Speakers

Edgardo Hernandez (he/him/his) is executive vice president at Eli Lilly and Company and president of manufacturing operations.

Ed served as senior vice president of global parenteral drug product, delivery devices and regional manufacturing from 2018 until 2021. In this role, he was responsible for global parenteral manufacturing, emerging markets manufacturing, drug-product contract manufacturing, packaging, and distribution operations. Ed provided oversight for manufacturing sites in 12 countries across North America, South America, Europe, and Asia; that manufacture the final parenteral product (non-oral) formulations of Lilly medicines.

Previously, Ed was vice president of Fegersheim Operations for Lilly’s manufacturing site located in France. Before that, he served as site head for two other Lilly manufacturing sites: Indianapolis Active Pharmaceutical Ingredient manufacturing from 2014 until 2016, and PR06 in Puerto Rico from 2012 until 2014. Ed joined Lilly in 2005 as an engineering services leader for Lilly del Caribe in Puerto Rico, after working for several years in positions for Pfizer and Pharmacia.

Ed is a native of Puerto Rico and holds bachelor’s and master’s degrees in chemical engineering from the University of Puerto Rico and North Carolina State University, respectively.

Laura Alquist joined Kite in 2016 and currently serves as Vice President and Global Head of Technical Operations.

She has more than 25 years of experience in all aspects of technical operations including manufacturing, supply chain, quality and information systems. Laura served as Vice President of Global Supply Chain at Kite before being named Global Head of Manufacturing in 2023. Under her leadership, Kite’s manufacturing team has improved its industry-leading track record for reliability and speed. Additionally, Laura successfully led the team in navigating the COVID-19 pandemic with zero supply disruptions to the patients and providers who rely on Kite’s therapies. Before joining Kite, Laura spent 20 years at Amgen in a range of global and operational roles of increasing responsibility across supply chain, manufacturing, quality and IT.

Laura holds a bachelor’s degree in business management from California Lutheran University and is APICS certified in supply chain operations.

Dr. Advant has served as Savara’s Executive Vice President, Global Technical Operations since March 2024. With approximately three decades of experience in the biopharmaceutical sector, he has considerable expertise in drug substance, drug product, and analytical development with early- and late-stage clinical and commercially approved biologics. Dr. Advant also has extensive expertise in technology transfer, scale-up and cGMP manufacturing (both internal and external) in a highly regulated environment. To date, Dr. Advant has helped launch multiple biologic assets across several therapeutic areas. Prior to joining Savara, he was VP, Manufacturing Operations at GSK, where he was responsible for multi-site drug substance and drug product operations. Previously he held roles of increasing responsibility at Celgene Corporation (acquired by Bristol Myers Squibb), Kemwell BioPharma, ImClone/Lilly, and Diosynth Biotechnology (now FujiFilm Diosynth Biotechnolgy), among others. Dr. Advant holds a Ph.D. in Pharmaceutics from the University of Connecticut.

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.

Andrea (Andi) Goddard serves as Chief Technical Officer at CatalYm. She brings three decades of global biotechnology experience, spanning all levels of operations — from the manufacturing floor to the C-suite. Andi joined CatalYm from Roche Pharma and Genentech, Inc. where she most recently was the Chief Quality Officer for Roche Pharma Technical Operations. In this role, she led a global team delivering end-to-end quality and compliance for Roche’s pharmaceutical commercial products and clinical pipeline. During this time, Andi was also a member of the Genentech, Inc. Executive Committee. Previously, Andi held various operational and executive roles in manufacturing, technology, and quality across Roche and Genentech. Andi holds a BA in Human Biology from Stanford University.

Sebastian Stening leads Roche’s global Device & Packaging organization, ensuring manufacturing readiness and orchestrating cross-functional collaboration across device development, procurement, quality, regulatory, supplier management, and site operations. He also serves as Global Head of Device, Packaging and Distribution Manufacturing Science & Technology, with responsibility for device industrialization strategy, end-to-end platform implementation, and medical device portfolio performance across Pharma TechOps.

Sebastian joined Roche from Bayer, where he established and led the Global Medical Device MSAT organization, spanning device development, industrialization, and technical lifecycle management for a broad portfolio across biotech, oncology, and cell and gene therapy. At Bayer, his responsibilities also included the development, industrialization, and launch preparation of the Eylea 8 mg drug-device combination product.

Prior to Bayer, Sebastian held multiple leadership roles at Sanofi across device development and industrialization, working on Dupixent across multiple functions to support submission and launch readiness. He holds B.Sc. and M.Sc. degrees in Business Administration and Engineering, with a focus on physics and medical devices, from the University of Applied Sciences Münster, and is a certified Six Sigma Black Belt.

Susan Abu-Absi, PhD, is a seasoned biopharmaceutical executive with more than 20 years of leadership experience spanning technical development, manufacturing, quality and global operations. Most recently, she served as Chief Operating Officer at Be Biopharma, where she led the company’s operational strategy and execution. Prior to Be Biopharma, she was Chief Technology Officer at 2seventy bio, leading technical development, supply and quality and supporting the commercialization of Abecma® as well as the advancement of multiple cell therapy programs. Previously, Susan held senior leadership roles at bluebird bio, where she played an integral role in the approvals of Zynteglo® and Skysona®, and at Bristol Myers Squibb and Bayer Healthcare. She holds a PhD in Chemical Engineering from the University of Minnesota and a BS in Chemical Engineering from the University of Toledo.

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.

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.

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.

Jose Torres-Vorshirm is Senior Vice President of Global Technical Operations at BioNTech, where he oversees the end-to-end technical operations supporting the company’s pipeline and operations. His responsibilities encompass advancing a broad range of modalities—including antibodies and mRNA-based therapeutics—through development, manufacturing scale-up, and commercialization.

With more than 25 years of leadership experience in biopharmaceutical technical operations, global supply chain, and manufacturing, Jose has built expertise in delivering complex biologics and advanced therapies at commercial scale. Prior to his current role at BioNTech, he served in leadership roles at AstraZeneca, Eli Lilly and Company, and Novavax.

Jose holds a Master’s degree in Technical Management from Johns Hopkins University, a Postgraduate degree in Business Management and Supply Chain from the University of Warwick in England, and a Bachelor’s degree from the University of Puerto Rico-Mayaguez. He is a recognized leader in driving technical operations strategy and execution to bring innovative therapies to patients.

Dr. Yun Mao is an accomplished leader in the pharmaceutical industry with over two decades of experience. She currently holds the position of Vice President of Drug Product Development within Global Product Development and Supply (GPS) at Bristol Myers Squibb. Yun earned her Bachelor of Science in Chemistry from Peking University, China, followed by a Ph.D. in Analytical Chemistry from the University of Minnesota.

Her career began as a Senior Research Chemist at Merck & Co., after which she progressed through roles of increasing responsibility, including serving as Executive Director overseeing an analytical sciences organization dedicated to all aspects of drug substance analytical development. In 2018, Yun joined Celgene to manage the company’s alliance portfolio, subsequently expanding her scope to lead portfolio strategy and the integration group at BMS.

As head of Drug Product Development, Yun leads efforts to develop innovative and patient-centric products for all small molecules and biologics at BMS. Outside of her professional commitments, Yun has been married for 28 years and is the mother of twin sons who recently graduated from college. In her personal time, she enjoys spending time with her family and friends, as well as caring for her dog, Simba.

Rodrigo Muradas is Vice President and Head of R&D GMP Quality at Takeda, where he leads the company’s global GMP Quality organization supporting all programs under development including medical device and digital health across Takeda portfolio. He is recognized as an international leader in transforming Quality from a compliance function into a strategic enabler of innovation.

With more than 20 years of global leadership experience across North America, Europe, and Latin America, Rodrigo has led large-scale organizational transformations, supported groundbreaking therapies, including cell and gene therapies and guided organizations through complex regulatory approvals while advancing digital and AI-enabled quality capabilities.

Passionate about innovation, science, and digital transformation, Rodrigo is committed to helping organizations harness emerging technologies to improve decision-making, accelerate development, and ultimately deliver better outcomes for patients. He has completed executive education at Harvard Medical School, MIT Sloan, Yale School of Management, Duke University, and IMD Business School, with a focus on healthcare innovation, digital transformation, executive leadership, and organizational performance.

