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

Case Study #5 - Keep Timelines Realistic

Case Study #6 - Begin with a Detailed RFP

DEL BioPharma was retained to commission the synthesis of a family of sugar-derived kinase inhibitors.  The client had already obtained a proposal from a CRO according to that CRO's independently derived chemistry plan.  On review of the chemistry plan, DEL BioPharma noted that the synthetic route was redacted in order to prevent sharing of the details with competing CROs.  In addition, many of the synthetic steps were problematic and the proposed sequence required use of extremely expensive starting materials.

In approaching this project, DEL BioPharma drafted an independent RFP (Request For Proposal) that contained

        - A detailed synthetic scheme beginning with common sugars

        - Supporting literature for all synthetic steps

        - Clearly defined program objectives

        - Expected target compound specifications

The results of this effort were reflected in the following:

        - The initial CRO provided a lower bid compared to their original bid

        - The client was able to generate competing bids from competing CROs all based upon the same RFP

A detailed RFP is the essential first tool supporting project design, tech transfer and generation of high quality bids from CROs and CMOs.

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