Medical Affairs and Stakeholders Engagement un an Evolving Healthcare System

Due to unprecedented challenging situation and the current pandemic time, stakeholders needs are changing and these uncertain times are accelerating approaches already existing within Pharma industry, in an era of digital disruption, therefore, more than in the past, flexible mindset and agility are needed. In addition to stakeholders needs, also environmental trends and approach are changing and these include medical education platforms, digital programs, data generation, next generation therapies, new ways of information exchange, pricing pressure and constraints, publications digital channels and AI. 

All organizations and functions are facing with these challenges and Medical Affairs, as other functions, has been widely impacted, especially with external engagement as with many other activities, typical of the function itself. 

More than in the past, Medical Affairs teams has to provide value, delivering impact for the benefit of all stakeholders, mainly by leading and overseeing several strategic activities. It’s evident, since a lot, the existing challenges in engagement external stakeholders, especially in the early engagement phases, whereas the produced effort – only apparently – cannot produce immediate tangible outcomes. 

Another point to consider, as in the past, is that the variety of stakeholders, according the diseases and their influence, also considering need in engagement multiple stakeholders (KOLs, investigators, patients, payors), with sometime, different priorities. The focus on digital health, precision medicine, integration with big data, diagnostics and therapeutics, with a complete understanding of stakeholder’s needs is therefore a “must”. Digital firstly, in fact, is changing external stakeholders approach, mainly within HCPs and patients experiences, according multiple dimensions. 

What really matters now and much more than in the past, is exploring new strategies, in a disruptive and challenging period, including advance targeting and 1:1 digital engagement, simplifying processes and operations, embracing the power of technology to transform medical, by digital, AI, advanced analytics and developing innovative and modern strategic plans and subsequent tactics. Flexibility and adaptability to change in a fearless context will be the winning factor, due to digital tools will replace or probably only implement, many of today’s “live” interactions. 

One of the most important activities within Medical Affairs, represented by delivering customer experience focused on science, through a deeper understanding of physician/patient journey, medical insights, unmet medical needs, must be shifted to all digital tools, to assess, build and develop the best external stakeholder engagement plans and actions ever. Medical Affairs has to co-lead the cross-functional and integrated team, in addressing the transformed healthcare landscape. There is, in fact, a relevant interest on the topic of customer insights generation by Medical Affairs to shape strategy and relevant customer engagement, through management of “real time” digital interaction tools, also providing digital services, beyond the product data, that finally means engaging external stakeholders, communicating scientific evidence with innovative and “omnichannel” approach. 

Digital innovation is playing an important role in transforming the Medical Affairs approach and insights capabilities, so new technologies and digital as well, are enabling Medical function to obtain, analyze and interpret all the collected information and insights, with different outcomes, including improving clinical studies and subsequent programs, pre-launches programs and LCM activities. This will be related not to insights only, but also on a better understanding of clinical trends and in understanding medical needs. Any winning and successful activity will depend on the ability of the Medical function to lead the scenario’s change and deeply gain from any insight, adapting its approach, strategies and tactics to gain from changes. 

Medical Affairs must build capabilities, through flexibility and adaptation ability, building knowledge and experience to realize the possibilities enabled by insights and advanced analytics, mainly through e-delivery information. The new multichannel tools, real time digital interactions, digital services & solutions, including, virtual events, webinar, e-meetings, will permit to Medical Affairs to lead and manage external focus and stakeholders collaboration, providing an high impact and continuing in building trusted and reliable scientific relationships externally. 

In this time of disruption, even if applicable also in the future, a successful factor will be to develop and transform Medical Affairs teams into Medical added-value teams, through provision strategic input to information exchange, late pipeline development support and LCM, by deep analysis of insights and their interpretation, for sharing and communicate scientific evidence. In this area, virtual events, e-congresses and other innovative ways of stakeholder engagement will help in the management of medical programs and will improve HCP decisions and patient outcomes.

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“Go-toMarket”: Medical Affairs, Strategies and Timings

“Go-to-Market” in Pharma is defined as a tactical action plan, that outlines the needed steps to succeed in a new market/therapeutic area. 

