Embracing Medicines Development as a Profession

Abstract

Medicines development has dramatically transformed in the preceding decades. It has evolved from a task undertaken by a small team to a complex series of activities, involving several functions and qualified professionals, across multiple, interrelated, scientific disciplines, worldwide. Conceptualized as a medical specialty, concerned with the research, development, and monitoring of medicines, and spearheaded largely by pharmaceutical physicians, the discipline has extended to embrace non-medically qualified scientists progressively taking on traditional roles within the medicines development ambit. There is expanded engagement of professional backgrounds. Each individual function contributes unique expertise and skills, but they all share a sense of identity, a collective commitment, and a common goal of improving human health and well-being, through innovative treatments. At the same time, milestone advancements in the research and development environment, in healthcare delivery, the regulatory ethos, data sharing with greater transparency, the exponential digitalization, and the emphasis on patient outcomes have imposed greater accountability in systems and processes, and across all global stakeholders. Increasingly, this demands a joint purpose, fostering continuous learning, and engendering a professional identity within the medicines development community, a coinage gaining incremental affirmation as equivalent to pharmaceutical medicine. The aligned set of related competencies and capabilities across the multi-professional teams involved, the sense of identifying concurrently across different, albeit complementary, communities of practice, the obligation of ongoing specialized knowledge training, the mandated enterprise-wide codes of ethics and moral conduct, and the intertwined career paths within the larger business organizational construct of academic institutions, regulatory agencies, and the biopharmaceutical industry—all profess to meet the criteria, and merit medicines development/pharmaceutical medicine be acknowledged, regarded, and recognized as a distinct profession of stature, in its own standing. The concept of pharmaceutical medicine has been floated since 1957, and has received considerable attention in scientific literature over the years. Yet, the discipline struggles to be universally understood and appreciated. This perspective scrutinizes related engendering influences and hindering elements, while advocating the furtherance of medicines development from a traditional occupation, emerging as a vocation, and transforming into a mature profession, with the vision and purpose of advancing better medicines for improved health outcomes for people, globally.

Key Points

The concept of profession is underpinned by ethics and morals of service beyond the traditional tenets and characteristics of required advanced learning and technical expertise.

Medicines development/pharmaceutical medicine has emerged as a complex array of activities, engaging an expanding spectrum of several inter-dependent functions and qualified professionals, across multiple scientific disciplines and professional backgrounds.

Albeit, with unique individual functional expertise and skills, there appears a shared sense of purpose, professional identity, commitment, and a common aspiration of improved health outcomes and human well-being, across these myriad disciplines.

This interpolation of multi-professional competencies and capabilities, specialized knowledge training, the demanding codes of ethics and moral conduct, in parallel with the interwoven academic, regulatory, and biopharmaceutical industry career paths, incrementally distinguish the profession’s recognizable attributes and entrustable professional accountabilities.

Introduction

What is our ‘why’? What is our ‘ikigai’, or reason for being [1]? All of us have encountered that moment of introspection, asking the quintessential existentialistic question, at some point along our professional journeys.

Perhaps, both personal and professional development are along a never-ending continuum, and the question ought to be reframed as “Who am I at this moment?”, even while seeking to answer, “Who do I want to become?” [2].

Social scientists and psychologists have long proffered that professional identity development—the development of the person, through socialization, extrapolating to a collective allegiance with a community of professionals, a profession—is essential, not only in the education of a health professional, but in “thinking, acting, and feeling” like one [3, 4]. When empowered by social purpose and belonging, individuals behave confidently, an attribute closely associated with both workplace satisfaction and career commitment [5]. There is instructive abundance of evidence supporting that boundary-crossing learning with peers promotes the integration of the professional self with the personal self—especially when bolstered by feelings of self-worth and a sense of integrity, with an orientation towards improving community-based care [6, 7].

Intriguingly, cognizance of one’s purpose may be perceived to be directly linked to a greater degree of accomplishment, and to a more meaningful personal sense of satisfaction, as a medicines development professional [6].

