Overview

April 28: Virtual Summit

This revamped one-day virtual event will present case studies and lessons learned from oncology and neuroscience, followed by roundtable discussions on master protocols, complex innovative designs (CIDs), and external data borrowing to assess bottlenecks and create solutions. Key findings, recommendations, and prioritized next steps will be published to drive continued collaboration.

Engage in vibrant group discussions with experts involved in clinical development, including biostatisticians, clinical researchers, technology experts, and regulators, and immerse yourself in cutting-edge insights—all from the comfort of your own space.

Registered attendees will have access to session recordings for two months post-summit! Stay flexible and catch up anytime. Can't attend live? Register anyway to access the recordings!

To view the key agenda highlights, click here.

Featured

Want to learn more about Clinical Innovation and Biostatistics Summit? You've come to the right site!

Who should attend?

Summit Designed for
- Academics
- Biostatisticians
- Clinical Development, Research, and Operations Professionals
- Clinical Safety & Pharmacovigilance
- Data & Data Standards
- Good Clinical Practice
- Nonprofit and Federal Government Representatives
- Patient Engagement
- Preclinical & Early Phase Research
- Project Management
- Quality Assurance & CMC
- Rare & Orphan Diseases
- Regulators
- Research & Development
- Statistics and Data Science
- Strategic Planning
- Technology
- Value & Access
- Other Vendors

Learning objectives

At the completion of this conference, the participant should be able to:
- Understand recent regulatory developments and guidance from the FDA impacting the design and conduct of clinical trials, including key takeaways from newly released documents and initiatives
- Describe the principles and potential benefits of innovative clinical trial designs, including master protocols and seamless phase 2/3 trials, and evaluate their application from an industry perspective
- Identify practical challenges and considerations in conceptualizing and implementing advanced trial designs across different therapeutic areas
- Analyze real-world case studies demonstrating successful use of master protocols and innovative approaches in oncology trials, with a focus on overcoming operational and regulatory hurdles
- Apply insights from regulatory updates and case studies to inform strategic decisions and improve the efficiency and quality of clinical research programs

Program Committee

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

Digital Learning Catalog

Download

Have an account?

Clinical Innovation and Biostatistics Summit

Overview

Featured

Exhibits

Highlights & Features