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

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

DEL BioPharma was retained to commission the synthesis of a known literature compound.  The RFP was generated and bids were obtained from multiple CROs.  The selected CRO did not provide the lowest bid but did have specific experience with related compounds commissioned through DEL BioPharma.  On initiation of this project, the following was agreed upon:

        - Weekly teleconferences would address ongoing progress

        - Any challenges regarding the project would be communicated by email as needed.

Initially, the CRO apidly advanced the expensive raw materials to advanced intermediates.  However, during the later stages of the synthesis, the CRO

        - Failed to communicate the status of the chemistry in an efficient and timely manner

        - Advanced impure materials into final stage reactions resulting in failed reactions and unnecessary consumption of intermediates

        - Demonstrated a laclk of ability to separate the final diastereomeric mixture

        - Failed to request appropriate amounts of replacement raw material resulting in higher costs to the client

Because the only communication for this project was either during the scheduled weekly teleconferences or when initiated by DEL BioPharma and because the CRO failed to follow suggestions and protocols regarding chemistry and purification, the CRO was terminated and the project was transferred to an alternate group.  Based on guidance from DEL BioPharma, the alternate CRO successfully completed the target compound.