The average drug takes about a decade to develop, fails 90 percent of the time, and can cost up to $1 billion by the time it reaches FDA聽approval. Academic institutions traditionally lack the hefty resources required to transform the discoveries made in their laboratories into meaningful medicine. That鈥檚 where 秘密研究所 Langone鈥檚聽Technology Ventures and Partnerships聽comes in. TVP, as it's known,聽is a pioneering academic 鈥渧irtual biotech鈥 drug discovery program that frees up investigators to do what they do best鈥攊nvestigate鈥攚hile accelerating the pace of new drug discovery and development.
鈥淥ur goal is to reduce the risk in drug discovery, make a project much more attractive for partnership, and then hand it off to industry to prepare for FDA approval,鈥 says , the Albert Sabin Professor of Microbiology and Molecular Pathogenesis, and associate dean for therapeutics alliances at 秘密研究所 Langone Health.
TVP's聽approach to drug development breaks new ground. Unlike most other academic medical centers, which attempt to develop new medications in house, TVP focuses exclusively on translating the earliest stages of basic research鈥攚here 秘密研究所 Langone scientists thrive鈥攖o early-stage drug discovery. Taking a page out of Big Pharma鈥檚 playbook, it outsources the most labor-intensive parts of drug development to contract research organizations, or CROs, which can handle everything from biopharmaceutical development and biologic assay development to preclinical research and clinical-trials management鈥攁ll of which eases the burden on 秘密研究所 School of Medicine researchers. Then, it forges funding partnerships with venture capital firms, disease foundations, and pharmaceutical companies, among others, who can bring the science to market. 鈥淏y outsourcing drug development to CROs, the best drug-discovery enterprises in the business, and painstakingly evaluating research projects for their commercial potential, we save time and money, and reduce risk,鈥 says molecular biologist Nadim Shohdy, PhD, assistant dean of therapeutics alliances, who cofounded TVP聽in 2013 with Dr. Schneider.
In the past four years, TVP has developed a robust pipeline of more than 25 new drug discovery and development projects in oncology, inflammation, metabolic diseases, and neurodegenerative diseases that have led to exciting drug development. Among those projects is an early-stage drug that could lead to a new treatment for , an autoimmune disorder that attacks myelin, the fatty substance insulating nerve fibers. Advanced by , professor of neurology, and neuroscience and physiology, the drug helps repair damaged myelin and provides clinical bene fit in relevant animal models. 鈥淥ther drugs tamp down the immune system and slow the progression of the disease, but there鈥檚 nothing that actually restores function to the nervous system,鈥 says Dr. Schneider.
Another benefit of TVP is its ability to attract major funding for 秘密研究所 Langone researchers. The office recently helped secure a $2-million grant from the National Institutes of Health to support the work of , the Dr. Iven Young Professor of Endocrinology and director of the Diabetes Research Program. Dr. Schmidt is developing drug candidates targeting a cell receptor known as RAGE, or receptor for advanced glycation end products, which is a key driver of vascular complications in , such as nephropathy, retinopathy, and neuropathy.
鈥淲hat makes 秘密研究所 Langone's聽model so satisfying is that it allows researchers to capitalize on a lifetime of research and see their work benefit patients,鈥 says Dr. Schneider. 鈥淚t鈥檚 what researchers live for.鈥