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Monday, June 16
 

3:45pm EDT

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Intermediate

This session will focus on assessing the effectiveness of current regulatory collaboration efforts and identifying how those principles can be applied to chronic disease areas outside of oncology, such as metabolic disease and obesity.

Learning Objectives

Describe the impact of global regulatory collaboration on patient outcomes; Discuss risks associated with chronic disease and its impact on society as a whole; Identify innovative ways to address chronic disease through regulatory innovation and collaboration.

Chair

Brad Jordan, PhD

Speaker

Project ORBIS and ACCESS Experience
Melissa Hunt, MSc

Applying Learnings from Project ORBIS
R. Angelo De Claro, MD

Considerations for Regulatory Collaboration in Chronic Disease
John Sharretts

Industry Perspective
Kevin Bugin, PhD, MS, RAC


Speakers
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
avatar for Melissa Hunt

Melissa Hunt

Director, Health Canada, Canada
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada... Read More →
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
JS

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States
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
  09: Regulatory, Session
 
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    00: Plenary
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    01: ClinSafety-PV
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    02: ClinTrials-Ops
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    10: RegCMC-Product Quality
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    11: Statistics-Data Science
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    13: Spotlight
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    14: DIAmond
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    15: Content-Hubs
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    16: Community-Rounds
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    17: Posters
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    18: InnovationTheaters
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    20: Short-Courses
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    Tutorial
  • Level
    Advanced
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    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
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EH
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