At the Biomanufacturing World Summit, Rodrigo will share his vision for how AI is transforming Quality into a strategic business partner accelerating innovation, strengthening risk-based decision-making, and enabling the next generation of biopharmaceutical development.

Aparna Deora is Head of BTx PharmSci Portfolio & Strategy at Pfizer, where she leads portfolio strategy, governance, and execution across a diverse pipeline of biologics, vaccines, and advanced therapeutic modalities. In this role, she partners with research, development, manufacturing, and commercial leaders to guide portfolio prioritization, resource strategy, and investment decisions that accelerate the delivery of innovative medicines to patients. [office.com]

With more than 25 years of experience in the biopharmaceutical industry, Aparna has held leadership roles spanning analytical and technical development, project leadership, technology development, business development, portfolio management, and strategic planning. She has extensive experience advancing complex programs across multiple modalities, including monoclonal antibodies, vaccines, mRNA, peptides, ADCs, and other biotherapeutic platforms.

Aparna is passionate about integrating science, strategy, and operational excellence to advance a high-impact portfolio that addresses significant patient needs. She is a strong advocate for collaboration, digital innovation, and data-driven decision making to enable successful portfolio outcomes and improve the lives of patients worldwide.

Kawa Chiu is the Chief Technical Officer of Abdera Therapeutics Inc. Kawa joined Abdera in 2022. She brings to Abdera more than 25 years of global manufacturing, supply chain and CMC experience across broad modalities.

Prior to Abdera, Kawa served as the vice president of CMC supply chain at Lyell Immunopharma, a cell therapy company focused on solid tumors. During her tenure, 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.

Siegfried Hackl, PhD, is Senior Vice President of Product Supply at Ultragenyx, where he has led External Manufacturing and Global Supply Chain Management since February 2017. He is responsible
for clinical and commercial supply across gene therapy, small molecules, biologics, and nucleotide
modalities. In this role, Dr. Hackl develops and executes manufacturing strategies and oversees a
global CMO and distribution network to ensure a robust, responsive, and financially accountable
supply system. He also contributes significantly to CMC development across Ultragenyx’s diverse and
innovative product pipeline and plays a key role in shaping the company’s quality mindset and continuous improvement culture, while actively supporting talent development, workforce agility, and
inclusion and diversity.

Prior to joining Ultragenyx, Dr. Hackl spent more than two decades at Boehringer Ingelheim (1993–
2017), holding a variety of senior leadership roles across Europe and the Americas. His positions included Head of Microbial Fermentation (Austria), Head of a European Manufacturing Alliance Project
(Germany), Vice President of Fill & Finish for all biotech molecules (Germany), Plant Manager and
Vice President of the BI manufacturing site in Mexico, Head of Systems Quality Assurance for BI Germany, Global Head of Biotech Performance Management and Lean Transformation, and Head of
Lifecycle Management for a blockbuster respiratory device platform.

Dr. Hackl holds an MSc in Biotechnology from the University of Vienna and a PhD in Pharmaceutical
Technology from the University of Berlin.

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.

Raghavan Venkat (Venkat in short) obtained his M.S. and Ph.D. degrees in Chemical Engineering at The Ohio State University and a Certificate in Business from the Wharton School at the University of Pennsylvania. Venkat joined MedImmune / AstraZeneca in 2006 and has worked in the biopharmaceutical industry for more than 30 years across many roles at GSK, Lilly and AZ. Over his career, Venkat has led teams or directly contributed to the commercialization of more than 12 biologics medicines, including Trulicity, Imfinzi, Beyfortus as well as Vaxzevriaand Evusheld that were developed in rapid response to the COVID pandemic. Venkat has strong expertise in pharmaceutical process and product development, especially in biologics process development and manufacturing, with keen interest and strength in novel modalities. At AstraZeneca, he currently leads the Biopharmaceutical Development function responsible for end-to-end CMC development of all biologics within the AZ pipeline.