On a larger canvas, corporations that can harness the power of purpose to drive performance and profitability enjoy a distinct competitive edge [8]. Such disruptive transformation, even at an institutional level, emphasizes that purpose matters.

A confluence of myriad factors could contribute to a sense of purpose and the formation of self-identity—and pride—as medicines development professionals, perhaps consequential to influences of professional choices and career path progression.

The biopharmaceutical industry is a strong contributor to global employment, and by extension, the world economy, in both developed and pharmerging countries. In 2022, this sector’s R&D activities alone, representative of the medicines development cadre, directly engaged 1.1 million people globally, reflecting a 175% increase since 2014, adding USD 227 billion to global GDP, illustrative of the magnitude of investment in R&D. The professionals contributing to medicines development endeavors are highly trained researchers, specialists with a high-level of technical expertise and training. Engaged personnel often receive qualified training and are exposed to new technologies and processes. This knowledge becomes an asset for the entire workforce, not just fostering economic development, but, as medical innovation is transmitted across the world, contributing to significant gains in average life expectancy and quality of life [9, 10].

Elaborating on the traditional medical roles within biopharmaceutical organizations, regulatory agencies, and contract research organizations, experts in related fields of life sciences—translational medicine, clinical pharmacology, regulatory sciences, health technology, drug safety and pharmacovigilance, pharmacy, pharmaceutical sciences, toxicology, market access, and health economics—with adequate specialized non-clinical and clinical training, collaborate as integrated members of medicines development teams. These two disparate groups, not necessarily implying a hierarchy of professions, would jointly be alluded to as medicine development professionals [11].

Moreover, the escalating complexity of modern medicines has necessitated the enlistment and cooperation of specialists with advanced non-medical training and expertise—inter alia, natural scientists, molecular biologists, geneticists, immunologists, device engineers, psychologists, bioethicists, and even artificial intelligence experts—in human trials, dramatically altering the medicines development ecosystem.

Besides, the scope of the pharmaceutical medicine professionals’ role has vastly expanded far beyond the realm of clinical research and development to encompass drug regulation, business practices, promotion and commercialization of medicines, people management and enterprise-wide leadership, and stakeholder relationships—all of which demand special attention to capabilities in practice, and emphasis on competency-based education and specialized training [12, 13].

More critically, this broadening role scenario also creates unique ethical and moral concerns and issues, not addressed, or at least, not adequately covered, under traditional mores and medical ethics—mandating the development of a specific ethical code for pharmaceutical medicine professionals [14]. The future of medicine, facing transforming socio-economic demographics, aging populations, multiple diseases, and virtual healthcare, is also poised to bring inherent challenges.

To this end, the original IFAPP International Code of Ethical Conduct for Pharmaceutical Physicians, from 2003, well-representing the specific core values of pharmaceutical medicine—the duty of care, competence and diligence, impartiality, probity, integrity, and accountability—was updated in 2018, with consideration for the rapidly evolving and growingly complex scientific environment of medicines development. Thus, the IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists (PPs & MDSs) addresses a much broader circle of pharmaceutical professionals, encompassing the amplified essential competencies [14].

In tandem with manifesting the extended individual skill sets, the management of multi-dimensional, multi-professional teams itself becomes an increasingly pertinent and relevant problem across several inter-related social, scientific, and corporate activities. This complicated ecosystem makes the sharing of several values fundamental for effective and sustainable teamwork: trust, ethics, and an articulated common purpose [15].

Appraising the global medicines development landscape—and by implication, pharmaceutical medicine, deemed interchangeable terminology—three critical elements emerge [5].

1. Career paths are frequently serendipitous, and likely circuitous, both within organizations and across the healthcare industry.

2. It is imperative to seize perceived opportunities and assume full responsibility for careers, possibly influenced by education and training, by role models and mentors, and by personal values and social moral boundaries.

3. Broadening the pool of opportunity is obligatory, continually reinventing oneself with experiences that help one to understand and appreciate one’s strengths and interests, and enriched by relationships connecting with peers and with social environments—in other words, the profession.

