Berlin: encouraging the healthy lifestyle - from exercise to wildlife

In Berlin for the 5th Forum on Companion Diagnostics, organised by the rapidly expanding Brandenburg-Berlin DiagnostikNet of biotech companies and affiliates.

The event has been hosted in the CoLaborator startup building on the former Schering, now Bayer campus. Outside, a volleyball court and all weather table-tennis tables - and a giant chessboard for those wishing to divert the mind.

In the city centre, tremendous buzz around the Brandenburg Gate with an international field

Kestrel with prey in the Tempelhofer Garten in Berlin

of runners, part of the international city move to encourage exercise through amateur runs. The latest field numbers I could find were 25,500 in Berlin for a recent Spring half-Marathon.

In the South of Berlin, an inspiring example of local democracy, Berlin citizens having voted to preserve the former Tempelhof airfield as a vast wild urban common land - the former site of the Berlin Airlift (or air bridge as locally known - Die Luftbrücke: 1948-1949).

This huge space is well worth enjoying while still protected wild city green land.
 

When I visited, the runways were in use by cyclists of all speeds, stylish rollerbladers, families with pushchairs, and general strollers.

There are numerous copses and tall grasslands rich in birdlife. Within 100 yards of the entrance, a kestrel catching an unlucky field rodent (above the old parachute drop training wires), sparrows nesting in an abandoned cargo plane, pied wagtail, goldfinch, wood warbler, swifts and skylarks, common nightingale, chiffchaff ...

Many good examples of making it as easy as possible at work and in leisure time to

Common Redstart in Berlin's Tiergarten

maintain a healthy active lifestyle. This is not only of course a key part of general wellbeing, but well-established to prevent serious diseases. Cardiovascular disease is the most obvious example. 

Healthy lifestyle is also well-evidenced as good for preventing cancers, and for providing clinical benefit in patients with cancer,  the focus of a one day Updates on Cancer Meeting being organised by the Fellowship of Postgraduate Medicine in London on Thursday 29th September, 2016.

Progress on Personalized Medicine? Updates from Harvard.

@HealthMed The 8th annual Personalized Medicine Conference took place at Harvard this week - a joint venture of Harvard Medical School, Harvard Business School and Partners Healthcare, lead by Professor Raju Kucherlapati, from the HMS Department of Genetics. Worth checking the excellent archive of past programmes, presentations and podcasts.
Meantime, some of the highlights?
- An excellent narrative on the partnership between Plexxikon (Peter Hirth) and Roche Diagnostics (Suzanne Cheng) to create a companion diagnostic/therapeutic pairing for vemurafenib (Zelboraf), the first FDA approved pairing for BRAF V600E positive metastatic melanoma
- Further case studies illustrating successful drug development using genetic approaches
- Personal case studies on the impact, clinical value and ethical and clinical challenges of genomic screening: from Joe Beery, Life Technologies, on detecting unrecognised treatable serious early childhood disorders, to John Lauerman, Bloomberg News, on consequences of sequencing for asymptomatic adults - questions on penetrance and future screening for onset e.g.  of metabolic disease and cancers

Harvard Medical School: New Research Building - Avenue Pasteur.

- Clinical potential, and regulatory and reimbursement challenges to introducing molecular diagnostics into clinical care pathways
- Leadership award to Randy Scott, In Vitae, whose discussion points included the relevance of Moore's Law (technology advancing) and Metcalfe's Law (people factors: exponential increase in interaction as network expands) to developments in personalized medicine
- Business models and their governance for use of genetic information
- A North Virginia (John Vockley, Inova) pioneering series of projects aiming to assess outcomes of neonatal genomic sequencing: from insight into preterm labour to prospective longitudinal follow-up to adulthood, supported by multi-generation family member sequencing combined with clinical histories
- The US Air Force Programme on Patient-Centered Precision Care (Dr Cecili Sessions), in partnership with the Coriell Institute and Johns Hopkins University,  aims of which include understanding the impact on health-related behaviour of providing personal genetic information on remediable medical disorders and on drug responses.
- A business school case study led by Professor Richard Hamermesh, Director of the HBS HealthCare Initiative, on reactive and proactive responses for development of companion diagnostics (1).
- Pros and cons of liberal vs. restrictive approaches to IP for genetic and other molecular diagnostics
- Engaging the policy community and the public in ethical, clinical, reimbursement and adoption issues for new diagnostics and treatments aimed at personalizing medicine, including case studies from the American Medical Association and the American Assocation for Cancer Research.

Personalized Medicine Conference website 
Companion and coupled diagnostics

Health Policy and Technology launched by FPM and Elsevier

@HealthMed The Fellowship of Postgraduate Medicine, in partnership with international publisher Elsevier, has launched the first issue of a major new international journal - Health Policy and Technology.

The first issue includes a paper on the pioneering new Centre for Health Technology Assessment of Devices and Diagnostics within the UK’s National Institute for Health and Clinical Excellence (NICE), and papers on e-health from the USA, India and Europe. 

There is also the first of a series of interviews in print, online and as podcasts, with international leaders in the field of health policy and technology, beginning with Sir Michael Rawlins, Chairman of NICE.

