BIONEWS RWE WEBINAR SERIES PART 2

Research + Expert Discussion

The Future of RWE

Refining the RWE framework through community collaboration

Virtual Event 2 of 2  

June 23, 2026
1:00 PM ET
60-minute webinar + Q&A

You’ll benefit most if you are:

This session is designed for pharma brand teams, medical affairs leaders, RWE and outcomes research professionals, insights and analytics teams, and agency strategy leads working in rare disease or specialty therapeutics. It is especially relevant for teams evaluating how community-sourced data and AI can augment or extend their current evidence strategies.

Event Summary

The evidence landscape is shifting in ways that most 2024-era RWE programs were not designed to capture. Patient communities are generating structured, continuous signals about treatment experience, trust, and unmet needs. AI is making it possible to detect patterns in that data at a scale and speed that traditional study designs cannot match. And emerging models for patient participation in research are rewriting the rules of who contributes evidence, how, and on what terms.

Panelists will discuss what a new RWE framework could look like as advances in data analytics, community-driven insights, and evolving regulatory expectations become more integrated into current models. The conversation will also focus on the practical steps needed to get there, including building the right infrastructure, partnerships, and approaches to support the next generation of RWE.

Panelists

Marcella Debidda

President, Patient Insights & Clinical Solutions
More
Rachel Smith Headshot

Rachel Smith

VP, Rare and Genetic Disease 

More
Rachel Smith Headshot

Jennifer Goldsack

CEO, Digital Medicine Society

More
A smiling young man with short dark hair and a light beard, wearing a maroon crewneck sweater and a thin gold chain necklace, standing in front of a bright yellow wall with large white text that reads "UNTIL IT'S DONE".

Tré LaRosa

Associate Project Manager, FNIH

More
A smiling young man with short dark hair and a light beard, wearing a maroon crewneck sweater and a thin gold chain necklace, standing in front of a bright yellow wall with large white text that reads "UNTIL IT'S DONE".

Megan Freed

Senior Director, Data & Health Technology Integration, PPMD

More
A black and white, close-up portrait of a smiling man with a light complexion. He has wavy, salt-and-pepper hair, short facial stubble, and is wearing clear-rimmed glasses. He is dressed in a dark button-down shirt, and the background is solid black.

Craig Lipset

Advisor, educator, and advocate

More
Marcella Debidda

Marcella Debidda

President, Patient Insights & Clinical Solutions

Dr. Marcella Debidda, PhD is a healthcare innovation leader with over 15 years of experience advancing research and care strategies shaped by the lived experience of patients and caregivers across organizations including Harvard Clinical Research Institute, Science 37, monARC Bionetworks, and Stanford Medicine X.

At Bionews, she leads the Clinical and the Patient Insights divisions, where she examines how rare disease patients find and act on health information, and how that behavior shapes robust data collection. She is widely recognized for developing scalable approaches to incorporate patient and caregiver expertise into research design, clinical development, and policy decision-making.

Dr. Debidda has led initiatives in patient-powered trial design, recruitment strategies, and sustainable community development across more than 50 conditions, integrating behavioral science and qualitative research to define what effective, trust-based rare disease engagement looks like for modern drug development.

Craig Lipset

Craig Lipset

Clinical Research Innovation Leader

Craig Lipset, MPH is a clinical research innovation leader with over 25 years of experience advancing decentralized trial strategies and medicine development across organizations including Pfizer, TransCelerate BioPharma, and the Decentralized Trials & Research Alliance (DTRA).

At Clinical Innovation Partners, he leads corporate and growth strategy, examining how digital health technologies and patient-centric approaches can optimize research design and scale clinical operations. He is widely recognized for developing industry-first initiatives to integrate patient engagement directly into the research process, including launching the first fully remote clinical trial and pioneering the return of data to research participants.

Lipset has led initiatives in patient-powered research design, decentralized trial adoption, and virtual care platforms across healthcare and life sciences sectors, integrating health informatics and digital solutions to define what innovative, accessible clinical research looks like for modern drug development.

Tré LaRosa

Tré LaRosa

Associate Project Manager, FNIH

Tré LaRosa is a scientific project manager, writer, patient activist, and public speaker with over seven years of research experience across basic, translational, and clinical labs. Throughout a decade of active advocacy, they have served on multiple clinical and scientific committees, including roles at the Foundation for the National Institutes of Health and Deloitte.

As the first patient advocate selected for the Cystic Fibrosis Foundation’s Clinical Research Executive Committee (CREC) , they collaborate with senior clinicians to review and score proposed clinical trial protocols. They have also served as a Research Lead , guiding the research design and methodology for patient-reported outcome assessments.

