Speakers

Sanat Chattopadhyay is responsible for the company’s (approx.  $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

Hilary Marston, M.D., M.P.H. is a Principal at Canal Row Advisors, a regulatory strategy consulting firm. Prior to this, Dr. Marston served as the Chief Medical Officer of the FDA. She oversaw clinical matters that involved multiple product development centers, including financial incentives for rare disease product development, combination product jurisdiction and research participant protection policy. She also led Agency response to health crises, including epidemics and shortages.

Dr. Marston previously served as Senior Advisor for Global COVID-19 Response on the White House COVID Team, Director for Medical Biopreparedness and Response at the National Security Council, and Policy Advisor for Pandemic Preparedness at the National Institutes of Health.

Dr. Marston trained in Internal Medicine at Brigham & Women’s Hospital.

Scott Gottlieb, MD, is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. He is currently a senior fellow at the American Enterprise Institute for Public Policy Research and a partner at the venture capital firm New Enterprise Associates.

Under his leadership, the FDA advanced new frameworks for the modern oversight of gene therapies, cell-based medicines, and digital health devices. The agency implemented new reforms to standardize drug reviews and made historic improvements in post-market data collection and the use of real-world evidence. He promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises. The agency’s prolific advances in new policy distinguished his tenure as FDA Commissioner, along with a record-setting number of approvals for novel drugs, medical devices, and generic medicines.

Previously, Dr. Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and, before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services. He is the author of the New York Times bestselling book “Uncontrolled Spread: Why Covid-19 Crushed Us and How We Can Defeat the Next Pandemic” and is a regular contributor to CNBC and CBS News’ Face the Nation. Dr. Gottlieb serves on the board of directors of publicly traded companies Pfizer, Inc., Illumina, Inc., and TempusAI.

Dr. Gottlieb is an elected member of the National Academy of Medicine and completed medical school and a residency in internal medicine at the Mount Sinai School of Medicine, where he currently serves on the executive committee of the Mount Sinai Health System’s board of directors and co-chairs the board’s education committee. He graduated from Wesleyan University, where he majored in economics, and currently serves on the university’s board of directors. Dr. Gottlieb lives in Connecticut with his wife and three daughters.

Kimberly has achieved several first-in-industry achievements throughout her career within life sciences. Currently at Johnson & Johnson Innovative Medicine, she shapes the long-term vision, strategic direction and execution of end-to-end supply chains and global manufacturing networks for emerging new modalities, including cell & gene therapy and radio pharmaceuticals.

Before joining J&J, Kimberly served as SVP, Global Supply Chain at Bristol Myers Squibb, where she oversaw plan, deliver, digital excellence and integrated product strategies for all commercial products in addition to plan for all clinical supplies. Under Kimberly’s leadership, the global supply team successfully launched more than nine new products, including several within hours of FDA approval,
and BMS was recognized on the annual ‘Supply Chain Top 25’ list by Gartner. Both achievements were firsts in the company’s history.

Earlier in her career at Novartis, Kimberly led the supply chain teams that achieved FDA approval and launch for the world’s first CD-19 CAR-T therapy and launched the first FDA-approved biosimilar.
Kimberly received her M.B.A. from the Wharton School, University of Pennsylvania and her B.S in Chemical Engineering from Northwestern University. She has been recognized as one of the Fierce Pharma’s ’20 Fiercest Women in Life Sciences’.

Kimberly serves on the Advisory Board of the Department of Chemical and Biological Engineering at Northwestern University and is passionate about mentoring tomorrow’s workforce to excel in STEM careers.

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

As the Senior Vice President for Specialty Care Manufacturing & Supply at Sanofi in Paris, Daniela Ottini oversees the global Manufacturing Network for Specialty Care products. With extensive experience spanning over a decade at AbbVie,  she has held leadership positions such as Vice President of External and Contract Manufacturing in Rome, Italy, and Vice President of Biologics Manufacturing in Dublin, Ireland. Her career highlights include managing diverse portfolios and leading strategic initiatives like the integration of AbbVie-Allergan for Operations. Previously, at Abbott, Daniela held various roles over 16 years, including Manufacturing Director in Italy and Regional Purchasing Manager in the UK.  She holds a degree in Chemical Engineering from Sapienza Università di Roma and a Master’s in Business Engineering from the University of Rome Tor Vergata.

Paul was appointed Chief Quality Officer at Bristol Myers Squibb in September 2024.  Prior to that he served as Vice President, Head of R&D Quality at BMS since 2023. A dynamic and strategic leader with more than 27 years of good practice (GxP) quality and compliance experience, Paul has demonstrated an ability to foster a culture of quality excellence. Most notably, he has helped shape the Quality strategy with a focus on proactive, risk-based and scientific principles, leveraging innovation to enable end-to-end, sustainable quality performance.

Prior to joining BMS, Paul held several senior-level Quality positions at Johnson & Johnson, most recently serving as the Head of BioResearch QA where he led risk-based quality and compliance oversight spanning preclinical, clinical and pharmacovigilance disciplines. During that time, he partnered with internal and external stakeholders to develop and implement innovative quality oversight, leveraging data analytics and technology solutions to deliver more effective, efficient and value-based quality outcomes. Prior to Johnson & Johnson, Paul held positions at Pfizer and Warner Lambert both in R&D and Manufacturing Quality. He holds a Bachelor’s in Biochemistry from the University of Scranton, an M.S. in Quality Engineering from Lehigh University and an MBA from St. John’s University.

Chris Crowell leads the Global Manufacturing team at Kite, overseeing the four-site commercial network that delivers industry-leading turnaround times for the company’s primary cell therapy, receives regulatory approvals from multiple jurisdictions, and is launching clinical trial production for a promising new asset.

