29-30 May 2018

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Day One
Tuesday April 18, 2017

Day Two
Wednesday April 19, 2017

07.30
Registration & Breakfast

08:30
Chair’s Opening Remarks

Addressing the Regulatory Pathway & Consumer Perception for CRISPR Gene Editing

08:35
FDA Oversight of Food from Plants Developed with Biotechnology

  • Patrick Cournoyer Consumer Safety Officer - Office of Food Additive Safety, U.S. Food and Drug Administration (FDA)

Synopsis

  • Regulatory requirements for food from new plant varieties
  • FDA’s Plant Biotechnology Consultation Program
  • FDA’s request for comments on plant genome editing

09:05
USDA Regulation of CRISPR-Modified Organisms

  • Neil Hoffman Chief Science Advisor, Animal and Plant Health Inspection Service & Biotechnology, Regulatory Services , United States Department of Agriculture (USDA)

Synopsis

  • Regulatory guidelines facing non-transgenic genetically edited crops and plants
  • Case studies of products that have gone through the regulatory process such as waxy
    corn and mushrooms
  • Regulatory status for non-GMO white bud, mushrooms and white seed corns

09:35
FDA Perspective on Animals Developed Using Genome Editing

  • Laura Epstein Senior Policy Advisor, Center for Veterinary Medicine, FDA

Synopsis

  • Describe regulatory approach set forth in FDA’s Revised Draft Guidance for Industry 187 on Intentionally Altered Genomic DNA in Animals
  • Encourage stakeholder input

09:55
Panel Discussion: Navigating the Regulatory Environment for CRISPR as Novel Breeding Technique

  • Neil Hoffman Chief Science Advisor, Animal and Plant Health Inspection Service & Biotechnology, Regulatory Services , United States Department of Agriculture (USDA)
  • Mike Mendelsohn Acting Chief, Microbial Pesticides Branch, Biopesticides and Pollution, Prevention Division, U.S. Environmental Protection Agency (EPA)
  • Patrick Cournoyer Consumer Safety Officer - Office of Food Additive Safety, U.S. Food and Drug Administration (FDA)
  • Laura Epstein Senior Policy Advisor, Center for Veterinary Medicine, FDA
  • Todd Barker Senior Partner, Meridian Institute

Synopsis

To provide more clarity on the current regulatory guidelines for utilizing CRISPR gene editing technology in the development of commercial products.

The panel will discuss and answer the following questions:

  • What can be learned from the long history of safe use of random mutagenesis in the development of useful new crop characteristics?
  • How might the outcomes achieved by new technologies like CRISPRs affect the regulatory profile in plants and livestock?
  • Knock-outs vs. insertions – What are the current regulatory guidelines?
  • What are the current regulatory guidelines for utilizing CRISPR gene editing in animals/ livestock?
  • What are the industry responsibilities in engaging consumers and the general public on CRISPR-edited commercial products?

10:50
Morning Refreshments & Networking

11:20
Building Consumer Trust in Gene Editing

Synopsis

  • CFI’s peer reviewed trust model provides a template for building trust in gene editing
  • Consumer research on beliefs and attitudes toward technology provide insight into consumer concerns and objections
  • The presentation will provide analysis and specific recommendations on how to build consumer trust in gene editing

Taking CRISPR to the Market: Preparing for Translational Biotechnology

11:50
Exploring the Path of Commercialization in Agriculture

  • Vonnie Estes Group Leader, Agricultural and Industrial Biotechnology, Caribou Biosciences

Synopsis

  • Supporting and developing appropriate regulatory frameworks
  • Building public acceptance and trust
  • Working in a global context
  • Who will profit and how will value be shared?

12:20
Waxy Corn Case Study: Highlighting CRISPR/Cas9 Edited Plant & Crops Currently Under Development for Commercialization

  • Tom Greene Senior Director, Research, Trait Discovery & Optimization , DuPont Pioneer

Synopsis

  • How is CRISPR/Cas9 being utilized to modify plant and crop traits?
  • Outlining the regulatory process for utilizing CRISPR gene editing technology
  • How has CRISPR/Cas9 enhanced plant and crop breeding practices and outcomes?
  • Utilizing CRISPR gene editing to reduce costs and time to market

12:50
Networking lunch

13:40
The Promise of Gene Editing: Creating Foods with Healthier Characteristics for Consumers

Synopsis

  • To present the most advanced and richest gene editing pipeline across the industry
  • To discuss Calyxt’s soybean, potato and wheat product pipeline, plus a discussion on the
    company’s technical approach, accomplishments to date, innovative path to market and
    current perspectives on gene editing

14:10
Taking Gene Editing into the Agricultural Commercial Market

  • Allan Wenck Head of Trait Validation US, Bayer CropScience

Synopsis

  • The ability to create precise mutations within plants has the potential to speed up breeding and to bring traits to the market quicker than traditional mutagenesis approaches
  • Precise targeting of the genome opens more flexible and efficient opportunities for stacking of traits
  • Surgically precise modifications within multiple crop species is a challenge that requires multiple solutions to overcome

14:40
Application of CRISPR/Cas9 to Study the Role of Genes in Domestication & Improvement of Solanaceous Species

  • Joyce Van Eck Assistant Professor, Director, Center for Plant Biotechnology Research , Boyce Thompson Institute

Synopsis

  • Efficacy of CRISPR/Cas9 in the Solanaceae
  • Traits related to domestication
  • Improvement of solanaceous species for specialty vegetable crops

15:10
Afternoon Refreshments & Networking

Harnessing CRISPR Gene Editing for Advanced Livestock Breeding

15:30
Accelerated Breeding of Natural Genetic Traits in Livestock with DNA Editing

  • Scott Fahrenkrug Executive Chairman and Chief Scientific Officer, Recombinetics

Synopsis

  • How is CRISPR being adapted to enhance livestock breeding?
  • How will this need to be communicated to consumers and the wider public?

16:00
Optimizing Methodologies for Genome Editing in Livestock

  • Bhanu Telugu Assistant Professor, President & CEO, University of Maryland, RenOVAte Biosciences Inc

Synopsis

  • Provide a rationale for performing genome editing in livestock (domestic pigs)
  • Describe constraints of genetic engineering in the pre-CRISPR era
  • Describe the genetic engineering in the CRISPR era. Including providing case studies for generating knockouts, knockins and introducing SNPs

16:30
Commercial Application of Gene Editing to Improve Animal Health and Production

Synopsis

  • Introduction to Genus
  • Review the progress for delivering Porcine Reproductive and Respiratory Syndrome virus resistance in pigs (PRRS)
  • Challenges for scaling gene editing in animal genetics
  • To discuss future livestock trait targets

17:00
Chair’s Closing Remarks

17:10
Close of CRISPR AgBio Congress