MD Biosciences Blog

Case study: 25 Preclinical CAIA studies, 18 months, 1 Out-licensed Compound

Posted by MD Biosciences

on Mar 7, 2011 2:14:00 PM

preclinical CRO, contract research, MD Biosciences

With the number of blockbuster drugs approaching patent expiration and pharma companies struggling to maintain pipeline and portfolios with in-house programs, companies are increasingly turning to licensing, aquisitions and partnerships. Early-stage licensing deals tend to carry more risk for pharma companies in-licensing. To offset this risk, additional data may be required from the pharma partner to confirm any internal research performed by the biotech/out-licensing company.

Mini-case study. MD Biosciences helps a medium-sized biotech company to develop Rheumatoid Arthritis drug for out-licensing in under two years.

A medium-sized biotech company approached us with a compound that showed some efficacy in rheumatoid arthritis (RA) with a business goal of out-licensing the potential drug within two years. In order to push this compound through in approximately 18 months, a strategic and precisely timed development program needed to be established. MD Biosciences was able to present the sponsor with a program that entailed 25 preclinical studies over the course of 18 months. This was made possible by modifying models such as the rapid 10-day Collagen Antibody-induced arthritis (CAIA) model. Each study was customized specifically to address the appropriate questions, building from one study to the next. 

The outcome was a successful preclinical program in which 25 carefully designed studies were executed with rapid turn-around times and quality, consistent results. This is critical to allow data comparison over the course of the development period. After 18 months, the compound was developed to an appropriate stage and the company succeeded in out-licensing in a multi-billion dollar deal, indicating this development program as central to the success.

About MD Biosciences

MD Biosciences approaches every preclinical study with the end result in mind. Careful study design is critical to deliver data that will inform about next steps. Often standard models don't address the questions properly and through either minor customizations or a custom developed model, a sponsor can be have access to data that is more informative. If you would like to speak with a scientist on a specific study design, please contact us.

Collagen antibody induced arthritis, CRO, contract research organization, preclinical

Topics: CRO/outsourcing