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Building patient partnerships in Medical Affairs: What can established and emerging biopharmaceutical companies learn from each other?
Authors:
- Avishek Pal, Global Medical Director, Cell and Gene Therapy, Novartis Oncology
- Dakota Fisher-Vance, Global Patient Advocacy Associate Director, BioCryst Pharmaceuticals
- Jackie Zimmerman, Patient Advocate and Entrepreneur
- Sarah McSorley, Scientific Director, Patient Partnerships, Envision Pharma Group
Traditionally, medical affairs teams have focused on scientific exchanges, primarily with the healthcare provider community. However, in recent years, medical affairs professionals have opened up to the exploration of opportunities to communicate to a wider nonscientific audience, including patients. It is no longer uncommon for medical affairs professionals to partner with their patient advocacy or engagement colleagues and become champions of patient involvement at different stages of the drug development process. With the value and unique insights that patients can bring from having the lived experience of their own condition recognized, the question now is, how can biopharmaceutical companies best partner with patients to ensure valued, ethical, and mutually beneficial interactions?
In 2022, the Medical Affairs Professional Society published its vision for the future of medical affairs in 2030.1 Some of the major changes proposed were that medical affairs should be at the center of societal issues such as access, health equity and outcomes, and patient centricity, and own the scientific aspects of patient engagement.1 Although significant progress has been made in recent years through patient advocacy and engagement teams, there is still much work to be done to identify opportunities to incorporate patient voices and ensure robust compliance of these interactions within medical affairs. Companies are acknowledging this gap and are beginning to develop medical affairs patient-centricity frameworks.2-4 Such frameworks should be sure to include effective partnerships between medical affairs and patient advocacy and engagement colleagues, to drive crucial change forward.
Successful partnerships involve understanding and implementing pragmatic and enabling practices for building effective and meaningful patient engagement strategies according to the size of their organization and the availability of resources. As a scientific writer working in patient engagement within medical affairs, I have witnessed this change in approach. This is why I was so excited to be able to have the opportunity to speak to Avishek and Dakota, to distinguish the key differences between, and opportunities for, established and emerging pharmaceutical companies, alongside Jackie, to understand the patient perspective and her experience working with organizations of differing sizes and structures.
In this article, we explore key questions on how medical affairs teams are expanding their work in patient engagement as well as how this is managed across different-sized companies who have variations in focus, resources, and scale.
Q: In your experience, what role do medical affairs and patient advocacy teams play in establishing meaningful patient engagement?
Avishek Pal:
The role of medical affairs and patient engagement and advocacy teams in biopharmaceutical companies can be defined by several factors, including the lifecycle of the product, therapy area (eg, chronic or rare conditions), organizational structures defining roles and responsibilities, and the objective, purpose, and type of patient engagement of common interest. The medical affairs and patient engagement/advocacy roles are to be viewed as champions and enablers who bring patient voices into the organization, identifying needs and opportunities for partnership throughout the drug development stages and beyond. At Novartis, the i4i Insights Discovery™ insight management platform was created in 2020 and implemented across the company in 2021-2022, to better understand the reality and lived experiences of people living with multiple conditions.5 Such platforms allow cross-functional teams to incorporate the patient voice into their strategies, therefore better addressing the needs of all stakeholders.
Patient engagement requires a level of openness, leadership support, and appreciation of value to be truly successful. Typically, more resources and a higher budget can be allocated with an increasing size of company, with dedicated patient engagement/advocacy and medical affairs teams for specific therapy areas or products and/or regions. In many larger companies, there is an increasing trend to include patients in almost all stages of drug development; some examples, although not an exhaustive list, are illustrated in the figure below.
For larger companies, there is often a risk of working in silos or projects becoming delayed due to ambiguity in processes and in the absence of predefined roles and responsibilities across line functions. To overcome this, patient advocacy and engagement colleagues, as the experts in the field, can play a crucial role in partnering with medical affairs to guide them through processes and best practices, including setting a clear purpose from the start. The win-win situation would be when medical affairs teams bring in their strategic views and program needs and this is complemented by patient advocacy and engagement colleagues with their patient partnership principles, best practices, and past learnings. It is also important to approach patient partnerships with an ongoing holistic mindset, rather than an as-and-when-needed ad hoc outreach. The former helps create common interests and visions, which can help in establishing effective ways of working.
