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.
