Drug Development Project Mgmt


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Example of an assignment in project management

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  • Adverse effects
  • 1). Active surveillance (eg, medical records reviews, patient or physician interviews, prescription event monitoring, data from disease or drug exposure registries). Further clinical studies (specific safety studies, larger studies over longer periods). Drug utilization studies (which describe how a drug is marketed, prescribed, and used in a specified population ム o ften stratified by age, gender, concomitant medications, etc ム a nd how these factors influence clinical, social, and economic outcomes Restricted use of the medicine (eg, for use/dispensing only in hospital, or where specific equipment [eg, resuscitation equipment] is available; availability only in limited unit sizes) Mitigating to reduce risk, no way to completely remove or avoid
  • Verbally summarize scope of work from previous slide
  • Drug Development Project Mgmt

    1. 1. Drug Development The process to bring a new drug to market Contributors: Lindsey LaRue, Chris Stearns, and Sirisha Karri
    2. 2. Who we are? <ul><li>CLS Pharmaceuticals </li></ul><ul><ul><li>Research and Development Team </li></ul></ul><ul><ul><li>Administrative Staff </li></ul></ul><ul><ul><li>Project Management Team </li></ul></ul><ul><li>Mission Statement </li></ul><ul><ul><li>“ We strive to bring the most innovative and advanced research in pharmaceutical technologies for the purpose of contributing to the overall quality of health care.” </li></ul></ul>
    3. 3. Background <ul><li>Founded in 1990 in Austin, Texas </li></ul><ul><li>20 years of drug development implementation and supervision </li></ul><ul><li>Seek to provide strategic vision for the following: </li></ul><ul><ul><li>Research & Development </li></ul></ul><ul><ul><li>Clinical Trials </li></ul></ul><ul><ul><li>FDA approval </li></ul></ul>
    4. 4. Scope of Work <ul><li>As CLS Pharmaceuticals project management team, we plan to oversee the development of new drug that is ready to introduce to the market. We will select the best research & development team for pre-clinical phases, ensure safety and thorough testing in our clinical trials, and provide substantial evidence for drug effectiveness to obtain FDA approval. </li></ul>
    5. 5. Milestones <ul><li>IRB Proposal </li></ul><ul><ul><li>IRB = Institutional Review Board </li></ul></ul><ul><li>IRB Approval </li></ul><ul><li>Clinical Testing </li></ul><ul><ul><li>Phase 1: Initial phase of clinical trials </li></ul></ul><ul><ul><li>Phase 2: secondary phase of clinical trials </li></ul></ul><ul><ul><li>Phase 3: Market testing of the drug </li></ul></ul><ul><li>FDA Approval </li></ul><ul><li>Release drug to market </li></ul>
    6. 6. Schedule/Timeline <ul><li>Pre-clinical: 4.5 years </li></ul><ul><ul><li>Preliminary Research: 3 years </li></ul></ul><ul><ul><li>IRB Proposal: 0.5 years </li></ul></ul><ul><ul><li>IRB Approval: 1 year </li></ul></ul><ul><li>Clinical Trials: 5 years </li></ul><ul><ul><li>Phase 1: 1.5 yrs </li></ul></ul><ul><ul><li>Phase 2: 1.5 yrs </li></ul></ul><ul><ul><li>Phase 3: 2 yrs </li></ul></ul><ul><li>FDA approval: 2.5 years </li></ul>
