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Increasing the Efficiency & Probability of Success of Clinical trials
The single biggest category of spending in innovative R&D is clinical development, and the costs for clinical studies were increased dramatically over the years, but with no proportional rise in the rate of new drug approvals. It is therefore crucial to use various managerial, strategic and scientific methodologies in order to improve the efficiency and probability of success in future...Continue reading
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Issues to be covered
- Challenges and opportunities in innovative drug development
- Pre-clinical planning & design
- Dose extrapolation from animals to human
- Starting & escalating doses in First-in-Human studies
- Clinical trials stages
- Fundamentals of study design & different clinical design types
- Strategic planning and clinical development
- Lessons learned from clinical programs execution
- Innovative methodologies and technologies in clinical testing
Who should attend
CPM, CTM, Clinical directors and any clinical/ IR&D executive that would like to expand his knowledge in drug/ clinical development.
Benefits to the Participants
- Acquaintance of the challenges and opportunities in innovative drug development from its early stage until approval
- Acknowledging the importance of efficient pre-clinical planning in support of human studies
- Attainment of effective tools for execution and analysis of pre-clinical testing prior moving to the clinic
- Acquisition of effective dose extrapolation techniques from animals to human and understanding of the calculation behind starting & escalating doses in First-in-Human studies
- Distinguish between early vs. late-stage clinical trials
- Recognize different study design types and gaining tools to select the optimal design
- Comprehend the value of strategic planning and effective clinical development in decision-making
- Acquaintanceship with innovative methodologies and technologies that will increase efficiency and probability of success of a clinical program
About The Lecturer
