Speakers

Melissa Seymour is executive vice president, Global Quality for Eli Lilly and Company.

Melissa previously served as the chief quality officer for Bristol Myers Squibb. In this role, she led the GPS Quality organization in setting the quality compliance strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality and compliance. Before joining Bristol Myers Squibb, Melissa was also the chief quality officer at Biogen. She has had prior roles providing oversight for QC laboratories and spent several years as the vice president of Corporate Quality, with responsibility for global compliance and quality systems as well as in-market Quality.

Melissa earned a Bachelor of Science degree in Biological Sciences and Biochemistry from North Carolina State University and an Executive Master of Business Administration degree from Duke University. She has over 25 years of experience in the quality arena, including quality positions at Novo Nordisk and Glaxo Smith Kline.

Melissa has been involved in influencing regulatory guidance through her participation on non-profit Boards of the Parenteral Drug Association since 2016, currently serving as chair-elect; as well as Rx-360 consortium focused on supply chain security vis-à-vis public health concerns and patient safety. She has been an advocate for simplification of post approval change processes, participating in industry forums, writing articles and interacting with regulators. She holds certifications from ASQ as a Certified Quality Auditor, Quality Engineer and Quality Manager.

Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing and technology transfer, as well as plant manager for the cell culture facility.

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

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible for the technical development, quality, and supply of preclinical, clinical and commercial programs within Moderna’s portfolio.

Dr. Collins joined Moderna from Novartis, where he held roles of increasing responsibility over the last nearly 30 years, focused on pharmaceutical production and manufacturing, including roles serving as Head of Global Chemical Operations and Anti-Infectives and as Head of Global Chemical Operations.

Dr. Collins received his Bachelor of Science in Chemistry and his Ph.D. in Organic Chemistry from University College Cork, Ireland. He also conducted post-doctoral cancer research at Arizona State University.

Tim Maines joined Alnylam in August 2017 as the Global Head of Quality Assurance and Quality Control and was promoted to Chief Technical Operations and Quality Officer in April of 2023, holding over 35 years of experience. Prior to joining Alnylam, Tim was a member of the senior leadership teams at Ariad Pharmaceuticals, Omthera Pharmaceuticals, Astra Zeneca/MedImmune, GTC Biotherapeutics (formerly Genzyme Transgenics) and Stryker Biotech where he provided strategic input and independent quality and technical oversight of each company’s global GxP operations. In total, these experiences resulted with the commercialization and market expansion of thirteen novel medicines, including four FDA-approved therapies at Alnylam.

Tim holds a Bachelor of Science in Biology/Microbiology from Gannon University.

Sheena Behn is an established global leader in the Pharmaceutical Industry with significant supply chain, manufacturing and development experience and expertise. She has worked at AstraZeneca for 25 years.

Sheena is currently VP Vaccine and Immune Therapies Supply Chain and VP for Oncology Supply, based in Cambridge, UK.

She was previously based in Gothenburg as VP R&D Supply Chain (2012-2014) running the global group for Clinical Supply at AZ; and before that VP for Wuxi Manufacturing site for 3 years, based in China (2010-2012).

Sheena is a Pharmacist who started her career working in London hospitals, before working in pharmaceutical development with GSK and then AZ before joining Operations in 2007.

Alexander Gaffney is a regulatory and media executive responsible for founding and leading the research division of AgencyIQ, the regulatory analysis division of the media company POLITICO. As the Vice President of Regulatory Policy and Intelligence, Alexander directs the division’s analysis of regulatory issues affecting pharmaceutical, biotechnology, medical device, chemical and food companies.

Before joining AgencyIQ, Alexander analyzed life sciences regulations as part of PricewaterhouseCoopers’s Health Research Institute and was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also served as Managing Editor for the company’s flagship publication, Regulatory Focus.

Alexander is regularly asked to speak to executive audiences about life science regulatory policy developments and his analysis and work (including his daily newsletter, FDA Today) is relied upon by many of the country’s top life sciences companies, law firms, trade associations, regulatory professionals, legislative staffers and public health officials. He has a master’s degree in Regulatory Science from the University of Maryland and his Regulatory Affairs Certification (RAC) in US regulation. He also serves as the co-chair of the Drug Information Association’s (DIA) Regulatory Policy and Intelligence Community and the Chair of RAPS’ Regulatory Intelligence Conference.