An accomplished science communicator, Tré has written over 300 pieces for professional columns, blogs, and newsletters, including work for Bionews, ndd Medical Technologies, and NeuLine Health. Their writing spans lay, medical, and scientific audiences , translating complex topics like pulmonary and neurological diseases, research theory, and patient-facing issues.

Megan Freed

Megan Freed

Senior Director, Data & Health Technology Integration, PPMD

Megan Freed is a public health data and engagement strategist with over twenty years of combined experience in network development, communications planning, and marketing for nonprofit organizations, health foundations, and clinical institutions.

At Parent Project Muscular Dystrophy, she serves as Senior Director, Data & Health Technology Integration, leading efforts that harness the power of Real World Data and digital technology to improve patient-centered research in the rare disease space. In her leadership role, she oversees the program execution of the Dystrophinopathy Clinical Research Network (DCRN), driving operational efficiencies, strengthening consortia partnerships, and deep-committing to impactful data sharing for Duchenne and Becker research.

Megan has led impactful data and communications initiatives across major healthcare and community frameworks, collaborating with organizations such as the Duke University School of Nursing’s Health Innovation Lab, Baylor College of Medicine, and the Dorothea Dix Park Conservancy. Leveraging her deep subject-matter expertise across health innovation and social policy , she actively shapes public health strategy, helps mission-driven leaders launch innovative digital products , and ensures that complex data frameworks translate into meaningful solutions that keep patient communities at the center of modern research.

Rachel Smith

Rachel Smith

Vice President, Rare and Genetic Disease, Parexel

Rachel Smith is a rare disease drug development executive and patient-focused leader with over 15 years of experience optimizing, innovating, and driving transformational change in clinical development strategies across organizations including GlaxoSmithKline, Veristat, and The Clinical Trial Company.

At Parexel, she serves as Vice President of Rare and Genetic Disease, leading global initiatives to push the limits of traditional evidence generation and build reimagined regulatory, statistical, and operational strategies. She is widely recognized for her expertise in cell, gene, and oligonucleotide therapies, championing novel solutions that keep patients at the center of modern drug development.

Rachel has led impactful initiatives across major international advocacy frameworks, collaborating with organizations like Global Genes, the EveryLife Foundation for Rare Diseases, and the UK Platform for Nucleic Acid Therapies (UPNAT). As a member of the EURORDIS European Regional Task Force, she actively shapes healthcare policy across the UK, Europe, and the USA, driving the development of the European Blueprint for Rare Diseases to ensure the real-world needs of the rare disease community are reflected in both policy and clinical practice.

Jennifer Goldsack

Jennifer Goldsack

CEO, Digital Medicine Society (DiMe)

Jennifer Goldsack is a healthcare innovation leader with seven years of experience as the founding CEO of the Digital Medicine Society (DiMe), advancing the safe and equitable integration of digital technologies into clinical practice. She is widely recognized for developing global standards for digital clinical measures, regulatory science, and the ethical implementation of digital health tools.

Jennifer serves on the Executive Committee of the National Committee on Vital and Health Statistics (NCVHS), advising on national health data policy and information strategy. Her work spans collaborations with pharmaceutical innovators, technology developers, and regulatory bodies to bridge the gap between clinical research and digital health adoption.

She holds a Master’s in the History and Sociology of Science, Technology and Medicine from the University of Pennsylvania and an MChem from the University of Oxford, where she also competed in Varsity Rowing and Rugby. By integrating rigorous science with policy leadership, Jennifer drives an evidence-based, patient-centric future for the digital era of medicine.

Four Themes

Trust as the new variable

Data from the Rare Trust Index shows how patient trust in AI, pharma, and research institutions is shifting. Trust is moving from a soft engagement metric to a hard evidence variable, heavily impacting future study design and clinical trial recruitment strategies.

Patient participation in research

Patient involvement is evolving beyond traditional enrollment. New frameworks emphasize patient contributed data, patient led research design, and compensation models that treat lived experience as a core, measurable research asset.

AI as infrastructure

Moving past the hype, AI serves as the infrastructure layer for next generation RWE. From natural language processing of patient narratives to automated community signal detection, AI is actively changing what counts as evidence and how fast it can be generated.

Real-time clinical trials

Traditional trial protocols break without continuous community data, AI powered monitoring, and active participants. Next generation designs leverage real time signal detection and synthetic control arms, showing exactly where community sourced data fits in.

Why Attend

See proprietary data

on how rare disease communities are already generating structured evidence signals

Understand

how AI is creating new categories of real-world evidence from patient community data

Learn why

trust is emerging as a measurable variable in evidence generation and study design

Hear diverse perspectives

on where RWE infrastructure investment should go next

Get a first look at findings from the Rare Trust Index exploring patient attitudes toward AI in research