DIA/FDA Biostatistics Industry and Regulator Forum

Co-sponsored with the FDA!

The DIA/FDA Biostatistics Industry and Regulator Forum is focused on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360-degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.

Now in its thirteenth year, the forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs, biologics, and combination products. This unique forum advances the dialogue between industry, regulatory agencies, and academia.

Preconference Short Courses

• Short Course 1: New Adaptive Design Guidance | 8:30AM-12:00PM
• Short Course 2: Data Monitoring | 8:30AM-12:00PM

On-Demand Complimentary Webinar

Structured Exploration of Clinical Trial Data
Gain an overview of a structured approach for safely applying these more advanced methods, discuss their application in practice, and explore how they can be used to guide scientific research.

Professionals involved in:

• Biostatistics
• Pharmaceutical Development
• Clinical Pharmacology
• Health Economy
• Epidemiology
• Regulatory
• Academia
• Government
  

• Describe the challenges and opportunities in applying CID and the role of simulation
• Identify the opportunities and challenges arising in patient-focused drug development
• Discuss the role that statisticians play in patient-focused drug development
• Explain how patient preferences and clinical outcome assessments can inform and influence regulatory submissions
• Discuss the unique challenges in the assessment of complex generics from statistical, clinical, and regulatory perspectives
• Identify GDUFA II enhancements for complex generics
• Describe the most common designs using Master Protocols and their utility in solving clinical development challenges
• Identify the operational challenges and considerations in executing Master Protocols
• Discuss the pros, cons, and common mistakes for Master Protocol designs through a panel discussion
• Discuss the estimand challenges and opportunities arising in oncology drug development
• Evaluate the differences among stakeholder views on clinically meaningful estimands
• Apply the estimand framework to the learner’s own clinical investigations
• Describe the collaboration of statistical science with data science in drug development
• Identify what has changed in the role of the statistician
• Describe opportunities for drug development based on advancements in new technologies and data analytics
• Identify common clinical issues that arise when characterizing the safety (and benefit-risk) of a pharmaceutical product
• Apply good statistical practice for safety related topics