Case Studies

Challenge Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum...

Challenge A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.

Challenge A company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA.

Challenge A medical device client needed help securing 510(k) clearance for a non-contact respiratory measurement device.

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...

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...

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...

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...

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.

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.

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

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...