a number of Sr. Management positions for companies including Genzyme Transgenics Corp. (GTC Biotherapeutics), Advanced Biosystems Corp., ImmuCell Corp., and Sepracor Corp. Mr. Couto received his B.S. Degree in Chemical Engineering with a minor in Economics from Rensselaer Polytechnic Institute.

Stephen Scypinski

Dr. Stephen Scypinski received his B.S., M.S. and Ph.D. degrees in Chemistry from Seton Hall University, South Orange, NJ USA. Involved in pharmaceutical research and development for over 30 years, Dr. Scypinski has held positions at Berlex Laboratories, Hoffmann-La Roche, the R.W. Johnson Pharmaceutical Research Institute, Eyetech Pharmaceuticals, and Bristol-Myers Squibb Company. He is presently Vice President, Pharmaceutical Technology for Daiichi Sankyo Inc. His professional interests encompass the development of pharmaceutical processes and methods for drug substances and dosage forms, technical transfer, stability, bioanalytical methodologies, and new technology as applied to the reduction of cycle time and enhancement of productivity in preclinical and pharmaceutical development. Dr. Scypinski has extensive experience in both line and matrix management. He has played a key role in the filing of over fifty global regulatory submissions for both synthetic small molecule and biologic products. Dr. Scypinski is also active in the scientific community, having served as General Chairman of the Eastern Analytical Symposium and Chairman of the Laboratory Robotics Interest Group of New Jersey. He serves on the President’s Advisory Councils of Duquesne University College of Pharmacy and the Stevens Institute of Technology Pharmaceutical Manufacturing & Engineering Program. Dr. Scypinski is also an adjunct professor at Duquesne University School of Pharmacy. He is the recipient of many awards, including the New Jersey Institute of Chemists Honor Scroll Award and the Distinguished Alumnus Award from Seton Hall University. Dr. Scypinski is the Editor-in-Chief for The Journal of Pharmaceutical Innovation and is co-editor of the textbook “Handbook of Modern Pharmaceutical Analysis”, currently in its second edition.

Sandra Casaca

Sandra Casaca serves as the Executive Director Quality Site Head at Allergan since 2018. Sandra is responsible for Quality organization, which encompasses Quality Assurance (including Quality on the Floor), Quality Engineering, Quality Systems, Quality Control and Third-Party Quality.

Prior to this role, Sandra had several leadership roles as a Director during her tenure at Amgen, including regional responsibilities over US/Canada/Brazil, Global Quality Management Systems, Site Quality Head in Brazil, Responsible Pharmacist and Regulatory Affairs Head in Portugal. She joined Amgen in 2008.

Before Joining Amgen, Sandra had several positions in Regulatory Affairs, CMC and in the early stages of her career in the Pharmaceutical Industry she was responsible for a marketing division in advanced wound care at Smith & Nephew.

Sandra Casaca holds a Master’s Degree in Pharmaceutical Sciences from University of Lisbon Faculty of Pharmacy in Lisbon, Portugal. She also holds a Post-Grad degree in Pharmaceutical Marketing from Ashridge University and a regulatory affairs specialist title.

Mihaela Simianu

Dr. Simianu is Head of Sterile Liquids Commercialization within Global Vaccines and Biologics Commercialization member of Merck Manufacturing Division. She leads biologics, vaccines and sterile pharmaceuticals product development and commercialization and supports in-line sterile product life cycle management.

Prior to this role she was Director of Regulatory Compliance at with Pharmatech Associates consulting group and Executive Director in Process Development with Amgen where she was accountable for advancing company’s portfolio of innovative drug products and management of organization’s assets.

Dr. Simianu was for 17 years with Eli Lilly and Company in technical and leadership roles with increasing responsibility as part of Lilly Research Laboratory and Manufacturing Science and Technology organization.

Dr. Simianu holds a Doctorate Degree in Chemistry from Marquette University, Milwaukee, WI.  She was a Postdoctoral Fellow in Biochemistry at Center for Biotechnology and Genetic Materials, Lincoln, NE. She has a MS/BS degree in Chemical Engineering and Pharmaceutical Technology from University of Cluj-Napoca (Romania).

Saul Fink

Saul is Vice President, Pharmaceutical Development at Goldfinch Bio where he leads teams for small molecule and biological assets to provide CMC strategic guidance, budgets and all operational activities to establish a supply chain for clinical supplies.

Saul is a biotech and pharmaceutical R&D leader. He has led CMC teams across many therapeutic areas for both small molecule and biologic assets. He also led large, complex strategy & business operations units with emphasis on financial & resource management, project management, capital facilities & equipment, tracking/reporting business performance and metrics.

