Juan Andres

As Chief Technical and Quality officer, Juan Andres is responsible for Technical Development, product supply at pre-clinical, clinical and commercial stages and quality across Moderna globally (i.e. CMC); chemistry, manufacturing and controls

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.

Carlo de Notaristefani

Michael Kopcha

Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Dr. Kopcha recently served as vice president, and global research and development franchise head, for cough, cold, and respiratory products at Novartis Consumer Health, Inc. in New Jersey. He joined Novartis in 2008 as the global head for pharmaceutical and analytical development, later serving as global head for new technologies and product innovation, and vice president and global head for global product development. At Novartis, Dr. Kopcha led the creation of a global R&D vision and strategies to drive innovation for the cough, cold, and respiratory franchise – through development, sourcing, manufacturing, and supply. He restructured and reorganized global product development to provide for a category-focused, globalized organization, and is credited for the creation of a successful strategic off-shoring/outsourcing program to increase project capacity and efficiency. Before joining Novartis, Dr. Kopcha served as vice president for pharmaceutical development at KV Pharmaceutical, Inc. in St. Louis, where he directed and managed analytical research and development, product development, process development and technology transfer, stability, drug delivery, project management, and external alliance. His experience also includes related roles with Schering-Plough, J&J, and Ivax. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy, from Rutgers University in New Brunswick, New Jersey. He served as an adjunct assistant professor in the Department of Pharmaceutics, Ernest Mario School of Pharmacy at Rutgers.

Wolfram Carius

Prof. Wolfram Carius is the EVP, Cell and Gene Therapy 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 nearly three 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 over 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.

Joanne T. Beck

Joanne Beck joined Boston Pharmaceuticals in 2019 from Celgene, where she was Executive Vice President of Global Pharmaceutical Development and Operations, and oversaw Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School, and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics and Catabasis Pharmaceuticals.

Arleen Paulino

Arleen Paulino, Senior Vice President, Manufacturing, leads Amgen’s commercial manufacturing organization. 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 and technology transfer, as well as plant manager for the cell culture facility.

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

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.

Brendan Hughes

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from internal and external sources. He is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy for Biologics in 2012. From 2015-2020 Brendan led MS&T for the company with responsibility for all technologies used in manufacturing including biologics, pharma products, parenterals and devices.

Before joining BMS, 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 Quality, analytical sciences as well as project leadership. Brendan came to US in 2001 joining the Biotech Development team 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 to work in Pfizer Global Manufacturing.

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 in the 1990s and later for ICH Q11.

Gerard Greco

Dr. Greco joined Takeda as the first Global Quality Officer of the company five years ago. Since that time he has led the transformation of Global Quality at the company in the development of one Quality Management System and the establishment of one Global Quality Leadership team. His scope of responsibility covers all elements of Quality in support of Manufacturing & Supply, R&D, Vaccines, and the Commercial businesses. During 2019 he has led the ongoing integration of Takeda Quality with Shire, as Takeda has grown to a Top 10 Pharma company during this time.

Jerry has over 35 years of experience in quality leadership roles in the pharmaceutical industry. He started his career as a microbiologist at Johnson & Johnson. He spent 17 years at J&J in leadership positions in microbiology and as site quality head for two of the company’s biologics facilities. He worked at Wyeth as head of International Quality, Global Pharmaceutical Quality and later at Pfizer as head of Specialty Biotech & Vaccines Quality. Before joining Takeda in 2014 he worked at Teva as head of Quality for their Global Manufacturing plants.

Jerry is a graduate of Rutgers University where he earned a Ph.D in Microbiology & Molecular Genetics.

Charles L. Cooney

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.

Ken Kent

John Kelly

Ger Carmody

Mark Butchko

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.

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.

Jens Vogel

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the area of biologics operations, development and technology management. From 2012 until 2020, he held positions of increasing responsibility at Boehringer Ingelheim (BI), including as President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics Development Leadership team at Bayer in Berkeley. Jens holds a PhD in Biotechnology from University of Braunschweig, Institute of Technology, Germany.

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.

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.

Derek Adams

Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was the Senior Vice President of CMC at Evelo Biosciences. At Evelo, Derek established the initial process development function and supply chain for clinical studies and drove strategy for product development. Prior to his time at Evelo, he served as Vice President of Technical and Strategic Product Development at Alexion Pharmaceuticals, where his responsibilities included developing and supporting all manufacturing processes globally as well as global clinical supply chain.  His Alexion career also included roles as Plant Manager for Alexion’s Rhode Island Manufacturing facility and head of upstream process development.  Derek began his career in process technical support for live virus vaccine production at Merck & Co, Inc.

Derek holds a Ph.D. in Chemical Engineering from the University of Minnesota and a B.S. in Chemical Engineering with High Distinction from Worcester Polytechnic Institute (WPI).

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.

Patrick 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.

Al Boyle

Al is Chief Technical Operations and Quality Officer 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.

E. Morrey Atkinson

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply network. In addition, Morrey is responsible for assuring reliable supply of Vertex’s transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of experience leading the development and commercial manufacturing of multiple products at organizations like Eli Lilly and Bristol Myers Squibb. An accomplished leader and builder of strong scientific, engineering, and operations teams, Morrey also has prior experience in process development for cell and gene therapies, including the development and manufacturing of one of the first gene therapy candidates for cystic fibrosis.

Uwe Buecheler

Uwe Buecheler, Ph. D. 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, Validation, CMC/GMP documentation and biological safety. For several years he was leading the Quality Unit as well as Process Science for Biopharmaceuticals. Starting 2006 he was appointed site head for the Boehringer Ingelheim site in Biberach, Germany, got member of the board of the German subsidiary being responsible for the mammalian cell culture business at the Biberach site Boehringer Ingelheim. Starting October 2010, he was responsible for global Biopharmaceuticals Operations including sites in Germany, Austria and US. Since May 2014 he is SVP Biopharmaceuticals responsible for the entire Biopharma Business Unit at Boehringer Ingelheim including the new site in Shanghai.

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 Advisory boards of University´s and the Society for Biochemistry and Molecular Biology (GBM). He is Chairman of the Biopharma Cluster South Germany and is Member of several (Bio-) Pharmaceutical Industry Associations e.g. the international leadership forum of ISPE.

Jon Cammack

Jon Cammack is the Chief Quality and Compliance Officer at Nevakar, Inc. He provides strategic direction and oversight of activities that align with business objectives, and ensures compliance with overall biopharma regulations and standards. Jon has over 25 years of commercial and development experience with medical products, including leadership roles in large and small pharma/biotech companies, and as a co-founder of a risk management consulting company. He has a Ph.D. in Pharmacology, holds advisory board positions, and also co-chairs the AAMI/ISO Working Group on Combination Products with John (Barr) Weiner of FDA’s Office of Combination Products.

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 7 years in the areas of technical innovation, including next generation data and analytics platforms; supply chain transformation; and resiliency /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, and the Big Data Advisory Board for Rutgers University.

Dennis Nsenkyire

Dennis is responsible for leading a high performing team responsible for designing, developing, and executing Janssen’s integrated end-to-end supply chain strategic roadmap in partnership with R&D, Commercial and global cross-functional teams.

Success in his current role is working with Commercial, R&D, and end-to-end Supply Chain leaders to translate customer/patient value proposition into an operational strategy and ensure the continual evolution of supply chain capability through innovation, agility, end-to-end value and people/leadership development.

Most recently, Dennis served as Vice President, Supply Chain Culture & Capability Development, where he led the development and implementation of innovative capabilities to further advance Supply Chain talent, skills, competencies, and development programs. Prior to that, Dennis held critical leadership roles responsible for J&J Supply Chain Insights, Strategy and Business Excellence where he led and shaped the development, deployment and execution of J&J Supply Chain strategy and strategic innovation programs.

Prior to joining the Supply Chain organization, Dennis led the Commercial Operations team at Ethicon (J&J Medical Device Sector), responsible for go-to-market models, sales force design and deployment, commercial analytics, planning, and operations.

Dennis joined Johnson and Johnson in 2002 at McNeil Consumer and Specialty Pharmaceuticals, where he held several leadership positions in Process Excellence and Business Strategy and Insights. Dennis also worked at J&J Vision Care, where he was responsible for market insights, sales force deployment, sales force compensation, CRM, territory management, and business analytics. Prior to Johnson and Johnson, Dennis held various leadership roles in Marketing,

Process Excellence and Engineering at Honeywell International and Therma Tru Corporation.

Dennis holds a master’s degree in Electrical Engineering from Arizona State University, an Executive MBA from Drexel University (Lebow College of Business) and is a Certified Process Excellence Master Blackbelt.

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.

Traci Seaman

Traci ran her own consulting company for nearly 15 years, focusing on issues management. She primarily worked with pharma companies with warning letter and consent decrees. She holds a bachelor’s degree in journalism and an MBA with an emphasis on Human Resource Management. She is a six sigma green belt and a certified professional coach. Traci is a believer in servant-based leadership, and a strong proponent of accountability. She studies the impact of accountability on company culture.

Traci is married to her husband Jim and they have two (grown now) sons. She enjoys traveling, sports, reading, DIY and spending time with family.

