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

 

DEL BioPharma was retained to commission and oversee the preparation of a set of target compounds within a strict 6-week timeframe.  The 10 target compounds were selected by a patent attorney and DEL BioPharma was assured that each compound could be prepared in 3 synthetic steps beginning with off-the-shelf commercial starting materials.  On evaluation of the project, the following was noted:

 

        - Preparation of several of the target compounds would not be successful due to compound stability issues

        - According to synthetic protocols, each compound would be a mixture of diastereomers

        - The required stereochemistry for each compound was not known

        - None of the required starting materials were commercially available

        - While the target compounds could be assembled in 3 synthetic steps, due to the lack of available starting materials, 9-11 synthetic steps were

          required to prepare each target.

 

In approaching this project, DEL BioPharma drafted a detailed RFP with the goal of achieving synthesis of at least 6 target compounds in the required period of time.  This was consistent with the client needs as resources were available for biological testing of only 6 compounds.  Following RFP drafting, DEL BioPharma

 

        - Recruited qualified CROs

        - Identified a group capable of successfully executing this project

        - Negotiated contract terms

        - Provided chemistry support and oversight

 

Within the 6-week timeframe, the following was accomplished:

 

        - 7 Target compounds were completed as diastereomeric mixtures

        - All 7 target compounds were separated into their individual diastereomers

        - 14 total compounds were delivered to the client

 

While all goals of this project were exceeded, this project had an extremely high risk of failure as evidenced by the refusal of most CROs to submit a bid given the tight time constraints.

 

Case Study #6 - Begin with a Detailed RFP

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

 

 

 

 

Copyright Daniel E. Levy, All Rights Reserved

 

 

 

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

 

DEL BioPharma was retained to commission and oversee the preparation of a set of target compounds within a strict 6-week timeframe.  The 10 target compounds were selected by a patent attorney and DEL BioPharma was assured that each compound could be prepared in 3 synthetic steps beginning with off-the-shelf commercial starting materials.  On evaluation of the project, the following was noted:

 

        - Preparation of several of the target compounds would not be successful due to compound stability issues

        - According to synthetic protocols, each compound would be a mixture of diastereomers

        - The required stereochemistry for each compound was not known

        - None of the required starting materials were commercially available

        - While the target compounds could be assembled in 3 synthetic steps, due to the lack of available starting materials, 9-11 synthetic steps were

          required to prepare each target.

 

In approaching this project, DEL BioPharma drafted a detailed RFP with the goal of achieving synthesis of at least 6 target compounds in the required period of time.  This was consistent with the client needs as resources were available for biological testing of only 6 compounds.  Following RFP drafting, DEL BioPharma

 

        - Recruited qualified CROs

        - Identified a group capable of successfully executing this project

        - Negotiated contract terms

        - Provided chemistry support and oversight

 

Within the 6-week timeframe, the following was accomplished:

 

        - 7 Target compounds were completed as diastereomeric mixtures

        - All 7 target compounds were separated into their individual diastereomers

        - 14 total compounds were delivered to the client

 

While all goals of this project were exceeded, this project had an extremely high risk of failure as evidenced by the refusal of most CROs to submit a bid given the tight time constraints.

 

Case Study #6 - Begin with a Detailed RFP

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

 

 

 

 

 

 

 

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

 

DEL BioPharma was retained to commission and oversee the preparation of a set of target compounds within a strict 6-week timeframe.  The 10 target compounds were selected by a patent attorney and DEL BioPharma was assured that each compound could be prepared in 3 synthetic steps beginning with off-the-shelf commercial starting materials.  On evaluation of the project, the following was noted:

 

        - Preparation of several of the target compounds would not be successful due to compound stability issues

        - According to synthetic protocols, each compound would be a mixture of diastereomers

        - The required stereochemistry for each compound was not known

        - None of the required starting materials were commercially available

        - While the target compounds could be assembled in 3 synthetic steps, due to the lack of available starting materials, 9-11 synthetic steps were

          required to prepare each target.

 

In approaching this project, DEL BioPharma drafted a detailed RFP with the goal of achieving synthesis of at least 6 target compounds in the required period of time.  This was consistent with the client needs as resources were available for biological testing of only 6 compounds.  Following RFP drafting, DEL BioPharma

 

        - Recruited qualified CROs

        - Identified a group capable of successfully executing this project

        - Negotiated contract terms

        - Provided chemistry support and oversight

 

Within the 6-week timeframe, the following was accomplished:

 

        - 7 Target compounds were completed as diastereomeric mixtures

        - All 7 target compounds were separated into their individual diastereomers

        - 14 total compounds were delivered to the client

 

While all goals of this project were exceeded, this project had an extremely high risk of failure as evidenced by the refusal of most CROs to submit a bid given the tight time constraints.

 

Case Study #6 - Begin with a Detailed RFP

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