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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Appendix A

Workshop Agenda

Innovation in Drug Research and Development for Prevalent Chronic Diseases—A Three-Part Virtual Workshop

February 22, March 1, and March 8, 2021

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

Part One: February 22, 2021
Opportunities in Discovery and Preclinical Research for
Prevalent Chronic Diseases
11:00 am–3:00 pm ET

11:00 am Welcome and Opening Remarks
CARLOS GARNER, Workshop Co-Chair

Vice President, Global Regulatory Affairs

Eli Lilly and Company

ANANTHA SHEKHAR, Workshop Co-Chair

Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine

University of Pittsburgh

SESSION I OVERVIEW OF R&D FOR PREVALENT CHRONIC DISEASES

Session Objectives:

  • Discuss the unique cross-cutting challenges facing preclinical research for prevalent chronic diseases; and
  • Highlight opportunities to overcome those challenges and mobilize the R&D innovation engine.

___________________

1 For more information, see https://www.nationalacademies.org/our-work/innovation-in-drug-research-and-development-for-prevalent-chronic-diseases-a-workshop (accessed October 29, 2021).

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
11:10 am A Patient’s Perspective on Mobilizing the R&D Innovation Engine

RUSS PAULSEN

Chief Operating Officer

UsAgainstAlzheimer’s

SESSION II FUNDING AND INVESTMENT DECISION MAKING IN DISCOVERY RESEARCH

Session Objectives:

  • Examine common causes of failures in discovery research for prevalent chronic diseases and how failures could be avoided or “go/no-go” decisions could be accelerated in the future;
  • Discuss whether investment and cultural incentives are in alignment for spurring the type of R&D that will address unmet need when it comes to prevalent chronic diseases; and
  • Consider the factors that determine which research areas key decision makers (e.g., investors, sponsors, researchers) decide to move forward.
11:25 am Response and Overview

SUSAN SCHAEFFER, Moderator

President and Chief Executive Officer

Patients’ Academy for Research Advocacy

11:35 am Funder Perspective

JASON MELLAD

Chief Executive Officer and Founder

Start Codon

11:50 am Public–Private Partnership Investor Perspective

JOSEPH MENETSKI

Associate Vice President of Research Partnerships

Foundation for the National Institutes of Health

12:05 pm Moderated Panel Discussion and Audience Q&A
12:30 pm BREAK (30 minutes)
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

SESSION III BIOSPECIMEN COLLECTION AND REGISTRY USE IN DISCOVERY RESEARCH

Session Objectives:

  • Consider lessons learned from other disease areas that could have cross-cutting applications for prevalent chronic diseases; and
  • Discuss the availability or need for high-quality biospecimen repositories and datasets that represent the patient populations most impacted by prevalent chronic diseases.
1:05 pm Introduction and Overview

HOWARD B. ROSEN, Moderator

Managing Director, BonVelo Ventures

Lecturer, Stanford University

1:10 pm Academic Perspective

ERICA WOODAHL

Professor, Department of Biomedical and Pharmaceutical Sciences

University of Montana

SESSION IV NEW TECHNOLOGIES ENABLING DISCOVERY RESEARCH

Session Objectives:

  • Discuss the unique cross-cutting challenges in preclinical research for prevalent chronic diseases and consider how new technologies could help researchers overcome these challenges; and
  • Consider lessons learned from other disease areas for which new technologies have been a key driver of progress.
1:25 pm Academic Discovery Science–Technology Perspective

JOHN NGAI

Director

BRAIN Initiative, National Institutes of Health

1:40 pm Artificial Intelligence for Discovery Science

ANDREW A. RADIN

Chief Executive Officer

twoXAR Pharmaceuticals

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
1:55 pm Regulator Perspective

QI LIU

Senior Science Advisor, Office of Clinical Pharmacology & Translational Sciences

U.S. Food and Drug Administration

2:10 pm Moderated Panel Discussion and Audience Q&A
2:50 pm Closing Remarks

CARLOS GARNER, Workshop Co-Chair

Vice President, Global Regulatory Affairs

Eli Lilly and Company

ANANTHA SHEKHAR, Workshop Co-Chair

Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine

University of Pittsburgh

3:00 pm ADJOURN

Part Two: March 1, 2021
Opportunities in Clinical Research for Prevalent Chronic Diseases
11:00 am–3:00 pm ET