Shannon Holmes

Shannon is the Director of Product Development Quality at Biogen, based in Research Triangle Park, NC. She leads a global team responsible for quality oversight and strategy of all products and devices in clinical development as well as lifecycle management of commercial programs. Prior to this role, Shannon was a member of the Regulatory Affairs CMC team at Biogen and led a global team responsible for early phase and commercial biological products as well as change management/compliance activities. While at Biogen, Shannon has led successful submissions for clinical, licensed, and post-marketing regulatory applications for biological and combination products. Shannon is an active member of the PhRMA Global Quality and Manufacturing Work Group. Prior to Biogen, Shannon worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting small molecules, biosimilars, and medical devices. Shannon received her PhD in Chemistry from the University of North Carolina and a BS degree in Chemistry from Davidson College.

Michael Boyson

Mike is responsible for global operations strategy, including life-cycle planning and overall operations value management for Takeda’s oncology portfolio and select small molecule therapies. Mike joined Takeda Oncology in 2002. Since that time, he has held various positions in External Manufacturing, Supply, Quality Operations, and GMP Training. Prior to joining Takeda, Mike was with Biogen’s Bioassay Development Group. He holds a B.S. in Microbiology from the University of Massachusetts, Amherst and is a graduate of the General Management Program at Harvard Business School. In his spare time, Mike enjoys snowboarding, running, hiking, improving his private pilot skills, and spending time with his wife and dog.

“The working lesson most important to me is that the power of ethnic, cultural, racial and gender diversity, plus a diversity of perspective is a critical success factor for teams.”

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

Brendan Hughes

Brendan is responsible for all of BMS Pharma and Biologics manufacturing from internal and external sources. He is based in Devens MA.

Brendan joined BMS as Head of CMC Strategy for Biologics in 2012. From 2015-2020 Brendan led MS&T for the company with responsibility for all technologies used in manufacturing including biologics, pharma products, parenterals and devices.

Before joining BMS, 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 Quality, analytical sciences as well as project leadership. Brendan came to US in 2001 joining the Biotech Development team 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 to work in Pfizer Global Manufacturing.

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 in the 1990s and later for ICH Q11

Thomas Seewoester

Thomas Seewoester is the Vice President External Supply, an organization that orchestrates a global operations network of external partners for contract development and manufacturing, materials, components and devices to extend Amgen’s capacity and capabilities.

Prior to this role he served as Vice President Site Operations Rhode Island, Amgen’s largest commercial drug substance manufacturing operation where he also oversaw the construction of a second next-generation plant.

He joined Amgen in 2001 and has held various positions in Process Development before gaining further operational experience through leading drug substance plants, a drug product plant, a device assembly and packaging plant and a small molecule API plant at Amgen’s California and Rhode Island locations.

Mr Seewoester worked at BASF and Abbott before. He was a postdoctoral fellow and holds a M.S. and a Ph.D. in Biotechnology from the Institute for Cell Culture Technology, Germany.

Andrey J. Zarur

Andrey co-founded GreenLight Biosciences in 2008 to develop advanced biological solutions to overcome some of the biggest challenges faced by the human race, including sustainable food production, response and preparedness for pandemics, and global access to effective human health.

He is a co-founder and was Chairman of the Board of Solid Biosciences, Inc. (NASDAQ: SLDB), a gene-therapy company targeting Duchenne Muscular Dystrophy. He is also co-founder and Chairman of the Board at Lumicell Surgical, an oncology company delivering advanced imaging solutions to cancer surgery. He has been a co-founder and senior executive in more than a dozen companies in the healthcare and clean energy sectors. Prior to starting GreenLight, Andrey was Managing Partner at Kodiak Venture Partners, an early-stage, technology-driven venture fund based in Boston.

Dr. Zarur carried out graduate doctoral studies in Chemical and Biomedical Engineering at the Massachusetts Institute of Technology, and Immunology at Harvard-MIT. Andrey is a frequent invited speaker at scientific and trade conferences, has authored a number of landmark peer-reviewed articles in prestigious scientific journals, holds over 100 provisional and issued patents and has been regularly quoted in international media on the pandemic and RNA vaccines, including recent opinion pieces in Fortune and Stat as well as quotes in the Financial Times, Investors Business Daily, Wired, Business Insider and CNBC.

Pascal Bécotte

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.

Franck Chassant

Since he completed his PharmD degree, Franck has been working in the industry for 20 years, with roles of growing responsibilities in pharmaceutical, vaccines and biologic manufacturing operations (drug substance and drug product) as well as industrial strategy, in France, Canada and the USA.

After leading large industrial and R&D campuses as site head in Swiftwater, PA and then at Marcy-L’Etoile, France, Franck is now in charge of Rare Disease, Oncology and Immunology Industrial cluster (5 sites), at Sanofi Speciality Care.

He is based in Boston with his wife and 2 kids.