Orphan drug commercialization consulting

Challenge A late stage biotech needed a clear understanding of the processes, resource needs and timelines to establish global commercial operations to launch their leading pipeline compound, a...
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Commercialization advice for rare diseases

Challenge A small, Swiss-based biotechnology company with a pre-commercial pipeline of therapeutic antibodies for rare and ultra-rare diseases was preparing to launch its first asset. This company...
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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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Valuation of a first in class, clinical stage small molecule to treat a range of tumor types

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...
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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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Pharma consulting in manufacturing transfer and scale-up for Phase III trials

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.
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Gap analysis of a US CMC data package for a European submission

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...
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CMC consulting for a company developing a peptide

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...
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CMC & manufacturing support for biotech developing a novel small molecule

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.
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