Dr. Joanne Beck is currently Chief Technology Officer at Abata Therapeutics. Prior to this, she served as Chief Technology Officer at Aerium Therapeutics and COO at Boston Pharmaceuticals, a private company developing candidates across multiple indications in cardiometabolic, oncology, and immune/inflammatory diseases. Prior to joining Boston Pharmaceuticals, she was Executive Vice President of Global Pharmaceutical Development and Operations at Celgene where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics and Astria Therapeutics.

Steven Johnson is currently Vice President of Quality Assurance Operations and Quality Site Head of Ultragenyx’s internal Manufacturing and Quality Control locations in Bedford and Woburn, Massachusetts (respectively).  Steven joined Ultragenyx approximately 6 years ago and has been a key Quality Leader developing procedures and processes to build out internal operations.  This included significant enhancements to company Quality Systems, establishment of a new Quality Control laboratory, and establishment of a new gene therapy manufacturing facility.  Previously Steve has held progressive roles within Quality Assurance, Manufacturing, and Quality Control at companies such as Genentech, Amgen, Baxter, and Shire.  Steve is an advocate for common sense, practical solutions grounded in Lean principles through value added thinking, waste removal, and simplification of processes.

Judy joined Gilead Sciences as Vice President, Global Supply Chain in January 2024.  She leads supply chain professionals responsible for end-to-end global supply chain strategy and execution to ensure uninterrupted supply of Gilead’s clinical product portfolio from trials through to launch. Close partnership with CMC functions including Product & Portfolio Strategy, CMC Regulatory Affairs, Technical Development, Manufacturing Operations and Quality Assurance will be critical part of her accountabilities. Judy is an accomplished healthcare supply chain professional with blended experiences in both big pharma and smaller, clinical-stage biotech companies. She is a visionary, solution-focused leader with a strong track record delivering best-in-class improvement strategies and strengthening portfolios. She has a passion for developing people to help them realize their potential and maximize their contributions.

Magaly currently works at Takeda as a Senior Director Quality Compliance for the Global Oncology & Biologics Division. Prior to joining Takeda she worked in consulting for Pharma-BioServ US Inc., MedImmune, Pfizer, Wyeth and Schering Plough in positions of increased responsibility. She holds a Bachelors Degree in Chemistry from the University of Puerto Rico and a Master Degree in Bioscience and Regulatory Affairs from the Johns Hopkins University in Maryland, US. She has comprehensive management experience in Quality Assurance, Quality Systems, Compliance, Quality Control, Validation and Manufacturing Operations. Magaly has participated as a lead in companies undergoing remediation efforts such as Consent Decrees and Warning letter environments in which she has developed expertise in quality systems design and implementation and Risk Management. She is Kepner-Tregoe Problem Solving Decision Making(PSDM) Certified Trainer, former ASQ Quality Auditor (CQA), US-RAC, and a PR Licensed Chemist. She was the PDA QRM IG Coordinator for the past couple of years and recently was appointed Co-Lead of this QRM IG.

Catalina Vargas is Senior Vice President and Global Supply Chain (GSC) Lead at Bristol Myers Squibb (BMS). A global pharmaceutical executive with more than 20 years of experience, Catalina currently leads a talented team, working to seamlessly deliver medicines to patients in more than 50 countries around the world. Under her leadership, Catalina has built a highly synchronized, transparent and sustainable supply chain organization.

Catalina joined BMS in 2018 as Vice President, Strategic Sourcing and Procurement, Global Product Development and Supply, where she managed a complex supply chain to bring critical medicines to patients. During her time in this role, BMS acquired Celgene, which at the time was the largest deal in biopharma history, and Catalina successfully integrated the Celgene and BMS sourcing and procurement groups.

Immediately prior to her current role leading GSC, Catalina was Chief of Staff to the CEO of BMS where she led strategic enterprise-wide initiatives and advanced the leadership team’s governance and decision-making model. With an exceptional record of building high performing and agile global teams, Catalina is a passionate advocate for inclusion.

Prior to joining BMS, Catalina was with Pfizer for 17 years, where she was tapped for leadership positions across strategic sourcing, operations, and external manufacturing.

Catalina has a bachelor’s degree in industrial engineering and a graduate degree in finance and capital markets.

Allyson Nicholson is a seasoned biopharmaceutical executive with 29 years of experience in end-to-end supply chain management, business reengineering, and digitalization, across a wide range of industries including banking, airline, food, public sector, consulting, and pharmaceutical. Allyson has a proven track record in process improvement, large systems implementations, and mergers and acquisitions. With extensive experience in clinical and commercial supply chains, Allyson has successfully led product commercialization and in-market execution, ensuring supply reliability.

