3. Drug Development Center for Drug Evaluation & Research • PRODUCT SAFETY • PRODUCT EFFICACY • PRODUCT SAFETY • SURROGATE EFFICACY Investigational New Drug (IND) • MANUFACTURING • VALIDATION New Drug Application (NDA) Marketing Approval Data Data Good Laboratory Practices Good Clinical Practices Quality System Regulations (QSR)
4. Medical Device Development Center for Devices Radiological Health • PRODUCT SAFETY • PRODUCT EFFICACY • PRODUCT SAFETY • PRODUCT EFFICACY Investigational New Device (IDE) • MANUFACTURING • VALIDATION 510K Pre Market Approval (PMA) Clearance Approval Data Data Good Laboratory Practices Good Clinical Practices Quality System Regulations (QSR)
5. Drug Development Pathway Unmet Need Target Identification & Validation Product Concept Lead Optimization & Preclinical Testing Preclinical Design Concept Phase I Safety Prototype Phase II Efficacy Clinical Prototype Phase III Large Clinical Testing Field Input Registration Regulatory Clearance Final Product Product Launch Market Support Studies Marketed Product Time to Market: 10-12 YEARS Investment Capital: US$800MM
8. Pharma Landscape Source: AXA Framlington * Value of products losing patent protection as a percentage of total company sales over next five years
9. The Valley of Death VC Investment IPO Window PRE 2000 PRE 2000 TODAY TODAY Research Preclinical Phase I Phase II Phase III NDA Approval Post Marketing TIME COST
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11. Why have IP? Competitors Enemies Public Customers Employees Vendors Know-How Ideas Inventions
12. Why have IP? Competitors Enemies Public Customers Employees Vendors Know-How Ideas Inventions
13. How to read claims Boss! The claims, the claims!!!
14. Types of Claims Process e.g., method of making a drug, methods of use Machine e.g., medical imaging instrument Composition of Matter e.g., new drug Article of Manufacture e.g., medical device, diagnostic kit, drug formulation
15. IP Strategies – Related Applications BioPharmaceuticals Making the molecule (process) Pharmaceutical Compound (formulation) Nucleotide, Protein, Antibody Method of Use Formulation, Efficacy Fragments, Derivatives, Analogues New Molecule Do not overlook the novel research technology that may be invented on the way to discovering a blockbuster drug Building a fortress around the basic invention/technology
16. IP Strategies – Related Applications Device Vacuum chamber in which the diamond like coating (blade coating) is applied Single point cartridge loading system – avoiding upside down attachment Indicator strip signaling when the shaver is no longer experiencing "the optimal shave" Rubberized contour grip for better handling New forward pivot design positioning the blades in an optimal shaving position Use of 3 staggered blade getting progressively closer to the skin Mach 3 Core Technology Building a fortress around the basic invention/technology
28. IP Strategies – Related Applications BioPharmaceuticals Making the molecule (process) Pharmaceutical Compound (formulation) Nucleotide, Protein, Antibody Method of Use Formulation, Efficacy Fragments, Derivatives, Analogues New Molecule Do not overlook the novel research technology that may be invented on the way to discovering a blockbuster drug Building a fortress around the basic invention/technology
