New alliances and approaches to research and development in the pharmaceutical and biotech sectors are accelerating the production of life-saving medicines
The pharma industry is used to unpicking complex patterns, but its greatest challenge has been restructuring its own DNA as drug development becomes more costly and blockbuster success more elusive.
Its new strategy is to partner with small, innovative firms at the cutting edge of scientific thought and laboratory research to reduce the multi-billion-dollar price tag of taking a medicine from bench to bedside.
Rigid monolithic structures are crumbling and collaboration, once unthinkable, is now a comfortable concept as the big players, startups and academia intertwine.
“Companies used to plough their own furrow, but now we have a collaborative nature that is doing very well,” says Charles de Wet, medical director of Boehringer Ingeleheim, a world-leading pharma company that majors in respiratory, cancer, cardiovascular and diabetes.
R&D executives shared concerns that the drug development process is too slow, cumbersome and inefficient
It is one of ten leading companies that founded TransCelerate, a non-profit organisation dedicated to solving common research and development problems. It has grown to 19 companies that share intelligence on new approaches to corporate governance and engage with regulatory bodies to remodel clinical trials.
“R&D executives shared concerns that the drug development process is too slow, too cumbersome and too inefficient, and that we needed to identify the bottlenecks,” says Dr de Wet.
Clinical trials, which can take up to a decade, are a money pit for pharmaceutical companies and TransCelerate is promoting new working practice that can streamline them without compromising safety.
But its ethos goes way beyond good housekeeping. The spirit is now for pharma to address disease pathways and crack molecular codes so that conditions can be intercepted before they cause their greatest harm.
Pharma has realised that it needs to re-evaluate the way it works as well as what it produces, and Janssen formed a risk-sharing partnership with the NHS and the regulatory body NICE that includes the first Patient Access Scheme in the UK where the NHS only pays for the company’s multiple myeloma drug when a patient has responded to treatment. It also has a Pay If You Clear scheme where it refunds medicine costs if a Hepatitis C patient is not free of the virus in 12 weeks.
Mark Hicken, managing director of Janssen UK and Ireland, says: “The healthcare landscape in the UK is changing and we are going to see more innovative ‘beyond the pill’ solutions that harness technological advances and free up NHS resources.
“This as an exciting opportunity to collaborate with the NHS and others, working in partnership on projects that will help patients to live longer, happier and healthier lives.”
In another age, Professor Yannick Jacques’ work tackling a critical disease pathway could have spent years in isolation at Nantes University research centre.
But now the distinguished French immunologist is connected with experts from three UK universities and a global consumer health pharmaceuticals company. His work on the IL-15 protein, which impacts autoimmune conditions such as psoriasis, rheumatoid arthritis and inflammatory bowel disease, has the fast-track factor.
It is a lighthouse signal of how pharma is opening up innovation and accelerating the route to novel therapies for diseases that cause misery.
The project is being nurtured by Johnson & Johnson, which has a nimble approach to innovation despite its gargantuan corporate profile of 275 companies operating in 60 countries with 128,700 workers.
Its London Innovation Centre, one of four worldwide, is a hive of networking and collaboration acting as the agitating force to link expertise with research potential.
The approach is changing the face of the quest to combat chronic non-communicable diseases, such as Alzheimer’s, cancers, cardiovascular disease and diabetes, which are on the march with growing and ageing populations.
“We are creating a culture to bring highly committed staff together and support each project with subject-deep experts with proven bench-to-product experience,” says Patrick Verheyen, head of Johnson & Johnson Innovation, London. “Professor Jacques had an incredible insight into IL-15 and we want to get this from the lab to the patient as soon as possible.”
These new relationships are paying dividends and Britain’s biotech industry is growing.
The silos of clinical research and product development have been dynamited clear of constraint
Celia Calcoutt, innovations and skills executive director of the Biotechnology and Biological Sciences Research Council, which funds scientific research across the UK, highlights that new biologic drugs have jumped from 6 per cent of the market in 2003 to around 70 per cent currently.
“The challenge is that low-hanging fruit has been picked so it is more difficult and more expensive for pharma companies, but demand from patients is growing so that pulls business in,” says Dr Calcoutt.
A changing landscape could also see greater links between nutrition and medication with study of the microbiome – the plethora of organisms that share our body –providing health solutions that reach beyond the pill and the syringe.
The silos of clinical research and product development have been dynamited clear of constraint.
As Mr Verheyen concludes: “Innovation is what happens when you bring experts together to look at the same problem.
“There will be a time when diseases like Alzheimer’s, which are now without a cure, will be stopped in their tracks.”