Cytel

OCTOBER 27, 2023

Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. With consensus of multiple stakeholders on “why” the change is needed, the speakers focused on “how.”

Clinical Trials 64

Clinical Trials Trials Clinical Pharmacology Clinical Development 64

Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read or listen now. Watch the video. Listen here.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.

FDA 40

FDA Science Clinical Trials Trials 40