The Tale of a Real-life SEND Test Submission

What to Expect When Submitting Your First SEND Dataset to the FDA

SEND test submission with Covance. Photo of binary codeWith the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our Covance SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand the FDA’s SEND submission requirements, build experience and confirm our readiness to help clients submit their SEND datasets.

During this process, we uncovered a couple of significant learnings:

  • Allow for adequate time to prepare and submit to the FDA
    • The process to deliver our first test submission took more than two months from kickoff to FDA notification
    • It’s important to start early to understand the preparation time needed for submissions
  • For test submissions only, the dataset must be submitted on a physical CD and sent to the FDA via postal mail
    • This came as a surprise to us, since SEND is a streamlined electronic format of the data
    • (Note: In a real submission, the SEND datasets will appear in a specific location labeled “tabulations” in the submission folder structure as described in section 7 of the FDA CDER/CBER Study Data Technical Conformance Guide).

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Accelerating Candidate Selection: Solutions for Lead Optimization Pharmacology & Toxicology

Lead optimization (LO) is one of the most expensive and time-consuming stages of the drug development process due to the number of programs running simultaneously and the number of molecules within each of those programs. Covance’s Lead Optimization Pharmacology & Toxicology services are designed to help you select the best molecule for candidate selection and further development. Our ability to integrate service lines, such as pharmacology, biomarkers, imaging and safety, and thoughtfully add endpoints to studies, maximizes the number of questions being answered in each study leading to improved probability of technical success. The following video gives an overview of our Lead Optimization Pharmacology & Toxicology services and the benefits of choosing Covance as your LO partner.

“Fail Fast” Using Toxicology Endpoints in Pharmacology Studies

“Fail Fast” Using Toxicology Endpoints in Pharmacology StudiesSuccessful drug development is increasingly dependent on a robust “fail fast” strategy that includes incorporation of safety / toxicology endpoints into lead optimization pharmacology studies. This early marriage of pharmacology and toxicology will provide insight into the margin of safety that is critical for advancing the molecule, the design of the GLP studies and the clinical plan. Biopharmaceutical companies that employ a “fail fast” strategy can make safety decisions from the integration of toxicology into pharmacology studies, which markedly reduces lead optimization cycle times and overall spend during this phase. Continue reading