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Medical Affairs Improves Patient Outcomes Through External Medical Education

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By: Kirtida Pandya1, Jacqueline Waldrop2, Maria E. Vassilakis3, Marc Sirockman4, Deirdre Jordan5, Ogün Sazova6, Patricia Jassak7, Tim Mikhelashvili8, Sarah Funderburk9, Ivan Desviat10

  1. Executive Director and Head, Medical Services and Operations, Sandoz, A Novartis Division
  2. Director, Oncology Grant Officer, Global Medical Grants, Worldwide Medical & Safety, Pfizer Inc.
  3. Senior Director, Medical Affairs, Standards and Excellence, Astellas
  4. President, MedEvoke
  5. Global Medical Affairs Excellence Lead, Sandoz, A Novartis Division
  6. Medical Director, Napp Pharmaceuticals, UK
  7. Director, IME and External Medical Affairs, Astellas
  8. CEO and Co-Founder, Amedea Pharma
  9. Medical Insights Director, Caudex, a McCann Health Company
  10. Director Medical Education & Outcomes Excellence, Abbvie

ABSTRACT

In the Medical Affairs Professional Society (MAPS) community, external medical education can be categorized based on the extent of influence and industry involvement; however, it should always have the ultimate goal of optimizing patient care and improving health outcomes. Medical Affairs (MA) professionals take the lead to reach this goal by establishing external education programs to address knowledge, competency, or performance gaps. Educational strategies are implemented while fully complying with all applicable laws and codes and considering variables such as regional differences. External medical education demands are continuously evolving, and MA needs to continue to evolve with these changes to establish effective education strategies. Furthermore, the swift change to virtual education platforms due to the current COVID-19 pandemic requires speed and agility across stakeholders. The adaptation of medical education tactics will ensure effective healthcare professional (HCP) education, which will ultimately lead to improvement of patients’ healthcare.

INTRODUCTION

The central mission of external medical education is to provide unbiased education to enhance healthcare professionals’ (HCP) knowledge, skills and competencies to improve patient outcomes. But what role do Medical Affairs (MA) professionals have in its creation and dissemination? The following article provides a brief overview of external medical education and gives insight into the integral role of MA professionals.

WHAT IS EXTERNAL MEDICAL EDUCATION?

External medical education can be defined as diverse educational approaches provided to various stakeholders, such as HCPs, payers, patients, and caregivers, through education initiatives that aim to address identified knowledge, competency or performance gaps. Medical education may address therapy area and disease education gaps through scientific conferences, company-led education, continuing medical education (CME) grants and fellowships or diverse collaboration with scientific and patient advocacy societies (https://community.medicalaffairs.org/on-demand-conferences, The Role of Medical Affairs in External Medical Education: A Roadmap, Slide 11).

 

THE PATIENT FOCUS OF EXTERNAL MEDICAL EDUCATION

In its simplest terms, the primary goal that unites the entire industry across its MA functions is better patient care. In a systematic literature review of 39 studies, Marinopoulos et al. showed that independent medical education was indeed effective in improving the clinical outcomes of patients1. This was supported by Cervero and Gaines, who found that CME improves physician performance and clinical outcomes2.

MA professionals play a major role in the education needed to improve physician performance and patient outcomes. Based on their insights from diverse channels, they identify knowledge and competency gaps, and unmet medical needs. These can be addressed and translated into education for all stakeholders. MA professionals communicate and disseminate fair-balanced information that is important in guiding relevant strategies or tactics; however, their exact role varies depending on the level of independence of the approach and the extent of direct involvement, policies, and compliance requirements.

THE DIFFERENT TYPES OF EXTERNAL MEDICAL EDUCATION

INDEPENDENT MEDICAL EDUCATION

Independent medical education is supported through grant funding and is planned and implemented without the influence or control of the commercial supporter. Programs can be either funded through unsolicited grants, where third parties submit proposals, or through grants submitted in response to a Call for Grant Applications (CGA) or Request for Proposals (RFP). A wide variety of educational strategies are used at different lifecycle stages of a medicine or device. In the earlier stages it is crucial to assess the needs of healthcare providers and begin to close knowledge gaps, while the peri- and post-launch stages require predisposing, enabling and re-enforcing educational methods (Figure 1)3.

External Medical Education Figure 1

Figure 1. The planning of external medical education is aligned to the life cycle stages of a medicine. QI, Quality Improvement.

To strive for success, MA professionals are advised to keep the end goal in mind, thereby following a “backward planning” strategy. The final ideal state is identified first, then potential knowledge and competency gaps are identified, and finally, budget is allocated to a grantmaking strategy. MA professionals must also take into account the therapeutic landscape and other compounds/products in the specified area of interest.

Unsolicited independent medical education grants have historically utilized a reactive transaction where companies accept unsolicited proposals from accredited providers. MA professionals have had to change their approach to be able to proactively influence the healthcare landscape across a broad spectrum of stakeholders’ perspectives. Supporting needs assessment projects and extensive information-gathering must be used first to inform an effective independent medical education strategy, whether grants are submitted spontaneously or in response to a CGA or RFP.

COMPANY-LED MEDICAL EDUCATION

Company-led medical education is another widely used form of external medical education. These activities are organized by individual pharmaceutical companies and might involve scientific committees, and/or independent scientific and professional organizations. Examples include scientific symposia, patient educational programs, company-sponsored meetings, and educational websites, among others.

Like independent medical education, company-led education is bound to the highest standards for quality, transparency and ethics in medical learning. Content must be relevant, credible, and timely, addressing educational gaps through a sound instructional design and outcome measure plan.

Regulatory agencies have diverse views on the classification of medical education developed by the pharmaceutical/biotech/device industry. Medical education and educational materials are rarely defined by their intent, but by the originator or the supporter. In this regard, industry-developed education/educational materials are considered promotional in many markets regardless of their nature and the internal function that develops them.

Medical education may play a role in influencing the market growth of therapeutics by increasing the awareness of disease states, treatments, and changing guidelines. However, the overall intent of medical education must not be to promote company products, devices, or solutions, but to improve HCPs’ knowledge of relevant data and integrate this into clinical competencies and skills which optimize patient outcomes.

It is important to note that various functions within the industry develop educational materials and scientific programs. While the medical education developed by the MA function does so in a scientific, non-promotional manner, there are components of education regularly developed or used by industry’s commercial function to complement their solutions with a primary intent to increase market share and sales of a product.

Legal and compliance implications in defining and implementing company-led education are extensive and are not addressed in this article. The MAPS Focus Area Working Group (FAWG) on External Education will be addressing these topics in an upcoming Standards and Guidance document and future e-Learning modules.

 

ASSESSING OUTCOMES AND HURDLES IN EXTERNAL MEDICAL EDUCATION

MA professionals need to measure the impact of educational initiatives on clinical practice and patient outcomes. Assessing relevance and effectiveness should be a continuous process throughout planning and implementation of an activity and needs assessment insights should inform the outcomes assessment plan. Activities should be continuously assessed for relevance and effectiveness and modified when needed. Moore and colleagues proposed a model of outcomes assessment that can aid MA professionals when evaluating activities for their impact on HCP performance and patient outcomes4.

To achieve positive outcomes for patients and healthcare systems, MA professionals need to be aware of potential hurdles they may encounter. Not only do they have the responsibility to ensure delivery of high-quality medical education externally, but they must also find a way to demonstrate the importance and positive impact of medical education to internal stakeholders. Furthermore, where previously physicians had the lead in making treatment decisions, due to rising healthcare costs, decision-making power is gradually shifting to a new set of stakeholders e.g., nurse practitioners and physician assistants who are helping to drive cost containment. It is crucial to be aware of regional differences affecting external medical education tactics (Figure 2). Variations in standard of care, availability of therapeutic products, and region-specific regulatory processes must be acknowledged when designing educational programs.

Regional Differences Medical Education

Figure 2. Regional differences in external medical education. CE, Continuing Education; CPD, Continuing Professional Development; HCPs, Healthcare Professionals.

 

WHY EXTERNAL MEDICAL EDUCATION NEEDS TO ADAPT

External medical education is rapidly evolving, and MA professionals must be ready for swift changes. Healthcare scientific data continue to increase and originate from an ever-expanding range of sources such as real-world evidence and social-listening programs. The need for external education supporting HCPs as they decipher and incorporate this information requires adaptive education strategies. Medical education is part of HCPs’ lifelong professional development and must address learning needs most relevant to their daily practice5. Increasing transparency in the industry requires data generation and dissemination around external medical education programs, particularly transfers of value (TOV) to HCPs. Additionally, patient advocacy groups are more frequently included in decision-making, maximizing patient insights and directing education strategies towards a more patient-oriented approach.

The recent rapid transition to virtual learning has enhanced disseminating educational content during the ongoing COVID-19 pandemic. MA professionals must adapt to challenging times and find new, diverse ways to generate, and disseminate educational content effectively to support HCPs’ and patients’ needs. A “one size fits all” approach is inadequate for virtual content when delivering medical education in the current situation. A tailored, agile approach aligned to the appropriate setting and audience will allow MA professionals to provide successful digital education and establish the most suitable forum within which to improve timely data dissemination. The right information and education delivered in the appropriate format to HCPs will translate into enhanced and more effective patient care, ultimately improving patient health outcomes.