11:00 am Welcome and Opening Remarks

CARLOS GARNER, Workshop Co-Chair

Vice President, Global Regulatory Affairs

Eli Lilly and Company

ANANTHA SHEKHAR, Workshop Co-Chair

Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine

University of Pittsburgh

SESSION I OVERVIEW OF R&D FOR PREVALENT CHRONIC DISEASES

Session Objectives:

  • Discuss the unique cross-cutting challenges facing clinical research for prevalent chronic diseases; and
  • Highlight opportunities to overcome those challenges and mobilize the R&D innovation engine.
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
11:10 am A Patient’s Journey

CHRISTIN VEASLEY

Co-Founder and Director

Chronic Pain Research Alliance

11:25 am Mobilizing the R&D Innovation Engine

CHRONIS MANOLIS

Senior Vice President of Pharmacy

University of Pittsburgh Medical Center Health Plan

SESSION II INVESTMENT AND FUNDING DECISIONS IN CLINICAL RESEARCH

Session Objectives:

  • Discuss whether investment and cultural incentives are in alignment for spurring the type of R&D that will address unmet need when it comes to prevalent chronic diseases; and
  • Consider the factors that determine which clinical programs key decision makers (e.g., investors, sponsors, and researchers) decide to move forward.
11:35 am Economics Perspective

KIRSTEN AXELSEN

Visiting Fellow

American Enterprise Institute

11:50 am A Payer’s Perspective: Pricing and Health Economic Drivers That Incentivize Development Investments

KEN EHLERT

Chief Scientific Officer

UnitedHealth Group

12:05 pm Moderated Panel Discussion and Audience Q&A
12:25 pm BREAK (30 minutes)

SESSION III INNOVATIVE APPROACHES TO EFFICIENT CLINICAL DEVELOPMENT

Session Objectives:

  • Discuss the unique cross-cutting challenges in clinical trials for prevalent chronic diseases (e.g., are the regulatory requirements predictable?);
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
  • Brainstorm and prioritize potential strategies to decrease costs and risks for development (i.e., highlight innovative ways to design clinical trials); and
  • Discuss ways to meaningfully engage communities and patients in clinical trials.
1:00 pm Introduction and Overview

BETTINA DRAKE, Moderator

Professor, Washington School of Medicine

Associate Director of Community Outreach and Engagement

Alvin J. Siteman Cancer Center

1:05 pm Community Health Researcher Perspective

KAREN WINKFIELD

Executive Director

Meharry-Vanderbilt Alliance

1:15 pm Industry (Regulatory Lead) Perspective

MICHELLE ROHRER

Senior Vice President, Global Head of Product Development Regulatory & Policy

Roche

1:30 pm Regulatory Perspective

JAMES P. SMITH

Deputy Director, Division of Clinical Policy, Office of New Drugs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

SESSION IV NEW TECHNOLOGIES ENABLING INNOVATIVE CLINICAL RESEARCH

Session Objectives:

  • Discuss the unique cross-cutting challenges in clinical research for prevalent chronic diseases and consider how new technologies could help researchers overcome these challenges; and
  • Consider lessons learned from other disease areas where new technologies have been a key driver of progress.
1:50 pm Biotech Perspective

GRACE COLóN

Chief Executive Officer

InCarda Therapeutics

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
2:05 pm Regulatory Perspective

ELIZABETH KUNKOSKI

Clinical Methodology Team, Office of Medical Policy

U.S. Food and Drug Administration

2:20 pm Moderated Panel Discussion and Audience Q&A
2:50 pm Closing Remarks

CARLOS GARNER, Workshop Co-Chair

Vice President, Global Regulatory Affairs

Eli Lilly and Company

ANANTHA SHEKHAR, Workshop Co-Chair

Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine

University of Pittsburgh

3:00 pm ADJOURN

Part Three: March 8, 2021
Case Studies in Prevalent Chronic Disease Research
11:00 am–3:00 pm ET

