Accelerating breakthroughs: Platforms for life sciences R&D
This article appears in the KM World magazine issue January/February 2019 [Volume 28, Issue 1] and provides insight into life sciences knowledge management, life sciences knowledge production and how Catalytic Data Science is working to change the life sciences R&D technology landscape.
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Publish date: Dec 21, 2018
Author: Judith Lamont, Ph.D.
The Pharmaceutical Research and Manufacturers of America estimates that bringing a new drug to market costs $2.6 billion in research and development (R&D). Thousands of compounds may need to be tested just to identify a handful that might have sufficient potential for the pharmaceutical company to file an Investigational New Drug (IND) application. Meanwhile, the success rate for those products that do reach clinical trials is only 12%.
The complex nature of the underlying sciences, as well as regulatory hurdles, makes the process slow and expensive. “It is typically very difficult to work across some of the large bodies of literature, data sets, and collaborative tools,” said Scott Sacane, CEO and co-founder of Catalytic Data Science. After working as a molecular biologist in two biotech companies, he was well aware of the challenges in getting from basic research to a commercial product.
As an analyst conducting research on biotech firms for an investment bank, Sacane later had a chance to see a different model for providing information. “When I was a sell-side analyst, we had easy access to vast storehouses of information on our Bloomberg terminal,” Sacane recalled. “Any kind of pricing data, news, charts, quantitative information, and collaborative tools, like the Bloomberg Messenger, were right at our fingertips. It was an amazing work productivity tool.” He realized that the same type of system for the life sciences would be extremely useful.
After doing some market research and speaking to colleagues to see if any such resource had been developed, he found that no such set of tools, integrated on one platform, was available. “A lot of information had been digitized, but much of the content was in PDF. There was not an integrated knowledge production or management platform for R&D in the life sciences.” Along with co-founder Jerod Clabaugh, an evolutionary biologist, Sacane began designing a product for this purpose.
The result was two integrated informatics platforms built for internal and external research project management, Catalytic Corporate Platform and Catalytic Alliance Platform. Catalytic Corporate Platform is an R&D cloud solution that brings together digital assets, visual data analytics, scientific workflows, and collaboration capabilities. The Catalytic Alliance Platform allows partners outside the organization to quickly create collaboration environments for generating, sharing, and storing data and documents, as well as workflows and analytics. The Catalytic platform provides organizations with a virtual secure private cloud, rather than using a multi-tenant configuration, to ensure that sensitive information is protected. Both are cloud-based, and team members can be up and running within a day.
Shopping online for life sciences R&D goods and services
As has happened in many enterprise-level applications, technology developed for consumer use is driving improvements in business technology. Users who are accustomed to making online purchases in their daily lives want the same convenience and streamlined experience at work. In addition, businesses want the benefits of customer self-service, including reduced costs and fewer demands on their employees.
One example is Scientist.com, an online service focused mainly on the pre-clinical stage of research. Pharmaceutical companies looking for contract research organizations (CROs) can choose from a listing of over 3,500 research services on the site. The purpose of this marketplace is to simplify the process of purchasing research services. Finding vendors, qualifying them, and managing the administrative aspects such as negotiating a contract can be very time consuming. Scientist.com claims to reduce the process to a fraction of the usual time. CROs can sign up at no cost, and pay a commission if they are awarded a contract.
Science Exchange, Inc. provides a marketplace for a broad range of services, including molecular biology, spectroscopy, nucleic acid services, and cell line authentication. In addition to drug discovery services, the site also offers services in other disciplines such as business development and computer sciences. Vendors include both university and private sector facilities. The number of orders received for each vendor’s services is posted, along with the percentage of positive ratings, similar to those on Amazon. Purchasers can request a quote by clicking a button.
Life sciences research vendors are also launching their own ecommerce sites, and they too are showing rapid growth. Within a few years, the majority of life sciences research sales are expected to come from ecommerce vendor sites and marketplaces, rather than in-person contacts. Certain parts of the sales process may need human intervention, especially for more complex contracts, but the efficiency and convenience of online interactions will promote to their growth. Along with the platforms that expedite the research itself, these ecommerce sites represent a new model in life sciences R&D.
One of the hot topics in biotechnology today is gene editing, which allows correction or disruption of some genes without interfering with others. A computational pipeline or data pipeline in the Catalytic platform is used to copy, move, and combine data from different sources and analyze it with sequential processing steps outside the originating computer environment. The data flows to a storage container such as a data lake from which other analytic tools call on.
When an organization implements the Catalytic platform, it already has more than 30 million open access documents in its content repository, including every drug patent since 1984. “Users can search the repository, retrieve the documents most relevant to their projects, and put them in a shared, secure folder,” explained Sacane, adding that they can also contribute data such as verified gene interactions and push a list of that data to an analytics engine. “For example, a gene function prediction map can be generated from the literature. This kind of workflow is common among users of our platform.”
The platform helps get smaller companies on an equal footing with larger ones because they do not need to make big investments in hardware, software, or IT infrastructure to support their R&D efforts. “Many small research organizations are focused on advanced areas such as therapeutic development, gene editing and gene therapies, including anti-cancer drugs,” noted Sacane. “The pace of innovation in R&D today is unlike anything I have seen before. Research projects produce tremendous amounts of data, but data alone is not productive unless there is a way to manage and understand it.” The Catalytic platform provides a single environment in which researchers can explore information, test products and analyze data, collaborate with others, and arrive at conclusions based on an efficient and informed research process.
Clinical trial data management
Missing, inaccurate, or inconsistent data is one of the most common problems in clinical trials. In a study commissioned by Oracleand conducted by Pharma Intelligence, more than half the respondents identified data completeness as a top operational challenge, and nearly half identified data quality as a challenge.
Large clinical trials can involve hundreds of doctors and thousands of patients from all over the world, and the studies can go on for several years. “Given that some data used in clinical trials is coming from electronic health records (EHR), labs, wearable devices, and online surveys,” noted Jim Streeter, global VP of life sciences for health sciences at Oracle, “it is important to be able to verify and cross-check.” A lab sample collection date in an electronic data capture system, for example, may not agree with the one recorded in lab results. The sooner these inconsistencies are detected, the less delay there is in obtaining test results.
Oracle has developed a set of applications that address needs along the value chain of pharmaceutical R&D, and the Oracle Life Sciences Data Hub for integrating them. Oracle’s InForm is an integrated electronic clinical data capture and management cloud platform that is used to capture patient data during a clinical trial. It allows all the doctors who are participating in the clinical trial to input patient data into a single system that the pharmaceutical company which is sponsoring the investigational new drug can access. InForm also applies edit checks, such as verifying that a date is in the proper format, to ensure data cleanliness. With InForm, the pharmaceutical company does not have to spend time aggregating data from several different systems or cleaning data that may be in different formats from different doctors.