CONCLUSION

MA professionals are uniquely positioned to serve as factual, impartial, trusted partners who align company strategy to meet healthcare stakeholders’ and patients’ needs. They lead implementation and support of external education with the goal of improving patient outcomes. Gathering internal and external stakeholder insights while keeping the end goal in mind will transform the ever-changing relevance and value of MA strategy and tactics. Thus, as the field of external medical education evolves, MA professionals must adapt accordingly by keeping abreast of the latest healthcare institutional system changes, regulatory codes and compliance needs, regional differences, and technology advances. This will ensure that our key stakeholders (HCPs) have access to quality, evidence-based scientific data to address education gaps to optimize patient care and impact health outcomes.

Elevate Medical Education

REFERENCES

  1. Marinopoulos, S. S. et al. Effectiveness of continuing medical education. Evid Rep Technol Assess (Full Rep), 1-69 (2007).
  2. Cervero, R. M. & Gaines, J. K. The impact of CME on physician performance and patient health outcomes: an updated synthesis of systematic reviews. J Contin Educ Health Prof 35, 131-138 (2015).
  3. Rogers, E. M. Diffusion of innovations (1st ed.). The Free Press of Glencoe Division of The Macmillan Co., 60 Fifth Avenue, New York 11, N. Y. (1962).
  4. Moore, D. E. J., Green, J. S. & Gallis, H. A. Achieving desired results and improved outcomes: Integrating planning and assessment throughout learning activities. Journal of Continuing Education in the Health Professions 29, 1-15 (2009).
  5. Davis, D. A., Barnes, B. E. & Fox, R. D. The Continuing Professional Development of Physicians: From Research to Practice. AMA Press (2003).
EU.MedTech.ELEVATE.Featured

A Compelling Strategic Role for Medical Affairs in the Context of the new EU MedTech Regulations

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By João D. Dias1, Cesar Sanz Rodriguez2, Raphael T.B. Tan3

1 Medical Affairs & Clinical Development, Haemonetics S.A., Switzerland, Medical Affairs Professional Society (MAPS) MedTech Focus Area Working Group (FAWG) EMEA Co-Lead

2 Medical Affairs, MSD International GmbH, Switzerland, MAPS MedTech FAWG EMEA Co-Lead

3 International Medical Executive Consultants (IMEC), The Netherlands, MAPS MedTech FAWG member

EU MedTech Regulations Divider

ABSTRACT

This article provides an overview of the new MedTech European regulatory environment and opportunities for the Medical Affairs function to evolve and bring value to the respective organizations. The European Regulations ask for an increased effort from manufacturers to generate and communicate clinical evidence on the safety and performance of their Medical devices, In vitro-diagnostics and Drug Device Combinations. In conjunction with increased quality standards they make a compelling case for Medical & Scientific Governance with a prominent role for Medical Affairs in many pre- and post-market processes. A transformation of Medical Affairs into a strategic business function makes the medical device industry an exciting place to be for Medical Affairs professionals.

INTRODUCTION

For over two decades, Medical devices and In-vitro Diagnostics have been regulated in Europe by Directives for MEDICAL DEVICES (MDD) and IN VITRO DIAGNOSTICS (IVDD)1,2,3 that were published in 1993 and 1998 respectively. A separate Directive for Active Implantable Medical Devices (AIMD) was published in 1990 with a last revision in 2009. According to these Directives, devices are approved for the European Single Market only after having obtained CE Mark for which manufacturers need to demonstrate conformity to essential requirements relating to the device’s performance and safety for patients and users. After public consultation by the European Commission in 2008 it became clear that an update of the Directives was needed, one reason being the simple fact that new technologies such as companion diagnostic devices were not yet covered. The need for revision gained traction after incidents with breast implants, transvaginal meshes around 2009 and metal-on-metal hip prostheses a couple of years later. Eventually, the revision process that started in 2012 resulted in the Medical Device Regulation (MDR) in which MDD and AIMD were combined and the In Vitro Diagnostics Regulation (IVDR)4,5. The new Regulations were published in 2017, with May 25, 2017 as the official date of entering into force. A transition period to full implementation of the MDR and IVDR was allowed for three and five years respectively, which means the MDR applies from May 26, 2020 and IVDR from May 26, 2022.

So far so good… and then the COVID-19 crisis struck Europe, right at the moment when the medical device industry and notified bodies are transitioning to the new Regulations. Therefore, in order to “take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus,” the European Commission has decided to move back the date on which the new MDR would fully apply by one year, to 26 May 2021. MedTech Europe, the European trade organization of medical device manufacturers, has advocated for a similar delay for the IVDR.

Since the early days of the global COVID-19 crisis the medical industry has made a so far unseen effort in finding (bio-)pharmaceutical solutions, developing vaccines and reliable test kits. Simultaneously, in an attempt to address the relative shortage of masks and intensive care equipment such as ventilators, traditional medical device manufacturers ramped up production. Although regulators accommodate the surge of new devices by fast tracks and exemption rules, new devices are subject to meticulous assessments of performance and safety. And rightly so, since national policies to curb transmission of the virus rely on the quality of diagnostics and personal protection equipment. Especially important is the scrutiny in assessing new medical devices which are intended to be used in the management of the most vulnerable and severely ill COVID-19 patients who end up in hospitals and ICUs.

EU MedTech Regulations Divider

MEDICAL DEVICE REGULATION (MDR)

In general the new Regulations devices, improve traceability and transparency and define stricter requirements to clinical evidence and post-market surveillance. The MDR now also regulates devices for cosmetic purposes such as colored contact lenses and cosmetic implant devices. The introduction of Unique Device Identification should improve traceability, and transparency is created by the European Databank of Medical Devices (EUDAMED) where all mandatory regulatory documentation on each device is kept and updated. Manufacturers must re-certify devices in accordance with the new regulations and update their technical documentation accordingly with special attention to higher clinical requirements for class III and implantable devices. A shift of focus from a mere pre-market perspective towards a life-cycle approach also includes stricter requirements regarding post-market surveillance, post-market clinical follow-up and vigilance.

This brings us to the Clinical Evaluation, which lies at the basis of CE mark approval and the life-cycle approach. It is defined as “a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety performance, clinical benefits of the device when used as intended by the manufacturer.” The Clinical Evaluation process is described in a MEDDEV (MEDical DEVices) guidance document. MEDDEVs promote a common approach to be followed by manufacturers and notified bodies that are involved in conformity assessment procedures. Although these MEDDEVs are not legally binding, it is expected that their guidance be followed, ensuring the uniform application of the various elements of the directives/regulations. MEDDEV 2.7/1 rev. 46 is the guidance document with regards to Clinical Evaluation and is prescriptive on the process, the required qualification of the evaluators and the contents of a Clinical Evaluation Report (CER).

The CER should “describe the intended clinical benefit and provide evidence of safety and performance” where performance is defined as “the ability of a device to achieve its intended purpose as stated by the manufacturer.” This report describes the risk profile of the device based on the technical documentation and provides an appraisal of all available clinical data related to safety and performance. Any evidence gaps and residual risk need to be addressed in Post-Market Clinical Follow Up (PMCF) studies to demonstrate long-term performance safety. The results from the intensified surveillance are laid down in the Periodic Safety Update Report (PSUR, mandatory for Class IIa/b and III) and Summary of Safety and Clinical Performance (SSCP, for implantables and Class III). These documents must be uploaded in EUDAMED, which allows public access to the SSCP.

Although European market approval of new devices can still be obtained by referring to clinical data of predicate equivalent devices, the MDR explicitly lists criteria by which equivalence can be claimed from a technical, biological and clinical perspective. The equivalence under the MDD was less well defined. Under the MDR, the predicate device must have a similar design, use the same materials and come in contact with the same tissues and body fluids, and be used for the same clinical indications. If a device does not meet these criteria, manufacturers need to generate their own clinical evidence with appropriate clinical investigations.

CE Marking requires Notified Body involvement for most medical device classes and is related to implementation of a Quality Management System, which must include plans pertaining to Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF). For non-sterile Class I devices, manufacturers can conduct the conformity assessment themselves and basically self-certify. For Class I devices that are sterile, measuring or reusable surgical instruments as well as for all higher device classes, oversight of a Notified Body is required. In the end, it is the Notified Body that issues a CE Marking Certificate and ISO 13485 Certification. Only with these certificates in place the manufacturer can prepare a Declaration of Conformity and put the CE Mark sign on their products and labelling.

EU MedTech Regulations Divider

IN VITRO DIAGNOSTICS REGULATION (IVDR)

In Vitro diagnostics (IVDs) are medical devices with which tests are performed using human specimens such as urine or blood. Familiar examples of such devices are pregnancy tests and tests for determining the level of glucose or cholesterol in the blood. The current directives distinguish between medium risk and high-risk lists of IVDs. Those IVDs not captured in these lists are automatically classified as low risk. Obviously more stringent market authorization procedures with Notified Body oversight apply to high risk IVDs. Whereas in the past only a minority of IVDs required involvement of a Notified Body, under the new classification an estimated 90% will now require it. The IVDD had some gaps and this binary system was thought to be no longer sufficient. Hence, like for the MDR, a risk-based approach classification was introduced based on the severity of the disorder tested for and possible consequences of an incorrect test result. Instead of two lists, the new IVDR now distinguishes four categories, Class A (lowest risk), Class B, Class C, and Class D (highest risk) and dictates that Class B and above IVDs will require oversight from a Notified Body as part of their conformity assessment.