Currently, Allyson serves as the Head of Global Supply Chain at BioMarin Pharmaceutical, where she is responsible for the successful execution and services of all global supply functions ensuring supply to patients for their commercial portfolio and pipeline candidates.

Outside of work she enjoys cooking, learning about wine, skiing and walking in a beach somewhere.  She currently lives in Boston with her husband, two young-adult children, and their two dogs.

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

Steven Wesel serves as director of upstream process development at Forge Biologics and he has been with the company for over 4 years. He oversees the development and tech transfer of upstream gene therapy production processes, including cell banking, seed train, bioreactor scale up, transfection, and harvest of viral vectors. Steven has worked in upstream process development in biotechnology for the last thirteen years and in gene therapies for the last seven years. His experience prior to Forge includes leading upstream process development at Abeona Therapeutics, monoclonal antibody upstream process development at Gilead Sciences, and vaccine upstream process development at Merck.  Steven’s expertise ranges from clonal selection to preclinical development through clinical manufacturing. He has worked with many scales, ranging from high throughput small scale Ambr15 (15 mL) bioreactors up to manufacturing scale 2000 L productions. He has a Master’s degree from Lehigh University and Bachelor’s from MIT in Chemical and Biological engineering. He also has an MBA from the University of North Dakota.

Dr. Jack Prior leads MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he spearheads global initiatives in process monitoring and AI-driven yield improvement for biologics manufacturing. Previously as Head of MSAT Digital, he led teams working to develop global process data analytics systems and to digitize laboratory operations for Industrial Affairs Specialty Care drug substance and drug product manufacturing.

His leadership spans nearly three decades at Sanofi-Genzyme, where he has led manufacturing science organizations supporting process characterization, modeling, technology transfer, and manufacturing operations for critical therapies treating rare genetic disorders. Throughout his career, he has focused on integrating process modeling and advanced analytics with manufacturing science to enhance biologics production across US and European operations. He has led manufacturing science teams supporting multiple tech transfers across the Sanofi network, including the team supporting transfer to a new continuous single-use digital facility, while advancing approaches to process modeling and scale-up.

Dr. Prior holds a Doctor of Science in Chemical Engineering from MIT, where his research in data reconciliation for bioprocess development laid the foundation for his work in process monitoring and control. His current work continues to advance manufacturing science through the integration of digital technologies, process modeling, and AI in biologics manufacturing.

Vinod Bulusu leads Products team in Global Technical Operations (GTO) and provides CMC leadership in Operations for Biologics modalities at AstraZeneca. Vinod, has about 20 years’ experience in commercializing biologics. Prior to AstraZeneca, Vinod worked at PwC as a management consultant and at Amgen led late stage process development and technology transfers. Vinod has a Masters in Chemical Engineering and an MBA.

An experienced Operations and Development leader with 25 years of experience, Cliff has defined his career thus far helping both small and large companies adopt and adapt new platforms and products to the needs of the product, pipeline and patients. His focus on the value and quality delivered by technical solutions has been applied across all phases of clinical and commercial production. He has also been privileged to build both organizations and facilities to deliver clinical and commercial products at a reduced speed.

Rohit Harve brings over 30 years of experience in the pharmaceutical and life sciences industry, with deep expertise across advanced manufacturing, supply chain operations, and Product Development.  He has led transformative initiatives ranging from continuous improvement programs and rapid process scale-ups to the deployment of leading technologies in process mining and AI.

Rohit’s career spans supply chain innovation, product development,  manufacturing strategy, greenfield facility planning, and operational excellence. He is known for designing fit-for-purpose solutions that are tailored to the unique needs of each organization, driving sustainable growth while navigating complex environments. With a passion for creating meaningful change, Rohit empowers organizations to unlock new value, accelerate innovation, and thrive in an evolving industry landscape.

Rohit has a Master’s in Chemical Engineering, UM Columbia, MBA from The Wharton School.

Abhijit is a Partner at PA Consulting, specializing in end-to-end, digitally enabled operations transformation. He brings a proven track record of designing impactful strategies and driving their execution—from the boardroom to the production floor.

He has successfully partnered with organizations ranging from Fortune 500 companies to pre-commercial ventures, consistently delivering significant, quantifiable value and EBITDA improvements. With deep global expertise in the biopharmaceutical industry, Abhijit’s work spans advanced technologies, including vaccines, biologics (mAbs, CGT, etc.), peptides, and complex formulations.

Passionate about advancing global healthcare, Abhijit holds a Ph.D. in Organic Chemistry with a focus on Oncology, and an MBA in Finance Supply Chain from the University of Tennessee, Knoxville and Master’s in Chemical Engineering, UM Columbia, MBA from The Wharton School.

