Whether you are a venture capital firm looking at placing several small bets on high-risk start-ups, or a later stage asset management or private equity investor considering providing the larger funding required in the later stages of clinical development, two factors are inescapable - drug development is always expensive, and the failure rate will always be high. 

While proprietary technologies that satisfy unmet medical needs and market demand are the driving forces of successful biotech launches, investors need to look beyond IP protection, documentation, and a strong business plan to manage risk and understand the value of an opportunity.  

Scientific due diligence - based on robust evaluation and analysis of the scientific rigour behind the potential asset - is critical to determining whether a start-up will be able to attract funding or be acquired at a later stage. This process requires independent subject matter expertise to get to the heart of the science behind the technology, substantiate the inventors’ claims and justify investment in its further clinical development. 

An independent contract testing laboratory can support investors in at least 4 important areas of scientific due diligence:

Verifying Data 
Providing comprehensive and unbiased analysis to verify that the generation and interpretation of data from the experimental settings, preclinical modelling and statistical analyses in the inventor’s scientific presentation stand up to third-party scrutiny.

Validating Data
Providing objective evidence of consistent reproducibility and accuracy and an important second data source (in addition to the inventors) to confirm scientific soundness of the findings.

Evaluating For Use In Humans
Regulators in Europe and North America evaluate safety before human trials can proceed, but do not demand evidence of potential efficacy. Consequently more than half of drugs that reach later-stage human testing fail because they do not demonstrate efficacy. An independent contract testing laboratory can help to objectively avoid the potential moral hazard of commercial interests and ensure that human trials are launched only when the case for clinical potential is robust.

Assessing Safety
Drug safety assessment is a regulatory requirement throughout the life of a marketed product, with human testing proceeding only after animal testing has identified potential toxicities and a likely safe dose has been determined. Identifying mechanisms of toxicity provides a head start in drug safety assessment, and an independent contract testing laboratory can undertake careful analysis using standard in vivo / in vitro models to build the toxicological profile of APIs. 

Scientific due diligence may also include assessing the target company’s formulation and manufacturing scale-up strategies, and in particular the need for early toxicological analysis of proposed pharmaceutical excipients.

As an independent contract testing laboratory with specialised expertise in regulatory requirements at every stage of the drug development continuum, the team at Hoeford Research brings scientific rigour to the analysis of data to support investors in their evaluation of the future viability and potential of an asset, with results you can trust.
 

Contact us for a discussion.