Luminal Arc’s work spans scientific, operational, and organizational challenges across CGT and biologics. These examples illustrate how the advisory posture shows up in practice.
Executive and Advisory
Partnered with CEO and CSO to launch and build a platform technology company focused on developing next generation envelope engineering capabilities for lentiviral vectors - interfacing with the board of directors, prospective investors, and external partners.
Established operational infrastructure at a CGT platform technology company, inclusive of establishing hiring practices, corporate cultural values, ways of working, and advanced data modeling.
Directed the construction of a new incubator space, hiring of the scientific team, and the campaigns that generated the data package to launch the flagship product at a CGT platform technology company.
Designed an end-to-end CMC operational roadmap for novel fusion protein, from preclinical through BLA, including sequencing and budgetary options for an accelerated approval pathway for board of directors.
Provided strategy to CEO and chairman of the board of a CDMO on how a new CGT capability could be integrated into their existing biologics offering, identifying the market segment, staged expansion strategy, operational gaps, and the narrative required to layer a new modality onto an established structure.
Builder (BioVex/Amgen, bluebird bio)
Created and directed LVV MSAT organization accountable for the technical commercialization activities for Abecma, Skysona, Zynteglo, and Lyfgenia, including BLA/MAA authorship (Module 3), PPQ strategy, leading critical investigations, and health authority inspections.
Established the process development capabilities and built team to support process characterization, control strategy development, PPQ readiness, and inspection readiness for lentiviral vector-based cell and gene therapies.
Successfully presented manufacturing process and control strategy for HSV-1 manufacturing process during FDA, EMA, and TGA inspections culminating in the commercial launch of Imlygic for the treatment of metastatic melanoma.
Hired and directed upstream process development team in the development of a commercial upstream engineered HSV-1 manufacturing process.
Foundational (TKT, Shire HGT, Therion Biologics)
Designed and executed bioengineering campaigns that were used to support the post approval platform change from the adherent serum containing platform to the suspension serum free platform, termed Replagal AF.
Co-developed late-stage upstream manufacturing process for engineered vaccinia and fowlpox platforms that were used to treat pancreatic and prostate cancer.