From Funding to Commercialization: How Regulatory Strategy and Market Access interact

Pharmaceutical product development has to fulfil today’s industry standards and the demands of regulatory agencies and HTA bodies. Omissions in the development path are often difficult to correct and in any case cost a significant amount of time and money and lead to a loss of sales.

Hence, a solid development plan and regulatory strategy is essential for the right steps in the right sequence to eventually succeed: “Drug approved”.

But the aspect that significantly drives the chances for investment as well as for partnering with pharmaceutical and biotechnology companies is the commercial success prospect.

Commercial success is primarily dependent on the comparative value of a given pharmaceutical product candidate perceived by patients, physicians and healthcare providers/payers. Without a demonstrated comparative value or cost benefit it is difficult to obtain reimbursement and a reimbursement price that warrants the development costs.

So, the knowledge about the market, competing products, patients’ needs and cost effectiveness tailored to the development stage of a product candidate and brought into synchronization with the regulatory pathway is essential for a successful pharmaceutical product development.