Journal article
Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report
American journal of transplantation, Vol.20(6), pp.1495-1502
06/01/2020
DOI: 10.1111/ajt.15833
PMID: 32090461
Abstract
On September 27-28, 2018 the Food and Drug Administration (FDA) and the Critical Path Institute's Transplant Therapeutics Consortium convened a public workshop titled "Evidence-Based Treatment Decisions in Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment." The workshop facilitated cooperative engagement of transplant community stakeholders, including pharmaceutical industry, academic researchers, clinicians, patients, and regulators to discuss methods to advance the development of novel immunosuppressive drugs for use in solid organ transplantation. Day 1 focused on the utility of biomarkers in drug development(,)with considerations for seeking regulatory endorsement for use in clinical trials. Biomarkers add value to drug development by improving patient selection criteria, safety monitoring, endpoint selection, and more. Regulatory endorsement through the FDA Biomarker Qualification Program encourages the use of biomarkers in drug development by instilling confidence and consistency in biomarker interpretation across trials. Public-private partnerships or consortia allow stakeholders to share expertise, resources, and data in pursuit of biomarker qualification. Biomarkers relevant to pretransplant risk assessment, early posttransplant care, and assessment of immune response, immunosuppressive drug efficacy, and graft function as discussed on day 1 of the workshop are described.
Details
- Title: Subtitle
- Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report
- Creators
- Roslyn B. Mannon - University of Alabama at BirminghamRandall E. Morris - Stanford UniversityMichael Abecassis - Northwestern MedicineDavid Axelrod - University of IowaShukal Bala - United States Food and Drug AdministrationGary S. Friedman - Pfizer (United States)Peter S. Heeger - Icahn School of Medicine at Mount SinaiKrista L. Lentine - Saint Louis UniversityAlexandre Loupy - Hôpital Necker-Enfants MaladesBarbara Murphy - Icahn School of Medicine at Mount SinaiPeter Nickerson - University of ManitobaMinnie Sarwal - University of California, San FranciscoInish O'Doherty - Crit Path Inst, Tucson, AZ USANicole Spear - Critical Path InstituteStephen R. Karpen - Critical Path Institute
- Resource Type
- Journal article
- Publication Details
- American journal of transplantation, Vol.20(6), pp.1495-1502
- DOI
- 10.1111/ajt.15833
- PMID
- 32090461
- NLM abbreviation
- Am J Transplant
- ISSN
- 1600-6135
- eISSN
- 1600-6143
- Publisher
- Wiley
- Number of pages
- 8
- Language
- English
- Date published
- 06/01/2020
- Academic Unit
- Surgery
- Record Identifier
- 9984322935602771
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