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| PHARMACEUTICAL MEDICINE |
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| Year : 2013 | Volume
: 4
| Issue : 3 | Page : 186-190 |
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An insight into the emerging role of regional medical advisor in the pharmaceutical industry
Sandeep Kumar Gupta1, Roopa P Nayak2
1 Assistant Professor, Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India
2 Professor & HOD, Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur, Tamil Nadu, India
| Date of Web Publication | 22-Jul-2013 |
Correspondence Address:
Sandeep Kumar Gupta
Assistant Professor, Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur - 621 113, Tamil Nadu
India
 Source of Support: None, Conflict of Interest: None  | Check |
PMID: 24010061 
 Abstract | | |
The position of regional medical advisor (RMA) is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. The RMA is a field based position whose main mission is to foster collaborative relationships with the key opinion leaders (KOLs) and to facilitate the exchange of unbiased scientific information between the medical community and the company. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. The major objective of the RMA is to develop the professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in the clinical research. The RMA can assist in the development, review, and follow-up of the clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidelines. Keywords: Clinical research, key opinion leaders, medical science liaison, medico-marketing, pharmaceutical industry, regional medical advisor
How to cite this article:
Gupta SK, Nayak RP. An insight into the emerging role of regional medical advisor in the pharmaceutical industry. Perspect Clin Res 2013;4:186-90 |
How to cite this URL:
Gupta SK, Nayak RP. An insight into the emerging role of regional medical advisor in the pharmaceutical industry. Perspect Clin Res [serial online] 2013 [cited 2023 Mar 23];4:186-90. Available from: http://www.picronline.org/text.asp?2013/4/3/186/115386 |
| Introduction | |  |
A recently established position within the pharmaceutical industry is the position of the regional medical advisor (RMA). The RMA is also known as the medical science liaison (MSL). This role is very similar to that of the medical advisor based at the corporate office in several ways except that it is normally field based and more marketing support orientated. Field-based medical liaison teams are expanding world-wide as part of the pharmaceutical industry's increased focus on global operations including emerging markets. [1]
The RMA or MSL is a field-based professional whose main responsibility is to foster collaborative relationships with the key opinion leaders (KOLs) by providing the medical and scientific support and thus, facilitating the exchange of unbiased scientific information between the medical community and the company and supporting sales and marketing colleagues in exploring business opportunities and contributing toward achievement of company's strategic objectives. [2],[3]
| Evolution of Field-Based Medical Support Programs | | |
The field-based medical support programs actually originated in 1967 at the Upjohn Company. With increasing sophistication of pharmaceuticals, more knowledgeable personnel were needed to facilitate scientific exchange. Hence, a small group of technically-oriented sales representatives who reported to sales was formed with the goal of improving the image of the company with researchers, KOLs, and investigators. These MSLs, as they were known, utilized face-to-face peer interactions to better understand what their customers needed and to leverage Upjohn products into ongoing research activities. [4]
With time, the original Upjohn model has evolved and the transition has been made to medical based teams and the E. R. Squibb (and subsequently Bristol Myers Squibb) is credited with this. In this model, the field-based medical liaison team entirely consisted of doctoral trained health-care providers who, due to the medical reporting structure, interacted with the health-care community on a peer-to-peer basis. As a result of this peer basis, the clinically trained field medical personnel elevated the relationship to focus on advancing standards of care and optimizing patient outcome, not product sales. [4] Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. [5]
Patil and Rajadhyaksha in their article on the roles of pharmaceutical physician in India have stated that RMA or MSL has emerged as a new concept in India. Mostly they are based at state capitals in each zone and cover a particular region. They further state that RMA can help doctors in regularly updating their knowledge. They have also outlined the roles of RMA in activities such as investigator-initiated clinical research proposals, new product identification, life line extension, and scientific communication. [6]
| The Key Objectives of RMA | | |
The major objective of the RMA is to develop professional relationships with the health-care community, particularly KOLs, through peer-to-peer contact. [2],[4],[6]
The other key objectives are medico-marketing support for product campaign development, implementation and in helping to shape marketing strategy and direction. The RMA can also facilitate clinical research at the regional level and can review and follow-up post marketing clinical activities. The RMA can support regional pharmacovigilance unit by imparting training and conducting training of doctors and field force. The RMA can provide quality scientific presentations for internal and external meetings, develop public-private partnerships, gather competitive intelligence and facilitate input for product life cycle plans. The RMA can interact with regulatory agencies and ensure that all regional medical activities and interactions are conducted with due regard to accepted standards of best practice. [2],[3],[4],[5],[6],[7],[8],[9]
[Figure 1] further illustrates various role of regional medical advisor.
