Bristol Myers Squib’s Global Regulatory Sciences function partnered with Core Precision to deliver companion diagnostic regulatory support across hematology, neuroscience, and cardiovascular therapy areas.

Over 20 Projects were directly supported including Breyanzi, Iberdomide, Golcadomide therapies and companion diagnostics, as well as global and cross-industry initiatives on advancing minimal-residual disease (MRD) diagnostics use in clinical trials and regulatory approvals.

This enabled successful regulatory interactions and approvals including SRD’s, IDE’s, and PMA’s in the US and IVDR and MDR compliance in Europe.

Merck KGaA’s Global Regulatory Affairs Translational Medicine & Devices Group partnered with Core Precision to provide companion diagnostics and device regulatory support for their early and late clinical stage oncology portfolios including marketed drug Tepmetko. This enabled successful regulatory submissions with FDA, EMA, BfArM, and PMDA.

King’s College London’s Commercial Institute partnered with Core Precision to support assessment of projects for seed funding and mentoring of principal investigators and their Teams to enable spinouts. This led to a number of successful spin-outs, including Quell Therapeutics, Leucid Bio, NeuroGeneus, and Mahana Therapeutics, including securing of over £300M investment.

Nottinghamshire Healthcare NHS Foundation Trust’s Clinical Trials in Breast Cancer Centre partnered with Core Precision to support for delivery of internally developed innovative cancer tests for chemotherapy treatment selection. Core Precision provide an assessment of commercialisations options, partnering models and recommendations on pathways to commercialise the tests. This led to highly successful acquisition of funding (>£5M) to further develop the tests and robust plans for obtaining regulatory approval and commercialising in key countries globally.

Liminatus Pharma Inc, a clinical stage cancer therapeutics company, and Iris Acquisition Corp, a publicly traded special purpose acquisition company, partnered with Core Precision to undertake due scientific and technical due diligence on their drug pipeline, develop robust clinical development plans, advise on in-licensing and business development opportunities, as well assist with investor relations and SEC filings. This led to Liminatus Pharma entering a SPAC merger deal with Iris Acquisition Corp.

AstraZeneca partnered with Core Precision to support their late clinical stage and marketed precision medicines. Therapies included Lynparza, Imfinzi, Tagrisso, and Iressa. Core Precision:

• Advised on how diagnostic tests should be developed and approved, who they should be developed with, and how to rapidly and effectively implement their adoption globally.

• Managed delivery of diagnostic development, managed laboratory networks, solved issues to aid rapid and effective test adoption, provided diagnostic training to field force, developed educational and training programmes, set-up and managed diagnostic studies, supported regulatory and HTA submissions, and undertook QC diagnostic activities for clinical trials.

• Delivered research on the testing environment and test adoption.