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Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)

1.0 RAC Credits Member: $0 NonMember: $25
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)

This is an On-demand recording from April 2022.


This webcast will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development. The historical 3x3 Phase 1 study design to establish a Maximum Tolerated Dose (MTD) was developed for cytotoxic agents (eg, platins). Now, most new agents are immunotherapies and other biologics for which a more standard dose-finding Phase 1 study is more appropriate; however, the “standard” 3x3 design to establish MTD is still being used. Project Optimus is intended to address this discrepancy and drive more appropriate dose selection for new, and existing, oncology agents. We’ll discuss the immediate implications on Phase 1 dosing and design, as well as the potential implications for products already into Phase 2 and 3 of development, including modeling and simulation. 

The presentation will be for 60 minutes followed by an optional 15-30 minute Demo/Q&A with the sponsor.


Registration Fees & Deadlines

Free 

 

Learning Objectives

Participants will: 

  • What is FDA’s Project Optimus
  • When and how Project Optimus is being applied to oncology products
  • Implications for Phase 1 study designs
  • Implications for oncology development programs, including those already into Phase 2 or 3

 

Who Should Attend?

Industry personnel involved in the following roles: 

  • Regulatory Affairs
  • Medical/Regulatory Writing
  • Clinical Operations
  • Medical
  • Project Managers
  • Clinical Pharmacology
  • DMPK

 

Instructors:

Claire Dyer

Claire Dyer
Certara Insight

Dr. Dyer is a director of submissions and medical writer with experience in multidisciplinary clinical, academic, and corporate environments. She has 20 years of experience in clinical development, including 15 years in medical writing and experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND) and Clinical Trial Authorisation (CTA) applications. Dr. Dyer has led submission teams, including project management, writing submission level documents as well as training and mentoring of junior writers. Her experience in therapeutic areas include cardiovascular, central nervous system (CNS), dermatology, endocrinology, gastroenterology, immunology, oncology, pain management, urology, and vaccines.

Steve Sibley

Steve Sibley
Certara Synchrogenix

With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles.

He has successfully supported projects from drug discovery through approval and life cycle management. These include significant roles in more than 75 submissions and, in several cases, leading the entire submission team and overseeing all documentation from Modules 1 through 5. Mr. Sibley drives the expansion of the company’s submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.  

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.  

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop. 

 

Questions

Contact the RAPS Support Center: 

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org   

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