The virtuous circle expounds as our interests and passions are informed by our life experiences, thereby shaping our purpose, which, in turn, drives our education and training, nurturing continuous learning as a life-long experience. The accentuation of education and training shapes our identity; and, as we evolve, this informs our purpose, a sense of oneness with our chosen profession [5].

The limited, albeit traditional, tenets of physician-driven pharmaceutical medicine, have flourished, seemingly arbitrarily, into the considerably broadened ambit of medicines development, with multiple scientific disciplines and professional backgrounds converging into the space, with the commensurate redefinition of desired knowledge, skills, behaviors, and even values and ethics. This circumstance, at once, complicates and mires in ambiguity, any reasonable analyses of aligned professionalism, of a common identity and purpose, because they do not purport to limit focus on the physician’s role in pharmaceutical medicine, but, rather to the much more comprehensive, multi-faceted, and multi-factored medicines development cadre.

Therein lies the dilemma that despite gainfully evolving over 65 years, the enormous meaningful contributions to patient care and global health notwithstanding, the discipline of medicines development still struggles to be universally acknowledged and find its rightful place in the pantheon of distinguished professions. Only by understanding and enhancing awareness of the status quo, the impediments that discourage, and the enablers that encourage, can one envisage and propose pragmatic solutions for a viable and sustainable way forward.

Concept of Profession

The concept of profession, as analyzed in sociological, legal, philosophical, and historical perspectives—and well enunciated for the three prototypical ‘learned’ professions, theology, law, and medicine—emphasizes the pertinence of moral dimensions and an ethic of service, beyond the traditionally defining characteristics of extensive learning, technical expertise, and erudition [16].

The route to attaining the status of a full-time profession, with commensurate credentialing, includes the establishment of university curricula and training programs, the formation of inclusive professional associations, and the presence and oversight of formal codes of ethics, preferably with global application.

In the medicines development arena, the emergence of the International Federation of Associations of Pharmaceutical Physicians (IFAPP) in 1975 [17], and the requisite accountability with professional behaviors enunciated in, and regulated by, an ethics code [14], the medicines development/pharmaceutical medicine competencies and capabilities mandated by the PharmaTrain syllabus [18], as well as the continuing professional development certification programs offered by the Faculty of Pharmaceutical Medicine (FPM) [19], are exemplary.

Under the aegis of the United Kingdom (UK) Royal College of Physicians, the FPM formalized the legal listing of pharmaceutical medicine, recognized by the UK Parliament, as a registered medical specialty, in 2002. It has its own specialty training program, Pharmaceutical Medicine Specialty Training (PMST), approved by the General Medical Council (GMC), and overseen by the FPM, the GMC, and the Joint Royal Colleges of Physicians Training Board (JRCPTB) [20, 21].

Still, this recognition has gained only limited momentum and in few other countries and regions. The Swiss Department of Health officially recognized pharmaceutical medicine as a fully board-certified physician specialty in Switzerland in 1999 [22]. Also, noteworthily, under a 2014 guidance administered by the Philippines national Food and Drug Administration (FDA), medical directors are required to either earn a Diploma in Pharmaceutical Medicine, as offered by the Philippine College of Pharmaceutical Medicine (PCPM), or pass the Specialty Board of Pharmaceutical Medicine examination, within three years of being employed by a pharmaceutical company in the Philippines [23, 24].

Invested in the discovery, development, evaluation, registration, monitoring, and medical aspects of marketing of medicines for the benefit of patients and the health of the community, pharmaceutical medicine is an international discipline with growing recognition and acceptance. What was conceptualized as a medical scientific specialty, has become a progressively multi-disciplinary profession—so much so that, in due course, IFAPP became renamed the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine [25].

Critically, in pace with the transformation of the discipline, education and training in pharmaceutical medicine evolved with equal urgency, amplifying the syllabus in alignment with most aspects germane to the development process of contemporary medicine. Notably, such programs deliver a comprehensive curriculum that spans the entire drug development process, reaching out to global markets, and targeting the exceedingly diverse range of professionals participating in the complex medicines development theater of operations, addressing educational inadequacies, even while fostering interdisciplinary collaboration [12, 13, 26].