Most recently, Chris served as the Site Head of Kite’s T-cell therapy commercial manufacturing facility in Amsterdam, managing a sitewide staff of approximately 1,000 employees and serving patients from throughout Europe and the Middle East. He joined Kite initially in 2021 as Vice President of Manufacturing and Site Head of Kite’s Research, Development & Manufacturing Center located in Santa Monica, California, bringing years of pharmaceutical manufacturing and operations expertise to Kite’s clinical site.

Prior to Kite, Chris served as the Executive Director and Plant Manager of Amgen’s Drug Substance manufacturing facility in Thousand Oaks, California that was responsible for manufacturing the company’s oncology pipeline products. He began his 28-year career at Amgen in their Analytical Development function within Quality and advanced in roles that spanned all phases of Chemistry, Manufacturing and Controls (CMC) commercialization – including Global Operations and Process Development. That comprehensive experience led to his recruitment by Kite.

Chris holds a bachelor’s degree in biological sciences from the University of California, Santa Barbara, and a Doctor of Philosophy in pharmaceutical sciences from the University of Colorado’s Anshutz Medical Campus. Born and raised on the East Coast, his dissertation focused on elucidating the relationship of changes in gene expression with changes in phenotypes of protein therapeutics impacted by cell culture media conditions.

Nitin Rathore, Ph.D., is currently the Vice President of Drug Product Technologies, Process Development at Amgen Inc., Thousand Oaks, California. Dr. Rathore has over 20 years of experience in process development and leads the Drug Product organization at Amgen encompassing both biologics and synthetics portfolio across all phases of development.

His organization focusses on commercialization of Amgen’s multi-modality portfolio covering molecule assessment, formulation development, process design, technology transfer, regulatory filings, and new product launches. His team also provides support to drug product manufacturing sites including both new product introductions as well as ongoing support to ensure supply of 40 commercial products. Dr. Rathore has experience in advancing next-gen technologies both in development space (automation and high throughput), and in the area of drug product filling, lyophilization and automated visual inspection. He is currently a member of Board of Directors for the IQ consortium and has been an active member of various other professional societies. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug product development and innovation in biomanufacturing.

Prior to Amgen, he worked in the process optimization group at Novozymes, North America. Dr. Rathore received his Ph.D. degree in Chemical and Biological Engineering from University of Wisconsin-Madison, Madison, WI.

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.

Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ – the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.

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.

Anders Vinther, founder of Quality Business Administration, is a well-known and respected quality leader in the pharmaceutical industry. He has founded, grown, and merged companies, led company culture, financial and compliance turnarounds, and helped many people developing their career.

Anders founded QBA to educate and develop experts and leaders in the pharmaceutical industry to become better Quality Business Leaders and for the Quality Function to become a core business competency. He is currently collaborating with the University of Dublin to realize his dream of a Quality Business Leader Certification Program.

Anders is a Danish and USA citizen and has worked with and in many cultures. He has held many global senior leadership roles in large and small companies including Sanofi, Genentech, Roche, Novo Nordisk, AGC Biologics, Intarcia, Kronos Bio. For more than 25 years Anders has also been active in developing the Quality function as a more active stakeholder in public health activities.

Anders is a multi-passionate entrepreneur. He is founder of CMC Biologics (now AGC Biologics), Quality Business Administration, and Flying Suitcase Wines, an award-winning winery where he is the winemaker.

Craig Beasley is the Chief Technical Officer at BlueRock Therapeutics. Prior to joining BlueRock, Craig was the Vice President, Cell Therapy Supply Chain at BMS, where he oversaw supply chain for BMS’s clinical and commercial stage cell therapy assets. Previously, Craig was Head of Manufacturing and Supply Chain at Juno Therapeutics and Vice President of Next Generation Manufacturing at Biogen. Prior to working in biotechnology, Craig worked for Union Carbide in process development. Craig holds a B.S. in Chemical Engineering from Purdue University.

Tim Moore has more than four decades of leadership experience in biopharmaceutical manufacturing and operations. Mr. Moore is the former Chief Technical Officer at Allogene. Prior to joining Allogene, he served as COO at Instil Bio. Mr. Moore was also the President and COO at PACT Pharma from October. 2019 to August 2022 as well as the Executive Vice President, Chief Technical Operations at Kite, a Gilead Company, from March of 2016 to September 2019. During this time Mr. Moore was responsible for overseeing the process development, manufacturing, quality and supply chain for the launch of Yescarta®, one of the first CAR T therapies to be developed, manufactured and commercialized, as well as advancement of the Kite pipeline. In addition, Mr. Moore globally expanded the biopharmaceutical operations to serve and support the US, EU, as well as key partners in Asia. Prior to Kite, Mr. Moore served as the Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore 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. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He was a member of ISPE, PDA and serves as a Board member for Cerus and BioLife Solutions, as well as an Board advisor to Cellares. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.

Aine’s career in the biomanufacturing sector spans roles in the UK, Ireland, and the US, with a strong focus on developing innovative solutions to expedite the delivery of medicines to patients. Aine Hanly has recently rejoined Amgen as Vice President, Quality. In this role, Aine will lead a global team accountable for all aspects of quality oversight for Amgen’s products, from early product and process design to manufacturing and product supply to ensure that quality standards are met and in compliance with applicable regulatory requirements.

Prior to her return to Amgen, Aine spent the past 4 years with Vir Biotechnology, an immunology-based biopharmaceutical company developing medicines for infectious diseases and other serious conditions. Aine was the Chief Technology Officer (CTO) and EVP Technical Operations, leading the company’s technical operations function, which included responsibility for end-to end GxP Quality and Data Strategy.

Prior to Vir, in her almost decade-long tenure at Amgen, Aine led teams across several Amgen sites (ACO, AML, AMA and ATO) including oversight of clinical manufacturing and clinical supply (MCS). Her leadership roles in Process development supported the commercialization of Amgen’s pipeline products and technical support for ongoing manufacturing operations. As the site head at Amgen’s Cambridge facility, Aine also led the site’s transformation and staff expansion.

