Description of how these justifications apply
Because the product required highly specialised manufacture using microinjection moulding (MIM) of API-containing formulations, production had to be separated from clinical trial services and a dedicated CDMO selected. The EMBED team and the Foundation prioritised an independent, structured global CDMO selection process, beginning with defining capability‑focused criteria, identifying and engaging 29 potential CDMOs, and holding introductory meetings with 14 to assess alignment with technical and GMP requirements. Based on these discussions, CDMOs were categorised by the extent of their MIM and API capabilities, leading to a detailed RFI issued to 12 candidates and NDA execution with 8 shortlisted organisations to enable feasibility assessments. This process was further narrowed through an RFP to three CDMOs, after which Promed Pharma was selected as the only provider able to meet the project’s technical, timeline and budget needs. Both the Foundation and other shortlisted CDMOs supported the decision, with final qualification to be confirmed through a due diligence site visit prior to contracting and project initiation.
As this work is the development of prototypes, PA23 allows for the direct award for this under Regulation 41 -
Schedule 5, para 2 -
The public contract concerns the production of a prototype, or supply of other novel goods or services, for the purpose of—
(a)testing the suitability of the goods or services,
(b)researching the viability of producing or supplying the goods or services at scale and developing them for that purpose, or
(c)other research, experiment, study or development.