Dakota Fisher-Vance:
The level of interest of medical affairs teams in patient engagement at emerging companies may vary, depending on the therapy area and the company’s level of experience. Many new or small companies lack the resources to hire for a dedicated role and thus may need to rely on colleagues with limited experience or bandwidth for engaging with patient communities. When there is a patient advocacy team, it is often small and may not have the capacity to cover all regions and country-specific organizations. This is a gap where medical affairs can step in and support at a country level, especially in regions where there is a more paternalistic healthcare model and/or regulations favor patient-oriented support originating from medical affairs.
Additionally, it is not uncommon for patient advocacy teams to be formed in reaction to an urgent need. In these cases, companies may not have the appropriate processes in place to involve patients, necessitating more of a focused collaboration with medical affairs teams to develop internal policies and other foundational work that set the stage for meaningful patient engagement.
However, a company being smaller also means it’s easier to get to know more of the company, including who to approach for specific requests; this can foster opportunities for more agility and leadership buy-in. These close relationships allow teams to quickly provide feedback from useful insights gleaned from patient engagements such as conferences and advisory boards, which can inform projects and strategic direction.
Q: When working with patients and patient organizations, there needs to be a focus on supporting mutual interests to ensure projects are reflective of a true partnership and meet the community’s needs. How do you personalize your approach to patient engagement?
Avishek Pal:
In large organizations, effective patient engagement requires a framework and systematic internal cross-functional partnerships to allow insights to be collected and used effectively. Projects should have the approach of always starting with the end in mind: setting objectives and defining success for all stakeholders allows for an internal consensus to be reached and contributes to a sense of achievement. Projects can be personalized by working with patient organizations to predefine needs and objectives, and establishing the roles and responsibilities of all stakeholders. Once projects are complete, medical affairs teams should ensure that they close the feedback loop to continue to build sustainable partnerships. This is achieved through continuous connection and exchange, keeping patients or patient organizations informed and seeking their feedback on interactions. Patients should be included throughout the process and not just for sporadic consultations, with a clear understanding of where the ideas can be incorporated and where they cannot, and why. It is also important to keep the communication transparent and continuous, to ensure common understanding, clarification of concerns, and rationales for decisions being made.
An example of such collaboration that comes to mind was established by medical affairs and patient engagement/advocacy colleagues working on an in-market treatment option for diabetes. The teams set out a long-term patient partnership plan by involving them through various tactics, from the Phase 4 study design stage through to congress presentation and journal publication. The patient community was organically engaged in the uptake and dissemination of the findings, and eventually those were incorporated rapidly as a recommendation in an imminent version of a clinical practice guideline. This had a wide implication for the patient community living with diabetes.
Dakota Fisher-Vance:
Listening is a core tenet of patient engagement, regardless of company size. The starting point is hearing from the patient organizations and then identifying strategic areas of overlap, which varies between programs and organizations. Smaller companies often have a lower budget available for patient engagement projects; therefore, teams require a robust triaging approach to understand patient needs and where the company is best aligned and able to support each community. Companies should be creative with the type of support they provide beyond financial support, volunteering time and skills (such as creative design and translation) to continue to develop relationships and support patient organizations’ needs. Likewise, they can share learnings back with the community, such as through patient and healthcare provider advisory board reports and involve patient authors in their publication plans.
Emerging companies may prioritize developing relationships with smaller, grassroots patient organizations rather than large patient organizations, where they can get lost in a sea of bigger corporate supporters. This allows the company to gather a deeper understanding of the patient organization’s specific needs and to work together more intimately.
Q: How do you measure success and demonstrate the value of patient engagement?
Avishek Pal:
For both established and emerging biopharmaceutical companies, determining the best methods for demonstrating the value of patient engagement is a work in progress. Regardless of function or company size, many companies often look for success in numerical metrics. This is understandable, as it is perhaps easy to gather and to demonstrate the impact within the organization; however, this needs to evolve into a value-driven approach.
Although metrics traditionally have a place in building confidence among senior leadership in order for them to continue to be supportive, in many cases the value of patient engagement can be more intuitive than being solely based on numbers. Additionally, patient partnership activities and engagements cannot and should not be motivated by sales or actual returns on investments. This further complicates the ability to tangibly showcase the value proposition of patient partnerships which, by the budget numbers alone, might be perceived as a high investment-questionable return scenario. Consequently, a mindset shift on value and opportunities is required. The understanding that initial projects might end up being fact-finding projects that will eventually lead to well-designed and high-impact projects is crucial for long-term success. This will help in building trust and relationships, both internally as well as with patient organizations. Monitoring, tracking, and learning from both challenges and achievements can shape future projects more effectively for success. Developing patient-centric frameworks to capture and harness insights should be a priority, to avoid an insular approach.
