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Monday, June 16
 

11:00am EDT

From Approval to Access: Integrating Patient Insights into Coverage Decisions
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Intermediate

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

Speaker
Kristi Martin, MA, MPA

Speaker
James D. Chambers, PhD, MPharm, MSc

Panelist
Campbell Hutton, MPH


Speakers
JC

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 →
avatar for James Chambers

James Chambers

Associate Professor, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, United States
James D. Chambers, PhD, MPharm, MSc, is an Associate Professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. His research interests include examining the factors that influence how insurance companies cover and reimburse medical technology... Read More →
CH

Campbell Hutton

Senior Vice President, Global Advocacy, Breakthrough T1D, United States
Campbell Hutton, MSPH, is Senior Director, Regulatory Affairs and is responsible for JDRF’s interactions with regulatory agencies, including the U.S. Food and Drug Administration. In this capacity, she oversees the regulatory affairs team to develop and implement JDRF’s overall... Read More →
KM

Kristi Martin

Director, Camber Collective, United States
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

3:45pm EDT

Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

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

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
avatar for Kristin Hatcher

Kristin Hatcher

Director of Pediatric and Rare Disease/ Alpha One Lived Experience Advocate, Global Liver Institute/Alpha One Patient, United States
avatar for Agathe Le Lay

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 →
BM

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 →
avatar for Patricia Roselle

Patricia Roselle

Head of Patient Stakeholder Engagement, Sanofi, United States
avatar for Martine Zimmermann

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

3:45pm EDT

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
TBD
Component Type: Session
Level: Intermediate

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

Patient Representative Perspective and Resources for Advancing PFDD
Silke Schoch

Industry Perspective
Samantha Roberts, PhD


Speakers
avatar for Samantha Roberts

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 →
SS

Silke Schoch

Director, Research & Programs, National Health Council, United States
avatar for Pujita Vaidya

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
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session
 
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    Advanced Analytics
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TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming