Dr. Adrian F. Hernandez

Innovation in clinical trials

Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez will talk about innovation in clinical trials, including transforming drug development through healthcare system partnerships. How can we solve the problem of how to accelerate clinical adoption for and patient access to our medicines while enhancing the long-term sustainability of drug development? What is the role of disruptive clinical trials, and how can pragmatic and RWD-enabled design change how we carry out trials? Dr. Hernandez will share his thoughts and answer some questions.

Dr. Hernandez will share his thoughts and answer some questions.

About Dr. Adrian F. Hernandez

Dr. Hernandez received his medical degree from the University of Texas-Southwestern Medical Center in Dallas. He completed his residency training in internal medicine at the University of California in San Francisco. Dr. Hernandez completed his fellowship in cardiology at Duke University Medical Center Cardiology in Durham, NC, as well as his MHS.   Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical trials, comparative effectiveness and health policy. Dr. Hernandez is a member of the American Society for Clinical Investigation and American Association of Physicians. He had led multiple large-scale patient-centered research programs, registries and clinical trials aimed at improving health across multiple conditions such as NIH’s Health System Collaboratory and PCORI’s PCORnet resulting in more than 700 peer-reviewed publications. 

Shreeram Aradhye

Development innovation in practice

What does development innovation mean in practice? Shreeram will share some personal stories of what it means to him personally and professionally.

About Shreeram

As President, Global Drug Development & Chief Medical Officer for Novartis, Shreeram Aradhye is responsible for advancing the Novartis pipeline of investigational medicines to bring transformative new treatment options to patients with serious diseases. Shreeram is passionate about developing investigational medicines, recognizing the hope and trust of patients participating in clinical trials. He has dedicated his professional career to improving patients’ lives, first as an academic clinician and then as a drug developer and business leader.

Shreeram took on his current role at Novartis in May 2022, rejoining the company after spending several years at US biotechnology companies, including leading the development of multiple clinical stage RNAi assets at Dicerna Pharmaceuticals. He first joined Novartis in 1999 and over the course of 20 years held a succession of leadership roles in the US, Switzerland, Germany and India, including Global Head of Medical Affairs for the Pharmaceuticals Business Unit and Development Head for the Neuroscience Franchise.

Lisa Hampson and Orla Doyle

Using multi-modal data in drug development: opportunities, challenges and future directions

Leveraging novel data modalities (e.g. proteomic, imaging and real-world data) to complement our clinical trial data could have a powerful impact on our understanding of diseases, as well as how we identify and evaluate innovative medicines. Orla and Lisa will reflect on these new data modalities, how these opportunities for innovation could transform medicine development, and the steps we need to take to reach this future. The presentation will be followed by a panel discussion with Novartis experts who will share their experiences of working with new data modalities and perspectives on the opportunities (as well as challenges) they bring.

About Lisa and Orla

Lisa and Orla are both members of GDD-Analytics. Orla is a member of Technology and Innovation where her role involves helping to enable and democratize innovative methodologies for Analytics. Her background is in the development of interpretable predictive models in different data sources including RWD, brain imaging and clinical studies. Lisa is a member of the Statistical Methodology group where her role is to support the development and implementation of innovative statistical methods. Her areas of expertise are in adaptive clinical trial design, use of real-world evidence and quantitative decision making, particularly Probability of Success.