Lecture Description

Unfortunately, Larisa was unable to send us her abstract before the federal government shutdown. She wrote to us saying that even though she is a visiting scholar with MIT, she is still technically a federal government employee and cannot do any work while the government is shutdown.

In any event, we are still moving forward in the hopes that the shutdown will resolve this week.

What kinds of tales might we hear about?

• Navigating the uncharted policy terrain around products of biotechnology, both nationally and internationally.
• Developing regulatory strategy for the first food from a genetically engineered plant – the now infamous Flavr Savr Tomato [imagine photo of tomato filled with giant syringes]
• The process of approving AquaBounty Salmon – the first GE animal intended for food use
• Dealing with government shutdowns? We’ll find out!

Note that Dr. Rudenko will also be speaking at the GES Colloquium earlier the same day. 

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About | Dr. Larisa Rudenko

Larisa Rudenko is currently a Visiting Scholar in the Program on Emerging Technology at MIT where she is studying science-and values-based concerns associated with emerging biotechnologies. She has served as the Senior Advisor for Biotechnology at the Center for Veterinary Medicine where she led the agency initiative to develop novel risk-based approaches and resulting policies for the products of animal biotechnology. She directed the program to develop a science-based policy for the the regulation of genetically engineered (GE) animals, and created and directed a new FDA administrative unit for the implementation of that program. She has been instrumental in developing science-based policies for the regulation of the products of biotechnology nationally and internationally. She has worked in different venues to develop paradigms to assess the risk/safety for genetic alterations in multiple systems from microorganisms to plants and animals (including humans).

Dr. Rudenko’s “firsts” include:

• Developing a regulatory strategy for the first food from a genetically engineered plant
• Producing the first comprehensive assessment of the safety/risk of animal health and foods from animal clones
• Overseeing the first guidance for the regulation of GE animals
• Implementing that guidance by overseeing the processes for the first approval relevant to a genetically engineered biopharm animal
• The first approval relevant to a GE animal intended for food use, and
• The first American to serve on a European Food Safety Authority panel.

Dr. Rudenko has worked on developing seminal international policies for the risk assessment of various types of genetic alterations and assisted reproductive technology; she is internationally recognized for successful leadership and collegial collaboration in developing coordinated strategies and harmonized consensus documents. She has served as a judge and safety advisor to the iGEMs competitions.

Prior to her tenure at FDA, Dr. Rudenko worked in the consultancy and venture capital fields. She received her PhD in Cellular and Molecular Biology from Stony Brook University after completing her doctoral work in DNA damage and repair at the Brookhaven National Laboratory; she is a Diplomate of the American Board of Toxicology.

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