As novel R&D establishments race to find new cures or better cures for existing chronic conditions utilizing genetic, phenotypic, and clinical data, the regulators have a challenge to establish appropriate frameworks and guidelines for evaluation and eventual approvals.

The pharmaceutical industry operates in one of the most regulated and active environments, with frequent changes effected by regulatory authorities.

Global pharmaceutical and life sciences specialists, working to deliver tailored business solutions across the entire pharma life cycle, are increasingly guiding the industry towards enhanced requirements for compliance, greater transparency and accountability while simultaneously trying to exploit data assets for better therapies. On one hand, there is a global quest to capture market share in an increasingly competitive marketplace of existing therapies, and on the other, to discover and innovate for treating complex, rare diseases for specific patient population.

Adequate and appropriate informatics to process the significantly large and complex volumes of biological data using ontologies and data standards are a must to deliver insights and outcomes. Overlay that with the real world evidence of existing therapies indicating their safety and effectiveness outside of a controlled clinical trial setting, and you have an opportunity to sharpen R&D efforts.

Challenges
In a move towards patient-centricity and outcome-based health care, the ability to immediately harness internal and real world data is quickly emerging as an imperative in the broader healthcare and life sciences industries.

Life science companies have always had large repositories of data. Due to the increased variety of data such as images, videos and voice data, the exploding volume of real world data, paper based files, product dossiers in PDF and scanned images, etc; managing data, retrieving it when required and gaining insights from information is becoming a big challenge.

Typically, healthcare and life sciences organizations utilize data assets for a variety of reasons such as:

• Data-driven decisions can reduce inefficiencies between the business, legal and IT, optimize existing information assets and address disconnects between different functions of an organization
• Data are the foundation upon which the value-adding analytics are built
• Along with solving regulatory issues, unstructured data supplies the key to many other business challenges

The real challenge here does not lie in collecting this data, but in integrating and analysing it to create a competitive advantage. In addition to aiding tactical and strategic decision making, innovation and R&D efforts are greatly enhanced as a result. Lastly, in today’s fast paced and dynamic environment, the ability to react in a near real-time manner and providing patients and care givers alike with a superior experience will be vastly driven by data and insights.

Managing data as portfolio of assets
Technology intervention becomes a key to gather the required data automatically and enforce compliance with standards and benchmarks, while maintaining high levels of data security. While companies are looking for the golden nuggets of information across the multitude of disparate data sources which could have significant commercial benefits, the increased regulatory scrutiny and demand for greater transparency and accountability for patient safety has imposed a serious burden on the industry.

Pharmaceutical companies require technology that can transform and integrate vast amounts of data generated from multiple sources. The technology must be capable of assimilating data swiftly and gauge company demands.  The efficacy and value of new drugs can be proved to the clients with this information.

Big data is an emergent trend and a number of pioneers, with their focused adoption and measurable benefits, are already making healthy strides in their journey towards better insights and data driven decision-making. To eliminate data–gap, technology companies focused on life sciences now prepare for the transformational tidal wave through ‘MARS’.

Role of MARS in life sciences
Data management
The demand for enhanced safety and effectiveness of drugs while ensuring affordability is driving new trends in clinical R&D efforts. From designing better studies, to identifying better performing clinical sites and faster enrolment of patients for very specific therapeutic area and indication combinations using phenotype and genotype information, life sciences companies and service providers alike are feverishly innovating. Companies are attempting to leverage cutting edge technologies and mobile platforms and tremendous advancements in basic science coupled with globs of real word evidence to sharpen their R&D efforts. The race for finding cures for rare and obscure diseases where the cohort of patients is fairly limited and esoteric is on. No longer will such patients feel isolated and in fact will be treated with medication that is personalized with effective outcomes.

Data analytics
Big data driven analytics for life sciences companies is a crucial component for their continued success. It helps the organization to enable patient centricity, drive innovation and rationalise operations to establish tangible and concrete value. Aggregating and analysing structured content and leveraging analytical techniques and tools for better insights is a no brainer. To supplement this with insights drawn from unstructured content including public domain data sources requires a special set of skills and technologies. Today’s advancements in big data technologies and analytical tools are simplifying these efforts leading to a better understanding of the world of life sciences and healthcare.

Data retrieval
The pharmaceutical industry is witnessing a decline in the growth rate of new drugs in the pipeline. With drug patents reaching their expiry period, it has become imperative for pharmaceutical companies to identify new avenues of growth. Sponsors, CROs, academic research establishments and technology solution providers and vendors are all attempting to create solutions to mine historical data, enable better and near real-time integration of complex clinical trial data so as to enable cross-functional analysis. The volume of historical data combined with fresh sources of rich and observational data in healthcare settings is key to uncovering better cures and newer cures for diseases and conditions that were hitherto left untreated. Statistical correlation of drugs and diseases using technologies that can scan large volumes of medical and scientific literature as well harvest data from healthcare portals that dispense genuine medical advice by healthcare professionals is yielding observations that are allowing for improved R&D efforts.

Data security
With the proliferation of structured and unstructured data records, healthcare organizations need to balance information technology and business priorities when it comes to retaining both patient and internal information records to remain in compliance with HIPAA, HITECH (Health Information Technology for Economic and Clinical Health) Act and other quality guidelines from CMS (Centers for Medicare and Medicaid services) Clinical Standards & Quality.

Is big data the way forward for life science, pharma sectors?
Regulatory bodies have been significantly expanding their compliance, oversight and enforcement activities (penalties for re-admissions, value-based purchasing & core measures improvement) in recent years, and this trend will only accelerate and add to the existing complex data integration needs.

The big data revolution opens up countless opportunities for the life sciences companies. Life sciences organizations need to embrace technologies and make adequate investments. They need to ensure that regulatory compliance activities align with the overall corporate strategies and investments in technology.

Some pharmaceutical giants having realized the potential benefits have planned budgets around it. Those who are agile in adopting and embracing these advancements and are in step with the trends will emerge as the clear winners in this highly competitive environment, thereby ensuring the survival of the fittest. Those who do not, will get left behind. The choice is clear!