A medical device company with limited experience in pharmaceuticals engaged Capital K to review a recently acquired portfolio of innovative medicines and prepare a development, market access and launch plan for the company's first medicine, along with general guidance for the following compounds. The plan included regulatory data generation, engagement with medical and scientific experts, targeted product information claims and the pathway to a reimbursed launch. Capital K's plan was integral to the company's successful foray into the new commercial area.
An innovative start-up company commissioned Capital K to provide strategic direction and support in order to develop an overall regulatory and market access strategy for a new Australian prescription drug-device combination product. The plan included mapping a pathway from design development, through non-clinical and phase I assessment to final market entry. Through Capital K's support, the company was able to successfully engage with investors for support in progressing the development activities.
An international pharma company requested Capital K prepare a report for management and to conduct a workshop for the cross-functional team on the operational elements of the Australian Government's Pharmaceutical Benefits Scheme reform activities. The tailored 'war gaming' session assisted with ensuring all stakeholders shared knowledge and agreed on the possible short- and medium-term impact of the reforms on the company's current and future medicine portfolio, enabling critical decisions to be made regarding planning and product forecasts.