Our client, a private equity-backed specialty pharmaceutical company experiencing rapid growth through mergers and acquisitions, was actively evaluating several late-stage development assets for potential in-licensing or acquisition. One of these assets was a monoclonal antibody (mAb) targeting a rare pediatric oncology indication. The asset had been developed primarily through a leading US university hospital and was made available for acquisition following a disappointing end-of-Phase 2 meeting with the FDA. At the client’s request, Alacrita was engaged to conduct a focused evaluation of the chemistry, manufacturing and controls (CMC), regulatory, and clinical considerations associated with the program.
Alacrita assembled a bespoke three-person core team for the engagement. This included a regulatory CMC specialist with biologics expertise, a senior regulatory affairs consultant with former agency experience, and a pharmaceutical oncologist with deep experience in pediatric indications. The project was overseen by the head of Alacrita’s Due Diligence Practice, who managed the workstream, synthesized input from the domain experts, and contributed directly to the strategic analysis.
The team conducted a thorough assessment of the asset’s development status, identifying key uncertainties across regulatory, clinical, and technical domains. Particular focus was given to the implications of the recent FDA meeting, which introduced uncertainty around the path forward. For each challenge identified, the team explored and evaluated mitigation strategies, drawing on precedent, experience, and practical constraints.
Although the asset was ultimately characterized as high-risk, the client’s internal team had strong experience with the therapeutic area and mechanism of action. With this context, and informed by Alacrita’s findings, the client elected to proceed with the acquisition. Alacrita continued to support the clinical development of the program following the transaction.
Alacrita brings deep, cross-functional expertise to high-stakes due diligence engagements, particularly where clinical, regulatory, and CMC uncertainties converge—as in this pediatric oncology case. Our consultants are seasoned industry professionals, ensuring that each due diligence exercise is informed, rigorous, and aligned with the asset’s complexity. Whether you're evaluating high-risk biologics, navigating FDA feedback, or assessing post-Phase 2 development strategies, our teams are built to deliver actionable insight with precision.