Parallel session 14: Risk analysis & regulatory reviews (4)
Tracks
Breakaway 2
Wednesday, May 3, 2023 |
16:00 - 17:30 |
Frisco / Burlington |
Details
16:00 - 16:05 Chair: Joe Smith Introduction
Speaker
Ms Pascale Delzenne
Regulatory Affairs Manager
Bayer
Regulatory approaches that compromise innovation: the case of agricultural biotechnology in the EU.
16:05 - 16:20Biography
Ir. Pascale Delzenne is Regulatory Affairs Manager, Traits for the Europe, Middle East, Africa region at Bayer CropScience. She has been working in risk assessment of genetically modified crops for more than 20 years. Pascale is graduated in agriculture engineering from the Catholic University of Louvain-La-Neuve (Belgium), with speciality in tropical and subtropical areas. Prior to Bayer, Pascale worked in fungicides research at Monsanto, taught in high schools and worked in the development of horticultural production for the Food and Agriculture Organization (FAO) in Gabon and Senegal. She now ensures regulatory approvals for Bayer CropScience´s traits products in accordance with the respective EMEA legislations while maintaining approvals for existing ones. Pascale also represents Bayer in Crop Life Europe (CLE) and is the chair of the CLE Food/Feed expert group.
Mrs Muffy Koch
Senior Regulatory Affairs Manager
J.R. Simplot Company
Risk Assessment and Regulatory Reviews: Three Requests from Developers
16:20 - 16:35Biography
Muffy Koch is a senior regulatory manager at the J.R. Simplot Company and has 35 years of experience in the regulation and safety assessment of GMOs. She was educated and trained in South Africa, as a botanist and microbiologist. She worked for 8 years as a microbial and plant genetic engineer, for 10 years as a South African interim regulator, for 15 years training regulators internationally in the safety assessment of GMOs, and more recently in Boise, Idaho, helping to confirm the safety of new potato varieties.
Dr Matthew Pence
Regulatory Manager
J.R. Simplot Company
Weight-of-Evidence Risk Assessment is Sufficient for Intractable Proteins
16:35 - 16:50Biography
Matthew Pence is a regulatory manager working at Simplot Plant Sciences, part of the J.R. Simplot Company. He received his PhD in Biochemistry and Molecular Biology from Wake Forest University using enzymology and X-ray crystallography techniques to study DNA replication of carcinogen-modified DNA, and was a post-doctoral fellow at Vanderbilt University before coming to work for the J.R. Simplot Company. He has worked in the biotech industry at Simplot Plant Sciences for the past 10 years as a regulatory scientist, and as regulatory manager. His contributions at Simplot include recombinant protein expression, protein assay development for risk assessment, event detection, and allergen and toxin bioinformatics screening for regulatory needs, as well as writing and submitting reports and dossiers, and working with regulators to obtain approvals for Simplot’s Innate® potato varieties at USDA, FDA, EPA, and in the Philippines. He is currently leading work on regulatory submissions at EPA and in Korea, and supporting submissions in China.
Mr Mike Connelly
Regulatory & Stewardship
Nuseed
Omega-3 canola offers essential nutrients for human and animal health, requiring a more balanced, trait-based approach in safety assessment
16:50 - 17:05Biography
Mike Connelly joined Nuseed’s regulatory affairs team in 2016, where he is responsible for registering and stewarding canola traits that provide health benefits to consumers. He brings 30 years of experience in global regulatory affairs and product development of plant biotechnology and crop protection products.
Mike is an accomplished business professional with expertise in global agricultural chemical and plant biotechnology regulations. He has a reputation for navigating regulatory processes with biotech seeds, pesticides and biocides as well as insect resistant management.
Mike has had a successful career in small, medium and large-sized companies, working primarily in registration and regulatory affairs, as well as product development testing in the field, sales, and provided regulatory consulting services. He is fluent in Spanish with a working knowledge of Portuguese. He obtained a BA in Biology and Spanish from the University of Minnesota, Morris, an MS in Entomology from the University of Minnesota, Twin Cities, and an MBA from Florida International University.
Chair
Joe Smith
Past President
ISBR
