The ongoing issue of expiring patents for many of the pharmaceutical industry’s blockbuster drugs is undoubtedly good news for the public, as generic manufacturers come in to break market monopolies and drive down costs.
It’s no secret, however, that the loss of patents is a major cause for concern in the drug development world, which is now struggling to come up with new wonder drugs to fill the deficit.
This year might be remembered as an annus horribilis in that respect, with more than a dozen big name drugs set to lose their patents by the end of the year, including the likes of Eli Lilly’s antipsychotic drug Zyprexa and Pfizer‘s massively successful cholesterol pill Lipitor, which in 2006 achieved sales of $12.9 billion.
As a result, big pharma has increasingly been leaning on partnerships with academic and charitable institutions to widen its talent pool, accelerate the drug development process and, in some cases, offset associated costs.
Although accusations of conflicts of interest make this a practice not without complications, research collaborations of this kind might be the key to getting innovative new drugs on to the market as quickly as possible.
A renewed focus on collaboration
A number of announcements in 2011 point towards a renewed interest from various quarters in encouraging a collaborative approach to developing new therapeutics.
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At the government level, incentivising pharma collaborations is beneficial for both the economy and public health; state encouragement of research partnerships seems to have ramped up in the last few years as the industry’s problems have become clearer.
In the UK, for example, The Technology Strategy Board and the Engineering and Physical Sciences Research Council (EPSRC) announced in September that they would be investing up to £9 million to support new alliances between pharmaceutical businesses and academic researchers to develop nanotechnology-based drug delivery technologies.
This was not a purely philanthropic endeavour; the aim of the investment is, according to the Technology Strategy Board, to "help ensure that the UK can become an early competitive adopter of these novel technologies".
In the US, the state-run National Institutes of Health (NIH) regularly funds industry collaborations, especially when it comes to developing drugs for rare disorders that might not otherwise be financially viable.
The country’s university system is also actively encouraging the academic world to reach out to industry and forge research affiliations. Earlier this year a collaboration between biopharmaceutical company Regulus and the University of California, San Diego, (UCSD) received an undisclosed contribution from the University of California Discovery Grant.
The partnership will leverage Regulus’s expertise in targeting microRNAs and UCSD’s innovative research into animal models of angiogenesis in order to develop anti-angiogenic microRNA-targeted therapies that could be quickly translated for the treatment of humans.
According to Regulus’s vice president of translational medicine Dr Hubert C. Chen, this new partnership is just one of the company’s nearly 30 academic collaborations, a network which he says "supports [the] microRNA discovery efforts that feed the company’s pipeline".
Facilitating new collaborations
Cooperation between industry and academia has become established enough that companies are starting to try innovative new approaches to partnering up. Increasingly, universities and industry players are making larger upfront investments to create centres for ongoing collaborative research, rather than participating in one-off arrangements.
In the US, pharmaceutical giant Pfizer has been highly proactive in setting up such centres, an unsurprising attempt to stimulate innovative research, given that its patent on blockbuster drug Lipitor is set to expire in late November 2011.
The company has so far established three so-called Centers for Therapeutic Innovation in the US, the most recent being based in Boston, a global hotspot for medical research.
Beth Israel Deaconess Medical Center (BIDMC) is one of the research institutions participating in Pfizer’s new centre, and its CEO Eric Buehrens shed some insight into the motivation for organisations like BIDMC to partner up with big pharma. "Academic medical centers play an integral role in the early discovery process that leads to drug development," he said.
"But moving these discoveries from the laboratory into the clinic has proven to be exceptionally challenging and costly. That’s why we’re so pleased to be part of this unique collaboration with Pfizer. Through the Centers for Therapeutic Innovation, scientists at BIDMC and throughout Boston will be able to see their research translated into potential therapies that can make a difference to the lives of patients."
The University of Manchester in the UK also announced in May that it had teamed up with GlaxoSmithKline and AstraZeneca to establish the Manchester Collaborative Centre for Inflammation Research (MCCIR) with a focus on translating basic research into new medications for inflammatory diseases. The initial investment for the centre is £5 million from each of the three partners, with the university and its industry partners providing scientists for the project as well as setting research priorities.
"Inflammatory processes underpin many of our priority areas of research and this is a ground-breaking collaboration," AstraZeneca’s executive vice president of innovative medicines Dr Menelas Pangalos said of MCCIR.
"The creation of the new centre is indicative of a new era of pre-competitive sharing within the pharmaceutical sector and with academic scientists, to bring our learning together to ensure the faster delivery of effective medicines to patients."
A completely different method of facilitating efficient research collaboration is through the advancement of IT software, which has the potential to simplify the process of sharing data between organisations and from myriad sites across the world. Indian IT company Wipro, for example, announced the launch of its Wipro Clinical Collaboration Portal, a cloud-based information management system, earlier in 2011.
The system is specifically designed to speed up the exchange of data between pharma sponsors and their research partners when conducting collaborative multiregion clinical trials, and Wipro promises it will reduce clinical trial cycle times by 20% to 30%.
Conflicts of interest
For all the advantages of private-public collaborations that can potentially benefit pharma companies, academic institutions and patients, there is still a significant ethical risk of such alliances in the form of conflicting interests. While universities and other public research organisations are tasked with conducting innovative research that is to the benefit of public health above all, pharmaceutical firms are ultimately beholden to their shareholders.
When pharma’s commercial goals and a university’s public service remit intersect, issues of conflicting interests rarely crop up, but it’s also true that the most groundbreaking therapies are not necessarily the most profitable. This conflict, in the simplest sense, can lead public research organisations down the path of researching industry-sponsored, money-making drugs rather than therapies that improve deficient areas of healthcare.
This kind of conflict prompted former editor-in-chief of the New England Journal of Medicine and senior lecturer in social medicine at Harvard Medical School Marcia Angell to widely criticise the corruption of academic research by the increased influx of corporate money since the 1980s.
In an article published in the Boston Review in 2010, Angell specifically highlighted a clinical trial of the antidepressant Serzone, the authors of which she asserted had a host of financial ties to the industry, including the drug’s developer.
It’s clear that if conducted in an unethical manner – one which prioritises profit to the detriment of public health – the relationship between academia and the pharmaceutical industry can be a profoundly unhealthy one. But although commercial gain will always be a consideration for big pharma, an honest sharing of resources can still be achieved as long as there is a clear, well-established public health goal that is never compromised.
A pertinent example is this year’s collaboration between Anacor Pharmaceuticals and Swiss not-for-profit foundation Medicines for Malaria Venture (MMV) to develop AN3661, a boron-based drug candidate for the treatment of malaria.
While Anacor contributed the boron chemistry platform technology that yielded AN3661, MMV’s funding and added expertise has sped the drug through the preclinical development phase.
"We were excited by AN3661 when Anacor presented the original cell biology data, and the strength of the scientific data has improved steadily over the last year," said MMV’s Chief Scientific Officer Tim Wells in September. "Anacor’s commitment to quality and efficiency has meant that by working in partnership we have been able to move the molecule through preclinical development in record time."
While the ethics behind some research collaborations provides significant cause for concern when it comes to the integrity of academic research, it appears there are ways for pharma companies and universities to enjoy a symbiotic relationship that ultimately benefits the patient.
If the world is to continue developing drugs through its current privately-funded model, it would seem these kinds of partnerships are going to become increasingly important as a key method of maintaining a steady flow of life-saving new therapies in the development pipeline.