A “Go-to-Market” strategy generally has, as main objectives, to:

  • Ensure a successful product launch defining plan and direction for all functions
  • Reduce time to market
  • Define a Patient journey map
  • Avoid the wrong path reducing costs associated with not adequate assumptions or failed product launches
  • Ensure regulatory implementation and compliance
  • Assess and define pricing strategy
  • Identify marketing tactics 
  • Assign budget for product launch and awareness activities
  • Increase ability to adapt to change

In assessing, the most valuable “Go-to-Market” strategy, it’s indeed relevant to assess, at least, the following:

  • Full knowledge and relevant competencies and functions in place.
  • Trends and key facts in the new therapeutic area.
  • Key stakeholders.
  • Patient Journey.
  • Markets assessment and potential. 
  • Global pricing analysis and strategy.

Because Medical Affairs is involved in critical decisions – together with R&D functions – for defining,  designing and implementing clinical studies, it’s important for Pharma/Biotech, to have in place adequate Medical Affairs structure for implementing the “Go-to-Market strategy” and in any case, quite a lot of time before any new product enters into the market, therefore, Pharma/Biotech companies must ensure to have Medical Affairs functions in place much sooner than in the past and at least three/four years before the company expects the product to go to market.

Medical Affairs, in fact, plays a pivotal role, especially if engaged in early phases of development strategy. For this reason, Medical Affairs personnel must have, not only deep and complete Medical and Clinical knowledge, but also relevant business understanding and several other cross-functional skills  that should include, in addition of excellent knowledge of therapeutic areas, also a deep knowledge and understanding of healthcare policies and local environment and healthcare scenario. 

This, in order to permit a good collaboration within the cross-functional/integrated launch team, particularly with R&D, Market Access/Helath Economics, Regulatory and Commercial functions, being able to understand the market scenario and landscape, recognizing any opportunity or issue, potentially affecting awareness programs and launches to the market in related countries or regions, assessing clinical evidence standards, helping Clinical Development teams in designing clinical trials to ensure that needed standards for efficacy, safety and value will be met for the relevant markets and coordinating with a broader team on the implications of any decision on the clinical program timelines and competitiveness, regulatory pathways, access and pricing issues or constraints.

It’s important indeed that Companies understand and assess key characteristics markets (geographic areas, regions, countries) before preparing the Go-to-Market strategy.

In my personal experience, as Medical Affairs and Clinical Research Director, for a new therapeutic area and new business for the Company, I joined a Company more than 4 years before the new product  entered into the market, being the only Medical Affairs resource in a cluster of countries – working within Region Europe Medical Leadership Team – starting from scratch and preparing the market for a new molecule, working with many different stakeholders, Key Opinion Leaders, Principal Investigators, Patients, Pharmacologists, Payors, External Vendors, working internationally with Global and within Regional cross-functional Team and building all the awareness activities (huge number of different and diversified activities for different stakeholders, to increase disease awareness, fix unmet medical and patient needs and many other topics) assessing the most relevant topics about the “Go-to Market” strategy, including Market Access potential issues and constraints, having benchmark with similar companies (company and country size/therapeutic areas/marketed/pipeline products) for building the proper teams (Medical, Marketing, HE) in the affiliates, building and maintaining strong and solid partnership with Scientific Societies and Patient Association Groups, speaking at the most relevant Congresses about Company R&D, pipeline and scientific data.

The early involvement of Medical Affairs, should indeed help the Company to develop a multifunctional extended Medical/Regulatory/Access strategy.

Another activity to not underestimate, whereas Medical Affairs can provide a relevant contribution in the process, is “Patient Journey”, that indicates 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, for example, is important to identify and address: 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), brand differentiation. In the patient journey several info should be obtained as, patient flow, percentage of patients remained at each step, which are major influence factors, which obstacles and constraints.

It’s also important to understand and address, in a pre-launch and post-launch period, any barrier, as “lack of gain access to treatment”.

In a patient journey, the customers (i.e.: physician/pharmacist/patients) are important stakeholders to consider in the analysis, to understand which are their needs, constraints, treatment and approaches. 

For all of the above reasons, the recommendation should be, to have Medical Affairs professionals (with a level of business skills, as well as expertise in communicating with multidisciplinary stakeholders), involved as early as possible, in order to think and assess with Clinical Development team, which end points should be  needed, to develop clinical/pivotal studies to successfully implement Clinical Programs, deepening their value by capturing any insight across the scientific landscape, bringing these back to the Go-to-Market/Launch team. 

In fact, Medical Affairs knows, working closely with Clinical Research and Access colleagues, about any clinical evidence needed to establish value as for the regulatory expectations and for this, is needed a strong knowledge of a specific therapeutic area, competitors and different mechanism of action, therapeutic algorithms including Regional and Country clinical guidelines and recommendations.

