How to Determine HED, FIH, and MRSD in Developing Biological Products (siRNA, ADC, Gene, and Cell Adoptive Therapy US
This course includes:
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
Course outline
From gene and cell therapies to antibody-drug conjugates (ADCs) and oligonucleotides, this masterclass delves into the nuances of FIH dosing. Explore key topics like pharmacokinetics, pharmacodynamics, and potency, all grounded in real-world applications. Imagine confidently navigating regulatory uncertainties and crafting tailored dosing strategies that bridge preclinical and clinical phases seamlessly.
What You’ll Gain
-
Advanced FIH Strategies
Learn to synthesize preclinical data and leverage clinical insights for safe, effective dosing. -
Regulatory Mastery
Stay ahead of global guidelines and address the unique challenges of novel therapeutic modalities. -
Actionable Insights
Develop robust strategies through interactive case studies and expert-led discussions. -
Expertise in Novel Modalities
Deepen your understanding of ADCs, gene therapies, and more.
Why This Masterclass?
-
Learn from the Best
David Xu brings over 30 years of expertise in developing FIH strategies and navigating regulatory landscapes. -
Comprehensive Content
Every session is packed with actionable insights designed for immediate application. -
Interactive Approach
Engage in case studies, Q&A sessions, and real-world problem-solving scenarios.
Who Should Attend?
- Scientists and researchers in drug development.
- Regulatory and compliance professionals managing novel therapies.
- Pharmacokinetic and pharmacodynamic experts.
- Anyone involved in translational medicine and FIH strategies.
Agenda Highlights
Day 1
- Cell Therapy: Safety evaluations, pharmacokinetics, and case studies.
- Gene Therapy: Potency assessments and tailored FIH strategies.
Day 2
- ADCs: Phase I dosing strategies and safety.
- Oligonucleotides: Pharmacometrics and regulatory alignment.
Dr. David Xu is a seasoned expert in drug development with over 30 years of experience across oncology, ophthalmology, immunology, regenerative medicine, and neuroscience. Dr. Xu has extensive expertise in designing First-in-Human (FIH) strategies for advanced therapeutic modalities, including gene therapy, adoptive cell therapy, and ADCs, with a proven track record of advancing projects from discovery to IND submission.
Key highlights of his career include:
- Led IND submissions for gene and cell therapies, ADCs, and small molecules, ensuring compliance with FDA, ICH, and OECD standards.
- Developing innovative strategies for RNA-editing therapies, CAR T-cells, and adoptive immunotherapies.
- Serving as a certified toxicologist (DABT) for 14 years, with technical expertise in ADME-T prediction, PK/PD modeling, and advanced analytical tools.
Dr. Xu’s deep understanding of advanced therapeutics and regulatory compliance makes him uniquely qualified to guide participants through the complexities of nonclinical drug development and IND preparation.
Access for 2 participants
Online Participation
1,590$
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Certificate of completion and LinkedIn certificate
-
Access for 2 participants
Online Participation with Recording
1,989$
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Recording access
- Certificate of completion and LinkedIn certificate
Request Agenda
Companies Represented By Our Participants
Proud Stories
What you'll get?
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
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