Aside from the risk-based classification, it will not surprise you that the new IVDR has more features in common with the MDR. As is the case for medical devices, the IVDR requires clinical evidence and post-market performance follow-up. This will require a Performance Evaluation plan and report for all IVD Classes, which will describe how to demonstrate scientific validity, analytic performance, and clinical performance.

EU MedTech Regulations Divider

COMBINATION PRODUCTS/DRUG DEVICE COMBINATIONS

Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine. In the European Medicines Agency (EMA) view, if the principle intended action of the combination product is achieved by the medicine, the entire product is regulated as a medicinal product under Directive 2001/83/EC7 or Regulation (EC) No 726/20048. However, MDR’s Article 117 brought some relevant additions. First, two categories were defined: (a) Integral, where the medicinal product and the device form a single integrated product (e.g. pre-filled syringes and pens) and (b) Co-packaged, where the medicinal product and the device are separate items contained in the same pack (e.g. reusable pen for insulin cartridges). Next, Article 117 also incorporated some relevant amendments to Directive 2001/83/EC to ensure combination products comply with the medical device legislation. Per MDR’s Article 117, the marketing authorization application should include a CE certificate for the device or an opinion from a Notified Body on the conformity of the device (except for non-sterile, non-measuring and non-reusable surgical Class I devices).

Probably as a reaction to the rapid growth of combination products in recent years and the need to bring further clarity in this area, in June 2019 EMA released for public consultation a draft Guideline on Quality Requirements for Regulatory Submissions for Drug-Device Combinations9. The aim of this Guideline is to clarify expectations laid down in Directive 2001/83/EC and address the new obligations in the MDR. EMA makes it clear that the Notified Body assessment and marketing authorization review would not result in duplicate assessments. The former will review the device alone, while the latter will ensure the safety and efficacy of the drug are not compromised by the inclusion of the device part. The consultation period ended in August 2019 and EMA is now due to finalize the Guideline in the second quarter of 2020.

It is also worthwhile making a reference to medical devices which may contain an ancillary medicinal substance to support the proper functioning of the device (e.g. drug-eluting stents). These products should comply with the medical device legislation. Yet, the manufacturer should also seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma, or if it is within the scope of the centralized procedure for the authorization of medicines. For other substances, the Notified Body can seek the opinion from EMA or a national competent authority. Of note, EMA has recently issued a Consultation Procedure for Ancillary Medicinal Substances in Medical Devices.

Companion diagnostics are seen by EMA as in vitro diagnostic tests that support the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment. Applicable regulations were discussed above. Yet, before the Notified Body can issue CE Marking, it must seek a scientific opinion on the suitability of the companion diagnostic to the medicinal product concerned from EMA or a national competent authority, as appropriate. Similarly, a scientific opinion would also be needed for some other medical devices made of substances that are absorbed by the human body to achieve their intended purpose. These devices are normally introduced into the human body via an orifice or applied to the skin. Last, we should not forget the so called “borderline products”. These are complex healthcare products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements. The European Commission publishes the ‘Manual on borderline and classification in the Community regulatory framework for medical devices’ which provides examples and recommendations for determination of classifications. National competent authorities classify borderline products either as medicinal products or, for example, as medical devices on a case-by-case basis based on the product’s composition and constituents, its mode of action and its intended purpose. This determines the applicable regulatory framework.

EU MedTech Regulations Divider

THE OPPORTUNITIES FOR MEDICAL AFFAIRS: MEDICAL & SCIENTIFIC GOVERNANCE

The new European regulatory environment (MDR, IVDR and EMA guidance on Drug Device Combinations) in conjunction with expanded quality standards for MedTech products and a rapidly changing reimbursement landscape are intensifying the need for a Medical Affairs role in the product lifecycle management. Furthermore, the increased trade organization’s guidelines as well as a more complex competitive environment in which the direct comparator might not be another MedTech product but instead a Drug or a Drug Device Combinations, all work favorably for Medical Affairs to step up its game and demonstrate its value in many regards.

The traditional competencies of Medical Affairs are still required to produce the new mandatory regulatory deliverables (Clinical/Performance Evaluation Report, Periodic Safety Update Report, Summary of Safety and Clinical Performance). However, more than ever Medical Affairs involvement needs to be formalized for various other key processes ranging from product development to device application. In order to give real meaning to patient and customer centricity, the inclusion of Medical Affairs contribution is indispensable with regard to, for instance, risk analyses, claims development and identifying user training needs.

In addition, medical and clinical research functions must lead in the development of coherent and affordable clinical research programs that serve regulatory compliance, reimbursement and commercial adoption purposes. The increased effort the companies must make to generate clinical evidence will undoubtedly put strain on human and financial resources. The careful planning and design of studies should avoid waste in time and money while providing the evidence the business needs in a timely fashion. Therefore, as non-inferiority assessments are giving space to superiority assessments, an increased is expected in reliance for regulatory purposes on less conventional evidence generation strategies such as registries, collaborative research and investigator lead studies.

Furthermore, ensuring the safe application of current devices, medical communication and interactions with healthcare stakeholders and health authorities, collecting and weighing medical intelligence on future directions in healthcare all require medical scientific oversight. The medical scientific oversight will be fundamental in the advancement of the company’s innovation agenda as the bar is higher than ever, as are the associated entry and maintenance costs.

EU MedTech Regulations Divider

CONCLUSION

The new environment makes a compelling case for installing a structure for Medical and Scientific Governance and a proactive strategic role for Medical Affairs. This in turn opens the discussion on how to develop and organize competencies around organizational capabilities that relate to the development of innovative and relevant devices, the substantiation of medical-clinical and health economic claims and ultimately oversight to ensure safe and appropriate use. Thus, we argue that now is the time to engage in captivating thought exercises about whether a company’s fabric with a prominent role of Medical Affairs adds to the organizational capability and resilience to handle current and future challenges.

This publication represents the consensus opinions of the authors and various members of MAPS, but does not represent formal endorsement of conclusions by their organizations

 REFERENCES

1. EU Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. EUR-Lex; an official website of the European Union. Published July 12, 1993. Accessed August 27 2020.

2. EU Council Directive 98/79/EC concerning in-vitro diagnostic medical devices. EUR-Lex. Published December 7, 1998. Accessed August 27, 2020.

3. EU Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, EUR-Lex, Published July 20, 1990. Accessed August 27, 2020

4. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. EUR-Lex. Published May 5, 2017. Accessed Aug 27, 2020.

5. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. EUR-Lex. Published May 5, 2017. Accessed Aug 27, 2020.

6. European Commission. MEDDEV 2.7/1 rev. 4 – Clinical Evaluation: A guide for manufacturers and notified bodies. Website of the European Commission. Released June 2016. Accessed August 27, 2020.

7. EU Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use. EUR-Lex. Published Nov 28, 2001. Accessed Aug 27, 2020.

8. EU Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. EUR-Lex. Published April 30, 2004. Accessed Aug 27, 2020.

9. European Medicines Agency – draft guideline on the quality requirements for drug-device combinations. EMA Website. Published June 3, 2019. Accessed Aug 27, 2020.

Learning.Agility

Learning Agility: An Emergent Capability for Future-Proofing Medical Affairs Strategic Planning

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By: Simon Kyaga1; Keith Morris2; Kiely Flanigan3

1Global Medical Lead, Psychiatry, Servier; 2Executive Managing Director, Scientific and Medical Affairs, Syneos Health; 3Director, Medical Affairs Syneos Health

 

ABSTRACT

This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. In essence, learning agility is a set of skills, competencies, and mindsets that support our capability of “knowing what to do when we don’t know what to do.”1 Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. Through the enablement of learning agile behaviors, the approach to strategic plans can be made with an eye toward ongoing reflection and updates. We define four descriptive behaviors (contextual curiosity, vision-driven adaptability, educated risk taking, and accountable learning) that match up to MAPS best practices in strategic plans and then discuss how to apply those learning agility behaviors. We conclude with future recommendations for the development and application of learning agility.

 

KEYWORDS

Learning agility, strategic plan, strategic thinking, medical strategy, capabilities enhancement

 

The COVID-19 pandemic has accelerated the need to develop Medical Affairs capabilities in learning agility. Not unlike various industry shifts over the years that have impacted the role of Medical Affairs, we’ve experienced a shift in the way Medical Affairs organizations are responding to changes affecting the execution of strategic plans. Field Medical is learning to engage stakeholders virtually and support HCPs in new ways as they engage with their patients through new technologies. Clinical trials adopted new protocols to protect patients and sustain recruitment. Conferences and congresses were postponed. Organizations are seeking flexible resourcing models to manage downturns in business and leveraging downtime to upskill team members. All of these changes have required an openness to change and the development of new skills to learn new ways of achieving our work objectives. We are now not only shifting how we do our Medical Affairs work, but also planning for a “new normal” as we navigate doing business virtually.

 

Yet, however uniquely disruptive COVID-19 has been, it is still only one more example of the bucket of business disruptions that have affected the skills, knowledge, and capability needs within Medical Affairs work. At the heart of the changes asked of us and our teams is learning agility. As a core capability associated with managing ambiguity and “knowing what to do when you don’t know what to do,” learning agility is particularly relevant and useful in developing adaptive and dynamic Medical Affairs strategic plans that stand the test of change and disruption.1

 

Learning agility in strategic planning is important because by incorporating learning agility behaviors and mindsets into the development and implementation of Medical strategic plans, teams are better able to pivot and innovate, as needed, to changing internal and external dynamics, while remaining in alignment to the overall medical vision and business objectives.

