Life sciences: the quest for innovation through collaboration
The average lifespan in the United States increased from less than 50 years to nearly 80 years over the last century, a remarkable change. Many illnesses have been essentially eradicated and the cure rates for others have improved dramatically, in large part because of new medications. Somewhat surprisingly, however, the number of new drugs introduced each year has not increased over the past few decades, according to a report prepared by the President's Council of Advisors on Science and Technology (PCAST) in 2012.
The rate has remained at the same level despite a tremendous increase in the amount of scientific knowledge available, and despite many advances in the available software technology that can support research in a variety of ways. In addition, R&D expenditures have also continued to rise for most of that time period, as reported in 2013 by Pharmaceutical Research and Manufacturers of America (PhRMA, phrma.org), but with no corresponding improvement in productivity.
Many explanations are offered. The price tag for developing a new drug is very high; numerous studies estimate the cost of development at more than $1 billion per drug, and the cost tripled between 1985 and the early 2000s. PCAST cites the gap between basic research and commercial projects and inefficiency in clinical trials as obstacles to innovation; the latter is significant because clinical trials represent the largest component (nearly 40 percent) in R&D costs in the biopharmaceutical industry. Even the large body of scientific knowledge has a downside-extracting actionable information is difficult.
Software products are available that can help address those issues. In its report on leading software vendors in the life sciences industry, IDC identified an array of vendors with solutions in knowledge management categories such as enterprise content management (ECM), business intelligence (BI) and discovery. Oracle was the leading company as measured by licensing revenue from the life sciences industry, with SAP and Medidata Solutions following.
One critical type of software application that could greatly aid innovation but is still not used effectively is collaboration. The number of organizations involved in the R&D process and commercialization of a new drug point to the need for effective collaboration, but that goal is often difficult to achieve. "The research process is highly variable," says Michael Shanler, research director at Gartner. "Scientists are not always as collaborative as their employers would like. They tend to work in silos and sometimes have inconsistent procedures
The lack of standardization has led to limitations in the clinical testing process. "Thousands of assays may be run during the development process, each designed by scientists who do things somewhat differently," Shanler explains. "This makes interpretation of the results complicated, and makes it difficult to collect and mine information across different projects."
Collaboration in clinical trials
In the past few years, the environment has changed somewhat, however, at least for clinical trials management system (CTMS) software. Initially focused on internal work, those products are broadening their reach to encompass:
- NextDocs, a provider of SharePoint compliance software for life sciences, added a Clinical Collaboration Portal to its Clinical Document Module. The collaboration portal is geared toward external partners, and augments the internally focused clinical document module.
- Virtify, which offers content and regulatory information management solutions for the life sciences industry, released Virtify Structured Content Management (SCM) in 2013. That product is designed to improve collaboration and automate documents required for stages of development from pre-clinical through product registration to commercialization.
- BioClinica OnPoint CTMS allows analysis of clinical trials data and is integrated with SharePoint. It is designed to support access to and use of data from multiple sources in real time, and phrma.org leverages the ability of SharePoint to handle large numbers of documents.
More broadly, however, collaboration is still not achieving its potential because in general it is still limited to a specific phase of the process. "Developing a drug is not just a process of working with a particular molecule and target within a laboratory. Since a lot of research is conducted outside of pharmaceutical firms, a globalized approach is required," Shanler says. "Extremely collaborative networks are needed." Over time, greater integration with multiple enterprise applications will be sought to provide that level of collaboration.
Open innovation is one tack that some pharmaceutical companies have taken to expedite the R&D process. A serious change from the closed, competitive stance that most pharmaceutical developers have followed in the past, open innovation requires an uncharacteristic sharing of information and processes. A number of initiatives have been launched in recent years.
In September 2012, a non-profit organization called TransCelerate BioPharma Inc. was founded by 10 major pharmaceutical companies to promote innovation in R&D. One of the initiatives was to develop a shared user interface for investigator site portals. By 2013, membership had grown to 18 companies, and several new initiatives were launched, including one to develop common clinical trial protocol templates. That effort represents an acknowledgment that the lack of standards in clinical trials poses a problem in data collection and interpretation.
AstraZeneca has been one of the most active pharmaceutical firms in advancing new ways of collaborating. A participant in Trans-Celerate, AstraZeneca also takes part in the European Lead Factory, announced in 2013 and described as a novel platform for innovative drug discovery. The group consists of pharmaceutical companies, universities and industry subject matter experts. The pharmaceutical companies are sharing chemical compounds with academia to provide new options for developing drugs.
In addition, AstraZeneca established its own portal for solving R&D problems through innovation, on which users can post and respond to R&D "challenges." Initially for internal use, iSolve now includes external participants and has more than 7,000 registered users throughout the world. Of 100 challenges posted, more than half have been addressed either completely or partially through the use of iSolve. The portal aims to engage individuals in different disciplines and functions to expedite innovation.
Spanning multiple systems
In collaborative environments, having a solid infrastructure is critical. Metalogix, for example, enhances SharePoint functionality by providing governance and aiding in access control. "Pharmaceutical companies need to audit who has seen information and what changes have been made," says Gail Shlansky, senior director of product management at Metalogix. That function is provided by Metalogix Control Point.
Metalogix products also help span differing versions of SharePoint and different work environments. "Nearly 40 percent of organizations are running more than two versions of SharePoint," Shlansky says. "Metalogix Replicator makes the technology more scalable and seamless across different regions. In addition, it can replicate information so it can be used in regions where bandwidth is low, while controlling access."
Innovation and analytics
Analytics is another capability that can support innovation. "The technologies for organizing and finding information are maturing, but the problems are becoming increasingly complex," Gartner's Shanler says, "including the lack of a robust IT infrastructure and appropriate applications. Data has a lot of variety and many different contexts, and is rarely captured perfectly."
Because of the quantity and variety of data in the life sciences industry, as well as the complex ways in which the data interacts, analysis can be difficult. Ayasdi has put topology, a mathematical technique used to describe shapes, to work in analyzing large quantities of disparate information. Not only was advanced mathematics used to analyze the data, the analysis also produces visualizations that help researchers interpret information that would otherwise be difficult or impossible to understand.