Vijay Raju joined Pioneering Medicines / Flagship Pioneering as Vice President, CMC in 2022. He is responsible for the technical development of the therapeutic portfolio across modalities in collaboration with internal project teams, Flagship platform companies and biopharma partners.

Prior to Flagship, Vijay was with Novartis for more than 14 years in various roles including Vice President, NCE Analytical R&D where his team contributed to an industry leading portfolio resulting in multiple marketing approvals. He was the sponsor of an industry top-tier CMC digital transformation program that enabled new ways of working and operational efficiencies. Earlier, he contributed to CMC strategy that included acquisitions / divestitures, building new capabilities and evolution of sites across the globe (in US, Europe & Asia). Before Novartis, Vijay was with Boehringer Ingelheim where he was responsible for commercialization of oral and inhalation products.

Ian Larson has been a valuable asset to Redaptive for over seven years, expertly managing engineering, operations, customer service, safety, and solutions. With a robust background in Pharma/Biotech spanning approximately 25 years, Ian has experience as a supplier, consultant, and working for pharma/biotech operating companies.

During his tenure as Senior Manager R&D at Baxter, Ian contributed significantly to the development of biologics (mAbs and fusion proteins PHI-IIa) and medical devices, from inception through commercialization, and managed their plant Capital Plan.

As a supplier, he worked for mechanical and general contractors to build projects for companies such as Genentech, Avantor, McKesson, Abbott, Baxter, and others across the US and EU

Ian’s leadership extends beyond his professional roles; he led the San Francisco Chapter of the International Society of Pharmaceutical Engineering as President.   He currently serves on two advisory boards: Aetos (CMO for biosimilars) and Celltheon (CRO for biologics development).

Ian is well-versed in working within cGMP, cGLP, and cGCP environments and leads Redaptive’s technical strategy for these facilities.

Neil Fausz is a Managing Director at Accenture, specializing in Life Sciences Supply Chain and Manufacturing Operations, within the firm’s Quality Practice. Based in Miami, Florida, he brings over two decades of experience in digital innovation, business transformation, quality management, and compliance across the pharmaceutical and biotech sectors.

Since joining Accenture in 2018, Neil has been instrumental in driving modernization in GxP-regulated environments, focusing on laboratory informatics, quality systems, and intelligent automation. His expertise lies in advancing business processes with technology to enhance operational efficiency and regulatory compliance. Neil is also actively involved in talent acquisition and development, seeking professionals passionate about reinventing quality management in life sciences.

Prior to his tenure at Accenture, Neil held leadership roles in various pharmaceutical organizations, where he led initiatives in laboratory automation, digital quality systems, and enterprise compliance solutions. His strategic approach to quality reinvention has been recognized in industry forums, including webinars on intelligent automation in quality management systems.

Neil’s professional philosophy centers on the convergence of science and technology to drive innovation in life sciences and improved patient outcomes. He is committed to fostering a culture of continuous improvement and excellence in quality management practices.

Austin is an experienced leader in business development and strategy within the pharmaceutical, biotech, and medical device industries. His career spans various roles at Fortune 500 companies, including Kelly Science & Clinical, IQVIA, and ThermoFisher, as well as leadership positions at NSF Health Sciences and Charles River. Most recently, he worked at Redica Systems, a SaaS software company specializing in Quality and regulatory compliance data intelligence. With a strong background in the complexities of bringing pharmaceuticals and medical devices to market, Austin has a deep understanding of customer needs and the multifaceted processes involved. His expertise includes laboratory and R&D, clinical trials, manufacturing, and Quality.

He is a recognized industry leader, serving as Immediate Past-President of the Southeast Chapter of the Parenteral Drug Association (PDA), a current member of the PDA Regulatory and Quality Advisory Board (RAQAB) and as a Regulatory Authority Engagement Liaison for the EMA Quality Working Party for PDA. He is also an active member of the International Society for Pharmaceutical Engineering (ISPE). Throughout his career, Austin has contributed to numerous industry publications and conferences. He holds a BSc and MSc in Nutrition & Food Science from Auburn University and has published research in several scientific journals.

Inna Ben-Anat is the Global Head of Smart Factories at Sanofi Manufacturing and Supply. In this role, Inna defines the vision and roadmap for Smart Factories, partnering with Digital and Business Units to achieve best-in-class performance through smart and sustainable manufacturing and digitization. Leveraging advanced technologies and AI throughout simplified and standardized industrial processes enables affordability and robustness of medicines and vaccines supply for the patients.

