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Project Optimus: Sponsors Register Concerns, Questions

 
• By Derrick Gingery

Meeting requests related to the Oncology Center of Excellence’s new dose optimization approach are increasing, along with sponsor questions, prompting the US FDA to determine how to clarify its intentions.

cancer therapy preparation
Sponsors still have many questions about Project Optimus. • Source: Shutterstock

SAN DIEGO – US Food and Drug Administration officials are finding that demanding dose-finding studies earlier in development is not as easy as it may appear in a policy document.

Key Takeaways

  • OCE’s Angelo De Claro said sponsors are unclear about many aspects of the center’s dose optimization program.

  • Among them is whether a randomized dose-finding...

Angelo De Claro, associate director for global clinical sciences in the FDA Oncology Center of Excellence, said sponsors continue to question the requirements and OCE is considering how best to...

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More from DIA

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule

 
• By Sue Sutter

Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.

CDER, CBER Report More Hiring Gains, But At Slower Rate Than Earlier In Fiscal Year

 
• By Derrick Gingery

Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.

More from Conferences

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.