Lastly – together with Commercial and Market Access teams – a segmentation of stakeholders, would be developed, to assess and determine whose engagement should be driven exclusively by Medical Affairs or should remain within the scope of Commercial or Market Access plans and activities.

“Go-to-Market”: Medical Affairs, Strategies and Timings


Field Medical Affairs in Pharma/Biotech: Effectiveness, Opportunities and Challenges

Medical Affairs has risen very fast in the last years, becoming after an initial phase of “supporting function”, a highly crucial “leading function”, representing a relevant pillar within Pharma/Biotech industry.

Since several years new functions have been built in the context of Medical Affairs, especially within Field based functions.

Field Medical Affairs includes mainly, Medical Scientific Liaisons (MSL), Regional Medical Liaisons (RML), Scientific Project Managers (SPM), Field Medical Advisor (FMA), Field Medical Manager (FMM), Regional Medical Managers (RMM), even if, all these job titles definitely represent, quite always, the same roles, as Field Medical Affairs, for differentiating these from Office based Medical roles (Medical Managers, Medical Advisors, Medical Affairs Scientists). 

External stakeholders have the need to know more about the available drugs and science behind these, tools, services and medical solutions and with this aim, Field Medical Affairs represents a function, within Medical Affairs, in a continuous evolution phase. Pharma/Biotech companies, through their Medical Affairs teams, are strongly positioned to lead and support in this way and Field Medical Affairs, will continue to be a relevant trusted source of information for Health Care Professionals, looking to improve the health outcomes of their patients.

Field Medical Affairs teams  maximizes Company’s value proposition, through medical and scientific projects, services, expertise and exchange of information, as well as the development of long-term relationships with medical, scientific community and patients organization groups. Field Medical teams can reach, indeed, more Health Care Professionals and other different stakeholders, acting as a liaison, between office based peers and external stakeholders.

Generally, main responsibilities and accountabilities for Field Medical Affairs teams include, but are not limited to:

  • Be the first point of contact for any scientific aspect related to the assigned therapeutic area.
  • Identify and develop high level relationships and partnerships with current and future Key Opinion Leaders and other  key external stakeholders. 
  • Engage in scientific exchange with Health Care Professionals, Investigators and with any external expert to identify unmet medical needs, evidence gaps and obtain insight.
  • Implement and disseminate high quality medical and scientific educational programs. 
  • Support safe and appropriate use of Company’s products through valuable scientific exchange with Health Care Professionals.
  • Collaborate with Clinical Research colleagues to ensure optimization of site selection for Company sponsored studies and to maintain a liaison with Principal Investigators and study teams, providing scientific support to clinical trials and CR colleagues
  • Warrant the provision of a proper scientific know-how on the therapeutic areas, to the Field Force, including general knowledge of specific diseases and competitive intelligence.
  • Identify local medical and patients needs, defining local Medical Plans, useful also for future performance assessment, metrics and KPIs identification.
  • Support Commercial/Market Access/Public Affairs functions, in ensuring the knowledge and acceptance of Company products in regional formularies, through the best available evidence of product’s value. 
  • Identify new medical opportunities and facilitate the collection and screening of investigators proposal regarding scientific activities to be assessed, including other Medical Affairs activities.
  • Ensure scientific and medical excellence with high compliance according Company’s SOPs and local normative and regulations.

It’s a priority, to invest in Field Medical Affairs for building team knowledge, permitting field teams to adapt to new ways of interaction – including digital and new technologies – that could increase Medical Affairs visibility and related impact for the organization. It’s therefore important to invest in Medical capabilities and skills, to permit to build knowledge and to reach external customers that, for different reasons, cannot be reached by other internal functions. In fact, especially in the last years, there is an increasing focus on hiring professionals with strong interpersonal engagement skills, high level of business skills, as well as expertise in communicating with multidisciplinary stakeholders

Being Field Medical Affairs the scientific face of an organization, these teams may need strong planned training programs, to ensure an up-to-date on the latest developments in the related therapeutic areas, to permit to confidently engage in scientific discussions with KOLs and other Health Care Professionals.

