A lack of real-world data (RWD) puts any commercialization strategy on shaky ground.
To stay competitive, every pharmaceutical company needs access to high-quality, recent RWD to effectively bring a therapy to market, satisfy postmarketing requirements and track early adoption post-launch.
Often, this data is needed before specific J-codes are widely adopted, which leaves critical details in the clinician’s free-hand notes in the electronic health record (EHR).
This webinar will discuss the opportunities in evaluating and leveraging RWD sources, including EHR unstructured clinical notes, to support business decisions surrounding a new therapy launch.
The featured speakers will also explore various methods, including the use of artificial intelligence, by which clinical notes can be curated for use at scale.
This webinar is part of the RWD in Action Series and will feature a discussion that includes:
- How high-quality RWD, such as EHR data, can support site selection and patient identification for clinical trials, observational safety and efficacy studies and track real-world usage to inform sales strategies
- How to evaluate EHR RWD sources and unstructured note curation
- Case studies leveraging EHR RWD for new therapies in thyroid eye disease, etc.
Register for this webinar to learn how real-world data can guide smarter decisions when launching new therapies.
Speakers
Michael Fronstin, Innovator in Life Sciences and Founder, Vireo Strategies LLC
Michael Fronstin is the founder of Vireo Strategies and currently serves as the Fractional General Manager at HealthVerity, where he is leading the launch of HealthVerity eXOs, a new Agentic AI platform embedded with claims and real-world data.
Previously, Michael was the Global Head of Clinical Research & Consulting and General Manager, Real-World Evidence (RWE) at Oracle Life Sciences and Cerner Enviza, where he championed the integration of patient centricity across Oracle’s life sciences portfolio.
Michael has been instrumental in linking patient-reported outcomes (PROs) and Social Determinants of Health (SDOH) data to claims and EHR datasets, driving deeper insights into patient experiences and real-world outcomes. Earlier in his career, he spent almost 20 years at Kantar Health in multiple roles, including Global Head of Innovation (RWE).
In addition to his industry work, Michael partners with patient advocacy organizations to build and leverage patient registries in rare diseases, advancing the use of RWE to accelerate access to new therapies. He holds an MBA in Healthcare Administration from the University of Miami Herbert Business School.
Manfred Stapff, MD, PhD, Founder and Principal, Candid - Advisory Inc
Dr. Manfred Stapff, MD, PHD, is a distinguished Physician, Researcher and Thought Leader in clinical research and data science. With over two decades of experience in the medical and pharmaceutical industries, Dr. Stapff has been at the forefront of integrating real-world evidence (RWE) into healthcare and beyond. He has held senior leadership roles, driving innovation and shaping strategies that bridge scientific rigor with practical application.
Known for his passion for evidence-based decision-making, Dr. Stapff has dedicated his career to empowering others to think critically and navigate the challenges of misinformation in today’s complex, data-driven world.
Katherine Vandebelt, CEO, Van de Bytes & Mentor Advisor, PharmStars
With over thirty years of experience in clinical research, Katherine has had the privilege of working across geographies and therapeutic areas, creating and transforming processes along the way. She remains passionate about driving digital adoption, a momentum that accelerated during the pandemic, and continues to learn and apply new approaches.
Her goal is to help introduce better experiences that make the clinical research ecosystem work for everyone: patients, healthcare professionals, sponsors and regulators.
Aracelis Torres, PhD, MPH, Senior Vice President of Data & Science, Verana Health
Aracelis Torres, PhD, MPH, is the Senior Vice President of Data & Science, where she oversees the Quantitative Sciences team, which develops rigorous methodologies to generate sound scientific evidence from real-world data, as well as the commercial services and operations team that manages client deliverables.
Dr. Torres is an Epidemiologist with over ten years of academic and industry experience. Before joining Verana Health, she served as the Director of Quantitative Sciences at Flatiron Health, where her work focused on translating real-world oncology data to generate evidence. While at Flatiron Health, she led efforts related to the development of real-world endpoints, novel study designs and prospective evidence generation while also serving as the Quantitative Sciences lead for the organization’s broader research collaboration with the FDA. She is also currently an Adjunct Professor at Columbia University Graduate School of Arts and Sciences, where she teaches a course on large-scale data processing and analysis.
Dr. Torres earned her PhD in Cancer Epidemiology from Johns Hopkins Bloomberg School of Public Health, an MPH in Chronic Disease Epidemiology from Yale University’s School of Public Health and a BS in Molecular, Cellular and Developmental Biology from Yale University.
Who Should Attend?
This webinar will appeal to senior professionals in pharmaceutical, biotechnology and clinical research organizations, especially those in the following fields:
- Biotech
- Clinical Trials
- Medical Device
- Life Science
- Commercialization & HEOR
- Drug Discovery and Development
- Patient Recruitment & Retention
- Pharma
- Pharmacovigilance
- Clinical Research
- Clinical Development
- Data Science
- Medical Affairs
- Health Economics & Outcomes Research (HEOR)
- Commercialization
What You Will Learn
Attendees will gain insights into:
- The impact high-quality RWD can play when bringing a new therapy to market
- How to evaluate RWD sources, specifically EHR data
- Methods and opportunities for curating unstructured EHR notes data using AI to support new therapies
Xtalks Partner
Verana Health®
Verana Health® is a digital health company revolutionizing patient care and clinical research by utilizing physician expertise and artificial intelligence to unlock the true potential of real-world data. With exclusive access to the world’s largest patient data sources in ophthalmology, urology and neurology, Verana Health is powering real-world evidence generation. Clinicians utilize these insights to improve the quality of care and quality of life for patients, and life sciences companies rely on the insights to accelerate the development of new therapies. For more information, visit www.veranahealth.com.
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