Collaborating with clinical focus
This article was originally published in Scrip
For some time now pharmaceutical industry chiefs have struggled with rising research costs, longer development times, falling R&D productivity and increasing pressures on operating margins. For the past decade, we have seen pharma companies reorganise their R&D structures, reduce their dependency on in-house R&D, smooth out chinks in the clinical supply chain and even focus on more targeted approaches to try and iron out the inefficiencies of drug research. With not much too show for their endeavours.
To make matters worse, in these cost-conscious times, not only do companies have to find new medicines that are clinically effective, these days they also have to demonstrate comparative effectiveness which can lead to higher costs and further delays in achieving an attractive return on investment. Something they have found is not easy to do in splendid isolation.
Recognising the need to collaborate with like-minded companies – some already have bilateral cooperation – ten of the world's leading companies have agreed to work together to identify and solve common drug development challenges through TransCelerate BioPharma, a non-profit organisation.
Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche (Genentech) and Sanofi – only Novartis is missing from the founding line-up – have agreed initially to finance and support initiatives designed to improve the conduct of clinical trials and help demonstrate the clinical and cost effectiveness of new medicines.
As a starting point, the collaborators have agreed on five projects including the development of a shared user interface for investigator site portals; mutual recognition of study site qualification and training; development of risk-based site monitoring approaches and standards; development of clinical data standards; and the establishment of a comparator drug supply model.
TransCelerate will not be a closed-shop and other companies, including biotechs, will be eligible to join up. More importantly, TransCelerate will not ignore existing efforts to improve pharma R&D efficiency, such as the Innovative Medicines Initiative, the Critical Path Institute, the Clinical Trials Transformation Initiative and the Clinical Data Interchange Standards Consortium, and will also tap into expertise residing in CROs and regulatory bodies such as the FDA and EMA.
It was always going to take a big idea like this to take on the massive challenge of improving the economics of drug development. Good luck to all involved, we all need you to succeed.