Research and Drug Development

The information and resources in this section can help you navigate in the Research and Drug Development area to identify issues classified for:
Disease models,
Disease/Translational resources,
Drug Discovery,
Clinical Development,

  1. Showing 9 results for:
  2. Research and Drug Development
All Subjects

Discovering New Therapeutics Uses for Existing Molecules (NTU) program, National Center for Advancing Translational Sciences (NCATS)

Published by IRDiRC

Orphan DrugDrug RepurposingNCATSResearch and Drug DiscoveryNTU-NCATSFunding

The NTU program aims to improve the process of developing new treatments for diseases by finding new uses for existing therapies that already have cleared several key steps along the development path. Existing or partially developed therapeutic candidates can be repurposed for use in new disease indications

View this resource Bookmark this resource

FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Regulatory AffairsClinical DevelopmentClinical Trial DesignRegulatory AdviceSpecial Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

View this resource Bookmark this resource

Clinical Research Networks

Published by IRDiRC

Research and Drug DevelopmentClinical DevelopmentNIHCRNClinical Trial ReadinessRare Disease Clinical Research NetworkCinical Trial Design

The RDCRN is made up of multiple individual, Rare Disease Clinical Research Consortium (RDCRC) and a Data Management and Coordinating Center (DMCC). The RDCRCs are intended to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness

View this resource Bookmark this resource

Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

Published by Nature Reviews Neurology

Biomarker DiscoveryResearch and Drug Development Disease or Translational Resource BiomarkerPain Therapeutic BiomarkerChronic PainBiomarker ValidationRegulatory Issue

This article outlined the NIH initiative, Helping to End Addiction Long-term (HEAL). A trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to provide guidance on biomarker discovery and rigorous validation to accelerate high-quality clinical research into neurotherapeutics and pain.

View this resource Bookmark this resource

Preclinical biomarker qualification

Published by the Society for Experimental Biology and Medicine

Research and Drug DevelopmentBiomarkerDrug Development ToolQualification BiomarkerRegulatory QualificationPreclinical

An overview of the biomarker qualification process that provides information on current evidentiary considerations. It also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process

View this resource Bookmark this resource

FDA Qualification process – Drug Development Tools

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and Research

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

View this resource Bookmark this resource

Regenerative Medicine Advanced Therapy (RMAT) Designation

Published by IRDiRC

Regulatory AffairsEarly Access SupportAdvanced TherapyRegenerative Medicine Advanced Therapy Designation

The RMAT Designation is analogous to the Breakthrough Designation designed for traditional drug candidates but applies to regenerative medicine treatments, and allows companies to interact with the FDA more frequently during the clinical development of the therapy. An RMAT-designated therapy is eligible for priority review and accelerated approval.

View this resource Bookmark this resource