The pharmaceutical industry has made important contributions to quality of life, longevity, economic growth and education at all levels, and is a key component of the government’s growth strategy. However, the industry is now under considerable pressure as the number of NCEs has not increased over the past decade, and there have been significant revenue losses as important drugs lost patent protection. Consequently, the sector has experienced major reductions in R&D budgets, closure of research sites and the loss of thousands of skilled jobs. A new and sustainable funding model with public sector participation is urgently required for world class UK scientists to invent and develop innovative medicines that meet the medical needs of the 21st Century, and contribute to economic growth. This perspective considers how these objectives might be achieved, and aims to stimulate discussion.
First, we should build a consensus of expert stakeholders with the common objective of informing and influencing future development of world class healthcare innovation in the UK. Learned societies and professional bodies have obviously contributed to the recent life sciences review, but we now need to work together to ensure proper focus on drug discovery. The government has stated a firm commitment to life sciences as a catalyst for growth, but emphasis appears to be on clinical trials, biologics and cell therapies rather than on cost effective and orally delivered small molecules that are the bedrock of any healthcare system.
Second, future R&D should focus on therapeutic areas of significant medical need where transformative new drugs will improve quality of life, and bring economic benefit. For example, a recent survey showed that 38% of Europeans suffered from mental disorders with depression being the single greatest burden of all human diseases. Brain disorders cost Europe almost Eur800bn per year which is more than cancer, cardiovascular and diabetes combined, and yet Pharma is withdrawing from neuroscience research. To encourage investment in such challenging areas, it will be important to define efficacy/safety criteria early in drug discovery programmes so that effective new agents can expect fair reimbursement and an acceptable return. This would minimise negative regulatory decisions currently taken after at least 10 years investment in discovery and development, and would have a positive impact on costs.
Third, we must address attrition as current failure rates during discovery and development are driving escalating R&D costs that are simply unsustainable. One approach would be to expand pre-competitive collaborations between industry/academia to focus on target selection/validation, predictive toxicology and to identify patient sub-groups that respond to agents with novel mechanisms of action. These initiatives would reduce risk, simplify clinical trails and lower costs which would make the sector more attractive for investment, and would also deter parallel and wasteful pursuit of non-validated targets. Companies would create IP through innovative, but distinctive, medicinal chemistry programmes.
Fourth, as Pharma contracts in the UK and Biotech struggles for new investment we must consider new models of drug discovery that capitalise on our outstanding record of innovation and productivity. A network of Therapeutic Centres of Excellence should be established where expert medicinal chemists released by industry can work within multidisciplinary environments to exploit innovative biology emerging from significant investments in UK biomedical research. Unused assets from Pharma could be included, and a flow of spin-outs would revitalise the biotech sector. Education and training of next generations of research scientists would also be delivered, and new jobs created.
Fifth, experienced industrial scientists should be also embedded in world class biomedical centres by creating new chairs in medicinal chemistry since chemists play a pivotal role in transforming biological discoveries into innovative new medicines. There is also a pressing need to invest in fundamental new chemistries to address challenging biological targets such as protein/protein and protein/nucleotide interactions that are currently beyond traditional drug templates. It is important to realise that the majority of medicinal chemistry “muscle” was located in Pharma and the significant expertise recently released should be re-captured within Therapeutic Centres of Excellence, or similar initiatives. If world class Pharma/Biotech talent is allowed to fade away, it will be extremely difficult to re-build quality in the future.
Finally, any new funding model may require reallocation of current budgets rather than new monies considering current deficit constraints. Encouragingly, the EU has recently announced “Horizon 2020” where investment of Eur80bn in R&D is aimed to improve long term competitiveness, and Eur8bn has been ring fenced for health care, which is considered to be a “major concern” Public private partnerships involving universities, research centres, and industry will play a key role, and Therapeutic Centres of Excellence make a natural and synergistic fit. Government, Funding Councils and Charities should now invest for future growth, as economic benefits will largely depend on a strong UK drug discovery capability that invents new medicines for world wide commercialisation. Lack of investment in translational medicinal chemistry will see UK biology discoveries exploited by the rest of the world which would be inconsistent with the government’s commitment to life sciences, and would be a major economic loss.
The positive benefits of such exciting initiatives would include:- UK discoveries would help meet the healthcare challenges of the 21st Century; quality of life would be improved within constrained healthcare budgets; important diseases areas abandoned by Pharma would receive proper attention with consequent patient benefits; assets not being pursued by Pharma would be revived and developed; economic benefits would flow as UK innovations enter world markets; the UK science base would be strengthened with exciting career opportunities for world class scientists to reap the benefits of our internationally competitive science education; new biology emerging from UK laboratories would be expertly exploited by world class medicinal chemists; the biotech sector would be revitalised as an additional source of innovation/discovery with a sustainable return on investment.
Written by Simon Campbell, Kingsdown, December 2011
The One Nucleus blog is written by individuals and is not necessarily a reflection of the views held by One Nucleus.
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