For this reason, is important to have a clear “on-boarding” plan, as for the office based Medical Affairs, and invest – in addition of course on the therapeutic area knowledge – on scenario and business understanding, increasing business acumen, curiosity, flexibility to adapt to different challenges, health economics topics, local healthcare scenario knowledge, speed, long-term vision and agility, product added value (not only from a scientific medical point of view, but also in terms of “value” itself), permitting to Field Medical Affairs Teams to interact with different customers, understanding their needs and being able to be recognized, externally and internally, as a reliable and preferred scientific partner. This, will provide at the end, a great recognition and visibility for Field Medical Affairs and for the Company, acknowledged to have invested in very well prepared Field Medical Affairs professionals.

A critical part – even if with a significant improvement respect to the past – could be sometime, represented by the metrics and performance assessment of Field Medical Affairs activities. 

This, has always been indeed, a “grey zone”, due to many activities of Field Medical Affairs could generally be quite difficult to measure. It’s, in fact, mainly for this reason, highly important that, appropriate internal processes and systems must be in place, to highlight and capture any insight, information, any other activity shared by Field Medical Affairs to external stakeholders, that could have impact on Health Care Professionals and patients as well. These processes could be different from one company to each other (each Company adapts specific metrics and KPIs) and it should also be related to Company business (i.e.: Primary or Specialty/Rare Diseases), but it also depends from the product LCM and/or launch phases. To assess and quantify the growth of relationships over time, CRM and other tools, provide the opportunity to monitor Field Medical Affairs impact in new and probably more effective ways.

To have clearly defined and easily measurable objectives, the most important thing should be to have a strong detailed Medical Plan, that includes Field Medical Affairs objectives, with goals aligned with Corporate strategy, defining an accurate goal description, clear KPIs, easy measurement of goal and related metrics, weight in percentage of the goal (all of the above must be agreed, singularly discussed and adapted with Manager’s input, in order to be finalized at the beginning of the year). For this reason, each Annual Plan, for any Field Medical Affairs member, should be tailored and assessed with the supervision of the Manager.  

Sometime, mid/end-year self-assessment could represent a “bias” and for this specific reason, it’s important that any activity, goal, objective, should include quantitative metrics (mainly due to the role itself, as external/customer facing role) and qualitative metrics (feedback by external stakeholders – and internal as well – engagement surveys, relevance of collected insights and their importance for the strategy, sharing of “best practice”, plus any other activity, as awareness programs, with high impact for the Company’s strategy). 

Nevertheless, often, the traditional quantitative metrics used for demonstrating effectiveness of Field Medical impact, could bring poor info on the real impact of Medical engagement work with external stakeholders, so recently, as anticipated, there is a trend in capturing more outcomes-based KPIs, with the aim to collect a shift in mindset, due to engagement. Additionally and as always , one of the most valuable metric to be used is based on “open communication”, therefore, sharing internally with the organization, ideas and insights captured by KOLs and experts face-to face meeting, increase Field Medical Affairs visibility and value for the organization.



Medical Insights in Pharma Industry

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.


Business Plan: a Medical Affairs perspective

A business plan is generally considered a process and specifically, a document, that summarizes the operational and financial objectives of a business – independently of the specific sector – and contains the detailed plans and budgets, showing how the objectives have to be realized.

The business plan is a tool to help to build a better business and it should not be considered as a just homework assignment.

I’ll be focused, for obvious reasons and personal experience, on Pharmaceutical Business Plan, providing high level information on its importance and how to build it in the best possible way, with a special focus on Medical Affairs perspective.

The business plan – that could also considered as Brand Plan (for a specific brand/product), Franchise Plan (dedicated to a whole Franchise/Business Unit/Division within the Company) – is created and implemented in a “cross-functional” approach, including inputs by the most relevant functions, within the Company.

The Business Plan has 3 main functions:

  • It is the starting point for developing ideas, first of all, by a deep analysis and understanding of multiple factors at all levels, from marketing, to medical, to finance, to all other involved functions, with the final goal to develop specific strategies.
  • It represents the main source to obtain the requested resources (i.e.: budget, headcounts), with a  detailed rationale, included into the plan.
  • It is also a “check tool”, that permit a continuous and rigorous control on effective performance, within certain assigned timelines. Generally, the previous plan – on annual basis – is the starting point for the new plan, and it’s mandatory, on a periodic basis, a continued revision and check of it, to assess any potential deviation from the original plan and subsequently act, with any needed corrective action.

