Drug Discovery and Preclinical Development (2 days)

Aims and Objectives

• Take home with you a set of successful strategies for integrating the science, regulatory and business aspects of drug development.

After the course you will be able to:

• Identify and manage critical factors when developing a drug
• Select relevant tools to identify drug candidates and their targets
• Know what to do after you’ve identified leading candidate molecule(s)
• Design an integrated drug development strategy and avoid common mistakes from product discovery to first in man study
• Conduct gap analyses in data to optimize use of resources
• Identify the relevant pre-clinical studies to support the first study in man
• Understand requirements for successful scale-up and validation
• Apply best practices to the development of new product initiatives
• Identify, assess and manage potential risks associated with non-compliance during development
• Map a product life cycle for your product

Course content

• Drivers for drug discovery and development
• Building a drug development program through integrating scientific processes with regulatory & business requirements
• Selecting relevant tools for high throughput screening and preclinical testing
• Role of patent management in the product life cycle
• Quintessential steps after lead candidate identification
• Application of biopharmaceutics to prototype formulation design
• Toxicology and safety pharmacology requirements for First in Man Study
• Guidelines for dose selection
• Regulatory issues
• Applying principles of pharmaceutical GXP to ensure compliance