    7. 7. Budget <ul><li>Many factors effect the budget </li></ul><ul><ul><li>NME Drug (New Molecular Entity) </li></ul></ul><ul><ul><li>Non- NME Drug </li></ul></ul><ul><ul><li>Drug Complexity </li></ul></ul><ul><ul><li>Risks and likelihood of failure </li></ul></ul><ul><ul><li>Opportunity costs </li></ul></ul><ul><ul><ul><li>Cost of investing over the time period of the project </li></ul></ul></ul><ul><ul><li>Time and amount of people involved </li></ul></ul>
    8. 8. Budget - NME <ul><li>Pre-clinical Phase </li></ul><ul><ul><li>$335 Million </li></ul></ul><ul><ul><ul><li>Direct Cost: $121 million </li></ul></ul></ul><ul><ul><ul><li>Opportunity Cost: $214 million </li></ul></ul></ul><ul><li>Clinical Trials & FDA approval </li></ul><ul><ul><li>$465 Million </li></ul></ul><ul><ul><ul><li>Direct cost: $280 Million </li></ul></ul></ul><ul><ul><ul><li>Opportunity Cost: $185 Million </li></ul></ul></ul><ul><li>Total: ~$800 Million </li></ul>
    9. 9. Budget - NME
    10. 10. Budget Breakdown <ul><li>Pre-Clinical Phase - Direct Costs </li></ul><ul><ul><li>Scientists </li></ul></ul><ul><ul><li>Researchers </li></ul></ul><ul><ul><li>Lab Technicians </li></ul></ul><ul><ul><li>Application costs for IRB proposal/approval </li></ul></ul>
    11. 11. Budget Breakdown <ul><li>Clinical Trials </li></ul><ul><ul><li>Testing clinic usage fees </li></ul></ul><ul><ul><li>Doctors </li></ul></ul><ul><ul><li>Pharmacists </li></ul></ul><ul><ul><li>Other Employees </li></ul></ul><ul><ul><li>Testing subjects </li></ul></ul><ul><li>FDA approval </li></ul><ul><ul><li>Proposal </li></ul></ul><ul><ul><li>Time to get approval </li></ul></ul>
    12. 12. Possible Risks <ul><li>Drug R&D </li></ul><ul><li>Clinical Trials </li></ul><ul><li>Seeking FDA approval </li></ul>
    13. 13. Preventing Risk <ul><li>R&D </li></ul><ul><ul><li>Strength of research </li></ul></ul><ul><ul><li>Strength of development team </li></ul></ul><ul><ul><li>Proper management </li></ul></ul><ul><li>Clinical Trials </li></ul><ul><ul><li>IRB </li></ul></ul><ul><ul><li>Further clinical studies </li></ul></ul><ul><li>FDA Approval </li></ul><ul><ul><li>Drug utilization </li></ul></ul><ul><ul><li>Active surveillance </li></ul></ul>
    14. 14. Quality Assessment <ul><li>R&D </li></ul><ul><ul><li>Supervisor for research team </li></ul></ul><ul><ul><li>Periodic updates </li></ul></ul><ul><ul><li>Researcher evaluations </li></ul></ul><ul><li>Safety </li></ul><ul><ul><li>Pre-clinical research </li></ul></ul><ul><ul><li>Assessing evidence from R&D </li></ul></ul>
    15. 15. Quality Assessment <ul><li>Effectiveness </li></ul><ul><ul><li>Clinical subject feedback </li></ul></ul><ul><ul><li>Pharmacist and physician feedback </li></ul></ul><ul><li>Adverse effects of the drug </li></ul><ul><ul><li>Clinical subject feedback </li></ul></ul><ul><ul><li>General public feedback </li></ul></ul><ul><ul><li>Pharmacist and physician feedback </li></ul></ul><ul><li>Cost comparison </li></ul><ul><ul><li>Budget assessment </li></ul></ul>
    16. 16. Summary <ul><li>Scope of work </li></ul><ul><li>Total time </li></ul><ul><ul><li>12 years </li></ul></ul><ul><li>Total cost </li></ul><ul><ul><li>$800 Million </li></ul></ul><ul><li>Who’s involved </li></ul><ul><ul><li>R&D Team, Management, Doctor, Pharmacists, Trial Subjects </li></ul></ul><ul><li>Goals </li></ul><ul><ul><li>Complete successful preliminary research to achieve IRB approval </li></ul></ul><ul><ul><li>Complete R&D of the NME </li></ul></ul><ul><ul><li>Conduct safe clinical trials to study effectiveness </li></ul></ul><ul><ul><li>Seek and obtain FDA approval </li></ul></ul>