KOL identification and management
The major roles of RMA is identifying KOLs and building relationships with them and it occupies more time than other activities. KOLs are those health-care practitioners who are considered experts by their peers within their respective fields for their research, publications, speaking, or influence. KOLs possess a unique credibility as their validity often stems from years of industry experience and medical affiliations. The RMAs need to develop and enhance relationships with the KOLs within the health-care community and act as a medical contact for KOLs and external medical experts. [2],[9]
KOL management is an essential component for a pharmaceutical company throughout the life-cycle process of a specific drug or product. Physicians often turn to fellow key opinion leading physicians for knowledge and advice on specific drugs when they have to choose from a myriad of drug options for their patients. [2],[9]
The RMA provide scientific and technical support to KOLs and maintain professional and credible relationships with the KOLs to ensure access to current medical and scientific information on the products and areas of therapeutic interest. The RMA contribute to timely and responsive dissemination of medical information, by exploring mutual clinical and scientific interests with the KOLs, by facilitating professional education and also by understanding the dynamics and unmet needs within therapeutic arenas. [2],[9] Apart from dissemination of medical information, the RMA can also interact with the KOL during advisory board meetings, speaker training, workshops, conferences, and further educational material development. [9]
The RMA participate in the selection process to identify KOLs to engage in collaborative efforts such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, Symposia, etc.) and also ensure a high level of scientific or educational integrity in these collaborative efforts. The RMA also build strong regional advisory boards and expert panels for the company's key therapeutic areas. The RMA can provide materials such as articles, slides, and education materials to KOLs on request. These materials are one way medical liaisons can provide benefit to their KOLs and fulfill an unmet educational need. [9]
Medico-marketing support
The RMA has an important role to play in medico-marketing support for product campaign development and implementation and in helping to shape marketing strategy and direction. The sales and marketing team are experts in business and the RMA can provide an invaluable regional and clinical perspective to assist in the construction of ethical and appropriate marketing plans. The RMA provide scientific and technical support for assigned products; deliver scientific presentations; actively participate in relevant brand teams and helps develop medical affairs strategies for assigned products. [3],[6],[8]
The RMA works closely with the sales and marketing teams to provide the strategic medical input into core brand (product) strategies and to support medical/marketing activities such as promotional material generation/product launches. The RMA also review and approve regional promotional materials. The RMA should have a strong grasp on information within their therapeutic area because in order to have quality relationships with KOLs, it is essential that medical liaisons be extremely knowledgeable. [3],[6],[8] [Figure 2] describes the communication between corporate and field medical affairs, sales and marketing team. | Figure 2: Communication between corporate and field medical affairs team, sales and marketing
Click here to view |
Clinical research
The RMA can facilitate investigator-initiated clinical research proposals from approval until completion, presentation, and publication. It is possible for a RMA to have valuable access to KOLs through his expertise in clinical research. The RMA can assist in the development, review and follow-up of clinical studies initiated within the relevant therapeutic area at the regional/local level. The RMA can lead regional/local clinical projects to ensure that all clinical trials are conducted in compliance with the ICH GCP guidelines. [2],[3],[5],[6],[9]
The guidance from external experts is often required in order to ensure that a clinical trial protocol is workable in practice. Because RMA knows the subject area and the local clinicians well enough, he can take their advice at the various stages of protocol development. [2],[3],[5]
The RMA can attend the academic meetings regionally, and communicate with clinicians and academics who have research interests in common with the company. The RMA can visit clinical units and meet potential investigators and their teams so as to understand local issues that may promote or hinder success. The RMA can also be closely involved in the process of assessing investigator and site suitability. The RMA can support the investigators by addressing queries about the study drug. Quite often, the RMA is underutilized in this capacity, which can lead to a missed opportunity for the pharmaceutical company in using a valuable resource in the research and development process. [2],[3],[5]
Pharmacovigilance and phase IV studies
The RMA can assist in the development, review and follow-up of post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV) at the regional/local level. The RMA can provide the regional pharmacovigilance support including training and medical assessment. The RMA can support the investigator by reviewing the reports of adverse events. The RMA can also help in dealing with customer enquiries on drug safety issues for assigned products. The responsibility for assessment of causality and decisions about appropriate further actions can also be carried out by the RMA at the regional/local level because of their strong clinical background. [5],[7],[9]
Medical writing
The RMA can use his medical writing skills in publications of local/regional clinical trials. The RMA can provide quality scientific presentations including posters, abstracts, and presentation slides for internal and external meetings. [5],[7],[9]
Training of doctors and field force
