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Oct 19, 2020 - Oct 21, 2020, Virtual

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The future of Medical Affairs: A virtual Q&A with Charlotte Kremer

The Astellas head of medical affairs follows up with answers to questions during her virtual keynote earlier this year



Charlotte Kremer, MD, MBA, is the Executive Vice President and Head of Medical Affairs for Astellas Pharma Inc. Dr. Kremer provides leadership for the Medical Affairs organization globally. She is also the Chair of the Board of the Medical Affairs Professionals Society (MAPS), a not-for-profit organization that focuses on enhancing the value Medical Affairs professionals provide to life sciences organizations through capability building, best practice sharing and promoting excellence in Medical Affairs. 
 
Charlotte presented the Medical Affairs keynote speech at this year’s virtual eyeforpharma conference. She also participated in a panel discussion alongside other industry leaders, sharing her views on the strategic value Medical Affairs provides in shaping the future of the biopharmaceuticals sector. This article addresses some of the key questions that were raised by the remote audience during those sessions. 
 
What do you think are the key priorities for Medical Affairs professionals to be ready for the anticipated wave of next generation therapies?
Today, Medical Affairs is set to be one of the most strategically important and valued functions in a pharmaceutical company – a bold statement for a function historically viewed in a support capacity, but one that has been confirmed by leading Medical Affairs experts, including Neil Croft and Matthew McLoughlin, whose research on behalf of Syneos Health paints an empowering picture of how Medical Affairs will continue to shape the industry at large.
 
Medical Affairs professionals need to be ready to understand and meet the needs of an ever-expanding stakeholder group, as the evolving dynamics of the healthcare environment and the next wave of specialty medicines come with new levels of complexity, knowledge gaps and evidence requirements. 
 
For instance, just in the United States, we are seeing a record number of new drug approvals – the Food and Drug Administration (FDA) approved 59 new drugs in 2018, 80% of which took advantage of an expedited pathway, such as Priority Review or Fast Track. This rise is increasingly targeting indications in smaller patient populations, through a deeper understanding of the biology of disease and pathology, with 58% of the drugs approved in 2018 receiving Orphan Drug Designation, almost doubling from 2017. 
 
With smaller patient populations and data available at launch, it will be increasingly important for Medical Affairs to understand the disease area and know our treatments inside and out. Generating post-approval data, especially in the real-world setting, will be vital so that we may understand the therapy and support its safe and appropriate use – a key responsibility for Medical Affairs, now and in the future. 
 
Finally, Market Access and Health Economic Outcomes and Research groups will also play an increasingly important role in identifying opportunities to create value for stakeholders and patients through the integration of insights from payers, Health Technology Assessment bodies, policy makers and patient groups. We, in Medical Affairs, are tasked with bringing key insights to critical teams and committees earlier to ensure that plans and investment decisions throughout the treatment’s lifecycle are robust and evidence-based from the start.
 
How do you intend to approach upskilling your teams to embrace the new realities of Medical Affairs?
 
There are three key focus areas and skillsets that are vital in enabling Medical Affairs realize its potential. 
 
First, medical and scientific understanding. Demonstrating a thorough understanding of the disease area, treatment paradigms and translating the implications of new data is essential to ensuring the safe and appropriate use of our medicines. That means the value of simple activities like journal clubs become hugely important. They allow us to stay informed of wider developments across the clinical landscape. In turn, this broader understanding means that Medical Affairs teams need to foster the skills to rapidly inform new therapeutic strategies and keep treatment guidelines updated. 
 
Secondly, our subject-matter expertise must be grounded in research and supported by clinical trials and statistics. The speed and nature of highly specialized drug development also means that our stakeholders are often hungry for additional real-world data that establish relevance for local health systems or economies. We therefore need to keep up to date with the emerging methods of generating epidemiological, clinical, or health-economic data. A lot of these data are likely to be produced through collaborations with specialists or academia but understanding the technical scope and value of these methods is critical. So, our need to generate and analyze different forms of data through data analytics will inform training and development, and recruitment strategies across Astellas and the wider industry.
 
