Introduction
In the ever-evolving landscape of the pharmaceutical and medical device industries, ensuring promotional materials’ scientific accuracy, balance, use of appropriate supporting data, and regulatory compliance is crucial. However, medical affairs departments often face significant challenges in managing these processes efficiently. This brief highlights the key issues and provides actionable insights to help industry professionals enhance their Medical, Legal, Regulatory (MLR) processes.
“Assigning resources that have broad medical review experience, expertise, and awareness of current guidelines and their interpretations are critical to efficient reviews.”
Current Trends and Challenges
A recent survey conducted among 556 pharmaceutical and medical device companies in the US reveals several important insights into MLR processes:
• Role Allocation: 44% of respondents report that medical directors handle promotional reviews, 23% rely on medical information teams, and only 15% have a dedicated medical promotional review role.
• Time Commitment: Approximately one-third of non-dedicated reviewers spend 25% or more of their workweek on material review, translating to 10-15 hours or more. This time commitment can limit their ability to focus on other key priorities within their broader medical affairs role.
• Training Gaps: Nearly 40% of respondents indicated they had not received formal training for their medical promotional review role.
• Resource Constraints: 69% of respondents reported that existing resources are stretched to cover the increased needs of the commercial team during a product launch, resulting in stretched teams and delayed review processes.
These findings highlight significant resource constraints and inefficiencies within current MLR processes. The lack of formal training, resource capacity, and back-up support, especially during product launches, further exacerbates these challenges.
A recently published article in Regulatory Focus explores these trends and emphasizes the evolving role of medical directors in promotional review. Regardless of the function within medical affairs the medical review role is assigned, this work often distracts from strategic priorities, leading to rushed reviews and increasing the risk of non-compliance. The article also underscores the importance of training in FDA regulations and negotiation skills to ensure accuracy and adherence to regulatory requirements.
Expert Insights from Panel Discussion
To discuss these challenges and the implications of these data, Dr. Jimmie Overton, Canopy’s Head of Global Medical Content Strategy participated participated in a webinar recently arranged by Impatient Health. Dr. Overton was joined by industry experts from Novartis, AbbVie, and the UC-Irvine School of Pharmaceutical Science for an informative and illuminating discussion. Here are some of the key takeaways and prescriptive advice that emerged from the session:
Efficient Resource Management
• Task Allocation: Prioritizing tasks and assigning the right resources are essential to maximize efficiency and impact. Ensuring that high-value resources like the Medical Directors focus on strategic decisions rather than routine reviews can significantly improve process efficiency. Assigning resources that have broad medical review experience, expertise, and awareness of current guidelines and their interpretations are critical to efficient reviews.
• Launch Planning: Proper capacity planning and resource allocation during product launches are crucial to manage increased workloads and prevent bottlenecks.
Investment in Training
• Continuous Education: Implementing ongoing training programs on FDA regulations, communication skills, and negotiation techniques is vital. Continuous education ensures that teams stay updated with the latest regulatory requirements and industry best practices.
• Skill Development: Emphasizing both technical and soft skills is crucial for effective MLR processes. Training should include not only regulatory knowledge but also negotiation and communication skills to navigate complex review processes.
Early Collaboration
• Cross-Functional Teams: Engaging MLR teams early in the content creation process prevents last-minute issues and fosters alignment. Early collaboration ensures that all stakeholders are on the same page and can contribute to a seamless review process.
• Strategic Partnerships: Strengthen relationships between regulatory, commercial, and MLR teams to drive efficiency and compliance. Building strong partnerships across departments is key to achieving compliance and strategic goals.
Leveraging Technology
• AI Integration: Utilizing AI and other technologies for content prescreening has the potential to help boost productivity. Companies continue to invest in developing a viable commercial solution to handle routine tasks, allowing human reviewers to focus on more complex issues. However, human oversight is essential to maintain accuracy and compliance.
• Claims Library: Creating and maintaining an approved claims library supports efficient content creation and simplifies the review process. A well-organized library ensures that all claims are accurate, compliant, and readily accessible, significantly reducing review timelines and improving overall efficiency.
Adapting to Change
• Flexibility: Remaining agile and informed on both evolving regulatory and market demands is crucial. Companies must continuously evaluate and improve their processes to stay ahead of industry changes.
• Process Improvement: Regularly updating and refining MLR processes ensures that they remain efficient and compliant. Continuous improvement helps companies adapt to new regulations and industry trends.
Conclusion
Optimizing MLR processes is essential to ensuring the compliance and effectiveness of promotional materials in the pharmaceutical and medical device industries. By addressing gaps in resource allocation, training, early collaboration, and the potential for future integration of technology, companies can enhance their MLR workflows while remaining focused on strategic objectives.
Industry professionals are encouraged to adopt these insights and strategies to strengthen their MLR processes. For organizations lacking in-house expertise or requiring additional support, partnering with experienced vendors like Canopy Life Sciences offers access to specialized resources and expertise. This ensures compliance and maximizes the efficiency of internal teams. To learn more about Canopy’s Medical Review Solutions, visit our web site, www.hellocanopy.com.
“Remaining agile and informed on both evolving regulatory and market demands is crucial.”
Dr. Jimmie Overton PharmD
Head of Global Medical Content Strategy
With over 25 years of experience in the healthcare industry, Dr. Jimmie Overton is a recognized medical affairs subject matter expert. He has experience and proven results across all facets of the function holding key leadership roles in:
- US and International Medical Promotional Review
- Global Medical Information
- Global Operations and Training
- Medical Excellence/Field Scientific Communications
- MSL Leadership
- Medical Education (CME)
- Medical Director
He served as the Vice President of Global Medical Information and Medical Promotional review at Allergan and as the Vice President of Global Medical Information for AbbVie. Prior to joining Canopy, he was a co-founder of Govise, Inc., the premier partner for medical review services. Dr. Overton is a registered pharmacist and holds a Doctor of Pharmacy degree from the University of Kentucky.
Dr. Janet Gottlieb
Head of Medical Review Solutions
Dr. Janet Gottlieb’s experience in research, diagnostics, medical devices, and pharmaceuticals in a career spanning over two decades provides critical insight into medical review. Prior to joining Canopy, she was a co-founder of Govise, Inc., the premier partner for medical review services.
She is adept in the formation, expansion, and training of the medical review function, and has experience in helping organizations improve their review process, resulting in greater consistency and efficiencies in workflows.
Dr. Gottlieb holds an undergraduate degree in Biological Sciences and Ph.D. in Medical Microbiology and Molecular Virology from the University of California, Irvine.
Canopy Life Sciences Expertise
At Canopy Life Sciences, we combine unmatched expertise gained from our years of experience supporting diverse clients to deliver best practices that are difficult to replicate in-house. Our team provides flexible, scalable solutions to adapt to fluctuating workloads, allowing your staff to focus on their core competencies while ensuring compliance and quality.
At Canopy Life Sciences, we provide:
• Specialized Expertise: Our experienced Medical Review team provides specialized insights and evaluations that ensure compliance and effective risk management. With a deep understanding of regulatory requirements, industry best practices, and the complexities of medical and promotional materials, we offer a level of expertise that can be difficult to cultivate in-house.
• Flexible and Scalable Services: Adaptable solutions to meet fluctuating workloads, allowing your team to focus on strategic objectives.
• Fee-for-Service Model: Agility and expertise without long-term commitments or resource strain.
• High-Quality Outcomes: Faster turnarounds and seamless integration with your team to achieve impactful results.
Partner with us to ensure your promotional materials remain compliant and effective, positioning your organization for long-term success.
