Exploring the Value of Medical Affairs Learning Experiences for Pharmacy Students and Residents.

The objective of this article is 3-fold: to strengthen the understanding of medical affairs (MA) among pharmacy professionals; to provide greater visibility into the value experienced by educators, learners, and the practice of pharmacy across the health care ecosystem when MA learning opportunities are available; and to provide a framework for organizations who seek to establish an MA experiential rotation. The authors collated information from published literature, anecdotal experience, and interviews with experiential education leaders from several colleges of pharmacy. As a result, the article summarizes the current perceptions of MA practice among educators and students and highlights how MA experiences may support pharmacy learners in the future.

A blueprint for success in real-world evidence: "glocal" approach to building capabilities and generating impactful evidence.

The past decade has seen the increasing influence and relevance of real-world data (RWD) and real-world evidence (RWE) in healthcare decision making. The value added by RWD/RWE has prompted the pharmaceutical industry to develop high performing systems and practices to harness the power of evidence generated at the global level. However, this worldwide transformation provides outstanding opportunities to support capability building within local affiliates and to impact key country-level stakeholders through resulting evidence. Therefore, we present an Evidence Blueprint Initiative, which links the global and local ("glocal") skills, and furthermore addresses the opportunities and gaps in evidence generation capabilities at the local level. Cross-functional experts were recruited at the local, regional, and global level to define best practices. A framework was developed to characterize the foundational expertise needed and to assess markets' existing capabilities. Subsequently, targeted roadmaps were developed and implemented to build capabilities in specific areas within each affiliate. The impact from the Blueprint is encouraging, resulting in improved local evidence plans, established evidence teams, enhanced RWD use and strategic implementation of patient centric science in local affiliates. The success of the Blueprint resides in empowering affiliates to realise their local evidence generation ambitions and to match them to their local context. It strengthens and expands the ties between various parts of the organisation and the external environment while building fit-for-future evidence capabilities from local affiliates.

Past, Present, and Likely Future of Nutraceuticals in India: Evolving Role of Pharmaceutical Physicians.

Nutraceuticals are gaining importance owing to the current pandemic situation and increasing focus on overall health. Nutraceuticals include products, which help in maintaining immunity and prevent diseases. It also includes products that support the optimal functioning of the human body. Poor nutrition plays an important role in lifestyle-related disorders as well. Various nutraceuticals have exhibited therapeutic potential, hence gaining popularity. Nutraceuticals are mainly categorized into dietary supplements and functional foods. With multiple factors contributing to the growth of nutraceutical industry in India, we are marching toward global leadership in nutraceuticals. Food Safety and Standards Authority of India (FSSAI) is solely responsible for regulating the approvals, promotions, and labeling standards for health supplements and nutraceuticals. As the understanding of these nutraceuticals is improving, the regulations are becoming stricter and there is a pressing need to monitor the usage of such products regularly and stringently. Nutrivigilance and phytovigilance are relatively new concepts in our country; however, regulatory authorities need to proactively observe the adverse effects and issues related to substandard and counterfeit nutraceutical products. Healthcare professionals including pharmaceutical physicians can play an important role in safeguarding the population by advocating the rational use of nutraceuticals, food supplements, and consumer health products.

Defining Insights.

BACKGROUND: Insights, when acted upon, can result in positive changes to the business, for HCPs, and ultimately for patients. Medical Information, as a customer facing function, is one of the groups that generate insights. Data and insights across different functions of an organization need to be compiled to provide a comprehensive view. The purpose of this paper is to develop a shared definition of insights and to provide a working guidance for the insight process. METHODS: Two surveys were conducted of the phactMI membership first to establish a shared definition of insights and then to benchmark current insight process. From this data and the shared experience of the working group a proposed guidance was developed. RESULTS: The developed definition of an insight is "An insight is the deeper understanding of the why behind trends of information that lead us to determine if an action is warranted". For the most robust outcomes, insight identification needs to be a cross functional activity. The proposed structured approach can be leveraged and customized for any organization and include the following five steps: INvestigate, Scrutinize, Identify, Take Action, and Enlighten (INSITE). CONCLUSION: The INSITE process provides a simple framework that should become routine for all Medical Information colleagues who are leading the work around insights. The process should be shared across all functions that participate in the insight generation process. This is another area where Medical Information can demonstrate leadership and highlight their value to the organization.

Advancing patient-centricity in Medical Affairs: A survey of patients and patient organizations.

