Bridging the gap between R and D and commercialization in pharmaceutical industry: Role of medical affairs and medical communications

Jain, Sonal

doi:10.5455/ijcbr.2017.33.12

Cited by 7 publications

(9 citation statements)

References 2 publications

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“…The current lack of a measure for MAPP performance in the pharmaceutical industry as well as their potential undervaluation in the pharmaceutical industry and vulnerability to role replacement (Jandhyala R, MBBS, unpublished data, 2020) necessitated the development and validation of the MAPPval instrument. While MAPPs have been recognized as playing an important role in the pharmaceutical industry in terms of ensuring the predominance of scientific integrity over commercial interests and the transition of drugs from R&D to commercial [ 25 , 26 ], their role and value have not been formally characterized. Conceptualizing and operationalizing a new construct such as the MAPPval requires careful selection of indicators to ensure complete accuracy.…”

Section: Discussionmentioning

confidence: 99%

Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

Jandhyala

2022

Pharm Med

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Background A pilot study conducted in 2020 suggested that Medical Affairs Pharmaceutical Physicians (MAPPs) may be inherently undervalued within the pharmaceutical industry and vulnerable to replacement by less qualified roles. There are currently no standardized metrics to measure MAPP performance, thus it is necessary to measure the value of MAPPs to employers and clarify the need for their specific skills. Objectives The first aim of this study was to identify a list of indicators to produce an MAPP value measurement tool, and the second aim was to determine its discriminant validity by showing that the 'MAPPval instrument' differentiated the MAPP role from other internal stakeholders (regulatory affairs, market access, commercial, and patient advocacy) in terms of accountability for pharmaceutical company activities and level of engagement with external stakeholders. Methods MAPPs were recruited using convenience sampling via professional networks and completed a qualitative online survey to identify a list of key role indicators using a consensus method known as the Jandhyala method. Responses were coded and scored, and aggregated responses were presented to participants in a Consensus Round. Participants rated their agreement with each item on a 5-point Likert scale, from strongly agree to strongly disagree. Indicators that reached a consensus index of > 50% (CI ≥ 0.51) were retained in the final MAPP performance instrument. Participants' retrospectively self-reported professional activities over a period of 12 months were used to validate the measure. A two-proportion z-test and Mann-Whitney tests were used to determine discriminant validity by showing whether the value of the MAPP role as defined by the instrument was significantly different from that of other internal stakeholders in terms of their accountability for and external stakeholder benefit from each MAPP activity. Results In total, 11 MAPPs participated in the Jandhyala method, which generated 22 unique MAPP value indicators. Payor-targeted activities and journal publications had the two highest awareness indexes (1.00 and 0.98, respectively). The retrospective study confirmed the MAPPval instrument's validity. MAPPs were the only internal stakeholder classified as accountable for at least one activity that benefited all four stakeholders. They were classified as accountable for activities that influenced significantly more external stakeholders than other internal stakeholders, even when activities influenced fewer than four external stakeholders. MAPPs were also accountable for significantly more activities recorded over the 12-month period than regulatory affairs, market access, commercial, and patient advocacy. Conclusions This study generated and validated the first measure of MAPP value to pharmaceutical companies. MAPPs have unique value to pharmaceutical companies compared with other roles in terms of their accountability for activities that influence regulators, payors, prescribers, and patients. Through their accountability for pharma...

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Section: Discussionmentioning

confidence: 99%

Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

Jandhyala

2022

Pharm Med

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“…Our definition varied from a previous definition ( Maeda, 2021 ) in four ways: the designation of medical affairs as a medical specialty, the leadership of medical affairs in medicine adoption, detail regarding the generation of real-world evidence and the specification of distinct stakeholders who benefit from medical affairs. The lack of designation of medical affairs as a medical specialty is common in published literature, with some perspectives viewing it as a partnership with physicians rather than a speciality comprised of physicians ( Bedenkov et al, 2020 ) and others as a partnership between non-physician medical staff and medical communications ( Jain, 2017 ). Most viewed the specialty as being staffed primarily by non-physicians who are not regulated by the General Medical Council (GMC) or other physician governance bodies ( Jain, 2017 ; Bedenkov et al, 2020 ; Maeda, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

“…While research has charted the evolution of medical affairs ( Jain, 2017 ; Bedenkov et al, 2020 ; Ashkenazy, 2020 ) and medical affairs pharmaceutical physicians (MAPPs) ( Setia et al, 2018 ; Sweiti et al, 2019 ), there is a lack of peer-reviewed research on the exact functions and scope of both the profession and the field of study, including a lack of standardised definitions. Standardised definitions are needed in the medical field to optimise research and clinical practice such that the impact of the profession on patient outcomes can be assessed and enhanced ( Armstrong and Mouton, 2018 ).…”

