IML; Maximising the impact of patient stratification for clinical and economic benefit
We aim to be the expert partner of choice to mediate, value, and manage strategic relationships and deals between the world’s top pharmaceutical developers, most innovative diagnostics companies and highly trusted regulatory agencies.
Medical treatments are developing rapidly and becoming ever more sophisticated, amid a great deal of uncertainty and associated risks. It is no longer enough to show that a drug is safe and works as well, or better, than the current therapy in order to gain approval.
There are compelling cost, efficacy and safety arguments for using objective diagnostic techniques to ensure the right treatment is given to the right patient – evidence-based, and personalised, medicines.
Companies developing new medicines are considering if a diagnostic is required to identify responders, or those who may suffer adverse effects to the drug. Showing the value of such a diagnostic is important to justify investment in its development and to obtain reimbursement when the drug is prescribed.
A requirement for a companion diagnostic test adds further complexity to an already challenging R&D, regulatory and reimbursement landscape. IML can address these new areas and help partners understand how best to value each component in the drug-diagnostic relationship.
Navigating the development programme of a drug is increasingly complex. IML has experts knowledgeable about the pharmaceutical industry in the development of new medicines, and about the diagnostics industry in the innovation and development of new technologies.
Integration of objective diagnostic testing of medicines may not yet be accepted as routine in all therapeutic areas, but the merger of the UK Medicines Control Agency with the Medical Devices Agency into a single regulatory agency is a clear sign of this developing. As regulators become increasingly conscious of the opportunities offered by an integrated medicines approach, so those involved in the development of such medicines may require additional guidance and support. IML can offer practical, hands-on support to help, thanks to strong contacts within the regulatory agencies both in the UK and internationally.
Our key strengths
With long-standing expertise in drug development and diagnostic technologies, IML works across the boundaries of medicine, diagnostics and regulation, to help our clients develop the right strategies to inform a cohesive development plan.
Due to our extensive network and experience within the pharma and diagnostic industries, we can identify the right partner(s) for our clients and broker the introductions.
Using our proprietary valuation tool we can help partners understand and agree a fair and appropriate financial basis for their relationship.
We have excellent links with the key regulatory agencies and can help advise on regulatory and reimbursement strategies.
As well as facilitating new relationships between pharma and diagnostics partners, we can also provide effective project management through to completion, including product launch.
To discuss working with IML, please click here.