Precision Medicines

  • • Identification, due diligence and selection of diagnostic companies for partnering

    • Project management of companion diagnostics co-development programmes and diagnostic studies

    • Training, monitoring and trouble shooting to ensure consistent, high quality results for clinical diagnostics studies

    • Technical support for diagnostics

    • Diagnostic assay development and implementation within clinical studies

    • Tech transfer to establish global diagnostic testing facilities

  • • Regulatory and development advice for biomarkers, companion diagnostics, digital health and other devices across a range of therapy areas and regions

    • Developing global regulatory strategy for Precision Medicines

    • Regulatory landscape mapping, assessing regulatory risk, and developing global filing strategies

    • Ensuring global development plans meet global regulatory requirements

    • Supporting Regulatory Interactions/Submissions (e.g. FDA- SRD’s, IND’s, PMA’s, EMA – IVDR compliance, PMDA)

  • • Developing and implementing Global Launch plans

    • Co-ordinating and delivering diagnostic projects/initiatives at a global and local/in-country level

    • Development and implementation of diagnostic strategies to maximise testing for therapy choices

Product Development

  • Our expert teams provide support through every step of development, including:

    • IP evaluation and due diligence

    • Developing and implementing preclinical strategies

    • Developing and refining clinical strategies, development plans and operations

    • Regulatory support across due-diligence, strategy development, hands on support for regulatory meetings, managing and preparing submissions including CTAs, INDs, BLAs

    • Pharmaceutical development, CMC- regulatory, QA/QC and supply chain support

  • Regulatory advice for companion diagnostics co-development

    Support for Regulatory interactions

    Companion diagnostics regulatory submissions

    Regulatory and development strategies across a range of therapy areas and regions

    Advice on organisational development and outsourcing key regulatory activities​​​

Strategy and Commercialisation

  • Out Team offers a combination of technical and commercial acumen to assist in developing and implementing commercial strategies and business plans.

    • Building out teams and capabilities

    • Business Analysis/Forecasting

    • Business Plans/Investor Pitch Decks

    • Commercial Strategy/Marketing

    • Market Access

    • Market Research

    • Opportunity Mapping

    • R&D Strategy

    • Sales and Operations

    • Supply Chain

  • Strategic support from drug-diagnostic co-development through to launch readiness and market uptake of novel drugs and diagnostics.

    Diagnostic expertise in progressing numerous therapies alongside companion diagnostics from discovery through clinical development and successful launch and uptake in countries around the world

    Experience across various disease areas, diagnostic technologies and drug co-development stages as well as launch readiness and post launch activities

    Partnering with companies to overcome obstacles and push the full potential of therapies and diagnostics towards regulatory and commercial success.

Business Development

  • Our expert team supports a broad array of services including finding and sourcing new assets, in-licensing, funding, due-diligence, partnering and deal-making.

    • Startups and from industry and universities/hospitals- providing strategic and hands-on support from IP transfer, setting up management and operational teams, funding, strategy development/execution, business development

    • Providing thorough and accurate due-diligence assessments

    • Asset search and evaluation activities

    • In-licensing, out-licensing, partnering and deal-making

    • Funding support including IPOs, PE/Venture, and SPAC’s

    • Undertaking valuations

    • Placement of CEOs, CMOs, COO’s

Healthcare Technology Solutions

  • Our Data Specialists and Programmers, utilizing AI, are developing healthcare technology and analytics solutions that address key needs to optimising precision medicine launches and genetic data analysis.

Companies we worked with

  • Established Pharmaceutical Companies

    • Astrazeneca

    • Bristol Myers Squibb

    • Merck KGaA

    • Novartis

    • AbbVie

    • Pierre Fabre

  • Startups/Growing biotechs, including

    • Liminatus Pharma

    • Zura Bio

    • Bicycle Therapeutics

    • Cytox Ltd

    • Pharma 313

    • Profeta Health

    • Levamen Therapeutics

    • Precision Medicines Ltd

    • Kancerbis Ltd

  • Academic Institutions, including:

    • King’s Commercialisation Institute, King’s College London

    • Nottingham NHS Foundation Trust

Strategic planning for pharma, biotech and life science companies

Working with pharma, biotech and life science organisations to deliver precision medicine

  • Our team has decades of large pharma experience working with organisations including GSK, Novartis, BMS, Astrazeneca and Roche to fill the gap in the capability needs of rising companies.

  • Strategic support from drug-diagnostic co-development through to launch readiness and market uptake of novel drugs and diagnostics.

  • Diagnostic expertise in progressing numerous therapies alongside companion diagnostics from discovery through clinical development and successful launch and uptake in countries around the world

  • Experience across various disease areas, diagnostic technologies and drug co-development stages as well as launch readiness and post launch activities

  • Partnering with companies to overcome obstacles and push the full potential of therapies and diagnostics towards regulatory and commercial success.

Drug-diagnostic co-development expertiese

  • Identification, due diligence and selection of diagnostic companies for partnering

  • Project management of companion diagnostics co-development programmes and diagnostic studies

  • Training, monitoring and trouble shooting to ensure consistent, high quality results for clinical diagnostics studies

  • Technical support for DNA and tissue based diagnostics

  • Diagnostic assay development and implementation within clinical studies

  • Tech transfer to establish global diagnostic testing facilities

Drug-diagnostic launch readiness and post-launch

  • Co-ordinating and delivering diagnostic projects/initiatives at a global and local/in-country level.

  • Development and implementation of diagnostic strategies to maximise testing for therapy choices.

  • Diagnostics and lab network partner management.

  • Diagnostic training of field force and capability development.

  • Setting up and management of diagnostic studies.

  • Managing quality assurance programmes.

  • Diagnostic market research.

  • Development and delivery of educational campaigns to drive diagnostic testing

  • Delivering diagnostic advisory boards

  • Support for health technology assessments

  • Accessing healthcare professional networks

Drug-diagnostic regulatory services

  • Regulatory advice for companion diagnostics co-development

  • Support for Regulatory interactions

  • Companion diagnostics regulatory submissions

  • Regulatory and development strategies across a range of therapy areas and regions

  • Advice on organisational development and outsourcing key regulatory activities​​​

Healthcare Technology Solutions

Our Data Specialists and Programmers, utilizing AI, are developing healthcare technology and analytics solutions that address key needs to optimising precision medicine launches and genetic data analysis.

Experience working with

•

GSK

•

Novartis

•

BMS

•

Astrazeneca

•

Roche

• GSK • Novartis • BMS • Astrazeneca • Roche