Prior to joining Amgen in 2012, Aine held roles of increasing responsibility in Pfizer (formerly Wyeth) Process Development, Product Supply and Quality including site head of Quality for Pfizer’s Grange Castle Manufacturing site in Ireland.

Aine earned her bachelor’s degree in biological chemistry and her Ph.D. in physical organic chemistry from the University of Ulster in Northern Ireland. She completed her post-doctoral fellowship at Creighton University School of Medicine before joining Yale University and CuraGen Corporation as a lead scientist, where she focused on gene isolation and validation using various molecular biology techniques.

Christopher Horan spent nearly 14 years at Genentech, a member of the Roche Group, where he held several leadership positions across technical operations, including as Senior Vice President, Global Product and Supply Chain Management for Roche in Basel, Switzerland. In that role, he led a 480-person team supplying all of Roche biopharma products worldwide. Mr. Horan joins Artiva from SanBio, where, as Chief Technical Officer (CTO), he led the process development, manufacturing, supply, and quality systems for their mesenchymal stem cell regenerative medicine approach to brain injury in support of a near-term registration in Japan. Previous to SanBio, he was Chief Technical Operations Officer at Dermira, where he led all aspects of pharmaceutical sciences, manufacturing, quality, supply chain, and procurement to launch the company’s first commercial product. He led the effort to prepare Dermira’s IL-13 monoclonal antibody program for Phase 3 trials and commercial filing and had a key role in supporting the company’s successful acquisition by Eli Lilly and Company. Mr. Horan started his career with over a decade of increasing responsibility in technical operations at Merck & Co. He earned a B.E. in engineering from the Stevens Institute of Technology in New Jersey.

Karen Walker is Chief Technology Officer at Kyverna Therapeutics. Ms. Walker has broad and deep industry experience developing biopharmaceuticals and cell and gene therapy (CGT) products. She brings extensive and pioneering expertise in the product development, manufacturing, and supply of cell-based therapies and associated analytics.

Ms. Walker has several decades of biotech industry experience, holding positions in Technical Development, Regulatory Affairs, and Quality at a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, Bristol-Myers Squibb, and several other small to mid-sized biotech companies. She comes to Kyverna from Roche/Genentech where she was Senior Advisor, Cell and Gene Therapy Manufacturing. In this position, she was instrumental in developing and implementing the strategy for CGT manufacturing and controls into the Roche/Genentech organization.

Prior to Roche/Genentech, Ms. Walker was Vice President of Global Quality at Seagen Inc., formerly Seattle Genetics, where she oversaw and directed the Global Quality Organization in the U.S. and Europe. Previously, she was Vice President and Global Head of Cell and Gene Therapy Technical Development and Manufacturing for Novartis’ CGT Unit. There, she led the Chemistry, Manufacturing, and Controls (CMC) teams through the formation of the strategies and execution of those strategies to develop KYMRIAH® (tisagenlecleucel) through the pivotal trial stage and to filing of the first CAR-T Biologics License Application (BLA) in pediatric acute lymphoblastic leukemia (ALL). During her time at Novartis and continuing to the present, Ms. Walker has been a strong and leading voice in the establishment of industry standardization and contributed to influence emerging regulatory guidances in the area of CGT products globally.

Ms. Walker holds a bachelor’s degree from St. Olaf College. She is a member of numerous pharmaceutical industry trade organizations, including the Alliance for Regenerative Medicines (ARM) Cell Therapy Manufacturing Committee, DeLoitte Industry Working Group for Advanced Therapy Medicinal Products (ATMPs), Parenteral Drug Association (PDA), PDA Biologics Advisory Board, where she was vice chair from 2018 to 2020, and the PDA ATMP Working Group.

Pascal leads Russell Reynolds’ operations in New York and Canada. He works closely with our healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives.

Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He also earned master’s and doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.

Marie-Noëlle Gagnon is a forward-thinking Chief Human Resources Officer with over 20 years of international experience leading transformative talent strategies across financial services, life sciences, automotive and creative industries. Known for her ability to drive large-scale change while preserving the human core of organizations, she bridges business imperatives with culture, creativity, and operational resilience.

As CHRO of Cirque du Soleil Entertainment Group, Marie-Noëlle led the end-to-end rebuilding of the company’s Talent function in the wake of the global pandemic. Her leadership has been instrumental in strengthening Cirque’s creative foundation while implementing scalable, people-centric systems that drive growth, agility, and employee engagement across a uniquely complex, global enterprise.

Prior to Cirque, she held senior leadership roles at Novartis in Canada, the United Kingdom, and Switzerland, where she shaped people strategies to support enterprise-wide transformation in a highly regulated, innovation-driven environment. Her ability to connect talent with long-term value creation has made her a trusted advisor in times of change.

Marie-Noëlle holds a BSc in Mathematics from Université du Québec à Montréal and an MBA from the McGill–HEC Montréal Executive Program. She is also certified in ESG and Sustainability, underscoring her commitment to responsible leadership and aligning people, planet, and performance.

With a passion for building purpose-led cultures and future-ready organizations, Marie-Noëlle is a creative catalyst and strategic partner to Boards and CEOs navigating disruption with intention.

Alicia Collins is the VP of Technical Operations at Tune Therapeutics.

Prior to joining Tune, Alicia was the Executive Director of Cell Therapy Global Patient Operations at Bristol Myers Squibb where she oversaw the management and orchestration of the end-to-end patient cell supply chain. Previous to that she was the Head of the Cell Therapy Global Supply Planning & Management organization at BMS and was part of the successful commercialization two cell therapies. Alicia has 28 years of experience in the pharmaceutical and biotech industry at Merck, Genentech, BMS, and Tune in both domestic and international roles. Her experience encompasses manufacturing, supply chain, external manufacturing, strategic sourcing, and materials management. Alicia has a B.S. in Integrated Science & Technology with a double-concentration in biotechnology and environmental science from James Madison University.

