Pharmaceutical Due Diligence
Since its inception 2009, Alacrita has conducted over 200 due diligence assignments for large pharma, biotech enterprises, and investors, underpinned by our ability to draw in expert consultants who are masters in each major discipline involved in healthcare R&D.
We undertake all aspects of technical and opportunity due diligence, including science/technology platforms, intellectual property, preclinical and clinical development, regulatory due diligence, pharmaceutical development and manufacturing, commercial and medical affairs.
Our expert network structure allows us to rapidly assemble technical due diligence teams that harness deep expertise across a wide-range of product modalities, functional disciplines and disease areas.
Our activities frequently include:
- An initial review of data to gain an understanding of materials available and expertise required
- Pre-DD assessment to identify any “red flag” areas
- Selecting and deploying teams of technical evaluators matched to the client’s need, and supplementing with primary and secondary research
- Reporting our findings in a risk assessment dashboard, enabling our client to quickly identify where key risks and mitigation opportunities lie
- Providing an opinion on whether the company or asset faces lower or higher than average risk, compared to industry averages
We also frequently leads focused internal DD exercises that prepare companies for exposure to DD by investors, acquirers or licensors.
The following list of recent projects and case studies can help illustrate the type of due diligence assignment we frequently provide to clients.
- Due diligence on a gene editing platform to inform a company research partnership: A private biotech client with a focus on innate immunity, was considering a research collaboration with an innovative new company in the field of gene editing. Before committing to this partnership, our client wanted an independent and expert assessment of the gene editing company, its pipeline and its platform technology, including an opinion on whether this company represented the best option for a collaboration of this kind.
- Investor due diligence on clinical stage oncology therapeutic company: A private equity investor bidding for a Phase III gene therapy asset at the point of regulatory submission required specialist DD input on the manufacturing and regulatory aspects of the product. The nature of the technology required a higher than usual level of specialization that the PE investor recognized would not be available in its standard DD vendors.
Assessing an AAV gene therapy for an ophthalmic indication: We were asked to conduct an assessment of an AAV gene therapy for an ophthalmic indication, focusing on market potential, technical and regulatory issues and the identification of key risks. The resulting assessment would be used by the client to decide whether to proceed with a proposed transaction.
Cardiovascular gene therapy due diligence: An academic organization was interested in developing an AAV vector-delivered gene therapy for a cardiac indication and required assistance with a technical review of their program and preclinical development recommendations.
Assessment of target opportunities for biologics pipeline: For a mid-cap pharmaceutical company seeking to establish an oncology biologics pipeline through partnership with a mAb development boutique, Alacrita assessed the quality of a range of target opportunities, the soundness of third-party contracts and the underlying IP position and risks.
Providing a reality check on an oncology cell therapy: Alacrita conducted a reality check on a clinical stage cancer biologic for a venture capital investor prior to a proposed $10m investment.
Providing scientific & immunological mechanism of action due diligence: For a major pharmaceutical company, Alacrita conducted scientific and immunology due diligence on a novel cyclic peptide targeting the complement cascade system.
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, analyzing 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
- Competitive landscape
- Market opportunity
- Company infrastructure.
Upon further discussion with the target company on issues raised during the initial review and analysis, we finalized our report to the investor summarizing 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 finalized.
Case Study: Providing data room due diligence for an Alzheimer’s treatment
Challenge: Our client, a major pension fund, was considering an investment in a Phase III neuroscience company, which was developing a small molecule to provide symptomatic relief of Alzheimer’s Disease (AD). Our client wanted to know the likelihood of clinical success in an ongoing Phase III clinical trial, therefore, one of our neuroscience consultants was selected to provide expert advice.
Our lead consultant had significant experience in neurology, psychiatry and molecular neurobiology, as well as 20-years experience in drug development from first-in-human studies through multiple Phase III clinical trials, across a range of CNS indications. Prior to joining the Alacrita network, he had been Chief Medical Officer and SVP in Drug Development at a neuroscience company.
Solution: Our diligence team reviewed the contents of the data room, including investor presentation, investigator’s brochure, Phase III protocol and statistical analysis plan, Phase II clinical study reports, publications and regulatory correspondence. Our work focused on:
assessing the appropriateness of clinical design, mitigation of adverse events and safety factors
identifying the risk factors facing the AD clinical program
determined completeness and appropriateness of regulatory response
assessing the likelihood of clinical success and reviewing the overall development strategy
We completed the due diligence within two weeks and provided initial feedback to the client’s investment team. Upon receiving further clarification from the company, we provided a written report to the client, setting out the major risk factors. Finally, we held direct communication with the client’s team to explain our findings and answer any questions.
Case Study: Due diligence of a late-stage gene therapy asset
Challenge: Our client, a global specialty pharmaceutical company, was facing a short deadline to making an offer for a late-stage gene therapy asset and was under considerable competitive deal pressure. This would be the client's first gene therapy asset and as such, the company did not have internally the specialized personnel required to conduct an expert due diligence of the opportunity. Alacrita was asked to conduct within a two-week period, a deep dive due diligence focusing on clinical, CMC, regulatory and related issues.
Solution: Alacrita assembled an expert DD team comprising a highly experienced medic, an ex-FDA gene therapy regulatory specialist, a gene therapy CMC specialist and a quality specialist.
Over a very limited timeframe, the team assessed the target's data room and identified a number of critical issues including some where the target had yet to disclose the relevant documentation. This complemented the work that our client's internal - though not gene therapy-experienced - team had done, and the combined group reached the appropriate conclusion that informed the client's deal team over how to proceed.