Original Link :

http://punetech.com/interview-with-dr-chitra-lele-pharma-and-biotech-outsourcing-in-pune/

Can you tell us about your background?

Dr. Chitra Lele is the Chief Scientific Officer at Sciformix Corp, a startup focusing on providing KPO (knowledge process outsourcing) services to pharmaceutical and bio-tech companies. Chitra has done her MS in Statistics from IIT Mumbai and PhD in Statistics from Stanford University. Chitra’s previous experience includes work as a biostatistician in cancer epidemiology at Stanford University and University of California, San Francisco and as a faculty member at the School of Statistics, University of Minnesota and the Indian Institute of Technology, Mumbai.

Tell us about what you do?

My Company is positioned as a KPO and the primary domain is pharma & healthcare. Ours is a data management/analysis/interpretation related company. We work for Global Pharma companies, primarily based in North America, who outsource the work to us. There are four primary areas in which work:

  • Statistics & programming: Pharmaceutical companies have to conduct clinical trials before they bring new drugs into the market. These experiments / trials have to be designed statistically & analyzed. A lot of statistics & programming is involved in it. This includes complex statistical simulation, modelling and analysis. It involves extensive programming, primarily using the software SAS, which is the most commonly used statistical software in the pharmaceutical industry.
  • Scientific Writing: We do all kinds of scientific writing that pharma companies need. For example, once a drug is in the market and consumed by a large section of a population, what kinds of adverse reactions are getting reported & what do they mean medically? We summarize that data and submit a safety report. All the pharmacological details of a drug, protocols and study result reports for the trials, medico-marketing literature and much more comes under scientific writing.
  • Safety Data Management (Pharmacovigilance): There is a toll free number present on package insert of medicines that are sold in the West. There you can report any issues regarding the drug. In the western countries, more so in North America, there is lot of awareness about this. Consumers as well as health care professionals, and pharmacists call that number to report adverse reactions. We run such call centres. There consumers might call to report adverse reactions to the drug, or any other quality issues with the drug, or medical doctors might call to ask if a particular medicine can be given along with other medication that their patients are already taking. We record such data, enter the data in Safety Databases, analyze and interpret it medically (for e.g, we assess if the adverse reaction is medically serious, and if it could be causally related to the drug) and submit reports to regulators around the world, including US FDA.
  • Regulatory affairs: We primarily provide document authoring and compilation services in the Regulatory Affairs area. For example, if there is a small change in the manufacturing process of the drug, it has to be reported, along with a pharmacological justification that this manufacturing change has no impact on the availability and action of the drug on the body. The report has to be submitted to regulators. When companies want to market their product in different geographies, dossiers have to be written, compiled and submitted as per the country-specific regulations.

Turning points in your career?

Looking back, I think that every experience was enriching whether good or bad, so I have no regrets. The turning point for me was, when I decided to go for BSC in mathematics. I was a good student throughout my academic years. So it would have been natural for me to go in for medical or engineering degrees. I thought at that time that I liked Mathematics and Medicine. After the 12th standard, I chose to go in for BSc instead of trying to get into medicine or a field related to medicine I am convinced that it was the right decision. Though my parents were disappointed at that time, they are now happy that I chose this path.