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.

Manisha Desai, a seasoned pharmaceutical executive and strategic leader, currently serves as the Senior Vice President of Product Development within Global Product Development and Supply (GPS) at Bristol Myers Squibb (BMS).  Throughout her 25-plus-year career at BMS, Manisha has developed extensive expertise in the biopharma industry, with a focus on end-to-end CMC development. This includes the design & development, scale-up, and technology transfer for both oral and parenteral drug products for BMS’s small and large molecule portfolio, as well as combination products, to manufacturing sites. In addition to her technical expertise, Manisha has excelled in developing and executing organizational strategy, leading strategic partnerships, building high-performing teams, managing large global organizations, shaping organizational culture, and guiding teams through change.

Manisha earned her bachelor’s and Masters degree in Pharmaceutical Sciences from the University of Mumbai, India; her Ph.D. in Pharmaceutical Sciences from the University of Michigan; and her MBA from the NYU Stern School of Business.

Outside of work, Manisha enjoys spending time with her family and friends, traveling, engaging in charity work, and watching shows on Broadway.

Stephen Hill is the Chief Operating Officer at Lyell. He is responsible for research and end-to-end development and supply of cell therapies to support Lyell’s clinical and commercial aspirations.

Hill was formerly Head of Biologic Operations at AstraZeneca where he was responsible for end-to-end supply of the commercial and late-stage clinical portfolio for Biologics that included oversight of six manufacturing sites across the US and Europe and five commercial products.

As Vice President Operations, Site Head at the AstraZeneca Frederick Manufacturing Center, Hill was responsible for the largest biologics manufacturing facility within the company’s global network. The site consists of a licensed, large-scale cell culture facility and recently commissioned small-scale facility.

Prior to AstraZeneca Hill served as Vice President Bulk Manufacturing at Amgen’s Puerto Rico facility and as Executive Director leading commercial formulation and filling and commercial drug substance operations.

Hill also served prior roles as Executive Director, Manufacturing Technologies leading manufacturing global networks and as Executive Director, Plant Manager leading clinical drug substance operations. In his corporate role he led manufacturing of the future, operations strategy, high reliability performance and manufacturing global network initiatives. In his plant manager role he was an effective change agent driving productivity improvement to deliver multiple pipeline new product introductions annually.

Hill joined Amgen from ICOS Corporation where he executed GMP clinical plant start-up and led manufacturing, ultimately transitioning the operation into a contract manufacturing business. Hill started his career at Immunex Corporation as an operator manufacturing Enbrel.

Hill holds a Master in Business Administration (MBA) and Bachelor’s in Microbiology (BS) and Political Science (BA) from the University of Washington.

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.

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.

L.-C. Campeau obtained his Ph. D. degree in 2007 with the late Professor Keith Fagnou at the University of Ottawa in Canada. He first joined Merck Research Laboratories at Merck-Frosst in Montreal in 2007 where he was recognized for key contributions to the discovery of Doravirine (MK-1439) a next generation non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. In 2010, he moved from Quebec to New Jersey, where he has served in roles of increasing responsibility. L.-C. is currently Associate Vice President and the Head of Small Molecule Process Research and Development. Over his tenure at Merck, L.-C. and his team have made important contributions to >60 clinical candidates and 7 commercial products. Under his leadership, his organization was recognized with 5 EPA Green Chemistry Challenge Award and 2 Heroes of Chemistry Award. His passion for scientific excellence is exemplified by >85 publications and patents, and >95 invited lectures worldwide. L.-C. was elected Fellow of the Royal Society of Canada in 2022.

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.

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.

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.

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.

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.