To begin, let us start with the simple but often overlooked fact that without the patient, the Pharmaceutical and Biotech World would not exist. Yet the importance of working with patients (and their caregivers and advocacy groups) has only come into focus for most in this industry, over the last decade.
For Medical Science Liaisons and others active in Medical Affairs, interactions with these constituents vary widely from company to company. Robert Grobel, (Vice President of Global Medical Strategy at Monocl), states,
“Medical affairs leaders are looking to build long-term, sustainable relationships with external scientific experts earlier in the product lifecycle. There is a greater focus on improving patient outcomes, addressing experts’ needs, and delivering timely science-based evidence.”1
How can this be compliantly accomplished and still give the patient a voice? Let us take a hypothetical look at some key questions to ask and answer to help frame the opportunity.
Why engage these key stakeholders?
By engaging the individuals afflicted with the condition under study, carefully derived insights can provide a cornucopia of ideas as to how to best address them during cross-functional strategy meetings.
Essentially, by including patients, patient advocates, and caregivers through an array of engagement activities, extremely valuable insights can be attained. Building engagement plans that include insights from these invaluable stakeholders may very well highlight unmet needs that may otherwise not be identified and are gleaned from the very populations we are trying to serve. These real-world concerns can then be used to support the development of the most effective clinical development programs.
Companies often learn valuable insights from patients after a product is already on the market. Imagine learning these insights during clinical development and incorporating them all along the product lifecycle.
Who drives engagement?
Understandably, Patient Advocacy is the first line for patient interaction, and utilizing these interactions is the primary step to engage patients. However, there are many different approaches to engage patients, patient organizations, and caregivers.
For instance, one approach might be to ask your physicians and Health Care Providers (HCP) as part of your KOL discussions, if they have an interest in speaking at Patient meetings. If so, as liaisons you can connect the head of the patient organization or the meeting organizer with the expert physician or HCP who treats the disorder to enable attendance at their meeting as a guest speaker.
What are some types of engagement?
Patient meetings are one way. If the corporate organization has a Charitable Grants or Education Grants program, particularly if the grants provided to the Patient Organization are unrestricted, representatives from the sponsor can often attend patient meetings. If allowed to attend, Medical Science Liaisons (MSL) will not initially actively engage with patients but can glean unmet needs through active listening. Patients like to share concerns with each other and often share solutions or best practices as well. This information is invaluable as it provides insights into the daily struggles and suggested solutions that can potentially be incorporated into the program and effect relevant change.
How to use insights gleaned from this type of engagement?
Educational tools can be developed to aid patients and caregivers in teaching others about the disease. Therapeutic approaches to the administration and treatment can be made easier by utilizing creative ways via suggestions often shared during patient meetings discussed above.
MSLs can share insights cross-functionally, thus ensuring the development of such programs within the company. For patient representatives, or patient advisory groups, their review allows for relevant feedback as protocols, and other aspects of the program grow during the product life cycle.
This feedback and evaluation of individuals who live with a particular disorder provide unique and useful perspectives toward further development, as described but not limited to,
- Program Development
- Clinical Development
- Educational Materials
- Quality of Life Concerns
Working with your Patient Advocacy Department to see how Medical Affairs can collaborate to further educate patients, families, and caregivers by providing medical review and oversight is another way to become involved.
We cannot appreciate a patient’s diagnostic odyssey or journey better than to hear it first-hand, utilizing a vetted agenda that compliantly allows an understanding of the disorder being researched.
These are some suggestions for engaging the often forgotten, but incredibly valuable patient KOLs.
Rita Zambelas, MSN, MSL-BC
Rita is a dynamic self-directed individual with an established history of working in the biotechnology industry. She demonstrates scientific and clinical expertise in Rare Disease and Oncology, and with her diverse therapeutic background, possesses a commitment to deliver. She is a strong professional leader who engages in cross-functional collaboration to pioneer and implements successful clinical programs and strategies designed to address and resolve complex problems and unmet medical needs.
As a professional in the healthcare/biotechnology industry, with 20+ years’ experience in a broad range of positions in the Biotech and Pharmaceuticals research arena; Rita is focused and highly motivated. She performs well in both individual and in team environments. Prior experience includes: Director, Medical Science Liaison, Associate Director, Medical Affairs; Medical Science Liaison; Clinical Science Liaison; Nurse Clinician; Clinical Research Coordinator; Institutional Review Board Coordinator; Clinical Research Monitor; Clinical Research Manager and Clinical Research Associate, to name a few. She has expertise in multiple therapeutic areas, including Rare and Orphan Genetic Diseases, Oncology, Hematology, Bone Marrow Transplant, Infectious Disease, Cardiovascular Disease as well as Medical Device. Where consistent integration of new information is imperative and expertise is needed, she focuses on the identification of complex problems and creative solutions. She is also a Board-Certified Medical Science Liaison (MSL-BC®).
Rita is married, lives in South Carolina, and has 5 children and in her spare time dabbles in arts and crafts and her dog(s).