Submitting 510(k) applications

Challenge A medical device client needed help securing 510(k) clearance for a non-contact respiratory measurement device.
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An imaging solution to measure injector depth

Challenge A medical devices company needed a way to measure drug injector depth in pediatric populations in order to conduct a clinical trial in very young patients. Their drug needs to be delivered...
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Designing and monitoring anti-NGF imaging endpoints

Challenge Anti-nerve growth factor (NGF) therapeutics are a new class of powerful analgesics in clinical development. They were put on clinical development hold by the FDA in 2012 due to...
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Providing clinical and medical support in immuno-oncology

Challenge A leading immuno-oncology biotech company with a pipeline of novel, first-in-class clinical stage assets needed medical support for multiple clinical and medical affairs activities in...
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Clinical strategies for a novel peptide-based cancer vaccine

Challenge: A US-based cancer vaccine company developing a peptide-based product was in clinical trials in its lead indication. Recent laboratory research had revealed the target antigens were also...
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Researching EU payers to inform Phase III designs

Challenge A therapeutics company asked us to provide feedback on a Phase III protocol design for its lead drug, specifically providing an EU payer perspective.
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Supporting a Chief Medical Officer

Challenge A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United States.
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Advising a Chief Medical Officer

Challenge An oncology-focused biopharma company needed support to develop a pipeline of kinase inhibitors in early- and late-stage development.
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Defining a clinical strategy in oncology

Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the...
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Providing expertise through an oncology scientific advisory board

Challenge An emerging drug discovery company, with a core expertise in molecular modelling, had developed a small molecule inhibitor for a novel cancer metabolism target. The company was looking to...
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Assessing antibody targets and IP risk

Challenge A mid-cap pharma company seeking to establish a biologics pipeline through partnership with a monoclonal antibody development boutique needed an assessment of target opportunities,...
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Advising educational institutions on technology transfer

Challenge A university in a developing country wanted advice on best practice for IP protection and technology transfer. Alacrita was engaged to develop a plan for provision of these services.A...
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