Rakesh Kakkar serves as Head of Manufacturing & Supply, Vaccines, US at Sanofi, where he leads vaccine manufacturing operations for over 2000 Sanofian’s across US sites. In this pivotal role, he oversees a comprehensive portfolio spanning manufacturing operations for Drug Substance and Drug Product, Supply Chain, Quality, Strategy, Technical Services, Engineering, Project Management, and Operational Excellence. His leadership has been instrumental in driving Sanofi’s vaccine manufacturing capabilities and ensuring the delivery of life-saving vaccines around the globe.

With over 25 years of distinguished experience in the biotechnology industry, Rakesh brings deep expertise in vaccines and therapeutic oncology immunoconjugates. Prior to his current role, he served as Head of Biologics Manufacturing at Sanofi, managing Drug Substance Manufacturing at the Swiftwater site. Before joining Sanofi in 2016, he spent 16 years at Pfizer Biotech/Wyeth in roles of increasing responsibility, where he led vaccine manufacturing operations and successfully localized vaccine manufacturing in emerging markets in Turkey, Russia, Argentina & South Africa.  His strategic acumen encompasses CMO evaluations, manufacturing process transfers, quality systems implementation, regulatory strategy for product launches, and the deployment of new technologies to maximize operational efficiency.

Rakesh’s contributions extend beyond operational excellence to strategic partnerships and significant capital investments. He has collaborated extensively with HHS/BARDA on pandemic influenza vaccine projects, demonstrating his commitment to public health preparedness. Under his leadership, the expansion of Swiftwater sites has included the building and licensing of new facilities representing over $1.2 billion in investment. His regulatory expertise is evidenced by his extensive interactions with FDA, EMA, ANSM, PMDA and various global regulatory agencies, as well as his service on the USP expert panel.

Dr. Kakkar holds a Ph.D. in Biochemistry from Guru Nanak Dev University, India, and an M.S. in Clinical Pathology from the University of Saskatchewan, Canada, where he also completed Post-doctoral fellowship at the College of Medicine. He has authored more than 33 peer-reviewed publications and is an active member of ISPE. Additionally, he served as co-executive sponsor for Sanofi’s VETS Employee Business Resource Group through December 2025, reflecting his commitment to fostering an inclusive workplace culture. Rakesh’s strategic vision and operational leadership continue to advance Sanofi’s mission of protecting health and enabling access to vaccines for communities in the United States and across the globe.

Eris H. Crosswhite is a global supply chain executive and the creator of Reticulative Logic (TM), a decision-governance architecture for enterprise AI. Currently Senior Director of Supply Chain Operations at Pfizer Global Supply, Crosswhite has spent two decades leading end-to-end supply chains for some of the world’s largest pharmaceutical, food, and beverage enterprises, with teams and operations spanning four continents. That dual vantage point, running global operations while architecting AI governance, frames the question at the center of this talk: how an enterprise keeps authority over its decisions as AI takes a growing share of making them.

Angela Jung specializes in recruiting transformational technology executives for global Fortune 500, private equity, venture capital, and growth-stage firms.

Based in New York, Angela is a leader in our global cybersecurity team and a member of our Technology Practice. She excels at recruiting Chief Information Officers, Chief Information Security Officers, Chief Technology Officers, Technology Operating Partners, and board directors. During her career, Angela has proven herself as a trusted advisor, delivering tailored leadership solutions to ensure her clients succeed in a rapidly evolving technology landscape.

Prior to joining Russell Reynolds Associates, Angela served in the US Army as a Military Intelligence Officer and was one of the first women assigned to an Infantry Battalion. She rose through the ranks from Lieutenant to Captain and held multiple leadership positions across information security, operational security, and anti-terrorism in support of a Brigade Combat Team’s operations in the Pacific Theater.
Angela received her BS in biology from the University of Miami and her MBA from Columbia Business School. She also speaks fluent Korean.

Miranda Neville joined Autolus in 2018 from the consulting firm AllianceBio where she spent four years as a Partner and supported several clinical stage CDMO and commercial biopharmaceutical companies. Following her BS at West Virginia University, she started her career at Human Genome Sciences, Inc. She spent 10 years at HGS in a variety of roles including Manufacturing, Engineering & Program Management, prior to its acquisition by GlaxoSmithKline.