​Birk Vanderweeën has served as Senior Vice President Global Technical Operations since January ’24. Prior to this, he was responsible for starting up the European organization and manufacturing facilities for Legend Biotech in Belgium. He brings more then 25 years experience in biopharmaceutical manufacturing, supply chain management and quality management. Prior to joining Legend Biotech, he had an international career at several global biopharmaceutical companies. Most recent, he served as the General Manager of the Janssen Pharmaceutica Small Molecule API site. Before that, at Teva Pharmaceuticals he was SVP regional quality for 12 biopharmaceutical manufacturing sites in Asiapac/Israel and VP of manufacturing in Japan. Most of his career Mr. Vanderweeën was with AstraZeneca in Belgium, UK and Japan holding leadership roles as VP manufacturing, VP global supply chain strategy and General Manager. ​

Mr. Vanderweeën holds a Master in Pharmaceutical Sciences from the University of Ghent, is a qualified Industrial Pharmacist and holds a Post Graduate in Management from the university of Brussels.​

SVP, Head of Global CMC at WuXi Biologics. Reporting directly to Dr. Chris Chen, CEO, leads the CMC function with responsibility for the overall CMC teams’ project delivery and key account management.

Prior to joining WuXi Biologics, Nuno was the SVP, Head of Biologics Development at Bayer Pharmaceuticals, member of the Pharmaceutical Supply Biotech Senior Leadership Team, responsible for all process development and clinical manufacturing of all cell therapy, gene therapy and recombinant protein therapeutics in both Berkeley, CA, USA and in Wuppertal, Germany.

Prior to joining Bayer in January 2021, Nuno was the Executive Vice-President of Technical Development at Coherus Biosciences, Redwood City, (Silicon Valley) CA, USA, member of the Executive Committee, reporting directly to the CEO and accountable for Process Development, Process Engineering, Tech-Transfer and Clinical Manufacturing (DS and DP) up to and including Process Validation/PPQ.

Prior to joining Coherus Nuno was Executive Director of Process Science (PD and Clinical MFG) at Boheringer-Ingelheim in Fremont CA where he worked for 7 years, and prior to that Nuno spent 9 years at Genentech (CMC Leader, group leader) and 4 years at a CDMO in Europe (Biotecnol SA.) as head of purification and analytical development.

Nuno has 20+ years of industrial experience in bioprocess development (cell line, cell culture, purification, analytical, formulation, drug substance and drug product) and GMP manufacturing of Biologics in both bacterial and mammalian expression systems. Vast experience in management, having led large groups (of up to 120p.), has been a member of executive and site leadership teams, reporting to CEOs and Site-Heads, responsible for large budgets, product portfolios, and strategic leadership of a wide range and scope of activities in all domains of Technical Development and Operations. During his career, Nuno, has significantly contributed to the clinical and commercial CMC development of more than 20 clinical products, 3 of which reached the commercial market.

Nuno is particularly passionate for technology innovation management, and in that context has led teams which made significant contributions to novel bioprocessing tools and techniques.

Nuno has a PhD in Biochemical Engineering, a Post-graduation (MBA equiv.) in Commercialization of Science and Technology, a Masters in Molecular Biology and an BSc. in Applied Chemistry.

Executive Director, Oceanside Site Operations, Gilead Sciences.

Over 25 years of experience in biologics manufacturing, site operations, process development and technology transfer across global clinical and commercial programs. She has held progressive leadership roles across Biogen, Genentech and Gilead where she has delivered complex capital projects, led global tech transfers and implemented new technologies in biologics manufacturing. She is passionate about building high-performing teams, operational efficiency, and fostering a culture of engagement.

Sang Yoon joined ImmunityBio in July 2024 as VP of Global Quality Assurance. Under Sang Yoon’s leadership, ImmunityBio Quality is currently executing a Growth-minded, Quality Culture while it executes a global expansion strategy for several biologics in its portfolio. Sang has over 25+ years of expertise in Quality across Drug Product Development, CMC, Medical Device Product Development, and Manufacturing Operations. He has worked at cell therapy startups as well as established biotech companies, and CDMOs. In his career, he has helped successfully commercialize cell therapy product, biologics, and medical devices.

Sang brings a broad international working experience in Technical Operations across Asia Pacific, Europe, and North America. Before joining ImmunityBio, he worked overseas and served as Sr. Director of Quality at Samsung Biologics CDMO. Previously, he worked at AtaraBio, Theragent CMO, Baxter Healthcare, Providence Health, and DaVita Medical Group with increasing roles and responsibilities.

Sang holds a Bachelor’s Degree in Industrial Systems Engineering and MBA from Depaul University. He is a certified Lean Six Sigma Master Black Belt, certified in QbD, Reg. Affairs certified, and a certified Maxwell Leadership speaker and trainer.

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

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

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

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

Krista Terry is a Senior Regulatory Group Director at Genentech, a member of the Roche Group, where she leads a team of regulatory professionals in developing and implementing end-to-end global regulatory strategies.

With over 25 years of experience in the biopharmaceutical industry, Krista is an expert in leveraging innovative regulatory strategies and regulatory reliance to accelerate global product approvals. She plays a key role in influencing regulatory policy matters, maintaining a current perspective on external developments, and driving internal efforts for process excellence and simplification across the biopharma portfolio.

