Product Development (7)

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...

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.

Challenge A UK public sector life sciences research institute focused on fundamental mammalian biology required an economic impact assessment of its science, as part of the evidence base accompanying...

Challenge A private equity (PE) investor was looking for a partner to be retained as an observer on the board of a regenerative medicine/advanced wound-healing company.

Challenge A biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s management and...

Challenge An established US biotech company was looking for a team of expert antibody consultants to help them understand the potential of monoclonal antibodies (mAbs) to treat bacterial infections.

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...