Revolutionizing Pharma: Navigating the Digital Wave in MLR Review
02 Oct 2023
The pharmaceutical industry has been experiencing an era of unparalleled innovation, particularly in the aftermath of the COVID-19 pandemic. Breakthroughs in rare and orphan diseases, novel mechanisms of action like gene therapy, and a surge in digital technology adoption have collectively propelled the industry to new heights. This digital transformation has led to a substantial increase in the volume of content and has fundamentally altered the way messages are disseminated. However, it's crucial to navigate this digital landscape while adhering to stringent compliance regulations.
At the Indegene Digital Summit, Vincenzo Bartoli (AstraZeneca), Jaime Blais (Janssen), and Moulakshi Roychowdhury (Allergan Aesthetics – AbbVie) discussed about incremental and disruptive ways to elevate the Medical Legal Regulatory (MLR) review process in response to digital advancements. The aim was to explore how this process can be enhanced to drive change and perhaps even proactively anticipate evolving needs; and the role of technology in revolutionizing content review and approval.
Here are some of the insights they shared:
A Customer-Centric Approach to Content Creation
One of the driving forces behind the digital transformation in pharma is the ability to personalize content for various stakeholders, including healthcare professionals (HCPs), patients, and caregivers. With the advent of digital technologies, such as modular content and omnichannel strategies, the possibilities for personalization have expanded dramatically.
Vincenzo emphasized the importance of a customer-centric approach, and the need to deliver content that is not only compliant but also relevant and valuable to healthcare professionals. This approach represents a significant shift from traditional content creation, towards "bite-sized" content, akin to Lego blocks that can be assembled in different ways to deliver personalized experiences to physicians. It places the customer at the center of content development, ensuring that it serves a meaningful purpose in clinical decision-making.
The North Star of MLR is that we cannot forget about the patient because at the end, the patient is the reason why we are delivering new medicine and science to our customers and healthcare professionals.
– Vincenzo Bartoli
Collaboration between the Commercial, Medical and Regulatory teams
Jaime shed light on the expanding role of Medical Affairs in the digital age. As the volume of data grows, it is Medical Affairs' responsibility to provide healthcare professionals with unbiased scientific knowledge and real-world evidence to support their clinical decisions.
There's a much greater dependence on more innovative evidence generation right now, advanced analytics, optimized clinical trials, collaborative research, and implementation research.
– Jaime Blais
Medical Affairs teams must proactively collaborate with the business to ensure that content is scientifically robust and well-positioned for success throughout the MLR review process. This collaboration is vital to ensure that the right information reaches HCPs at the right time, enhancing their ability to make informed decisions.
Likewise, Moulakshi discussed the challenge of maintaining compliance in the face of personalized content. How can businesses ensure that all these modular, personalized pieces fit together seamlessly while still adhering to regulatory parameters?
Early collaboration between marketing and regulatory teams is crucial for understanding how different content pieces can come together to form a compliant and cohesive message. By working together from the outset, businesses can avoid wasting time, money, and agency resources on content that may need substantial revisions later in the process.
I truly believe that if we're doing the right thing for the patient, there is usually a compliant way forward.
– Moulakshi Roychowdhury
The panel also discussed the importance of proactively educating health authorities about industry innovations. Health authorities, while conducting valuable research, often face resource constraints. Pharma companies have an opportunity to share their insights and data to help inform and guide the creation of practical and relevant guidelines.
Adapting to newer formats of digital content
The panelists also discussed the challenges posed by the diverse formats of digital content. The different content formats are intimately tied to the channels in which they are delivered. In a world where patients and HCPs access information through diverse digital channels, including social media and video platforms like TikTok, reviewers must adapt. Medical and Regulatory reviewers must engage with digital platforms, learn their functionalities, and collaborate with marketing teams to understand how content can be effectively disseminated while ensuring scientific accuracy and compliance with regulations.
What we realize is that we're no longer reviewing pieces or promotion that is on flat PDFs. What we're reviewing is dynamic material, and we have to view it the way our audience members are going to view it.
– Moulakshi Roychowdhury
The Crucial Role of Agility
One recurring theme throughout the discussion was the importance of timing. In the digital age, HCPs and patients need access to the most up-to-date and relevant information to make informed decisions. The timing of content delivery should align with the dynamic nature of digital platforms and the needs of the audience. Content must be created, reviewed, approved and delivered when it is most relevant and impactful.
The panel also touched on alternative approaches to content creation, particularly the concept of agile pods, that consist of cross-functional teams, including reviewers, agencies, and marketers, working together to create and review content iteratively. Rather than following a linear process, agile content creation allows for more flexibility and efficiency.
The timely manner in which we can really deliver relevant content can make a difference for the physician and for the patient who then can benefit from the treatment
– Vincenzo Bartoli
The Promise of AI and Automation
The potential applications of AI and automation in content review and approval are vast. AI can assist reviewers in analyzing large datasets, fact-checking claims, and even generating content. However, there is a need to understand and manage the data that AI relies on. Also, human decision-making remains a crucial part of the process. The combination of human expertise and AI capabilities holds the promise of faster and more efficient content review.
I actually think AI Is probably going to have the biggest impact on the development and review of these promotional materials that we will probably have seen in the last 20 years.
– Jaime Blais
Alignment between Global and Local Content Strategies
The panel also touched upon the challenges of adapting global content for local markets. Each affiliate may have different patient needs and regulatory environments. Finding a balance between global consistency and local adaptability is an ongoing challenge, but it's one that requires continuous learning and flexibility.
Having a global strategy and a global messaging map and ensuring that there's sort of worldwide alignment around you know the clinical benefits that are coming from our clinical studies and our real-world evidence is critical
– Jaime Blais
As digital innovations continue to shape the industry, it is imperative that all stakeholders collaborate and adapt to ensure that patients and healthcare professionals receive accurate and timely information, ultimately leading to improved healthcare decisions. Personalization, compliance, agile content creation, AI, collaboration across functions and with health authorities, as well as global-to-local strategies are all vital components of this transformation. The journey toward a more customer-centric, digitally adept, and agile pharmaceutical industry has begun, and it's one that promises to save lives and enhance patient outcomes in the digital age.