Biotech Commercialisation. Why an Accurate Clinical Development Forecast is Necessary Early in Drug Development
The aim for many biotech companies taking a discovery into clinical development will be to generate data from phase 1 studies, not only to understand the potential of their discovery but often also to attract further investment or a potential licensing deal.
However, one of the keys for the successful commercialization of any therapy is to ensure there is a clear and realistic clinical development plan well beyond phase 1. Why is it important for research groups of biotech companies to develop a detailed clinical strategy even when the commercialization goal is to out-license early in development?
The time and cost take a specific therapy through clinical development to market are critical in determining the accurate estimate of a product’s value. Patrick Frei, CEO of Venture Valuation, a biotech valuation company which has served more than 400 biotech clients, globally says the product value is the key for a successful licensing deal. “Without a realistic product value there is a high risk that the value gap between the licensor and the licensee will be too large.”
Understanding the time and cost for a therapy to reach the market requires knowledge of regulatory requirements specific for that therapy and indication at various stages of development. An effective development plan should also include tools of modern clinical development strategy, staged development approaches, estimated pre-market access costs and expected prices in major markets.
Additionally, phases of clinical development are no longer siloed as they once were. Seamless study designs, integrated early phase studies and adaptive, in silico evidence and adaptive designs are mainstays of modern clinical development plans. Designing phase I studies alone without considering further development will impact the effectiveness of development, especially now in a highly competitive market where an efficient development strategy is as important as the discovery itself. Armstrong Clinical supports research groups and biotech companies design effective early phase studies using the spectrum of available methodologies to best determine the safety and potential effectiveness of a new therapy. Our specialists in clinical development strategy and pricing can generate accurate downstream development plans and pricing estimates to help you understand the value of your product. In doing so, we can support the critical commercialization needs of your group