First-in-Human (FIH) Dose Selection for Advanced Therapeutics

Masterclass on First-in-Human (FIH) Dose Selection for Advanced Therapeutics

Days

Hours

Minutes

Seconds

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

This two-day intensive masterclass equips participants with practical frameworks and step-by-step methodologies to confidently determine First-in-Human (FIH) doses for advanced therapeutics. Covering gene therapy, cell therapy, oligonucleotides, and ADCs, attendees will explore real-world case studies and regulatory strategies. Learn to translate preclinical findings into clinical dosing decisions while minimizing risk and accelerating drug development pipelines.

What You’ll Gain

Master structured FIH dose calculation frameworks for multiple therapeutic modalities.
Gain insights from real-world case studies in gene therapy, cell therapy, oligonucleotides, and ADCs.
Understand regulatory expectations and align scientific strategy with IND requirements.
Learn to anticipate and avoid common pitfalls in early-phase clinical dosing.
Build confidence in designing safe, effective, and efficient clinical development plans.

Why This Masterclass?

Determining the first human dose is one of the most critical and high-risk steps in drug development. This masterclass offers a rare combination of scientific depth, regulatory insight, and practical application. Participants gain hands-on methodologies, actionable frameworks, and expert guidance to streamline FIH dose selection for advanced modalities, ensuring safer and faster translation from bench to clinic.

Who Should Attend

Drug development scientists and pharmacologists
Translational medicine and regulatory affairs professionals
Preclinical and clinical researchers in gene therapy, cell therapy, oligonucleotides, and ADCs
Biotechnology and pharmaceutical professionals involved in IND preparation
Anyone seeking to enhance expertise in early-phase clinical dose selection

Agenda Highlights

Day 1 – Gene Therapy & Cell Therapy (Combined Highlights)

Overview of gene therapy and cell therapy landscapes and classifications.
Risk assessment and delivery strategies for gene therapy applications.
Real-world ocular and CNS gene therapy case studies for FIH analysis.
Introduction to cell therapy types and applications, including Treg T cells.
Case studies on CAR-DNT Cells and Double Negative T Cells with FIH calculations.
Step-by-step FIH dose calculation frameworks for CAR-T and MSC therapies.

Day 2 – Oligonucleotide Therapeutics & ADCs (Combined Highlights)

Classification, mechanisms, and mode of action for oligonucleotide therapeutics (ONT).
Safety evaluation and delivery strategies for ONT IND applications.
Practical ONT FIH dose calculation with real-world case study (RNA Editing ADAR).
Core principles of ADCs including antibody, payload, and linker considerations.
ADC toxicity assessment and FIH dose calculation methodology.
Developing Recommended Phase 2 Dose (RP2D) for ADCs with regulatory alignment.

About Trainer

Dr. David Xu is a board-certified toxicologist with over 30 years of experience in drug development across oncology, ophthalmology, immunology, regenerative medicine, and neuroscience. He specializes in First-in-Human (FIH) strategies for gene therapy, adoptive cell therapy, oligonucleotides, and ADCs.

Core Expertise:

Therapeutic Modalities: AAV, lentivirus, CRISPR/Cas9, siRNA, NK and DNT cells, CAR-T, MSCs, ADCs
Regulatory Compliance: Non-GLP/GLP studies aligned with FDA, ICH, OECD standards
Technical Excellence: PK/PD modeling, HPLC, LC-MS, DMPK tools

Leadership Roles:

Independent Consultant, Corium Innovation – pre-IND strategy advisor
Executive Director, Edigene – directed nonclinical studies for RNA-editing therapies
VP of Non-Clinical, Ruichuang Biotech – optimized CAR-T and ADC strategies for regulatory submissions

Dr. Xu combines scientific depth, regulatory insight, and hands-on development experience, offering participants practical frameworks directly applicable to FIH dose selection.