 

This article aims to position learning agility as an emergent capability that supports the future-proofing of Medical Affairs strategic planning processes and outputs. Our position is that learning agility is a capability that should be developed internally and applied to the development and operationalization of strategic plans. We then define four descriptive behaviors that map to aspects of Medical Affairs strategic plans and discuss how to apply those learning agility characteristics.

 

Medical Affairs Strategic Planning

Medical Affairs strategic plans include both intellectual components, such as situational analyses and medical strategies, as well as tactical components, including tactical and operational plans, and assessment and measurement metrics.2 Medical plans are important because they guide decision making across the organization and support the communication and assessment of Medical Affairs’ efforts and impact.

 

Medical Strategic Planning is an integral part of setting strategic direction and articulating the tactics for driving Medical Affairs value and impact for patient and organizational outcomes. But, how do you create a realistic and viable strategic plan given a VUCA (volatile, uncertain, complex, and ambiguous) Medical Affairs ecosystem? What brings Medical strategic plans to life beyond and ensures it gets referenced more than once a year in the annual planning process? How do we make the strategic plan content memorable and keep it top of mind with our key audiences? We suggest that the secret to effective Medical Affairs strategic plans is learning agility.

 

In a Medical Affairs context, learning agility brings key behaviors and mindsets into the Medical planning, development, and execution processes that ensure the content contains relevancy and resonance for the organization. Although variations exist between companies in terms of influences affecting the strategic planning process (e.g., preferred timing of Medical support of launches, products, therapeutic area considerations, and operational competencies versus strategic positioning priorities), the Medical Affairs strategic planning process reflects multiple stakeholder insights, business objectives alignment, and tangible data for strategic decision making. The strategic plan is not intended as a fixed manual that is reviewed once a year.

 

To be of service to Medical Affairs and the broader organization, a strategic plan must be a living document that is flexible enough to incorporate new insights and maintain relevancy in the face of changing priorities and dynamics.

 

There are several descriptive behaviors team members can use in approaching the development, communication, and operationalization of strategic plans to support success:

 

Each of these behaviors is based on the capabilities needed to design, communicate, and execute on a strategic plan. The descriptiveness of the terms reflects a desire to position these learning agility behaviors as both foundational and aspirational. Learning agile behaviors are both critical for the here and now in performing work, but also for guiding toward the future and inspiring learning and development.

 

Learning Agility

Learning agility is relatively new to the Medical Affairs scene, but it is starting to see more traction as our industry seeks to build capabilities in individuals and teams to navigate and harness the rapidly changing nature of Medical Affairs. Originally used to develop the managerial capabilities of high-potential, high- performing talent, learning agility can be applied not only at the individual level, but also at the team and organizational levels, and is associated with higher levels of organizational performance.3,4 For purposes of this article, we’ll focus on developing learning agility at the individual level and use the following definition:

 

Learning agility is a capability associated with adapting to change and uncertainty by applying previous lessons learned.

 

Learning agility requires both adaptive readiness to change and proactive innovation in times of ambiguity.5 In essence, learning agility activates the value and impact of Medical Affairs strategic planning components (i.e., situational analysis, medical strategy, tactical and operational plans, and assessment and measurement metrics) despite change and shifting expectations internally and externally.

 

When it comes to Medical Affairs strategic plans, it is no longer sufficient to rely on the intellectual and tactical domains of competence. Successful Medical Affairs strategic plans reflect a collective organizational capability—an integrated representation of knowledge, skill, and mindset—that brings to life within the plan the flexibility to adapt, learn, and pivot toward changing needs. Learning agility is the “how” behind the “what” of Medical Affairs strategic plans.

The integration of learning agility and Medical strategic planning is important to how both strategic and day- to-day operational decisions are made. This is even more important today as Medical Affairs is being asked to communicate and demonstrate its impact and value within competing priorities from more diverse and increasingly challenging internal and external stakeholder needs. In addition, due to COVID-19 disruptions, including closed conferences, Medical Affairs is forced to reconsider how to communicate and how to balance between strategy and tactics in an uncertain environment.

 

 

Mapping Learning Agility Behaviors to Medical Affairs Strategic Planning Processes

 

Using the strategic planning framework developed by MAPS, the section below looks at the fundamentals of Medical strategic planning and suggests related learning agility behaviors and mindsets that are instrumental to both intellectual and tactical outcomes. The learning agility behaviors form a kind of permeable flexibility and protection that ensures the strategic plan is created and maintained with maximum adaptiveness (as seen in the above diagram). Learning agility brings strategic plans to life and articulates specific behaviors that support the strategic plan having bigger impact through greater relevancy. A strategic plan must be relevant to have impact and the learning agility behaviors associated with MAPS’ four elements of strategic plans makes them applicable for the teams using them.

 

 

Medical Strategy figure

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUMMARY

 

In this article, we have identified learning agility as an emergent capability that brings to life and ensures the relevancy of Medical Affairs strategic plans. Specific applications were discussed for each learning agility behavior in context to its associated strategic planning element. The importance of developing the skills and mindsets to navigate change, uncertainty, and disruption are evident, now more than ever with COVID-19, and important to developing the capabilities to harness the future, whatever may come within Medical Affairs.

 

REFERENCES

1. Hallenbeck, G., & Santana, L. (2019). Great leaders are great learners: How to develop learning-agile high potentials. Center for Creative Leadership white paper, 1-16.

2. MAPS Annual Conference (2020). The importance of Medical strategic planning. Conference presentation: Miami, 1-23. Access in the Community Portal.

3. De Meuse, K.P. (2017) Learning agility: Its evolution as a psychological construct and its empirical relationship to leader success. Consulting Psychology Journal: Practice and Research, 69(4), 267–295.

4. McCann, J., Selsky, J., & Lee, J. (2009). Building agility, resilience and performance in turbulent environments. People & Strategy, 32(3).

5. Doeze Jager-van Vliet, SB, Born, MPh, & van der Molen, HT (2019). Using a portfolio-based process to develop agility among employees. Human Resource Development Quarterly, (30), 39–60.

6. Bourgoin, A. & Harvey, J-F. (2018). Professional image under threat: Dealing with learning–credibility tension. Human Relations, 71(12), 1611–1639.

 

Download the full article.

Joseph.Eid .Interview

Interview: The Value of Medical Affairs

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Joseph Eid, MD, SVP, Head of Global Medical Affairs at Bristol Myers Squibb, describes how Medical Affairs can ensure representation of the patient voice in product development, and the positive shift and elevated prominence Medical Affairs is achieving within companies.

 


If the video above does not play, or to view full screen, CLICK HERE to open in a new window.

 

Download the Presentation

Members may also download a PDF copy of Dr. Eid’s panel discussion on The Value of Medical Affairs from the MAPS 2020 Global Annual Meeting as well as a recording of the session in the Community Portal.

 

View the White Paper

You may also view our latest white paper on the Communicating the Value of Medical Affairs, by clicking here.

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Managing Your Career – Part 3: Five Modern Medical Affairs Competencies

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Five Modern Medical Affairs Competencies

Dr. Qasim Ahmad, Corporate Officer, Head of Medical Affairs, Japan, Novartis

 

Since joining the pharmaceutical industry (PI) 2 decades ago, I have been lucky to have lived through and experience the exponential growth of medical affairs function, not only in size and ever expanding responsibilities, but also the importance and value it brings to the industry. There are several internal and external factors, contributing in the evolution of medical affairs from a mere support function to becoming a core pillar, and an equal partner with drug development and commercial functions with the PI.

In recent years, we have seen significant and unprecedented advances in biotechnology, delivering novel treatments and data sets, faster than ever before. There is an information overload, which calls for smart and innovative ways to design, analyse, disseminate and communicate the value of evidence, to the right end user (the customers), at the right place and the right time.

Concurrently, health systems across the world are becoming over-burdened, facing considerable sustainability challenges, due financial constraints, ageing, increasing population, changing disease patterns, persisting as well as new communicable diseases (COVID-19) and cost burden of chronic non-communicable diseases, including cancers.

You must also develop command on evolving health care environment and be equipped to meet the challenges associated with growing drug approval complexities and health technology assessment criteria for access. Develop unique competencies and transformative operating models to address these requirements, build capabilities that are ideally suited for medical affairs organization to generate data beyond traditional registration trial safety and efficacy packages, to facilitate evidenced based decisions making based on patient centric, clinically meaningful, health outcomes, access and quality of life real world data (RWD) data sets.

As you think of building your career in medical affairs, keep the above opportunities and challenges in consideration, the following 5 core medical affairs competencies will help nurturing your talent as patient and customer centric medical champions, ready now for future.

  1. Enterprise Perspective
  2. Functional Excellence
  3. Health System Thinking
  4. External Facing Organization vs Internal focused
  5. Effective Leadership & Governance

 

 

1. Enterprise Perspective

Medical Affairs has evolved to be one of the most strategically important and valued functions in a pharmaceutical industry. As successful medical affairs professionals, you need to build the skills and scientific acumen like that of a clinical development expert, while demonstrating the strategic intellect and real life customer oriented mind-set of a commercial leader. You will have to champion cross functional navigation, show enterprise vision, logical and critical thinking, develop broad and long range strategic direction throughout product life cycle and build bridges between unlimited internal touch points as well as external stakeholder.