Previously, Inna served as the Head of Global Manufacturing Strategies and Technologies at Amgen. Before that, Inna was the Global QMS Technology Transfer and Commercialization Head at Merck, following 11 years at Teva in various leadership roles, including Head of the MS&T organization within the Americas operation, Head of Product Robustness, and Global QBD Strategy.

Inna holds an M.Sc. in Quality Assurance and Reliability and a B.Sc. in Chemical Engineering, both from Technion, Israel Institute of Technology.

Linda Lai is an Associate Vice President, Plant Manager, for the AML6 Drug Substance manufacturing facility at Amgen’s site in Juncos, Puerto Rico.

Linda joined Amgen in 1996 and has held various positions in Process Development, Biosimilars, Supply Chain, and Manufacturing at Amgen’s California, Seattle, and Puerto Rico locations. Her bioprocessing and leadership experience includes commercialization through process development, technology transfer, Product Delivery Team leadership, and strategic business case development. Linda has performed process development and manufacturing activities at bench, pilot, and commercial scale. During Covid, she served as Executive Director for External Supply, responsible for managing the relationship with GMP raw material and device suppliers and leading Raw Material Resiliency efforts.

Linda has a combination of technical, business, and strategic experience to guide her as an Operations leader. She holds a M.B.A from Pepperdine University and a B.S. in Chemical Engineering from UCLA. In 2023, Linda was recognized as a Healthcare Businesswomen Association Rising Star.

Sunny Patel is a strategic and results-driven leader with over 15 years of experience at the FDA, GSK, Gilead, and Cook Medical. His expertise spans supplier quality oversight, external manufacturing, and regulatory compliance across biologics, small molecules, medical devices, and consumer healthcare. With Master’s in Bioengineering and MBA, Sunny seamlessly blends technical acumen with business insight.

A strong advocate for supplier collaboration and strategic partnerships, Sunny has shaped and led global initiatives that enhance supplier reliability, mitigate risks, and ensure regulatory excellence. He has played a pivotal role in integrating newly acquired assets, strengthening inspection readiness, and optimizing material management strategies. Beyond delivering business impact, he is passionate about developing top-tier talent, fostering high-performing teams, and mentoring next generation leaders.

As a leader in Business Strategy and Operations at Gilead Sciences, I drive strategic analyses and cross-functional partnerships that shape both our immediate priorities and long-term vision. My work focuses on critical network analysis and operational strategy, ensuring Gilead remains at the forefront of innovation in the pharmaceutical industry.

Prior to Gilead, I spent 24 years at Genentech, where I held leadership roles across MSAT, Quality, Supply Chain, Production, and Strategy. This diverse experience provided me with a deep understanding of manufacturing excellence, operational strategy, and quality leadership. I developed a strong foundation in corporate strategy and execution through my roles at Genentech. Now at Gilead, I leverage this expertise to advance transformative solutions in life sciences, strengthening our impact on global health.

Celia joined Neuraly in 2019 and has over 20 years of experience in drug and vaccine development, as well as medical device and diagnostic projects.

Before joining Neuraly, Celia worked at Opgen as Director of Project Management where established the Project Management Office (PMO). Prior to that, she was at Novavax in various project management and quality roles. Prior to Novavax, Celia worked for a consulting firm, Integrated Project Management Company, establishing PMOs and managing projects of varying complexity with globally dispersed teams for different biopharmaceutical companies, including Genentech and Roche. Prior to that, she started her life science career in the Biosciences Division of Stanford Research Institute in Menlo Park, CA.

Celia earned her MBA from University of Maryland’s Smith School of Business and holds a PMP certification from the Project Management Institute (PMI) since 2008.

Before joining Neuraly, Celia worked at Opgen as Director of Project Management where established the Project Management Office (PMO). Prior to that, she was at Novavax in various project management and quality roles. Prior to Novavax, Celia worked for a consulting firm, Integrated Project Management Company, establishing PMOs and managing projects of varying complexity with globally dispersed teams for different biopharmaceutical companies, including Genentech and Roche. Prior to that, she started her life science career in the Biosciences Division of Stanford Research Institute in Menlo Park, CA.

Celia earned her MBA from University of Maryland’s Smith School of Business and holds a PMP certification from the Project Management Institute (PMI) since 2008.

Vaishali Shukla is a proven leader with expertise in quality and in developing the teams required to deliver it.

In her current role as VP, of Quality at Lilly, Vaishali leads new API manufacturing sites. In this role, Vaishali oversees functional and site strategies, setting overarching goals and objectives as well as developing and executing short- and long-term strategic direction.

