Lucknow: The second day of the International Toxicology Conclave saw the focus shifting to Regulatory Toxicology and Computational Toxicology.
Dr Poonam Kakkar, Chief Scientist, CSIR-Indian Institute of Toxicology Research (CSIR-IITR), Lucknow kicked off the session on Regulatory Toxicology with her lecture on “Integrated Approaches to Tackle Current Challenges in Regulatory Toxicology”. She brought into focus the paradigm shift from hitherto conventional markers of toxicity to recent in silico / in vitro test systems for safety assessment. These approaches, in addition to being less time taking also meet the requirements of reducing animal experimentation. Describing the processes that encompass discovery and development of small molecule oncology drugs, Dr Shekar Chelur, Research Director, Aurigene Discovery Technologies Limited, Bengaluru apprised the gathering that toxicologic pathology plays a very vital role in early candidate drug identification and supports its development through the lead optimization stage. The decision to stop development of an oncology drug candidate due to toxicologic reasons is a complex and nuanced process, he said. A presentation on small molecules drug development was very aptly followed by one on “IND Submission and Filing for Biosimilars” by Dr Vishal Pavitrakar from Lupin Limited, Pune. Evaluation of region specific regulatory pathways which inturn determine the requirements for IND submission will make the process more robust and less time taking, he opined. Differences between regulatory requirements of different regions was discussed. Shifting gears from oncology and biosimilars to agro chemicals, Mr K S Thyagarajan sought to draw the attention of the academicians, industry representatives and policy makers to the many challenges faced by Indian agriculture. Integrated Pest Management Systems with a judicious use of agrochemicals and more effective regulations are the need of the hour.
The presentations were followed by a panel discussion between all the speakers and other invited experts on the current global regulatory frame work and the way forward. The broad consensus was for greater collaborations and hand-holding between industry and academic institutions in order to be able to meet the challenges in terms of a more robust and facilitating regulatory environment to be able to meet global challenges of human health both in infectious and non-infectious diseases.
