Q&A Project Optimus: What you need to know
The study designs and dose-finding strategies that have dominated decades of oncology drug development are becoming obsolete as the FDA’s Project Optimus takes full effect. We rounded up our regulatory experts and asked them to share their perspectives on 28 of the top questions from sponsors.
Related Insights
Blog
Navigating the path to conditional approval: avoiding pitfalls in oncology drug applications
Feb 4, 2025
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Webinar
Advancing mRNA-based drug development and vaccine manufacturing
Jul 1, 2024
Webinar
Navigating the complexities of AML drug development
Oct 30, 2024
Webinar
Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)
Nov 12, 2024
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Jun 4, 2024
Webinar
Accelerating delivery of radiopharmaceutical trials
Oct 3, 2025
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Blog
A hybrid model supports globally diverse site participation for a retrospective cancer study
Jul 24, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Whitepaper
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Related Insights
Blog
Navigating the path to conditional approval: avoiding pitfalls in oncology drug applications
Feb 4, 2025
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Webinar
Advancing mRNA-based drug development and vaccine manufacturing
Jul 1, 2024
Webinar
Navigating the complexities of AML drug development
Oct 30, 2024
Webinar
Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)
Nov 12, 2024
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Jun 4, 2024
Webinar
Accelerating delivery of radiopharmaceutical trials
Oct 3, 2025
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Blog
A hybrid model supports globally diverse site participation for a retrospective cancer study
Jul 24, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Whitepaper
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023