The next policy maker to be featured in this series (June 2012 issue of HPT) will be Professor Gonzalo Calvo, former chair of the European Medicines Agency Cardiovascular Working Party, and Chair of the European Association of Clinical Pharmacology and Therapeutics, which represents the national clinical pharmacology societies from the 29 established and accession countries in Europe and their ~4000 clinical pharmacologist members.

Background to new journal and to the FPM.

Online launch by Elsevier of FPM journal - Health Policy and Technology

@HealthMed Health Policy and Technology was launched online on 14th March by the international publisher Elsevier on behalf of the Fellowship of Postgraduate of Medicine (see Editorial on Launch). The print version of the journal will be published later in March.
The first issue of the journal features editorials, reviews and original research by an international range of contributors from USA, Norway, Holland, UK and India. 
Key themes of papers in the issue include diagnostics, technology for drug discovery, e-Health, and health technology assessment, and health policy.
There is also the first in a series of interviews with senior health service, research and industry professionals, and policy makers, starting with Clinical Pharmacologist Sir Michael Rawlins, Chairman of the UK's National Institute for Health and Clinical Excellence.

Helpful links
Podcast of interview with Sir Michael Rawlins, Chair of NICE
HPT website
Background to FPM and the launch of HPT
Fellowship of Postgraduate of Medicine website

The 'Magic of Medicine' at the Dana Centre

@HealthMed The Science Museum’s Dana Centre in South Kensington in London aims to provide updates for adults on contemporary science, technology and culture in an informative and innovative format. For those who can't make it in person the Centre makes its events available for interaction online or by smartphone.

The next event at the Dana Centre - on 16th February - is a sell-out session on the Magic of Medicines, organised jointly with the public engagement team at the British Pharmacological Society. Themes will range from drug discovery from Nature by the ancient Babylonians and Greeks such as that chewing meadowsweet or willow bark relieves pain, to new experimental approaches to drug discovery, latest advances in personalizing medicines, supported by companion diagnostics, to the need to maintain vigilant pharmacology and related expertise ready to combat new and unresolved disease challenges, in the face a declining pharmaceutical sector.

What's on at the Science Museum’s Dana Centre.

The Science Museum’s Dana Centre is a collaboration between the British Science Association, the European Dana Alliance for the Brain, and the Science Museum. It is part of the Wellcome Wolfson Building, which is supported by four principal donors - the Wellcome Trust, the Wolfson Foundation, The Dana Foundation and the Garfield Weston Foundation.

FPM to launch a new journal on Health Policy and Technology

@HealthMed Health Policy and Technology (HPT), the new official journal of the Fellowship of Postgraduate Medicine (FPM), will be launched in March 2012 as a cross-disciplinary journal, which will focus on past, present and future health policy and the role of technology in clinical and non-clinical national and international health environments. HPT will be published by Elsevier, a major international publisher of scientific, technical and medical information

The FPM continues to publish its first international publication, the Postgraduate Medical Journal, launched in 1925. HPT provides a further excellent way for the FPM to continue to make important national and international contributions to development of policy and practice within medicine and related disciplines. The aim of the FPM in establishing this new international journal is to publish relevant, timely and accessible articles and commentaries to support policy-makers, health professionals, health technology providers, patient groups and academia interested in health policy and technology.

Topics covered  by HPT will include
- Health technology, including drug discovery, diagnostics, medicines, devices, therapeutic delivery and eHealth systems
- Cross-national comparisons on health policy using evidence-based approaches
- National studies on health policy to determine the outcomes of technology-driven initiatives
- Cross-border eHealth including health tourism
- The digital divide in mobility, access and affordability of healthcare
- Health technology assessment (HTA) methods and tools for evaluating the effectiveness of clinical and non-clinical health technologies
- Health and eHealth indicators and benchmarks (measure/metrics) for understanding the adoption and diffusion of health technologies
- Health and eHealth models and frameworks to support policy-makers and other stakeholders in decision-making
- Stakeholder engagement with health technologies (clinical and patient/citizen buy-in)
- Regulation and health economics

Professor Wendy Currie will lead the journal as its founding Editor-in-Chief. Her research, consultancy and publications focus on policy-making for large-scale information and communications technology (ICT) projects in health, financial services and government.

The first issue of Health Policy and Technology will focus on Electronic Health Records in the 21st Century, with papers discussing implementation targets for EHRs in healthcare organizations, cross-border policies for EHRs, financial and non-financial costs of introducing EHRs, clinical and patient engagement with EHRs, government policy for EHRs and country comparisons, security and governance practices in relation to EHRs, and the role of EHRs in campaigns to improve citizens' health and reduce health inequalities.

The first issue also includes a paper on the pioneering new Centre for Health Technology Assessment of Devices and Diagnostics within the UK’s National Institute for Health and Clinical Excellence (NICE). There is also the first of a series of interviews with international leaders in the field of health policy and technology, beginning with Sir Michael Rawlins, Chairman of NICE.

