THE life sciences industry is transforming. Increased focus and scrutiny for quality and compliance by global regulatory authorities, prevalence of rare diseases and access to relevant patient cohorts, and fierce competition for market share on a global playing field are some of the factors driving this transformation. Additionally, the need to respond to pricing pressure while substantiating the proof of a product’s effectiveness in curing a disease condition is forcing companies to achieve greater efficiencies while doubling up on R&D efforts. All these factors are forcing pharma organizations to reexamine their portfolios, product development strategies and technology implementation models to ensure patient safety while overcoming drug shortages and maintaining affordability of life saving drugs.
Pharmacovigilance in 2020 – future horizons and efficiencies in data acquisition, evaluation and risk management
To manage the ever increasing volume of information, companies have turned to cost-effective resources. Jeffrey Ho, Principal Consultant, Navitas Life Sciences, highlights how the advent of technology will contribute to a more sustainable model of pharmacovigilance
Faster decision making and better trial oversight at all levels requires truly next generation data integration and analytics. Source and format agnostic data aggregation aided by modern data lake architecture and advanced analytics deliver interactive visualizations to identify new signals, discover hidden insights, minimize risks to trial success enabling data-driven faster decisions and successful outcomes.
Indian drug cos scramble to comply with new data regulation in EU, the second largest market for exports
EU is second largest destination for pharmaceutical exports constituting about 12 percent of total Indian pharmaceutical exports of USD 17.27 billion in 2017-18.
Artificial Intelligence (AI) will significantly transform or impact the life sciences space. This along with robotics and cognitive technologies is important to better outcomes, safety, and compliance and lower costs, stated Ram Yeleswarapu, president and CEO, TAKE Solutions Limited.
Technology advancement brought paradigm shift in Clinical Trial design, execution and management. Despite technology advancement and regular monitoring, the clinical trial industry and regulatory agencies are facing new challenges and fail to enhance patient safety.
Life Sciences executives are realizing that supply-chain improvement can not only lead to significant increases in shareholder value, but it can provide competitive advantage in sales channels and accelerate the launch of new products through to profit.
The success of innovator biologicals with downsides of high costs and patents expiring have contributed to development of Biosimilars coupled with advantage of regulations, adaptability by physicians and patients. Biosimilars being complex molecules need to have sound scientific strategic approach to development, manufacturing and research. Few legal issues have not dampened Biosimilar companies to have strong pipelines, quality and focused timelines to provide affordable and effective drugs to patients in need.
The global healthcare industry is primed for disruption and the use of SMAC (Social, Mobile, Analytics, and Cloud technologies) are poised to drive this revolution. The age-old adage that ‘prevention is better than cure’ could not have been more relevant today. It is true that developed nations spend an insignificant amount on preventative healthcare and the focus is more on cure.