It’s no secret that major forces have pushed the pharmaceutical industry to think differently about how it operates and how it can deliver greater value to society. The good news is that we’re seeing more connected, more agile and more outcomes-focused organizations arise from the disruption.

R&D teams have increasingly broken free from traditional scientific silos through increased internal collaboration and external partnerships with biotech and academia. They have embraced transformative science and technological advances and we are starting to see a new generation of medicines forged by our enhanced ability to capture, interpret and apply data.

Our engagement models have also adapted to changing stakeholder needs. More specialty products with more complex data mean that our clinical and access stakeholders are demanding deeper scientific exchanges to understand the patient impact and value to society.

What’s changed in Medical Affairs?

Like many pharma companies, the role of Medical Affairs at Astellas has transformed in recent years, from a support function to a strategic organization to internal and external stakeholders.

Today, Medical Affairs is comprised of the most important and valued capabilities in the business, playing the role of key connector between internal pharma and external stakeholders.

We are driving scientific exchange and evidence generation with an ever-expanding external stakeholder community of healthcare professionals, scientific experts, health authority bodies, payers and patients.

Our role is not just limited to knowing what these stakeholders want and need. We’re fulfilling information needs through data-generation (clinical trials and real-world data analyses), data sharing through publications, medical information and scientific exchange, pinpointing the investments and activities that will drive the biggest impact for each of these groups. The result, ensuring the safety, efficacy, value and real-world utilization of our therapies are fully understood.

As Medical Affairs integrates its wealth of external insights into a consolidated and aligned strategy to guide its own global activities, it also needs to align with Commercial and R&D colleagues. Through governance and operational excellence, Medical Affairs ensures information needs and data are shared across organizations, as and when needed, to enhance the effectiveness and impact of all respective groups.

Leading value creation in the future

As our operating environment has changed, Medical Affairs has become a more business-savvy, scientifically influential, connected and agile function. While we’re making great progress, companies like Astellas know that the disruption won’t stop.

New challenges lie ahead, such as our ability to address wider societal issues and to create value for a variety of stakeholders that is wider than ever before. Another key challenge for us will be the use of artificial intelligence to generate data from combined big data sources, such as clinical health records, real-world data and the variety of ‘omics’ data sets. This information will need to be delivered in an increasingly digitally-savvy way, for example via interactive medical information websites and other digital channels.

We also know that downward pricing pressures are unlikely to go away. We will need to demonstrate how innovations create value to a wider variety of stakeholders than ever before. So, every commercial decision will have greater consequences.

With this mind, I believe that Medical Affairs professionals must continue to build on the range of capabilities that enable them to act as orchestrators of company strategy with R&D and Commercial functions. Central to this is effective leadership. Medical Affairs leaders need to be ready to interact with the C-Suite and inform corporate strategies because it is helping companies to make smarter decisions and focus performance measures on patient-centric outcomes. And that’s value creation that makes a real difference.

8/18/16 10:06:55 AM — Astellas portrait session. Charlotte Kremer © Todd Rosenberg Photography 2016

Charlotte Kremer, M.D.

EVP, Head of Medical Affairs,

Astellas Pharma Inc.