Section: Introductionmentioning

confidence: 99%

“…Previous work has addressed the functions and unique value of MAPPs to pharmaceutical companies ( Jandhyala, 2022 ), but as yet, there has been no empirically generated definition of medical affairs. While definitions have been proposed within empirical studies on related topics ( Jain, 2017 ; Maeda, 2021 ), and growing attention has been given to what changes have occurred in the role of medical affairs post-COVID-19 ( Rajadhyaksha, 2020 ; Ghosh et al, 2021 ), there is no consensus on what constitutes medical affairs and its boundaries of scope. Different understandings of medical specialties may affect how they are practiced and regulated as well as healthcare policy and how training is governed ( Jamoulle et al, 2017 ).…”

Section: Introductionmentioning

confidence: 99%

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Development of a Definition for Medical Affairs Using the Jandhyala Method for Observing Consensus Opinion Among Medical Affairs Pharmaceutical Physicians

Jandhyala

2022

Front. Pharmacol.

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Background: There is currently no standard definition of medical affairs, despite its increasing importance to the pharmaceutical industry. The evolution of medical affairs necessitated the development of a standardised definition to guide policy and practice to ensure that patients’ interests remain central amid shifts that have, in the past, created fertile ground for ethical violations.Objectives: The aim of this study was to use an empirical method to observe a consensus of expert opinion on the definition of medical affairs to guide policy and practice within this function.Methods: In total, 11 medical affairs pharmaceutical physicians (MAPPs) completed a qualitative online survey to identify a list of key items to define medical affairs using the Jandhyala method for generating a consensus of expert opinion. Responses were coded and scored, and aggregated responses were presented to participants in a consensus round. Participants rated their agreement with each item on a 5-point Likert scale from strongly agree to strongly disagree. Indicators that reached a consensus index of >50% (CI > = 0.51) were retained. Items were categorised per previously defined medical affairs functions to determine the scope of the definition. A comparative content analysis using a previous definition identified in the literature was conducted to determine the utility of the definition generated here.Results: In total, 11 MAPPs generated 15 unique items to define medical affairs. Item awareness indices ranged from 0.24 (‘communication/education’) to 1.00 (‘design/strategy’). All items had a CI of more than 0.5 and were included in the final definition. All items could be categorised per previously defined medical affairs functions. Comparative content analysis showed that our definition varied in four ways: the designation of medical affairs as a medical specialty (and its primary aim, therefore, is to protect patients), the leadership of medical affairs in medicine adoption, the generation of real-world evidence and the specification of distinct stakeholders who benefit from medical affairs.Conclusion: A standard definition of medical affairs that incorporates the key principles of medical affairs as a medical specialty that leads medicine adoption and generates real-world evidence for specific stakeholders may protect and further the interests of patients by governing practice and policy.

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“…As regulatory bodies increase scrutiny on the promotion of therapeutic products, the medical affairs department has played an important role in separating R&D and commercial functions to reduce the commercial influence on R&D efforts. 1 , 2 Medical affairs serves as a liaison between the two functions, facilitating the transition of drugs from R&D to commercial. 3 Although the marketing department designs and provides pharmaceutical sales representatives (PSRs) with visual aids to engage physicians, medical affairs play a vital role in approving and providing feedback on such information tools.…”

Section: Role Of Medical Affairs In the Pharmaceutical Industrymentioning

confidence: 99%

Evolving role of pharmaceutical physicians in medical evidence and education

Setia¹,

Ryan²,

Nair³

et al. 2018

AMEP

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The role of pharmaceutical physicians who are the experts working in pharmaceutical companies has progressed over the last few decades, from supervising research and development (R&D) studies and/or providing support to marketing teams to serving an independent critical function. In this review, we focus on pharmaceutical physicians serving medical affairs functions in the pharmaceutical industry. Historically, members of the medical affairs team mainly provided a bridge between commercial teams and the R&D sector and between the organization and external stakeholders. Such teams may even have been managed by other departments, with an emphasis on acquiring and generating data for regulatory purposes. In recent years, the role of medical affairs has broadened due to a change in focus and the increasingly stringent regulatory landscape. Strict regulations require the detachment of commercial from medical activities within pharmaceutical organizations. This change provides an opportunity for a different type of partnership, allowing scientifically minded and medically driven initiatives. This article summarizes the key role of pharmaceutical industry-based physicians in medical affairs and discusses the emerging and evolving role of medical affairs for value creation in evidence generation and medical education.

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Bridging the gap between R and D and commercialization in pharmaceutical industry: Role of medical affairs and medical communications

Cited by 7 publications

References 2 publications

Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

Development of a Definition for Medical Affairs Using the Jandhyala Method for Observing Consensus Opinion Among Medical Affairs Pharmaceutical Physicians

Evolving role of pharmaceutical physicians in medical evidence and education

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