Satarupa Das leads commercial product CMC teams, providing end-to-end technical CMC leadership for regulatory submissions and approvals, yield and CoGm improvements, and strategies that support uninterrupted supply, business continuity, and risk mitigation. She also serves as the Operations representative for pipeline products, helping drive operations readiness for new product launches. In her current role, she leads a team focused on agile CMC approaches for accelerated approvals, as well as the implementation of alternative raw materials to improve cost of goods, sustainability, and supply resilience across the product lifecycle. Before joining AstraZeneca, Satarupa worked at Novavax in Manufacturing Quality Control and technology transfers and at Covance as a Lead Scientist in clinical studies. She holds a PhD in Biochemistry and completed her postdoctoral training at the National Cancer Institute, NIH.

Seb is the Senior Director of Oligonucleotide Development at Avidity Biosciences, where he leads a team focused on development, characterization, and validation of processes to manufacture late-stage assets such as Del-desiran, Del-brax, and Del-zota.  Prior to joining Avidity, Seb was a Scientific Director at Amgen, where he led teams managing the development of processes to prepare small molecules, oligonucleotides, glycosides, and peptides, in all phases of CMC development.  His teams delivered processes for the manufacture of Omecamtiv Mecarbil, Sotorasib, and Olpasiran. Seb is the recipient of an ACS Mid-Career Investigator Award (2024) and an active member of IQ and EPOC working groups.

Hans Nowak II is a seasoned operations executive whose career spans nuclear submarines to global pharmaceutical manufacturing. He has led manufacturing, supply chain, and engineering organizations across cell therapy, pharmaceuticals, biologics, and medical devices, and is recognized for building production systems that are safe, compliant, and reliable at scale. Having operated and engineered nuclear reactors at sea, he applies the discipline behind high-reliability, complex systems to biomanufacturing, accelerating products to first-in-human and enabling scale to commercial supply without sacrificing quality.

At Ossium Health, Mr. Nowak serves as Senior Vice President of Manufacturing Operations, leading the company’s end-to-end operations with direct oversight of production output, product quality, and distribution. He also shapes Ossium’s strategy for expanding its product range, scaling manufacturing capacity, and driving continuous competitive improvement under a safety-first, quality-always mindset. Under his leadership, Ossium has brought multiple products to market and achieved 100x revenue growth, while significantly reducing cost and consistently exceeding delivery and quality targets.

Prior to Ossium, Mr. Nowak served as a Senior Engagement Manager at McKinsey & Company, where he led pharmaceutical, biologics, and medical device manufacturers through operational, quality, and digital transformations of manufacturing sites, supply chain and network optimization, and product development strategies that accelerated approvals of new molecular entities. Before McKinsey, he spent over a decade in engineering and operations leadership roles, including as an Associate Director at Eli Lilly’s multi-product plant, home to the clinical and first commercial production of multiple blockbuster parenteral therapies.

Mr. Nowak is a graduate of the United States Naval Academy, where he earned BS degrees in Applied Mathematics and Quantitative Economics. He continued his education at MIT as a Leaders for Global Operations (LGO) Fellow and Siebel Scholar, graduating first in his class with an MS in Mechanical Engineering and an MBA from the MIT Sloan School of Management. He is certified in nuclear engineering, operations research, and business analytics.

Nidhi Shah is a pharmaceutical and biotechnology leader with over 30 years of experience in biopharmaceutical manufacturing, cell therapy, aseptic operations, quality control, and business leadership. As Senior Director of CAR-T Cell Therapy Manufacturing Operations at Bristol Myers Squibb, she leads manufacturing operations supporting innovative cell therapy treatments. Recognized for her results-driven leadership and operational excellence, Nidhi has extensive expertise in strategic operations, quality systems, regulatory compliance, and commercial manufacturing within highly regulated environments.

A recognized industry thought leader, Nidhi represented the United States as a delegate in the global revision of ISO Standard 14644-5, collaborating with international experts to shape best practices and standards for cleanroom operations. Throughout her career, she has successfully supported and participated in inspections and audits conducted by health authorities worldwide, reinforcing a strong culture of quality and compliance.

Nidhi has been an active contributor to several leading industry organizations. She has served on the Planning Committee for PDA’s CCS (Contamination Control Strategy) Workshop and has been a featured speaker at industry forums. She also co-authored the “Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool” for the Parenteral Drug Association (PDA), collaborating with four industry colleagues, and has presented on this work at PDA workshops.

