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.
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