Insights from the Medical Affairs Professional Society EMEA 2019 Conference

The Evolving Role of Medical Affairs

BY Matt Booth, Senior Director, Scientific Services and Nichola Gokool, Director, Customer Strategy, Parexel - 10.23.19

The role of Medical Affairs professionals is evolving at a rapid rate.  In addition to providing scientific support, Medical Affairs now has much greater strategic importance by providing in-depth understanding of the disease area, healthcare systems and most importantly, the needs of internal and external stakeholders. 

How are the responsibilities of Medical Affairs expanding?

In today's biopharmaceutical organization, Medical Affairs bridges the gap between internal stakeholders including regulatory, clinical, commercial and market access teams.

To provide effective insights, Medical Affairs should be engaged early in the drug development process including the development of the target product profile (TPP) and defining strategic imperatives for a drug or medical device.  Medical Affairs should function as the strategic lead for launch readiness and medical launch excellence planning.  We recommend that Medical Affairs remain involved with a new drug for two to three years post-launch.  After this post-launch period, they should re-focus their expertise on the pipeline compounds (assuming no additional indications are on the horizon). 

External engagement and communications should include interactions with five important stakeholder groups: physicians, payers, patients, the public and policy makers.  Medical Affairs provide an integral role in listening to and representing the voice of the patient, ensuring patient unmet needs are considered at every stage of the drug development journey.

With increasing scrutiny from payers and greater demand for Real-World Evidence (RWE) to understand how a product performs in a real-life clinical setting, Medical Affairs professionals play a central role in defining and seeking the evidence required to support these market demands.  This can best be achieved by ensuring that RWE is considered as an integrated component of the overall evidence generation strategy, with the RWE plan developed in parallel, and complementary to, the clinical and regulatory development plan. 

Who is the Medical Affairs Professional of today and tomorrow?  

To be successful in the evolving Medical Affairs role, individuals need to expand their skillset beyond medical expertise to demonstrate business and leadership capabilities.  Executive Leadership Teams within biopharmaceutical companies should recognize Medical Affairs as a strategic, leadership function providing them with appropriate training opportunities and granting them greater decision-making authority. 

What is the future vision for Medical Affairs? 

A digital ecosystem, including technology platforms, artificial intelligence, advanced data analytics and cloud-based solutions will drive improved healthcare solutions for patients.  Medical Affairs should lead effective use of these digital solutions in their organizations.  For example, data generation, diagnostics, health monitoring and patient education are all areas where leveraging technological innovation can make an impact. 

An aspirational goal for Medical Affairs and healthcare in general would be the creation of a unifying, user-focused, health care platform for use by any patient with any illness, receiving any treatment or using any medical device.  Such a platform would need multi-pharma buy-in and long-term support.  Platforms geared towards this have included Google Health and Microsoft HealthVault, both of which focused on centralizing a patient’s health records.  Unfortunately, Google Health closed in 2012 and Microsoft’s HealthVault will close on 20 November 2019. 

Regulatory and privacy issues seem to have contributed to the lack of success.  The success of any future platform will rely not only on incorporation of patient records but also the various treatment monitoring dashboards that are currently siloed on various independent pharma websites and apps.  Medical Affairs leads, as well as patients, are key to the success of any future unifying platform. 

According to The Medical Futurist, Dr. Bertalan Mesko, ‘patients of the future will be empowered, educated and electronically savvy.'  Therefore, patient engagement is paramount to the success of future biopharmaceutical strategic decision making.  Dr. Mesko recommends that Patient consultants are involved at the highest levels of strategic decision making within every biopharmaceutical organization. 

How can Parexel support your Medical Affairs Team?

At Parexel, we understand the valuable role of Medical Affairs and have developed a dedicated suite of solutions designed to support the Medical Affairs teams of the future. Contact Matt Booth (matt.boooth@parexel.com) or Nichola Gokool (nichola.gokool@parexel.com) for further information. 
 


We are always available for a conversation.

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