Regulatory and Toxicology Requirements for Submitting an IND: Focus on Small Biotechnology Companies and Limited Resources
The objective of this PDDI Symposium is to instruct Principal Investigators from academia and small biotech as to the necessary components and endpoints for IND-enabling studies. Small businesses seek support for their research from the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant program. Phase II SBIR and STTR grants take existing, promising compounds through the various steps of drug discovery and development. The expectation is that a promising New Molecular or Biologic Entity (NME or NBE), or entities, will have been identified as potential pharmacological treatment agents and that the entities will have gone through sufficient preclinical testing to justify their continued development. The endpoint of the SBIR funding is the completion of the work needed for compliance with the U.S. Food and Drug Administration’s requirements for an investigational new drug (IND). This includes all the work necessary to begin the process for translation into clinical trials [e.g., safety pharmacology, large-scale production carried out under Good Manufacturing Practices (GMP), toxicology testing, formulation and analytical methods development, and a clinical evaluation protocol].
Those attending this PDDI Symposium will be better prepared to complete the IND-enabling studies that are an integral part of Phase II SBIR grant applications.
Please access the Agenda for the Symposium HERE