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Saber, Haleh
US Food & Drug Administration
Symposium 7: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?
Location:Grand Ballroom E-H
Haleh Saber
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2 - First-in-Human Dose Selection of Immune-activating Biotherapeutics in Oncology
Haleh Saber
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Sahre, Martina
US Food & Drug Administration
Symposium 5: Contemporary Issues Related to Pediatric Drug Development
Location:Grand Ballroom E-H
Martina Sahre
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1 - Introduction
Martina Sahre
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Schmidt, Stephan
Univ of Florida
Symposium 8: Use of Real-time Simulation for Decision Making in Clinical Pharmacology
Location:Grand Ballroom I-K
Stephan Schmidt
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3 - Opportunities & Challenges to Implementing Precision Dosing
Stephan Schmidt
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Shah, Ankit
US Food & Drug Administration
Symposium 4: Hot Topics
Location:Grand Ballroom I-K
Ankit Shah
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2 - Clinical Pharmacology Regulatory Considerations for Recent Oncology Approvals
Ankit Shah
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Shahin, Mohamed
3 - Tanabe Young Investigator Award: Mentorship, Networking & Family: The Unsung Heroes of My Journey in Clinical Pharmacology
Mohamed Shahin
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Shebley, Mohamad
AbbVie Inc
Symposium 8: Use of Real-time Simulation for Decision Making in Clinical Pharmacology
Location:Grand Ballroom I-K
Mohamad Shebley
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4 - Session Recap & Points to Ponder
Mohamad Shebley
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Smith, Kirsten
National Inst on Drug Abuse
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
Location:Grand Ballroom I-K
Kirsten Smith
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3 - Preclinical & Clinical Data on Kratom as Predictors for Abuse Liability
Kirsten Smith
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Stodtmann, Sven
AbbVie Inc
Symposium 8: Use of Real-time Simulation for Decision Making in Clinical Pharmacology
Location:Grand Ballroom I-K
Sven Stodtmann
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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
Sven Stodtmann
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Sun, Kefeng
Takeda Pharmaceutical Co Ltd
Symposium 10: First-in-Patient Dose Prediction for Adeno-associated, Virus-mediated Gene Therapy
Location:Grand Ballroom E-H
Kefeng Sun
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4 - Clinical Pharmacology Considerations for Recombinant Adeno-associated, Virus-based Gene Therapy: Focus on Biodistribution, Immune Response & Durability
Kefeng Sun
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