 

2. Functional Excellence

In order to demonstrate value, your medical affairs competencies should be geared to exceed internal and external expectations, meeting the demands of above mentioned expanding responsibilities, while acquiring new skills and capabilities. You will need an all-rounder approach, adapting new technologies, digital tools, precision medicine approaches, and introduce novel engagement models. Thus continuously striving for medical and operational excellence, not only in designing and delivering high quality clinical trials based on meaning actionable insights, but also excellence in executing deep scientific exchange with medical experts, incorporating the voice of patient, payer and all stakeholders at launch, and across life cycle strategies.

 

 

3. Health System Thinking

In medical affairs, you are perfectly placed to lead, plan and deliver health care solutions and to shape the environment, playing a key role in health systems sustainability. You should build capabilities and competencies to assess health system needs and developing solutions, supporting public health initiatives; disease awareness & educational training programs; research collaborations in area not only limited to company core business (orphan diseases, rare indications, special populations); managed patient access programs and many other patient focused projects, partnering with health system players. You will require special skills for this mind-set shift, and thinking beyond the pill to building trust with the society. This competency is distinctive and vital for future role of medical affairs.

 

4. External Facing Organization

As part of modern medical affairs organization, you should have involvement and ownership across life cycle of assets, from early development to late stage planning. Either you are in field medical teams, medical advisors or MSLs (medical science liaison) role, you are the eyes and ears of the organization to external world. With external customer base expanding beyond prescribers and policy makers, you well have to learn rule of engagement and proficiency to work with providers, payers, private non-state health actors, patients and patient advocacy groups, as they are all taking central stage in health care decision making. This will be the game changers in reversing the traditional internal fixated industry approach to a strategic patient and customer focused, outward facing organization. Building this core competency by incorporating patient journey, stakeholder need assessment and changing health care limitations in your strategies, will enhance collaborations, speed of innovation, resource waste reduction and improved patient outcomes.

 

5. Effective Leadership

Modern medical affairs is not a support function, it is about leading from the front as equal partner with commercial, departing from prior passive back seat mind-set and demonstrate value to the organization through proactive leadership, vision and measurable impact. You will have to steer this transformation from current medical advisory role to leadership status, breaking unnecessary internal silos and taking ownership as well as accountability of business deliverable. Creating this new room within the organization will requires your commitment, change agility, interpersonal skills and inspiring leadership to take on completely new responsibilities or replacing those previously championed by other functions.

 

Conclusion

Traditional sales and commercial models are becoming obsolete, success of future pharmaceutical frameworks relies on vision, foresight and appropriate investment in building medical affairs (MA) talent, ready now for future. With ever changing external landscape, regulations and compliance requirements, the role of medical affairs will continue to grow as the key pillar, vital to achieve organizational objectives. By building these core competencies, you can demonstrate to your leadership, the value medical affairs brings, and its strategic far reaching business impact.

 

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Managing Your Career – Part 2: How To Maximise Your Chances of Success at Interviews

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How To Maximise Your Chances of Success at Interviews

By Alan McDougall, MD, VP, Head of Medical Affairs, Asia-Oceania Region, Astellas

 

Interviews are stressful but you can reduce your adrenaline levels through proper preparation. Medical Affairs has transformed in the last decade and there are a number of key competencies which are sought after and which you should attempt to demonstrate through each and every contact you have with both the recruiter and your prospective employers. Below is a not exhaustive list of the most desirable competencies and behaviours.

 

Communication

The ability to communicate clearly and effectively and through a variety of channels is essential for anyone working in medical affairs. Having a high level of knowledge but an inability to share it or teach it effectively is of little value. Communication also includes using appropriate body language, listening skills and the ability to provide feedback. Make sure every verbal or written contact you have with the company or the recruiter is carefully thought through and proof-read in the case of written contacts.

 

Passion and enthusiasm

Employers want to hire someone who demonstrates a passion to work at their company, sometimes described as being “hungry” for the role. Having the right attitude is often more important than knowledge, because attitude is very hard to train but knowledge can be learned. Carefully word your cover letter and individualise your CV for each job to stress key experiences or skills that are mentioned in the advertisement and job description (JD). Spend time browsing through the company’s corporate website and come armed with pre-prepared questions which are thoughtful and specific to the role and the company. If possible, ask about a recent company press release and the implications (if any) for the role for which you are applying.

 

Technical skills

Medical affairs positions require certain technical skills that are usually listed in the job advertisement or JD. You should already possess many of the skills the company is looking for, at least to some degree. You may not yet be an expert in all of them but there should be a solid foundation upon which you can build. Typically, at interview, these technical competencies will be assessed (presentation skills, therapeutic area knowledge etc.). Take note of the JD, advert and recruiter’s comments and use every contact opportunity to mention where your current technical skills fit the role being offered.

 

Work ethic

It should go without saying that employers expect you to be at work on time, do what you were hired to do, meet targets and deadlines and work to the best of your ability. Sadly, we have all worked with colleagues who do not always meet these basic requirements. Make sure you are early for interviews, meet all deadlines when replying to emails, phone messages etc. and do everything you can to give your prospective manager confidence in your own work ethic. You have only a few contact opportunities with your potential next company and so make sure each one says something positive about you and your personal standards.

 

Flexibility

More than ever before, employees need to react quickly to changing business conditions. Agile companies and agile teams are currently popular subjects in articles written by business thought leaders. Employers need employees who can quickly adapt to change. Come to interview with examples of how you demonstrated your own agility – perhaps covering another role on top of your own, taking on a project about which you had no little or no previous experience and delivering a successful outcome or dealing positively with an unpredictable environmental change.

 

Resilience

We all typically get challenging but (hopefully) achievable goals and deadlines. The key to successful delivery is often being able to work hard and to keep moving forward when you encounter the inevitable and frustrating obstacles that regularly happen in business. Come to interview with examples of how you overcame particularly difficult challenges and show that you did not give up but that you persevered and ultimately met your objectives.

 

Teamwork

Little in the pharmaceutical industry is achieved by a single individual. Roles in medical affairs are becoming more diverse and specialised and therefore there is an increasing need for reliance on your colleagues to get things done. The ability to get on and work collaboratively with others is therefore a key competency. Using real examples, show how you contributed to successful teamwork under challenging circumstances and how you “did not give up”.

 

Life-long learner

As product portfolios and market environments change, there is a need to seek out new information, challenge your beliefs and explore new ways of doing things. Long-held “facts” can change when new contradictory evidence emerges. People who are naturally curious with an interest in learning combined with a willingness to share this with others, make great co-workers. At interview, explain what new skills or knowledge you have learned, how you applied this at work and describe the impact that it made.

 

Problem-solving skills

Managers look for people who are motivated to take on business challenges, ideally with minimal direction. Most of us prefer our employees to “come to us with solutions not problems”. Employees should see when something needs to be done and react accordingly. Come to interview with examples of how you observed an issue at work, took ownership of it and solved it. This can be even more impactful if it wasn’t in your job description in the first place.

 

Loyalty

Employers want people to stay with them for many years due to their financial investment with the recruitment company and the time spent on interviews and on your on-boarding process. Multiple job moves in a relatively short time period with different companies is usually an alarm bell and indicates a risk that you will not stay long if you are even offered the job. If you unfortunately have had several short-term moves recently, make sure that you come to interview with a clear explanation as to why and what you learned. Try hard not to criticise your current or previous companies or managers as this can come across quite negatively, even if you feel you have every right to do so. Employers always prefer someone running towards the role on offer than someone running away from their current job as the former is a positive choice whereas the latter can be simply escaping to “any port in a storm”.

 

Conclusion

It is a truism to say that you only have one chance to make a good first impression and so at interview be well prepared and make sure you have done your homework well in advance. Tell the employer why you really want this job and make sure your passion and enthusiasm come to the forefront. Show your agility, resilience and ability to learn, which are all highly valued competencies by employers. Finally, do remember that all contacts with the employer and recruiter, no matter how trivial, are likely to be judged so make them count!

 

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Managing Your Career – Part 1: A crash course on how to manage your career in Medical Affairs

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Managing your career – Part 1: A crash course on how to manage your career in Medical Affairs

By Cezary Statuch, MD, VP, Medical, International Markets, Biogen

Like many things in life, when managing your career timing is everything, and being in the right place at the right time is important. Knowing whether it is the right time for you to move on is not always easy. The pharma and biotech industries are an attractive place to pursue your professional dreams, and some markets are in great demand for medical affairs talent–so the phone rings more often than ever with calls from headhunters. Unfortunately, at times of high demand for talent the recruiters are less likely concerned if you have completed your career cycle, and if your skill set fits what they are after you will have to deal with serious temptations. Here are a few tips on how to manage your career planning and how to get ready for your next job.

  • Look back and do a quick assessment of your career to date. Understanding your career trajectory, what you have accomplished and where you want to go will significantly help with the challenge. But most importantly understanding your limitations is critical. Only when you know them will you be able to close the gaps. Ask yourself these questions: Have you have been in your current role long enough? Have you completed a career cycle? Have you fully learned the role? “Job jumpers” or “non-stickers” as I call them are very easy to spot. If you happen to have a very short stint in the role, be prepared to provide a compelling explanation why.

 

  • Understanding what the industry can offer is a common challenge for candidates, especially the younger ones. The knowledge of basics of drug development and the commercialization process is crucial as it will help in understanding what opportunities exist in your country/territory and how to navigate them. The industry has evolved dramatically over the past decade and there are many roles now which never existed previously. There is a wealth of resources offering insights into how pharma companies are structured. Many companies offer training in the drug-development process as part of their curricula for employees. If your company does not, look online. Talking to more senior colleagues is also a good source of acquiring that knowledge.

