Recent advances in biology offer unprecedented opportunities to discover new treatments for nervous system disorders. Biotherapeutic development, however, has inherent complexities with regards to characterization, manufacturing, delivery, and administration. Many academic laboratories and small business enterprises don’t have the full scope of expertise and resources needed to translate and guide their therapeutics into the clinic. For instance, all therapeutic candidates including biologics, must obtain the requisite toxicology and safety pharmacology data package and undergo regulatory review by the Food and Drug Administration (FDA). If the researchers cannot successfully navigate or overcome these hurdles, they may ultimately have difficulty attracting venture capital investment or pharmaceutical industry interest.
Building upon the success of BPN for small molecules, the NIH Blueprint for Neuroscience Research established the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics), which includes the spectrum of biologics:
- biotechnology products and biologics-based therapies (e.g., peptides, proteins)
- gene-based therapies (e.g., oligonucleotide and viral based)
- cell therapies, and
- other novel emerging therapies (e.g., microbial and microbiome therapies)
BPN-Biologics provides non-dilutive funding and resources for biotherapeutic drug discovery and development, from lead optimization through phase I clinical testing. We offer grant funding for work that you intend to do yourself and in-kind access to NIH-funded contract research organizations (CROs) for activities that you prefer to outsource and consultants with expertise in various aspects of drug discovery and development. You decide which combination of funding, CROs, and consultants will best fit your drug development needs. In addition, your institution is assigned the intellectual property rights to therapeutic agents discovered and developed within the program.