Implementing Lead Optimization Strategies for Small Molecules

3 IMPLEMENTING LEAD OPTIMIZATION STRATEGIES FOR SMALL MOLECULES 

As mentioned earlier, discovery safety activities have value for small molecules and biotherapeutics. However, the approaches and assays utilized will differ based on the molecular platform. 

Assessment Component Items for Consideration Example Evaluation Resources 

Therapeutic area and patient population Level of safety required Unacceptable/undesirable clinical AEs Potential interactions with comeds Engage clinical and drug safety representative Literature and public databases 

Competitive landscape Safety of competitors (same target) Safety of competitors (same/related pathway) Literature and public databases Competitive inteUigence Internal assessment of competitors (biologies or small molecules) 

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