The business plan, is generally developed on annual basis – according the financial year timelines for each company – and is related to a 12 months timeframe; differently, the LRP (Long Range Plan) shows a more “high level” info on a more prolonged time (typically 5 years).

The plan should be accurate, detailed and completed regarding the contents, even if this could be generally adapted and updated, according any internal/external occurring factor; for this reason, the periodic monthly check is a “must”.

The business plan, is also important, because of it is considered, as an internal guideline for reaching the Company objectives and for this reason, it represents the main document of strategic planning for a Company.

During the plan preparation, companies that are already in the market, take advantageous from the previous years data and experience and also the planned strategies/activities, could be related to the previous ones, taking in consideration any subsequent success, fail and lesson learned.

As anticipated, continuous update of the business plan represent the presupposition of its important function as “check tool”, for effective performance of any product/franchise.

The finance section of previous year plan, represents an important starting point as well and the planned financial info need to be constantly checked and verified for alignment and for controlling company performance.

Main typical elements to be considered and included in a business plan are generally the following:

  • Market scenario understanding (socio-economic, epidemiologic, commercial, target audience, external stakeholders…)
  • Competitive landscape and any other external factors
  • Market Researches, epidemiological studies and disease registries
  • Marketing/Commercial assessment and strategy
  • Medical assessment and strategy (highlighted below)
  • Regulatory and Market Access assessment and strategy
  • Communication strategies
  • Forecast prevision
  • Budget and financial summary

During the preparation of the business plan, it’s mandatory to arrange plans and objectives/goals within specific temporal timeframe and the section dedicated to the objectives is the most important within this context, because in this part should be assigned the main milestones and related timelines.

The programs described and presented in the business plan, should concern mainly to the more important milestones, differently, within the aim of the internal planning, will be useful to have, as appendix, more detailed calendars and activities/programs/tactics.

As anticipated, Medical Plan represents a part of the whole Business Plan and it’s a summary of all medical activities and projects, generally planned on annual basis as well.

With the growing experience, some identified key steps to have in mind, to reach the objective to prepare a successful Medical Plan, are listed below:

  • Identify key brand priorities: have a good understanding of priorities and uncover any opportunity related to the benefit of a product/brand
  • Obtain external insights and collect info from the experts in the specific therapeutic areas: have a good understanding of disease state, market scenario, identifying patient population and gaining a fully understanding of unmet medical and patients needs, prioritizing patients opportunities and confirming or assessing brand positioning, taking advantage of key learning from the previous medical and clinical activities.
  • Address specific areas of research: take insights from clinicians and experts, also on potential new areas of research in related medical therapeutic areas or specific population sub-settings.
  • Understand competitors approach and future launches and activities: analyze and map market players and main competitors, assessing gaps, clinical data, medical projects.
  • Prepare a SWOT analysis including potential projects and related impact: build a SWOT analysis by an accurate assessment, collecting reliable information from impacting sources and this, will represent a complete summary of the most relevant market insights, including any “patient journey” with subsequent “bottlenecks”; it’s also important in this phase, to identify in advance any key issue, as well as any relevant potential opportunity.
  • Identify and build relevant medical innovative projects: develop medical strategies and activities, according the therapeutic areas, unmet medical needs, disease awareness needs, specific new MoA of molecules, external focus and diversified approach with different external stakeholders.
  • Let global strategies be cascade locally and ideas and projects personalize at Country level, according local needs: identify any barrier and “bottleneck” for projects development.
  • Be innovative and maintain high scientific and quality standards: always consider first, the delivering of innovative therapies to improve the life of patients, with high impact projects and strategies.
  • Define outcome indexes for each project/activity: describe key points for any identified project, including summary, activity description, objectives, timelines, milestones.
  • Identify budget and cost breakdown: highlight budget gaps (+/-) versus previous medical plans and according to Long Range Plans, LCM, assess and deeply consider any new indications, line extensions, new formulations, plus any other eventual point raised by SWOT analysis or by any other external influencing factor.
  • Monitoring activities and projects with GANTT chart: project management is crucial and is important to have the possibility to make changes, readapting and readjusting projects and budget with any corrective action to put in place.

Of course, the above considerations are applicable to both Global Business Plans and to Country Business Plans, even if, these last need to take as starting point the Global Brand Plans and subsequently adapt these to local needs and market scenarios.

Last but not least, is mandatory to reconcile scientific opportunities with business and this should be done by being aligned with Global development and growth strategy, identifying key priorities, being innovative and thinking “out of the box”, always maintaining scientific approach, ethics and quality at the most high standards.



