The document summarizes the process of bringing a new drug to market. It involves pre-clinical research for 4.5 years, clinical trials for 5 years, and seeking FDA approval for 2.5 years, for a total of 12 years. The estimated total cost is $800 million, including $335 million for pre-clinical research and $465 million for clinical trials and FDA approval. The process involves research and development teams, management, doctors, pharmacists, and clinical trial subjects working towards milestones of IRB proposal and approval, completing the three phases of clinical trials, and ultimately obtaining FDA approval to release the new drug to the market.

1. Drug Development The process to bring a new drug to market Contributors: Lindsey LaRue, Chris Stearns, and Sirisha Karri

2. Who we are? CLS Pharmaceuticals Research and Development Team Administrative Staff Project Management Team Mission Statement “ 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.”

3. Background Founded in 1990 in Austin, Texas 20 years of drug development implementation and supervision Seek to provide strategic vision for the following: Research & Development Clinical Trials FDA approval

4. Scope of Work 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.

5. Milestones IRB Proposal IRB = Institutional Review Board IRB Approval Clinical Testing Phase 1: Initial phase of clinical trials Phase 2: secondary phase of clinical trials Phase 3: Market testing of the drug FDA Approval Release drug to market

6. Schedule/Timeline Pre-clinical: 4.5 years Preliminary Research: 3 years IRB Proposal: 0.5 years IRB Approval: 1 year Clinical Trials: 5 years Phase 1: 1.5 yrs Phase 2: 1.5 yrs Phase 3: 2 yrs FDA approval: 2.5 years

7. Budget Many factors effect the budget NME Drug (New Molecular Entity) Non- NME Drug Drug Complexity Risks and likelihood of failure Opportunity costs Cost of investing over the time period of the project Time and amount of people involved

8. Budget - NME Pre-clinical Phase $335 Million Direct Cost: $121 million Opportunity Cost: $214 million Clinical Trials & FDA approval $465 Million Direct cost: $280 Million Opportunity Cost: $185 Million Total: ~$800 Million

9. Budget - NME

10. Budget Breakdown Pre-Clinical Phase - Direct Costs Scientists Researchers Lab Technicians Application costs for IRB proposal/approval

11. Budget Breakdown Clinical Trials Testing clinic usage fees Doctors Pharmacists Other Employees Testing subjects FDA approval Proposal Time to get approval

12. Possible Risks Drug R&D Clinical Trials Seeking FDA approval

13. Preventing Risk R&D Strength of research Strength of development team Proper management Clinical Trials IRB Further clinical studies FDA Approval Drug utilization Active surveillance

14. Quality Assessment R&D Supervisor for research team Periodic updates Researcher evaluations Safety Pre-clinical research Assessing evidence from R&D

15. Quality Assessment Effectiveness Clinical subject feedback Pharmacist and physician feedback Adverse effects of the drug Clinical subject feedback General public feedback Pharmacist and physician feedback Cost comparison Budget assessment

16. Summary Scope of work Total time 12 years Total cost $800 Million Who’s involved R&D Team, Management, Doctor, Pharmacists, Trial Subjects Goals Complete successful preliminary research to achieve IRB approval Complete R&D of the NME Conduct safe clinical trials to study effectiveness Seek and obtain FDA approval