Case Studies

Challenge: A clinical stage stem-cell company with its own proprietary cell lines had developed technologies to enable production of exosomes at a commercially relevant scale. The company asked...

Challenge: A European biopharma company focused on immuno-oncology therapeutics was developing small molecule and monoclonal antibody agents for three targets of high interest in the I/O field. The...

Challenge: A biotech company that had recently completed a late-stage clinical trial for its first-in-class mAb therapy for a chronic inflammatory skin disease wanted to test the use of a newly...

Challenge: A biopharma company required expert due diligence for a potential transaction with a clinical stage biotech focusing in inflammation and fibrosis. Alacrita was commissioned to provide an...

Challenge: A pharma company sought Alacrita's support in providing high-level go/no-go pre-due diligence of two early-stage strategic investment opportunities. The company had so far been focused on...

Challenge: A European biopharma company developing synthetic lipids required a critical appraisal of data generated by a University research group using natural lipids in oncology. It wished to...

Alacrita's regulatory affairs consultants provide support to biotech, pharmaceutical and medtech clients, as well as companies and investors conducting regulatory due diligence. Our regulatory team...

Challenge: Alacrita was engaged due diligence and valuation support by a listed clinical stage biotechnology company. The biotech needed to benchmark the technical strengths and weaknesses of two...

Challenge: A listed biotechnology company had developed a significant capability in viral vector manufacturing and was considering spinning it out into a joint venture with a major CDMO. The client...

Challenge: A family office invested in a European, VC-backed company sought Alacrita's expert view of re-investing in the company, following a Phase III trial failure in the immunology space. The...

Challenge: A company with a microbiome-conditioning product was seeking the optimum strategic positioning to enable a trade sale to a major company. Unusually for a venture in this field, the company...

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in...