The biomedical sector (pharmaceutical, biotechnology, medical engineering technology & healthcare related industries) is  a high risk high returns sector in a highly competitive marketplace. Products and services that directly impact human health, the extremely high cost of R&D with a high degree of uncertainty of returns, the constant pressure for shorter product lifecycles, the highly litigious patent environment & ethical issues surrounding the life sciences are just some of the unique industry challenges that make it essential for the biomedical science researchers and business executives to understand legal risk issues at both the strategic and technical levels.

As a project or contract in-house counsel, I provide strategic risk management services and IP value creation for the biomedical sector. 

Like all businesses, the biomedical sector has to balance risks with returns. With billions of dollars spent annually in R&D in the biomedical science sector and the growing emphasis on “commercial biomedical science”, players in this sector also need to understand how to develop strategic intellectual property approaches covering biomedical patent prosecution, clearance and Freedom to Operate analysis, interference proceedings, litigation, IP portfolio management and strategies and techniques of technology commercialization. 

The interplay of science, technology, business and the law will affect corporate revenue streams, market position and shareholder value. This program designed by Zaid Hamzah  will help participants in the whole biomedical science eco-system navigate through this increasingly competitive landscape to achieve their business goals while complying with societal ethical norms. The program provides a concise introduction to strategic legal risk management issues and strategic value creation in the entire biomedical science value chain including:

• Legal liability issues from R&D, clinical trials, production of devices and market rollout
• Protection of innovation through intellectual property (patents, copyrights, trade marks and trade secrets)
• Commercialization of biomedical science innovation through strategic licensing and technology transfer including unique licensing arrangements relating to genome

Targeted primarily at biomedical scientists, researcher managers, business executives and investors in the biomedical sector, this “how to” legal strategy program is not specific to any legal jurisdiction. Outlining the general principles of law and legal risk management strategies in the biomedical sector in any country, the program is designed to equip the participants with the skills to identify and understand strategic legal risk issues common to all jurisdictions.

In a step by step approach, the program equips the participants with the skills to ask the right questions and to analyze legal issues the way lawyers do. In this way the non lawyers can be better prepared when they speak to their legal and business advisers. Checklists, sample agreements & biomedical patents and real life & hypothetical case studies used in this program in turn facilitate the learning at the operational or technical level of execution.