Optimizing Development Programs for Regulatory Approvals

Optimizing Development Programs for Regulatory Approvals: The Importance of Phase II

Re-thinking why trials fail and how to balance an optimal trial design with FDA prospective, Dr. Lee Simon is talking about a holistic approach to trial design and regulatory approval to maximize the changes of access while accelerating drug development.

Join our live webinar – Optimizing Development Programs for Regulatory Approvals: The Importance of Phase II presented by Dr. Lee Simon, IAG’s Member of Scientific Advisory board and world-class scientist, with vast experience in taking new drugs through all stages of the development.

Key discussions points:

  • Limitations of RCTs and why they fail?
  • Regulatory pathways in the EU and USA
  • Innovation in trial design vs FDA perspective

The session will begin with the presentation, followed by a live Q&A to give the audience the opportunity to gain insight into their own development programs.

Date: 5th May 2020

Time: 12 pm EST / 5 pm GMT

Register here !

About the Webinar:

This webinar is organized by IAG, Image Analysis Group, a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. www.ia-grp.com

Dr. Lee Simon is a rheumatologist, physician and research scientist with extensive drug development experience. He served as a director of FDA division for of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products and currently advises many biotech and pharma companies on designing impactful clinical programs.

Questions or need help registering, please email <eden.chrifi-alaoui @ ia-grp.com>