Preclinical Drug Development Consulting

The road from positive efficacy findings to filing for IND (Investigational New Drug) application is arduous, time-consuming, and costly. Many early-stage drug-discovery teams, particularly at small organizations and in academic programs, have insufficient experience on how to best travel this road, so as to get to IND as fast as possible, with the least expenditure, and with a compound that is most likely to be successful. Such teams can benefit tremendously from the advice of a drug-development consultant.

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Why Drug Development Consultants Are Needed

The technological changes in preclinical drug development that began in the late 1990s have dramatically changed the path to IND, and these changes are continuing, especially with regard to new FDA advisories about drug-drug interactions and safety testing of drug metabolites.

Apredica's expertise is in moving drug-discovery programs from the point of efficacy to the point of initiating the GLP studies required for regulatory filings.

Our experience has been that many drug-discovery teams are unintentionally misguided by the directions provided by investors because those directions are based on the milestones required for achieving a positive return on investment and not on the milestones required for making a drug-development program successful. On the surface these milestones would seem to be just different markers on the same path, but these differences in how the path is marked cause substantively different paths to be taken from one milestone to the next. For example, because first-in-human studies are such an important investment milestone, drug-development teams tend to be at risk of conducting such studies prematurely, encountering failures that could have easily and inexpensively been avoided through more-thorough preclinical research.

Our Preclinical Drug Development Consultant

Our preclinical consulting service is provided by Apredica's Chief Scientific Officer and President, Katya Tsaioun, Ph.D. Dr. Tsaioun is a worldwide recognized authority on preclinical testing and ADME Tox, and is a frequent speaker at pharmaceutical industry conferences. Prior to founding Apredica, she lead drug discovery and development teams at GPC Biotech, Surface Logix, and NitroMed.

Contact us to discuss how Apredica's preclinical consulting services can help you eliminate time, cost, and risk on your journey to IND.