Saul has held key strategy and business operations leadership roles in pharmaceutical development, translational medicine, discovery, regulatory, pharmacovigilance, biostats, manufacturing and supply chain. He was a key leader in R&D and manufacturing M&A transactions and strategic planning.

Saul spent a good part of his career in the pharmaceutical industry with Bristol-Myers Squibb (BMS). In these roles he worked closely with C-suite and other senior executives to accelerate strategy execution, business transformations and operational performance. Saul led a multi-disciplinary, global integration manufacturing team following the acquisition of Amylin Pharmaceuticals by BMS and AstraZeneca (AZ). He then participated in the $7B divestiture of the BMS diabetes portfolio to AZ including the negotiations for deal close and led the BMS manufacturing transition team. He also drove the recent R&D transformation across 7 sites.

Saul received his B.S. in Chemistry from Millersville University and Ph.D. in Chemistry from the University of Houston

Saul has substantial not-for-profit board and local government experience. He is currently a member and President for the Millersville University Foundation Board. He formerly served as a councilman for East Brunswick (NJ) township. Saul is a licensed recreational pilot.

Jean Bender

Jean Bender is Vice President of Pharmaceutical Sciences and Technology, accountable for leading and delivering (through contract partners) all aspects of CMC for Visterra’s therapeutic product pipeline. Responsibilities include process and analytical method development, characterization and validation; technology transfer and manufacturing of drug substance and drug product for clinical supply; managing clinical supply logistics and authoring CMC sections of regulatory submissions.

Prior to Visterra, Jean served as Senior Director, BioProcess Engineering at Medimmune LLC where she was responsible for process development engineering, scale-up and transfer of drug substance processes to internal and external manufacturing sites. Previously she held roles of increasing responsibility within Genentech Inc., most recently as Principal Engineer in Purification Development in which she was responsible for tech transfer and licensure of monoclonal antibody processes within the Genentech/Roche manufacturing network. She has authored more than 15 publications and presentations within her field and holds a patent for preparing highly concentrated antibodies by ultrafiltration.

Jean received her MS in Chemical Engineering from the University of California, Berkeley and her BS in Chemical Engineering from Lehigh University.

Jean is on the Board for the Recovery of Biological Products Conference Series, and on the Advisory Board for Bio-Works and on the Advisory Board for the Chemical Engineering Department at Lehigh University. Jean is active in several technical organizations, including the American Chemical Society and the BioInnovation Group (BIG).

Brendan Hughes

Brendan leads MS&T for Bristol Myers Squibb with responsibility for all technologies used in manufacturing including biologics, pharma products, parenterals and devices.  Brendan is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy in 2012.  Before that he led MS&T and Technical Services teams in Wyeth and Pfizer.

Brendan has worked in the US, Ireland and the UK. He started his career in the UK working for Wellcome which then became Glaxo-Wellcome and then GSK; roles included leadership positions in analytical sciences as well as project leadership.  Brendan came to US in 2001 joining the Biotech Development in Wyeth.  He later joined the leadership team for the Wyeth Grange Castle biotech start-up in Ireland from 2003-2010 and returned to US in 2010.

Brendan received his B.Sc and Ph.D in Biochemistry in Ireland and carried out post-doctoral studies in Oxford UK.  He was a member of the ICH Expert Working Group which drafted the initial Quality Guidelines for biotech products and later for ICH Q11.

Thomas Seewoester

Thomas Seewoester is the Vice President of Site Operations for the two Amgen sites in West Greenwich, Rhode Island and Woburn, Massachusetts. At Amgen’s 75-acre West Greenwich campus the company manufactures the drug substance or active ingredient of many biotherapeutics including Enbrel®, Vectibix® and Repatha®.

Thomas joined Amgen in 2001 and has held various positions in Manufacturing and Process Development at Amgen’s California and Rhode Island locations.

In his 27 years of industrial bioprocessing and leadership experience he has developed over 40 clinical and commercial processes and created knowledge to commercialize some of the most successful biotherapeutics. He gained his operational experience through leading three different drug substance plants, a drug product plant, a device assembly and packaging plant and a small molecule API plant.

In each of these roles, he successfully developed and matured new processes, operations concepts and technologies for their successful deployment and commercialization.

Thomas is known to champion a culture of safety, global teamwork, innovation and operational excellence to generate product and data most efficiently while continuously improving a business operation.

Before joining Amgen, Thomas worked at BASF Bioresearch Corporation/Abbott Bioresearch Center.

He was a postdoctoral fellow and holds a M.S. and a Ph.D. in Biotechnology from the Institute for Cell Culture Technology, Germany.

Michael Boyson

Adeline Low

Jon Cammack

LeAnn Pipkins