From a technical perspective, proficient use of stakeholder engagement platforms is key – aggregating and analyzing data to generate insights that inform strategies. To keep up with external trends and industry changes, Medical Affairs must increase its digital capabilities, from gathering insights using Artificial Intelligence, to generating Big Data in the real-world, to identifying new ways of engaging with key stakeholders, such as virtual Advisory Boards, virtual scientific exchange and interactive medical information platforms. We need to prioritize which activities have the biggest impact. No organization has unlimited resources, so our success can also be defined by what we decide not to do. 
 
Finally, we must also demonstrate a thorough business acumen so that we may realize our strategic vision. To deliver value and drive impact, we must cultivate insights to add strategic value to asset planning and commercialization and we must be experts in what matters most to patients so that we can effectively communicate the value of Medical Affairs.
 
To be the proactive, strategic leader, we need all Medical Affairs colleagues to understand the right behaviors and skillsets to ensure all Medical Affairs regions and functions are enthusiastically involved at every level. We need to have the right capabilities and be lifelong learners – training, itself, is a valued skill. As our industry evolves, so should our knowledge base. We must be agile and open to learning new things. 
 
Can you describe the lasting impact of the COVID-19 crisis on Medical Affairs?
 
The impact of COVID-19 has had a profound effect on us all, both personally and professionally. We have all had to adapt to a new way of working, one driven by virtual collaboration platforms and digital technologies. 
 
We have enabled several virtual collaboration platforms to enhance Medical Affairs teams’ ability to maintain interactions with healthcare providers – this has also empowered the virtual presentation of scientific data to ensure we continue to create and deliver value for patients and stakeholders. We have also accelerated the use of virtual Advisory Boards with the onset of COVID-19.
 
As the global pandemic has accelerated many aspects of remote working, access to data and sharing new learnings, digitally, is going to be key. The COVID-19 pandemic has created a ‘new normal’ and I anticipate that virtual engagements, will become routine practice across the industry by 2025. 
 
How will the changes in using real-world data affect clinical trials for Medical Affairs?
 
There is a huge opportunity in real-world data. The deeper value is in seeing how treatments comparatively behave in specific populations during routine clinical practice – a shift from interventional to comparative real-world studies. With accelerated development programs and regulatory approvals based on limited data, there is a huge opportunity for Medical Affairs to partner with internal and external stakeholders and supplement clinical trial evidence with real-world evidence post authorization. 
 
Regulators and Health Technology Assessment bodies are increasingly interested in optimizing the use of real-world data for regulatory decisions, while recognizing the strengths and limitations of real-world evidence. 
 
Our goal should be focused on accessing and interpreting real-world data to continuously learn about the safety and efficacy of our compounds in real life, in different patient subgroups. Informing our external stakeholders about the newest data and insights, clinical development strategies and fill critical evidence gaps, increasing efficiency in how we bring new, value-based treatments to patients. 
 
What are your tips for helping Medical Affairs ‘go beyond the product’ and showcase their qualitative key performance indicators to their internal partners?
 
To be ready as a hub for unlocking the potential of the many data sources available to pharmaceutical companies, we must continue to build our knowledge, experience and capabilities in Medical Affairs to realize the possibilities enabled by insights and advanced analytics to ‘go beyond the product’. 
 
Focusing on delivering qualitative impact by tying multiple performance metrics to our strategy and focus on delivering actual value – not just using metrics to measure key performance indicators. 
 
Finally, we should continue to demonstrate the essential role of Medical Affairs and impact we deliver in contributing to the value of a pharmaceutical company. We can do this through our continued evolution to becoming a more business savvy and agile function, demonstrating a solid grounding in our strategy, articulating a clearly communicated value proposition and being champions of proactive leadership. 
 
It is up to the Medical Affairs professionals to realize this potential and drive value – value for internal stakeholders, external partners, and ultimately, value for patients.
 

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Pharma Awards Europe

Oct 19, 2020 - Oct 21, 2020, Virtual

Join the best in the industry as they celebrate success, innovation and how pharma is creating value for patients and healthcare