Development of Crop Protection Products: An Industry Perspective. Keith S. Rucker Technical Service Specialist

Transcription

1 Development of Crop Protection Products: An Industry Perspective Keith S. Rucker Technical Service Specialist

2 Need for Continued Crop Protection Product Development Wild oats White Mold on Peanuts Treated Potato Blight Untreated Untreated Treated Untreated Treated

3 Relation of Arable Land and Population One hectare of arable land must feed a rising number of people (Amount of arable land is constant at approximately 1.5 bn ha) / ha 4.0 / ha 7.0 / ha The world population is constantly increasing

4 Agricultural Area Required to Produce Sufficient Foodstuffs With & Without Crop Protection Theoretical Potential: Earth Surface Area: ca. 31 bn. acres Status Quo Year 2000 World Population: 6.0 Bn People Year 2025 World Population: 8.5 Bn People 14.2 bn. acres without Crop Protection 10.3 bn. acres Desert, glaciers, mountains etc. 9.1 bn. acres Forest, Steppe 33% 29% 9.6 bn. acres without Crop Protection 3.6 bn. acres with Crop Protection 8.2 bn. acres Grassland, Prairie, Cities 3.6 bn. acres Arable Land 26% 12% Source: D.T. Avery, US-Hudson Institure - FAO

5 2050 Est Billion 6.2 Billion 5.4 Billion Billion Billion Billion Billion Billion Food Production Pat Tegges, PNAA Education Foundation, 12 th Annual RISE Meeting Land area worldwide used by agriculture 1950 to 1994, approx. 5.8 million square miles.

6 Still a Strong Need for Innovation New Active Compounds New Modes of Action Favorable Profiles Safety Selectivity Sustainability

7 Global A.I. Development Stages Early Phase Research Phases Pre- Development Development Genomics + Target Screening in vivo UHTS Mode of Action Analysis Hit Lead Generation Lead Research Pre- New Trade Products 1.5 p.a. Patents, Literature Nat. Products Compounds : >200, year BCS-US Nomenclature: Candidate Pre-

8 High Throughput Screening (HTS) Early phases highly automated Screen 200,000+ compounds annually

9 Global A.I. Development Stages Early Phase Research Phases Pre- Development Development Genomics + Target Screening in vivo UHTS Mode of Action Analysis Hit Lead Generation Lead Research Pre- New Trade Products 1.5 p.a. Patents, Literature Nat. Products Compounds : >200, years BCS-US Nomenclature: Candidate Pre-

10 Research: Lead Generation

11 Global A.I. Development Stages Early Phase Research Phases Pre- Development Development Genomics + Target Screening in vivo UHTS Mode of Action Analysis Hit Lead Generation Lead Research Pre- New Trade Products 1.5 p.a. Patents, Literature Nat. Products Compounds : >250, years BCS-US Nomenclature: Candidate Pre-

12 Research

13 Global A.I. Development Stages Early Phase Research Phases Pre- Development Development Genomics + Target Screening in vivo UHTS Mode of Action Analysis Hit Lead Generation Lead 1 year Research Pre- New Trade Products 1.5 p.a. Patents, Literature Nat. Products Compounds : >200, year 6-7 years BCS-US Nomenclature: Candidate Pre-

14 Pre- /

15 Global A.I. Development Stages Early Phase Research Phases Pre- Development Development Genomics + Target Screening in vivo UHTS Mode of Action Analysis Hit Lead Generation Lead 1 year Research Pre- New Trade Products 1.5 p.a. Patents, Literature Nat. Products Compounds : >200, years BCS-US Nomenclature: Candidate Pre-

16 U.S. Regulatory Process Apply to EPA for Federal Pesticide Registration At same time, petition for establishment of Tolerance(s) EPA review takes a minimum of 2 years but averages 4 years State approvals add 3 to 24 months depending on state

17 U.S. Regulatory Process Registration data generation takes a minimum of 3 years & includes: Product Chemistry Ecological Toxicity Mammalian Toxicity Non-Target Plant and Insect Toxicity Environmental Fate Metabolism and Residue Chemistry

18 U.S. Regulatory Process Additional data are considered in the development and provided to EPA for use in evaluations and risk assessments, including: Neurotoxicity (acute exposures) Dislodgeable Residues (worker exposure, non-dietary exposure) Processing Studies (dietary exposure) Market Share Percent Crop Treated ions Estimated Environmental Concentrations Mechanism of Toxicity in Mammals

19 Screening Success Diminishing The number of compounds Bayer CropScience screens per year to discover just one or two new commercial products 200, , , ,000 50, ,000 38,000 20,000 11,000 5, 's 1960's 1970's 1980's 1990's 2000's

20 Time to First Sales Increasing 11 Years from Discovery To Market * 2000* 2007** years *Phillips McDougall for American Crop Life / European Crop Protection Association / **Bayer

21 Development Costs Increasing 300 $270 M $m * * 2000* 2004** 2007** *Phillips McDougall for American Crop Life / European Crop Protection Association (*Aventis, BASF, Bayer, Uniroyal, Dow, DuPont, FMC, Monsanto, Sumitomo, Syngenta /** Bayer)

22 Economics of Pesticide Commercialization 7-10 years into the development process Investments up to $270 million in development & registration costs Already 10 years into the 17-year patent life Sales of technology to date = $0; Expenses = $270 million RESULT is (-$270 million) and not one unit has been produced Basic manufacturing economics take place from this point forward Bottom line: BCS has 7 years to recover the costs of development of this compound, as well as, the cost of investigative research

23 New Product Introductions