Role of Animal Medicines in Ensuring a Safe Food Supply

1
Role of Animal Medicines in Ensuring a Safe Food
Supply

• KJ Varma,
• Vice-President RD PharmaceuticalsIntervet/Scheri
  ng-Plough Animal Health
• IFAH Europe Annual Conference
• Brussels, Belgium
• June 12, 2008

2
Our Common Goal

• Ensure a safe, secure, abundant, high quality,
  affordable, and environmentally-friendly supply
  of animal protein

3
World food situation redefined by new driving
forces

• Food consumption and production are influenced by
  global changes in standards of living, climate,
  energy prices, urbanization and population
  (IFPRI, 2007).
• Production is moving to regions offering the best
  natural resources.
• With specialized and large-scale production,
  animals are moved within and between countries.
• Animal products are shipped around the world to
  meet increased food demand and requests for
  affordable prices.
• Consumer demand for higher food quality is
  increasing

FAO, 2007
Increasing challenges for animal health in a
globalizing and ever intensifying agricultural
sector
4
What is the ideal safe food supply?
Pharmaceutical industry perspective

• Low microbial burden
• Parasite-free
• Violative residue-free
• use of best science in establishing withdrawal
  periods
• Zoonotic and food-borne disease-free
• Full traceability
• Consumer friendly

5
What is the ideal safe food supply?
Pharmaceutical industry perspective

• Infectious disease-free livestock
• fight infection while minimizing resistance
• responsible use of antimicrobial agents
• develop new modalities of fighting infection
• prevent infection
• prevent spread of infection between regions by
  accurate screening of cattle and products prior
  to transport
• respond rapidly to emerging diseases

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Fight Infection While Minimizing Resistance
responsible use of antimicrobial agents

• As an industry, we need to endorse concepts of
  responsible use of antimicrobial agents
• Responsible Use of Medicines in Agriculture
  Alliance (RUMA)
• European Platform for the Responsible Use of
  Medicines in Animals (EPRUMA)
• RiskBenefit decisions need to be evidence-based,
  not emotion-based
• scientific research
• participation in surveillance programs
• proper use of Risk Analysis
• communicate risk levels to the public

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Fight Infection While Minimizing Resistance
Responsible Use of Antimicrobial Agents - Proper
Use of Risk-Analysis
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Fight Infection While Minimizing Resistance
develop new modalities of fighting infection

• Immunostimulation
• Decrease stress
• delivery systems
• anxiolytics
• Address resistance factors
• e.g. antibiotic efflux pump inhibitors

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Fight Infection While Minimizing Resistance
develop new modalities of fighting infection

• Non-antibiotic antimicrobial therapies
• biofilm disruption
• virulence factor inhibition (next slide)
• phage technology

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Fight Infection While Minimizing Resistance

Virulence Factor Inhibition - Example
leukotoxin
M. haemolytica
Exciting new molecular targets -- so-called
"virulence factors" that bacteria use to thrive
once they are in the host -- present an
alternative, potent means of combating bacterial
infection
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Fight Infection While Minimizing Resistance

• Prevent Infection
• Genetic tools to design better vaccines
• Genetic sequencing of pathogens facilitates
  better vaccine design DNA, recombinant vectored
  vaccines, subunit approaches
• Improved vaccine formulations for better efficacy
• Immune stimulating complex (ISCOM) technology and
  other advances in adjuvants are enhancing
  efficacy and duration of immunity for vaccines
• Improved delivery of vaccines
• Oral delivery allows vaccination of livestock in
  later stages of growth
• Sustained release technology offers the promise
  of single injection to deliver vaccine antigens
  at varying times during growth
• Improved diagnostics
• screening for infectious diseases in transported
  animals and animal products

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Norwegian salmon productionEffect of vaccination
on antibiotic use
Vibriosis vaccine
60
350
300
50
Furunculosis vaccine
250
40
Oil-based vaccines
200
Tons of Antibiotics (bars)
1'000 Tons of Salmon (red line)
30
Combination vaccines
150
20
100
10
50
0
0
1987
1989
1991
1993
1995
1997
1981
1983
1985
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Fight Infection While Minimizing Resistance
respond rapidly to emerging diseases

