Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

Why Should You Attend:

Drug development has a poor track record, with only about 1 in 10 clinical development candidates making it to approval, and with 50% of drugs in Phase 3 trials testing no different from placebo. At the same time, acceptability of regulatory submissions demands improvement, with a recent dramatic increase in NDA filings rejected without review on grounds of insufficient quality. Over the past decade, the FDA has worked with the pharmaceutical and biotech industries to devise a way to improve both the quality of regulatory new drug submissions as well as the success rate of drug development. One outcome of this collaboration is the FDA Guidance on End-of-Phase 2A meetings.

This webinar will describe how drug developers can use the FDA end-of-phase 2A meeting to facilitate development through better decisions and regulatory acceleration while improving compliance with FDA Guidelines and expectations.

Learning Objectives:

• Understand FDA expectations regarding the meeting and how to comply with the guidance
• Understand how the meeting can help optimize usage of a new drug and lead to better understanding of its limitations
• Understand how the meeting can lead to better development decisions and facilitate regulatory approval

Areas Covered in the Webinar:

• Background and history of the guidance
• Why Was the Guidance Developed
• What Is Included in the EoP2 Meeting
• How Is the EoP2 Meeting Accomplished
• Pilot Program
• Draft Guidance and Comments
• Final Guidance and Impact
• Scope and content of a successful meeting
• Current State of Knowledge of Drug in Disease State
• Efficacy/Safety Pharmacology
• Toxicology
• Pharmacokinetics/Pharmacodynamics
• Modeling and Simulation Status
• Impact of Knowledge on Design of Subsequent Clinical Trials
• Dose Selection, Dose-ranging and Placebo/Active/Comparator Issues
• Novel Clinical Trial Designs and Disease-state Considerations
• Patient Selection, Drug Interactions, and Special Populations
• How to design development activities to comply with the intent of the guidance
• Prior to IND Submission
• Early Clinical Program
• Cross-program Modeling
• Simulating Post-meeting Study Designs
• Advantages of Participating in an EoP2 Meeting
• Collaboration and Knowledge-sharing with FDA
• Early Regulatory Input to Design of Clinical Trials
• Potential for Facilitated Regulatory Review
• Improved Quality of Knowledge Submitted for Regulatory Review

Who Will Benefit:

• Drug Development scientists and managers
• Regulatory Affairs experts
• Technical writers
• Compliance specialists
• Clinical trial specialists

Instructor Profile:

Roger D. Toothaker, is the founder of PKPD Strategies, LLC, a New Jersey-based consulting organization dedicated to improving the quality and successfulness of drug development and regulatory submission activities. Mr. Toothaker has over 30 years of nonclinical and clinical drug development experience with both small molecules and biologics across all major therapeutic indications, and has held positions in industrial, contract, and academic settings. He received his PhD in Pharmaceutics from the University of Wisconsin, and is a member of AAPS, ASCPT, and AAAS.

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