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International Clinical Trials

A New Engine

It won’t be news to anyone reading this article that we have a problem in drug development. Pharmaceutical companies are having to face up to not just one but three major issues, any of which would on their own prove a tough nut to crack. The fact that they are all converging at the same time is creating a perfect storm that shows no sign of abating, leaving the industry to fight three major fronts:
  • A paucity of new drug approvals: 2010 was one of the worst years on record, with the European Medicines Agency showing only 41 fi nalised applications, compared to 125 in 2009. Applications were up in 2011, but we’re still a long way off from the steady stream of new approvals that the industry needs in order to remain viable (1)
  • Spiralling drug development costs: an analysis of 1,200 drug approvals dating back to the 1950s tells a grim story. The amount of money a company had to invest per drug in 1970 was around $100 million; by 1990 that fi gure had increased to $500 million; by 2009 it had reached $4 billion; and it is now heading towards $10 billion (2)
  • A tranche of products coming off patent over the period 2012 to 2014: this looming patent ‘cliff’ will result in more than 110 pharmaceutical products losing patent protection, including 14 blockbuster drugs (3)
These problems emphasise the fact that the current drug development process is broken, and the industry needs to find a new model before it can move forward again.

In light of all of this, it is not surprising that stocks of some of the industry’s biggest players – including Pfizer and Merck – are down 40 per cent from a decade ago, and the industry as a whole has cut 300,000 jobs. It is pretty clear that the current model of drug discovery will not be suffi cient to dig the industry out of this hole. As Corey Goodman, a former Pfizer executive and the founder of Exelixis, put it: “We don’t just need a Band-Aid, we need transformational change.”

Towards a New Model

It is likely that no one solution is going to cure the industry’s woes and put it back on a path to profi tability. Rather, a set of solutions will be required, working together to address the varied issues confronting drug development. Reduced R&D costs, combined with a more flexible approach to development, are likely to form part of the new model. The industry can no longer support huge internal R&D groups, nor can it maintain scientific expertise along every step in the development pathway, from lead identification to new drug application. “Biology is too complicated for any one company,” commented Stephen Friend of Sage BioNetworks.

The future model of drug development needs to embrace a cost- and risk-sharing model in which drug companies can reduce their internal fixed costs and instead outsource activities to smaller specialist suppliers.

According to Bernard Munos, a former executive at Eli Lilly – and listed by FierceBiotech as one of the 25 most influential people in biopharma today – the drug industry needs to cut research and development. “The industry needs to spend research money in an entirely new way. Instead of chasing improvements to blockbuster drugs that help lots of people a little bit, it should focus on true breakthroughs that help patients a lot. And rather than do the research in-house, companies should close their labs and outsource the work to tiny, nimble start-ups.”

It is a model that the industry has been adopting to a greater degree at the very front end of its pipeline: acquiring or licensing the rights to promising lead compounds from small, fleet-footed start-ups (see Figure 1). Effectively, companies are de-risking their early research efforts by allowing other companies to shoulder much of the risk. In return, the pharma company pays a premium for the products it acquires, but the premium is worth the reduced risk and cost that it receives in return.

We can see the same outsourcing model creeping into the back end of the development pipeline as well, with the industry increasingly outsourcing its clinical trial activities to CROs. Here again, companies can reduce their internal fixed costs, replacing them with external variable costs.

Outsourcing drug development in this way has become an indispensable resource for pharma companies, saving millions of dollars by predicting early failures, as well as contributing to the greatest successes in pharmaceutical innovation.

With the front and back ends of the pipeline being outsourced, this leaves only the development work in the middle; the work of refining and advancing lead compounds through to the investigational new drug stage is the main focus of the internal R&D organisation.

For a variety of reasons, this has been the last area to undergo a transformation; the work of lead development is piecemeal and complex, with many small experiments needed that differ from compound to compound, making this part of the process inherently harder to outsource. The industry finds it relatively easy to outsource a large chunk of clearly defined work, such as conducting clinical trials for a new compound. For a big single effort such as this, it makes economic sense to spend the time finding a CRO, negotiating the contract and monitoring progress. However, for lead optimisation – with the multitude of small independent tasks that need to be performed – the act of searching for individual suppliers for each piece is time-consuming and hard to justify on an economic basis. That model is changing.

Research Exchanges

Private research exchanges are a new way for pharmaceutical companies to empower scientists, showcase internal science and manage relationships with external research partners. By bringing together services from all research providers into one web-based platform, research exchanges make it easy for scientists to communicate both with each other and with outside experts.

Each private exchange has the tools to efficiently manage a wide network of internal and external partners from the perspective of a large research organisation. An exchange simultaneously serves as a request management system, a vendor management system, a service management system and an e-commerce system. Users can request quotes, rate vendors, compare services, track orders and more – all from one private web portal. This is why we are beginning to see the world’s most forward thinking pharma companies start to manage their research with private research exchanges (4).

According to Mike Snowden, Vice President, Discovery Sciences, at AstraZeneca: “By connecting our internal and external science, the virtual laboratory platform is creating a new approach for our scientists to run experiments with an optimal balance of speed, quality and cost. We look forward to assessing how the virtual laboratory platform impacts and accelerates productivity in the R&D pipeline.”


The arrival of research exchanges has heralded a new era of virtual drug discovery. By enabling research scientists to access any service and any expert in just a few mouse clicks, they can dramatically improve productivity, reduce costs and promote innovation. This paradigm shift in research strategy could be exactly the enabler that the pharma industry needs in order to shake off one more piece of the old broken model, and take a step towards a new drug development model – one of reduced cost, shared risk and increased outsourcing.


1. Where will new drugs come from? Editorial, The Lancet 377(9,760): p97, January 2011
2. Munos B, Lessons from 60 years of pharmaceutical innovation, Nature Reviews Drug Discovery 8: pp959-968, December 2009
3. 2011 CMR International Pharmaceutical R&D Factbook, Thomson Reuters, London
4. Visit:

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Kevin Lustig has spent most of the past 30 years either managing research groups or running his own experiments at the bench. He is a co-founder and Chief Executive Officer of Assay Depot, the world’s largest online research exchange for drug discovery and development. In 2001, he founded and ran R&D at Kalypsys Inc, a 100-person fully integrated drug discovery company that raised over $170 million in venture funding and put fi ve drug candidates into human clinical trials. Prior to Kalypsys, he directed lead discovery at Tularik. Kevin carried out postdoctoral work at Harvard Medical School after receiving a PhD degree from the University of California, San Francisco, an MS degree from the University of Missouri and an AB degree, magna cum laude, from Cornell University.

Maria Thompson has a background in molecular genetics and over 18 years of experience in pharmaceutical and diagnostic research and development. She has held a variety of positions including Head of Genome-Wide Screening for type 2 diabetes, Six Sigma Black Belt, Principal Consultant and VP of Scientific Affairs, as well as running a private consulting company providing scientific and technical advisory services to clients across the life science industry. Maria holds a BSc in Genetics and a PhD in Molecular and Cellular Biochemistry from the Royal London School of Medicine.
Kevin Lustig
Maria Thompson
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