This stellar effort is substantially promoted by the milestone Council for International Organizations of Medical Sciences (CIOMS) initiative on Recommended Standards of Education and Training for Healthcare Professionals Participating in Medicines Development [27]. Additionally, the long-existing guidance by regulatory agencies across the globe, including the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), among others, progressively advance frameworks that help shape the identity of like-minded medicines development professionals and industries, by setting and monitoring standards and expectations for clinical research and development, for ethical conduct, for data processing, and for good manufacturing practice.

In parallel to the evolution of a profession, methods of assessing progress toward the related professional identity, the nature of the identity in formation, and its wider socialization, need addressing. For the medical community, Miller’s pyramid of assessment of medical competence, clinical skills, and performance—‘Knows,’ ‘Knows how,’ ‘Shows how,’ and ‘Does’ [28]—has been proposed to be complemented by a more reliable indicator of professional behavior, incorporating the values and attitudes of the professional into the identity of the aspiring physician. Thus, a fifth level, added at the apex of the pyramid, reflecting the assimilation of a professional identity, should be ‘Is’ [29].

Equally relevant is the postulation that the pinnacle ‘Is’ level, while conceptualized for the physician, should potentially be relevant for, and applicable to, the development of all individuals in their respective medical-related professional roles [30]. This realization may facilitate the learning journey and identity development for professionals navigating the emerging universe of medicines development, and the engaged multi-disciplinary teams.

With the gamut of licensures, specialty certifications, continuing professional development (CPD) offerings, and the accreditation of institutions and training programs, undertaken by a professional association to maintain standards of the group, such professionalism needs to be ostensibly motivated by ethics, and the desirousness of elevated moral conduct.

Of particular relevance is that in navigating this rapidly changing medicines development ecosystem in a dynamic industry, the core medical affairs organizations continue to predominate and embrace the vision of being the ‘third pillar’ of biopharmaceutical companies, with research and commercial—with the importance of medical affairs leadership coming into even sharper focus [31].

Entrusting the Profession

On a wider plain, a critical element is trust.

The essence of trustworthiness is pivotal for any criterion of professional standing and acceptance [16]. Any vocation or occupation seeking to gain credibility as a professional entity and authority must not only establish its technical expertise basis, carve out an exclusive jurisdiction linked to the requisite skill domains and training standards, but also convince stakeholders of the trustworthiness of its unique services.

The principal drivers of trust are judgments of competence and a deep emotional component—a feeling of affinity, of comfort, of a sense of security and identification with an individual, an organization, and by extrapolation, a profession. Conversely, impressions of low competency, with poor affinity, engender distrust. A third essential driver of trust is meaning—which, when alluding to an individual, organization, or profession, implies a higher sense of personal or shared purpose [32].

In parallel with the advent of competency-based medical education, the concept of entrustment advocates that trust in professional competence encompasses more than the observation of ‘doing’ in practice—Miller’s ‘Does’ level [28]—but rather a capability of adaptive competence, with a readiness to encounter known/unknown challenges. Clearly, this qualification for a professional, and by extension, a profession, mandates qualities beyond the observed and expected proficiency for practicing the profession. In fact, this prompted the proposed additional new acme for Miller’s pyramid, ‘trusted’, combining the personal characteristics linked to identity formation (‘is’), with the promise of the capacity to adapt for future readiness [29, 33].

Being trusted may be perceived as one of the most crucial characteristics of health care professionals, with important ramifications for continuing professional development. A specialty certification affords presumptive trust, implicitly conferred. Within the medicines development framework, such entrustment would appear to demand both previously demonstrated competence in the applicable domains, as well as trustworthiness—summarized as capability, integrity, reliability, humility, and agency [33].

In the emerging global healthcare scenario, trust in the healthcare industry is increasingly strained and circumspect. Public mistrust in the biopharmaceutical corporations and allied institutions has intensified, likely due to perceptions of primarily commercial interests, as well as the focus on some conduct of pharmaceutical manufacturers interpreted as inappropriate. Be that as it may, this unfavorable media and public perception is disturbing, if it leads to poor patient adherence, limited participation in clinical trials, and even rejection of effective health interventions, including vaccines and medication programs [34].

