Products: Integrated Medicines Ltd (IML) seeks to impact three opportunities:

(A) the association of an existing diagnostic test with a medicine that is currently in or nearing the market place;

(B) the production of a diagnostic test manufactured exclusively for the purpose of aiding the launch & marketing of a late-stage medicine; and

(C) the development of novel tests, from identification and clinical validation of surrogate biomarkers through to approved diagnostics, in parallel with early-stage medicines development programmes.

For Pharma/Biotech companies:

We aim to be the trusted partner of choice to broker, value, and manage relationships and deals between the world’s top pharmaceutical developers, most innovative diagnostics companies and highly trusted regulatory agencies.

The Context

Patient stratification is a compelling business model for companies working in drug discovery and development. Use of surrogate biomarkers enables stratification to shorten clinical trials and drug development cycles, leading to extra years at peak sales. Developing surrogates into approved diagnostic tests can then help products reach peak sales faster or achieve higher peak sales through market expansion.

Diagnostic tests can also be used to increase efficacy or minimize adverse drug events within an objectively defined treatment population, thus facilitating sales of a premium priced "niche" medicine differentiated from generic or proprietary competitors.

IML works with the major pharma and biotech companies to help scope the global diagnostic landscape to identify the right technology partner for specific candidate molecules in development. We can also help with the “rescue” or reprofiling of molecules which have failed in clinical trials but with a companion diagnostic are safe and effective in specific patient cohorts.

For Diagnostics Companies:

The pharmaceutical sector is a major purchaser of diagnostic services. The benefits of integrating diagnostics into the drug development pipeline are increasingly recognized by pharma companies, where the attraction of developing a diagnostic product with a large earnings potential for an exclusive drug is obvious. Yet pharma and diagnostics companies have traditionally operated independently, so finding the right partner remains a challenge in this fast-moving global industry.

IML can help find a drug in development which could benefit from your diagnostic technologies. We can also advise on co-development opportunities and manage the co-development project and partners. Using our proprietary valuation tool we can broker the financial elements of the relationship, offering a robust, evidence-based approach to negotiations.

For Contract Research Organisations:

Many CROs have yet to fully exploit the opportunity to offering clinical support services that include the application of disease and pharmacodynamic surrogates. We believe the use of surrogates, or carefully-selected diagnostics, that shorten clinical programmes and/or enhance clinical decisions will differentiate the proactive CRO. In addition, the clinical validation of a novel biomarker can be a source of revenue through IP, particularly in therapeutic areas where diagnosis and/or monitoring response is limited.

IML understands these opportunities and can help you develop your capabilities through use of diagnostics to increase your customer base and client offering. We can also broker relationships with potential new clients and support your business to help maximize your opportunities.

For Reference Laboratories:

Accredited reference laboratories will have an increased profile as the stratification of patients becomes more embedded in disease treatment and patient care. Use of diagnostics at point-of-care or centrally will require the development of new competences and adoption and validation of high throughput, cost effective new technologies.

IML can help reference laboratories develop these capabilities, as well brokering relationships with pharma companies who will also be using your services.

For Health Technologies Assessment Agencies:

As a health technology assessment agency, you need to make hard decisions about efficacy, value-for-money and impact on disease treatment or prevention. A proven companion diagnostic can radically influence the cost effectiveness of a pharmaceutical post approval as well as patient experience and care pathway. IML has been contracted by the UK’s Technology Strategy Board to help with the development and modeling around use and impact of diagnostics for sepsis. Here, we bring together clinicians, health economists and technology providers to model the potential impact of a rapid point of care diagnostic for sepsis in emergency care.

IML can help you effectively assess these issues by brokering relationships with providers, commissioners and usersof appropriate technologies to increase the adoption of of new innovations in health and disease management.