May 12, 2017
By Jill Johnston, BioSpace.com Contributor
The life sciences industry has reached a tipping point. The pressure to innovate specialized products and get them to market quickly on a global scale is not going away. The ecosystem of stakeholders continues to expand and outsourcing will remain a core part of trial strategies—in fact, sponsors will increase their reliance on contract research organizations (CROs) to perform essential functions, according to the Tufts Center for the Study of Drug Development. Yet the current model will not accommodate the rise in complexity. What now?
The industry must come together to define and implement common approaches to improve efficiency. And it is—new collaborations are forming and fast-becoming a strategic priority for life sciences companies.
In September 2012, some of the world’s most successful biopharmaceutical companies joined forces to form the non-profit organization TransCelerate BioPharma. Its stated mission is “to improve the health of people around the world by simplifying and accelerating the research and development of innovative new therapies.” Focused on the development of model frameworks for the efficient execution of clinical research, the group works to identify solutions for industrywide challenges, ultimately enabling accelerated trial timelines and enhanced patient safety.
Other collaborative partnerships for preclinical support have also formed. The Innovative Medicines initiative launched the European Lead Factory to build a joint European compound library that can be accessed by both private and publicly funded institutions and act as a catalyst for drug discovery. In 2014, the public-private Accelerating Medicines Partnership (AMP) was created, linking the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) with 10 biopharmaceutical companies and several non-profit organizations in a five-year partnership focused on jointly identifying and validating promising biological targets for therapeutics.
The importance of such industry collaborations is increasing. As the pace of innovation has accelerated, the number of clinical trials has risen dramatically (based on stats provided by ClinicalTrials.gov)—yet the time and effort to bring new treatments to market remains long and complex, according to the Tufts Center for the Study of Drug Development. Finding patients and investigators to participate in studies is harder and competition is intensifying among sponsors seeking to collect more data and differentiate their products in the marketplace. Consequently, data is collected from a variety of sources— in different formats—placing a heavier burden on companies to manage it all.
The need to improve efficiency, augment resources, and leverage best practices has also led sponsors to increasingly outsource their research and development work to CROs. But with more stakeholders in the mix, plus different processes and systems used across sponsors and partners, the ability to share information and make real-time decisions is difficult. Clinical investigators, CROs, and sponsors regularly use manual processes to manage documents and data—often sharing information via email—which limits collaboration and creates redundant work. These issues lengthen trial timelines and often discourage investigators from participating in future clinical trials.
To address these challenges, TransCelerate introduced the Shared Investigator Platform (SIP) Initiative, with the aim of providing the industry with a centralized platform that is interoperable with various clinical solutions, streamlining communications between investigators, CROs, and sponsors, and reducing duplicate requests during a trial.
TransCelerate also recently announced it will integrate a cloud-based content management solution with their SIP to enable sponsors, sites, and CROs to easily assess and exchange information during clinical trial execution. The cloud application will help sites consolidate study document requests, alerts, and notifications in the TransCelerate-sponsored SIP, allowing investigators to spend less time on administrative tasks and focus more on clinical research. It centralizes information-sharing and establishes an easy, consistent process for document access and information exchange to dramatically reduce administrative burden in trials and increase operational efficiency.
In addition, companies gain visibility across all studies—something that’s been historically hard to get and that has hindered the ability to capture insights across their full portfolio. It’s a consolidated view of trials, regardless of which specialized, participating providers have contributed. It enables unified clinical operations, where all team members, regardless of their location or their employer, can collaborate on the same platform and manage content and data seamlessly across a trial.
A collaborative ecosystem in life sciences is now urgent. Fortunately, this new centralized model of information exchange is not only proof that technology has evolved to now support a more unified clinical research environment, but also signals a willingness within the industry to adopt common operational processes. In short, the global life sciences industry is ready —and technically able—to collaborate.