Dakota Fisher-Vance:
For emerging companies who lack the resources to develop platforms like i4i, creativity is key. Given the relative newness of patient advocacy and engagement roles within the biopharmaceutical industry as a whole and the anecdotal nature of patient engagement insights, teams must be clear and socialize what potential actions could be derived from these learnings. For example, it may be widely known that patients dislike a test required by all trials in the disease state, but a patient advocacy board reveals that patients do not understand why the test is required. Trial recruitment materials can educate on this and potentially improve recruitment, patient advocacy needs to highlight this connection, and track outcomes when the insight is actioned.
It is tempting to tally up numbers to demonstrate value but this can be time consuming for a small team and often doesn’t generate meaningful data for the company or patients. Instead, focus on documenting “wins” wherever they occur, such as meaningful quotes from patients and advocacy groups, instances where knowledge of patient community dynamics has saved the company money or reputational damage, and increased internal demand for patient involvement. This approach can help in speaking the numerical language of leadership while supporting the broader value story.
Q: What is the patient perspective?
Jackie Zimmerman:
The best partnerships between patients and biopharmaceutical companies happen when the partnership itself is attached to real business outcomes for the company, and has clearly defined goals, deliverables, and expectations for the patients.
In my experience, early-stage biopharmaceutical companies tend to be more eager to work directly with patients than some of the more established companies. They see the value in consulting patients about their lived experiences and are more likely to do it for the real value in listening to and learning from patients. However, many early-stage companies are still not paying patients what they deserve, if anything at all. Without adequate payment, companies like this may employ new and inexperienced patients for their projects, limiting the efficacy of their partnership.
Established biopharmaceutical companies are arguably the opposite of early-stage companies, in that they are less likely to hire patients for projects that create a real impact, but they are more likely to pay them for this work. Compensating patients for their experience is still a relatively new concept, but larger companies can typically provide an honorarium or stipend for these partnerships. With appropriate payment, seasoned patient advocates are more likely to work with these companies but would rather be working with companies that showed an earnest interest in their perspectives.
In shifting to seeing patients as actual qualified partners, there is an opportunity for biopharmaceutical companies to speak directly to their core client base and to learn what their communities want and need. Any part of the business that interacts with patients needs to consult with patient advocates in order to ensure that that process is running efficiently to achieve the desired outcomes and their key performance indicators. Starting at the beginning in research and development, patients need to be consulted on clinical trial design to find out how to appeal to potential participants, to encourage participation and recruitment goals, and to have better long-term trial outcomes. By asking patients to review the touch points they encounter, companies can understand their lived experience. They get to see what happens once a medication goes to trial or market, what it’s like for a patient to get access to it, or which barriers contribute to lack of access.
In conclusion, irrespective of company size, the optimal way to meaningfully involve patients is through open collaboration, communication, and sharing of best practices. This is a lesson that can be applied to all medical affairs professionals throughout their careers. As we continue to evolve this field, new ways to harness and track insights should be considered to ensure valuable outcomes for all stakeholders.
References
- MAPS Visionary Working Group; MAPS Executive Consortium. The future of medical affairs 2030. Medical Affairs Professional Society; 2022. https://medicalaffairs.org/wp-content/uploads/2022/06/MAPS-Future-of-MA-2030-1.pdf.
- Ashkenazy R. Building the case for developing a medical affairs patient-centric framework collaboratively. Drug Discov Today. 2020;25(3):475–479. https://doi.org/10.1016/j.drudis.2019.11.011.
- Amin D, Vandenbroucke P. Advancing patient-centricity in Medical Affairs: a survey of patients and patient organizations. Drug Discov Today. 2023;28(7):103604. https://doi.org/10.1016/j.drudis.2023.103604.
- Willgoss T, Escontrias OA, Scrafton C, et al. Co-creation of the Global Patient Experience Data Navigator: a multi-stakeholder initiative to ensure the patient voice is represented in health decision-making. Res Involv Engagem. 2023;9(1):92. https://doi.org/10.1186/s40900-023-00503-9.
- Knowles SKZ, Klein B. How Novartis deploys a new model of creativity to understand patients better. Int J Pharm Healthcare Marketing. 2023;17(3):311–326. https://doi.org/10.1108/IJPHM-11-2022-0100.
