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In 2021, the FDA has approved many novel products that serve previously unmet medical needs or significantly help to advance patient quality of life. The broad indication wise distribution of all CDER’s 2021 drug approvals indicates notable advances in drug discovery Read more
In 2020, despite several challenges due to the COVID-19 pandemic, the FDA has approved many novel products that served previously unmet medical needs and significantly helped in advancing patient's quality of life. Read more
It is amply clear that digitization and utilization of data science is playing an important role in all aspects of human lives. Drug discovery and development is no exception. How far we have successfully implemented digitization and data science in drug discovery and development? Is this reality or a far-fetched dream? Read more
Drug resistance and inadequate response to commonly administered drugs across different therapeutic indications poses a major challenge to clinicians and researchers. This leads to unnecessary heath care costs and is incurring additional research expenditure. Despite marked improvement in new therapies, many patients experience progression of disease or disease recurrence asserting the need for early detection of drug response/resistance by evaluating biomarkers. Read more
Big data analytics was used as early as in 1600s for predicting epidemics of bubonic plague in Europe. Though records of decision-making from health care data are available from Babylonian times, demographer John Graunt pioneered the principles of statistical analytics in health care which were used for predicting mortality at a population level in London. Read more
“Pharma is taking a more of a data-driven and strategic approach to Drug Repurposing,” says Nandu Gattu, Ph.D.,  Senior Vice President, Pharma Analytics and Drug Repurposing at Excelra, a data and analytics company. “Instead of waiting for serendipity driven drug repurposing, companies are evaluating the alternative indications of the drug considering the drug target, what pathways the particular drug is up-regulating and down-regulating; understanding what similar drugs are available; and examining current clinical trials that are being conducted.” Read more
Model informed drug discovery and development (MID3) is a paradigm of data analytics in drug development which facilitates the development and application of various quantitative approaches like exposure-response, biological, and statistical models to characterize pre-clinical and clinical data. Read more
Protein implicated in the progression of cardiac disease is a novel biomarker associated with inflammatory status and disease severity in patients with COVID-19 Read more
Apelin-13, a 13 amino acid oligopeptide which is the ligand for the apelin receptor is reported as a diagnostic biomarker whose levels are higher in both dry-type age-related macular degeneration (AMD) patients and neovascular AMD patients compared to the control group. Read more
Biologics, also known as biological products, are any type of medicines derived from living organisms such as humans, animals, or microorganisms via highly complex manufacturing processes and administered under closely monitored conditions. Read more