The productivity of the pharmaceutical industry has decreased drastically over the past few decades. This affects the number of new therapeutics and drugs available to treat patients. Some ideas have been proposed to ease the process of bringing a drug to market and to promote innovation in biotech companies. Here are some that were discussed at Biovision, in Lyon, in March.
In March, the Biovision World Life Sciences forum hosted a session on promoting innovation in the pharmaceutical industry. Peter Lachmann, emeritus professor of immunology at the University of Cambridge, gave an introduction to the current biotech system. He emphasized that “the present system of taking drugs to market has become unsustainable, hugely expensive and unproductive.” The fact is that “there has been huge progress in medical knowledge, but the actual productivity [of biotech companies] has fallen about 50 fold in the last 60 years. A billion dollar spend is now about 2% of what it was years ago”.* The system for using scientific knowledge to create medical products is broken. “The result is a disaster.”
"There is no drug with biological activity that does not also occasionally have undesirable side effects" Peter Lachmann. Source : Fotolia/Alexander Raths.
Many obstacles between drugs and the market
“Today the process of phase 1-2-3 clinical trials is estimated to take about 10 years and cost more than a billion dollars,” explains Lachmann. As a result of the high cost of this process, only a few big companies have the means to cover the cost of bringing new drugs to market. Startups and small companies can’t usually get past phase 2 trials to phase 3, which involves large numbers of people and looks for rare side effects. Hence, many highly promising products remain semi-abandoned at that stage, while biotech companies go bankrupt.
And yet, Europe is an important place of investment in pharmaceutical R&D. “In 2011, industry invested 27.5 billion euros in the field,” says Hervé Gisserot, president of Les Entreprises du Médicament (LEEM), also representing GlaxoSmithKline. The system really needs to be optimized but the question of how remains to be seen.
Productivity decrease of pharma companies. Nature Reviews Drug Discovery 11, 191-200 (March 2012). http://www.nature.com/nrd/journal/v11/n3/fig_tab/nrd3681_F1.html
A quicker, more open transfer to market
According to Peter Lachmann, clinical trials could be improved by “allowing patients, if they wish, to be given drugs at the end of phase 2, providing that they were given all the relevant information. It would be voluntary and run alongside the current regulatory process.” This would make the drugs available earlier and give patients the opportunity to make an informed decision.
Hervé Gisserot says the French association of drug companies, LEEM, believes strongly in the new paradigm proposed by open innovation. This means abandoning the old system of internal development. “Open innovation scans internal and external sources of ideas. It brings them to the market via multiple paths.” This is a process that Cécile Tharaud sees as “a new organization to ease technology transfer and integrate new partnerships all along the drug development to the market.” She adds that today’s definition of intellectual property does not ease this new organization. There is definitely a need for radical change.
Abolish Phase 3 trial
Lachmann isn’t the type to avoid controversy, and has ideas about what form that radical change could take. He proposes the immediate diffusion of drug surveillance information into a public database, with suitable anonymity, of course. This goes along with a radical proposal: the abolition of phase 3 trials. The emeritus professor feels that “Phase 3 trial test groups are not representative of the population that takes the drug in the end. They exclude people that don’t comply, people that have various co-morbidities. They are a rather self-selected population to start with.” According to him, “it would cut time and cost in half to abandon phase 3 trials and invest in post-marketing surveillance to monitor both efficacy and side-effects.”
Towards homogenous policies in Europe
Christian Bechon, along with all the speakers, emphasized that Europe needs to establish stable and homogenous rules for innovation. After the Thalidomide disaster between 1957 and 1961, the public tolerance of risks posed by drugs became totally unrealistic, added Lachmann. The EU instituted a directive on Product Liability, which makes drugs subject to strict liability. This means that even if no better option is available or if a risk-benefit analysis is in favor of giving the treatment, the providers of the drug are still liable. “This is one of these things that was done in a moment of great indignation, which makes no sense at all. As a consequence the control system is now unrealistically strict.” According to the immunologist, “there is no drug with biological activity that does not also occasionally have undesirable side effects.”
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* Lachmann P. J. (2012)
Biovision session on Innovation in Europe