Our integrated specialist team supports all key areas of drug and precision medicine development, regulatory and commercialisation
Precision Medicine Clinical, Regulatory and Commercialisation
Precision Medicines regulatory support across hematology, neuroscience, and cardiovascular therapy areas and advancing minimal-residual disease (MRD) diagnostics use in clinical trials
An Established Pharma Companies’ Global Regulatory Sciences function partnered with Core Precision to deliver companion diagnostic regulatory support across hematology, neuroscience, and cardiovascular therapy areas
We placed full time senior Precision Medicines Regulatory Expertise from the Core Precision Team over 26 months. Over 20 Projects were directly supported including three late stage and commercialized 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/MDR compliance in Europe
Identification of diagnostic partner to develop a companion diagnostic for biotech’s lead therapy
Core Precision was tasked to identify a diagnostic partner for a cancer biotech to develop a companion diagnostic for their lead precision guided therapy.
Core Precision:
Identified CROs and other laboratory organisations with the potential capability and track record to develop the required companion diagnostic. Potential partners were identified through previous experience of vendor selection and IHC biomarker analysis supporting clinical studies, as well as primary and secondary research utilising Core Precision’s extensive network
Compiled a Request for Information (RFI) questionnaire that was sent to selected vendors
Selected a short list of preferred vendors, compiled risk register and provided detailed analysis of preferred vendors
Precision Medicine Clinical Trial Execution
An established pharma company partnered with Core Precision to undertake QC activities of several clinical trials involving data from clinical trial assays. Core Precision:
Established a quality management system
Undertook realtime QC of data
Led the necessary investigations and implementation of solutions for identified issues
Devised solutions to strengthen partners QC procedures to ensure long term improvements in quality
Companion diagnostics and device regulatory support for early and late clinical oncology portfolios, marketed drugs and IVDR Capability setup
An established pharma companies’ 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 several marketed drugs
Full time senior precision medicine regulatory expertise was provided to the function over 24 months
Over 15 Projects were directly led, enabling successful regulatory submissions with FDA, EMA, BfArM, and PMDA
A new capability was setup to ensure compliance and submissions under European IVDR and MDR regulations
Review of companion diagnostic plans and provision of expert opinion on strategic questions
A leading French multinational pharmaceutical company requested Core Precision to review their companion diagnostic plans and provide an expert opinion on several strategic questions
Core Precision’s strategy and technical experts reviewed the programmes and undertook primary and secondary research to provide an overall strategic assessment and detailed answers to the specific strategic questions
Global Commercialisation of oncology precision medicines
An established pharma company partnered with Core Precision to support their late clinical stage and marketed precision medicines. Four marketed precision medicines were supported, Core Precision:
Developed Precision Medicine commercial strategies and implementation plans
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
Delivered research on the testing environment and test adoption of various tests
Setup expert panels to provide insight and inform strategic planning
Strategic review of diagnostic companys’ pipeline
A diagnostic company undertaking research and pilot studies with several pharmaceutical companies to develop companion diagnostics tasked core precision to provide a strategic review of their pipeline.
We provided a detailed review including solutions to key strategic issues
Recommendations were provided for assay development strategies for use in clinical trials for companion diagnostic approvals, regulatory requirements and development roadmap for their assays, optimum pathway to develop early-stage assays to clinical trial assays and companion diagnostic approvals, and compliance with European IVDR and MDR regulations
Product Development
Assessment of potential breast cancer curative therapy
Core Precision was asked to provide a detailed assessment of a novel therapy in the late preclinical stage targeting cancer stem cells under development as a potential curative treatment in breast cancer. The client, a start-up biotech, was considering investment for clinical development, and was tasked by the Board for an external expert view of the strengths of the asset, route to regulatory approval and its competitive positioning.
Core Precision with its cross-functional Team consisting of a medical oncologist, CMC expert, drug safety expert, and business analyst reviewed all the preclinical data, publications, and gathered insights from its expert medical oncology network on the latest research underway on assets with a similar mechanism of action and clinical setting.
We concluded that although the preclinical asset had compelling activity, there were significant hurdles to overcome before an IND or CTA could be submitted and the clinical development plan would incur significant cost and time. The Board accepted the conclusions of the Team and decided not to develop the therapy independently and to partner on the further development of the asset.
Developing preclinical and clinical development strategy for an endocannabinoid system targeted therapeutics company
A European start-up company focussed on developing therapies targeting the endocannabinoid system (ECS) tasked Core Precision to review its pipeline, develop its preclinical and clinical development strategy and plans, as well as identify vendors to undertake key outsourced activities.
Core Precision assembled a cross-functional Team consisting of a world renowned basic and translational researcher on the ECS, pharmaceutical development expert, and industry expert on developing cannabis based medicines as well as a clinical experts in the key targeted clinical settings
Our experts conducted an in-depth review of current know how and literature on each asset and which disease areas showed most promise for the assets and a ECS targeted approach. We undertook a deeper assessment of highly promising disease areas including an analysis of the competitive landscape and development of preclinical and clinical strategies that offered a high level of differentiation and quickest route to market. We also indentified suitable CRO’s to undertake key outsourced activities
Due-diligence of cancer vaccine, CAR-T therapies, and novel immune check-point inhibitors
A growing clinical stage cancer therapeutics company based in the U.S. partnered with Core Precision to undertake scientific and technical due diligence on their drug pipeline and on prospective assets to be in-licensed. Core Precision:
Assembled an expert Team consisting of the foremost subject matter experts including cancer vaccine development, CAR-T therapies and immune check-point inhibitors
Undertook a review of clinical, preclinical safety and efficacy and regulatory data for pipeline assets and prospective in-licensing assets
Provided and presented to the Board a robust due-diligence report that informed strategic development and in-licensing decisions
Developed preclinical and clinical development plans including key work packages and identified vendors to undertake activities
Developed regulatory strategies for pipeline products and put in place key documentation and processes required for regulatory interactions and good practice
Undertook search and evaluation activities to support in-licensing of new assets to support the pipeline
Assessment of early opportunities for seed investment, mentoring of Principal Investigators, and supporting spinouts
The Commercial Team of a leading University in the UK partnered with Core Precision over a 5-year period to support assessment and selection of projects for seed funding, mentoring of selected Project Teams, and facilitate spinout of the technologies. This led to several successful spinouts which secured over £300M investment from leading VC investors.
Business Development, Strategy & Commercialisation
Regulatory strategy, commercialisation and partnering of innovative cancer tests for chemotherapy treatment selection
A leading UK University and Hospital’s Cancer Centre partnered with Core Precision to support the delivery of internally developed innovative cancer tests for chemotherapy treatment selection.
Core Precision provided:
An assessment of commercialisations options and partnering opportunities
A roadmap for obtaining regulatory approval and commercialising in key countries globally
Recommendations on pathways to commercialise the tests.
This led to the successful funding to further develop the tests and several partnering opportunities with global diagnostic companies
Setup of pharmaceutical quality and operational services pharma company in Europe
Core Precision was tasked by an investor to facilitate the setup of a CRO delivering pharmaceutical quality and operational services in the UK and Europe to biotech and pharma clients.
We formed the Management Team and Operational Teams
Setup the QMS
Led all requisite activities and regulatory interactions/submissions to achieve licensing approvals from the Irish Health Products Regulatory Agency and UK Medicines and Healthcare Products Regulatory Agency
We also supported business development activities to identify and onboard clients
Advising a publicly traded special purpose acquisition company
A publicly traded special purpose acquisition company listed on NASDAQ partnered with Core Precision to undertake due diligence on a targeted acquisition of clinical stage cancer therapeutics company and subsequently facilitate the acquisition.
We delivered a robust due-diligence report to the Board which led to the decision to proceed with the acquisition to create a business with a pro forma enterprise value of over $330m
We also led on the development of robust clinical development plans, authored key segments of the SEC filing, advised on in-licensing and business development opportunities, as well assist with investor relations activities
Support for startup clinical stage cancer medicines biotech
Core Precision was asked by a clinical stage biotech startup spinout from an established pharmaceutical company to support it in its early stages of formation and securing of investment.
Key areas of support included:
Negotiating licensing agreements and developing corporate strategy
Development of preclinical and clinical plans investor slide deck preparation
Business plan development
Company valuation
Alliance management, recruitment and setting up of management and operational teams, recruitment of Scientific Advisory Board, and supporting with investor presentations and due-diligence queries