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.

Alex Simmonds, MBA is a proven life sciences and tech startup leader, innovator, entrepreneur, strategist. He is an ex-Accenture, ex-Genentech, now back at BMS as Drug Development Innovation Lead, mixing up new things in clinical development and solving hard problems for patients and sites with the three essential D’s of innovation: Digital, Data and Design.

Dominick DeGrazio is an Early Device Project Engineering Lead in the Early Engagement and Deviceability Group at GSK. He’s been in this role since Fall 2022 and focuses on the assessment of early-stage large and small molecule products within the portfolio intended for combination product development. With over a decade of industry experience, Dominick has previously held roles at PTC Therapeutics, Janssen R&D, Oncobiologics, and West Pharmaceutical Services. His expertise spans across end-to-end drug product development, tech transfer and fill/finish, analytical development, primary packaging, and device/combination product development. He has successfully partaken in the commercial launch of multiple gene therapy and biologic drug products approved on the market including Upstaza, Darzalex Faspro, and Tremfya to name a few. Dominick graduated from Franklin and Marshall College in 2012 with a B.A. in Biochemistry & Molecular Biology and Neuroscience.

Tara Schultz is a highly accomplished Digital Transformation specialist with expertise in Agile methodology, business case development, and product roadmap creation. She is recognized as a trusted advisor and thought leader in the field, advocating for the agile culture and its potential to revolutionize business operations and drive innovation. Ms Schultz’s collaborative approach and ability to align stakeholders have consistently led to successful outcomes and the achievement of organizational goals.

As an experienced coach, Ms Schultz plays a pivotal role in guiding and mentoring developers, scrum masters, and product owners within an agile framework. Her leadership skills inspire and empower teams, resulting in improved productivity, enhanced collaboration, and the successful delivery of complex projects. During her four-year tenure as Associate Director IT Project Manager at Bristol Myers Squibb, Ms Schultz has made significant contributions by leading agile transformations in Drug Development IT. Productivity of the team and optimizing processes, leveraging her strategic mindset and ability to navigate complex environments.

In summary, Ms Schultz is a Digital Transformation thought leader with a wealth of experience in AGILE methodology, business case development, and product roadmap creation. Her expertise, coupled with her ability to champion agile culture and philosophy, has made her a trusted partner for organizations seeking to drive innovation and achieve their digital transformation goals. Ms Schultz’s technical expertise, leadership skills, and passion for driving change make her an asset to any organization, consistently improving operational efficiency, enhancing customer experiences, and fostering sustainable growth.

Jakob Alme joined Sage Therapeutics in 2021. As the Head of Digital Health, he is focused on rethinking care and how it is delivered to help patients and families impacted by brain health disorders. In this role, he leads the function’s efforts in implementing digital health strategies across the organization, ranging from preclinical and translational through development, commercialization, and on-market planning. Prior to his time at Sage, Mr Alme led the digital health asset design for immunology at AbbVie, and also held roles in clinical operations, compliance, and data sciences. He holds a BS in Health and Human Performance from the University of Montana.

Dr Maria Jison is a distinguished Pulmonary-Critical care physician at AstraZeneca and serves as Global Clinical Head in the Respiratory & Immunology therapeutic area, overseeing the late phase clinical development strategy for the Fasenra portfolio. Her career reflects a deep commitment to patient advocacy and the underserved, blending direct patient care, public health, and technological innovation. Dr Jison has held pivotal roles in the eICU during its early stages and at the FDA Center for Devices and Radiologic Health. Driven by her passion for patients and fostering innovation, Dr Jison developed the AIRE Mobile Unit, AstraZeneca's mobile clinical trial pilot program. This newly launched initiative has quickly become a catalyst for collaborations in health equity both in the community and within the company. With a goal of broadening access to clinical trials for underrepresented populations, this initiative underscores Dr Jison's commitment to ensuring equitable access to cutting-edge research and treatments for all patients.

Bharat Koyani, Associate Director in the Digital Biomarker team at Regeneron Pharmaceuticals, is leading the development of digital biomarker efforts for targeted indications. With over a 5 years of experience in implementing digital biomarker in Phase I-III clinical trials, Mr Koyani has been instrumental in identifying fit for the purpose DHT. Mr Koyani earned his MSHS from the George Washington University.

Katerina Placek, PhD, is a Senior Manager in Digital Health Sciences at Takeda where she advises clinical teams on the selection and implementation of digital tools in clinical trials. She leads device validation studies, assesses new technologies, and supports teams in digital biomarker development across therapeutic areas, specializing in Neurology. Prior to her role in Digital Health Sciences, Dr Placek was a Manager in Quantitative Sciences at Takeda where she worked as a data scientist in Neurology, including on projects involving digital endpoints. Dr Placek holds a PhD in Neuroscience from the University of Pennsylvania, an MSc in Experimental Psychology from the University of Oxford, and a BA in Psychology from St. Mary's College of Maryland.

Zackary “Zak” Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics and innovation adoption. Many of these projects involve creating, compiling, and analyzing very large datasets. Mr Smith completed his BS at Florida Southern College and received his MA from Brandeis University. He is a former research analyst at Tufts CSDD and has worked as a research assistant at Harvard University and at the University of Massachusetts.