Product Development (6)

Challenge Our client specialized in the development of proprietary monoclonal antibodies directed towards novel targets for the treatment of immune-mediated and fibrotic disorders, including orphan...

Challenge A stem cell research company had developed a target product profile (TPP) for a novel therapy for glioblastoma (GBM). The company asked Alacrita to conduct a comprehensive review of the GBM...

Challenge Our client offered a genetic ancestry test in the form of a home kit that contained a buccal swab to collect customer DNA and an analysis service using a SNP array-based chip. Results were...

Challenge A well-capitalized, private biotech company with a drug discovery platform identified multiple first-in-class and best-in-class compounds targeting critical pathways widely involved in...

Project: For a listed US biotech company with marketed products, Alacrita's pediatric oncologist consultant provided ongoing support with Phase I/II design, protocol development and medical oversight...

Challenge A new academic spin-out company in Europe had acquired the rights to the intellectual property covering a new diagnostic agent. This molecular MRI imaging tool is envisioned to be useful in...

Challenge Dual-energy X-ray absorptiometry (DXA) has been used extensively in clinical trials in osteoporosis. DXA is increasingly being used to examine bone density in trials of drugs that could...

Challenge A start-up company was planning to license an immunomodulatory product from a European pharmaceutical company. The therapy had been unsuccessfully tried in allergic disorders, but the...

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...