Gain an insight means obtain an accurate and deep understanding about some (complex) situation.

Medical insights represent one of the most valuable information that Medical Affairs team can provide within Pharmaceutical industry. Today, more than in the past, pharmaceutical organizations are facing new challenges, due to the high complexity of environment, socio-economical hurdles, market access and budget constraints, stringent regulations, crowded markets and high competitiveness level.

The role of Medical Affairs in this context, became crucial, playing a critical role in assessing the unmet medical, patients and market needs and for a correct brand value definition, product positioning and for supporting brand communication.

For this reason and for defining critical strategies and tactics, high level medical capabilities must be achieved for Medical Affairs personnel, mainly for obtaining the needed medical insights from different stakeholders, for preparing the market for a successful launch and for the post-marketing activities as well. It’s crucial indeed develop, increase and maintain some skills that are mandatory for obtaining medical insights, taking advantages from these and for leading critical strategic processes.

Some of the most relevant competencies Medical Affairs Team should have, include:

  • Excellent medical and scientific knowledge
  • Strong business acumen
  • High mindset flexibility and agility
  • Relevant networking and ability to build relationships
  • Strong analytical and cross-functional skills
  • Excellent communication skills with ability to communicate at all levels
  • Strong customer focus
  • Long term vision

 The most relevant medical insight could include, even if not exhaustive:

Clinical insights: through these insight, Medical team will be able to deeply go through the therapeutic areas, including disease state, epidemiology, physiopathology, diagnosis, complications, treatment, competitors, guidelines, prognosis. All these information are living info, changing within specific timeframes and also according geographic areas. In this phase of assessment, is important to address any data gaps on the product either in development or just marketed, for identifying new studies, PMOS or HEOR studies. To achieve this, in addition to personal curiosity and willingness to learn, it’s important a trustable link with external experts, physicians and any other relevant stakeholder able to provide relevant insights. HCP engagement is indeed a crucial accountability for Medical Affairs personnel.

Market insights: these are very important insights, mainly gained from different sources and often in a cross-functional way; through these insights, general and also more detailed specific information on the market will be gained, including socio-economical scenario, market needs, any factor influencing the market, budget constraints, identification of centers of excellence and main stakeholders (multi-stakeholders) in a specific therapeutic area, therapeutic algorithms, regulation and policies, digital environment evolution, any other relevant market factor. Moreover, to have a relevant understanding of the market, is crucial to have in mind at least, the following:

  • Market definition
  • Environment
  • Competitors
  • Customer analysis and adoption pathway
  • Market segmentation

All of the above will help in building the basis of market segmentation, understanding which are the customers attitudes and goals from treatment, that at the end, represents a driver.

Patients insights: these are probably the most valuable insights, obtaining info directly from the patients, through patients associations groups, that today, more than in the past, are a very “relevant voice”, being in many cases “expert patients”, taking part in complex projects and working closely with institutional healthcare, organizations and government bodies. In the last years, in fact,  the importance of patient education has been stressed, especially now that, through the web, mass media, educational activities in hospitals, communities and patient groups, patients have easy access to information therefore, expert patients have indeed the unique opportunity to clarify patient priorities, which in turn may better inform clinical decision-making. Expert patients should be able to both help other patients will illness self-management and work with physicians in ensuring the development of comprehensive care and disease management.

Patient Journey is an assessment indicating the sequence of care events, which a patient follows from the point of entry into the system, triggered by illness, until the patient is discharged from hospital to home, or due to worsening or death. In a typical patient journey, is important to identify – as example – and address the below:

  • Patient population (according epidemiological data and/or available disease registries)
  • Seeking treatment
  • Consulting physicians
  • Approaches to physicians and therapies
  • Diagnosis
  • Treatment
  • Barriers and bottlenecks (for diagnosis, treatment, access to therapy)
  • Product differentiation

In the patient journey several info should be obtained as, definition of patient flow, percentage of patients remained at each step, which are major influence factors, which obstacles and constraints exist.

Product insights: obtain and deeply evaluate product insights through internal sharing of information, including mechanism of action, efficacy, safety, way of administration, compliance and adherence; working within the cross-functional team in developing the brand positioning, core value proposition and key messages; working with external stakeholders (physicians, pharmacologists, investigators worked in specific trials, any other expert) for a better comprehension of clinical practice, unmet medical and patient needs, to deeply address and discuss on the correct product positioning, validating communication messages.

Value insights: analyze the economic impact of a product, perform budget impact analysis, discussing with payors and health-economists the added value of a product, obtaining relevant insights, useful for the “place in therapy” and knowing in advance any potential concern or issue that could affect the launch of a product or its correct positioning into the market; obtain any insight highlighting the value (direct or indirect) for the patients, caregivers, HCPs, hospital administrations and community.

Digital insights: critically analyze any trend and strategy of digital innovation to find new solutions in the field of digital health; weight risks and opportunities, evaluating strategic scenario, regulatory and normative scenario and trends from real-world data analysis.

In all these above steps/examples of collection of insights, a SWOT analysis will represent a fundamental tool to identify and check any strength/weakness/opportunity/threat.

Medical Affairs, to fulfil all of these steps, playing a critical role, must build and exploit different skills and competencies, mainly by external focus, liaising with the experts/HCPs during scientific conferences, face-to-face meetings, round tables, advisory boards and in any other opportunity to meet the external stakeholders for obtaining useful insights and advisorships. By creating a link with external stakeholders, in addition, obviously with the internal ones, there will be the concrete possibility to obtain as many info as possible, that should not be feasible basing only on simple assumptions. The tight professional relationships with external stakeholders represent indeed a good validation of any internal assumption.

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Medical Affairs Director with strong experience in Pharma/Biotech multinational companies. MD, Board Certified General Surgeon, with 25+ years of career in both clinical setting and pharmaceutical industry. Author of more than 30 scientific papers, on different topics (autoimmune diseases, rheumatology, dermatology, oncology, infectious diseases, general surgery, angiology, metabolism), published on peer-reviewed journals Developed in progressive leadership roles at Local and International levels with leading Multinational Companies. Quickly gains peoples’ loyalty and buy-in with passion, energy and open communication. Skilled at driving results through global teams in complex matrix structures with an inspiring and collaborative leadership style. Core business competencies include: Medical Affairs, Clinical Development, KOL Management, Leadership, Business Analysis, Strategic Planning and Execution, Marketing Communications, Networking, Publications Development, Public Speaking, Startup, New Products Launch, Go-to-Market strategy, Process Improvement, Employee Coaching and Mentoring. Therapeutic area experiences include: Immunology, Rheumatology, Dermatology, Gastroenterology, Virology, Endocrinology, Metabolism, Pain, Gynaecology, Oral Care, CNS, Pulmunology, Antiinfectives, Cardiovascular and Thrombosis.

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