Rapidly cleaned up the due-diligence document repository for a Phase I Canadian firm that supported a successful funding round

On a very compressed timeline, working in conjunction with John M. Farah, Jr.:

    •     reviewed documents in a partially-filled electronic data room

    •     identified missing and un-necessary documents

    •     authored a CMC summary with hot links to the supporting documents

    •     prepared a guide to the data room for potential investors

OUTCOME: The work was finished on-time for the investor’s review and the funding was secured.

                            +_+_+_+_+_+_+_+_+_+_+_+_+

      Prepared CMC assessment and recommendations for a US Phase 2 drug that successfully supported the firm to obtain investment funding

Performed gap analysis and risk analysis

  .   Reviewed existing CMC documents and FDA correspondence

  .   Audited API manufacturer

Prepared prioritized plans for gap filling and de-risking, recommending:

  .   Additional characterization of starting materials and of API

  .   Justification of specifications and controls

  .   Prompt qualification of photostability assay and initiation of photostability study

  .   Prompt preparation of additional API Primary Reference Standard

  .   Demonstration of robustness of impurity assays particularly for structural- and stereo-isomers

  .   Screening to understand probability of polymorph formation

  .   Change primary packaging component to comply with FDA informal guidance to industry

  .   Establish work plan to prepare for an End-of-Phase 2 meeting with FDA focused on CMC

  .   Establish a compliant internal Pharmaceutical Quality System

Authored CMC overview (with hyperlinks to supporting documents) for potential investors

OUTCOME:  The recommendations have been largely adopted and were tacitly endorsed by accredited investors in a successful subsequent funding round.

                            +_+_+_+_+_+_+_+_+_+_+_+_+

 

     Led CMC due diligence for acquisition of a “Phase-3-ready” drug; identified gaps/risks that resulted in abandoning the acquisition and preventing potential financial loss

Reviewed CMC documents and FDA correspondence, performed gap & risk analyses      .     existing supplies were not suitable for completing Phase 3 trial

  .     delivery device was not capable of appropriate dosing & had unacceptable stability

Developed two timelines requested by potential acquirer for initiation of Phase 3 trial    .     very aggressive, high-risk timeline;  and,  moderately aggressive timeline

Identified and recommended development and manufacturing partners

Prepared cost estimates for development work and manufacturing clinical supplies

OUTCOME:  The planned acquisition did not proceed.

                            +_+_+_+_+_+_+_+_+_+_+_+_+

      Contact us at  +1 484 758-0654 or by email