Recognizing the tryst between science and politics, the trust deficit in the health ecosystem, encompassing governments and the biopharmaceutical industry, not only jeopardizes meaningful healthcare advances, but, simultaneously, threatens public perceptions of impropriety with, and societal judgements maligning trust in, the medicines development profession and in its engaged disciplines and professionals.

From an antitrust viewpoint, this poses a conundrum. By delivering on the promise of innovation, the outputs of medicines development/pharmaceutical medicine initiatives may also be prohibitively inaccessible to patient communities and societies, especially in low- and middle-income countries. In this delicate cost/quality equation balance, while costs are measurable, value and quality are daunting to quantify [16]. Is medicines development to be perceived as a monopolistic trade or business, rather than a profession? While advocating for the profession, would suggesting an aura of professional differentiation, an ‘illusion’ of uniqueness, be perceived as unethical, as in any business?

Positive Reinforcement

The Intrinsic Motivation

Ikigai, a concept deeply embedded in Japan’s cultural tapestry for centuries, translating to ‘life’s worth’, embodies the essence of embracing a way of life, a philosophy, a purpose. It encompasses do what you love—passion; do what the world needs—mission; do what you can be rewarded for—vocation; and do what you are good at—profession [1].

A groundswell of discovery of the self—dimensions of interests, values, skills, and rewards—motivate and influence the adoption of the tenets of a ‘profession’, either through oneself, or through one’s sphere of influence, engaging managers, teachers, or the organization.

A sense of values realization, high motivation, professional responsibility and accountability, capacity for goal accomplishment, and the heritage and dynasty of a chosen profession, are key contributary personal influencers [35].

An Identity Continuum

Identity is not fixed or static. It continues to evolve and adapt throughout life and careers, shaped by expanding learnings and experiences [36]. Identities are transformational and co-constructed in both personal and professional interactions [7].

Professional identity is built on the edifice of personal identities evolving through life. Internal factors—values, ability and traits, attributes, and personal circumstances—guide the heightening awareness of identification with a profession along the journey, this being a deliberate process [37].

External factors—family, friends, gender, culture, and context—are key influences [7], as are the learning environment, workplace-based training, and societal and peer expectations [37]. Identities are formative, their development susceptible to being steered into integrated and consistently applied professional identities [7].

An anticipated market demand for specialists of the chosen profile, alignment of training to professional real practice, eminent recognition and prestige of the profession in society, and a rewarding work ethos with high societal guarantees, are complementing social motivations [35].

Notably, identities within a profession could manifest during or at the end of learning experiences or education training, likely observed with multiple strategies, at several points in time, and by various stakeholders [30]. Correspondingly, staying true to personal values, as they relate to the core values of the profession, is a vital ability [38].

On other levels, professionals frequently negotiate boundaries between personal and organizational identification, which does not intrinsically entail identification with a role or a function, but rather refers to a perceived resemblance with the organization as a social category. Individuals relate to the attributes recognizable as prototypical for the members of the profession or organization. This association generates a sense of oneness and belonging, through which the characteristics and the goals of the organization become gradationally integrated or congruent with those of the individual, who will attribute and value behaviors and ethics shared with the organization [39].

The recognition that purpose-driven organizations have more engaged employees, better customer loyalty, superior innovation and transformational change, and greater financial performance [8] certainly advocates for medicines development professionals, with a strong sense of purpose, relating with the larger organizational values, facilitating the socialization of the profession.

Today’s professional role identity can be considerably different from that of a decade earlier, not just owing to individual and organizational factors, but also to evolution in what the collective profession embraces, represents, and exhibits [40].

Mentors and Role Models

Not all of the multiple factors exert equal influence along the process of socialization in shaping professional identity towards a profession. The most powerful are mentors and role models, in tandem with the accumulated individual experiences [36].

