A New Facet of ‘Data Integrity’ With Novel Therapy… And Much Beyond

The peril of breach of data integrity involving a top Indian pharma player, jolted many, probably for the first time, on September 17, 2008. On that day, the USFDA, reportedly, issued two ‘Warning Letters’ and an ‘Import Alert’. These were related to … Continue reading

Gene Therapy Price: Commercial Viability And Moral Dilemma

On May 24, 2019, Novartis announced the US-FDA approval of ‘the first and only gene therapy’ – Zolgensma, for a type of Spinal Muscular Atrophy (SMA), a lifesaving treatment for infants of less than 2 years of age. This unique drug halts disease progression … Continue reading

A Disruptive Innovation to Fight and Cure Intractable Diseases

Several important facets of health care often arrest general attention. These are also widely discussed, analyzed and argued vehemently – with each person or group trying to justify one’s own point of view. Among these, following 6 critical areas, broadly … Continue reading

An Evolving Paradigm of ‘Price-Value Model’ Of Pharma Value Delivery System

May 4, 2016 edition of the ‘MIT Technology Review’ published an interesting article carrying the headline, “The World’s Most Expensive Medicine Is a Bust”. The obvious question that floats at the top of mind: What is this most expensive drug … Continue reading

Cancer Cure: Inching Towards The ‘Holy Grail’?

In a Press Conference on August 20, 2015, the 39th President of the United States, now 90-year-old  Jimmy Carter, revealed (video) that during a liver surgery earlier this month the doctors diagnosed that he has cancer. The type of cancer that he … Continue reading

A Disruptive Innovation in Healthcare – Personalized Medicines

Tufts Center for the Study of Drug Development (Tufts University) in its publication named ‘Impact Report’, November/December 2010 articulated, “Biopharmaceutical companies are committed to researching and developing personalized medicines and within their development pipelines, 12%-50% of compounds are personalized medicines.” … Continue reading