Accelerated pathways are emerging in individual countries that are designed to speed therapies through the approvals process and onto the market for patients who have unmet needs. Following on from our EU focus, in this post we look at the key schemes to date, that are in place in the UK, Japan and USA to […]
The drug development process is a long one – depending on the specific therapeutic and disease, it can take up to 15 years for a product to be ready for market access. Once a drug is submitted to the European Medicines Agency (EMA) for marketing authorisation, the agency aims to issue an opinion within 210 […]
All of the stakeholders involved in drug development and market access would like the right treatments to be available to the right patients, but in times of increasing austerity drug costs make this challenging. Payers need to see the value of a drug outside a clinical trial and in a real-world setting, in order to […]
For many years, the route to market access has been focused around completing clinical trials and meeting the safety and efficacy data needs of the regulators. This data is then used to persuade payers that the therapeutic is safe and works, and is therefore worth paying the price demanded. However, as budget cuts bite, competition […]
When thinking about getting new pharmaceuticals to the market, many companies focus efforts on getting products through approval, and so tailor their market access strategy to meeting the regulators’ needs. However, for a successful market access, any company needs to have a strategy to meet the needs of the payers as well as the regulators. Planning […]
Since the completion of the human genome project in 2003, researchers at the 1000 Genomes Project have sequenced over 2500 human genomes from 26 groups of people around the world; the genome of a human from around 430,000 years ago has been sequenced; and the UK plans to sequence 100,000 human genomes from NHS patients. […]
Starting the market access plans as early as possible, even during the early stages of development, will improve a company’s chance of success at drug launch.