Current guidance on advancing patient-centricity in Medical Affairs is insufficient. A framework was previously proposed from a Medical Affairs perspective, without direct patient input, featuring five focus areas: medical strategy; medical communication; evidence generation; patient engagement; and patient care experience. We conducted a literature review to evaluate and provide background on those focus areas. Consequently, two new focus areas were identified: digital health and patient medical education. Because the patient perspective provides an important value-add, we consulted on the seven priority areas identified with patient and patient organizations through questionnaires. The gathered responses implied that they were accurately prioritized to increase patient-centricity. However, this must be tested on a larger sample size to validate its feasibility.

Development, validation and implementation of the medical affairs pharmaceutical physician work-related quality of life instrument.

BACKGROUND: Medical affairs pharmaceutical physicians (MAPPs) are at risk for low work-related quality of life (WRQoL). The aim of this study was to develop, validate and implement the first WRQoL instrument for this population. METHODS: A prospective observational cohort clinical study, the Medical Affairs Pharmaceutical Physician Work-related Quality of Life (MAPPWrQoL) Instrument Development and Patient Registry (MAPPWrQoLReg), was registered in November 2021 (NCT05123846). Thirteen MAPPs and 12 non-MAPPs participated in development and validation between December 2021 and January 2022. Development used the Jandhyala method for observing proportional group awareness and consensus. Discriminant validity analysis used the WRQoL Scale as a reference standard and assessed whether the instrument could differentiate between the groups. Twelve MAPPs and 12 non-MAPPs self-reported their WRQoL in the registry each month from February 2022. Recruitment and data collection are ongoing; 6-month data between February 2022 and August 2022 are reported here. RESULTS: Two participants were excluded from the registry. Chi-squared analysis showed a significant difference between the MAPPWRQoL instrument and WRQoL Scale (p = 1.029e-08) with acceptable sensitivity (89.19%) and specificity (75.00%). There were significant between-group differences for total scores at each follow-up (p = .003; n = 6 questions). Chi-squared analysis showed a significant difference between MAPPs' and non-MAPPs' ability to answer MAPPWRQoL instrument items (p = .002629), with acceptable sensitivity (91.9%) and near-acceptable specificity (66.7%). MAPPs' WRQoL did not change significantly over 6 months. CONCLUSION: Discriminant validity of the 39-item MAPPWRQoL instrument was confirmed. The Jandhyala method successfully developed and validated a specific WRQoL instrument and may be applied to similar populations, such as junior doctors and UK general practitioners.

Professional qualifications of medical affairs pharmaceutical physicians and other internal stakeholders in the pharmaceutical industry.

Background: Medical affairs pharmaceutical physicians (MAPPs) have unique value to pharmaceutical companies due to their accountability for activities that benefit regulators, payors, prescribers and patients. This study assessed whether MAPPs' specialist training and education in pharmaceutical medicine could account for this level of value by determining whether there was significant variation in education and training between MAPPs and other internal stakeholders of pharmaceutical companies. Methods: A systematic search of LinkedIn profiles from the 10 pharmaceutical companies by revenue was conducted between June and October 2021. Job title and type and year of undergraduate and postgraduate qualifications were extracted. A one-sided Mann-Whitney test assessed for differences in the total number of qualifications between MAPPs and other internal stakeholders involved in medical affairs using MAPPs as the reference group. Other internal stakeholders included medical affairs pharmacists (MAPharm), other medical affairs professionals (MAOth), and market access (MAcc), commercial (COmm) and sales professionals. Sub-group analysis determined differences in undergraduate and postgraduate education. Results: In total, 524 profiles were included. Compared to all other internal stakeholders, MAPPs had a significantly higher number of undergraduate (p < 0.001) and postgraduate (MAPharm, p = 0.003; MAOth, p = 0.004; MAcc, COmm and Sales, p < 0.001) qualifications. Additionally, MAPPs had a significantly longer time to industry than other internal stakeholders apart from MAPharm. Of those with clinical qualifications, MAPPs were almost twice as likely to have business qualifications. Conclusions: Of all internal stakeholders, MAPPs had the highest number of qualifications and the best match between expertise and the contextual demands of decision-makers in the pharmaceutical industry. Pharmaceutical companies in the UK can use these findings to clarify role boundaries and decision-making power based on the nature and level of expertise of each internal stakeholder.

Parallel publication of articles and congress presentations for industry-sponsored research: strategies for success.

