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SRNT February 19, 2003 Frank Vocci, Ph.D. DTR&D / NIDA / NIH /DHHS

Smoking Cessation Pharmacotherapy: Accelerating Discovery to Development Medications Development Overview. SRNT February 19, 2003 Frank Vocci, Ph.D. DTR&D / NIDA / NIH /DHHS. What is Drug Discovery, Development & Review?.

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SRNT February 19, 2003 Frank Vocci, Ph.D. DTR&D / NIDA / NIH /DHHS

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  1. Smoking Cessation Pharmacotherapy: Accelerating Discovery to DevelopmentMedications Development Overview SRNT February 19, 2003 Frank Vocci, Ph.D. DTR&D / NIDA / NIH /DHHS

  2. What is Drug Discovery, Development & Review? • Drug Discovery & Development is the integration of the many disciplines, including: • basic research • non-clinical development • clinical development • biostatistics • data management • pharmacometrics • regulatory • marketing

  3. What is Drug Discovery, Development & Review? • identify • evaluate • develop • achieve regulatory approval • successful launch … of new chemical entities (NCEs/NMEs) and new biological entities (NBEs).

  4. What is Drug Discovery, Development & Review? • Regulatory Review is the integration of many disciplines, including • pharmacology/toxicology • non-clinical • clinical/biostat • pharmacometrics • regulatory & DDMAC • risk management

  5. What is Drug Discovery, Development & Review? • …to determine whether there is: • adequate knowledge about the new NME/NBE • to make an informed evaluation about the benefit-risk ratio... • to decide whether the product should be: • approved for marketing, and • for which segments of that nation’s population

  6. Drug Discovery, Development & Review Stages • The stages of drug development & review include: • Identification (Drug discovery) • Optimization (Lead selection) • Evaluation(s) (Proof of mechanism) (Proof of principle/concept) • Development (Evidence) Effectiveness/Safety • Review (Regulatory review) • Launch (Product introduction) • Post-Marketing (Market expansion)

  7. Decisions--Fail Early & Fail Cheaply • The intent here is to conduct the crucial experiments early in order to identify as soon as possible projects that normally would be failing later in the clinical development process.

  8. Drug Discovery & Development Decisions • First we see the key decision points represented by a • Lead identification • Enter development • First in humans (FIH) (What dose?) • Proof of mechanism/concept/principle (PoM/PoC/PoP) • Phase 2/3 transition (Differentiation) • Submission • Approval , Risk management program and Launch • Post-market program • Post-market surveillance • Next generation products

  9. Post-Market Drug Discovery, Development & Review ~$ 500-800 Million / 4-10 Years Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  10. Biomarker Surrogate Endpoints Clinical Effect Clinical Outcomes Post-Market Drug Discovery, Development & ReviewAdapted from Pharmaceutical Executive, January 2000, page 80 ~$ 500-800 Million / 4-10 Years Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  11. Biomarker Surrogate Endpoint Clinical Effect Clinical Outcomes Post-Market Drug Discovery, Development & ReviewAdapted from Pharmaceutical Executive, January 2000, page 80 ~$ 500-800 Million / 4-10 Years Scale up & Launch Lead Optimi- zation Regula- tory Review Drug Develop- ment Lead identifi- cation Eval- uate Post Market Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  12. Post-Market Drug Discovery, Development & ReviewAdapted from Pharmaceutical Executive, January 2000, page 80 ~$500-800 Million / 4-10 Years Genomics & proteomics Biotech Scale up & Launch Lead Optimi- zation Regula- tory Review Drug Develop- ment Lead identifi- cation Eval- uate Post Market Drug Discovery High Throughput Screening Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  13. Post-Market Drug Discovery, Development & ReviewAdapted from Pharmaceutical Executive, January 2000, page 80 ~$ 500-800 Million / 4-10 Years Regulatory Interactions Toxicity Testing Scale up & Launch Lead Optimi- zation Regula- tory Review Drug Develop- ment Lead identifi- cation Eval- uate Post Market Chemistry & ADME Clinical Trials Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  14. Post-Market Drug Discovery, Development & ReviewAdapted from Pharmaceutical Executive, January 2000, page 80 ~$ 500-800 Million / 4-10 Years Regulatory Interactions Document Preparation Scale up & Launch Lead Optimi- zation Regula- tory Review Drug Develop- ment Lead identifi- cation Eval- uate Post Market Bulk & Finished Prod. Manufacturing Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  15. Post-Market Drug Discovery, Development & ReviewAdapted from Pharmaceutical Executive, January 2000, page 80 ~$ 500-800 Million / 4-10 Years Regulatory Interactions Genomics Document Preparation Toxicity Testing Biotech Scale up & Launch Lead Optimi- zation Regula- tory Review Drug Develop- ment Lead identifi- cation Eval- uate Post Market Drug Discovery High Throughput Screening Chemistry & ADME Clinical Trials Bulk & Finished Prod. Manufacturing Decisions: Enter Develop- ment Submission Proof of Concept Lead ID Ph 2/3 Trans. FIH Approval

  16. The Outcome of R&D 5 4.5-5 3.5 1.6 1.3 1 INDs FILED I II III NDAs BLAs Files NDA BLA Appr’d Impact of “Unprecedented Targets?”

  17. Drug Development Process:Reasons for Research AbandonmentINDs filed 1985-1989 Efficacy 41% Safety (Human & Animal) 26% Economics 29% Other 4% J. DiMasi, Clinical Pharmacology and Therapeutics, July 1995, pages 1-14

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