Role models, admired for being and behaving as professionals, and mentors, acting as experienced and trusted counselors, engaging closely within the professional community, have considerable impact on both the individual psyche, and with establishing the ethos within the profession, as doyens of the community of practice that individuals aspire to enlist in [36].

The presence of role models and mentors, facilitating professional development through self-reflection skills, and fostering a positive learning environment, cannot be emphasized enough [37]. Facilitating pedagogic platforms, an environment for mentorship and coaching, to inspire individuals to meaningfully reflect on, understand, and synergize developing identities, would further the interests of the profession [38].

A compelling collateral benefit of these pedagogic innovations in medicines development is the potential to significantly contribute to the improvement of care quality, enhancing the overall healthcare experience for both patients and their caregivers.

Thus, this complex network of social interaction, role models and mentors, experiential learning, and explicit and tacit knowledge acquisition, influences the wider socialization of a profession for individuals.

Challenges to Mitigate

Motivation Not Always Manifest

The inherent nature of professional identity formation is an internalization, rather than an outward behavior display of professionalism. Though intertwined, these are distinct constructs, lacking any universal parameters for assessing professional identification separate from ‘professionalism’ [30].

Individual experiences steer association with a given profession over time. This is an ongoing process, progressing along differing timelines, making any demonstration or observation of a community of like-minded individuals within a profession difficult, or even not feasible.

Secondary socialization into a profession, involving individuals with already-established complex personal identities, of necessity requires some degree of repression of elements of existing identities [3].

In the context of medicines development, aspiring individuals must imbibe the language of the profession, understand the hierarchies and power structures, and learn to live with ambiguity. Such socialization implies negotiation with values of self and a compromise—behaviors that can result in ‘identity dissonance’, as elements of the preexisting identity conflict with those mandated by the profession, potentially culminating in anxiety and stress, as individuals either accept or reject the changes [3].

The reality of modern-day medicines development practices necessitates interdisciplinary collaboration. While, historically, professional identity would have emphasized individual accomplishment and accountability, this attitude is increasingly difficult to reconcile with in the new paradigm, where an integrated individual–organizational professional identity is requisite, encouraging behaviors that avoid centering around isolated, individualized actions and thinking, but rather a group, collaborative endeavor [36]. By extension, the profession’s norms and practices need to be both inclusive and diverse, enabling community behavior, even while permitting relatedness to one’s own personal self and identity.

Unrealized Identity

There remains limited awareness of the scale and operations of medicines development as a distinct and cohesive entity, despite the burgeoning numbers of multi-disciplinary professionals practicing in the varied functions in drug discovery, development, evaluation, registration, monitoring, and access of medicines, for the benefit of patient communities and for society at large. Individuals and functions operate as siloed experts within the overall process of phased drug development, with little cross-functional collaboration, exchange, and opportunity, likely hampering personal and professional growth aspirations.

More pertinently, there are few uniformly established and globally regulated credentialing norms and requirements for enlisting or participating in the biopharmaceutical industry or in the medicines development enterprise-wide workforce. This poses a substantial, continued hurdle in the universal acknowledgment of the consistently high-quality standards, the accountabilities, and by implication, the recognition and value of medicines development. The acceptance, encouragement, and endorsement by industry associations and regulatory bodies in individual countries and regions, as implemented in Switzerland, the UK, and the Philippines, is both pioneering and exemplary [20–24].

Compounded by the paucity of mandated, defined educational or competency requirements to engage in the process, and the apparent inconsistency of professional training with actual practice, variable levels of competence, and value to the organization and to stakeholders, is often observed. The perceived mismatch between graduate profiles coming from traditional academic programs, with the needs of the emerging disciplines related to medicines development, in the rapidly evolving healthcare landscape, remains perturbing.

Likewise, in today’s multi-dimensional teams’ environment in medicines development, with a strong allegiance to their origins in the rigorous, advanced education for entrenched professions, such as medicine and related specialties, it is conceivable to expect a conflict of assertion of influence of identities. This can create a dichotomy with those professionals in not only their own identification with the tenets of their new chosen profession, but also with other expertise backgrounds and disciplines, equally committed to medicines development, for professional identity opportunities.