Recent increases in the practice of parallel publication, during which a peer-reviewed manuscript is published concurrently with the first dissemination of the same key data at a medical congress as a late-breaking abstract, have highlighted substantial value for this method of publication. Parallel publication can increase access to new clinical information for healthcare providers and patients, as well as promote engagement and reach of the publication and presentation. As the practice becomes more common, there is a need for strategies to address the multiple challenges involved in the development process, such as shortened timelines, journal and congress policies, and stakeholder alignment. We surveyed journals, congresses, and publication professionals on the challenges of parallel publication and recommendations for success. Recommendations from journal editors and congress officials included the importance of adhering to timelines and early communication. Insights from a community of publication professionals showed that timelines and the author review process were among the key challenges of parallel publication development and stressed the importance of clear roles and expectations for authors. To provide real-world insights, we present 3 case studies of successful parallel publication development, highlighting the crucial role of journal selection, planning around data availability, and adapting to unpredictable circumstances. The recommendations described here may provide publication professionals with strategies to successfully plan, execute, and carry out parallel publication.

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

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.

Medical Affairs/Medical Science Liaison: Organizational Structure and Medical Contributions / 医薬品情報学

Objective: To identify the organizational structure and medical contributions of Medical Affairs/Medical Science Liaison (MA/MSL) and its impact on the spread of the coronavirus-19 (COVID-19) infection.Method: We conducted a web-based survey for 45 pharmaceutical companies based in Japan. The outcome of 43 questions related to organizational structure, business activities, key performance indicators (KPI), and indicators of medical contribution were analyzed and compared.Results: Responses were received from 43 pharmaceutical companies (95.6%; 26 Japanese and 17 foreign). The total number of MSLs exceeded 1,000 with an average of 30.1 MSLs/company. MSLs supervised an average of 21.8/MSL Key Opinion Leaders/Key Thought Leaders (KOLs/KTLs). There were eight MSL organizations per company on average, and Phase II/III had the most number of MSL organizations. Further, 22 companies (56.4%) had MSL organizations in the oncology area. All the companies were independent from departments mainly engaged in "sales and promotion activities," and the most common KPI was “collection insight from KOL/KTL.” Despite having medical qualifications and highly specialized degrees, training was provided continuously to improve expertise. Based on the life cycle of products, Japanese companies are promoting evidence generation and medical events with KOL/KTL supported by internal and external insights and foreign companies are promoting medical-education activities. Due to the COVID-19 pandemic, the number of “in person” activities have significantly decreased and that of "online" activities have increased considerably, and this trend might continue even after the end of the pandemic.Conclusion: The organizational structure and medical contribution of MA/MSL are partially different between Japanese and foreign companies. MSL continued to increase; however, the organization and activities were affected by the product.

Contributions of the Medical Affairs Department to Healthcare Professionals and the Effects of the New Coronavirus Disease 2019 Pandemic on the Contributions / 医薬品情報学

Objective: The purpose of this study was to assess the opinions of healthcare professional regarding the contributions of the Medical Affairs department. Furthermore, we aimed to identify factors influencing and reasons for the contributions in the new coronavirus disease 2019 (COVID-19) pandemic situation.Design/Methods: A web-based survey was conducted among healthcare professionals (Key Opinion Leader/Key Thought Leader, KOL/KTL) who had multiple contacts with the Medical Affairs department, Japan.Results: The responses of 141 KOL/KTLs in Japan were collected; 77.3% of the respondents indicated that the contributions of the Medical Affairs department exceeded their expectations (achieved the expected level of contribution). The most common responses were “the identification of unmet medical needs” and “the dissemination of medical and scientific information, providing advanced medical and scientific information;” other responses included “promoting sales of the company's drugs.” The requests from KOL/KTLs regarding quality were “knowledge about biological and clinical statistics” and “proposal and quick response ability from the perspective of medical staff and patients,” but these responses were partially different between physicians and pharmacists. COVID-19 has resulted in substantial changes, for example, “face-to-face” interactions have significantly decreased from 91.5 to 50.4% and “Online” interactions have significantly increased from 20.6 to 70.9%. However, the effects of the declaration of emergency state could not be identified. The KOL/KTLs requested to make the meeting times more appropriate, conduct in-depth two-way discussions, provide latest information, and discuss about professional manners and behaviors.Conclusion: In summary, regardless of the changes in the types of activities caused by COVID-19, the Medical Affairs department has made substantial contributions to healthcare professionals, who highly appreciated them. Furthermore, depending on responses of individuals whose expectations could not be met, areas of improvements have been suggested.

Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan.

Medical affairs has received a lot of attention in recent years in Japan, but it is also often misunderstood or poorly understood in the healthcare industry in Japan. In the United States, the function of medical affairs has been established for a long time, whereas its history in Japan is relatively short. Many scandals in clinical trials occurred with inappropriate relationship between medical doctors and the sales departments of pharmaceutical companies from 2012. These incidents undermined confidence in clinical trials in Japan and triggered the enforced separation of sales departments from the conduct of post-marketing clinical trials and evidence generation. There have been growing compliance issues identified in marketing and sales practices, and off-label promotion is also becoming an issue in Japan. These issues resulted in the establishment of independent medical affairs departments from sales departments in pharmaceutical companies operating in Japan. Due to the short history of medical affairs in Japan, the roles and responsibilities vary between companies in Japan. Medical affairs departments aim to fulfill unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. People working in medical affairs need to engage in scientific exchange activities with key opinion leaders independent of sales departments. Through these activities, medical affairs ensures that patients receive optimal medical care. Medical affairs in Japan is still developing, and its roles, responsibilities, and functions are improving. This article covers the history of medical affairs in Japan and the current status and future perspectives of medical affairs in Japan.

Medical affairs post-COVID 19: Are we ready to take the baton?

The spread of coronavirus epidemic has resulted in a change in the work schedule for Medical affairs professionals in the pharmaceutical industry. There has been an increase in virtual scientific interactions and prioritization of scientific communication. In the long term, this is likely to affect the structure and responsibilities of Medical affairs teams. New areas such as interactions with patients' groups, leading treatment access in specific channels of health-care delivery and role in specialty care are likely to be an integral part of the Medical Affairs function. Along with that, Medical Affairs teams would take a proactive role in developing platforms for real-world evidence programs and forging cross-industry partnerships. To make this successful, Medical affairs teams will have to build specialized skills such as expertise in healthcare, use of digital technology, patient engagement, and soft skills such as agility and ability to influence. The future of medical affairs is set for a major change.

The Roles, Organizational Structure, Responsibilities, Recruitment, Skills, Performance Indicators and Future Trends of Medical Science Liaison in Japan―Results of a 2019 Questionnaire / 医薬品情報学

Objective: The purpose of this survey was to identify the roles, organizational structure, responsibilities, recruitment, skills, performance indicators and future trends of Medical Science Liaisons (MSLs). In addition, we compared the trend of changes with past surveys.Method: We contacted 52 pharmaceutical companies with a questionnaire survey on MSLs which included 28 items and analyzed the anonymized results using a web response system in Japan.Results: Responses were received from 40 companies (76.9%). The range of MSLs in each company was 0 to 80, the average number for companies withone or more MSLs was 23.6 (median was 13.0). Except for one company, the definition of “MSL” was generally the same. Except for one company, MSLs operated independently of the sales promotion activities. One MSL was responsible for an average of 21 Key Opinion Leader/Key Thought Leaders (KOL/KTL). The key performance indicators (KPI) for MSL activities mainly focused on quantitative indicators such as the number of information collections from KOL/KTL. On the other hand, qualitative indicators were also incorporated suchas feedback from KOL/KTL. “Knowledge of clinical medicine” and “Communication skills” were necessary skills for all companies. 41.9% of companies had an in-house certification program. Some companies will retain and/or decrease the number of MSLs in the future. MSLs were required to have advanced medical expertise as well as medical professional qualifications, and it was confirmed that there are various options for career plans such as MA, R&D, and promotional departments. No matter what the MSL’s therapeutic area (TA), many companies had high expectations for their activities.Conclusion: The current status of expected mission and responsiblities, KPI, size and career plans for MSL were revealed. Companies want MSL’s to play a central role in the inplementation of medical strategies and contribute to internal and external stakeholders.

[What Is Medical Science Liaison?]

Currently, the role of medical representative (MR) is responsible for providing information to medical doctors from pharmaceutical/medical equipment companies. In recent years, however, the newer role of medical science liaison (MSL) has been established to construct evidence and provide advanced medical and scientific information to health care professionals. This position, independent from the sales division of a pharmaceutical or medical equipment company, has already been established in Europe and the U.S. The MSL helps to combat concerns of conflicts of interest (COI) concerning the sophistication of expert information, and in support of clinical research. I will introduce the role of the MSL in Japan.