Dr. Umang Trivedi has over 15 years of experience in leading and coordinating biologics manufacturing activities to the strategy and execution of new product launches. He joined Daiichi Sankyo in Oct 2021 as a Director of CMC Management & Operation organization where is he is responsible for leading cross-functional CMC team and operations across multiple sites spanning from IND through post-BLA, including life-cycle management. The team owns all of Daiichi Sankyo’s growth and biologics products. From 2011 to 2021, he held positions of increasing responsibilities at Merck within Biologics Process Development Commercialization and Global Technical Operations Organization. Prior to Merck, Umang was with Vaxinnate, where he led pre-clinical and clinical product development efforts for recombinant protein based seasonal influenza vaccine. Umang holds PhD degree in Chemical Engineering from University of Western Ontario, Canada

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

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

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

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

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

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

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

Jake Greenwood is a Vice President at Project Farma with more than 15 years of experience in the life sciences industry. At PF, he leads strategic growth initiatives and client engagement efforts, helping forge partnerships across the pharmaceutical and biotech sectors. His work supports PF’s mission to deliver next-generation manufacturing solutions for advanced therapies and other transformative treatments.

Before joining PF, Jake began his career in preclinical research, managing vivariums in Maryland and North Carolina, and later spent five years in the Architecture, Engineering, and Construction industry, supporting the delivery of nearly $500M in capital projects. He is a past Chapter President of the ISPE Chesapeake Bay Area Chapter and remains dedicated to accelerating therapies from development through commercialization to improve patient outcomes.

Lyndsey Young is the Executive Director of Quality at Tr1X, where she leads quality strategy and compliance for allogeneic cell therapy programs. With over 17 years in the biotech and pharmaceutical industry, she has built and scaled high-performing teams and Quality Systems to support clinical development and commercial products. Her experience spans a broad range of modalities, including monoclonal antibodies, small molecules, diagnostics, and cell therapies, with expertise in GMP, GCP, and GLP oversight. Lyndsey started her career in analytical and process development at Amgen and Teva Pharmaceutical before moving into Quality leadership roles at companies such as Halozyme and Zymeworks. She is passionate about making quality a driver of innovation and helping bring safe, effective therapies to patients.

Dawn is CMC Regulatory Affairs leader with over twenty-two years of pharmaceutical industry experience currently a Senior Director and Group Manager, Oncology Biologics at AstraZeneca. She leads a team of regulatory professionals working on antibody drug conjugates and radio conjugates. Throughout her career she has worked on vaccines, monoclonal antibodies, and biologic-device combination products across therapeutic areas in infectious disease, respiratory and immunology, and oncology across the product lifecycle. She has a passion for innovative regulatory strategies, problem solving and life-long learning.

Mikaella Gorelik is Vice President of Global Product Supply & Development Procurement at Bristol Myers Squibb, appointed in October 2024. She leads a $4B global procurement portfolio across direct materials, external manufacturing, product development, logistics, and capital projects. Mikaella is driving transformation through AI integration, supplier strategy, and sustainability—including Scope 3 decarbonization and human rights initiatives—while enabling enterprise-wide cash optimization and tariff mitigation.

A strategic and agile leader with over two decades of experience in biopharmaceuticals, Mikaella has built high-performing teams and led complex network strategies across procurement, supply chain, and business development. Prior to joining BMS, she held senior roles at Sandoz and Novartis, where she led business development and licensing deals, managed supplier relationships across global markets, and directed strategic procurement for APIs, excipients, and external supply operations. Her early career at Pfizer included global category strategy and analytics roles supporting both R&D and manufacturing.

Mikaella holds a Bachelor of Science in Management Information Systems from Drexel University and is certified in Lean Six Sigma Green Belt. She is a recognized voice in procurement transformation.

Joe leads Supply Chain Planning at J&J Innovative Medicine, where his team is responsible for demand planning, production planning, inventory management, planning excellence, and strategic capacity.  Joe brings 25 years of supply chain experience including external manufacturing, procurement, strategy, and planning.  Prior to J&J, he was a consultant at Kearney, where he supported clients in the Food, Paper, and Chemical Industries.  Passionate about talent development, coaching, and support for military veterans, Joe mentors former service members transitioning into private sector roles.

Vishal is a seasoned executive with over two decades of experience leading global, multi-node supply chain operations across the pharmaceutical, biotech, and cell/gene therapy companies. Currently serving as Vice President of Supply Chain at Beam Therapeutics, Vishal built the company’s GMP supply chain capabilities from the ground up, supporting a diverse clinical portfolio that includes autologous/allogeneic cell therapies, in-vivo LNP gene therapies, mRNA, gRNA, vector and plasmids.

His career spans leadership roles at Autolus, Juno, Alexion, Novartis, Amgen, and Abbott, where he delivered transformative results in supply, raw materials and capacity planning, procurement, warehouse operations, logistics, and manufacturing strategy. Vishal has led large-scale business process and technology transformations, including ERP and advanced planning system implementations (SAP, APO, Kinaxis RapidResponse, Camelot Lean Suite), and has deep expertise in Oliver Wight “Class A” Sales and Operations Planning (S&OP) processes.

Vishal holds a Master’s degree in Industrial Engineering from North Carolina State University and a Bachelor’s in Mechanical Engineering from Nirma Institute of Technology.

Eric is the Executive Director of Supply Chain Business Performance & Transformation within Bristol Myers Squibb. Eric leads the digital and process programs across Supply Planning horizons. His team champions innovation by leveraging data and technology to enhance operational excellence and drive the digital-first strategy within Global Supply Chain. Prior to his current role, Eric successfully integrated long-term strategic planning into global supply chain.

Prior to joining BMS, Eric spent 17 years at Merck including roles within Network Strategy & Execution and Supply Chain Management, where he led significant projects across supply planning, new product launch and manufacturing.

He holds Bachelor degrees in Chemical Engineering and Business from Lehigh University, and a Masters in Operations Research from Columbia University.

Christian Phillips joined Inozyme in December 2022, initially as Vice President of Quality, where he rebuilt and scaled the company’s Quality organization. He now leads all CMC efforts supporting the late-stage development and registration of INZ-701, a recombinant fusion protein for rare mineralization disorders. Christian brings over 25 years of multidisciplinary leadership across sterile drug development, quality systems, technical operations, and manufacturing, operating within both innovator and CDMO environments.

Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs, serving concurrently as the Head of Policy, Advisory and Intelligence and the Head of Small Molecule Regulatory Affairs. Her duties include leadership of a global team covering CMC regulatory and advocacy (development and lifecycle) for health authority submissions, as well as serving as a key contributor to several ongoing global initiatives. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council, and supporting multiple other advocacy efforts (review/inspection standards, nitrosamines, PDUFA, and KASA). In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and served on the ISPE Board of Directors from 2022-2025.

Previously, Sarah served at AstraZeneca for over 5 years, holding roles in the CMC Regulatory Affairs space. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018, where she and served as a primary, secondary and tertiary reviewer before being selected (2009) as a senior management official. She held multiple leadership roles in CDER’s Office of Pharmaceutical Quality, where she contributed heavily to many ongoing strategic and advocacy initiatives across the assessment and inspectional spaces.

Prior to joining FDA, she completed a postdoctoral fellowship at the National Institute of Health. She is trained as an organic chemist and possesses a PhD in organic chemistry (Oklahoma State University, 1999). She also has a B.A. in chemistry (Earlham College, 1994).

Senior Technology and Cybersecurity Leader with over 25 years of experience in the life sciences industry.  Strategic leader driving innovation through technology.  Leading the global OT cybersecurity program at Johnson & Johnson.

Bethany Silva is the Life Sciences Industry Manager for Endress+Hauser. In this capacity, she is responsible for the strategic direction, vision and growth of the Life Sciences Industry in the U.S. Bethany has worked with several life science companies with positions in research and development, process development, marketing and technical sales. She brings more than 20 years of experience in sales and marketing to the role, 15 years dedicated to life sciences.

Jason Pennington is the Director of Digital Solutions for Endress+Hauser USA.  Since beginning his career with the company in 1998, he has served the company in a variety of marketing, sales and product development roles. In 2018, Pennington supported the State of Indiana to become the first director of an Industrial Internet of Things incubator, The Indiana IoT Lab. The initiative aligned startups, academia and industry with the from the core manufacturing, agriculture and logistics economic sectors throughout the state. During this time, he was the technical lead for the First Challenge, a $9M USD grant awarded by NIST for First Responder Location and Tracking System Development. Since returning full-time to Endress+Hauser in 2022, Pennington is responsible for strategy, development and application platforms that connect industrial assets to the company’s people and processes.

Dr. Ashley Hesslein is a people-focused leader in the biopharmaceutical sector, with 22 years of experience in process development, regulatory interactions, and product launches. Most recently, she was engaged in Bayer Healthcare’s top priority: a global transformation initiative labeled “Dynamic Shared Ownership”. In this capacity, Dr. Hesslein collaborates with global leaders to reduce operational costs and enhance innovation.

Previously, she served as VP of Biological Development and Early Stage Clinical Manufacturing, where she led a team of up to 163 employees. Dr. Hesslein played a key role in launching Bayer BioPartnering Solutions, attracting companies to leverage Bayer’s development and manufacturing services, while also expanding Viral Vector projects and Cell Therapy capabilities on-site.

Honored as one of the “Most Influential Women in Bay Area Business” in 2023, Dr. Hesslein is dedicated to mentoring the next generation of scientists as an advisory board member of the PDA and a guest lecturer at UC Berkeley’s Master’s Bioprocess Engineering program. She earned her PhD in Molecular Biophysics and Biochemistry from Yale University.

Alec Nielsen is co-founder and CEO of Asimov, a Boston-based mammalian synthetic biology company. He holds a B.S. in Bioengineering and Electrical Engineering from the University of Washington, and a Ph.D. from MIT Biological Engineering, where he researched foundational biochemistries for synthetic biology, computer-aided genetic circuit design, and machine learning applications in biosecurity. Alec’s mission is to advance humanity’s ability to design living systems, enabling biotechnologies with outsized benefit to civilization.

Bill is a seasoned biotechnology professional with nearly 20 years of industry experience, primarily focused on Cell Therapy. His expertise spans Supply Chain, Program and Project Management, and Manufacturing Operations. Throughout his career, Bill has contributed to leading organizations including Celgene, Bristol-Myers Squibb, Carisma Therapeutics, and BlueRock Therapeutics. Appreciate the unique challenges of working in the Cell Therapy landscape, collaborating with like-minded peers and strategic partners to drive critical milestones such as manufacturing site start-ups, first-in-human (FIH) and clinical trial initiations, and commercial launch readiness.

Humberto Moran is a biomanufacturing operations executive with two decades of leadership across global healthcare organizations and emerging biotech companies. As Vice President of Technical Operations and Maryland Site Head at Sensei Bio, he oversees CMC, Quality, Facilities, Engineering, and IT, driving alignment between operational execution and corporate strategy. Recognized for his Lean leadership and quality-first mindset, Humberto has delivered measurable improvements in efficiency, cost control, and safety. His experience spans four facility start-ups and key roles at MacroGenics, MedImmune/AstraZeneca, Amgen, Baxter, and Abbott, where he led cross-functional teams through complex manufacturing and scale-up initiatives. A Rutgers University graduate and Lean Six Sigma Green Belt, Humberto is known for fostering innovation, operational excellence, and collaborative leadership.

Judith earned her PhD studying the genetic background of autism, then led a research group that focused on mutations linked to cancer and epilepsy, using viral transduction to genetically modify cells. At Bielefeld University, she supported virus-based projects as the lead scientist for BSL2. Since 2019, she’s been a senior advisor at Körber Pharma Software, where she helps ATMP manufacturers move from paper to digital, build their digital ecosystem roadmaps, and develop holistic process model data concepts.