It is also not implausible that with reorganized roles, redefined functions and departments, and even institutional allegiances, individual personal and professional identities and purpose commitments get subsumed, and likely subservient, to that of the larger organization—giving vent to despondency and detachment from the profession’s principles and ambitions.

Ambiguous Metrics and Extrinsic Impediments

This scenario warrants the need for systematic, structured, incentivized, practice-orientated, global, postgraduate professional development training, across the gamut of complexities in medicines development, for involved professionals—opening up further opportunities in related arenas, while fostering an ethos of collaboration, with a sense of shared purpose.

However, the relative lack of standardized parameters, compounded by potential biases, and the limited evidence correlating competency training to patient and healthcare outcomes, continue to be barriers that have precluded the development of global standards of workplace-based assessment at the ‘does’ level [33].

Additional barriers exist. Political, regulatory, and even institutional elements may impede fuller manifestation of formal training and/or certification of competencies in medicines development. Organizational/institutional factors include insufficient awareness and understanding of roles and contributions, lack of professional recognition, and poor functional interactions and relationships [41].

Such deterrents to practice risk reducing productivity capacity. Eliminating restrictions and unnecessary barriers would enable leveraging the full potential of the advanced education and training received by healthcare professionals, thereby benefiting health systems, patients, families, and communities with high-quality services, and improving access to care and health equity [41].

The formidable demands of advanced education, and the elevated expectations from medicines development professionals, could be overwhelming for individuals, provoking self-doubt and burnout. Moreover, with the continuous emphasis on competencies and capabilities, and the pervasive influence of organizational and stakeholder politics, developing personal, professional, and organizational identities requires deep understanding and ongoing reflection on personal values, beliefs, and confidence.

Moreover, given the encumbrances to formal recognition of the profession itself, this could induce low self-esteem, discouraging, rather than galvanizing aspirants.

Being a moving target, professional identity is challenging to assess, shaping and reshaping over multiple stages and timelines. Besides, practices in the medicines development and healthcare environment are constantly evolving. Importantly, this professional journey is not a linear process, potentially with individual setbacks and deterrents [30].

Several external factors hinder, more than embrace, the establishment process for the medicines development profession. Interaction between senior and newer industry members can be very hierarchical, a collectivist culture not always constructive towards understanding of roles and professional development [37].

Practices within the profession may be more exclusionary than inclusive. ‘Classism’ still pervades organizations, standardization of norms conflicts with the necessity to accommodate diversity, and different cultural and ethnic backgrounds may have differing interpretations of professionalism [3]. It is imperative the profession of the future be more open to the expertise of other communities of practice, in order to be sustainable in an equitable, globalized world.

Again, understanding the context, and the uniform regulation of education, licensure, accreditation, and certification, congruent in terms of scope and focus of identified roles in medicines development, would facilitate navigating the complex health and social needs of global patient communities.

This limitation with metrics, assessing the long-term impact of interventions with educational programs, at both the individual and organizational level, and with defining the value of the emerging profession, remains an impediment.

Dissuading Influencers

Not surprisingly, the potential negative impact of lapses in professional behavior exhibited by role models is not conducive to the profession’s image and trustworthiness, as aspiring entrants may unwittingly replicate these behaviors [36].

Unprofessional conduct and professional lapses will remain issues, continuing to mandate the need for comprehensive and stringent codes of conduct [3].

The Predominance of Digital

The transformation of pharmaceutical physicians’ and medicine development scientists’ roles across the enterprise, in parallel with the refashioning of regulatory guidance and rules that accept, evaluate, and approve serial data culled from global patient-centred trials, has triggered the need for a reconstruction, or overhaul, of the competency and capability building journey. To gainfully leverage automated digitally-enabled real-time data capture and evaluation, juxtaposed with generation of new insights deploying advanced and predictive analytic modelling, the learning pathway needs to be bolstered by continual, dynamic refinement of both the content and the process. It is envisaged that this capability continuum for the medicines development profession would need unvarying complementing of the allied knowledge, skills, and behaviors, by agile, optimized decision-making processes, for any meaningful consequence [42].

