Incentives, Disincentives for Research & Development of New Antimicrobial Drugs & Alternatives to Antibiotics for Food Animals*

Incentives and disincentives to researching and developing new antimicrobial drugs and non-antibiotic alternatives for use in food-producing animals was the focus of a workshop March 17-18, 2016, in Washington, D.C.  The workshop was a collaboration of Farm Foundation, NFP, and USDA’s Economic Research Service.

Keynoting the workshop was Catherine Woteki, USDA Undersecretary for Research, Education and Economics. Other speakers included representatives from FDA’s Center for Veterinary Medicine, academic researchers, animal health pharmaceutical company representatives, global animal health associations and biotech development companies. Presentations are posted below from those speakers who have given permission to do.

The rise of antibiotic resistance and the decline in the number of new antibiotics being developed creates great concern for the future of human medicine.  There is a burgeoning literature on methods to incentivize the development of new antibiotics for human use.  Much less discussed are similar concerns for food animal products.

To understand how to incentivize research and development of new antimicrobial drugs and novel products requires understanding the market for animal pharmaceuticals, how to bring a product to market, the regulatory protocols required to bring products to market, the regulations on use of antibiotics in food production, and the overlap between human and animal antibiotic use and development.

This workshop examined these factors. It also explored the types of interventions that might be used to incentivize research and development of new antimicrobial drugs and novel products for use in food animals. This workshop was not intended to explore the chain of antimicrobial resistance from farm to fork, or antibiotic stewardship practices in livestock production.

The workshop was targeted to policy makers, researches and government agency staff, as well as representatives of the human health, livestock production, veterinary medicine and animal health industries.

*Since “novel products” 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.”

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
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
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
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
Animal Health Products: What Does Our World Look Like?
Rob Hunter, Provetica Animal Health

The Landscape of Animal Health Innovation
Grady Bishop, Elanco

Concurrent Sessions
Session 4A: Connecting Human and Animal Pharma Development
Moderator: Gail Hansen, Hansen Consulting
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
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
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

Session 6:  Government Dollars, Government Levers and Public-Private Partnerships
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
Session 7A:  Solutions: Private Sector and Federal Agencies 

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
Mark Cook, University of Wisconsin
Hua Wang, Ohio State University
Dave Donovan, Agricultural Research Service, USDA
Lucia Mokres, EpiBiome


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