This week a "Winter School" training event is being held for researchers from academia and industry working on advanced therapies; cutting edge medicines including gene therapy, cell therapy, and tissue engineering products. This the event is being organised by two RCSI (Royal College of Surgeons in Ireland)-led and European Union funded projects at the cutting edge of advanced therapy development; AMCARE (Advanced Materials for Cardiac Regeneration) and DRIVE (Diabetes Reversing Implants for enhanced Viability and long-term Efficacy).

The aim of this programme, which takes place in the Galway Bay Hotel, entitled "Translational Reality of Advanced Therapy Medicinal Products", is to train researchers on all the steps involved in translating an advanced therapy product from the lab bench to the patient's bedside.

These new medicines are at the forefront of scientific innovation, offering potential ground breaking new treatments for diseases and injuries of the human body. However, because of their complicated nature and lack of a track record, only a limited number of advanced therapy medicinal products (ATMPs) have so far made it through the late stage of clinical development and gained approval for use in patients.

The AMCARE and DRIVE projects are characterised by strong partnerships between academic researchers and high-tech industrial partners capable of navigating the legal, regulatory and manufacturing obstacles involved in advanced therapy development.

Experts from the consortium partners have been sharing their knowledge of stem cell manufacture and pre-clinical assessment, Intellectual Property protection, innovation in industry and how to develop effective partnerships, business planning and securing venture capitalist funding. They will be joined by experts from the Health Products Regulatory Authority (HPRA) who will deliver training on the regulatory framework for ATMPs. HPRA are Ireland's regulatory body who are responsible for the approval of all medicines, including advanced therapies, for use in Ireland. Drs Maura O'Donovan and Niamh Curran will impart their expertise on ATMPs regulation and highlight common pitfalls to avoid during development and in clinical trials.

The training event is funded by the European Union under the auspices of the AMCARE and DRIVE EU projects. AMCARE has received funding from the European Union's Seventh Framework Programme for research, technological development and demonstration under grant agreement no. 604531. DRIVE has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement no. 645911.