Competitive and market landscape for CAR T-cell therapy

Challenge A biotech company developing a platform technology to improve the safety of CAR T-cell therapies asked Alacrita to conduct a comprehensive competitive landscape to better understand the...
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MHRA scientific advice for a UK PhII trial in PSC

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...
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Comprehensive review of the glioblastoma (GBM) landscape

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...
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Target product profile creation

Challenge A UK based privately-held biotechnology company developing and exploiting a proprietary technology platform for optimising and controlling gene therapy expression was looking to evolve its...
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Advice for regulatory approval of a new Ancestral DNA device

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...
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Interim Chief Medical Officer for Fibrosis Company

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...
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Development support for first-in-class pediatric oncology drug

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...
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Advising on intellectual property for precision medicine diagnostics

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...
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Expert advice on DXA in clinical trials

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...
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Strategic and operational support for a start-up oncology company

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...
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Part time oncology chief medical officer for a medical supplement

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...
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Providing technical transfer and validation of a commercial manufacturing process for tablet formulations

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...
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