Redefining and enabling new ways of thinking and working requires new skill sets. Inadequate capabilities often include analysis of patient and physician experience, trial and portfolio design thinking, advanced analytics, digitization, and automation, which all could go amiss unless specifically and deliberately building on existing traditional capabilities, or even in-sourcing critical talent [42].

Particularly in today’s context, it is critical to recognize that the incremental deployment of digital technologies, such as artificial intelligence (AI) and machine learning, despite their overwhelming benefits for healthcare, may equally be harmful to professions and occupations. This is especially relevant with the potentially damaging impact on professional role identities, as AI takes over a broad range of professional tasks [40]. With rapid adoption of newer technology, professions must continually reconfigure their roles—an essential component of both individual personal professional identities and collective-level occupational identities—in an effort to maintain the profession’s integrity against external changes. This could trigger members of the profession to reinterpret themselves, with reshaped identities, through the perspective of the new technology, as it affects the profession’s redefined practices and boundary negotiations with others [40].

The preponderance of the digital space in medicines development, its surging far-reaching contributions notwithstanding, also potentially threatens the traditional fabric of professional role identification, mandating changing assumptions for interactions of individuals within the profession, and with other stakeholders, thereby enabling professionals to better cope with the ground-level shifts.

Conclusion

This reflection prompts the realization that as career paths in medicines development transition through university, professional associations, industries, and organizations, while fueled by both curiosity and a sense of purpose, there is implicit acknowledgment of the social and environmental influences, and of contending with multiple stakeholders, along a circuitous professional journey.

Is an intrinsic sense of purpose an adequate driver for fueling the growth of both the individual and the profession, in an increasingly global universe, with divergent socio-economic and cultural backgrounds? Or does this search for self and professional identity warrant credentialing with advanced education and professional qualifications, overseen by the mandatory operational code of norms and ethics? The eminently interactive interdependence between inherent, individual nature and societal, experiential nurture may be more ubiquitous than is evident.

The constant evolution and transformation in the medicines development landscape today, merits, nay, demands reconciliation of the collision of commercial pressures with values, with ethics, and with moral standards. Career choices and transition decisions are often predicated on this. The social construct of the positive, motivating influences, countered by the potentially negative, dissuading factors, is potent, and warrants caution. A stark mismatch between one’s internal moral compass and the expected ostensible external behavior could trigger a very real cognitive dissonance [5]. The ensuing stress is assumably destructive not merely for the individual, but, also for the organization, and for the profession.

What is the mantra for nurturing the fledgeling profession of medicines development?

That enabling endorsement by biopharmaceutical industry associations and oversight organizations, globally, is fundamental for professional acceptance and for societal trust. That purpose and passion must be pursued with authenticity, being mindful of the inevitable transitional shackles. That clarity on the direction to follow, secure in respective, multi-dimensional professional identities, by seeking out mentors to obtain a different perspective and for counsel with recentering and rechallenging, is crucial. That engaging with, socializing, and championing the wider medicines development community is paramount, even while transitioning progressively through ‘knowing,’ ‘showing,’ and ‘doing,’ to ‘being’ [5].

Conceptualizing the burgeoning scale and scope of the contribution of the medicines development profession to medical knowledge, to patient care, to public health outcomes, to life expectancy and quality of life, and to human welfare, is mind-opening. It is imperative to delineate and to communicate this frame of reference, to leverage the rich heritage, and to build on the vision and purpose of the medicines development profession’s legacy. Conceivably, the future will imbue both its obligation and its value.

Declarations

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No official funding or grant support by any organizations has been received, or should be inferred, for this submission.

Conflict of interest

The views and opinions expressed in this review article are those of the author and are not intended to represent the position of any organizations. There are no relationships that could be construed as potential conflicts of interest.

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Author contributions

Conceptualization and data curation, writing, critically reviewing, and editing the manuscript, and approving the submitted final version.