by Dr Fintan Walton, CEO, PharmaVentures.

The key to success in the pharmaceutical industry is the ability to understand and manage the risks of products going through clinical development and into the market. Most pharmaceutical professionals tend to focus on understanding the clinical risk as a means of managing the certainty of commercial success. This is also true when it comes to determining the value of a drug in clinical development. What is often not fully understood is the certainty of getting the right price and probability of reimbursement for the drug. Furthermore, the actual clinical development programme and the Target Product Profile (TPP) for the potential product may be even more risky and even incorrect if the price and reimbursement of the product is not investigated or understood.

Today, prices for drugs are under greater pressure and scrutiny worldwide with considerable risk in getting that strategy right. That is why it is important for even early-stage biotech companies with products in early clinical development to have a clear understanding as early as possible of the probability of getting their clinical, pricing and reimbursement strategy correct. Clinical trials are not just important for getting regulatory approval, it is also essential for providing vital and relevant data to payors.

Many companies seeking partners believe that it’s not their task to consider these aspects of product market access and that this responsibility belongs to the future partner. This is a very dangerous assumption, as it may be too late by the time an interested party is aware of the opportunity.

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