Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report

Roslyn B. Mannon, Randall E. Morris, Michael Abecassis, David Axelrod, Shukal Bala, Gary S. Friedman, Peter S. Heeger, Krista L. Lentine, Alexandre Loupy, Barbara Murphy, Peter Nickerson, Minnie Sarwal, Inish O'Doherty, Nicole Spear, Stephen R. Karpen

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1495-1502
Number of pages8
JournalAmerican Journal of Transplantation
Issue number6
StatePublished - Jun 1 2020


  • biomarker
  • clinical trial design
  • immunosuppressant
  • kidney transplantation/ nephrology
  • off-label drug use
  • translational research/science

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)


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