 

  • Compete for the right job, one which matches your skill set. Understand your strengths and create a competitive advantage. Create a simple checklist of attributes/skills which may differentiate you from other candidates competing for this position and sell yourself well.

 

  • Do not be a title junkie! Titles are important as they help to position us in the industry and make us proud of what we have achieved. We all like attractive titles, particularly those which reflect our seniority, but beware of inflated titles which are easy to spot. Do not take the job simply because it offers a higher grade or a more impressive title, as this could easily put your career on the wrong track. Reversing this could take a long time.

 

  • Having a great boss is a big draw, but don’t choose the job purely because of the manager. Follow the job content and opportunity to learn, not the person. Your boss will always remain part of your professional circle and you will always be able to rely on his/her career advice, even if you stop working together.

 

  • Having the right work-life balance is critical for your success, so ask yourself how moving to your next career step will affect your personal life and if you are ready for it. Frequent travel, need to relocate, necessity to work out of hours—these things can seriously impact your job satisfaction.

 

  • Creating the right image is very important and is a process which takes time. You can start with creating a high-quality LinkedIn profile. LinkedIn has become a powerful tool. Read profiles of those whom you respect and admire. Use a professional, high-quality photo and ensure the use of proper English. When you apply, provide a quality CV adapted to showcase your skills for the role for which you are applying.

 

  • Always respond to recruiters but be very transparent about your true intensions. Do not interview if you are not seriously considering the opportunity. Telling recruiters that you are not ready to change the job yet will speak highly of you, proving you to be loyal to your organization and mature about your career goals. They will remember that and will keep you on their radar screen.

 

  • Get help from those around you. Pay attention to relationships and build your social capital. The pool of professionals in the industry is defined, and so is the number of companies. The proverbial “small world” applies to our industry as well, so take care of your reputation, not only within your own company, but most importantly within the industry. Become visible within your organization and outside of it. Build your own pool of advisors, coaches and mentors. They can be peers, but don’t have to come from the same department or the same company.

 

  • Make your company aware of your aspirations; otherwise your manager may assume that you are not interested and therefore not consider you for the job you want. Apply for the jobs which may be a stretch for you even if you think that the probability of getting them is low. It will send a strong message to your manager as to what you aspire to, and will help you and your manager to understand what you need to learn to land the job the next time. Treat every interview as a lesson and always ask for feedback. Unfortunately, providing high-quality, timely feedback for those candidates who failed to get the job is still not a common practice in the industry. If feedback was not provided to you, do not be afraid to reach out to the hiring manager or the recruiter to discuss the outcome of your interview. Constructive feedback is an invaluable source of direction for your future career steps and providing it is not always easy. You may need to be persistent and ask questions as to why the interview was not successful or why you were not chosen. Regardless how well you are supported in your career development, there is one principle which should always guide you: remember that ultimately, you own your career and no one else but you should drive your development.

 

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Purpose-driven culture: How to make an impact in a value-driven world

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Executive Vice President & CMO, UCB, Iris Loew-Friedrich discusses the importance of a purpose-driven culture to employee engagement

 

Caring for people – patients and colleagues – coupled with the science are the twin elements that form the foundation of Professor Doctor Iris Loew-Friedrich’s approach to her role. And this aligns neatly with the vision of her employer, global biopharma company UCB, and provides a platform for collaboration both within and outside the organization.

A physician by training, Professor Loew-Friedrich started her professional life at the Frankfurt University Medical School and has always tried to combine patient care with high-quality research. Today she is Executive Vice-President Development and Medical Practices and Chief Medical Officer at UCB, where she provides global strategic leadership across a range of areas.

“I still very much consider myself a physician, so patient care is really at the center of what drives me – and more generally it’s care for people: people living with diseases and also people in our company, in my organization and people in our industry are what motivates me very much.” This approach chimes with the way UCB articulates its vision: “Inspired by patients. Driven by science.” Professor Loew-Friedrich is confident that this “really sends out a message about who we want to be.”

 

Culture is a key driver

She explains: “I think culture is the key driver and so creating a culture that gives colleagues a sense of purpose and the opportunity to make a meaningful impact is important. At UCB, we have one central question that we ask all the time: how will what we do make a difference for patients living with severe diseases? It’s the value-creation topic that is at the center of all of our work.”

And, of course, this vision resonates especially within the Medical Affairs function.

“Our mission in Medical Affairs is to drive the continuous modernization and integration of data from multiple disciplines and sources. Then we need to translate them into actionable insights with scientific integrity, efficiency and transparency so that we optimize the patient and healthcare professional experience. That’s a mission behind which we can all align. We try to ensure that all colleagues in our Medical Affairs practice understand how each of them contributes to this mission and we combine this with forming a culture of high-performing teams.

 

“Everybody is focused on the same purpose of creating value for patients. On top of this, we try to ensure that we are an organization that cultivates learning, innovating and high performance and all of that integrated with opportunities for personal development, recognition, and rewards. It is the entire package that is required to attract the talent for the future and to maintain and develop that talent in our organization.”

Moreover, continuous learning is key to fostering agility and adaptability, according to Professor Loew-Friedrich. “As the environment keeps changing so quickly, the ability of an organization to be agile and to adapt is very important and so these are important traits that we’re looking for when we are hiring talent – a mindset to innovate, to grow, a mindset of continuous learning.”

 

How can the organization attract this type of talent? “We aim to create the sense of purpose, the sense of belonging, and key opportunities for personal development and growth. In line with our practice thinking, we are trying to establish communities of colleagues who either have the same role in the organization or who work in the same geography or who are engaged around the same patient population. So, our communities are aligned on common themes and we see that as a major driver of identification with the Medical Affairs organization and a source of inspiration and learning.”

 

Leadership

Leadership for Loew-Friedrich has always been about empowering people to have maximum impact in a team environment. “I consider myself very much as someone who creates opportunities and empowers people. I believe you cannot be a leader without being passionate about what you are doing. Of course, we need to be very objective in our decision-making.”

Asked about the key capabilities to be developed within Medical Affairs as we move towards value-based medicine, Professor Loew-Friedrich is clear: “From my perspective the biggest topic is probably around creating and mastering medical insights. The second area of focus is collaborating very broadly for evidence generation.

“In terms of generating and mastering medical insights, I think we have already plenty of data available but how do we then use the data to truly generate insights? For me, this means that it’s not about just generating outputs and results, but really going one step further and distilling meaningful insights, providing context and ultimately driving impact. “On the second topic – collaboration for evidence generation – I think we have plenty of opportunity to join forces with academia or other institutions outside of our industry to invest our joint resources into the acceleration of the advancement of medical science. If a medicine gets to a patient in its first indication, there is a vast opportunity in terms of further knowledge and insights being generated: how can we get to the best ideas and how can we turn them into a true win-win situation that will create value for patients? This is where I believe we can collaborate closely with academic institutes, patient advocacy groups and other stakeholders to really get to the best possible outcome.”

 

Professor Loew-Friedrich points out that collaboration will be enhanced by advanced technology. “What I am seeing for the future is that we need to launch artificial intelligence capabilities – so that we use the data to simulate scenarios that will very objectively inform the next steps and ultimately enhance patient care. One of the big topics around collaboration for evidence generation is building on the strengths of human intelligence and artificial intelligence and establishing seamless interaction between both.”

How can we measure our performance in this new world? “Performance management is a topic that we continuously need to evolve and that is not as easy as it sounds. We’re trying to move away from very simple, quantitative measures – number of scientific exchanges, number of publications, impact factors – to measuring the quality of our analytical skills and the insight generation. Getting to meaningful qualitative measures is not an easy task. And I understand it’s not only difficult for UCB, it’s a challenge for the entire industry.”

Finally, the new operating model elevates Medical Affairs from a supportive role into a strategic decision-maker and trusted scientific partner: how is this change manifesting itself within the organization? “We are moving towards an integrated model that provides the Medical team the right space to be a trusted scientific and strategic partner ‘eye-to-eye’. What we need to continue to enhance is leadership and business acumen of our medical colleagues. This is not only about scientific leadership and leadership in insight generation, it’s also leadership in the most classical sense of providing direction, engaging and inspiring colleagues – inside Medical Affairs and beyond. That’s a work in progress and a key competency that we continue to strengthen in the organization.”

 

Prof. Dr. Iris Loew- Friedrich: Career Path

 

Rise.Medical.ELEVATE

The Rise and Rise of Medical

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Can Medical professionals step up to a more strategic role? Dr. Ameet Nathwani discusses the need to define and measure our contribution, and why we must join together as a community to reshape the future of healthcare.

 

As technology advances inexorably transforming the healthcare landscape, Medical is poised for a more strategic role within pharma – that’s the view of former Chief Medical Officer of Sanofi, Ameet Nathwani. However, nobody with whom he works closely would be surprised to learn that he is not a fan of the term “Medical Affairs”.

“This harks back to an understanding of the way that Medical functions used to work about 15 or 20 years ago, which was much more around supporting the scientific base of the commercial organization. I prefer to just refer to the Medical function as it has evolved and expanded enormously; it’s a much more strategic function now and where it sits in Sanofi, reporting directly to CEO level speaks loudly to the progress made in this regard.”

