Ibogaine Research

A Non-Profit Approach to Developing Ibogaine into an FDA-Approved Medication Rick Doblin, PhD Multidisciplinary Association for Psychedelic Studies

Three Basic Points ,[object Object],[object Object],[object Object]

FDA’s Track Record ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

FDA is our Ally ,[object Object],[object Object],[object Object]

FDA Organizational Change ,[object Object],[object Object]

FDA Institutional Change ,[object Object],[object Object],[object Object]

FDA’s New Policy for Psychedelic Research ,[object Object],[object Object]

FDA Follows Through: MDMA ,[object Object],[object Object]

FDA Follows Through: Ibogaine ,[object Object],[object Object]

NIDA: Just Say Maybe, Not. ,[object Object],[object Object]

FDA Input to NIDA ,[object Object],[object Object]

Dr. Wright’s Letter to NIDA ,[object Object]

NIDA: Just say No! ,[object Object]

Ibogaine Research: Not Enough $$$ ,[object Object],[object Object],[object Object]

NIDA in 2003 ,[object Object],[object Object]

Privately-Funded Ibogaine Research ,[object Object]

The Costs of Drug Development: A Stretch but Within Reach ,[object Object],[object Object],[object Object]

Drug Development $ Estimates ,[object Object],[object Object]

Major Papers ,[object Object],[object Object],[object Object]

Most Recent Estimate ,[object Object],[object Object]

Industry Insider View ,[object Object]

Whittling Away ,[object Object],[object Object],[object Object],[object Object]

Opportunity Cost ,[object Object],[object Object]

Cost of Failures ,[object Object]

Number of Failures Per FDA-Approved Drug ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Cost of the Failures ,[object Object],[object Object]

Preclinical v. Clinical Costs ,[object Object]

Cost of Success ,[object Object],[object Object],[object Object]

Small firm/Non-Profit Advantage ,[object Object],[object Object]

Still Big Numbers, But... ,[object Object],[object Object]

The Advantage (Finally) of working with Demonized Drugs ,[object Object],[object Object]

Medline Papers on Ibogaine ,[object Object],[object Object]

Quasi-Underground Research ,[object Object],[object Object]

Estimating Number of Subjects: Pilot Studies ,[object Object],[object Object]

Patients to be Enrolled in Phase III Clinical Trials ,[object Object],[object Object]

Patients Enrolled in All Studies ,[object Object],[object Object]

Cost per Patient in US Clinical Trials ,[object Object],[object Object]

Summary Estimates ,[object Object],[object Object],[object Object]

Relative Costs ,[object Object],[object Object],[object Object]

Step 1: Comprehensive Literature Review ,[object Object],[object Object]

Step 2: Obtain Independent Supply ,[object Object],[object Object]

Step 3: Complete Phase 1 Study. ,[object Object],[object Object]

Step 4: Standardize ,[object Object],[object Object]

Step 5: Conduct Phase 3 Studies ,[object Object],[object Object]

Non-Profit v. For-Profit ,[object Object],[object Object]

Final Thought From Albert Einstein ,[object Object],[object Object]

If Psychedelics Become Prescription Medicines, How Should They be Regulated? ,[object Object],[object Object]

DEA Fear: Legalization for Medical Use = Legalization for All uses. ,[object Object],[object Object]

The Issue of Off-Label Prescriptions ,[object Object],[object Object],[object Object]

DEA Relatively Weak After Drug Approved for Marketing ,[object Object],[object Object]

Key FDA Regulatory Issues ,[object Object],[object Object]

Strategic Approach: Incremental Change ,[object Object],[object Object]

Limits Imposed by Regulatory System ,[object Object],[object Object],[object Object],[object Object]

Limits Can Be Relaxed Over Time ,[object Object],[object Object]

Contingency Plan in Case of Success ,[object Object]

Putting on My Authoritarian Hat ,[object Object],[object Object]

Rules for Radicals ,[object Object],[object Object]

Are you experienced? ,[object Object],[object Object]

The Psychedelic Clinic ,[object Object],[object Object],[object Object]

Staffing Requirements ,[object Object],[object Object]

Staffing Requirements ,[object Object]

National Patient Registry ,[object Object],[object Object]

Mail - Order Prescriptions Only ,[object Object],[object Object]

Advertising ,[object Object],[object Object]

Gradual Expansion of the Function of the Clinic ,[object Object],[object Object],[object Object],[object Object],[object Object]

Ibogaine Research

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Ibogaine Research