KEY NOTE ADDRESS: Molecule to market
Dr Ramesh Jhawar, President of Ajanta Pharma, and a veteran with over four and half decades of experience in the life sciences industry was the keynote speaker at FDD Conclave 2019. He spoke at length on the topic, ‘Market to Molecule’ and elaborated on the importance and relevance of generics medicines industry in the Indian context.
He gave a rundown on the opportunities and benefits in this arena and spoke on the challenges faced by generic medicines manufacturers on economical, technical and regulatory fronts. Examining different aspects of generic development, Dr Jhawar expounded on the patent landscape, availability of DMP grade API, RLD evaluation, product development, analytical method development, manufacturing of exhibit batches, pivotal bio-study, stability evaluation and ANDA filing.
He pointed out how formulation development is a core activity of our industry and emphasised that we need to develop strategies which will help us optimise our resources and enhance our outcomes. He also accentuated on how scaling up a product is a science in itself but also said that the pharmacist working on the bench has limited understanding about the process. It is important to overcome this limitation. Stressing on the role of a well written protocol in the successful outcome of a biostudy, Dr Jhawar said that if the protocol does not include exclusion criteria, it can cost the company a bio-equivalence study. Thus, it was a very insightful session with several takeaways for the audience.
Watch Full Session Video here: