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Pulmonologists call for speedy respiratory drug development and approval process

Our Bureau, Mumbai
Tuesday, November 20, 2018, 08:00 Hrs  [IST]

With the increasing burden of respiratory diseases globally and particularly in India, and the burgeoning costs of inhaled medications that are projected to run into billions of dollars, pulmonology and respiratory experts have called for speedy drug development and approval process.

The global respiratory diseases have been recognised as a major cause of suffering and deaths and respiratory clinical development is becoming more and more challenging due to several reasons. There is a pressing need to accelerate drug development and approval processes, said Dr Parameswaran Nair MD, PhD, FRCP, FRCPC, respirologist at St. Joseph's Healthcare Hamilton, Canada while speaking at respiratory symposium.

The symposium, held by Cliantha Research on November 17 at Hotel Taj Santacruz, Mumbai, witnessed participation of about 125 industry experts including senior delegates from pharma, life-science and clinical research industry as well as leading pulmonologists from all corners of India.

India has tremendous talent, infrastructure to contribute to clinical development of respiratory drugs, he said while talking on biomarkers and study designs for bioequivalence and comparative efficacy studies for generic products.

Dr Nair emphasized the need to exchange clinical, regulatory and bio-analytical science amongst the stakeholders in clinical development.

India has a tremendous potential to contribute to the global knowledge base because the country witnesses a lot of diseases which perhaps the western world do not see. And therefore India has the patient pool on which it can do research and this research will help and inform global policies, said Dr Sundeep Salvi MD, DNB, PhD (UK), FCCP (USA), Hon. FRCP (Lon), director of the Chest Research Foundation, Pune, India while sharing his views on burden of chronic respiratory diseases in India and similarity in asthma and COPD diagnosis in India.

Dr Piyush Patel, MD, FRCPC, principal scientist, Inflamax Research (Cliantha Group), North America shed light on regulatory expectations/experience in global respiratory study.

He discussed current trends in respiratory disease screening to diagnosis, treatment and management which can help in the conduct of clinical trials globally.

 

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