Interactions between the pharmaceutical industry and healthcare professionals (HCPs) represent a complex relationship between scientific innovation, patient care, as well as commercial benefits. Ethical collaboration with the medical community supports pharmaceutical companies’ mission of helping patients by developing new medicines. An important part of this partnership is ensuring that HCPs can access the latest and most accurate information about medicines including new developments in relevant therapy areas.
Within the pharmaceutical industry, medical affairs cover a wide range of responsibilities with the aim of fulfilling unmet medical needs through generation of scientific evidence and delivery of scientific value to key stakeholders. Patients are at the centre of the medical affairs mission and the underlying reasoning for any medical interaction or medical activity is contribution to the care of patients. As such, medical affairs specialists must not only have expert knowledge of the therapy area and relevant products, but also have strong ethical decision-making skills and ensure compliant conduct of their activities.
The ability to support patients and drive innovation in the treatment landscape depends on effective collaboration and communication not only with the medical community but also with internal colleagues across commercial and non-commercial functions. Clearly understanding each other’s roles and responsibilities within an organisation is key in fostering a professional, ethical mindset, and enabling effective and compliant cross functional working practices.
In this blog post we aim to focus on collaborative work within the medical affairs function, which is unique in its position of managing a broad range of external and internal medical/scientific relationships. As such it has developed to include several roles that hold a wide breadth of responsibilities.
Medical science liaisons (MSLs) are generally considered to be externally facing. They cover a designated territory where they manage relationships with HCPs. MSLs aim to ensure that all necessary information is provided on request to the medical community to enable the best patient care. Being a medical/scientific partner to external stakeholders puts MSLs in a unique position, where they can collect invaluable insights from the field. Sharing this knowledge with internal cross functional teams makes an MSL a key strategic partner. MSLs work closely with internal medical colleagues, sales, marketing departments and many others. They can also run medical projects, bring innovative ideas, and ensure compliance.
Another function playing a significant role in the field is the clinical operations department. Clinical operation teams design, plan and run Phase I-IV clinical trials and include several different roles, such as clinical study managers (overseeing the trial), clinical study administrators (performing the trial’s administrative tasks) and clinical research associates (CRAs; visiting research sites to ensure the trial is running appropriately). Clinical operations colleagues are important medical partners who interact with investigators alongside MSLs. In general, a close relationship is fostered between MSLs and CRAs. While CRAs hold operational and regulatory expertise, MSLs have the technical knowledge and relationships with HCPs. For example, MSLs are often involved in site selection and the feasibility processes; providing scientific support during initiation visits as well throughout the lifetime of the study. Interplay between these two roles enables a smooth process of running trials.
Internally facing medical advisors (titles may vary between companies) act as therapy area and medical product specialists responsible for preparing and executing medical affairs strategic plans. As such, medical advisors collaborate closely with MSLs as well as regional and /or global medical teams to define and lead local medical activities, including advisory boards, medical education, and data generation plans. Medical advisors also act as partners to marketing colleagues by providing clinical and scientific input into brand initiatives. They are usually responsible for providing advice on medical and ethical matters to wider teams as well as commercial: medical material reviews, ensuring it is accurate, balanced and in line with the local codes of conduct, such as the ABPI. In order to identify and address scientific and medical needs, medical advisors may also maintain strong relationships with key external stakeholders.
Medical Information is responsible for handling unsolicited requests related to company’s products; including both on-label and off-label data by preparing and providing approved oral and/or written responses. To prepare accurate responses, medical information colleagues often perform literature and global data base research. Medical information queries can come from both external and internal stakeholders. As such, it is not uncommon for MSLs to ask for medical information support with hard-to-get information.
During interactions with healthcare professionals, MSLs may be informed of adverse events or safety concerns regarding the company’s product. As per the company’s pharmacovigilance policy on adverse event reporting, MSLs submit such information to ensure that adverse event reporting is done in a compliant manner. To guarantee a smooth follow-up process, MSLs may collaborate with the pharmacovigilance department. Pharmacovigilance teams work to detect, assess, understand, and report adverse effects or any other drug-related problems with an overall aim of ensuring patient safety in relation to use of medicines and safeguarding public health.
Effective cross-functional work between field and head-office medical colleagues requires excellent communication and a mindset of belonging to one team with the same mission: aligned to a clear strategy. Field-based colleagues are the direct link with the external environment, representing the voice of both the HCPs and patients. Sharing this knowledge with internal medical colleagues enables better understanding of existing topics/issues, generation of new ideas, leading of successful medical projects and delivery of valuable medical education.
As an example, let’s look at MSL collaboration with the medical advisor during the organisation of an advisory board to prepare a drug for the launch into the market. The knowledge of the clinical landscape and relationships with the HCPs that the MSL holds play a crucial role during the initial steps of such project. The MSL and medical advisor will work together to prepare a detailed agenda ensuring all the questions of internal stakeholders are addressed. Then the MSL will identify HCPs who may be able to help achieve the objectives of the advisory board. The MSL will also advise on choosing the right chair for the advisory board. Ideally, the chair should be a respected peer as well as a good moderator, able to manage discussion and obtain answers to the company’s questions. Once the agenda and attendee list has been finalised, the MSL will help with sending out invitations, preparing pre-work materials, slides and briefing HCPs. On the day of the advisory board MSL may play an active role in engaging HCPs and shaping discussions, which are transformed into a medical report by the MSL or a medical writer. After the event, the newly obtained knowledge will be disseminated to the medical team as well as the wider business to shape the preparation for the launch of the drug.
Another example of MSLs working together with the medical advisor is MSLs sharing the insights from the field with the wider medical department. During their field visits, MSLs may have identified an unmet educational need amongst HCPs that has developed following a recent change in the environment. This could be a sudden emergence of a pandemic leading to a need for a broader knowledge in virology, a rise in obesity levels requiring familiarity with modifiable lifestyle factors and many others. With a main goal of improving patient care, the medical team may agree to develop an educational piece, which can come in various formats (e.g., MSL slides, speaker event, webinar, etc.), to be rolled out to the medical community.
MSLs are at the centre of enabling a positive change in patient care, the success of which largely depends on collaborative efforts and effective communication within the organisation.
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