The Future of Healthcare? Kill the bugs save the world! Part 2

Trevor Lewis

Medical Device Consultancy

(Continued from “The Future of Healthcare? Kill the bugs save the world! Part 1”)

So, what about the good news?

Hopefully, after reading Part 1, readers are left in no doubt about the scale and seriousness of the war that needs to be fought against the spread of infectious diseases. The issues raised literally affect all of us! The good news is that many very talented people are working to keep antibiotics effective, searching for new medicines and looking for new innovative ways to treat patients with infectious diseases, which now includes remarkable antivirals. This is all occurring in an ever more regulated world, where an ever increasing amount of ‘personalised’ medicines are challenging regulators all around the world. Patients are now typically very well informed and know that medicine can often provide a solution tailored to individual predispositions, genetic or environmental, and want truly personal and personalised therapies.

The Massachusetts Institute of Technology’s Lincoln Laboratory (MIT) last summer may well have made one of the most important breakthroughs in healthcare with the development of a broad-spectrum antiviral. 1

However this good news should be moderated by the fact it has only been tested in the laboratory and not yet on humans. So although it is at least ten or even twenty years from being placed on the market, it does look very promising and is surely a development that may one day be considered as significant as the introduction of penicillin. It is important to detect most infections quickly to ensure treatment is effective and make it as personalized as possible. Currently, most patients afflicted with viral infections are simply told to go home and let nature take its course. In a few decades time, this absence of any useful medical intervention will be seen as primitive and totally unacceptable. Emerging and rapidly evolving viruses are a threat to human health on a truly global scale and providing an appropriate and matched therapy is going to become ever more important, especially for novel influenzas and other hard to treat infections.

Another important landmark from last summer was the US Food and Drug Administration’s (FDA’s) latest “Strategic Plan: Advancing Regulatory Science”. This plan has as a priority the stimulation of innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes. In the UK, the Technology Strategy Board’s (TSB) announced on the 10th April 2012 an £8 million grant for “…twelve new research and development projects that aim to improve the future diagnosis, detection and management of sepsis” that will be matched by UK companies receiving the funds – a total approaching £16 million. Previous investments assessing the impact of near-patient testing of around £1 million and a budget for other related diagnostic projects totalling around £7 million indicate a sense of purpose. This is topped off by a £180 million funding bridge for medical breakthroughs aimed at small and medium sized enterprises (SMEs) and academics to develop healthcare solutions to healthcare challenges announced on the 11th April 2012 by the TSB. 2

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“It is important to detect most infections quickly to ensure treatment is effective and make it as personalized as possible.”

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These projects are likely to encompass projects for personalised or stratified medicine, regenerative medicine, molecular diagnostics, eHealth and mHealth solutions. Whilst this may initially seem a large scale funding initiative, in the range of £150,000 to £3 million per project, this is small compared to those at the European level.

The European Union’s Seventh Framework Programme (FP7, 2007-2013) is currently funding over 30 research projects into antimicrobial resistance for a diverse group of pathogens with a total budget of around €150 million. These include twenty projects concerned with bacterial infections, seven viral infection projects, four protozoan infection projects, and one fungal infection project (although many of these overlap and are complementary in various ways). The European Commission (EC) and Innovative Medicines Initiative (IMI) have put more than €22 million into two important diagnostic projects: TheraEDGE and RAPP-ID. Indeed since 2000, the EC has funded 26 projects with a total budget of €56 million, targeting the development of diagnostics.

Currently, the use of antibiotics is rarely based on the results of a diagnostic test, and the initial patient diagnosis is empiric. An example project that could prove very useful in both the commercial and clinical exploitation of point-of-care (POC) tests is the TEMPOtest-QC, an integrated tool-kit for the clinical evaluation of microbial detection and antibiotic susceptibility.

IMI is, with the EC, funders of projects like RAPP-ID mentioned above that is aiming to develop technologies to combat hospital acquired infections (HAI) and improve the efficiency of clinical trials for treatments of TB, respiratory infections and blood infections (sepsis). IMI has a fighting budget of €2 billion and is currently funding 23 projects with a combined budget of over €450 million that cover drug safety, efficacy, knowledge management, education and training. This large budget is still dwarfed by traditional global defence spending of around US$2 trillion.

