Carrie Northcott, PhD is the Head of Digital Sciences, within the Biomeasures, Endpoints and Study Technologies (BEST) group at Pfizer, Inc. She leads a driven and diverse team that is developing, validating, and utilizing digital health technologies (DHTs) and novel digital endpoints (NDEs). These DHTs and NDEs are used to further characterize diseases for patients, health care providers and scientists, as well as demonstrate drug efficacy in clinical trials. Carrie has a diverse scientific background in Pharmacology, Toxicology, and Physiology which provides her unique insight into understanding how these NDEs provide meaningful information to patients, physicians and researchers to better treat and understand diseases.

Kinsuk Shah is currently Sr. AD, Combination Product Steward at Boehringer Ingelheim, responsible for device lifecycle management and strategy for Cyltezo. Mr. Shah is accountable for continuing development and oversight of CP manufacturing + supply, leading an interdisciplinary team of internal SMEs (e.g., drug product, packaging, final assembly, device, quality). Prior to joining BI, Mr. Shah was Director of Device Development at Viridian Therapeutics, responsible for device strategy and development, including establishing internal and external capabilities within the device space, evaluation and selection of wearable and auto-injector devices. Mr. Shah has over 10 years of drug-device combination product experience from Janssen, West and Alexion. Prior to Viridian, Mr Shah was at Alexion, where he was responsible for Strategy and Program Management for ongoing device dependent programs. At West Mr Shah was the Business Development lead for the SmartDose and SelfDose platforms, successfully partnering with multiple pharmaceutical companies in establishing joint combination product programs for each product.

Dr Charmaine Demanuele is an Executive Director in the AI/ML Quantitative and Digital Sciences group within Global Biometrics and Data Management, Pfizer Research & Development. She leads a team of statisticians and data scientists that bring end-to-end clinical trial innovation with digital health technologies, imaging and statistical, AI/ML methodologies. Her group works across Pfizer's portfolio and leverages models such as Bring-Your-Own-Device and Decentralized Clinical Trials to enable efficient, patient-centric trials and faster breakthroughs for patients. Prior to joining Pfizer, Dr Demanuele was a neuroscience research fellow at Harvard Medical School and Massachusetts General Hospital in Boston, US where she used multimodal neuroimaging to investigate sleep and cognition in health and schizophrenia. Her research has been published in high-impact publications and she received several awards including a prestigious Young Investigator Grant from the Brain & Behavior Research Foundation.

Dr Demanuele received her Bachelor's degree in Engineering from the University of Malta, her PhD in Neuroscience from University of Southampton, UK, and completed postdoctoral work in psychiatric neuroimaging at the Bernstein Center for Computational Neuroscience and Central Institute of Mental Health in Germany.

Dr. Monica Swinney has more than 20 years of experience in the design and development of medical devices, pharmaceuticals, and combination products. She is currently the Sr. Director of New Product Planning and Drug Delivery Innovation for Gilead Sciences. Prior to Gilead, she held both strategic and technical leadership roles with Eli Lilly, Becton Dickinson, Johnson & Johnson, and Dexcom. Dr. Swinney holds a Ph.D. in polymer science from MIT a B.S. in chemistry from the University of Massachusetts, is the recipient of many industry awards in innovation and product development, and is an inventor on over 75 patents.

Henrik Bengtsson is Senior innovation Lead at Novo Nordisk's Bio Innovation Hub on Kendall Square, Boston. Dr Bengtsson has worked for Novo Nordisk for 22 years and has received a lifetime award for producing 100+ patents. This has been done together with his team including many PhD & Postdoc students. Prior to entering the medical device field, Dr Bengtsson invented a new type of amplifier and was part of starting up the company Bang & Olufsen ICEpower A/S focused on bringing professional audio solutions to market. Today his main interests include innovative new medical device concept development, data science, modeling and digital health.

Dr Manish Gupta is passionate about connecting biology and drug product design to create the best medicine for the patient. Dr Gupta has championed science and risk-based product development for multiple oral and parenteral commercial drug products (across small molecules and biologics) and has successfully led regulatory filings and interactions across agencies. Dr Gupta has 20 plus years of industrial experience and is currently serving as Executive Director, leading Drug Product Development Steriles (~100 team members).

Dr Derek O'Hagan is currently a Senior Advisor in GSK Vaccines R&D and a Senior Fellow. Prior to Dr O'Hagan’s current role he was the Global Head of Discovery Support and New Technology in GSK Vaccines. Previously, he was VP, Global Head of Vaccine Chemistry and Formulation for Novartis Vaccines. Dr O'Hagan has extensive experience on Vaccine Adjuvants, including R&D on several included in licensed products, and he was a member of the Team that initiated RNA vaccines in Novartis Vaccines (2009). Additionally, Dr O'Hagan is a Fellow of the American Association of Pharmaceutical Scientists. He was awarded the Conference Science medal of the Royal Pharmaceutical Society of Great Britain, and the Young Investigator Research Achievement Award of the Controlled Release Society. Dr O'Hagan was once named as the ‘most inventive scientist’ in Chiron. He proudly has 175 peer reviewed publications (h-index 104, Google Scholar) and has been named inventor on >70+ patents.

Marisa DeMartino is a Director and Head of Feasibility in Global Clinical Operations at Vertex Pharmaceuticals. Marisa carved a pathway for data-driven operational feasibility in rare disease and leads a team who support end to end aspects of feasibility from strategic planning through protocol and site feasibility. Marisa collaborates with teams in and outside of clinical trial operations to enhance and develop innovative and scalable processes. She believes each feasibility assessment is truly unique and is particularly interested in the application of data analytics to support trial predictability and risk identification.

Lily Xu is a Senior Principal Data Scientist in the corporate data science team at Vertex Pharmaceuticals. She has a wealth of experience building cutting-edge data science solutions for clinical operations and commercial strategy across multiple disease areas. With a passion for collaborating with cross-functional teams, Dr Xu has spearheaded projects on predictive patient modeling, large-scale claims analytics, GenAI for clinical documentation, data-driven protocol design, and centralized site intelligence applications.

Before Vertex, Dr Xu was a Research Scientist at Philips Research North America, where she leveraged genomic sequencing and data science to manage healthcare-acquired infections. Dr Xu holds a PhD in Biological Engineering from MIT and the Broad Institute and a Bachelor’s degree in Bioengineering from UC Berkeley.