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DIA 2023 GAM Keynote!

DIAmond Sessions represent rare opportunities for deeper connection with regulatory leadership through insightful dialogue. Join us in Boston, MA to help illuminate pathways and processes toward the interconnected future of global health.

DIA 2023 DIAmond Sessions will allow for deeper discussions into critical themes from the keynote plenary session. Expect thought-provoking conversations around some of the major themes of DIA 2023, including an exploration of diversity, AI and innovation— from cutting-edge technologies to novel approaches to research and development.

  • Monday, June 26 | 10:45 - 11:45AM


    Navigating the Constellation of Efforts to Increase Representation in Clinical Research

Generative technologies such as ChatGPT and other large language models are driving the future of health. Applications such as communication with patients, adverse events and early drug failure prediction, and integration of data from diverse sources are all within sight and are currently impacting the way we work today and our thinking about the future. However, there are issues of trust, transparency, bias, and ethical challenges to finding appropriate expertise and resources, and other considerations that will make adoption difficult. This session will examine the current and future state of large language processing and will be followed by a solution room that will examine what is needed for the future.

Session Chair and Speakers

Resin Miller-Alexis

Alexis Miller

Executive Director, Global Regulatory Policy (US Lead), Merck

Karen Hicks

Karen Hicks

Deputy Director, Office of Medical Policy, CDER, FDA

Alysha Croker

Alysha Croker

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada

Gelise Thomas

Gelise Thomas

Assistant Director, Strategic DEI and Health Disparities, Case Western University

Sandra Kweder

Sandra Kweder

Principal, Drug and Biological Products, Greenleaf Health

Roberta Albany

Roberta Albany

Patient Advocate, Cancer In The Know

View Session Details

  • Tuesday, June 27 | 8:30 - 9:30AM


    Full Exposure: Artificial Intelligence to Advance, Replace, and Add Efficiency for Patient Benefit

    Generative technologies such as ChatGPT and other large language models are driving the future of health. Applications such as communication with patients, adverse events and early drug failure prediction, and integration of data from diverse sources are all within sight and are currently impacting the way we work today and our thinking about the future. However, there are issues of trust, transparency, bias, and ethical challenges to finding appropriate expertise and resources, and other considerations that will make adoption difficult. This session will examine the current and future state of large language processing and will be followed by a solution room that will examine what is needed for the future.

Session Chair and Speakers

Alison Cave

Alison Cave

Chief Safety Officer, The Medicines and Healthcare products Regulatory Agency MHRA

Hoifung Poon

Hoifung Poon

General Manager, Health Futures, Microsoft

Stephen Hahn

Stephen Hahn

CEO-Partner, Flagship Pioneering; Chief Executive Officer, Harbinger Health

Johan Ordish

Johan Ordish

Head of Digital Health and Innovation Policy, Roche, United Kingdom

Stacy Hurt

Stacy Hurt, MBA, MHA

Patient Advocacy Ambassador, Parexel

Nancy Dreyer

Nancy-Dreyer

Chief Scientific Officer Emerita, RW Strategies, IQVIA; President, Dreyer Strategies LLC

View Session Details

  • Wednesday, June 28 | 8:30 - 9:30AM


    A Case Study for Illumined Therapeutic Development: Shining the Light on ALS

    The range of treatment modalities now available is promising for patients but frameworks to guide prioritization of development are lacking. Considerations before developing a new approach include benefit/risk, patient preferences, manufacturing, technology and data use, and payment and access. This session will examine these issues through the lens of a case example and include discussion of clinical applications and clinical reality, patient perspectives, regulatory considerations, and current and future clinical development pipeline (s).

Session Chair and Speakers

Peter Sorger

Peter Sorger

Head of Therapeutic Science, Harvard Medical School

Mark Albers

Mark Albers, MD, PhD

Assistant Professor of Neurology, Harvard Medical School
Frank Wilkens Jr and Family Endowed Scholar, Department of Neurology, Massachusetts General Hospital

James Berry

James Berry, MD

Assistant Professor of Neurology, Massachusetts General Hospital
Co-director of the MGH Neuromuscular Division and ALS Unit, Massachusetts General Hospital

Nazem-Atassi

Nazem Atassi

Vice President, Global Head of Early NeuroDevelopment, Sanofi

Lagier-Tourenne

Clotilde Lagier-Tourenne

Associate Professor, Neurology, Harvard Medical School; Associate, Neuroscience, Massachusetts General Hospital

Metha Lahar

Lahar-Mehta

Head, Global Clinical Development, Amylyx Pharmaceuticals

Stacy

Stacy Rudnicki

Vice President, Clinical Research, TA Lead, Neuromuscular Disease, Cytokinetics

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