Elaina Haeuber

Elaina has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry through positions at large pharma, small biotech, and CROs. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

Puja Myles

Dr Puja Myles is Director of the Medicines and Healthcare products Regulatory Agency’s (MHRA) specialist real world data research service, the Clinical Practice Research Datalink (CPRD). She is a public health specialist and prior to joining CPRD, was a public health academic at the University of Nottingham, UK. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK) and has a doctorate in epidemiology. She has been the MHRA’s strategic lead on the development of synthetic data generation approaches and applications since 2017. In addition, she has led on Regulatory Science initiatives including AI explainability, handling concept drift, data quality standards for regulatory purposes, regulatory evidence derived from computer modelling and simulation approaches.