RRD International, a strategy-driven biotech and pharmaceutical product development company, announced today that it has entered into a partnership with the National Institutes of Health (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program as a regulatory support and development partner.
The RRD and TRND partnership will focus on two rare disease drug development projects: Hereditary Inclusion Body Myopathy (HIBM), a rare adult-onset neuromuscular disorder and Niemann Pick type C1 Disease (NPC1), a rare neurodegenerative genetic disease.
"We look forward to combining the product development strengths of RRD with the resources of the NIH TRND program to develop important new treatments for these rare diseases," said Charles (Chuck) Finn, Ph.D., President, CEO, and Co-Founder of RRD International.
As a new congressionally mandated program, TRND is designed to advance preclinical and early clinical development of new drugs for rare and neglected diseases. The program also drives forward adoption of new technologies and treatment paradigms which improve product development efficiency for these diseases. TRND has formed numerous collaborations with researchers from academia and industry to work on specific rare or neglected diseases.
"TRND has established partnerships with companies and researchers to identify the most promising molecules that may result in new treatments for rare and neglected diseases," said Christopher P. Austin, M.D., director of the NIH TRND effort. "It is important to note that drug development is not a trivial process and the failure rate for any molecule or compound is high."
The program aims to speed development of new drugs that might otherwise be ignored by industry because they are too early in the development process where the failure rates are high or would not be sufficiently profitable. To make a potential compound attractive to private partners in order to get a treatment to patients, TRND advances a potential compound through the drug development process to the point where it can be tested in people. TRND provides all aspects of preclinical development needed to turn promising compounds into potential medicines ready for clinical evaluation.
"This partnership is another validation of our development philosophy and the success we've achieved with other products," said Scott Tarrant, Chief Business Officer at RRD International. "Work on these rare diseases will demonstrate the flexibility of our asset-centric model and how RRD efficiently drives development while mitigating cost and risk factors which, historically, have served as barriers to new therapies for rare and neglected diseases."
The TRND program will collaborate with academic organizations, foundations, biotechs, and pharmaceutical companies to develop clinical candidate drugs that can be adopted by biopharma for completion of clinical development and FDA approval. In addition to individual drug development projects, TRND is developing technologies and paradigms to reduce the very high risks and cost of drug development. The ultimate goal is to "de-risk" rare and neglected disease drug development by accomplishing lead optimization through an FDA Investigational New Drug (IND) application and, when needed, proof-of-concept in human studies.