Development of Crop Protection Products: An Industry Perspective Keith S. Rucker Technical Service Specialist
Need for Continued Crop Protection Product Development Wild oats White Mold on Peanuts Treated Potato Blight Untreated Untreated Treated Untreated Treated
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) 12.5 1.7 / ha 4.0 / ha 7.0 / ha 7.5 10.3 6.0 2.5 2.5 1950 2000 2050 The world population is constantly increasing
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
2050 Est. 2000 1993 10.3 Billion 6.2 Billion 5.4 Billion 1994 1990 5 Billion 1980 4 Billion 1965 3 Billion 1930 2 Billion 1800 1 Billion Food Production 1980 1996 1800 1930 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.
Still a Strong Need for Innovation New Active Compounds New Modes of Action Favorable Profiles Safety Selectivity Sustainability
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 : >200,000 100 25 8 4 2 1.5 1 year BCS-US Nomenclature: Candidate Pre-
High Throughput Screening (HTS) Early phases highly automated Screen 200,000+ compounds annually
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 : >200,000 100 25 8 4 2 1.5 1-2 years BCS-US Nomenclature: Candidate Pre-
Research: Lead Generation
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 : >250,000 100 25 8 4 2 1.5 1-2 years BCS-US Nomenclature: Candidate Pre-
Research
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 : >200,000 100 25 8 4 2 1.5 1 year 6-7 years BCS-US Nomenclature: Candidate Pre-
Pre- /
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 : >200,000 100 25 8 4 2 1.5 7 years BCS-US Nomenclature: Candidate Pre-
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
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
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
Screening Success Diminishing The number of compounds Bayer CropScience screens per year to discover just one or two new commercial products 200,000 200,000+ 150,000 100,000 50,000 0 46,000 38,000 20,000 11,000 5,000 1950's 1960's 1970's 1980's 1990's 2000's
Time to First Sales Increasing 11 Years from Discovery To Market 10.5 10 9.5 9 8.5 8 1995* 2000* 2007** years 8.3 9.1 10 *Phillips McDougall for American Crop Life / European Crop Protection Association / **Bayer
Development Costs Increasing 300 $270 M 250 200 $m 150 100 50 0 1975-1980* 1990-1995* 2000* 2004** 2007** *Phillips McDougall for American Crop Life / European Crop Protection Association (*Aventis, BASF, Bayer, Uniroyal, Dow, DuPont, FMC, Monsanto, Sumitomo, Syngenta /** Bayer)
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
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