Peter Attia MD - How a Drug Gets Approved: Safety, Trials, and Funding | Susan Desmond-Hellmann M.D., M.P.H
The discussion focuses on the different phases of drug development, explaining the purpose and process of each phase. Phase one is primarily concerned with safety, determining if a drug is safe for human use, both in single and multiple doses. This phase typically lasts about a year and costs tens of millions of dollars. Phase two aims to prepare for phase three by establishing dosage, schedule, patient selection criteria, and forming a hypothesis for the drug's effectiveness. Costs increase significantly in this phase, reaching into the 20s to 40s of millions. An example is given of a drug tested for colon cancer, which successfully moved from phase two to phase three, focusing on median survival rather than overall survival. The video highlights the complexity and expense of bringing a drug to market, which can take a decade and cost a billion dollars.
Key Points:
- Phase one focuses on safety, determining if a drug is safe for human use.
- Phase two prepares for phase three by establishing dosage and patient criteria.
- Drug development can take a decade and cost a billion dollars.
- Phase one costs tens of millions, while phase two costs 20-40 million.
- Example of a drug for colon cancer moving from phase two to phase three.
Details:
1. 🔬💰 The Complexity and Cost of Drug Development
1.1. Preclinical Studies
1.2. Phase 1 Clinical Trials
1.3. Phase 2 Clinical Trials
1.4. Phase 3 Clinical Trials
1.5. Financial Implications
2. 🧪 Preclinical to Phase One: Ensuring Safety
- Identifying the best method to target molecules, whether through small molecules or antibodies, is crucial for drug development.
- The FDA plays a critical role in questioning and ensuring a method's efficacy and safety through rigorous approval processes, ensuring that only the safest and most effective drugs proceed to human trials.
3. 📊 Phase Two: Paving the Way for Phase Three
- Phase One is dedicated to establishing the safety of a molecule for human use, assessing safety in single and multiple administrations.
- Preclinical packages and IND submissions are crucial for a seamless Phase One, typically lasting around one year.
- Phase One costs range in the tens of millions, while Phase Two expenses escalate into the 20s to 40s of millions, contingent on the trial's scale and complexity.
4. 🏁 Phase Three and Cancer Research Case Study
- Phase two prepares for phase three by establishing dose, schedule, patient selection, and hypothesis.
- After establishing the dose and schedule in phase two, a phase three study in colon cancer research included a comparison of treatments with and without Avastin.
- The phase three colon cancer study showed an 8-month increase in median survival for stage four colon cancer patients with the addition of Avastin.
- This study marked the first significant advancement in colon cancer treatment in years, creating excitement in the field.