The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promises. (December 2018)

• Record Type: Journal Article
• Authors: Choudhary, Shambhunath; Walker, Audrey; Funk, Kathleen; Keenan, Charlotte; Khan, Imran; Maratea, Kimberly
• Other Names: Heinz-Taheny Kathleen guest-editor.; Frazier Kendall guest-editor.; Ramaiah Shashi guest-editor.
• Is Part Of: Toxicologic pathology. Volume 46:Number 8(2018)
• Page Start: 1006
• Page End: 1012
• Publication Date: 2018-12
• Subjects: SEND -- SDTM -- nonclinical studies -- drug approval -- FDA; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/0192623318805743
• Languages: English
• ISSNs: 0192-6233

Abstract

The Standard for the Exchange of Nonclinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies that enables the U.S. Food and Drug Administration (FDA) to modernize and streamline the review process. As a result, patients may benefit from speedier approval of new drugs. However, SEND implementation and compliance can be challenging and require effective cooperation between pharmaceutical companies and contract research organizations. In order to improve Society of Toxicologic Pathology (STP) members' awareness about SEND, including the steps, obstacles, and mistakes to avoid in its implementation while applying for FDA approval, the Career Development and Outreach Committee of the STP sponsored a career development lunchtime series panel discussion entitled "The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promise" in conjunction with the STP 37th Annual Symposium. The presentations and discussion at this workshop provided perspectives of experts including pathologists and information technology professionals familiar with the SEND submission process and FDA reviewers. This article is designed to provide brief summaries of their talks as well as the questions asked during this well-received panel discussion.