Chemical Development

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    Chemical Development - Presentation Transcript

    1. Chemical Development Lead Candidate to IND, and Beyond Richard Donaldson, Ph.D. VP Chemical Development Ricerca Biosciences, LLC May 23, 2007
    2. What is Drug Development? Idea Biological Target Development Lead Candidate Chemical Compound
    3. From IP to IND Development Discovery Chemistry Chemistry Discovery Development Biology Biology
    4. Development Chemistry, IND Timeline: 9-14 Months to CMC Section • Scalable Process Identified • Analytical Methods Developed • Tentative Specifications Determined • Regulatory Starting Materials Identified • Stability •
    5. DC, IND, Month 2 Process Benchmarking • Demonstration Sample (Preliminary Tox) • AC Method Development and Qualification • Reference Standard Prep and Characterization • Salt Screen Study (Optional) • Polymorph Screen (Optional) •
    6. DC, IND, Month 4 Toxicology Lot Preparation (1-3 Kg) • Analytical Methods Verified (GLP Release) • Tentative Specifications Verified • 28-Day Tox. Studies Start • Regulatory Strategy in Place •
    7. DC, IND, Month 8 GMP-Grade Lot Preparation (5-10 Kg) • Stability-Indicating HPLC Method Developed • Impurity Profile Determined • Residual Solvents Method Developed (ICH) • GMP Analytical Release Testing •
    8. DC, IND, Month 9 GMP-Grade Lot Stability Study Start (1-3 Yr) • Chemistry Campaign Report Completed • IND CMC Section Completed • IND Filed •
    9. IND to NDA R&D Clinical R&D • Development Chemistry • Regulatory Compliance • Continued Biology Testing •
    10. IND to NDA Issues Manufacturing Cost • Process Scalability • Analytical Method Development • Stability • Packaging and Storage •
    11. DC, Phase I/II Process Research (Robust Process, Plant) • Critical Variables Identified • Radiosynthesis, ADME • Impurities and Metabolites Synthesis • Phase II Campaign (10-50 Kg, Plant) • API Campaign Documentation •
    12. DC, Phase I/II Potential Showstoppers Osmium Tetroxide, Alkyl Mercury, etc. (Toxic, • Waste Issues) Benzene, aziridine, etc. (Carcinogenic) • Azides, Dinitroaromatics, etc. (Shock Sensitive) • Carbon Disulfide, Methylhydrazine, etc. (Extreme • Flammability)
    13. DC, Phase I/II Process Alternatives cat OsO4, NaIO4 O OH O OH Benzene HN + -H2O O N Options: Toluene, Cyclohexane
    14. Analytical DC, Phase I/II Analytical Methods Upgraded • Impurities and Metabolites ID • Analytical Methods Documentation • Drug Product Formulation Studies •
    15. Phase I/II Common Issues New Impurity • High Residual Solvent, Solvate or Entrainment • Trace Metal Impurities, Pd, Fe, Ni, Etc. • Scalability Issues, Temperature, Agitation, Etc. • Raw Material Sourcing, Quality • Rigorous QC Testing •
    16. DC, Phase III Validation Protocol • Critical Variable Ranges Determined • Development Report • Process Validation, 3 Lots at >10% Scale • Campaign Documentation • Pre-Approval Inspection •
    17. NDA Approval - The Ultimate Goal FDA Approval • Commercial Sourcing Strategy • Commercial Launch Amounts • Raw Material Sources Identified • Commercial Partner in Place •
    18. Keys to Drug Development Success Anticipate and Expect Problems • Never too Early to Plan Ahead • Maintain Flexibility • Trade off Between $$ and Timing • Plan for Success •
    19. Chemical Development Lead Candidate to IND, and Beyond Richard Donaldson, Ph.D. VP Chemical Development FEBRUARY 5, 2007

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