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Bethesdan Hotel

Apr 28, 2025 7:00 AM - Apr 29, 2025 5:00 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Biostatistics and Clinical Innovation Industry and Regulator Forum

Gain access to novel, thought-provoking findings and collaborate with experts on charting the best path forward in biostatistics and clinical trial innovation.

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Overview

April 28-29: Forum

Join us in charting the best path forward in cross-disciplinary collaborations that drive innovative approaches to clinical trial design and execution. A unique forum of experts involved in clinical development, including biostatisticians, clinical researchers, technology experts, and regulators, will discuss cross-disciplinary team science, regulatory guidance updates, and lessons learned from case studies of innovative clinical trial designs to set the stage for a multi-stakeholder dialogue that resolves barriers to progress and facilitates transformative change.

The revamped 2025 forum will:
Present case studies and lessons learned from oncology and neuroscience; Provide subsequent roundtable discussions on master protocols, complex innovative designs (CIDs), and external data burrowing to assess bottlenecks and create solutions; Lead to the publication of each roundtable’s findings and recommendations and concrete next steps towards continued collaborative work.

The forum is designed for professionals involved in medical product development, including biostatisticians, physicians, clinical researchers and clinical operations professionals, regulators, technology experts from the pharmaceutical and biotechnology industry, academics, representatives from nonprofits and the federal government, contract research organizations, and other vendors.

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Exhibits

Highlights & Features

Who should attend?

  • Conference Designed for

    • Biostatistics
    • Clinical Development, Research, and/or Operations
    • Clinical Safety & Pharmacovigilance
    • Data & Data Standards
    • Good Clinical Practice
    • Patient Engagement
    • Preclinical & Early Phase Research
    • Project Management
    • Quality Assurance & CMC
    • Rare & Orphan Diseases
    • Regulatory
    • Research & Development
    • Statistics and Data Science
    • Strategic Planning
    • Technology
    • Value & Access

    Program Committee

    • Michelle  Detry, PhD
      Michelle Detry, PhD Director, Adaptive Trial Execution & Senior Statistical Scientist
      Berry Consultants LLC, United States
    • Satrajit  Roychoudhury, PhD
      Satrajit Roychoudhury, PhD Executive Director, Statistical Research and Innovation
      Pfizer, Inc., United States
    • Yun  Wang, PhD
      Yun Wang, PhD Deputy Division Director
      FDA, United States
    • Yunfan  Deng, PhD
      Yunfan Deng, PhD Senior Mathematical Statistician
      FDA, United States
    • Jessica  Kim, PhD
      Jessica Kim, PhD Supervisory Mathematical Statistician
      FDA, United States
    • Shiowjen  Lee, PhD
      Shiowjen Lee, PhD Deputy Director, Division of Biostatistics, OBPV, CBER
      FDA, United States
    • Munish  Mehra, PhD, MS, MSc
      Munish Mehra, PhD, MS, MSc Managing Director and Sr. Principal Biostatistician
      Quantum Biopharma, United States
    • Tobias  Muetze
      Tobias Muetze Associate Director, Statistical Methodology
      Novartis, Switzerland
    • Pabak  Mukhopadhyay, PhD
      Pabak Mukhopadhyay, PhD Executive Director, Late Statistics, Head of Breast Cancer Strategy
      AstraZeneca, United States
    • Ping  Li
      Ping Li Statistical Analyst, CDER
      FDA, United States
    • Lisa  Rodriguez, PhD
      Lisa Rodriguez, PhD Deputy Division Director, OB, OTS, CDER
      FDA, United States
    • Joshua  Sampson, PhD
      Joshua Sampson, PhD Senior Science Advisor
      FDA, United States
    • Jennifer  Schumi
      Jennifer Schumi Director, Statistical Innovation
      Amgen, United States
    • Pritibha  Singh, MBA, MSc
      Pritibha Singh, MBA, MSc Senior Manager, Corporate Affairs Analytics & Insights
      Novartis AG, Switzerland
    • Li  Wang, PhD
      Li Wang, PhD Senior Director, Head of Statistical Innovation
      AbbVie , United States
    • Peiling  Yang, PhD
      Peiling Yang, PhD Supervisory Mathematical Statistician
      FDA, United States

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