How to Determine HED, FIH, and MRSD in Developing Biological Products (siRNA, ADC, Gene, and Cell Adoptive Therapy US
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
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
★★★★★
Marsha Miller
Pragmatic approaches and clarification on when statistics is useful and when not. Perfect guidance through the official guidances out there and pointing out where they are sometimes contradictory and therefore confusing during application in daily work. Very honorable teacher and very good at making complex things understandable. As the head is spinning after such intense training, the hand-outs and workshop documentation given will help in having the learned content re-called
★★★★★
Michael Durschlag
James provided a comprehensive, detailed, and complete view of Annex 1 updates, tied it to QRM and to PICS guidance. He delivered the material in an easy-to-understand format, and we did not experience any problems with the streaming. The slide material provided will be very useful as a reference.
★★★★★
Nancy Musik
This was a very in-depth training, and I especially appreciated the real-life examples or possible solutions and real industry examples and mitigation approaches. Trainer definitely a SME on this subject and was able to provide lots of information and background details to explain Annex 1 intentions.
★★★★★
Vyara Kuneva
The training offered a large scope of relevant information, presented in an understandable and interesting way. The hands-up approach, supported by examples and simulations makes the content easy to understand and remember. The lecturer was excellent, and the course was very well organized.
★★★★★
Walter Drexler
I have never seen such an extensive session on statistics for practitioners on all these burning topics provided. It basically covers all of them we also discuss in our company. A great spectrum of topics covered.
★★★★★
Seth Byers
Well organized presentation, very knowledgeable presenter, great atmosphere
★★★★★
Hassan Abdu Al Asmary
Touched my needs, Mr. James is a wonderful lecturer who made it easy and clear.
★★★★★
Gabriela Saucedo
The facilitator and expert, the documents shared, the excellent facilitation skills of James and being engaged in the session.
★★★★★
Vassia Papakonstantinou
I really liked the flow of the presentation, and the way modules were explained using the appropriate ICH references
★★★★★
Nereus Jethro Abad
I enjoyed the class and found it informative, engaging and filled with valuable insights.
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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