Beyond the Hype: A RWD-Driven Approach to Clinical Trials

Real-world data (RWD) is reshaping clinical trials. From smarter trial design to faster recruitment and greater diversity. But turning that promise into practice isn't easy. Disparate data sources, messy EHRs, and unstructured clinical notes stand between researchers and the insights they need.

Join us as we explore how AI is helping life sciences organizations finally unlock the full value of RWD, including new findings from the Tufts Center for the Study of Drug Development (Tufts CSDD).

Register Free: https://www.pharmexec.com/pe_w/beyond-the-hype

Event Overview:

The successful application of real-world data (RWD) in clinical trials has been getting a lot of attention as a highly promising new technique with significant potential to change the way clinical trials are run, from improving trial design to increasing diversity to accelerating recruitment. Yet, with any innovative field, there are challenges in putting theory into practice. The biggest challenges with RWD include collecting, aggregating and analyzing disparate data sources such as electronic health records (EHRs) or medical claims. Even more challenging, much of the richest information in EHRs is locked away in unstructured clinical notes, requiring advanced artificial intelligence (AI) to uncover patterns, details and insights that truly matter.

Drawing in part on new industry research from the Tufts Center for the Study of Drug Development (Tufts CSDD), this webinar will explore how life sciences organizations are successfully utilizing RWD and AI to transform clinical trials today — and what untapped potential still lies ahead.

Key Learning Objectives:
In this webinar, attendees will gain a better understanding of:

• Strengths and opportunities of various RWD sources and the power of combining them in the clinical development process
• How AI is used to transform clinical notes in EHRs to support clinical trial strategy
• Real-world examples featuring the use of RWD to enhance trial design, accelerate patient identification, improve efficiency and understand treatment patterns and outcomes long-term
• Potential applications of RWD across the drug development life cycle

Who Should Attend:

• Clinical research
• Clinical development
• Data science
• Medical affairs
• Health economics and outcomes research (HEOR)
• Commercialization
• Real-world evidence
• Regulatory
• Study startup

Speakers:

Ken Getz, MBA
Executive Director and Research Professor
Tufts Center for the Study of Drug Development

Ken Getz, MBA, is the executive director of the Tufts CSDD and a research professor at the Tufts University School of Medicine. He is an internationally recognized expert on pharmaceutical R&D management and execution, protocol design, contract service provider and investigative site management, eClinical technology and data usage and patient engagement. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Getz has published extensively in peer-reviewed journals, books and in the trade press. He holds a number of board appointments in the private and public sectors. He received his MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and his bachelor’s degree from Brandeis University. Getz is also the chairman of the Center for Information and Study on Clinical Research Participation (CISCRP) — a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise — and the founder of CenterWatch, a leading publisher in the clinical trials industry and one of several businesses that he has sold.
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Ashley Brenton, Ph.D.
Vice President, RWE
Syneos Health

Ashley Brenton, Ph.D., is the vice president of RWE at Syneos Health, where she leads RWD and RWE strategy and execution. Brenton has 25 years of experience in RWE and genomics, developing and executing innovative strategies for life sciences. She also has deep expertise in multimodal RWD, including claims, clinical, lab, genomic and multiomic data types. Prior to her career in industry, Brenton was a genomic engineer in academia. Brenton earned a doctorate in entomology with a designated emphasis in vector-borne diseases from UC Davis; she also holds a bachelor’s degree in public health studies from Johns Hopkins University.

Mike D'Ambrosio
SVP, Global Head, Real-World
Research (RWD/RWE)
Parexel International

Mike D’Ambrosio has 22 years of industry experience at the top five CROs, including in RWE/RWD general manager roles, leading RWE/RWD and medical affairs cross-functional teams (operations, consultancy, epidemiology, health economics and outcomes research and data sciences). He has preclinical, clinical, real-world research and consultancy operational delivery experience at the project, portfolio and asset levels. His specific expertise lies within oncology and rare-disease asset development. He has led a successful build-out of real-world evidence solutions consultancy and medical affairs businesses within the CRO environment, building innovative RWD/RWE solutions to drive value creation across life cycle management. D’Ambrosio joined Parexel in February 2024 to lead the global RWR organization and is accountable for growth and strategy, RWD/RWE solution design, epidemiology, COA sciences and sensor solutions, scientific data organization (data partnerships, insights, next-generation data solutions, etc.), real-world research operational delivery and excellence and thought leadership. 

Ashley Daigneau
Head, Clinical Trials
Verana Health

Ashley Daigneau is the head of clinical trials at Verana Health, where she oversees the strategy and execution of innovative clinical research solutions that leverage real-world data. Daigneau has more than 20 years of experience supporting the development of real-world evidence strategies and overseeing clinical study execution. 

Register Free: https://www.pharmexec.com/pe_w/beyond-the-hype