Despite their unique potential, the ATMP registration path has its hurdles and can be extremely difficult. This is due to the products’ scientific complexity and the equally complex regulatory approval process, which in turn will impact market access and availability for eligible patients.

Meeting regulatory requirements is probably the most challenging aspect of new drugs, especially for ATMP developers, even if they are well-equipped small and medium-sized biotech and pharma companies. Some key aspects should be carefully considered when developing novel ATMPs in Europe and in the largest Southern European markets. This goes for instance for the interaction with the Spanish Agency of Medicines and Medical Devices (AEMPS).

A lack of understanding and miscommunication between developers and regulatory agencies can delay, or even prevent the development of new treatments, potentially preventing promising ATMPs from reaching patients.

Biotech and pharma medical affairs departments can pave the way to overcome those issues and promote the expedited development plan for a new treatment by delivering a precise key stakeholder’s engagement plan.

Starting an engagement plan in the early stages is vital

An effective stakeholder engagement plan means identifying and actively involving all relevant parties throughout the drug development lifecycle. This plan should focus on clear communication, early and continuous interaction, and addressing the specific needs and concerns of each stakeholder group.

It also requires a thorough knowledge of the registration process and access dynamics in the big Southern European markets, e.g. Italy and Spain. This is true, regardless of whether or not the innovative product has demonstrated efficacy in the trials. But it is vital to address your company’s development strategy and to ensure that you are on the right track.

From a headquarter point of view, you will benefit greatly from specific local expertise at regional and country level to achieve effective networking capabilities. Only then will you be able to create a framework that is useful to assess stakeholders’ overall expertise and influence, validate your stakeholder mapping and prioritise stakeholders based on combined matrix of influence and engagement feasibility.

If you would like to make your ATMP accessible to patients in the Southern European markets as quickly as possible, please feel free to benefit from my experience by contacting me via info@infill.com and we can arrange a meeting to discuss this further.