Artificial Intelligence in Drug Development: Patenting and Regulatory Aspects
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This book discusses how Artificial Intelligence developments have revolutionized the area of medicine and how companies use them to develop applications. While the book covers the growth of AI in medicine and the early developments in AI based medical tools, it provides an in-depth analysis of the current developments in relation to the area of medical diagnostics. The book focuses on how enterprises and institutes have developed their intellectual property portfolio, particularly patents, in this area. Cross-country patenting analysis helps in understanding key areas of growth in certain markets and also company strategies and arrangements. The introduction of AI based products in market is subject to regulation. The developments in policy and regulation influence the development and deployment of such products into the market. This book brings focus to the development of policy and regulation and how regulatory developments impact the introduction of AI-based healthcare products from a cross-country perspective. Further, how regulatory developments lead to the evolution of standards, build reliability and safety in this area are also examined. The unique aspect of this book is the comprehensive coverage of the dual aspects of the nature and scope of AI-based innovations in health care and the related drug regulatory aspects which are imperative for the understanding for students, researchers, and those who work in this area.
Kavita Sharma is currently pursuing her doctoral studies in patenting and regulation related to AI in health care from Rajiv Gandhi School of Intellectual Property Law, Indian Institute of Technology, Kharagpur. She has also completed her LL.M. from the same institute in 2017. She completed her B.A. LL.B. from Dibrugarh University, Assam. She worked as Assistant Professor prior to joining IIT Kharagpur for her PhD studies. She had worked on standard essential patents as a part of her LL.M. dissertation. Her research interests primarily include IP Law. She has presented her research papers in various national and international seminars and conferences. Her articles have been published in renowned journals. She has also gained experience through internships in inter-governmental organizations such as AALCO.
M. Padmavati is Professor in Rajiv Gandhi School of IP law, Faculty of Interdisciplinary Sciences and Engineering, Indian Institute of Technology Kharagpur. With more than fifteen years teaching and research experience, she specializes in patents. She teaches the subjects of patent law, patent procedure and drafting, biodiversity law, and TK protection among other subjects to undergraduate and master students of law. Her primary area of research includes intellectual property and commercialization of recombinant and herbal drugs and drug regulation, biodiversity law, studies on implementation of IP. Prior to joining IIT Kharagpur, she was Senior Scientist at Monsanto Research Center, Bangalore, where she coordinated invention disclosure filing. She has many research as well as consultancy projects, from Ministry of Human Resource Development, DST etc. She has been awarded the Microsoft-Young Faculty Scholarship in Intellectual Property. She is Advisor to the IPR Cell, IIT Kharagpur.
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