Medical Affairs is rapidly becoming the “third strategic pillar” of pharma organizations, alongside R&D and commercial, write Matthias Evers and fellow authors at McKinsey.
To meet its potential, Medical Affairs (MA) needs tools that allow teams to organize and analyze data quickly. These tools must also help MA teams contextualize data from various sources and communicate relevant insights to appropriate audiences.
The future envisioned by Evers et al. promises to place Medical Affairs at the center of vital conversations; however, bringing that future into the present poses challenges. If your MA team regularly faces the following pain points, your essential next step may be data integration.
Are Your Product Launch Efforts Scattered and Inefficient?
Medical Affairs teams face several challenges during a product launch. One widespread risk is missing product launch goals — a risk that can be exacerbated by a lack of data integration or data agility. Budget overruns and compliance risk are also common risks, and both can worsen when material data is not easily accessible.
With data integration, one hurdle to launch goals is a lack of clarity about who is in charge of data integration and related tools. Is data integration the responsibility of Medical Affairs, Commercial, a specially-tasked team, or a collaborative workgroup?
Putnam’s Lori Klein, Elaine Nguyen, and Sneha Dutta recommend fostering cross-functional partnerships from the outset. Building these relationships improves efforts to bring data integration to life and helps Medical Affairs teams meet product launch goals by fostering relationships between MA and other teams — allowing every interested party to spot potential hurdles during the product launch process and address them before they become roadblocks.
Early access to integrated data in the product launch process is crucial, note Arron Mungul and fellow presenters in a 2023 MAPS webinar. They stress that “product launches do not share the same starting point,” making it essential to understand key issues unique to each product launch:
- How is the level of unmet need in the market defined? For instance, how many patients don’t reach therapeutic targets on existing treatments? How difficult is it to treat patients who don’t respond to standard of care therapies? What is the burden, inconvenience, or cost to patients to access the standard of care treatment?
- How is the launching product differentiated from available therapies? Does it provide more clinical improvement, expand the treatable population, and/or lower the burden of access for patients or prescribers?
Without data integration, teams may struggle to answer these questions — or even risk attempting a product launch without clear answers.
Collaboration on data integration can also solve big data’s attention problem. As the amount of data increases, our individual human ability to focus on any one part of the whole decreases.
“The age of information overload that was ushered in with the dawn of the internet has drained our attention economy and has conditioned us to be less receptive to new information, including the customers we need to reach with both commercial and medical information,” write Stacy Hartung and Suma Ramadas in a 2023 article in Pharmaceutical Executive.
By improving data integration, Medical Affairs, clinical trial teams, and others involved in the product launch process can focus their attention, streamline their efforts, and limit the information demanding their attention to the items that are relevant in the moment. Data integration can thus focus product launch efforts, improving efficiency and ensuring that products meet their launch goals.
Are Regulatory Concerns Ending Your Projects Before They Begin?
Meeting regulatory expectations has advantages beyond compliance. “As a linking function within a company and with its external stakeholders, MA can provide proactive input in policy generation and enable effective governance by adherence to standards of accountability, ethics, and compliance, as well as transparency,” write Daniel Furtner and fellow authors in a 2023 opinion piece in Pharmaceutical Medicine.
Once a Medical Affairs team has systems and processes to ensure regulatory compliance, adding new digital platforms or tools risk disrupting that system. Each new tool needs to be examined within the context of existing compliance systems and processes, otherwise the whole thing can feel too complex — especially when the current system already works.
Regulatory concerns are real and removing data silos raises challenges like confidentiality. Some data, like patient’s identifiable health information, simply cannot be shared across an organization, write Hartung and Ramadas. Medical Affairs teams must stay current on regulations and policies regarding data privacy and merge these practices into data integration methods — or use digital tools that integrate regulatory compliance tools automatically.
Regulatory issues can also arise when integration causes interoperability problems, writes Donal Tobin, CEO at Integrate.io. When two systems cannot read data generated in the other system, they lack interoperability and cannot share information effectively.
Addressing interoperability can make data integration complex and costly, and it can also come with regulatory hurdles. “Questions about access, processing, treatment and storage of personal data” arise, many of which are covered by various regulations or laws in varying countries, write António Castanheira, Hugo Peixoto, and José Machado in a conference paper on addressing healthcare interoperability and regulatory compliance.
Challenges in managing regulatory concerns peak with new technologies for which little to no regulatory guidance currently exists. For example, in a 2023 article in the Journal of Pharmacy and Practice, Karen Ka Yan Ng and Peter Chengming Zhang describe the use of machine learning to analyze pharmaceutical data and provide MA-specific insights. Where regulation has not caught up to the uses of technologies like machine learning, however, data integration projects that use these technologies may stall.
Does Your Team Keep Missing Key Patterns in the Data?
Healthcare generates vast quantities of data. More than 2 zettabytes (2 trillion gigabytes) of healthcare data existed by the end of 2022, according to an estimate by McKinsey’s Jeffrey Algazy and fellow authors in an October 2023 article.
Yet most of that data — up to 80 percent by some estimates — remains unstructured, writes Kaveh Safavi, Senior Managing Director, Consulting Global Health at Accenture. Data integration provides opportunities for Medical Affairs teams to identify key patterns and insights in data in a timely manner.
“This explosion in data provides a unique opportunity for better medical affairs decision making. Specifically, it is now possible to close the loop by measuring deviations from optimal care in claims data, reorienting strategies, and quantifying the impact of medical affairs activities to reduce suboptimal care,” write Algazy et al.
Handling larger-than-ever volumes of data is only the first step in data integration for Medical Affairs. The second step is to leverage that data effectively to guide decision-making.
A Deloitte study of pharmaceutical product launches found that “inadequate or incomplete understanding of market and consumer needs” imperiled launches in more than 30 percent of small and midsize drug companies and over 55 percent of large companies, write Jeff Ford and fellow Deloitte researchers. Ford et al. urge Medical Affairs teams to invest more heavily in data integration to avoid missing key information about markets and consumers that can undermine a product launch.
Missed information, regulatory concerns, and imperiled product launches can all result from lack of data integration and the symptoms it produces: poor communication, foregone insights, and cumbersome processes. When these symptoms arise, attention to improved data integration with tools designed to communicate with one another may be the answer.
Images used under license by Shutterstock.com.
Authored by Reed McLaughlin, Senior Vice President, Customer Management
Reed McLaughlin has spent the last 14 years developing an unparalleled rapport with clients and customers to create environments of success. As Senior Vice President of Sales, Mr. McLaughlin has been able to continually grow the business and improve Anju’s outreach and strengths. A leader in Sales and Customer Service, Reed has helped elevate Anju toward a brighter future.