India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Pharma strikes strategic bench- to-bedside precision medicine collaborations in Spain
Having recently spent a couple of days holidaying in the sweltering hot Extremadura region of Spain, I couldn't quite separate myself from recent research we have conducted in the country as part of our upcoming report on molecular diagnostics - indeed, I found myself wondering about the state of precision medicine in this autonomous community (CCAA) bordering Portugal as I drove past the Infanta Cristina hospital in Badajoz, the most populous city of the region.
A busy summer of precision medicine
Upon my return, I was interested to find that the Extremadura Health System (SES) is in fact seeking to implement personalised medicine through a pioneering proposal entitled MEDEA. It aims to help physician prescribing through a prior patient genetic analysis, which will be part of a health card, in order to optimise treatment efficacy and reduce side -effect risks.
Another CCAA bordering Portugal is Galicia, where industry leader Roche entered into a collaboration with Galician Health Services (SERGAS), also in June 2015. The collaboration aims to promote research, training and personalised medicine, whilst contributing to the sustainability of the healthcare system. Although full details have yet to be disclosed, it has been announced that the initiative will seek to improve access to innovative treatments, particularly those that address therapy gaps and life-threatening diseases.
A CCAA of considerably more strategic importance for drug manufacturers is Cataluña, home to the Vall d'Hebron Oncology Institute (VHIO) in Barcelona that became the first scientific centre in the world to undertake the determination of RAS biomarkers in patients with colorectal cancer through a revolutionary liquid biopsy (a biomarker test based on blood samples). This was made possible through an agreement signed in February 2015 with Merck Serono, a division of Merck KGaA , centred on the molecular diagnostic test OncoBEAM. The VHIO is part of the Hospital Vall d'Hebron, a reference public institution in Spain. In the initial stages, the pioneering technique will be used as part of the VHIO's research programme.
In June 2015, the University Hospital Foundation Jimenez Diaz in Madrid entered into a similar agreement with Merck Serono. Although OncoBEAM has yet to receive a European Conformity (CE) mark, both agreements represent a significant advancement in precision medicine. OncoBEAM itself is the fruit of a collaboration between Merck Serono and Sysmex Inostics that will allow to undertake a liquid biopsy, which is heralded as a fast and minimally invasive method to determine the state of the RAS (KRAS/NRAS) mutation in tumours. It only requires a single blood extraction instead of a tissue biopsy or a surgical procedure, and considerably saves time since it can provide an outcome in 2-3 days.
Highlighting the importance of manufacturers establishing links in economically important CCAAs with renowned public institutions, AstraZeneca has also recently formed a joint alliance with the VHIO to work on research projects in early development phase throughout the company's oncology portfolio. The tie-up in June 2015 falls in line with the company's continued aim to develop molecular targeted medicines and personalised treatments whilst specifically looking at molecular profiles for patient selection and drug resistance, amongst other hot topics.
In the meantime, Roche Diagnostics has been busy with deals bolstering the technological diagnostic capabilities of key institutions in Cataluña and Madrid.
For the latter, Roche Diagnostics linked up with the University Hospital 12 de Octubre of Madrid in July 2015 that seeks more precise and personalized diagnostic test results. But the main objective is to develop and implement new advanced diagnostic techniques and the creation of a sample bank that will help evaluate the effectiveness of current and future techniques. As a result of the deal, the hospital is striving to become a reference centre in the development of diagnostic tools that will allow its seven laboratories to advance their daily work and efficiency whilst improving patient clinical diagnosis.
Another interesting case in point is the new application unveiled in June 2014 by Roche Diagnostics that helps improve the efficacy of the treatment of difficult-to-treat HIV patients. It uses Roche's pyrosequencing (a next sequencing generation, NGS, technology) platforms and Advanced Biological Laboratories result interpretation software, which are able to detect with great precision HIV that has become resistant to treatments. This study received a grant from the Spanish Ministry of Economy and Competition and was promoted by the Cataluña Health Department and spearheaded by leading Spanish research institutions in HIV/AIDS. This example illustrates the efficiency and potential cost-savings associated with a NGS technology in a disease area beyond oncology, which is currently the predominant area of interest in precision medicine.
These initiatives highlight how the pharmaceutical industry is finding ways to navigate the fragmented and still economically constrained payer landscape in Spain to improve market access to their precision medicine products in an era characterised by significant advances in the molecular diagnostics field.
You can learn more how precision meds are changing the market access landscape in our new study. We are offering a sample chapter and a table of contents for your review.
Tania Rodrigues is a senior life sciences research analyst for IHS
Posted 5 October 2015
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