Richard Richieri brings over 30 years of expertise in biologics manufacturing, specializing in the design and optimization of processes across all classes of biologics. He played a key role in launching Avid Bioservices and expanding its capabilities to include both stainless steel and single-use bioreactor systems, helping to establish industry standards for cost-effective production. Rich has presented his comparative studies at major conferences and is widely recognized as a thought leader in disposable manufacturing technologies. His consulting work includes serving as a Samsung Global Advisor for biosimilars and leading biologics production at Syngene International. Rich holds chemical engineering degrees from UCLA and UCSD, where he focused on enhancing monoclonal antibody production through cell cycle modifications.

Business leader with more than 20 years’ experience providing solutions to global pharmaceutical and biotech companies in the areas of contract manufacturing, bioprocessing single use, capital equipment, drug product packaging and delivery devices.

Peng Jiao, Ph.D. in 1998, has almost 30 years of experience in the fields of biopharmaceuticals and biotechnology with the deep knowledge in mammalian cell culture and microbial fermentation process development, technology transfer, scale-up/scale-down, large-scale production, bioreactor design, plant design and construction. In recent years, he has been focusing on new generation technologies for bioprocesses and biomanufacturing, and next generation engineering technologies for plant construction and operation.

In the early stages of his career, he led dozens of product development and production projects, and has successfully achieved commercial production of over ten products, including small molecules and biologics products.

In 2007, Dr. Jiao first came up the PanFlex® concept. With years of iterative development, the PanFlex® system has been applied (or partially applied) in the design and construction of more than 15 biomanufacturing plants, including the P03 GMP manufacturing facility with the world’s first 30,000-litre ultra-large product lines within 15 months from 2022 to 2023. Now Dr. Jiao is leading his team to develop the next generation “Mega-factory” and is expected to lead the 4th wave of biological manufacturing for the benefit of patients worldwide.

He had teaching and post-doctoral experience at Tsinghua University and Massachusetts Institute of Technology from his early days. After that, he worked at several biopharmaceutical companies, such as Novartis and Lonza Biologics. In 2014, he founded Boston Institute of Biotechnology (BIB) and BiBo Pharma.

With 15+ years of experience, Anouk helps companies navigate complex supply chain and operations challenges. Passionate about value chain thinking, she inspires organizations to break silos and connect strategy to execution across their entire ecosystem. She combines strategic insight with hands-on expertise in transformation, digital enablement, and customer delivery to unlock tangible business value. Anouk builds strong relationships with leading organizations, such as Henkel, AstraZeneca, Beiersdorf, Duvel, Johnson & Johnson, driving growth, resilience, and lasting impact.

Isabel Tian is the Director of Scientific Affairs at Cellares. She is passionate about accelerating patient access to life-saving therapies through automation and innovation. With a background spanning process development, CMC, and scientific marketing, Isabel bridges science and business strategy to shape product roadmaps, guide executive decision-making, and position Cellares as the global leader in industrialized cell therapy manufacturing. She holds a B.S. in Chemical Engineering from New York University and a Ph.D. in Nanoscale Engineering from SUNY Polytechnic Institute.

Adam Pfeiffer is a Senior Vice President at Project Farma with over 20 years of life sciences consulting experience. In his role, he leads firm-wide business strategy and collaborates closely with operations, marketing, and business development teams to expand Project Farma’s global partnerships across the biopharmaceutical sector. Adam has supported numerous drug manufacturers in bringing life-saving therapies to market, with deep expertise in engineering, commissioning and qualification, and GMP compliance for advanced therapies and large-molecule biologics. His experience spans clinical and commercial manufacturing, where he has played a critical role in delivering complex capital projects that support the development and delivery of cutting-edge treatments. Adam holds a degree in Chemical Engineering from Colorado State University.

Michalle Adkins is Director of Life Sciences Strategy and Communications at Emerson. She leads initiatives that shape Emerson’s growth and influence in the Life Sciences sector—driving customer-centric product messaging, amplifying industry presence through consortiums and events, and providing strategic context to internal teams. Previously, Michalle led Emerson’s Life Sciences Consulting team, partnering with top pharmaceutical and biotech companies to deliver impactful solutions using tools like the Digital Plant Maturity Model and business justification frameworks. With over 20 years at Emerson and 13 years at Merck & Co., she brings deep expertise in instrumentation, automation, manufacturing, and scheduling. Michalle holds a B.S. in Chemical Engineering and an M.E. in Industrial Engineering from Penn State, along with a Six Sigma Black Belt Master’s Certificate from Villanova.

Joe Goodman is the General Manager of the Americas region for Honeywell Life Sciences, where his team partners strategically with the company’s global clients and prospects, identifying the quality and manufacturing system solutions that best fits their needs. Joe is recognized as a thought leader in the fields of quality systems, regulatory compliance, and the implementation of enterprise software within the Life Sciences manufacturing industry. Before joining Honeywell, Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black Belt. He owes much of his penchant for process and solution design to his time spent in that role. Joe also speaks internationally at Compliance and Manufacturing events.

Ignacio Nunez, M.Sc., MBB

Ignacio Nunez is an accomplished executive in the life sciences and advanced materials industries, with extensive expertise in biologics, cell and gene therapies, and complex manufacturing systems.

As Chief Operations Officer of CellReady, Ignacio has driven the company’s operational expansion in the cell and gene therapy sector, focusing on next-generation medicines and strategic execution across partnerships with global biologics companies, startups, academic institutions, financial investors, and CDMOs/CROs. His leadership has enabled large-scale organizational transformations, delivering substantial reductions in capital expenditure and development timelines while strengthening GMP manufacturing, quality, and supply chain performance.

Previously, Ignacio played a key role in pioneering the industrialization of next-generation therapies, contributing to the commercialization of several of the first FDA-approved cell and gene therapies. He also founded BioExcellence, where he developed a high-throughput manufacturing model adopted to design and optimize some of the world’s largest cell therapy production facilities.