[Expectations of an Academic Detailer from a Pharmaceutical Industry Perspective].

In the pharmaceutical industry, a Medical Affairs ("MA") professional collects, organizes and transmits information about a health care product based on the judgment of science, medicine and ethical values, thereby optimizing the product's value, improving corporate value, and assuring quality medical care. The role of the MA is to construct a "medical strategy" through the process of collecting, analyzing and evaluating information. On the other hand, Academic Detailing is "a new approach to drug information that actively disseminates drug comparison information from a pharmacological viewpoint, linking the drug's foundation to clinical practice." Cooperation between Academic Detailing and a pharmaceutical company's MA will be an essential relationship in realizing advanced prescribing proposals in the future, with the ultimate goal of optimal medication regimes for patients.

Evolving role of pharmaceutical physicians in medical evidence and education.

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.

Survey on Role,Responsibility and Skill to Clarify the Medical Science Liaison in Pharmaceutical Companies―Result of the Questionnaire Survey in 2017― / 医薬品情報学

Objective:The purpose of this survey was to identify the roles,responsibilities and skills of medical science liaisons(MSLs) in Japan. In addition,we compared to the prior survey results in 2011,2013 and 2015.Method:We contacted 47 pharmaceutical companies with a questionnaire survey on MSLs which included 22 items and analyzed the anonymized results using a web response system.Results:The total number of MSLs increased compared to prior surveys(ranged from 0 to 110). Many companies need MSLs with medical professional qualifications and sophisticated medical expertise. The roles and responsibilities MSLs were expected to perform included managing thought leaders(TL)and/or key opinion leaders (KOL)and implementing medical strategies. On the other hand, issues reported included management of MSLs and cooperation with other stakeholders in the company,and a still low level of recognition of MSLs.Conclusion:The roles of MSL are diverse,and while their activities and status are becoming established they are not yet unified across companies. It is recommended that at the earliest opportunity the roles,responsibilities and key performance indicators(KPI)of MSLs are defined,and educational programs established so that they can act as effective liaisons with medical professionals.

Fostering Competence in Medicines Development: The IFAPP Perspective.

IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) is a nonprofit organization with the mission to promote Pharmaceutical Medicine & Medicines Development (PM&MD) by enhancing the competencies and maintaining high research ethical standards of Pharmaceutical Physicians and other professionals involved in medicines development worldwide, leading to the availability and appropriate use of medicines for the benefit of patients and society. About 30 national professional associations related to PM&MD, involving 7000 professionals, are affiliated to IFAPP. Medicines development has traditionally been a challenging enterprise, with high risk, high investment, and potentially high returns in the lengthy and complex process of identifying a new chemical entity as a candidate for development and possibly succeeding in bringing it as a pharmaceutical product to the market. However, the emergence of genomics, translational research, biomarkers, and precision medicine pose challenges going forward involving allocation of resources, price, market access, and cost-effectiveness as opposed to the traditional concepts of "efficacy" and "safety." Education and Continuing Professional Development (CPD) are a major focus of IFAPP. The International Conference on Pharmaceutical Medicine (ICPM) is the largest event for our organization; ICPM is held every 2 or 3 years and is aimed to provide the state of the art in key areas for our discipline and profession. The paper is a reflection on the role of competency-based education and training for Pharmaceutical Physicians and medicines development scientists, as was discussed during the recent ICPM 2016 held in Sao Paulo, Brazil on April 18-19, with the support of the Brazilian Association of Pharmaceutical Medicine, and gathered around 200 representatives from the pharmaceutical, clinical research and regulatory arenas from all over the world,.

The Early Engagement Model in Product Development: Linking "Proof of Concept" to "Proof of Medical Value".

In a rapidly changing health care environment, it is more important than ever that pharmaceutical manufacturers improve the quality and efficiency of their research and development efforts in order to help ensure the right drug gets to the right patient at the right time. The evolving role of the Medical Affairs, Health Economics & Outcomes Research (HEOR) and other functions engaged in evidence generation within the pharmaceutical industry is leading to earlier involvement in the clinical development process so that the proof of concept for new therapies can be more strongly linked to the proof of medical value. In this article, the authors outline key components of an Early Engagement Model that connects the proof of concept to proof of medical value through a systematic approach linking molecular profile with early insights on disease, unmet needs, stakeholder requirements, and patient-centric differentiation.