Future Biotech Forum is organising a two-day conference dedicated to the biosimilars industry called the Future Biotech India 2013 in Hyderabad from July 25 to 26. This event aims to address the huge market opportunities for the biosimilars along with critical regulatory, commercialisation, technological, and R&D challenges amongst others, in the backdrop of over US$ 79 billion worth of biologics going off patent by 2015.
The event is expected to shed key insights on the regulators view on the dynamic Indian, EU and US FDA regulations that will pave way for the companies to put their biosimilar products in these markets.
It will also help the industry to address critical queries on commercialisation of biosmilars, product pipeline and development and investment challenges to propel biosimilar products along with analysing the extent of product comparability with the innovator molecule that will drive the biosimilar market in India.
The event is designed to help the companies to devise effective linking of process development to technological expertise in manufacturing scale up in the development of a biosimilars. It will also focus on giving insights into the next generation mAbs development and working around the clinical challenges with biosimilar drug development to successfully mAbs biosimilars, while navigating roadblocks around upstream process to improve biosimilar product quality.
It will also focus on overcoming the challenges in the disposable downstream process for fast, flexible and cost-effective manufacturing process. This initiative is expected to bring together 100 plus senior management comprising of heads of technical, R&D, biologics, biosimilars, manufacturing, process development, product development amongst others from biopharma and biotech firms.
Some of the key speakers who will be sharing their insights during this event includes A Chandra Sekhara Rao, deputy drugs controller (India), Central Drugs Standard Control Organisation (CDSCO), Hyderabad; Bobby George, vice president and head, regulatory affairs, Reliance Life Sciences; Umesh Shaligram, director, research and development, Serum Institute of India; M K Sahib, director, Genomics and Biotechnology, Wockhardt; Dr Arvind Mishra, joint president, corporate QC/QA and regulatory affairs, Cadila Pharmaceuticals; Susobhan Das, senior general manager, early stage and product development and translational science, Intas Biopharmaceuticals; Jaspreet Singh, head, quality, Lupin Pharmaceuticals; Dr Nilesh K, head, quality control, MabPharm; Dr Meenakshi Malik, principal scientist, molecular biology, Biocon Research Centre; Shilpy Kochhar, deputy manager, Biotech Consortium India Limited (BCIL); Dhananjay Kapale, senior manager, production, Lupin Pharmaceuticals; Dr Asma Ahmed, assistant professor, department of chemical engineering, BITS Pilani (Hyderabad campus) and former senior scientist, biologics, Dr Reddy’s Laboratories, to name a few.