Tuesday, August 27, 2013

Interventional Medicine: Collaboration in Action

I have a vision of the future of medicine and healthcare that I cannot square at this time with the businesses of the present, the financial models, the research and development pathway and the regulatory environment.
At the core of this mis-match is that treatment will be multimodal.  Small molecule medicines are one small component of the future.  We are really looking at combinations, diagnostics, drugs and devices etc. ‘Patient Centric Solutions’ as mentioned by Tony Farino of PwC at the opening of his panel session at the recent EU BioPharmaceutical Conference 2013 held in Divonne des Bains, France.
People talk about ‘Personalised Medicine’ – this sums up the individual tailoring of medicine that is almost necessarily unaffordable.  As time goes on we need to find a way, not just to affordability but to understand that in the single mission of treatment of each patient we do it safely and ensure the greatest possible efficacy. This, to me, is better described as Interventional Medicine and this means that, to be best treated we need to diagnose, administer and monitor the patient.  All this is possible if we combine skills, technologies and regulatory paths.
Let’s think this through from the perspective of the business models in Pharma.
At this conference a member of our audience said, ‘We must consider we are in the healthcare business’. ‘Innovation is woefully lacking in the business model’.
Another quote was, ‘It doesn’t have to stay like this’.

No it doesn’t and the good news is that the industry isn’t staying still. Our industry is changing rapidly – every facet of the once successful FIPCO model is now challenged and shown to be vulnerable, if not totally unsuitable.  But this has not gone unnoticed and the leaders of companies in our industry in large and small enterprises are making the change.  Sometimes the change is taking the form of a dramatic site closure in a big pharma.
Take the shutting of GSKs Verona site – their centre for CNS diseases research.  The reaction to this – shock and exclamations of ‘it’s sad’ and ‘it’s mad’!
I don’t think so.  This was a productive site with some of the best pharmacologists and chemists in our industry who had developed some of our best CNS drugs that we use today.  But they had reached the end of the road.
CNS medicine will not just come from pharmacologists and chemists.  In the future we need:
                Genetics – analysis
Diagnostic and imaging substances and technology
Functional MRI and other measures
Professionals in interpretation of these measurements
Therapeutic modalities like:
                Small molecules
Biological agents
Stem cells
Encapsulation technologies
Implantation systems
Professional surgeons
Monitoring skills amongst professionals across healthcare including in nurses, the patients and their GPs

This does require a rethink of the business model from front to back of the process from Discovery research through to the market and healthcare delivery.  Of course Verona had had its day – let’s start building now the alternatives for our industry.  Where you might well ask?  Start within our biomedical research institutes and align those skilled in the knowledge of R&D processes with those with brave new ideas but who are not conversant with translation.  Breakdown traditional specialist silos and encourage team work amongst chemists, biologists, mathematicians, physicists, engineers and surgeons…….
Change may be slow, it may be frustrating, but it is happening and it is up to us to encourage it.  The last bastion of resistance will be the large pharma commercial teams who want answers before they can be given as they try to figure out market access.  They can’t do this without our help to demonstrate the advantages of our drugs, suitably delivered, packaged, formulated and presented with the right accompaniment and by the right people.  Companies will continue to seek the value proposition for these medicines and if they require collaboration, multidisciplinary teams and a new business model these will emerge.
My panel at the Eu Biopharma conference used 4 case studies to show examples of early entries to market that bring together drugs, diagnostics and devices. Their stories show that this is not easy but their examples help to show how we must strive to improve the process to make the delivery of new breakthrough medicines possible.  Through these examples the audience heard of companies’ motivations to navigate the regulatory quagmire to deliver these products which begins to shine light on why it is worth the effort and how the final product improves the value proposition for the medicine as well as the safety and efficacy of the drug for the patient.
My panellists were;
Iain Miller, formerly from GE Healthcare and bioMerieux, from Healthcare Strategies Group.   Iain described two products from GSK and BioMerieaux  that have recently received approval accompanied with a Braf molecular mutation test as a companion diagnostic.
Sue Herbert from Merck Serono who described two smart devices for improving compliance and the cost benefit of two established biologic agents.
Guenter Janhoffer from BTG described two combination products which were differently assessed by the FDA, one for which they considered the drug division should lead and the second where they considered the device division should lead the review. Nevertheless both divisions have to have oversight of the products.
Grant Castle of Covington and Burling told a story of a Medtech company who had an approved device but found that partnership with large pharma companies which intended to use the device for their medicines came up against medicines regulators who made such significant difficulty for the device assessment alongside a medicine that the company had to alter their business strategy completely.

All panellists gave strong accounts demonstrating that the pioneers in our industry are from multiple companies and disciplines and that it will and does take significant perseverance of the sort they described for us to move this field of interventional medicine and personalised treatment forwards.