Archives: Speakers

Noolie Gregory is a seasoned professional with over 20 years of experience in the pharmaceutical and Contract Research Organisation (CRO) sectors. With expertise spanning Clinical Development, Medical Affairs, Real World and Late Phase studies, and Early Access Programs, and has a proven track record of driving impactful results across diverse therapeutic areas.

In recent years, Noolie has focused on leveraging patient- and site-facing technologies to ensure patient-centered design and accelerate the delivery of clinical studies. Her dedication to improving study execution and patient experience has made a significant impact in the field. Notably, Noolie has extensive experience in oncology and has played a pivotal role in the development of several major medicines.

In her role of Head of Evidence Generation Noolie is working across all the Sciensus services lines to enable evidence generation services to support our clients to maximise their patient interactions and generate new insights to accelerate medical affairs and launch activities.  The team are working to offer all types of RWLP designs as well as EAPs.

After Reyna completed a Master’s in Nutrition in 1998, and  a short stint at a Endocrinology clinic and Research center she was recruited by Ilex Oncology, and got a crash course in clinical research. During her career she had run the gambit of clinical research, working as a CRA, Project Manager, and later Independent Consultant. After a 4 year hiatus from corporate and contractor life that included staying home with young kids, pursuit of some food/nutrition related entrepreneurial interests and a position on the Wheatsville Food Coop Board of Directors, she answered the siren call of research and again joined the ranks of pharmaceutical professionals.

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.

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.