New dynamics in the healthcare ecosystem

Underpinning this evolution are a series of distinct trends (see Figure 1) including the digital health revolution, the empowerment of the patient, and a requirement for continuous evidence generation. He explains: “It takes seven to eight years to develop a drug and, in that time, the healthcare system, the digital technologies, the innovation available, the way physicians practice, what the expectations of patients are, may have all fundamentally changed. So the question is: is the biologically innovative drug still relevant to patients and the healthcare system at the end of a long development process? And how do we ensure that digital health technology – the superconvergence of mobile, social, biometrics, genomics and AI – is being capitalized in everything we do? We see integrating digital health as a fundamental role of the Medical organization; from building a drugs-plus type of approach, through to real-world evidence is something the Medical function has to master.”

 

Taking control of RWE

Another driver of Medical’s current transformation is the requirement for continuous evidence generation. This is the melding of Real World Evidence (RWE), digital health, post-approval evidence and patient insight. “At Sanofi, Medical is in charge of the Real-World Evidence platform. We’ve built it and we, in turn, provide a service to R&D, Medical teams and Market and Patient Access. We should be able to move earlier into development, by leveraging the RWE platform for adaptive registration approaches to new products. With a really effective Real-World Evidence platform, good analytics and a transparent network, you could set up a very comprehensive, continuous observational program that continually helps to refine the benefits and risks of our products in real life as well as uncover new indications.”

Nathwani thinks how we maximize RWE will define the Medical function’s strategic value in the future. “We can’t be regarded as a strategic function if we’re not looking at how we can play a relevant role in the rapidly changing healthcare system. So, as a Medical function, we need to understand and define what the future of Medical should be in anticipation of these changes. How do we re-define ourselves? Where do we get our inspiration from – which other parts of the business or which other businesses do we send our medical teams to for inspiration? For example, are some of our Medical teams spending time at the Consumer Electronics Show, where you can pick up signals on future trends and behaviors of consumers in general – how a view of how these trends could be applied to the health sector? At Sanofi, we spend a lot of time engaging with tech companies to try and get a sense of where they are going and brainstorming on how to apply these to health. The main message is that Medical needs to look at what’s happening broadly in the world of technology, analytics, as well as in the traditional areas of medicine and healthcare, and zealously bring some of those ideas back internally to assess if we can integrate them to help us improve outcomes for patients.”

 

Measurement for Impact

One of the key challenges for Medical involves clarifying its new remit within the organization. Sanofi has selected nine strategic priorities for the function (see Figure 2), which serve as a roadmap for the transformation within the context of the evolving healthcare landscape. For Nathwani, the clarity this provides is a fundamental first step to making the function more value-driven, from early development right through to the end of the product lifecycle.

“There’s been a reluctance to measure the impact of Medical in the past as there wasn’t a clear definition of what it can achieve. We don’t measure return on investment, as commercial metrics don’t apply. We’ve been through this whole exercise of what we could do and what success looks like and how we measure the value that we bring: have we really made an impact on patients and physicians, have we fundamentally changed healthcare systems, have we introduced a drugs-plus solution that has truly improved outcomes? Do physicians regard the information provided by the Medical organization as credible, is the quality of the dialogue good, has it changed behavior? While complex and not easy to measure, these are the performance measures that we are trying to formulate in each pillar of our activities.”

 

Culture

Much of the work around redefining Medical’s role within the organization goes beyond just structural issues, and there are considerable challenges around culture and changing roles and expectations. “It’s probably the hardest thing to do right now. A first step is having top-down support. Following that, at the grassroots level, is there a clear roadmap or vision, is the platform that we’re trying to build and the vision for Medical truly understood by all stakeholders at all levels, including within the Medical function? There are many individuals in Medical today who have very different experiences and mindsets, some from a time where Medical occupied a more traditional support function role and maybe some of the teams are not fully convinced that we can truly make a difference to the strategic direction of the organization. It’s vital to get the whole organization on board and that comes from having a strong conviction, and a clearly defined roadmap of how to make this happen.”

A key component of a successful transformation will be an expansion of Medical’s capabilities – to allow a company to understand the patient experience, access, and influence a broad array of external healthcare stakeholders, and to act as a liaison between the medical community and the internal research organization.

“We described the required capabilities of the future Medical organization and we are creating the training platforms to accompany that. And we help them to understand the processes by which you transform. It’s not easy at the country level, where the ‘rubber hits the road’, because the pressure of the business and the resources and experience to lead change is much more difficult to obtain. We have taken the long view, so when we hire today, we try to hire for the future. We try to bring in people who have a better understanding of biotechnology, drug development, are strong on analytics and with a solid grounding in medicine, and where possible, a strong interest in the digital side. It’s tough. We also look for people with a very strong patient-centric focus as the energy and passion these individuals bring to our organization is tremendous, and keeps us grounded in our purpose”.

 

Together is better

With today’s life science industry now under extreme pressure to deliver superior medical outcomes while simultaneously cutting the cost of drug development, the time is right for Medical organizations to earn their place at the leadership table by creating opportunities to deliver new value for both patients and the healthcare ecosystem. Different companies are at different stages of maturity in terms of their progression towards being a fully-fledged strategic partner. However, the lack of a unified voice is hampering progress, Nathwani suggests.

“Our weakness is the heterogeneity of the role that Medical plays across organizations. We have extremes, from Medical as a well-accepted key strategic partner, right through to other organizations where Medical is probably more in the mainly customer support role. That heterogeneity means that it’s very hard to get alignment. If you look at the R&D organizations across industry, there is more clarity around their value and role. The main R&D leaders regularly meet together in a pre-competitive forum to look at the future direction of R&D and discuss macro trends. We don’t systematically do that across the Medical leaders in industry. There are a few useful platforms, but given the heterogeneity of our roles, the discussions are not consistent and our collective influence and voice is not at the level it could be.”

Nathwani is a strong advocate for Medical Affairs coming together as a community to decide on the future direction of MA. “We need to align on what are the key priorities that we believe Medical should be working towards across industry. For example, can we agree what would be a reasonable way to present the value of Medical internally and externally? Can we agree on what are the areas that Medical should try to drive within organizations – be that digital or drugs-plus or lifecycle management, and so on. Can we agree on the optimal methodologies for collecting and using RWE or utilizing advanced analytics for post-registration studies? What’s our approach on the many industry topics around bioethics?

“For example, in our organization, Medical runs the Sanofi Bioethics Committee, which helps to form company-wide positions on fundamental issues such as data transparency, the way we conduct trials, our approach to patient groups, positions on nanotechnologies or genetic therapies. Medical could be much more instrumental on matters like these if we had a platform across industry which could integrate positions from other companies and gain alignment on them. There’s a lot of areas I think that an organization like MAPS could focus on, to really elevate the Medical organization and its voice in our industry.”

Medical has a window of opportunity to become a strategic function. It needs to make itself relevant to the changing healthcare ecosystem and is well-positioned to do so but it could easily “miss the bus” on this if it carries on as is.

The future of the function is very much in our hands, Nathwani believes. “It depends on what we do next. In fact, I think we’re at a tipping point right now. We either prove our innovative value by adapting to and addressing the external changes happening in healthcare and our industry, or we will continue to remain a mainly support function. There’s a lot to do. If we can, for example, use Real World Evidence platforms to fundamentally change the way we carry out drug development, understand patients and diseases, and leverage these to bring through our biologic innovations faster, more safely and at a reduced cost, that to me will be a remarkable achievement.”

 

3

Digital Health: The Road Ahead for Medical Affairs

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As real-world data and advanced analytics start to transform life sciences, Medical Affairs is transitioning to a new strategic role. However, grasping this opportunity requires a significant mindset shift, and MA professionals will need to acquire a new skillset.

The amount of data we are currently generating is astronomical. According to one often-quoted article on Forbes.com, some 90 percent of the data in the world was generated over the past two years alone. [1]

Today’s world is defined by data, with 2.5 quintillion bytes of data created everyday – and that pace is only accelerating as the Internet of Things (IoT) expands. No surprise then that Mike Devoy, Chief Medical Officer, Head of Medical Affairs & Pharmacovigilance at Bayer, predicts that the time is right for digital to transform our thinking about healthcare.

“I believe digital is going to become more and more important and, over time, it will transform how healthcare is delivered and also how drugs are researched and discovered. We’ve seen the explosion in data coming from the intensified use of wearable devices, sensors and so on, but now we have the computer power and the technology to start to really understand that information and turn it into relevant action.”

Moreover, Medical Affairs stands at the very epicenter of this digital revolution in healthcare, given the function’s scientific credentials and its potential to define, gather and interpret data to generate the insights that will deliver meaningful outcomes for the entire spectrum of healthcare stakeholders – but especially patients and healthcare professionals.

Sources:1: Bernard Marr, “How Much Data Do We Create Every Day? The Mind-Blowing Stats Everyone Should Read,” Forbes, May 21, 2018, https://www.forbes.com/sites/bernardmarr/2018/05/21/how-much-data-do-we-create-every-day-the-mind-blowing-stats-everyone-should-read/#228be95b60ba.

 

Unique role

“In Medical Affairs, we have a unique role because we have a deep understanding of our products and knowledge of diseases. We should be looking to fit the new knowledge and insights that we can collect from Real-World Evidence (RWE) into delivering even better solutions for patients and the healthcare system. And, because we are in daily contact with healthcare professionals, patient associations and other stakeholders, we should be the ones who play a critical role in transforming that into something that actually meets the needs and provides services and solutions for end-users. By connecting what’s coming out of our R&D, the strategy behind the products from a commercial point of view, we could build this into an overall, integrated patient care vision.”

