Pharmaceutical Due Diligence

Alacrita’s pharmaceutical due diligence work involves working with clients to understand the reason for the due diligence as well as particular areas of focus, the depth of assessment and the timelines. Given the breadth and depth of our consulting expertise, we undertake all aspects of due diligence, including science/technology, intellectual property, preclinical and clinical development, regulatory, manufacturing, commercial and medical due diligence. Our clients include pharma companies, biotech companies and financial investors.

Our due diligence activities will often include:

  • an initial review of the data to gain an understanding of the materials available and the expertise required
  • acting as a local scouting office, to broaden our client’s geographic reach
  • selecting a team of technical evaluators who are matched to the client’s need; we sometimes supplement our consultants’ expertise with primary or secondary research
  • reporting our findings in a risk assessment dashboard, enabling our client to see quickly where any key risks lie
  • providing an opinion as to whether the company or asset faces lower or higher than average risk, compared to industry averages.

We also perform reality checks, which are often useful before entering into formal due diligence and can reveal areas that present greatest risk. This could then be the focus of more detailed analysis.

Featured Case Study: Due diligence on a novel T cell therapy and discovery platform

Challenge:

A VC investor wished to make an investment in a California-based preclinical biotechnology company with a discovery platform and novel T cell therapies for cancer and other diseases. Alacrita was commissioned to use its experience in cell therapeutics to perform a technical due diligence on the company to highlight any key risks and to propose mitigation strategies.

Solution:

Alacrita reviewed information provided by the client and compiled a report, analysing the following key areas in the technology platform and therapeutic programs:

  • Therapeutic focus
  • Molecular targets
  • Scientific rationale
  • Pre-clinical data
  • Regulatory status/correspondence
  • CMC issues
  • Clinical development plans
  • IP
  • Competitive landscape
  • Market opportunity
  • Company infrastructure.

Upon further discussion with the target company on issues raised during the initial review and analysis, we finalised our report to the investor summarising the above points and outlining the key risks in the programs. The company agreed that the identified risks were indeed material, and one of the predicted issues occurred shortly after our report was finalised.