Larisa Rudenko has spent her career evaluating emerging biotechnologies in the private (consultancies) and public sectors (US FDA).  Dr. Rudenko moved from the bench to more policy-oriented pursuits by developing novel methods for the risk/safety assessment of substances with non-traditional characteristics, including the products of biotechnology. Following work in the private sector, including venture capital, she was recruited by the US FDA to serve as the senior advisor for biotechnology and inaugural Director of the Animal Biotechnology Interdisciplinary Group at the Center for Veterinary Medicine. There she was the primary author of seminal risk/safety novel approaches adopted by the US and that have functioned as the basis of similar approaches in other countries. She served as a subject matter expert to the US Trade Representative in negotiations with the EU, participated in key roles representing the US in Codex Alimentarius Writing/Working groups, expert consultations at the OECD, and as an expert in briefings to various Ministries and governmental regulatory agencies. She serves on several grant review committees in the US and Canada. At BioPolicy Solutions, LLC, she and Co-Founder Dr. Laura Plunkett continue their work in emerging biotechnologies, including developing regulatory strategies for new products or new methods of manufacture for more traditional products; providing due diligence reviews for investors or companies seeking funding; post-market vigilance; and participating in advisory groups to governmental agencies and philanthropies interested in policy issues associated with the bioeconomy, regulatory reform, and developing efficient, science-based approaches for the products of emerging biotechnologies their responsible implementation. She has a PhD in Cellular and Molecular Pharmacology and is a Diplomate of the American Board of Toxicology.