In addition, Nidhi previously served as an Executive Board Member of the ISPE New Jersey Chapter and currently contributes to the ISPE Global Aseptic Conference Planning Committee. She also serves as a liaison and panelist for Women in Pharma, advocating for professional development, leadership advancement, and diversity within the biopharmaceutical industry.

Krista has been in the pharmaceutical industry for 30 years and brings expertise across both large pharmaceutical organizations and startup biotech environments. She is a results-driven leader specializing in GxP quality management throughout all phases of drug development. Krista is passionate about advancing modern, risk-based quality strategies that foster a strong culture of quality, maximize resources, and reduce non-value-added activities. Recognized for delivering exceptional results in rapidly changing environments, she has a proven track record of building cultures of quality, empowerment, and accountability across global, cross-functional, and matrixed organizations.

Ella Hwang is a Vice President–level Quality executive with 28+ years of leadership across biopharma and biotechnology organizations, from early clinical-stage startups to global commercial companies. Recognized for building risk-based, dynamic Quality Management Systems throughout the product development lifecycle. Led GMP contract manufacturing and testing, GCP Sponsor clinical trials and inspection readiness efforts aligned with FDA, ICH, EMA, WHO, and EU GDPR requirements.

Trusted strategic Quality partner to Clinical, CMC Technical Operations, Regulatory, R&D and Supply Chain leadership. She is recognized for building high-performing Quality organizations that enable regulatory confidence, operational excellence, and long-term enterprise value. Diverse expertise across GMP, GCP, and GLP supporting biologics, monoclonal antibodies, small molecules, antibody-drug conjugate (immunotherapy), vaccines, sterile injectable drug products, and combination product.

Ms. Hwang currently serves as Vice President of Quality at Abcuro, where she leads global Quality strategy, governance, and inspection readiness across clinical development and BLA commercial readiness. Previously, she held Quality leadership roles at Bolt Biotherapeutics, Roche/Genentech, Gilead Sciences, and CSL Seqirus, where she managed technology transfer, validation, and commercial launch preparation activities for complex biologics and sterile products.

Yuyi Shen is a biopharmaceutical executive with ~20 years of experience building and leading CMC, Technical Operations, and global supply chain organizations from early development through commercial readiness. She currently serves as VP, Head of Technical Operations & Supply Chain, where she owns enterprise CMC strategy across multiple clinical and IND-enabling biologics programs and governs 20+ global CDMO partners across drug substance, conjugation, fill/finish, packaging, and distribution.

Dr. Shen has spent her career at the working interface of CMC and Quality — leading late-phase development and BLA readiness planning, including validation master strategy, PPQ roadmap, and inspection preparedness, all of which depend on the two functions reading the same risk signals early and acting on them together. She has built structured, risk-based planning processes and cross-functional governance frameworks that advance programs ahead of schedule by surfacing technical and quality risk before it hardens into a delay or a finding, and she has translated that shared risk picture for boards and investors as a trusted CMC and manufacturing-risk advisor.

She brings this practitioner’s view of CMC-Quality partnership — what genuine trust and shared ownership look like day-to-day, and how to keep them intact as a program’s definition of “ready” shifts on the road to commercial launch — to this session. She is a recognized industry thought leader in CMC strategy, CDMO governance, and commercialization readiness, and a frequent invited speaker and conference chair at global biomanufacturing forums including Supply Strategy, World ADC, and BioProcess International.

Kara has over two decades of global experience in the development and manufacturing of a broad range of biologic therapeutics. Trained in chemical and biological engineering, she began her career at Merck & Co., where she contributed to the development and manufacturing of live-virus vaccines. Kara subsequently joined Genentech, a member of the Roche Group, where she spent over 14 years working in areas of increasing responsibility across process development, manufacturing sciences, CMC team leadership, and global technology strategy.

Prior to joining Enlaza Therapeutics, she served as Senior Vice President, Head of CMC & Process Development and a member of the executive team at NGM Biopharmaceuticals. In that role, she led a multi-disciplinary team to deliver three successful first-in-human molecules in less than 12 months and built capabilities to support registrational trials for two lead programs.

