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Presentations from Incentives, Disincentives to R&D Workshop

Incentives and Disincentives for Research and Development of New Antimicrobial Drugs and Alternatives to Antibiotics for Use in Food Animals*

March 17-18, 2016
Auditorium at Patriots Plaza III, 355 E St. SW, Washington, D.C.

Agenda

Thursday, March 17

Welcome:  Stacy Sneeringer, Economic Research Service, U.S. Dept. of Agriculture (USDA)

Keynote address: Catherine Woteki, USDA Chief Scientist and Under Secretary for Research, Education and Economics

Session 1:  Why Do We Need New Antimicrobials or Novel Products For Use in Food Producing Animals?
Moderator: Cyril Gay, Agricultural Research Service, USDA
Panelists:
 The Yin and Yang of Innovation for Food Animal Disease Interventions
Tom Shryock, Antimicrobial Consultants, LLC

 Antibiotics, Alternatives Incewntives: What's All the Hubbub?
Tom Campi, Elanco Animal Health

Session 2:  Regulatory Review Processes of New Drugs and Novel Products
Moderator: Neena Anandaraman, Office of the Chief Scientist, USDA
Panelists:
 Regulatory Review Processes of Antimicrobials and ALternatives to Antimicrobials
Cindy Burnsteel, Center for Veterinary Medicine, Food and Drug Administration (FDA)

 General Licensing Requirements and Regulatory Considerations
Byron Rippke, Center for Veterinary Biologics, Animal and Plant Health Inspection Service, USDA

 Regulatory Review Processes of New Products: 2015 Global Regulatory Review and Global Harmonixation
Carel du Marchie Sarvaas, Health for Animals

Concurrent Sessions

Session 3A:  Animal Diseases, Antibiotic Use and Resistance in Animals

Moderator: Chase Crawford, Association of American Veterinary Medical Colleges
Panelists:
 Antimicrobial Resistance in Bovine Respiratory Disease
Brian Lubbers, Kansas State University

 Diseases of U.S. Livestock Requiring Antimicrobials, USDA APHIS National Animal Health Monitoring System
Kathe Bjork, Animal and Plant Health Inspection Service, USDA

 Perspectives on Needs for Therapeutics for Animal Helath and Safe Food
M. Terry Coffey, Smithfield Hog Production Division
 
Session 3B:  Animal Health Industry:  Basic Research, Development, Testing and Marketing
Moderator: Ron Phillips, Animal Health Institute
Panelists:
 Animal Health Products: What Does Our World Look Like?
Rob Hunter, Provetica Animal Health

 The Landscape of Animal Health Innovation
Grady Bishop, Elanco

Not available: (The Sequence of Success: New Product Development from the Startup Perspective
Lucia Mokres, EpiBiome)

Concurrent Sessions

Session 4A: Connecting Human and Animal Pharma Development
Moderator: Gail Hansen, Hansen Consulting
Panelists:
 Discovery and Development of Veterinary Antibacterials
Jeffrey Watts, Zoetis

 BARDA's Role in Combating Antibiotic Resistance
Joe Larsen, Biomedical Advanced Research & Development Authority (BARDA), U.S. Dept. of Health and Human Services

 A One Helath Perspective on antibicrobial Drug Development
Laura Kahn, Princeton University

Session 4B:  Challenges to Research, Development & Commercialization of Non-Antibiotic Products
Moderator:  Karin Hoelzer, Pew Charitable Trusts
Panelists:
 Bringing an Animal Product from the Petri Dish to the Market
Cindy Burnsteel, Center for Veterinary Medicine, FDA

Not available: (Alternatives to Antibiotics:  Challenges and Opportunities for Combating Antimicrobial Resistance
Cyril Gay, Agricultural Research Service, USDA)

 Success and Impact of Alternative Approaches on Antibiotic Resistance Mitigation
Hua Wang, Ohio State University


Friday, March 18

Session 5:  Incentives and Disincentives to Developing New Antibiotics and Novel Products for Use in the Livestock Sector
Moderator: Stacy Sneeringer, Economic Research Service, USDA
Panelists:
 Antibiotic Discovery and Development in Animal Health: A Landscape of Conflicting Busienss Signals
Rick Sibbel, Merck

 Project Funding Roulette: Where Should the Bet Be Planced?
Tom Overbay, Expedite

 Observations from an Academic Entrepreneur
Mark Cook, University of Wisconsin

Not available: (Phage Endolysins as Alternative Antimicrobials: From Protecting Ethanol Fermentation to Treatment for Drug-Resistant and Intracellular Staphylococcus Aureus
David Donovan, Agricultural Research Service, USDA)

Session 6:  Government Dollars, Government Levers and Public-Private Partnerships
Moderator: James MacDonald, Economic Research Service, USDA
Panelists:
 The Economics of Incentivizing Innovation
Matt Clancy, Economic Research Service, USDA

 Fighting Resistance: How Can Government Incentives Stimulate New Antibiotics for Animal Health?
Andrew Toole, U.S. Patent and Trademark Office

 USDA's Extramural Investments in Sciences Supporting Development of Alternatives to Antibicrobials
Gary Sherman, National Institute of Food and Agriculture, USDA

 Developing Partnerships to Commercialize USDA-ARS Research
Rob Griesbach, Office of Technology Transfer, Agricultural Research Service, USDA

Concurrent Sessions   (No slides for these)
Session 7A:  Solutions: Private Sector and Federal Agencies 

Moderator: Stacy Sneeringer, Economic Research Service, USDA
Panelists:
Tom Shryock, Antimicrobial Consultants, LLC
Tom Overbay, Expedite
Cindy Burnsteel, Center for Veterinary Medicine, FDA
Rick Sibbel, Merck
Joe Larsen, BARDA
 
Session 7B:  Solutions: From Basic Science to Commercial Application
Moderator: Maria Bowman, Economic Research Service, USDA
Panelists:
Mark Cook, University of Wisconsin
Hua Wang, Ohio State University
Dave Donovan, Agricultural Research Service, USDA
Lucia Mokres, EpiBiome

Wrap-up

*Since “alternatives to antibiotics” is a large umbrella, this workshop focuses on antimicrobial activity targeting multi-resistant animal pathogens, such as: bacteriophage and bacteriophage gene products, essential oils, immune enhancers, innate defense molecules, naturally-occurring antibacterial lytic enzymes, organic acids, phytochemicals, prebiotics, probiotics, small interfering RNAs, therapeutic antibodies, lytic enzymes, cytokines, and vaccines.

A note on language:  In the policy sphere, the phrase “alternatives to antibiotics” is used to refer to many products, the use of which may lessen the need for traditional antibiotics. However, depending on a number of features, these products may not be marketed as drugs, and therefore do not go through the same regulatory review as drugs. Hence marketers of these products do not refer to them as “alternatives to antibiotics,” since that would be a claim that they have drug-like properties. While the use of the term “alternatives to antibiotics” is in the title of the workshop, we want to be clear that participation in the workshop does not indicate that a participant’s company is making any drug claims about its marketed products.

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