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
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
Navigating the complexities of AML drug development
Oct 30, 2024
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Article
New endpoints for early-stage cancer are gaining regulatory traction
Jan 28, 2022
Webinar
Advancing mRNA-based drug development and vaccine manufacturing
Jul 1, 2024
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Blog
Preparing for the New Era of Hybrid Regulatory Inspections
Jul 11, 2022
Article
EU Orphan Drug Designation – overcoming regulatory challenges
Jul 20, 2022
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Blog
What Do the Next 10 Years Hold for CRISPR?
Jul 27, 2022
Blog
U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?
Aug 17, 2022
Related Insights
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
Navigating the complexities of AML drug development
Oct 30, 2024
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Article
New endpoints for early-stage cancer are gaining regulatory traction
Jan 28, 2022
Webinar
Advancing mRNA-based drug development and vaccine manufacturing
Jul 1, 2024
Article
Five strategies for meeting the requirements of Project Optimus and improving the chances of approval
Nov 10, 2022
Blog
Preparing for the New Era of Hybrid Regulatory Inspections
Jul 11, 2022
Article
EU Orphan Drug Designation – overcoming regulatory challenges
Jul 20, 2022
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Blog
What Do the Next 10 Years Hold for CRISPR?
Jul 27, 2022
Blog
U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?
Aug 17, 2022