A Crawl, Walk, Run Strategy Toward Virtual Studies in Real World Research

Join this webinar for a discussion of real world research in virtual studies, including what they are, how they are designed and conducted, and how the clinical trials industry is moving rapidly in the direction of these studies.

In this webinar, featured speakers will discuss why patient-centric strategies in real world settings are more and more common, as well as how innovation has allowed us to integrate seamlessly into the lives of patients. Examples of lessons learned as well as successes across the ‘crawl, walk, run’ spectrum will also be shared. The speakers will round out the webinar with a discussion of their vision for where these studies – in terms of operational models, real world data assets, and innovative technologies – are headed.

Expert speakers will focus their discussion on answering key questions, including:

• What are virtual studies?
• Why should you care about virtual studies in a real world setting?
• How is technology impacting the evolution of these studies?
• Where do we go from here?

Topics will include:

• Answering challenges with real world examples: patient engagement, endpoints, regulatory acceptance, global reach
• Data: a key factor defining what is, and can be, the future state of virtual studies

Speakers

Maria Harrison, Vice President, RWS, PRA Health Sciences

Maria Harrison, BS, Vice President, RWS, has over 30 years of experience in managing all aspects of drug and device development in both the pharmaceutical and CRO industries. Prior to joining PRA, Ms. Harrison was the Vice President of Operations in North America for clinical and post-approval services at a large CRO, where she had overall responsibility for all operational aspects of over 100 projects. Throughout her career, she has managed numerous clinical studies of various sizes on a global basis, across all clinical phases, and in multiple therapeutic indications. Specifically, in the last 10 years, she has been responsible for overseeing global real world/post-approval research in the areas of product registries, disease registries, risk management programs (including risk evaluation and mitigation strategies [REMS] and European Union risk management plans), post-authorization safety studies, minimal risk diagnostic biomarker studies, retrospective chart review studies, and other real-world evidence studies. These studies cover multiple indications and all services from protocol development through manuscript publication. They range from small investigator-initiated studies to large, global registries inclusive of over 10,000 patients, 500 sites, and 30+ countries. Ms. Harrison has held numerous positions within clinical monitoring, project management, line management, and business development, and she has also served as the business unit leader for RWS. She is a notable industry speaker and chairperson at many global medical affairs conferences on topics specific to real world and post-approval research.

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Meg Richards, Executive Director, Scientific Affairs, RWS, PRA Health Sciences

Margaret (Meg) Richards, PhD, MPH, Executive Director, RWS, joined PRA with over 30 years’ experience as an epidemiologist and health services researcher in both the public and private sectors. Dr Richard’s private sector experience includes serving as a safety epidemiologist and outcomes researcher at Abbott Labs and TAP Pharmaceutical Products, respectively, for a total of 6 years. Immediately prior to joining PRA, she served as the Vice President of Data Analytics & Epidemiology/Real World Strategy and Analytics at Mapi Group (now ICO at ICON). She served nearly 7 years as an Executive Director of Epidemiology/Real World Outcomes at PPD Inc. and 3 years as Director, Global Patient Safety & Risk Management at the Genzyme Corporation. At both Abbott (now Abbvie) and Genzyme (now a Sanofi company), Dr. Richards managed the quarterly data mining and ‘signal’ (safety issue) detection and evaluation programs for each company’s post-marketed product line. Her public sector service includes 10 years with the Rhode Island Department of Health, the Illinois Department of Public Health, and Quality Partners of Rhode Island (a Centers for Medicare and Medicaid Services quality improvement contractor). Dr. Richards received her BS in Nutrition from the University of New Hampshire and her Master of Public Health and doctoral degree from the University of Illinois at Chicago’s School of Public Health, after which she served a 2-year tour of duty with the US Public Health Service as a member of the Centers for Disease Control and Prevention’s Epidemic Intelligence Service.

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Kathleen Mandziuk, Vice President, Patient Strategy, PRA Health Sciences

Kathleen Mandziuk, MPH, RN, Vice President, Patient Strategy, leads PRA’s global patient recruitment and retention group. Her team identifies barriers to patient engagement and leverages internal and external solutions (such as social media, technology, and supportive services) to facilitate enrollment and decrease the burden of study participation for patients, caregivers, and sites. Ms. Mandziuk has a research career of 20+ years, including clinical trial and real-world clinical research and diagnostic development. Following her nursing training, Ms. Mandziuk joined the clinical development industry in data management and expanded into a variety of roles there and in project management. She then moved into a Scientific Affairs role supporting sponsors with strategy, study design, and protocol development. After 10+ years in the scientific role, Ms. Mandziuk transitioned to lead PRA’s innovative Patient Strategy group. Her experience includes studies ranging from 60 to 18,000 patients in US, Canada, Europe, Latin America, and Asia Pacific and a variety of therapeutic areas (neurosciences, oncology, dermatology, gastroenterology, women’s health, ophthalmology, and men’s health). She holds a master’s degree in public health from Drexel University.

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