A symbiotic relationship between biotech/medtech and medical charities

A symbiotic relationship between biotech/medtech and medical charities

Partnerships between biotech and medtech companies and the third sector can offer benefits to each. Charities can gain valuable expertise in drug or device development from working collaboratively. They can use their influence to shape the direction of research effort. And they can support research with the aim of seeing breakthroughs that may not be achievable under the incentive structures currently available to private companies.

In turn, advantages to the company may include access to the results of basic research carried out by or in partnership with the charity, benefits flowing from the charity’s unique relationship with patients, and sometimes direct financial investment.

The patient voice

Charities can have an important role in enabling affected patients to shape the development of treatments. Failure to take account of what really matters to patients can lead to poorly directed R&D activity. It can mean that the wrong clinical trial endpoints are chosen, for example. Innovative companies are already recognising the need to learn from patients at all stages of the development process, particularly for rare diseases. Rare skin disease specialist Fibrocell Science, for instance, depends on interaction with patients and carers to inform development from an early stage. And patient advocacy can be important in supporting patients with the use of new medicines and devices. Small charity INPUT, for example, focuses on helping diabetic patients to benefit from insulin pump therapy, and to gain access to it through the NHS.

Industry grouping the UK BioIndustry Association (BIA) selects an annual “Charity of the Year” – currently Parkinson’s UK – to support. In addition to fundraising support, the connection seeks to promote the patient voice within the industry, connecting the charity to “influential thought leaders within our strong ecosystem of corporate businesses, networks, academia, and associates”.

Taking research from bench to bedside

Charities are developing an important role acting as intermediaries between the different participants in medical research. They often have links to NHS bodies through partnerships established to improve patient care and support, and these can form the basis of link-ups between companies developing new products and clinicians able to participate in the development process.

The NHS Diabetes Prevention Programme, for example, emerged from the NHS’s strategy of building stronger partnerships with charitable and voluntary sector organisations announced as part of the 2014 Five Year Forward View. In this programme charity Diabetes UK works alongside Public Health England and NHS England to deliver a targeted behavioural intervention programme aimed at reducing the incidence of Type 2 Diabetes. This kind of close working relationship can build trust between charities and clinical settings that may be invaluable to those developing new products and services.

Many medical charities maintain databases of clinical trials relevant to their patient populations, enabling developers of new medicines to build a cohort of patients to participate in a clinical trial, even for rare conditions. Cancer Research UK provides a searchable database of clinical trials for many different types of cancer allowing patients to identify trials that might be relevant to them.

Connections and tools like these can play a key role in helping biotech and medtech companies access the clinical settings and patient cohorts needed to take a medicine or device into the clinic.

Investing in private sector research

Many charities have long experience of investing in their own research projects, often in partnership with academia. The Crick Institute is a recent example of a charitably funded biomedical research institute, whose founding partners the Medical Research Council, Cancer Research UK, Wellcome, University College London, Imperial College London and King's College London include both medical charities and universities.

Funding private sector research is potentially more problematic. Charities must be careful to avoid stepping outside their permitted scope of activity. But some have found ways to fund research in a way that both raises funds and furthers the charity’s objectives by supporting research projects in development through the clinic.

The British Heart Foundation has established a Translational Award scheme to support early stage development of new cardiovascular medicines and technologies to the point where they are attractive enough for follow-on funding. It actively collaborates with biopharma companies to help bridge the funding gap for promising innovations.

A new approach - the Dementia Discovery Fund

The DDF was set up in 2015. Convened by the UK government as a new way to bring financing to dementia research, participants include charity Alzheimer’s Research UK along with an impressive collection of pharmaceutical and biotech companies, as well as the Department of Health.

DDF works with academic partners to fund new projects and create new spin-outs. It has developed a portfolio of biotech start-ups and collaborative projects across a range of new and neglected research fields.

With high profile support from philanthropist tech billionaire Bill Gates, DDF aims to combine a focused investment strategy to tackle dementia with an attractive return for investors. The fund approaches companies working in areas of interest without waiting for applications, and in many cases proactively creates its own projects.

Importance of maintaining independence and keeping to charitable objectives

Among the substantial benefits of collaboration, however, charities do need to be careful to maintain their independence and adhere to their charitable objectives. Guidance on working collaboratively is available - The Association of the British Pharmaceutical Industry (ABPI) has worked with charity representatives to produce a guide to collaboration between pharmaceutical companies and charities.

The Association of Medical Research Charities (AMRC) represents 140 health and medical research charities. Its membership invested more than £1.6bn into health research in 2016. Levels of experience for charities varies. The trend towards becoming more entrepreneurial is recognised by the AMRC, and it offers detailed guidance on working with industry for charities starting out on this path.

The Charity Commission has recently carried out a consultation on draft guidance exploring how a charity with a connection with a non-charitable organisation can maintain its independence and comply with its legal duties.

The guidance is not confined to the medical charity sector, and extends more broadly into areas like political activity and fundraising, but it provides a useful backdrop for a charity in assessing a new collaboration or partnership.

This guidance is not revolutionary – the principles it embodies will be familiar to trustees and their advisers. But the detailed guidance will be helpful in shaping a project where charitable and non-charitable organisations want to work together.