12
October

03:00 PM BST

Moving Beyond The MTD : FDA Project Optimus Impact on European Drug Development

What to expect

Overview of Discussion

In the rapidly evolving world of clinical oncology drug development, therapies are becoming safer, patients are living longer, but dose optimization is becoming harder. The FDA’s shift towards early phase dose optimization is fundamentally changing how clinical trial programs are designed, managed, and run. This shift requires more time, more patients, and more costs for sponsors who are looking to further develop their asset. European drug developers must be cognizant of these new regulatory requirements to preserve opportunities for global commercialization.
This boardroom will help you:
-Understand FDA Oncology Center of Excellence Special Projects
-Manage the FDA’s new Project Optimus requirements from a medical, scientific, and operational perspective
-Plan a strategy to evaluate the efficacy of a wider range of doses in your early development programs

Agenda

-What it is and what are the goals
-FDA expectations
-Medical, scientific, and operational support

Meet the Facilitators

The virtual boardroom will be lead by our expert Facilitator

Matt Cooper, PhD

Executive Director, Therapeutic Strategy Lead, Oncology Worldwide Clinical Trials

Matthew Confeld

Assistant Director, Clinical Research Methodology Worldwide Clinical Trials

More about Worldwide Clinical Trials

More information

At Worldwide, we believe a personalized approach is the only way to unlock the power of everyone working on a study – from operational and therapeutic experts to site partners and scientists. That means you’ll always have direct access to our experts. You’ll be able to tap into more than 30 years of therapeutic experience on a global scale. And your mission is our mission – we are dedicated to working with you to meet your goals.

Further Information

Interested in attending this virtual roundtable or running your own? Drop us a message today and we will get in touchrn

Here To Help

Want to know more? Interested in sponsoring the event? Need help registering your team? Just get in touch and a member of the team will be happy to help.

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Worldwide Clinical Trials Virtual Boardroom – 12th October 2023

Moving Beyond The MTD : FDA Project Optimus Impact on European Drug Development

Overview of Discussion

Agenda

21st Century Cures Act and Oncology Center of Excellence (OCE)

Recent FDA OCE Projects

Focused discussion regarding Project Optimus

Meet the Facilitators

Matt Cooper, PhD

Matthew Confeld

More about Worldwide Clinical Trials

Further Information

Here To Help

Select days you wish to attend You can add multiple days

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Select days you wish to attend You can add multiple days

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VAT Excluded

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