Ignacio holds B.S. and M.Sc. degrees in Chemical Engineering from the University of Granada and is a certified Lean Six Sigma Master Black Belt.

Michiya Kanzaki has more than 40 years in Business Development with a demonstrated history of working in the BIO-pharma industry. Skilled in Negotiation, Business Development, Marketing Strategy, and Cross-functional Team Leadership. Strong business development professional.

As the Bioprocessing Product Manager at Repligen, Nick Randall is passionate about empowering and supporting customers at the forefront of biotechnology development. He has ten years of experience as a cross-functional scientist specializing in process and product development, operations, manufacturing, automation, and analytical technologies. Nick attempts to leverage this experience to help develop and launch products with critical-to-life applications.

Rainer Haemmerle is the Executive Director of Manufacturing at Boehringer Ingelheim Fremont Inc., where he leads end-to-end commercial biologics manufacturing for U.S. Biopharma. With over two decades of experience at Boehringer Ingelheim, Rainer has held leadership roles in Contract Manufacturing, including Director of Commercial Manufacturing in Shanghai, China, and key positions in Quality Operations and Biologics Production in Vienna, Austria. His career has been marked by the successful launch of numerous biologic molecules worldwide, as well as spearheading initiatives in human error reduction, leadership development, and major CAPEX expansion projects. Rainer holds a Master’s degree in Biology from the University of Vienna, Austria, with research experience at Universidad Autónoma (Spain), Universidade de Brasília (Brazil), and the Weizmann Institute (Israel).

Jeff Davis is Vice President and Foster City Manufacturing Site Head at Gilead. His current scope includes API, OSD, and Biologics DS manufacturing, Commercial Label & Artwork management, Serialization, Manufacturing Strategy, OE, and Digital Transformation. Prior to Gilead, Jeff was at Genentech where he held a variety of roles across Manufacturing, Supply Chain, and Process Development.

Angela Goodenough is the Executive Director of CMC, Analytical Development and Quality Control and Interim Head of Clinical Supply Chain at AnaptysBio, a clinical-stage biotechnology company focused on delivering innovative biotherapeutics for autoimmune and inflammatory diseases.

She is a seasoned biotechnology professional with nearly 20 years of industry experience in both domestic and international roles covering a broad range of modalities, including monoclonal antibodies, antibody-drug conjugates, recombinant human enzymes, botulinum toxin, and small molecules. Her primary expertise in all things analytical, from Research through Commercialization, has provided her with the unique opportunity for cross-functional collaborations with all areas of product development and beyond, leading to broader experiences in Compliance, Lab and Facility Design, Bioanalytical, Purification, and now Clinical Supply Chain. Throughout her career, she has contributed to leading organizations including Bristol-Myers Squibb, WuXi Biologics, and Amicus Therapeutics.

She is passionate about enriching the lives of patients through the development of safe and effective therapies.

Angela earned a B.S. and Ph.D. from Vanderbilt University, both in Chemistry.

Carlos Candido serves as Vice President, External Manufacturing, MSAT & Supply Chain at Be Biopharma, where he oversees Technical Operations activities supporting development of a novel engineered B-cell therapy platform currently in the clinic. Carlos has over 20+ years biotech experience, including senior roles at bluebird bio, Danaher, Alexion, Sanofi, Genzyme and Biogen, leading manufacturing & supply operations across several modalities including CGTs, biologics, mRNAs and oligos. Carlos holds a B.S. in Chemical Engineering from Northeastern University.

At Cognite, Bill drives customer success in energy, manufacturing, and process industries by leveraging the company’s industrial AI, data contextualization, and platform capabilities—including Cognite Atlas AI™.

He is known for aligning technology with measurable outcomes, building high-performing teams, and scaling regional operations in complex, asset-intensive sectors.

Bill holds a Bachelor of Science in Chemical Engineering from the Rose‑Hulman Institute of Technology.

B.J. leads Accenture’s Global Quality Practice and specializes in Quality Reinvention for Life Sciences – taking a holistic approach to make Quality a strategic business capability for clients.  Drawing on foundational experience from Toyota as they setup manufacturing leadership in NA during the 2000’s, he has worked the last 15+ years in Life Sciences across Quality and Laboratories.

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.

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

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

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

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

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

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

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

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

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

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

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

Sanat Chattopadhyay is responsible for the company’s (approx.  $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

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

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

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

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

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

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

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

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

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

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

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

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

Pascal leads Russell Reynolds’ operations in New York and Canada. He works closely with our healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives.

Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership.

Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He also earned master’s and doctorate degrees in business administration from Athabasca University in Canada, where he focused his research and dissertation on CEO succession. Pascal speaks fluent French and English.

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

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

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

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

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

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

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca.  He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc.  Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK.  Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

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

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

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

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

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

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

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

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

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

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

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

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

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

His spare time interests include Danish and EU Politics.

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

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

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

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

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

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

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

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

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

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

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

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

Prior to Abdera, Kawa served as the vice president of CMC supply chain at Lyell Immunopharma, a cell therapy company focused on solid tumors.  At Lyell, Kawa oversaw CMC programs that enabled three IND approvals, established the company’s autologous patient supply chain, and implemented a progressive cloud based, integrated manufacturing systems.  Prior to Lyell, Kawa spent 14 years at Genentech in South San Francisco and at Roche in Basel, Switzerland in roles including head of Oceanside drug substance manufacturing, global head of technical operation strategy, global head of biologics operational excellence and global head of supply planning.  Kawa started her career and held a number of manufacturing positions at Merck & Co., Inc.

Kawa holds a B.S. in operations from The Ohio State University, a M.Sc. in Engineering from University of Pennsylvania, an MBA from New York University, and a Master in Public Health from U.C. Berkeley.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Christine earned a BS in Biology from Bloomsburg University.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sarah has her PhD in Physical Chemistry from MIT.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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