With more than 20 years of experience in the biopharmaceutical industry, she is an expert in a broad variety of subjects ranging from early clinical development to commercialization of Cell and Gene therapy, Peptide, ADC, biologics & small molecules.

Vaishali’s career includes work at BioVest International, Takeda Pharmaceuticals, Shire Pharmaceuticals, UniQure, and Kite where she implemented novel processes for continuous development.

With a BS in Biology, master’s degrees in Botany, Regulatory Affairs, Pharmaceutical Economics and Policy, and a Ph.D. in Pharmaceutical Science.

Vaishali lives in the Indianapolis area and is the proud mother of her daughter Smita, who is following her footsteps as a female trailblazer in the biosciences.

Dottie Barr serves as Senior Vice President, Manufacturing and Technical Operations, joining Lantheus in 2015. Ms. Barr has served in positions of increasing responsibility at Lantheus, including most recently as Vice President of Manufacturing and Supply Chain, and brings more than 35 years of industry experience. Prior to joining Lantheus, she served as Vice President, Supply Chain, Materials, and Logistics at T2 Biosystems. She has also held positions of increasing responsibility at Haemonetics, where she ultimately rose to the position of Vice President, Global Supply Chain. Ms. Barr earned a Bachelor of Arts in economics from Framingham State University and a Master of Business Administration from Babson College. Dottie’s Philosophy “Find your passion and do what you love!

Katherine Farley is an innovative product leader.  As Senior Director of Product at MasterControl, she oversees the product strategy and roadmap for industry-leading digital manufacturing solutions, leading high-performing teams to develop products that exceed customer expectations and drive growth.

With expertise in aligning product vision with market needs, leveraging data-driven insights, and fostering cross-functional collaboration, Katherine has successfully led major initiatives, including launching several new products within MasterControl’s manufacturing portfolio. She is passionate about building transformative solutions that solve real-world challenges.

Katherine holds a Master of Science in Information Systems from the University of Utah and a Bachelor of Arts in International Business and German, with a minor in Economics, from Western Washington University. She is based in Salt Lake City, Utah.

David Frank joined Modular Devices as Chief Commercial Offer in 2024, where he spearheads commercial strategy and drives business growth for the company’s cleanrooms team. David is known for his complex problem-solving, business process improvement, and global business transformation expertise. Prior to joining Modular, David led commercial expansion at Azzur Group, where he played an instrumental role in launching Azzur Cleanrooms on Demand. His work in scaling commercial teams is recognized as transformative, with significant revenue and brand influence. David holds a BA in economics from The Pennsylvania State University, along with Lean Six Sigma Master Black Belt and PMP certifications from Villanova University.

Christine Goldschneider is a distinguished leader in the biopharmaceutical industry with over 30 years of experience. Currently serving at Sanofi as Vice President, Head of Alliances, Manufacturing & Supply Specialty Care and previously as a Strategic Manufacturing Franchise Leader at Sanofi for Dupixent and Rare Blood Disorders and Rare Disease, Christine has demonstrated exceptional skills in driving collaboration and leading strategic manufacturing product planning with high impact on cost reduction and enabling expanded market access.

Throughout her career, Christine has held pivotal roles in large biopharmaceutical manufacturing organizations such as Sanofi, Lonza, and AbbVie. At Sanofi, she currently serves on the Bioatrium Board, a Joint Venture with Sanofi and Lonza and works with multiple manufacturing collaboration partners strengthening the manufacturing relationships. Her prior roles in Sanofi in strategic product lifecycle management built on her past strengths in manufacturing production and engineering. Christine’s hands-on manufacturing experience at Lonza included leading the site MSAT team and tech transfers, leading Drug Substance manufacturing operations, and in customer program management. At AbbVie, Christine learned the fundamentals of process engineering and plant start-ups. Christine’s ability to develop strategic vision while, while motivating high-performance teams has consistently led to impressive results. Her diverse experience, from process engineering to executive leadership, has equipped her with a comprehensive understanding of the biopharmaceutical industry. Christine holds a BS in Chemical Engineering from the University of Delaware and an MBA in Finance from Clark University.

A recipient of the 2015 Women to Watch Award from the Boston Business Journal, Christine is known for her determination, integrity, and willingness to challenge the status quo. Her customer-focused approach and reputation for efficiency and quality have been instrumental driving innovative solutions to execute her passion to reduce cost of goods to enable broader access to critical life-saving and life-changing medicines.

Dr. Michael Kraich is Vice President of Global Project & Product Management within Boehringer Ingelheim’s Biopharma Contract Development and Manufacturing Business called BioXcellence.

