INCORPORATE ADD CLAUSES - FOLLOW-ON STUDIES - IND-ENABLING GLP TOXICOLOGY

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INCORPORATE ADD CLAUSES - FOLLOW-ON STUDIES - IND-ENABLING GLP TOXICOLOGY The NIH Blueprint Neurotherapeutics Network (BPN) is part of NIH Blueprint for Neuroscience Research, a collaborative framework that includes the NIH Office of the Director together with eleven NIH Institutes and Centers, that support research on the nervous system. The BPN was launched to enable neuroscientists in academia and biotechnology companies to develop new drugs for nervous system disorders. The BPN provides non-dilutive funding for small molecule drug discovery and development, from hit-to-lead chemistry through phase I clinical testing. Through the BPN program, investigators together with the NIH build a team and leverage drug discovery and development experts who can help them advance their basic research into human testing. This is accomplished through a combination of grant funding and access to a full range of NIH-funded drug discovery development CROs (medicinal chemistry, pharmacokinetics/ADME, toxicology, drug manufacturing, drug formulation and phase I clinical trials) and, most importantly, access to NIH funded consultants with extensive pharma experience spanning all drug development stages to help guide the team. A fundamental hallmark of the program is that the research institution retains the intellectual property rights. With a strong track record of success, the BPN program provides an excellent opportunity to translate basic and applied findings into novel clinical candidates and advance them to the clinic. The goal is to generate the required data to de-risk further funding for subsequent clinical trials, partnership, or out-licensing.