It is more or less widely accepted that the historical model of R&D in the life sciences is no longer fit for purpose. Despite this, society desperately needs pharmaceutical companies to continue innovating and producing novel therapeutics for the unmet needs of patients.
But what are the key incentives for drug companies to keep pushing for innovation in R&D and manufacturing? And what stands in the way of achieving efficiencies as they bid to become leaner and more focused?
Drug development is a “lengthy, complex and expensive process”, taking typically more than 15 years and costing more than $1 billion to bring a new drug to market, acknowledges Dr Shu-Dong Zhang, senior lecturer in the school of biomedical science at Ulster University.
Zhang says the reality is that for every successful agent, many more drugs will have failed along the way due to complex safety and efficacy issues. In a bid to make this bloated process more streamlined and efficient, pharmaceutical companies have largely switched from the “blockbuster” drugs of old to targeted therapies that are highly specific in how they fight illness. Therapies such as biologics to treat autoimmune conditions and various forms of cancer and other specialty drugs now make up more than 50 per cent of the global market.
According to Zhang, one of the key elements of successful drug development nowadays is the identification of particular therapeutic targets, which requires in-depth understanding of the precise mechanisms underlying different diseases.
“It is crucially important for drug companies to have a pipeline of drug development projects with well-characterised targets and the technologies to design and discover new molecules to effectively modulate the targets,” he explains.
Zhang adds that another form of drug innovation, drug repurposing, has also been a boon for the pharmaceutical industry. Essentially the process of identifying new uses of existing approved drugs, as the approved drugs have known and acceptable safety profiles, significant time – and money – is saved by repurposing them for new disease indications.
“Pharmaceutical companies and health research funding bodies all recognise the importance of drug repurposing for complex human diseases, including rare diseases,” says Zhang.
“Closer industry-academia collaborations and integrated computational– ie big data – experimental and clinical drug repurposing approaches are needed to tackle the challenges and seize the opportunities in drug development,” he adds.
According to Michael Finn, life sciences partner at law firm Pinsent Masons, criticisms levied at “big pharma” are unjustified and it is in society’s best interests to ensure they continue to innovate.
“Innovation has always been at the centre of what life sciences companies do. The industry is often disparaged for being motivated by profits. Their agenda is actually to do good. Ideas for new products are not formed on profits, they are formed on finding a solution to a problem, often a very serious illness,” he explains.
Massive investment
Yet this requires massive investment, an investment that won’t necessarily be guaranteed a return. As medical treatment becomes more specialised – and drugs budgets face increased scrutiny – pharmaceutical companies have had to undergo a paradigm shift in how they develop and market new drugs. But this works both ways – Finn points out that national health services, like the HSE, need to be open to innovative pricing solutions proposed by industry.
“The diseases that require treatment in modern times don’t have the economies of scale that blockbuster drugs had in the past. Companies must continue to innovate to develop products that improve the quality of life for people with rare and debilitating diseases, yet at a cost that is affordable for countries around the world,” says Finn. He adds that advances in technology, including artificial intelligence, should help bridge the considerable gap between intensive research costs and what countries can afford to pay.
Echoing Zhang, Finn says collaboration will also be essential within this new paradigm of innovation. “Companies need to be open to collaboration and dialogue in drug discovery, particularly at a pre-competitive stage. The more knowledge that can be pooled together and shared, the more efficiently new treatments will be discovered. Organisations like the Innovative Medicines Initiative who spoke at the Irish Pharmaceutical Healthcare Association’s InnovateforLife conference recently, have been paving the way in this regard,” he says.
“From a patient quality-of-life and public-health perspective, it is critical that pharma and medtech companies keep innovating,” says Colin Kavanagh, partner at law firm Arthur Cox. On a more local scale, efforts to ensure ongoing innovation by pharmaceutical companies in Ireland should be prioritised by Government, he adds.
“In order for Ireland to remain relevant to the research side of the industry, it is critical that the Government ensures that global market-leading incentives and infrastructure support innovation here, and not just for the multinationals but also Irish talent.”
Kavanagh believes that in order to encourage innovation, Ireland must support clinical and manufacturing process research, “both financially and in terms of legal and bricks-and-mortar infrastructure. Allied to that we need to ensure that new, cost-effective products are made available to patients.”
Finn echoes this by saying pharmaceutical companies do not lack motivation, but they may need help from other stakeholders to ensure their investment is worthwhile. “The main driver for any company is to improve the quality of life of the patients they seek to help. The main incentive is to reduce the costs of researching, developing, producing and improving a product. This means a product can be made available as quickly as possible to patients who need it the most, which in turn translates into funding for future R&D and realising a return on investment.”