Michael has more than 15 years of experience in Biopharmaceutical Development, Manufacturing, Project Management and Contracting. In his previous role he was heading the Global External Manufacturing Network of Boehringer Ingelheim’s Animal Health Business accountable for the strategic development and management of a global CMO and API supplier network. Before this, he was a member of the site leadership team of the Biopharma Site in Biberach, Germany, leading the local CMC Project Management organization dedicated to CMB customers.

Venkatesh Srinivasan, Ph.D. has served as our Chief Technical Operations Officer since May 2023. From April 2022 to May 2023, Dr. Srinivasan served as our Senior Vice President, Process, Analytical and Formulation Development. Prior to that, from March 2011 to March 2022, Dr. Srinivasan worked at Bayer AG, where he was most recently, the Vice President of Global Manufacturing Sciences and Technology. Dr. Srinivasan also co-founded GlycoRx Partners, LLC, a company focused on developing novel, half-life extended pharmaceutical proteins and peptides based on a unique glycoengineering platform, where he was a partner from 2009 to 2011. Prior to that, Dr. Srinivasan worked for Phyton Biotech, LLC where he served as Senior Director, Bioprocess Development and Director, Business Development. Dr. Srinivasan received his B.S. in Chemical Engineering from Indian Institute of Technology, Chennai, and his Ph.D. in Chemical Engineering from the State University of New York. He also held post-doctoral appointments at the School of Engineering, Cornell University, and at the Antibody Engineering Laboratory, University of California, Davis.

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.

Jacob Greenwood has spent his 15+ year professional career working in the Life Sciences industry. At Project Farma, Jacob is a strategic leader, creating and fostering client relationships and building brand awareness within the pharmaceutical and biotech industries.

In addition to his experience with Project Farma, Jacob spent 5 years as a business development professional within the Architecture, Engineering, and Construction industry, delivering projects totaling nearly $500M. Prior to developing his sales career, he was an active member of the preclinical research community, managing vivariums in both Maryland and North Carolina. Jacob remains committed to helping medicines and therapies move through the research and development stage into manufacturing and ultimately into a position to positively impact the lives of patients.

In his role, Scott leads strategic operations, collaborating with business development, technical operations, talent acquisition and marketing to create growth for the organization. Scott is an accomplished, results-oriented leader with over 30 years of experience managing organizations and global capital projects in the life sciences industry. He is proficient in all aspects of project delivery, including planning, design, construction, commissioning, qualification, and validation, and has developed multiple procedures, best practices and tools pertaining to these activities. Scott also has a proven track record of significantly growing organizations, securing high-impact partnerships, advancing company goals and expanding footprints in the industry.  He is an active ISPE member and has delivered multiple industry presentations.  Scott has a BSEE degree from Purdue University and is PMP certified.

Lindsey Daniel, PE, is the Head of Global Operational Excellence for Takeda’s Biologics Operating Unit, where she leads enterprise-wide performance improvement initiatives across a global network of manufacturing sites. With over 13 years of experience in the pharmaceutical industry, Lindsey has held leadership roles in engineering, operational excellence, and product strategy. Her leadership is grounded in a holistic approach to solving problems and a strong belief in empowering teams to own and sustain change. Lindsey is a licensed Professional Engineer (PE) and a certified Lean Six Sigma Black Belt. She is actively involved in the International Society for Pharmaceutical Engineering (ISPE), serving as the Chair of the 2026 ISPE Facilities of the Future Conference, and as the Vice President of the ISPE Boston Chapter.

LeeAnn Chrisco is an accomplished Quality Assurance executive with over 20 years of leadership in GMP manufacturing and compliance. As Director of Quality Assurance at INCOG Biopharma Services, she provides strategic QA oversight across manufacturing, packaging, and quality control, ensuring global regulatory compliance. LeeAnn has led audit readiness, regulatory agency interactions, and facility startups for clinical and commercial operations. Her expertise spans technical transfer, aseptic processing, and quality systems innovation. A contributing author to ISPE and BioPhorum publications, LeeAnn brings deep industry insight and a passion for building high-performing quality cultures in fast-paced, regulated environments.

Arul joined Axplora as CCO on July 18, 2022. Based in Raubling (Germany), Arul oversees the Global Marketing Strategy and Business Intelligence and has a global role bringing together the BU Marketing organizations to foster our business impact in close relations with the BU Presidents and the sales teams.

