Case Studies

Case Study #1 - Follow the Literature

Case Study #2 - Keep it Simple

Case Study #3 - Find the Right Talent

Case Study #4 - Efficient CRO/CMO Oversight Requires Chemistry Expertise

DEL BioPharma was retained to provide chemistry oversight of a complex multi-step synthesis consisting of:

        - 18 Linear synthetic steps

        - 22 Total synthetic steps

        - Multiple protecting group manipulations

        - Use of toxic heavy metal reagents in 3 steps

        - A scale-limited Birch reduction

Upon review of the protocols developed during the pilot synthesis, immediate recommendations were made regarding workup and isolation procedures that resulted in an overall doubling of the product yield.  Additional modifications and improvements to the chemistry resulted in the following:

        - Identification of a new target compound with stronger IP and comparable (if not better) biological properties

        - 16 linear synthetic steps

        - 18 total synthetic steps

        -  Minimal use of protecting groups

        - No toxic heavy metal reagents

        - No Birch reduction

        - >90% Reduction in cost of goods

        - Incorporation of additional improvements is ongoing

The new target compound is currently entering phase I clinical trials.

Case Study #5 - Keep Timelines Realistic

Case Study #6 - Begin with a Detailed RFP

Case Study #7 - Success Depends on 2-Way Communication