11:00 am Welcome and Opening Remarks

CARLOS GARNER, Workshop Co-Chair

Vice President, Global Regulatory Affairs

Eli Lilly and Company

ANANTHA SHEKHAR, Workshop Co-Chair

Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine

University of Pittsburgh

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

SESSION I CASE STUDIES ACROSS THE R&D LIFE CYCLE: MOBILIZING COMMUNITIES AND RESOURCES, ANALYZING PAST SUCCESS

Session Objectives:

  • Consider lessons learned in research across the R&D life cycle in several disease areas that could have cross-cutting applications for many prevalent chronic diseases.
    • Discuss how research and patient communities have been mobilized to address discovering treatments for some example diseases, and how those approaches led to success.
    • Discuss examples of successful development for prevalent chronic disease treatments and what aspects of those approaches led to success.
  • Discuss potential strategies to spur drug R&D innovation for prevalent chronic diseases.
11:10 am Introduction and Overview

GRACE COLÓN, Moderator

Chief Executive Officer

InCarda Therapeutics

11:20 am Success Story from Cystic Fibrosis

ROBERT K. COUGHLIN

Managing Director, Life Sciences, JLL

Former President and Chief Executive Officer, MassBio

11:35 am Digital Innovation for Treating Prevalent Chronic Diseases

RAOLAT ABDULAI

Global Clinical Lead, Immunology & Inflammation

Sanofi

11:50 am Investing in One Treatment, Applying to Multiple Diseases

ROBERT HEINE

Distinguished Eli Lilly Scholar

Eli Lilly and Company

12:05 pm Moderated Panel Discussion and Audience Q&A
Discussion Questions:
  • How can patient advocacy affect drug research and development?
  • What can we learn from these examples about psychiatric disorders, cardiology, or other prevalent chronic diseases?
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
 
  • How might success be replicated, and what might the investment look like for other prevalent chronic disease areas?
  • What options exist for trials examining multiple indications?
  • How might these successes be replicated or apply in the future, and what might the investment look like for other prevalent chronic disease areas?
  • How have digital advancements changed approaches to developing treatments for prevalent chronic diseases, and how might they affect development in the future?
12:45 pm BREAK (30 minutes)

SESSION II RECAP AND POTENTIAL FUTURE STRATEGIES

Session Objectives:

  • Reflect on approaches and potential strategies to spur drug R&D innovation for prevalent chronic diseases; and
  • Brainstorm potential strategies to spur drug R&D innovation for prevalent chronic diseases (i.e., highlight promising avenues forward that merit additional time, effort, funding, or attention).
1:15 pm Summary Presentations by Session Moderators (10 minutes each)

GRACE COLÓN

Chief Executive Officer

InCarda Therapeutics

BETTINA DRAKE

Professor, Washington School of Medicine

Associate Director of Community Outreach and Engagement

Alvin J. Siteman Cancer Center

HOWARD B. ROSEN

Managing Director, BonVelo Ventures

Lecturer, Stanford University

SUSAN SCHAEFFER

President and Chief Executive Officer

Patients’ Academy for Research Advocacy

Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
1:55 pm Moderated Panel Discussion and Audience Q&A
Discussion Questions:
  • Are there common characteristics of disease areas routinely more affected than others by either discovery and preclinical- or clinical-stage research barriers?
  • What cross-cutting strategies could enable investment?
  • How might overall risk for stakeholders innovating in prevalent chronic disease treatments be lowered, with an eye toward integrating policy with stimulus?
2:50 pm Closing Remarks

CARLOS GARNER, Workshop Co-Chair

Vice President, Global Regulatory Affairs

Eli Lilly and Company

ANANTHA SHEKHAR, Workshop Co-Chair

Senior Vice Chancellor for Health Sciences and Dean of the School of Medicine

University of Pittsburgh

3:00 pm ADJOURN
Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×

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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
×
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Suggested Citation:"Appendix A: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2021. Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26291.
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Next: Appendix B: Biographical Sketches of Workshop Speakers »
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Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic disease. As a result, prevalent chronic diseases are producing immense health care costs as well as preventable suffering and death. On February 22, March 2, and March 8, 2021, the National Academies of Sciences, Engineering, and Medicine, convened a workshop to discuss barriers to innovation in this space and examine strategies and incentives to support equitable, person-centered drug R&D for prevalent chronic diseases.

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