TBD

Scientific Review Officer

Reporting Avenues for Concerns Related to Integrity or Fairness

The Advancing Therapeutics (ZRG1 MCST (81)) study section reviews applications that promote new therapeutic strategies for addressing non-cancer related diseases and extend foundational work by evaluating therapeutic efficacy and preclinical safety/toxicity in animal models and in pilot clinical trials. The major emphasis of this study section is to advance preclinical development of therapeutic strategies that exhibit potential for translation to the clinic. Studies include, but are not limited to, therapeutics for infectious diseases.

Review Dates

Topics


  • Late-stage diversification and optimization of lead compounds for therapeutic efficacy
  • Advanced preclinical drug toxicity and pharmacokinetic/pharmacodynamic studies in animal models
  • Development of therapeutic strategies and rational combinations of existing drugs with novel agents
  • Evaluation of gene- and drug-delivery strategies, including formulation development of new drugs and reformulation or combinations of existing drugs
  • Early-stage clinical trials of novel therapeutic and drug-delivery strategies involving pharmacokinetic, pharmacodynamic, toxicologic, or pharmacogenomic endpoints
  • Development and application of mathematical and computational methods for the investigation of therapeutic strategies

Shared Interests and Overlaps:

There are shared interests in drug development with Drug Discovery and Molecular Pharmacology A, B (DMPA, DMPB) and DCAI (81).  Applications that emphasize late-stage drug development efforts are reviewed in MCST (81). Applications that emphasize early-stage drug development, such as discovery of novel agents and characterization of mechanism of action are reviewed in DMPA and DCAI (81) (for infectious diseases) or DMPB (for all other diseases, excluding cancer).

There are shared interests in drug delivery nanomaterials with Innovations in Nanosystems and Nanotechnology (INN).  Applications that emphasize nanomaterial efficacy, safety, or toxicity in animal models or pilot clinical trials are reviewed in MCST (81). Applications that emphasize the design, synthesis, and development of nanomaterials are reviewed in INN.

There are shared interests in gene and drug-delivery strategies with Drug and Biologic Therapeutic Delivery (DBTD). Applications that emphasize treatment efficacy, safety, or toxicity in animal models or pilot clinical trials are reviewed in MCST (81). Applications that emphasize foundational technological advancements or are focused on bioengineering principles are reviewed in DBTD.

There are shared interests in nucleic acid-based therapeutics with BBBT (81).  Applications that emphasize efficacy, safety, or toxicity in animal models or pilot clinical trials are reviewed in MCST (81). Applications that emphasize fundamental design, delivery, and targeting of nucleic acid therapies are reviewed in BBBT (81).

There are shared interests in drug disposition and safety with Drug and Biologic Disposition and Toxicity (DBDT).  Applications that emphasize therapeutic efficacy or focus on the development of therapeutic strategies as the endpoint are reviewed in MCST (81). Applications that focus on the disposition and toxicity of drugs, including mechanistic pathways involved in drug toxicity, are reviewed in DBDT.