• We continue to discover new infectious disease
  entities.
• WHO estimates that 70 of the emerging diseases,
  occurring in humans, are related to wild or
  domesticated animals.
• When animal diseases are not prevented, the
  social, economic, and environmental costs to
  humans can be significant
• Bluetongue
• Avian Influenza
• Foot and Mouth Disease
• PRRS
• Circovirus
• The Industry goal is to develop innovative
  vaccines that address unmet needs and improve
  animal disease protection as well as the duration
  of that protection

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Parasite-free

• Historical innovations
• endoparasiticidal agents (e.g., benzimidazoles)
• ectoparasiticdal agents (e.g., pyrethroids)
• endectocidal agents (avermectins)
• vaccinations (coccidiosis, anaplasmosis)
• Future innovations
• screening of novel crop-science molecules for
  endectocidal activity
• identification of new antigenic targets

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Violative Residue-Free
Use of Best Science in Establishing Withdrawal
Periods

• Safety testing to determine safe concentrations
  (as defined by Regulatory Guidelines) of
  potential residues
• excellence in residue chemistry techniques
• radiochemistry
• cold chemistry
• selection of compounds with high safe
  concentrations and/or which deplete rapidly
• minimal biotransformation to decrease complexity
  of Human Food Safety programs and ensure
  excellent comparative metabolism (avoid multitude
  of metabolites and marker residue confusion)

16
Zoonotic and Food-Borne Disease Control

• Avian influenza
• Rabies
• Food Borne Disease (Salmonella, Campylobacter)
• Bovine Spongioform Encephalopathy

17
Traceability
Supply Chain Integration (meat branding)
Breeding/Genetics Nutrition Health Equipment Perso
nnel Financing Buying/Selling
International Demands
Government
Consumer
Special Interest Groups
Food Safety
Track calf from stable to table
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Better communication of benefits to the consumer

• The consumer is demanding more of government and
  industry
• greater concern for food quality
• greater concern for animal husbandry techniques
• The Media plays on these consumer fears
• All stakeholders (producers, processors, AH
  Industry, Government) need to do more to
  publicize the safety of our food supply and the
  benefit to both the animal, the consumer, and the
  environment of the use of therapies developed by
  the pharmaceutical industry
• healthier animal
• more abundant and higher quality product to the
  consumer
• more efficient production of animal protein
  results in less use of land/fertilizer per
  kilogram of protein produced, with less emission
  of greenhouse gasses

19
Human versus Animal Health Industry

• AH markets are much smaller yet the regulatory
  burden for development of a medicine for food
  animal use is high
• Development of a Human Food Safety dossier (which
  ultimately may or may not be successful in drug
  approval) costs many millions of dollars and 7
  years to accomplish.

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Human versus Animal Health Industry
AH markets are much smaller yet the regulatory
burdenfor development of a medicine for food
animal use is high
Estimated changes over the past 15
years Source IFAH Benchmarking Study

• Regulatory requirements drove up costs by 150
• Development time increased by 4.5 years on
  average
• Defensive RD absorbs 20-35 of resources

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Human versus Animal Health Industry

• To ensure continued flow of food animal medicines
  an increase in the efficiencies of the drug
  approval process is required
• Harmonization of drug approval process globally
  (VICH)
• Cooperation of Global Science-based Organizations
• World Animal Health Organization (OIE)
• Terrestrial Animal Health Code
• Antibiotic Resistance work
• Manual on diagnostic tests and vaccines
• Animal Welfare work
• Codex/JECFA
• Committee on Residues of Veterinary Drugs in Food
• Committee on Pesticide Residues in Food
• Residue/contaminants limits
• WHO
• Zoonoses

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Conclusions

• There are increasing challenges for animal health
  in a globalizing and ever intensifying
  agricultural sector
• A smaller world means that disease can spread
  across the globe, emerging in more susceptible
  populations, including diseases that can transfer
  from animal to man.
• Increased innovation in disease control and
  prevention at the source is critical.
• While development of effective disease prevention
  is important, veterinarians also need innovative
  treatments for a wide variety of diseases and
  pests.
• The RD provided by the research-based
  pharmaceutical industry is critical to respond to
  these changing conditions.
• Balancing natural resources, husbandry practices,
  performance enhancement and health management
  with the global regulatory environment and
  consumer acceptance will be essential for
  facilitating innovation.

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Conclusions

• With the continued cooperation of Industry,
  Government Agencies, and other stakeholders, we
  can technically ensure a food supply which
• is derived from livestock which are optimally
  protected from infectious, parasitic and zoonotic
  agents
• has a low microbial burden and
  no violative residues
• is fully traceable
• meets consumer demands

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Thank you