Since the first days of the pharmaceutical industry, data has been kept in secret, expensive silos by companies wanting to hold on to information that could give them a competitive edge, often at the expense of development. Even if a company did want to share its data, IT resources were rarely available to make it cost effective to do so.
Now all that is changing. The Biobanking and BioMolecular Resources Research Infrastructure (BBMRI) project, funded by the EU, is challenging pharma to find solutions for sharing ethics, security and access across a pan-European database. If they get it right, the results could be groundbreaking.
BBMRI comes at a time when some of the biggest names in pharma are recognising that progress lies in the sharing of information and resources, and a new unified approach to development. Head researchers at companies such as Pfizer and Roche are saying access to shared information is vital if the biggest questions in pharma today – from cancer to AIDS – are to be solved.
There is no shortage of IT players willing to woo the pharmaceutical industry. Software companies, including the likes of IBM, have been trying to win over big pharma for some time, but have had little success in proving that their solutions can meet the industry’s needs.
Biobank of the future
The idea of a biobank is nothing new. What this new project hopes to do, however, is build a sustainable model for a biobank that works in the interest of researchers, both private and public, offering low-cost access to infrastructure and samples while upholding the highest ethical standards set by the EU and other internationally governing bodies.
The end result, it is hoped, will be a faster reaction time to epidemics, better availability of research tools for universities and other organisations and, more importantly, for private business, better access to a more succinct and standardised set of research samples – access that could give industry new impetus to conduct research into areas previously thought unachievable.
BBMRI has received the support of pharma players large and small, and it is drawing on the expertise of privacy advocates and leading healthcare professionals to solve key issues such a resource will pose, one of the biggest being a shared-access IT system that holds standardised data, which can be extrapolated in many different ways.
Professor Kurt Zatloukal, BBMRI coordinator and deputy director of the Medical University at Graz, Austria, said the IT infrastructure for such a project poses as many problems as sample patents and ethics do. For a start, a website will need to be created, data silos produced, access codes created at varying levels and data from numerous holders will need to be transposed in a way that is recognisable to all industry users. Add to this the security risks, standardisation of data entry and maintenance and support of systems, and the enormity of the task at hand seems overwhelming.
BBMRI is looking to set up a series of expert centres that will provide access to bio samples, and a database that will contain all research findings using these, regardless of whether public or private organisations are behind them.
“What we are looking at with BBMRI is really one solution [for bio resources for sampling] for all of Europe,” Zatloukal says. “This is going to be partly for, and part of, academia, big pharma and small to medium-sized enterprises.
“Furthermore, the expert centres created under BBMRI will be highways for transnational research collaboration. They will also have to meet standards for the rest of the world, for example China. We hope to collaborate more with nations outside of the EU in the hope that this will advance research and increase access to samples, to help push the development of cures for the next big disease.”
Right start for pharma IT
To get anywhere near this stage, BBMRI first has to come up with a solution that has the potential to work for all industry players. Even within one pharmaceutical company, few solutions are created for open access, making information sharing difficult at best.
Pfizer Biotherapeutics and Bioinnovation Center senior vice president and CSO David Cox says he believes the pharmaceutical industry will fast reach a dead end if such issues are not addressed soon. The rise in biopharmaceuticals is largely behind this. Bio samples are much more costly to obtain and work with, and the patient data required to get effective results only adds more layers to the spreadsheet.
Cox says bio research pushes up development costs substantially. He estimates that every clinical trial that starts with a 1 / 35 lead can cost up to $1.25m per drug. This means pharmaceutical companies can no longer afford to play the research game on their own. They can also no longer afford to be backward when it comes to IT.
“Getting access to information is going to be very important when it comes to treating big disease,” Cox says. “We can do so much more with the right technology, but still it seems like pharmaceutical companies and IT providers are in two completely different worlds. In the future though, I think IT is going to have to be synonymous with clinical trials and research. Where it is being used today makes it clear that IT can help us to work effectively using less but more specific samples. But in the end bespoke solutions will be required.”
Roche Genetics vice president and director Professor Klaus Lindpaintner believes that advancements in biomedicine will only come with a unified approach and a new focus on not just the specimens but the data that accompanies them.
“The future for research depends on our ability to address the cost of treatment with the height of [clinical trial] risk,” Lindpaintner says. “We need to get to a point where we can share access to specimens and data, and select our samples at the outset of any development programme. Only truly innovative approaches to research will work now.”
Take a chance with IT
The big names in IT may have been trying to enter the pharmaceutical scene, but so far it has been the universities and research centres that have truly made headway in this market. The BBMRI biobank project itself heralds a handful of research teams that are close to understanding the true IT needs of clinical trials and development.
With one such team, European Bioinformatics Institute medical informatics coordinator Dr Maria Krestyaninova has been carefully dissecting the needs of bioresearchers to come up with a solution that decides just how much information can be siloed using IT. Her team’s solution can query data over a large number of parameters. Each sample can be broken down into numerous paths so, even before a trial starts, samples with undesirable characteristics can easily be excluded.
“We can deal with high-volume, complex data,” Krestyaninova says. “We are working on four large R&D projects for such IT solutions across the EU and in Russia, all dealing with a highly competitive user community.”
But Krestyaninova says, despite their positive results so far, there are still many obstacles that need to be overcome, obstacles that in many cases are unique to the pharmaceutical community. She hopes that the groundwork set by the BBMRI project will at least help to identify these.
“More people are looking for a database or interface to help them formulate what is going on in their studies, and in many cases there is a need to house those projects with multiple data partners, all dealing with different stages in design,” she says. “What we need to come up with is a database that can work even if the expectations of the user are not known at the outset of a trial, or the development of a drug. We also need to know how performance is evaluated, what is crucial and vital to development and how to provide this as a service to end users.”
If an answer to these questions can be found, it could not only benefit the pharmaceutical industry at large, but also provide a source of funding for BBMRI, which hopes to be self funding without being a burden on research institutes or end users without private funds. At the end, for BBMRI, the more users it can garner for its IT solutions the better the result, as data becomes more formalised and functional for those conducting trials.
The ultimate outcome could be a crucial shot in the arm for medical outcomes around the world. So much so that Hans Lehrach, director of the Max Planck Institute for Molecular Genetics and head of its Vertebrate Genomics department, says, it could even be the answer to providing a raw human genome.
“We are convinced a number of our treatments combined with human genome will give us a much better concept of a person’s second-stage treatment for cancer,” Lehrach told a consortium of members that met to discuss BBMRI’s most recent work.
By 2013, he believes that with the right technology, his institute could come up with a raw human genome and, possibly, take a step in the right direction towards a cure for cancer.
Arena International, the events firm tied in with this title, is hosting the Biosimilars event in Brussels, Belgium 16-17 March and the Competitive Intelligence in Pharma event in the USA, 13-14 April this year. For more information, visit the events page on this site or www.arena-international.com/pharma.