“CROs need to be faster, smarter and more responsive to accommodate”
Dr Sujay Singh
CEO, IMGENEX India Pvt Ltd.
IMGENEX India Pvt. Ltd., a Bhubaneswar based biotechnology company has received several grants from Department of Biotechnology to develop drugs for osteoporosis using nanotechnology based drug delivery. Its biosimilar trastuzumab will be ready for preclinical study at the end of 2017. Other biosimilars in the pipeline includes humira, avastin, embrel and stellara. In an interaction with BioSpectrum India Dr Sujay Singh, CEO, IMGENEX India Pvt Ltd. shared his views about the issues before the CROs and how to improve situations.
Excerpts of the interview
What are the major issues before the industry?
The FDA stated that clinical studies conducted in association with a drug or medical device must follow Good Clinical Practice (GCP) guidelines and is reviewed by an independent ethical committee (IEC) to reduce the unethical practice and poor quality. India’s clinical trial industry faced serious legal challenges and disruption of all clinical trial activities due to 2011 litigation challenging the regulatory framework and patient safety guidelines. The result was the implementation of restrictive threetier clinical trial application process, which considerably delayed approval timelines and India became less competitive in comparison to other emerging markets for conducting clinical trials.
Do you feel the clinical research space in India will get boost?
Considering the advantages of a large and diverse genetic pool of a treatment-naive population combined with cost savings and increasing difficulty in sourcing patients for clinical trials in developed countries, India stands aside as a prime choice for clinical trials. Apart from that with highest disease burden (cancer incidence of one million patients and a prevalent population of 2.5 million), India specifically offers a tremendous opportunity in contributing data for oncology trials. To support this, oncologists are increasingly using genomic testing to generate quality genomics data and identify patients based on their genomic profiles.,India has the highest number of FDA-approved manufacturing plants outside the US. With increasing focus on constraining healthcare costs in the US, India’s low-cost manufacturing capabilities combined with high quality standards are advantageous.India also has proven capabilities in mmedical skills, IT capacity, and a large pool of scientific manpower with 200 years of shared legacy with the US in medical education and medical practice.
And can India bounce back as clinical research hub in the coming years?
In recent years, there was a decline in the number of clinical trials, which was associated with an increase in reported clinical research mishaps, negative media coverage, activist protests, stagnation of the regulatory process and departure of sponsors and collaborators. In 2014, CDSCO has taken cognizance of patient safety and reimbursement in case of mishaps and made fresh guidelines and protocols for patient consent, issued a directive that clinical trials could only be carried out at accredited centers with stringent quality checks by ethics committees, and limiting the number of concurrent trials by a Principal Investigator. In 2016, CDSCO has also issued GCP inspection checklist to help sponsors and sites. In a way, CDSCO has taken initiative to ensure better quality trials and cleaner data ensuring patient safety. The evolving process positively supports clinical research in India. With 12-13% year-on-year growth, the Indian pharma industry is rapidly achieving a distinctive position in the global pharma space with CROs and clinical trials.
What are you suggestions to improve the situations of the clinical research space in the country?
CROs need to be faster, smarter and more responsive to accommodate the needs, combination regimens, delivery system and companion diagnostics. Apart from managing complexity, they should utilize creative study design tool such as adaptive design, which means the ability to gather and visualize data faster which is essential to make smarter decision. They should focus on cost containment and shortening development timelines without compromising quality data generation, while guidelines on subject protection, documentation and audit practices need to be strictly enforced.