Another area where the RMA can contribute is in the training of salespeople. The RMA can ensure that sales representatives are knowledgeable in their therapeutic area, well-briefed and able to conduct their business in an appropriate fashion. The RMA can also train and develop speakers on the company's products. The RMA can train the clinical trial investigator and other site staff on the study protocol, International Conference on Harmonisation - Good Clinical Practice Guidelines requirements and the compound under study. Additionally, the RMA has the crucial responsibility of ensuring that those conducting the study have been thoroughly trained in the use of diagnostic instruments and rating scales required by the protocol. [4],[5],[7],[9]
Public-private partnership
RMA can play an integral role in developing public-private partnerships by identifying local/regional educational opportunities and conducting medical educational training for key external stakeholders. [6]
Competitive intelligence and market research
The pharmaceutical company will consider developing new indications, applications, and dosage forms as part of life-cycle management of the product and the continuing understanding of its scientific profile. All this will require a close watch on competitor companies and products. The RMA can develop awareness and understanding of competitor issues/intelligence - for example, product strategies, studies, commercial messages, positioning, etc., - and communicate, where appropriate, within the Company. The RMA can attend scientific meetings and symposia and gather competitive intelligence and report back to their respective company. [2],[7],[9]
New product identification, life line extension
The generic competitors rapidly enter the market once the patent expires because pharmaceutical product has a limited life cycle. The pharmaceutical company has to adopt a number of strategies to try to extend patent life such as line extensions, reformulations, fixed dose combination products or switching to over-the-counter sales. The RMAs can facilitate KOL input into product life cycle plans. RMA can play a proper part in helping to evolve commercial policy and identify opportunities. The RMA can obtain feedback and advice from KOL about company products or pipeline through peer-to-peer interactions and advisory boards at local/regional level. [2],[6],[7],[9]
Regulatory responsibility
The pharmaceutical industry is highly regulated industry. The RMA can play a crucial role in interacting with these agencies at regional level and can conduct discussions about regulatory query. [2],[5],[7],[9]
Legal responsibility
The RMA needs to ensure that all regional medical activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies, and accepted standards of best practice. It is a moral and legal responsibility of the RMA to quickly recognize the problems related to drug safety and act promptly on this knowledge. These decisions also take place within a legal frame-work and it is a requirement that adverse reactions are reported to the regulatory authorities. [3],[4],[5],[9]
| Qualification of The RMA | | |
A medical degree is required for RMA because the nature of the KOL interactions requires the regional medical adviser to be knowledgeable in their therapeutic area. Advanced degrees provide the confidence to the RMA to be able to talk with KOLs on a peer level. Prior experience is also key which provides real-world experience. A medical liaison with a high level of experience but no advanced degree can still be highly successful in the role. [9]
| Challenges in The Role RMAs | | |
The RMA role is challenging as they need to keep up with all the latest medical information and trends as well as they need to find time to conduct desk work because for the majority of the time they need to travel. RMAs need to travel a lot and one need to enjoy this opportunity. In order to effectively communicate with the KOLs, the RMA needs to keep them well-informed. Hence the RMA must frequently attend professional and scientific meetings. RMAs need to make presentations and this is one of the most critical aspects of this position. These can include internal presentations for their own department, presentations for physicians and KOLs, and presentations at national meetings. [2],[3],[5]
It is important for the RMA to be able to interpret clinical study data and other information as necessary to be able to educate physicians and other prescribers on the appropriate use of a product. The RMA need to have an understanding of clinical research as well as the ability to critically evaluate clinical studies, an understanding of the process of drug development and an understanding of the national and regional health environment. [2],[3],[5],[6]
Relationship building plays an important role in successfully carrying out these jobs, as well as in developing good public relations. Problem solving is another important element in the role of an RMA. Resolving problems can enhance long-term relationships with both internal and external clients. Innovative thinking or new ideas are important components of working with KOLs and other health-care professionals. Creating new and better ways to communicate information to consumers, other health professionals, and media about product advances requires creativity. [2],[3],[5]
The corporate medical affairs team and field based RMA team should have regular communication regarding long- and short-term goals, strategies and KOL activities. It is also important to establish communication between corporate and field based medical affairs team, sales and marketing team. [3],[5] [Table 1] gives details regarding skills required for the role of RMA.
| Conclusion | | |
The RMA is a field based position whose main mission is to foster collaborative relationships with the KOLs and to facilitate the exchange of unbiased scientific information between the medical community and the company. The position of RMA is relatively new in the pharmaceutical industry and its roles and responsibility are still evolving. Now, the position of the RMA has evolved into comprehensive, complex, highly interactive, targeted, highly strategic, innovative, and independent role since its inception by the Upjohn Company in 1967. [5]
| Acknowledgments | | |
I gratefully acknowledge the help of my colleagues in the Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Siruvachur, Perambalur - 621 113 Tamil Nadu, India.
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[Figure 1], [Figure 2]
[Table 1]
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