Siva Ramamoorthy, Head of Operations, Ephicacy India
How important are analytics and statistical methods for the pharmaceutical sector?
The pharmaceutical industry develops, produces, and markets drugs that are licensed for use as medications. Pharmaceutical companies are subject to a variety of laws and regulations regarding patenting, testing and marketing of drugs. It takes an average of 12 years (eight years remain from the 20 years' patent granted) and over USD350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to a regulatory body such as FDA to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.
Current challenges in the pharma industry include shortening time to approval; identifying meaningful end points and criteria for treatment effectiveness; handling erroneous data; dealing with global regulatory environments. All of these have implications as to how statistics has evolved and continues to evolve in the drug industry.
Statisticians play significant role in designing and analysing the experiments (here, experiments mean clinical trials), thus ensuring the clinical study objectives are met, thereby reducing the likelihood of any repeat experimentation and hence reducing cost, time and any implied ethical considerations.