Scientific Due Diligence
Alacrita's scientific due diligence team provides a comprehensive, tailored assessment of your target asset, drug development program, or company. Our approach is rooted in ensuring every assessment we conduct has the appropriate subject matter expertise. To achieve this, we draw from a network of over 250 senior consultants, each with at least 20 years of previous industry experience. This ensures a meticulous evaluation that is not only thorough and accurate, but precisely on target. Our clients - including large pharma, biotech, universities, and investors - have trusted us for over fifteen years to deliver scientific due diligence that informs decision-making by accurately confirming value and mitigating risk.
As a result, we're able to undertake all aspects of technical, scientific, and opportunity due diligence, enabling us to provide comprehensive insights that our clients rely on.
Click here for more information on our due diligence expertise.
Recent Scientific Due Diligence Projects
- Performing Rubidium-82 market research: A company was looking to build a capability in radionuclide imaging and was seeking merger and acquisition opportunities in Europe and the USA. One target company was developing a new Rubidium-82 radionuclide generator, which was used for cardiac imaging. We were commissioned to conduct scientific, regulatory and commercial due diligence on the target company. As part of the commercial due diligence, we interviewed 45 cardiologists across the USA and Europe, building a picture of the commercial attractiveness and reimbursement prospects of the product in development. We identified major flaws in the company’s execution plan and commercial projections, fundamentally undermining the business case for our client’s investment.
- Assessing oral delivery of biopharmaceuticals: An incoming lead investor needed to assess a proprietary platform technology for the oral delivery of biological drugs. Our scientific due diligence team took on the project, whose scope included assessing the following items: strength of preclinical data in comparison, as far as data was available, with competing approaches; IP ownership and likely strength of patent protection; clinical and regulatory strategy and execution, including key risks and likelihood of success; competitor landscape, including direct and indirect competition and market potential; manufacturing feasibility, investment needs and likely COGS, and; overall budget to reach product registration and market launch
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Providing scientific due diligence of a novel drug formulation: An established medical device company looking to make a strategic investment needed commercial, regulatory, IP and scientific due diligence on an investment opportunity in the diabetes therapy area. For the commercial due diligence, we undertook both US and EU market assessments through literature review and primary research with clinicians and patients. The resulting market forecast revealed that the product’s market potential was substantially lower than previously thought. We reviewed the company’s regulatory strategy for 505 (b)(2) regulatory approval in the US and identified a number of additional areas that needed to be addressed in the development plan. During the IP analysis, we concluded that significant work would be necessary for the product to be considered novel or inventive given the state-of-the-art therapy at the time.
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Providing due diligence in neurology generics: A venture capital investor needed an assessment of the scientific, regulatory and market risks in a neuroscience specialty pharma company developing a range of products through the 505 (b)(2) regulatory pathway. Our team provided an assessment of the likelihood of investor returns with two possible scenarios, and advised on the most likely exit triggers/timing. The client expressed a high level of satisfaction with the work.
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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.
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Scientific, Technical & Commercial Due Diligence of a Portfolio of Biotech Companies: A PE fund was looking at the potential purchase of a package of minority holdings in a portfolio of biotech companies on the secondary market. The fund approached Alacrita to conduct a due diligence of the core holdings across a range of technologies and therapeutic areas. The due diligence covered scientific, technical and commercial factors.
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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.
Scientific Due Diligence Case Studies
Challenge: Alacrita conducted a risk assessment and due diligence of a small molecule oncology compound that had been identified from a phenotypic screen. The molecule was in a Phase I/II clinical trial for a range of tumor types.
Solution: Our scientific due diligence team reviewed the results of numerous experiments which had been designed to deconvolute the mechanism of action. The data suggested that the molecule was potentially acting through multiple mechanisms of action, specifically a highly promising, difficult to drug, oncogenic pathway. The majority of the studies had been conducted at a highly regarded academic cancer center and were of good quality. However, there was limited in vivo data to support the key contentions of the mechanism of action.
Nevertheless, the data showed that the compound had in vivo efficacy in several models, especially when combined with the standard of care. The toxicology studies had been appropriately designed and conducted and the results did not appear to be of significant concern. The clinical development (two ongoing Phase I clinical trials) was too early to draw meaningful conclusions, however, we noted that the clinical development plan had been empirically developed, rather than rationally based on mechanism of action. The IP was sound and the CMC/formulation was adequate for the particular stage of development.
A major risk for our client was the attractiveness of the molecule to a partner. Pleiotropic mechanisms are generally unfavorable to pharma, who prefer to see potent and selective activity against a well-defined, high interest target. We cautioned our client that the target company would need to generate compelling evidence of efficacy (and safety) to attract significant partnering interest from big pharma..
Challenge: A private equity investor was considering a transaction in a company supplying therapeutic proteins derived from biological sources for the treatment of numerous diseases in the neurological, autoimmune, hematological and other rare conditions. The target was a mature company operating in a well-developed sector of the industry. The PE investor commissioned Alacrita to conduct in depth technical, regulatory and market due diligence recognizing that its traditional DD providers lacked the specialized expertise and hands-on experience that Alacrita can provide.
Solution: Alacrita's CMC and regulatory experts reviewed the contents of the online dataroom and conducted mini-audits of key manufacturing facilities in the US and Europe. They interviewed key personnel and identified a number of significant issues. Similarly, Alacrita's market analysis team identified critical areas of risk inherent in the target's business plan and provided a report putting the target company in the context of the industry sector as a whole.
We participated in meetings with the PE and the target to review our findings. The PE investor used Alacrita's output to revise the deal structure to take account of additional investment needs that had not hitherto been foreseen.
Challenge: A NASDAQ-listed biotech asked Alacrita to conduct a technical, scientific and commercial due diligence on a prospect reverse merger candidate. After screening numerous companies, our client identified a strong candidate with a pipeline of IND-ready compounds with potential applications principally in immuno-oncology and also some non-oncology indications. The client requested Alacrita to investigate four pipeline candidates in oncology and perform a commercial appraisal of the opportunity and competitiveness of the products.
Solution:
The due diligence project performed by Alacrita comprised two parallel and related tasks:
- A technical review of the target data room contents to identify risks, gaps, weaknesses and inconsistencies, commenting specifically on receptor selectivity, pharmacokinetic profile, preclinical toxicology and safety pharmacology.
- A commercial appraisal of the prospects for the molecular class in general, and the target's competitive position versus other pipeline candidates.