Dr Steven Bradshaw: EU Scheme to Fast Track Next Generation Drugs Launches

This week saw the launch of the new EU scheme to fast track next generation drugs, a move which will promote greater understanding, in Dr Steven Bradshaw’s opinion.

Dr Steven Bradshaw, Global Healthcare Policy Expert

Steven Bradshaw is a global healthcare policy expert, who works as a consultant to some of the world’s top pharmaceuticals companies and think tanks.

As such, Bradshaw regularly weighs in on matters of European healthcare policy i.e. the recent decision by the Italian government to substitute AMD drugs, employing his expertise to bring fresh insight to the matters that are reshaping European healthcare policy, which is why the launch of this scheme was one that Bradshaw felt he must comment on.

The Second Innovative Medicines Initiative Launches

This week the continent’s second Innovative Medicines Initiative (IMI 2), was officially announced. Furthermore, it was revealed that the scheme would come with a 3.3 billion-euro budget, as well as a target of fast tracking development of the new generation of medicines, with a focus on those of unmet medical or societal need.

The Agenda for the IMI 2 Strategic Research, which borrows significantly from World Health Organisation Priority Medicines for Europe, and the World report, will also be designed to place a greater significance on speeding up patient access to new treatments. Furthermore, this week saw the launch of the first IMI 2 call for proposals; which included topics on type 1 diabetes, along with retinal diseases; both areas that are in dire need of new treatments.

Raising Awareness of Type 1 Diabetes

Notably, there is no cure for type 1 diabetes, and it is known to affect an estimated 17 million people across the globe. Consequently, the scheme will seek to progress understanding of the disease, as well as approach the absence of tools and technologies, which would aid in helping to detect a patient’s risk of developing the condition.

The budget for this project is reported to total 35 million euros; Horizon 2020 provided 17.6 million euros to the project, whilst large pharmaceuticals firms who are taking part in the scheme contributed 12.6 million euros. Meanwhile, a further 2.2 million euros was donated by the JDRF diabetes charity and patient organisation, which is set to coordinate the scheme, and a final 2.2 million euros was provided by the Leona M and Harry B Helmsley Charitable Trust.

Tackling the Issues of Retinal Diseases

Meanwhile, retinal diseases – which are a leading cause of blindness internationally – are the second topic of the first call. Currently, no effective treatment exists for diabetic retinopathy or dry age-related macular degeneration (AMD), nor standard outcome measures that are applicable to patient’s daily lives.

Both the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission have put forward half of the 14 million euro budget for this project. These funds will be used to produce new tools and methods, which will aim to accurately depict the effect of these conditions on patient’s normal lives. Furthermore, they’re hoping that these observations could be employed in clinical research to determine the validity of potential new treatments for retinal diseases.

The Project Will Address Unmet Medical Needs

According to Pharmatimes, the partners in the project wrote that it will seek to address, therefore, an unmet medical need that is also acknowledged by European medicines regulators.

They went on to write: ‘IMI is a public/private partnership between the Commission and EFPIA. The IMI 2 programme will build on the successes of IMI’s first phase (2008-2013), which has delivered breakthroughs in areas as diverse as diabetes, autism and medicines safety, and will expand the partnership to all players in the health ecosystem.’

Dr Steven Bradshaw Comments

In Steven Bradshaw’s opinion, these projects are vital to efforts to understand and produce methods to address critical unmet needs in therapy areas such as retinal diseases and type 1 diabetes, as only through a greater understanding of how they affect patients everyday lives, can we fully address the problems they pose and develop treatments.

Dr Steven Bradshaw image