Kara completed her Ph.D. and M.S. in Chemical Engineering at Stanford University, where she was a National Science Foundation Graduate Fellow conducting research in cell-free protein synthesis. She received her B.S.E. in Chemical Engineering with a certificate in Engineering Biology from Princeton University.

In his current role as SVP Technical Development at BioMarin, Ganesh Vedantham is responsible for strategic and technical oversight of Process & Product Development, Clinical Manufacturing, and CMC Lifecycle Management. Previously, Ganesh spent more than two decades at Amgen/Immunex in increasingly senior roles across the organization in various sites. He is known for demonstrating strategic vision, the ability to build and lead diverse and high-performing teams, and encouraging open, collaborative, supportive, and driven cultures. Ganesh earned a Ph.D. in chemical engineering from Carnegie Mellon University, a M.S. in chemical engineering from Rensselaer Polytechnic Institute, and a B.Tech in chemical engineering from the Indian Institute of Technology, Kharagpur.

Scott Barnard is the Managing Director, North America at Bluecrux, driving growth and innovation in supply chain strategy, digital transformation, and operational excellence across the US market.  He drives consulting services and proprietary SaaS offerings like Binocs™ and Axon™, helping organizations transform their supply chains into smart, efficient and AI powered value chains. A former US Navy officer and Tulane University graduate, Scott blends strategic leadership with deep operational experience.

James Ward is a Senior Account Manager at Bluecrux, where he partners with life sciences organizations to improve planning, scheduling, and operational efficiency across research, quality, manufacturing, and supply chain functions. With a background in Biology and a Master’s degree in Entrepreneurship, James has spent his career helping biotech and pharmaceutical companies navigate growth and increasing operational complexity.

As Chief Executive Officer at Havior, Krystyna Riley doesn’t just lead a behavioral science consultancy—she embodies its principles. With over 15 years at Havior, she sees what others often miss: that the biggest barriers to performance aren’t technical—they’re human.

What drives Krystyna? Helping leaders cut through complexity and unlock what’s already possible in their organizations. Under her leadership, Havior has become the trusted partner for companies ready to accelerate performance by changing how their people work together. Her approach blends strategic clarity with deep empathy—because sustainable results require both.

Krystyna brings a rare combination: a CEO’s vision and a behavioral scientist’s insight. She helps leaders see their challenges differently and build organizations where performance and people both thrive.

Want to explore how behavior shapes business results? That’s the conversation Krystyna lives to have.

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.

Joseph Panella serves as Head of Biologics Manufacturing at Sanofi, where he leads large-scale production of life-saving biologic therapies. With extensive experience in biologics manufacturing operations, Joseph has been instrumental in driving operational excellence, implementing advanced manufacturing technologies, and optimizing production systems to enhance patient access to critical medicines.

Throughout his career at Sanofi, Joseph has championed the adoption of innovative manufacturing platforms, including single-use systems, to improve flexibility, reduce contamination risk, and accelerate production timelines. His expertise spans process optimization, technology transfer, quality systems, and regulatory compliance in GMP environments.

Joseph is passionate about advancing the biologics manufacturing field through collaboration and knowledge sharing. He holds a strong track record of leading cross-functional teams to deliver complex manufacturing solutions while maintaining the highest quality standards. Based in Framingham, Massachusetts, Joseph continues to drive manufacturing innovation in support of Sanofi’s mission to chase the miracles of science.

Amy Gamber is Vice President of Manufacturing and Supply Chain at Kyverna Therapeutics, where she leads manufacturing and supply chain strategy supporting the development and commercialization of cell therapies. Previously, she served as Lifecycle Lead for Kyverna’s SPS Program, partnering across technical, clinical, regulatory, and commercial functions to align development activities with product strategy. With more than 20 years of biopharmaceutical experience, Amy has held leadership roles at Atara Biotherapeutics, Amgen, Novartis, and CSL Seqirus. At Atara, she led strategic execution of the company’s first EU commercial partnership for a lead cell therapy asset before advancing to Vice President of Manufacturing and Supply Chain. Her experience spans manufacturing, supply chain, CMC strategy, lifecycle management, and commercialization planning.