The aim of the Fellowship of Postgraduate Medicine (FPM) is to promote international calibre excellence in postgraduate medical education through its publications, clinical and scientific meetings, and other activities.  The FPM is a British medical charity that was founded at the end of World War I, when it pioneered development of post-graduate educational programmes in all branches of medicine.

Its foundation was the result of a merger between the Fellowship of Medicine and the Postgraduate Medical Association, with Sir William Osler the first president of the new organisation. The FPM is supported by Fellows with expertise in the practice of medicine, medical education and publishing, and research in medicine and related disciplines.

HPT website

FPM website

FPM contact email

Companion diagnostics - a new concept for safer medicines?

@HealthMed Diagnostics can be used in several ways: to establish the nature, subtype and severity of disease; to monitor wanted response to treatment with lifestyle, drugs and/or devices; to monitor for disease progression and for adverse effects of treatment. The term 'companion diagnostics' describes coupling diagnostic imaging or laboratory investigations with selection and monitoring of treatment. Although a logical idea, its use in the medical setting appears surprisingly recent.

In the late and 1980s and 1990s, reports of the use of combination diagnostics appear largely applying to veterinary and dental practice.

The partner term 'companion therapeutics' was used in a 2003 commentary on the FDA  "Draft Guidance for Industry: Pharmacogenomic Data Submission" issued on November 3, 2003, which noted that the [pharmaceutical and biotech] 'industry is now expected to accelerate its development of diagnostics and companion therapeutics towards the goal of personalized medicine'. Implicit in this evolution of a personalised approached to medicines is the recognition that diagnostics will not necessarily identify that a given patient may have a safe or effective treatment flagged as the result of testing.

An early example of a pharmacogenetic companion diagnostic is the UGT1A1 molecular assay for in vitro diagnostic use. This pharmacogenetic test was approved in 2005 by the FDA for use as a companion diagnostic to a specific drug therapy. The test was to be used to identify mutations in this gene in patients who may as a result be at increased risk of adverse reaction to the anti-cancer drug irinotecan. 

2006 and 2007 discussion of companion diagnostics pointed both to more efficient patient selection for clinical trials and a more profitable approach for drug developers. 

Current descriptions use narrower definitions of companion diagnostics as referring to tests to 'identify and detect genetic, protein, or gene expression markers to predict whether a drug works or causes adverse effect in patients'. However there is a long history of coupling tests with treatment choice and refinement, in every therapeutic area from cardiovascular disorders such as hypertension and raised cholesterol, to anaemia and treatment of lung, gastro-intestinal, renal and neurological disease.

To date there are only 75 publications in the PubMed research database with companion diagnostics as a key term, with a typical recent example from August 2011 in Nature Reviews on Clinical Oncology by La Thangue and Kerr applied to cancer chemotherapy: Predictive biomarkers: a paradigm shift towards personalized cancer medicine.

© DRJ Singer 

Companion diagnostics to personalise medicine

@HealthMed What common link is there between confusion, dementia, dyspepsia, heart failure, hypertension, liver failure and stroke (apart of course from excess alcohol in some)? They are all syndromes - clusters of symptoms and physical signs with many possible causes, risk factors and co-morbidities.
Earlier approaches to treating these health-related conditions were largely based on trial on error until the most effective treatment(s) were identified. While pragmatic, in many that may lead to a delay in achieving effective disease control, while exposing some patients to unnecessary risk of adverse drug reactions.
The relatively new term 'companion diagnostics' describes the concept that coupling careful selection of biomarkers of disease and risk factor phenotype, of therapeutic response and early warning of risk of adverse reactions, will provide a more rapid route to safe and effective drug selection and monitoring.
Major current challenges include the relative immaturity of research evidence on cost and clinical effectiveness of combining companion diagnostics with specific therapeutic strategies. A major potential driver to improve systematic assessment of companion diagnostics will come from the extension of the activities of NICE (the UK's National Institute for Health and Clinical Excellence) from pharmaceutical and other treatments into assessment of diagnostic technologies (Diagnostics Assessment Programme), including companion diagnostics. This will be complemented by the role of NICE in commissioning new research where significant gaps are identified. 
A further important challenge is the fragmentation of diagnostic services within clinical health services. There are practical reasons for having multiple local diagnostic capacity for serious acute illnesses for which very rapid access to sophisticated diagnostics is potentially life-saving or critical to minimise preventable complications, from early selection of effective treatment. Where there is the luxury of more than a few hours delay without significant risk to the patient, e.g. while using 'holding' empirical treatment, there needs to be more research on relative effectiveness of local compared with remote lab diagnostic strategies. There are also practical issues to be resolved among biotechnology companion diagnostic developers where joint licensing agreements are needed when multiple diagnostics are indicated from different source providers. And standardisation of testing is needed across national health service and private laboratories to ensure that results of these new diagnostic tests are validated.
And of course when there is a single test, implementation is more straightforward. However where multiple tests are needed within a companion diagnostics portfolio, there will need to be a regular programme of induction and refresher education for prescribers on how best to use and interpret results of this new testing strategy. This will be particularly important for interpreting the currently less familiar genotype based tests.