Plenary Session: Scientific, Regulatory & Operational Considerations for Working With Gene-based Medicines: Are You Ready to Conduct Gene Therapy Research?
Plenary Session: Scientific, Regulatory & Operational Considerations for Working With Gene-based Medicines: Are You Ready to Conduct Gene Therapy Research?
4 - McKeen Cattell Memorial Award: Association Between Baseline Use of Angiotensin-Converting Enzyme Inhibitors & Angiotensin Receptor Blockers & Death Among Patients Tested for COVID-19
Industry Theater Presentation: Presented by Certara
3:10 PM - 3:30 PM PT
Industry Theater Presentation: Antibody-Drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development Presented by Certara
Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an Example
Faculty: Jack Henningfield, PhD – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
CE: 1.5
8:00 AM - 9:30 AM PT
Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an Example
Faculty: Jack Henningfield, PhD – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
CE: 1.5
8:00 AM - 9:30 AM PT
1 - Introduction, Brief History & Pharmacology of Kratom
2 - The Current Regulatory 8-Factor Analysis & Its Use in Substance Abuse Liability
Faculty: Jack Henningfield, PhD – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
8:00 AM - 9:30 AM PT
3 - Preclinical & Clinical Data on Kratom as Predictors for Abuse Liability
2 - Real-time Trial Simulations to Understand the Impact of Assumptions & Design Choices on Expected Trial Results for Anti-amyloid Antibody in Alzheimer's Disease
4 - Why Are FDA-approved Drug Labels Pertaining to Food-Drug Interactions Essential to the Advancement of Therapeutic Optimization of Oral Cancer Drugs?