Development, validation and clinical qualification of molecular diagnostic LDT for standard-of-care and drug industry
Description of Session: Molecular Diagnostics (MDx), e.g. IHC, DNA/RNA-based assays have been emerging tools for standard-of-care or for different purposes, including CDx, in drug development. The field is very attractive but challenging and ambiguous with no robust analytical or regulatory guidance available. This seminar will cover the scientific, technical, clinical, quality, compliance and regulatory aspects of MDx.
Program Objectives:
- Emphasize the critical clinical value of MDx in standard-of-care and drug development
- Explain the imminent challenges currently facing the field and their impact on clinical and economic aspects
- Set up best-in-class, yet feasible, practices to enhance probability of success and, hence, return on investment (ROI).
Will address the topic from analytical, clinical, regulatory and compliance aspects
Level of Instruction: INTERMEDIATE - ADVANCED
- BASIC: Entry level; no prior knowledge of subject necessary to attend this program;
- INTERMEDIATE: Refresher course; some basic knowledge required;
- ADVANCED: Highly technical; for those with at least five years of experience in a specialty area.
Format: (Lecture, slides, discussion group, live webinar, archived webinar, Computer-Driven Instruction, etc.)- In person seminar
Place and address:
Speaker: Abdel Halim, PharmD, MSc, PhD, DABCC-
President, Biomarkers and Diagnostics Consulting
Professional affiliation: DABCC-Clinical Chemistry, DABCC-Molecular Diagnostics, DABCC-Toxicology, FAACC
Program Time Table: CONTACT HOURS PROPOSED: 6
- Begin time: 9:00 am EST End time: 4:00 pm_EST
- Break(s): two 15-min each
- Lunch: 30 min