 

 

Top three areas of focus

Dr Devoy sees scope for applying digital innovation across a range of areas but suggests that R&D, patient outcomes, and safety are the three to focus on initially. There is significant potential for how we conduct clinical trials: for example, using artificial intelligence (AI) within R&D as part of the drug discovery process, and also helping to better characterize and stratify disease and the according patient populations for study.

“If you look at a disease such as heart failure, we still have a pretty simple way of categorizing patients based on clinical examination, imaging investigation and some clinical tests. But almost certainly there are more different types of heart failure in terms of the underlying pathophysiology. So, if we can apply digital learning and artificial intelligence to better stratify these areas and therefore to personalize treatments, then I think we will overcome a lot of hurdles to improving patient care.”

 

Cost is already a major issue in healthcare and digital has the potential to help unlock cost-savings for healthcare systems and wider society, as well as for industry.

Digitally integrating electronic medical records (EMR), both to identify patients and then also to follow up and stay connected with them is another considerable area of potential.

“I think there are already examples starting to happen that could dramatically reduce the cost of particularly large outcome studies which you have to do in areas like cardiovascular. There are significant gains that can be achieved by applying technology to make the studies more efficient, more precise, simpler to conduct, and so able to be conducted more quickly and more cheaply.”

Digitally integrating electronic medical records (EMR), both to identify patients and then also to follow up and stay connected with them is another considerable area of potential. “We should be looking at diagnostic technology and EMR to detect and diagnose disease much earlier and enable informed decision-making – that will allow us to intervene with prevention before people become physically sick at the stage they might currently be diagnosed.”

Adherence and product safety are two further areas of great promise for digital.

“For as long as I’ve been in the industry, something we’ve talked about but struggled with is finding ways that we can help patients adhere to the treatment that they’ve been prescribed, so that we actually deliver better outcomes. The use of sensors, wearables and other applications may offer such a solution for enhancing treatment adherence. I also believe that we can help better understand the benefit-risk of our products using AI and big data approaches to identify safety signals and issues with products earlier.”

 

Challenges

However, the fact that the technology is so new and accompanied by such a weight of expectation inevitably implies some formidable challenges.

“We read every day about how digital is transforming everything we do – be that personal finance, or interactions with retail – so I think the expectation from society is that healthcare will also transform in that way. But, clearly, healthcare has quite rightly some additional challenges relating to the sensitivity of people’s health data and taking the right care of that. So, we need to work with regulators, governments, patients and physicians to make sure that these solutions are accessible, trusted, compliant and fitted to people’s expectations.

As companies, we need to adapt to working and developing and being successful in a digital environment. So, that will mean hiring and developing new talent with the right skills in areas like data science and data privacy. But, also, we are not just competing with other healthcare companies, now, but numerous other technology companies and other industries for those skill sets. It’s not just hiring new people, but also developing capabilities, making our current employees more savvy about working with digital – how those technologies could be applied, what the potential options are.

One area where Medical Affairs in most companies is usually taking a lead is understanding, communicating and generating real-world evidence. That is going to put increasing demands on Medical Affairs organizations to be able to access and analyze large data sets. To turn this into useful and meaningful evidence that can inform both the decisions of our organizations but also inform other stakeholders such as regulators, physicians and patients.”

 

New digital culture

At Bayer, digital is already driving new business models and the organization is cultivating a new digital culture across its various businesses. “Digital will change our business models and how we relate to patients and healthcare professionals – it’s a high priority for us and we have created a strategic framework as well as a digital agenda to help us become future-ready. We really want to make digital technologies an integral part of our overall business acumen, value chain, lifecycle management and decision-making, and we’re looking at that as a critical aspect of our overall business. We also recognise that a lot of the innovation and expertise is going to come from outside and from different areas, from different sorts of companies.

“One thing I believe we’ve done very successfully is build up an approach for actively seeking external collaboration. ”Among the initiatives is a global program called Grants4Apps, established in 2013, where Bayer reaches out to companies that are in the early stages of developing in the digital health and care space. Bayer acts as incubator and offers mentoring support and access to Bayer expertise and knowledge to help them develop their business models and solutions. Meanwhile, the Grants4Apps Dealmaker program is a unique opportunity to acquire Bayer as a customer and is tailored for mature teams, startups and companies that have a solution ready to go for identified challenges.

We also partner with research institutions across the world and, where it makes sense, with various technology companies that are also entering the healthcare space. You look at who are the partners that are meaningful to your stakeholders – like patients and healthcare professionals – and how do you do something with that partner that creates more value. We strive to enhance our ecosystem (for example with subsidiaries in San Francisco and Boston) and constantly monitor the external environment trying to link business challenges and evidence needs to potential technological solutions.”

 

Quality and quantity of data

Nevertheless, to harness the potential of RWE – both from EMR and sensors and devices – companies such as Bayer will need to make sure they have the ability to handle large volumes of data, that the data is of the right quality and data privacy is respected, and that they have the right skills and methodological approach to succeed in this space. “I think we need to make sure that we operate to a high standard of scientific integrity and quality because there are certainly risks if you don’t. And you need to bring in different skill sets in areas that will allow you to collect, analyse and interpret that data.” Bayer has been working hard to find people with skills in areas of big data analysis, including data scientists and epidemiologists.

 

 

 

 

Strategic role

In conclusion, Dr Devoy emphasizes that all of these changes imply a significant mindset shift on the part of MA professionals, who will be moving from their traditional support role to much more of a strategic focus. This will involve the function engaging much earlier in the value chain.

“Medical Affairs will get involved in the early project discussions [helping] research colleagues think about the best approach in terms of patient target groups, disease, models, linking to external expertise and knowledge. He also envisages Medical building a strategy aligned with global and key countries where the function will conceive or build a medical strategy aligned with the overall plan, both in terms of data generation and communication.

“In some key topics, such as real-world evidence, Medical is very much the function that takes the lead role in working with all the internal and external stakeholders to create the strategy and then execute it across the organization. You see it in very tangible things in terms of resource deployment, which has changed very significantly over the last five years.”

Going forward, Dr Devoy sees Medical as being the trusted partner between businesses and key external stakeholders – patient bodies, physicians and regulators – articulating the value companies are providing to healthcare systems and to patients. MA potentially has a unique understanding of how that value can be created and delivered, and a key role in developing the evidence and solutions around that value in collaboration with internal and external partners such as R&D colleagues, digital providers, physician groups and patient advocates.

“As patients become more empowered to make healthcare choices, it’s more important than ever for healthcare companies to create compelling and satisfying experiences. Digital solutions and innovation have never been more at the forefront of healthcare and are an important part of Bayer’s long-term strategy. These solutions can drive down costs or boost efficiency, build connections to patients and dramatically improve patient outcomes.”

 

About

Dr Michael Devoy is the Executive Vice President for Medical Affairs and Pharmacovigilance for the Pharmaceuticals Division at Bayer AG. He is also the Chief Medical Officer of Bayer AG. He joined the former Schering AG in 2005 as Senior Vice President of Global Medical Development and was appointed to his current position in 2014.

 

Dr Devoy studied Medicine and Pharmacology at University College London and graduated with a Bachelor of Medicine/Bachelor of Surgery (MB, BS). He is a member of the Royal College of Physicians in London. He has extensive experience across Clinical Development and International Medical Affairs. His career in the pharmaceutical industry began when he joined Glaxo Group Research in Clinical Pharmacology.

 

 

 

Leadership Lessons

“Probably the most important leadership experience came in my early career, when I became a Medical Director of a country – in that case Australia – where I had to operate with a greater degree of independence, lead quite a large team at the time, and balance all the diverse demands of the different stakeholders that interact with you: patients, physicians, researchers, regulators and internal colleagues in the business. I learned a great deal there about my leadership style: what my values were and what my drivers were, particularly through facing difficult issues and talking, reflecting on what we were trying to achieve; why and how you’re going to do that; and staying true to yourself in managing through those difficult topics.

“In terms of the sums, we had some financial challenges. I had to find a way of making my organization more efficient and responsive, and that was an important – and also, at the time – difficult experience. I then took on more senior global roles and an important step there (which I think applies to a lot of leaders in pharma and Medical Affairs) is managing globally dispersed teams with colleagues in lots of different time zones and countries. This involved balancing people with different cultural expectations, different perspectives on what good leadership looks like and how things should be communicated, how things should be managed, and managing and leading in that set-up.

“I’ve learned something from every leader I’ve had, in terms of how I’ve evolved and grown. In my leadership approach, one important learning I had with a leader was when one day I went to ask if I could do something and they said: ‘You should not be coming to ask my permission.

Come when you need my forgiveness.’ That was at a relatively early stage in my career and I think that gave me a perspective to take more personal responsibility and accountability for addressing situations and finding solutions. Not that it always went to plan, so I think then you accept you also have to take the responsibility for your decisions.

“Also, I had the privilege to work with leaders who modeled the best behaviors in terms of what ultimately is our priority in this industry, which is ensuring that the patients we serve receive the best treatments and optimum care and that we make sure that the trust they put in us as pharmaceutical healthcare companies is fulfilled. I would say that I learned equally from leaders who came from the commercial side of pharma and those who came from a scientific and medical side – all those different individuals have brought aspects to how my style of leadership has evolved.

“You don’t need to be the friend of your leader but, it’s important that you respect and understand their roles and actions and that they understand what you’re doing and how you’re doing it and what your vision is, and how that fits with the overall bigger picture.”

 

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