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

Publication ,  Journal Article
Stegall, MD; Troy Somerville, K; Everly, MJ; Mannon, RB; Gaber, AO; First, MR; Agashivala, N; Perez, V; Newell, KA; Morris, RE; Sudan, D ...
Published in: Am J Transplant
March 2019

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.

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Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

March 2019

Volume

19

Issue

3

Start / End Page

625 / 632

Location

United States

Related Subject Headings

  • Transplant Recipients
  • Surgery
  • Societies, Medical
  • Risk Assessment
  • Prognosis
  • Patient Safety
  • Organ Transplantation
  • Maximum Tolerated Dose
  • Immunosuppressive Agents
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Stegall, M. D., Troy Somerville, K., Everly, M. J., Mannon, R. B., Gaber, A. O., First, M. R., … 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. Am J Transplant, 19(3), 625–632. https://doi.org/10.1111/ajt.15214
Stegall, Mark D., Kenneth Troy Somerville, Matthew J. Everly, Roslyn B. Mannon, A Osama Gaber, M Roy First, Neetu Agashivala, et al. “The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement.Am J Transplant 19, no. 3 (March 2019): 625–32. https://doi.org/10.1111/ajt.15214.
Stegall MD, Troy Somerville K, Everly MJ, Mannon RB, Gaber AO, First MR, Agashivala N, Perez V, Newell KA, Morris RE, Sudan D, Romero K, Eremenco S, Mattera M, Spear N, Porter AC, O’Doherty I. The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement. Am J Transplant. 2019 Mar;19(3):625–632.
Journal cover image

Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

March 2019

Volume

19

Issue

3

Start / End Page

625 / 632

Location

United States

Related Subject Headings

  • Transplant Recipients
  • Surgery
  • Societies, Medical
  • Risk Assessment
  • Prognosis
  • Patient Safety
  • Organ Transplantation
  • Maximum Tolerated Dose
  • Immunosuppressive Agents
  • Humans