30 Minute Interview

'We Want to Build Upon Changes in the Indian Market'

After US, Mumbai became the third city to host a Drug Information Association (DIA) office. DIA, a non-profit organisation comprises approximately 23,000 members worldwide who are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products. Linda McGoldrick, Executive Director, DIA, speaks to Arshiya Khan on DIA's plans for India. Excerpts:

Linda McGoldrick Executive Director, Drug Information Association (DIA)

Why is DIA coming to India at this particular juncture?

We are aware of the changes that are taking place in the Indian market. And we want to build upon those changes. The statistics are incredible. More than 15 per cent of the world's clinical trials are expected to be conducted in India by 2011. There are also more than 250 Indian biotech companies that did not exist as little as five or 10 years ago. Growth in the clinical trials industry in India has been fueled by a large patient population and an organised healthcare system. That is why this is an important time for DIA to become a leader and to identify and convene industry meets on the most important topics on an international level. DIA has been conducting seminars and conferences for the past eight years. It was time for us to establish a greater presence in India by opening an office in India that will help us increase our educational offerings and build our membership and volunteer base in the region.

What investment plans do you have for India over the next five years?

The next five years will be a very exciting time for DIA in India. In addition to having opened the new office and hosted the first Indian Annual Regulatory Conference in April, we hope to develop subsequent flagship meetings on industry topics/ disciplines of global importance, establish an India membership program, and develop and deliver educational and professional development opportunities.

What is DIA's USP, as far as conference content and speakers are concerned?

Our focus is on a neutral forum and to involve everybody in drug discovery and development globally on a common platform. There are four pillars and principles to DIA—industry, regulatory, academia and patients. So everything that DIA does globally relates to our four principles in order to bring higher quality of medicines to the patients. We do this through meetings, training, webinars, and e-learning modules that bring together top leaders from the industry to discuss important topics. We have also worked with the US Food and Drug Administration, the European Medicines Agency (EMEA—Europe), Pharmaceuticals and Medical Devices Agency (PMDA—Japan), and State Food and Drug Administration (SFDA—China) to create a dialogue with international regulators and industry. We look forward to building similar relationships in India. For example, the first Indian Regulatory Conference, held in April, included regulators from Sweden, US FDA, India, Japan, Canada, and Switzerland, as well as representatives from the WHO.

Why did you choose the regulatory aspect as the theme of the first DIA conference in India?

As a multidisciplinary organisation, DIA provides a neutral forum for all areas of drug development and lifecycle management. However, regulatory affairs is a large and important topic to our global constituency, including India. In fact, a large percentage of the DIA membership, conferences and training focus on clinical research and regulatory affairs.

What are your future plans for India by way of events, themes?

According to our plan, we are aiming to have three conferences in India every year. The first India Regulatory Conference took place in April, and will be followed by a conference focusing on clinical trials in November.

What is the growth in terms of events and revenue you are projecting for the next five years?

DIA operates as a financially independent non profit organisation that funds itself from meeting and membership fees. But our goal remains to reach out to more people in as many areas as possible and to attract the highest quality leaders and speakers in the industry. Utilising and adapting existing DIA content and a ‘train-the-trainer’ model, we hope to develop and deliver professional training (including instructor-led, in-company, eLearning, and blended learning courses) on clinical trial design and execution, project management, and other critical pharmaceutical industry activities.

Do you have any plans to collaborate with academia and industry associations in India?

We have been approached by people to collaborate on educational and professional development programmes. We may collaborate with universities to complement the existing training programmes run by various institutions in India. There are quite a few proposals in the pipeline to bring best practices for the students and professionals. And we are anticipating more partnerships as we grow. We are extremely excited about our move into India and are committed to its long-term success.

arshiya.khan@expressindia.com