Diagnostics: IP Practices, Challenges and Opportunities

Where it converges with therapeutics, diagnostics is seeing the beginning of a new era. Exciting advances are being made in the development of biomarkers for clinical use beyond the research setting. Regulatory bodies including the FDA are increasingly receptive to trial designs incorporating companion diagnostics. Next-gen sequencing takes the industry to new heights of the enabling technologies, which fuel the growth of personalized medicine. Yet complex and unpredictable regulatory and IP policies present practical challenges for the industry, and investment has been anemic. This panel will discuss the rapid technological advances in diagnostics and personalized medicine, and the challenges and opportunities facing the industry. The panel will explore investment strategies and relevant business models for this space, and alternative financing options for new and growth companies.

This module explores how IP practices have changed in recent years, and analyzes the current state of the sector. This module also discusses new fields in diagnostics, including genome sequencing and the evolution of biomarkers. For interviews and case studies, view the side bar. Check back soon for more stories!

Faculty

Qin Shi, PhD, JD, Managing Principal, EdgeTech Law

Qin Shi, PhD, JD, is currently the managing principal of EdgeTech Law, a boutique law/advisory firm based in California with a global clientele. Dr. Shi is an intellectual property litigator and also advises clients on transactional matters including cross-border partnerships and alliances.

Her practice covers a range of technologies and industries, including computer electronics, digital gaming applications, and biopharmaceuticals and medical technologies. For over twelve years Dr. Shi has represented established and emerging companies and institutions in the procurement, transaction, and enforcement of IP rights. She has recognized expertise in all aspects of IP and technology law as well as with related regulatory compliance issues. EuroMoney’s International Expert Guide identifies Dr. Shi as a leading expert regarding China in the field of Intellectual Property and Patents. She was previously with several large US and global law firms, including Paul Hastings, Howrey, Latham & Watkins, Fenwick & West, and Heller Ehrman.

Before her legal career Dr. Shi has had significant industry experience in research, technology management, product development and marketing in computer technologies, informatics, and life sciences. She was one of the early bioinformaticians and remains close to the new fronts of genomics, pharmacogenomics, and synthetic biology among other fields. Dr. Shi has widely published and given presentations in law, business, and science. She serves on a number of committees of the ABA, AIPLA, IPO, LES, and is also a member of IEEE, ISCB, and AAAS.

Qin Shi, PhD, JD, is currently the managing principal of EdgeTech Law, a boutique law/advisory firm based in California with a global clientele. Dr. Shi is an intellectual property litigator and also advises clients on transactional matters including cross-border partnerships and alliances. Her practice covers a range of technologies and industries, including computer electronics, digital gaming applications, and biopharmaceuticals and medical technologies. For over twelve years Dr. Shi has represented established and emerging companies and institutions in the procurement, transaction, and enforcement of IP rights. She has recognized expertise in all aspects of IP and technology law as well as with related regulatory compliance issues. EuroMoney’s International Expert Guide identifies Dr. Shi as a leading expert regarding China in the field of Intellectual Property and Patents. She was previously with several large US and global law firms, including Paul Hastings, Howrey, Latham & Watkins, Fenwick & West, and Heller Ehrman. Before her legal career Dr. Shi has had significant industry experience in research, technology management, product development and marketing in computer technologies, informatics, and life sciences. She was one of the early bioinformaticians and remains close to the new fronts of genomics, pharmacogenomics, and synthetic biology among other fields. Dr. Shi has widely published and given presentations in law, business, and science. She serves on a number of committees of the ABA, AIPLA, IPO, LES, and is also a member of IEEE, ISCB, and AAAS.

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