Words by James Coker
There has been an increasing focus on the development of precision medicine in the pharmaceutical industry over recent years. In this article, we analyse the critical role medical affairs needs to play in ushering in this new era of treatment.
Treating patients according to their personal genetic characteristics has long been thought of as a future phenomenon; this mindset must change. The recent growth and increasing sophistication of techniques such as gene sequencing, biomarkers, big data analytics, and companion diagnostics, provide the fuel the pharmaceutical industry needs to drive to this destination. They now need the specialist navigators who will steer them carefully through the complex, bumpy roads ahead. Medical affairs is well placed to pick up the A to Z and direct this journey due to their medical knowledge and experience in building collaborations.
“By gathering insights from the field and bringing them back in house, MA can help guide clinical development as to the most suitable, practical, and meaningful biomarkers around which to base precision medicine”, declares Thomas Beveridge, Director, Medical Affairs Oncology, Ipsen.
MA is the beating heart of medical knowledge contained within the pharma industry, and such insights could not be more relevant when it comes to precision medicine. “In precision medicine, even more so than in conventional medicine, a complete understanding of the disease, including diagnostics and biomarkers, and not just simply of your medicine, is needed”, explains Michael Zaiac, Head of Medical Affairs, Oncology Region Europe, Novartis.
Extensive insights into the mechanisms of disease is essential; but alone it is not a sufficient qualification for MA to start taking a lead role in this area. Utilising the novel techniques that have come to the forefront in recent years to identify complex genetic patterns and biomarkers should become a priority for this department.
“With the right data capturing and analytical experience, MA teams can generate insights into targeted treatments for post-marketing surveillance after early approval as well as highlighting the gaps for future developments”, says Zaiac. “To make this happen we need to invest into the data and analytical skills of our medical teams and support them in co-creating data networks with primary suppliers.”
When dealing with areas such as genetics, which are highly complex and specialised, tapping into the minds of others is a wise step to take. Firstly, much closer lines of communication must be established between MA and R&D departments internally within pharma companies, merging their respective expertise to work out the possible targets for future medicines. “Closer collaborations with R&D are essential in order to identify biomarkers and genetic mutations that may be key for precision medicine”, states Beveridge. “The two-way communication between clinical development and MA, in general, needs to be much stronger. That would improve upon the access, and understanding, of internal data regarding biomarkers.”
MA teams must be able to transmit a complete understanding of the predictive marker and its power
Reaching out externally to those particularly experienced in this area is likewise essential. “Internal data can be discussed under a confidential disclosure agreement (CDA) with expert external stakeholders during scientific exchange, allowing us to pressure test these data sets. Closer collaborations with our heath economics and outcomes research colleagues are also essential”, adds Beveridge.
Even once biomarkers have been identified and agreed upon as a basis for clinical development, the job of MA is far from over. At this stage, their role arguably becomes even more crucial. Attention will then turn towards outlining the relevance and efficacy of the precision medicines to all stakeholders, which is a trickier prospect than with conventional medicines. This task requires all of MA’s well-honed communication skills, and beyond that, deep understanding of the disease and its biomarkers are critical.
“Regulators and HCPs often look for very significant enrichments of positive outcomes using predictive markers/biomarkers, with the marker negative populations having <50% chance of response as the marker population or no chance of response. HTAs and payers can sometimes be satisfied with somewhat less acute differences when using precision medicines”, notes Zaiac. “MA teams must be able to transmit a complete understanding of the predictive marker and its power, assuring all stakeholders that testing and marker guided use of medicines is useful for our patients.”
MA has to become the driving force if pharma is to take full advantage of the huge promise that precision medicine offers to patients. Their deep medical insights should be combined with the expertise of R&D colleagues and external partners, enabling the discovery of workable clinical biomarkers. Demonstrating value of these medicines to the various stakeholders is another challenging task for MA in this area, which requires extensive understanding of the disease and the ability to explain the medicine’s value according to different stakeholder expectations.