Iridium Consulting Partners is a boutique consultancy firm specializing in CMC project management and technical leadership through all stages of development. The firm prides itself in its ability to provide strategic guidance leading to the creation of fast, lean, and phase appropriate development programs that translate to successful, on time submissions

Recruited to lead CMC teams in the creation / implementation of NDA submission plans for late stage projects. Direct CM&C teams overseeing all aspects of drug development, including API, formulation, analytical, manufacture, packaging, labeling, supply chain and document creation for IND/IMPD filings. Lead CMC teams in technical, operational and strategic trouble shooting. Serve as CM&C representative to multiple program teams.  Drove on time creation / submission of CMC sections of omaveloxolone (Skyclarys®) and bardoxolone NDAs -US Approval of Skyclarys® granted Feb 2023 / MAA review in progress -Bardoxolone regulatory submissions NDA - Feb 2021 / MAA - Oct 2021 Accelerated development of Ph2 cemdomespib program through use of PBPK modeling as an alternative to more time consuming and expensive clinical formulation bridging Directed risk mitigation response to unexpected stability results with an enabled formulation of a preclinical program Collaborated with Ph2 Clinical team to enable a cost and time efficient adaptive design Ph2

Retained to lead development team bringing tablet formulation of Zejula® (ovarian cancer drug) to submission and apply Six Sigma expertise to redesign business processes. Direct CMC teams in the creation of development plans, budgets and risk plans. Create efficient development strategies that mitigate risks and present to internal governance committees for review. Use clinical and toxicology data to inform CMC investment decisions. Accelerated sNDA/MAA submission by identifying development issues and advocating for vendor change. Consolidated scope and applied stability-bracketing approach to speed filings to FDA/EMEA/ROW. New tablet formulation offered increased manufacturing robustness, decreased cost, reduced pill burden and facilitated first time availability in hot, humid markets. Strengthened key strategic alliances by spearheading project to understand partner perception of GSK and opportunities to improve. Led follow up initiatives to improve collaboration through contract simplification, partner recognition, and improved internal decision making. Drove commercial Zejula® OPEX savings of $1.1M. -Cut 2020 API costs $473,000 by leading project to adopt risk-based review of batch records and clarify responsibilities to address gaps/eliminate overlap between technical and QA groups. -Averted $630,000 loss by working with team to create/implement plan extending usable shelf life of drug product by bright stocking a subset of validation supplies for labeling at future date once extended shelf life available.

Led CMC teams in drug and device development. Directed teams in multiple due diligence efforts to determine strengths/weaknesses, critical issues, stage of development, and COPS, while creating integrated development plan and overall recommendation. Led Six Sigma teams in the creation of solutions to long-standing problems within Development and Discovery through application of Six Sigma DMAIC / DFLSS, Lean, and IDEO-inspired methodologies.  Accelerated synthetic-peptide development by identifying a means to shorten time to first human dose by 2 months, with limited expense and liability. Designed template to be used by less experienced project managers

-Led cross functional program teams in the development of cross functional development plans

-Developed robust, commercially representative chemical processes suitable for scale up-Assisted in the writing portions of IND / NDAs