Mumbai-based biotechnologist now heads global clinical research body

Mumbai-based biotechnologist Dr Nimita Limaye has become the first Asian and first woman to be elected global head of the Society of Clinical Data Management based in the United States. At 43, she is also among the youngest to be chosen for the post.

 

SCDM is a global body that plays a key role in providing thought leadership in health care and sets global standards and best practices for managing data pertaining to clinical trials, which are needed to prove the efficacy and safety of every new drug and significant biotechnology product.

 

“I am deeply honoured at being selected to this hugely important and significant position on behalf of my country,” Dr Limaye told DNA.

 

“As the global chairperson of the body, crucially concerned with enhancing the key domain of world health care and better life quality, the challenges are huge,” she said.

 

“I have a huge agenda cut out for me, be it in South America, Europe, Asia, Africa, North America, Australia, or my own country, but I am confident that with the enormous support which SCDM, hopefully the government of India, Indian industry, my professional peers and colleagues, and the media will offer me, much can be done.”

 

Dr Limaye said she hoped to make full use of India’s undoubted advantages — a large pool of patients, faster patient recruitment, well-trained English-speaking physicians, and IPR protection, besides lower costs.

 

Over 100 pharmaceutical companies, including Fortune 100 companies such as Pfizer and Merck, are currently outsourcing clinical trials in India. Major players like Siro, where Dr Limaye is vice-president, Cognizant, Wipro, TCS, Mahindra Tech-Satyam, Quintiles, Accenture, IBM, and Intel are part of the Indian clinical data management scene.

 

This rapid acceleration of the market, driven by the urgent need for newer drugs for both existing and newer diseases, as also revolutionary developments in agriculture, marine and other biotechnology frontiers, has created huge challenges for medical manpower and health-care infrastructure.

 

Dr Limaye, however, believes there is an urgent need to bring on board certified professionals to allow India to further establish itself as a location that is not only intellectually and technically strong, but also one that follows best practices and is aware of the latest trends.

 

With the current annual recruitment rates of 20 patients per trial site, the country will require 10,000-15,000 highly trained professionals annually. Currently, India has only a quarter of that figure.

 

“These professionals will have to be trained in technical areas — clinical research, GCP (good clinical practice), ethics, regulatory systems, IT. Besides, they will be required to have other soft skills — leadership, teamwork, communication skills, negotiation skills and conflict management,” said Dr Arun Bhatt, former president of the Indian Clinical Research Association.

 

“Further, India is one of the few countries where almost 75% of the health-care expenditure comes from private citizens,” said Dr Limaye. “Thus, there is all the more reason to accelerate the development of low-cost, high-quality, effective drugs and help to address the health-care challenges that developing countries, including ours, face.”

 

The other issue that remains to be addressed in terms of clinical data practices is what drives patients to enrol in clinical trials. The prime reason is lack of funds, which eventually forces a patient to register for trial drugs to receive some kind of treatment.

 

Thus, access to better and more cost-effective drugs would help patients in India, said Dr Limaye. To achieve this, the SCDM, in collaboration with 40 countries around the world, strives to adopt best practices to ensure high-quality data, and approves only safe and effective drugs.