A Chartered Chemical Engineer from the UK with an MBA from INSEAD, Arul has a 25-year business career as a General Manager, Executive Coach and Commercial Negotiator. He led Commercial (Marketing & Sales) and Operational (Technical Operations & Supply Chain) organizations at Novartis, Baxalta & Shire in several countries and has also served as CEO of a Swiss Biologics CDMO. Most recently, he has been supporting a major German pharma company set up a global rare dermatology business.

Arul likes to practice his six languages at our sites, while indulging in a conversation or two about the local region and sports, many of which he follows. Outside of work, he is an avid skier and hiker with his family.

As a Co-Founder & Chief Product Officer at Mareana, Vishal has spent his entire career at the intersection of technology, science and business. He has worked with IBM, SAP on multiple software products and has spent over 10 years with Johnson & Johnson in transformation projects around Supply Chain and Manufacturing.

His current time is spent working with customers in defining and shaping the future of Manufacturing Intelligence for regulated industries.

Ganesh is the Director of CPV at BMS, with over two decades of experience in pharmaceutical development, tech transfer, and commercialization. He has led large-scale product launches, managed global CMOs, and driven innovation through QbD, DoE, and PAT. His current focus is on enhancing manufacturing efficiency and driving continuous process verification in highly regulated environments.

Ganesh Krishnamoorthy is the Director of Downstream Process Development at Forge Biologics, an AAV gene therapy manufacturing company based in Grove City, Ohio. He has a Bachelor’s in Pharmaceutical Sciences from Annamalai University, a Master’s in Bioprocess Technology from the University of Mumbai, and a PhD in Biochemistry from the University of Oklahoma that provides him with both the theoretical and practical knowledge to navigate the complex landscape of biopharmaceutical manufacturing.

With over 15 years of experience, his expertise spans drug discovery, protein science and downstream process development in both academic and industry settings. Ganesh has been with Forge biologics for the past 3 years and has been responsible for leading the Downstream Process Development Division playing a key role in developing AAV platform production process, improving downstream recovery and quality of AAV gene therapy manufacturing. Prior to Forge biologics, he worked at Cytovance biologics as Senior scientist making significant contributions to process development of plasmid DNA manufacturing, protein purification and late-stage process characterization and has presented in several webinars related to plasmid manufacturing processes. At Forge biologics, Ganesh contributed as a speaker in a webinar involving a discussion to solve Downstream Challenges in AAV purification. Ganesh has spent most of his career as a healthcare scientist and has contributed to extensive research projects ranging from tackling antibiotic resistance to life transforming gene therapy development. He is passionate about designing efficient purification process that ensure high quality gene therapy treatments.

A seasoned pharmaceutical leader with over 18 years of experience. Uday Aich leads teams that ensure the highest product quality and regulatory compliance standards. Uday Aich is the Director, CMC Strategic Lead at Bristol Myers Squibb, a role he has held since June 2022. Uday is overseeing CMC-related analytical, technical, strategic, and operational elements. He manages control strategy, specification, comparability, global regulatory filings, change control, quality investigations, and implementation. Uday has also spearheaded the network process and analytical integrated control strategy to simplify quality control and process testing, minimizing cost and risk while maximizing product quality through a science and risk-based approach.

From November 2018 to June 2022, Uday served as Associate Director, CMC Strategic Lead at Bristol Myers Squibb for biologics and small-molecule products. In this capacity, he led the successful submission of regulatory filings for multiple products, resulting in product approval and market launch.

Before joining Bristol Myers Squibb, Uday was a Principal Scientist at Sanofi from 2011 to 2017. He led early and late-stage biologic product development, focusing on HTP and PAT technology innovation, managed the analytical testing lab, and drove business processes for analytical harmonization.

He chaired the BPOG cross-industry forum for ILM-RTR innovation, developing a technology roadmap, white paper, and business case for novel analytical and process technologies, including digitalization.

Uday is known for building high-performing and agile teams and passionately advocates diversity and inclusion in the workplace. He holds a Ph.D. in Biochemistry from the Indian Institute of Technology Madras and recently completed an executive leadership program from the Wharton School.

Jin Seok Hur, Ph.D., brings over 18 years of pharmaceutical industry experience since graduating with a doctorate in Chemical Engineering from Purdue University in 2006. His research focus is in downstream purification processes. He began his career with Novasep (now Axplora) in the US as a process development scientist in 2006, advancing to R&D Manager in 2008. From 2011 to 2013, he managed R&D and GMP Kilo Labs at Novasep in Pompey, France. Returning to the US in January 2014, he became the Technology Director and is currently responsible for General Management of Axplora US and Global ADC Platform Management.