To reinforce the strategically important projects, a workshop was held during late September 2011 that resulted from the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), a high level group involving some of the very best people in the field globally who have produced recommendations following summit meetings between US and EU officials concerned with antimicrobial resistance. There is a strong desire to cooperate on this very important health priority by both the US and EU: The EU-US Summit Declaration agreed upon on 3 November 2009 called for the establishment of “a transatlantic taskforce on urgent antimicrobial resistance issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities, prevention of both healthcare- and community-associated drug-resistant infections, and strategies for improving the pipeline of new antimicrobial drugs, which could be better addressed by intensified cooperation between us.” The objectives of the taskforce are to increase the mutual understanding of the US and EU activities and programs relevant to the antimicrobial resistance issues, deepen the transatlantic dialogue, provide opportunities to learn from each other, and promote information exchange, coordination, and cooperation. The European Centre for Disease Prevention and Control (ECDC) provides the secretariat for the taskforce and publishes documents relating to the taskforce’s work. The TATFAR report, “Transatlantic Taskforce on Antimicrobial Resistance: Recommendations for Future Collaboration between the US and EU 2011,” covers many important topics and includes high level recommendations.

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“Currently, the use of antibiotics is rarely based on the results of a diagnostic test, and the initial patient diagnosis is empiric.”

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As a result of TATFAR, a collaborative public meeting was held during late September called “EU-US Workshop: Challenges and Solutions in the Development of New Diagnostic Tests to Combat Antimicrobial Resistance.” This meeting was co-sponsored by the National Institute of Allergy and Infectious Diseases and the EC’s Directorate General Research and Innovation and was held in Brussels. The speakers, leaders in their fields, provided the meeting with a very comprehensive discussion of the whole subject. The presentations and findings are published and provide many insights to those concerned with the fight against bacterial infections. 3

It is clear that healthcare is going to get ever more personalised and global as the war on bugs becomes ever tenser and a battle cry may be required along these lines: “Kill the bugs save the world!”

A More Regulated World too…

The most recent significant guidance for personalised/stratified medicine diagnostics is from FDA: Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices (14th July 2011). 4

The proposals (expectations) for companion diagnostics include:

• Draft guidance issued 14th July 2011 and final guidance expected by 30th June 2012.

• Definitions and general policies.

• Suggests trials must be conducted under full Investigational Device Exemption (IDE) Regulations, i.e. a submission and review by FDA is required. A ‘pre-IDE’ consultative process is highly recommended.

• Encourages where possible the concurrent clinical evaluation of the drug and diagnostic, ultimately resulting in approval for both the drug and diagnostic on the same day at the end of the process.

It is crucial for manufacturers to pay attention to the imminent revision of the EU’s medical device directives and to assess the likely impact on the direction of medical technology regulations for many years to come. It is clear that IVDs will now be subject to a risk-based classification in Europe, in line with the Global Harmonization Task Force (GHTF) approach. It is also likely that other GHTF approaches will be adopted now or in the near future following Study Group 5’s most recent publication on the 16th September 2011 entitled, “Clinical Evidence for IVD Medical Devices: Scientific Validity Determination and Performance Evaluation.”

At the EU-US workshop on antimicrobials and diagnostics, Professor Rosanna Peeling, Chair of Diagnostic Research, London School of Hygiene and Tropical Medicine, suggested that the required diagnostic tests can take 2-10 years and $10-100 million to develop, 2-5 years to get through regulatory approvals, and another 5-7 years to get adopted. This means it could take around 9-22 years before a test is in widespread routine use. Given the potential casualties in the war on bugs and economic consequences, we as a society, indeed globally as the human race, need to make these developments happen faster and use our resources wisely – the future of our healthcare depends on it.

References:

1 http://web.mit.edu/newsoffice/2011/antiviral-0810.html

2 http://www.innovateuk.org/news-media.ashx

3 http://ecdc.europa.eu/en/activities/diseaseprogrammes/tatfar/pages/index.aspx?MasterPage=1

4 www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf

Part 1 of this article can be viewed here

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About the author:

This article was written by Trevor Lewis, Principal Consultant of Medical Device Consultancy, and was commissioned by PiR Limited.

Trevor has been an independent consultant for around 17 years, after working in industry for than 10 years. Trevor provides specialist business development assistance for universities, medical device, in vitro diagnostic (IVD), biotechnology and pharmaceutical companies. He supports and mentors senior management with their strategic planning, marketing, product management, quality systems and regulatory compliance in the US and Europe. He has become a well known and respected regulatory expert, ultimately leading him to assist in the training of national regulatory authorities and senior officials in the European medical device directives, especially in Egypt and Turkey. He is a partner in the major European Commission-funded diagnostic project TheraEDGE and an advisor to another large scale diagnostic project funded by the Innovative Medicines Initiative known as RAPP-ID.

PiR is a brand synonymous with providing innovative senior resourcing solutions to life science organisations. As a result of our exclusive focus on the sector, we have an understanding of many of the issues faced by pharmaceutical, biotechnology, diagnostic and medical device companies in the 21st century.

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How do you see our healthcare in the future?