Case Study

Supplier Selection & Management

Changing Horses in Mid-Stream: An exercise in regulatory archiving and supplier selection

Fulcrum's client was a global technology commercialisation company with diverse interests including a share of the intellectual property associated with a ‘big pharma’ partner’s biotechnology product.

After some years in a joint development programme, during which some twenty trials had been completed to the end of Phase II, the leading partner had decided that the product no longer fitted their future plans. Fulcrum's client was ready to invest alone in a re-engineered phase I and II strategy but needed advice and support. Their key objectives were:

• Transfer and archiving of a vast amount of data, protocols, reports, correspondence and electronic data associated with the twenty, existing trials from their former partner.
• Transfer and maintenance of the safety database and regulatory responsibilities associated with the CTX and IND.
• Transfer and archive of wet tissue samples.
• Retrieval of CMC and Manufacture records from third parties.
• Critically the client also needed Fulcrum convene a strategic advisory board of global opinion leaders and multidisciplinary experts in order to assist them in outlining the re-engineered development strategy.
• Finally the client needed to source a manufacturer to provide new batches for the forthcoming bank of studies.

There were a number of additional hurdles in the way of what was going to be a complex and arduous process. For example some of the previous ‘joint venture’ suppliers (and regulatory authorities) had only dealt with the ‘big pharma’ partner and most contracts and confidentiality agreements were drawn up with this party. Needless to say the CTX and IND were not initially in our client’s name.

Fulcrum's Project Director was familiar and well experienced with selecting multiple suppliers and melding those into a working team. The Director was able to select outsourcing providers, negotiate competitive contracts and implement key study components in a very short time.  

Fulcrum benefited the Client through the following key milestones:

• Having been appointed to the project, Fulcrum completed transfer of the safety database within 2 months and all project data was transferred within 6 months;
• New suppliers for drug safety, paper archive/scanning, wet tissue storage, drug substance and drug manufacture were chosen, contracted and managed;
• An electronic archive (that contained all regulatory documents) was assembled in an e-Room (secure online collaboration space provided by Fulcrum). This archive was accessible by client and suppliers under tiered password protection; and
• Fulcrum put together a strategic advisory board to inform the next phase of development.

Fulcrum continued working with the Client, and managed subsequent studies through the next phase of development.

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