DIA 2025 Global Annual Meeting: Full Schedule

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11:00am EDT

#107: From Approval to Access: Integrating Patient Insights into Coverage Decisions

Monday June 16, 2025 11:00am - 12:00pm EDT

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-513-L04-P; CME 1.00; RN 1.00

Despite advances, patient engagement (PE) in post-approval access decisions remains limited, complex, and unclear. This session examines how patients can offer value-based insights and explores pathways to strengthen PE in product access decisions.

Learning Objectives

Identify existing opportunities to incorporate patient input into access determinations; Recognize patient-contributed information and data that could broaden the evidentiary base for CMS and other payers; Discuss the resources and frameworks needed for CMS to systematically and scientifically engage with patient communities.

Chair

June Cha, PhD, MPH

Speaker

Vital Voices from Patients in Access Determination
June Cha, PhD, MPH

Patients Engaging with CMS: Opportunities, challenges, and lessons learned
Kristi Martin, MA, MPA

Patient Perspectives: Are They Missing from Commercial Payer Drug Coverage Policies?
James Chambers, PhD, MPharm, MSc

How Breakthrough T1D has Engaged CMS
Campbell Hutton, MPH

Speakers

June Cha

Policy Director, FasterCures, Milken Institute, United States

June Cha is a policy director at FasterCures, Milken Institute Health. She brings decades of experience in infectious diseases research, non-profit, multilateral, and bilateral organizations, government, and the pharmaceutical industry, where she has focused on US and global health... Read More →

James Chambers

Professor, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, United States

James Chambers is a Professor at Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies. His research focuses on insurance coverage of medical technology and the role of cost-effectiveness in U.S. health care.

Campbell Hutton

Senior Vice President, Global Advocacy, Breakthrough T1D, United States

Campbell Hutton, is Senior Vice President, Global Advocacy at Breakthrough T1D, a non-profit organization whose mission is to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes (T1D) and its complications. In her role she oversees the regulatory affairs... Read More →

Kristi Martin

Director, Camber Collective, United States

Kristi Martin is a seasoned health policy expert with over 20 years of experience in the public sector, private sector, and philanthropy. She is currently a Director at Camber Collective, a strategy consulting firm known for its analytic rigor and human-centered approach. Kristi began... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Patient Experience, Payers
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience,Payers
Tags Session

3:45pm EDT

#141: How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development

Monday June 16, 2025 3:45pm - 4:45pm EDT

202A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-539-L04-P; CME 1.00; RN 1.00

A multi-stakeholder panel will discuss: regulatory pathways and consideration for early engagement with regulators, harmonization efforts to standardize use of PED, present frameworks to support Industry planning, and explore future opportunities.

Learning Objectives

Discuss regulatory pathways for early engagement to streamline PFDD; Examine regulatory considerations and harmonization efforts to standardize the collection and use of Patient Experience Data; Recognize how to evaluate frameworks available to support industry planning of PFDD studies; Describe best practices for ensuring successful patient-focused study planning and regulatory decision-making.

Chair

Pujita Vaidya, MPH

Speaker

FDA Perspective
Valentina Mantua

Patient-Experience Data in Development Programs and Regulatory Decision-Making
Juan Garcia-Burgos, MD, PhD

Patient Representative Perspective and Resources for Advancing PFDD
Silke Schoch, MA

Industry Perspective
Samantha Roberts, PhD

Speakers

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands

Juan García Burgos is a Qualified Medical Doctor specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development... Read More →

Valentina Mantua

Associate Director of Regulatory Science, OND, CDER, FDA, United States

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States

Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →

Silke Schoch

Director, Research & Programs, National Health Council, United States

Silke Schoch is the Director of Research & Programs at the National Health Council. Ms. Schoch joined the National Health Council in 2017 and has been a project manager for many of the NHC’s patient engagement-focused projects including the Patient Experience Mapping Toolbox and... Read More →

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States

Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Regulatory Convergence and Harmonization, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Convergence and Harmonization,Patient Experience
Tags Session

3:45pm EDT

#142: Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience

Monday June 16, 2025 3:45pm - 4:45pm EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-540-L04-P; CME 1.00; RN 1.00

Addressing data gaps in drug development, especially capturing patient experiences in both rare and non-rare diseases, is crucial. From Proof of Concept to Proof of Value, integrated evidence planning and incorporating patient voices in Target Product Profile (TPP) creation drive comprehensive evidence generation.

Learning Objectives

Discuss the utility in global drug development context, including post-marketing efforts; Identify strategies to create a patient informed comprehensive Target Product Profile; Recognize strategies outlined in the interactive guide to align PAG and industry efforts in creating a comprehensive Target Product Profile.

Chair

Agathe Le Lay, PhD, MSc

Speaker

What are we Missing: Potential Data Gaps in Drug Development and the Importance of Capturing Lived Experience in rare and non-rare Diseases
Kristin Hatcher, MEd

From Proof of Concept to Proof of Value: An Industry Approach to Integrated Evidence Planning Throughout the Product Lifecycle
Agathe Le Lay, PhD, MSc

New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Patricia Roselle

New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Bruce E. Miller, PhD

Panelist
Martine Zimmermann, PharmD

Speakers

Kristin Hatcher

Director of Pediatric and Rare Disease/ Alpha One Lived Experience Advocate, Global Liver Institute/Alpha One Patient, United States

Agathe Le Lay

Global Head of Value Evidence & Patient Insights, H. Lundbeck A/S, Denmark

Agathe Le Lay is the Global Head of Value Evidence and Patient Insights at H. Lundbeck A/S, and is responsible for leading a global team responsible for the strategic planning and delivery of scientific evidence supporting R&D assets as well in-line brands. Agathe is an expert in... Read More →

Bruce Miller

Chief Scientific Officer, COPD Foundation, United States

Dr. Miller is the Chief Scientific Officer of the COPD Foundation overseeing its patient-focused research programs. Inclusion of patient partners is a requirement for any research activity the foundation supports. Dr. Miller has been a participant in the Paladin Consortium since its... Read More →

Patricia Roselle

Head of Patient Stakeholder Engagement, Sanofi, United States

Patricia leads a global team of Patient Engagement Leads within the Patient Informed Development & Health Value Translation unit within R&D at Sanofi, using patient insights to drive a patient disease strategy and to guide Research & Development decision making. Ultimately, we aim... Read More →

Martine Zimmermann

Senior Vice President, Head of Global Regulatory Affairs, Ipsen , France

Dr Zimmermann joined Ipsen in January 2023 as SVP, Head of Regulatory & Quality R&D, based in France and since January 2024, SVP, Head of Global Regulatory Affairs. . She has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Rare Disease, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Patient Experience
Tags Session

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