Case Studies

Challenge A private biotech company was preparing for an IPO. The company was developing a first-in-class small molecule inhibitor with the potential to treat a range of tumor types. The company was...

Challenge A start-up biotechnology company was developing a new oncology therapeutic for the treatment of advanced solid tumors. The product consists of four FDA-approved and well-tolerated...

Challenge A US biotech company had a small molecule anti-cancer drug on the market in the US and other products in development. The company needed CMC consulting expertise in order to access European...

Challenge A small biotech company had undertaken several projects in clinical development and needed focused CMC consultancy support in progressing to the next phases of these ventures.

Challenge A small regulatory company had been commissioned to review the development data package available from a US biotech company for a liquid inhalation product, with a view to using the data...

Challenge A small biotech company was developing a peptide and needed support in taking the compound to first-in-man studies and Phase II clinical trials. This was the first time the company had...

Challenge A biotech company was developing its first oral compound — a novel small molecule. The company needed support in taking the compound to first-in-man studies and Phase II clinical trials.

Challenge A biotech company engaged in licensing discussions with a number of major pharma companies needed help with risk adjusted NPV (rNPV) valuations for each program.

Challenge A US venture-funded biotech was planning a pivotal trial with a highly efficacious infectious disease therapy. It asked Alacrita’s pharma market access consultants to conduct a high-level...

Challenge: Our client needed an assessment of the market opportunity and value proposition for a novel anemia therapy in order to facilitate discussions with potential partners.

Challenge An established US biotech, aware of the importance of incorporating market access factors into clinical trial design, wanted to conduct strategic research for a novel advanced breast cancer...

Challenge A US medical device company wanted to understand how UK payers would view their technology.