The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement

Mark D. Stegall, Kenneth Troy Somerville, Matthew J. Everly, Roslyn B. Mannon, A. Osama Gaber, M. Roy First, Neetu Agashivala, Vanessa Perez, Kenneth A. Newell, Randall E. Morris, Debra Sudan, Klaus Romero, Sonya Eremenco, Maria Mattera, Nicole Spear, Amy C. Porter, Inish O'Doherty

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

The Transplant Therapeutics Consortium (TTC) is a public-private partnership between the US Food and Drug Administration and the transplantation community including the transplantation societies and members of the biopharmaceutical industry. The TTC was formed to accelerate the process of developing new medical products for transplant patients. The initial goals of this collaboration are the following: (a) To define which aspects of the kidney transplant drug-development process have clear needs for improvement from an industry and regulatory perspective; (b) to define which of the unmet needs in the process could be positively impacted through the development of specific drug-development tools based on available data; and (c) to determine the most appropriate pathway to achieve regulatory acceptance of the proposed process-accelerating tools. The TTC has identified 2 major areas of emphasis: new biomarkers or endpoints for determining the efficacy of new therapies and new tools to assess the safety or tolerability of new therapies. This article presents the rationale and planned approach to develop new tools to assess safety and tolerability of therapies for transplant patients. We also discuss how similar efforts might support the continued development of patient-reported outcome measures in the future.

Original languageEnglish (US)
Pages (from-to)625-632
Number of pages8
JournalAmerican Journal of Transplantation
Volume19
Issue number3
DOIs
StatePublished - Mar 2019

Keywords

  • clinical trial design
  • editorial/personal viewpoint
  • immunosuppressive regimens
  • kidney transplantation/nephrology
  • mathematical model
  • organ transplantation in general
  • quality of life (QoL)
  • side effects
  • translational research/science

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)

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    Stegall, M. D., Troy Somerville, K., Everly, M. J., Mannon, R. B., Gaber, A. O., First, M. R., Agashivala, N., Perez, V., Newell, K. A., Morris, R. E., Sudan, D., Romero, K., Eremenco, S., Mattera, M., Spear, N., Porter, A. C., & O'Doherty, I. (2019). The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement. American Journal of Transplantation, 19(3), 625-632. https://doi.org/10.1111/ajt.15214