Highlights & Features
What is happening at the Clinical Innovation and Biostatistics Summit
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- Opening Remarks – Senior leaders from DIA, Pfizer, and the FDA set the stage for discussions on regulatory and scientific advancements in clinical trial design
- Regulatory Updates and FDA Initiatives – Overview of the FDA’s new Clinical Trial Innovation Initiative (C3TI), guidance on adaptive clinical trials (ICH E20), and insights on benefit-risk assessments for new drug and biological products
- Innovative Clinical Trial Designs – Exploration of Master Protocols and seamless phase 2/3 designs to improve efficiency in clinical trials, with industry perspectives on implementation challenges
- Case Studies on Novel Trial Approaches: (1) Master Protocols in Oncology – Practical examples of how these designs improve trial execution. (2) Innovative Neuroscience Trials – Cutting-edge approaches to trial design in neurological disorders
- Challenges and Opportunities in Master Protocols – Focus on platform and basket trials, regulatory perspectives, and discussions on external data borrowing
- Implementation of Innovative Designs – Panel discussion on real-world challenges and best practices for applying innovative trial methodologies
- Play a key role in creating a path towards effective, cross-disciplinary collaborations that drive innovative approaches to clinical trial design and execution
- Engage in thought-provoking discussions that bridge the gap between statistical and clinical perspectives
- Be at the forefront of the most recent academic, regulatory, and industry insights
- Take deep dives into real-world applications, focusing on cutting-edge methodologies in diverse therapeutic areas
- Gain a deeper understanding of new regulatory initiatives and guidances on clinical trial innovations, adaptive clinical trials, and benefit-risk assessments of new drugs and biological products
- Explore cutting-edge approaches, lessons learned, and innovative solutions
- Connect with experts, peers, and industry leaders to expand your professional network and open doors to collaboration and future opportunities
Session Alignment for 2025!
Session 1: Regulatory Updates and Experiences
The FDA has played a major role in guiding and collaborating with researchers to promote the efficient and safe development of drugs. This session focuses on regulatory updates, including a new FDA’s initiative and two recently published FDA guidance documents for industry on the design and conduct of clinical trials.
Session 2: Clinical Trial Innovative Designs and Approaches – Setting the Context and Presenting the Industry Perspective on Conceptualization and Implementation Challenges
Innovation in clinical trials is an ongoing goal with a desired outcome of improving efficiency when investigating new therapies while maintaining the necessary scientific rigor for acceptance in clinical use as well as regulatory approval. Two general areas of innovation are the use of Master Protocols and seamless trial designs. This session will include one session discussing the use of Master Protocols to obtain trial efficiency and a second session discussing recent design innovations to facilitate efficient learning through seamless phase 2/3 and enrichment designs. The session will conclude with audience questions and discussion.
Session 3: Case Study Introduction of Subsequent Discussions
This session will showcase two compelling case studies highlighting innovative approaches to clinical trial design and execution. Each case study provides a deep dive into real-world applications, focusing on the challenges, solutions, and outcomes of cutting-edge methodologies in diverse therapeutic areas.
Case Study 1: Master Protocol Implementation in Oncology
Master protocol case studies in oncology will be discussed. A practical example of effective master protocol design and execution will be presented. Regulatory opinions on implementation and evaluation will also be discussed.
Case Study 2: Innovative Design in Neuroscience Trials
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