Business Analysis in Pharma Industry: from Market Research to Patient Journey. A Medical Affairs view

Business analysis in Pharma industry, either during the early phases of drug development phase or close to the launch, represents a relevant preparatory part – especially for the preparation of Business Plan – in which Medical Affairs is a main contributor, because of deep knowledge of the disease state, epidemiological data, competitors, link with external experts, deep understanding of unmet medical and patients needs and other topics, below described. To achieve the objective, the priority that all relevant functions – cross-functional working is vital for the success – as Medical Affairs, Marketing & Sales, Market Access & Corporate Affairs, Business Operations, Regulatory and Finance – as “high performing cross-functional team” – provide their contributions and insights for a deep understanding of the market scenario, highlight and assess any threats or opportunity. Market Research is one of the critical component for assessing a deep situation analysis and represents an import tool for analyzing and understanding the market scenario, either in early phase of development, or in pre-launch time, or during post-launch. The reasons to carry out market research in a business are mainly to answer questions, gain insight, get confirmation, generate ideas, develop understanding of current market scenarios and discover unmet needs. As markets in which the products compete become bigger, more complex and more crowded, the decisions that companies have to take, have greater consequences than ever before, therefore, in order to increase the probability of making the right decisions, market research can be used so that decisions are made from a position of knowledge and insight, as opposed to assumptions and guess work. Appropriate market research will provide the data from which insights can be obtained and hence increase the chance that the correct decisions are made and are an excellent tool to gain insight into market and customers and hence, to create a solid competitive advantage. Some topic to consider and that need to be asked at each stage, with different sub-questions for each topic, should include, at least: •Defining the problem and research objectives •Developing the research plan and methodology •Implementing the plan and collecting and analyzing data •Interpreting and reporting the findings The several business questions that arise throughout the examined period, can be answered by the data collected through qualitative and quantitative research. The decision of which type of research to use will also be a “trade-off” between the available budget, the level of accuracy required to sufficiently answer the business question and any potential time constraints. The insight that can be gained from market research, as anticipated, can positively impact on the product launch performances due to the competitive advantage gained in the marketplace, but also impact in the early phase of drug development, as during the pivotal trials protocol development, as well as in the post-launch activities, especially regarding the LCM of a product and also the competitors projects and activities. Before starting a business analysis to understand the market, is crucial to have in mind, at least, the following: •Market definition •Market segmentation •Competitors •Environment •Customer analysis and adoption pathway In a business analysis the most relevant input should be driven by SWOT analysis and Critical Success Factors (CSF). In the SWOT, the segment evaluation will provide a measure of the attractiveness of the segments evaluated. During the business or situation analysis of the market, an important activity to consider, should be the Environmental Analysis, that generally include a “two stage” process: •PEST analysis (Political, Economic, Social and Technological), for identifying the factors which will have the greatest impact on the product/brand over the plan period •Assessment of Implications of the identified factors CSF are those aspects of a strategy that must be achieved to successfully meet objectives and to secure competitive advantage. Patient Journey is a formal term for 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: •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) •Brand differentiation In the patient journey several info should be obtained as, patient flow, percentage of patients remained at each step, which are major influence factors, which obstacles and constraints. It’s also important to understand and address, in a pre-launch and post-launch period, any barrier, as “lack of gain access to treatment”, that could briefly simplified as mainly: 1.Clinician lack of Knowledge of product 2.Clinician limited experience & confidence 3.Clinician not “allowed to use” In the first case, levers of growth should be, as example, pre-launch strategy, Med Ed activities, congresses data spread, publications, relationship management, any other “awareness” activity linked with the company, disease management or product data; in the second case, an example of lever for growth should be represented by latest “expert opinion” or any other “consensus paper”, local trials (including investigators initiated studies), peer usage; in the third case, also in this case, as a simple example, some lever of growth could be represented by the inclusion into hospital formularies or national/central guidelines and recommendations to follow. In a patient journey, the customers (i.e.: physician/patients/pharmacist) analysis are important stakeholders to consider, to understand which are their needs, constraints, treatment approaches (physicians) and considerations (patients). Other assessment will be focused mainly on the market characteristic, trend and size. Medical Affairs function must be able to provide main contribution and added-value, for obtaining and addressing the above topics, working in a cross-functional way with other function, as an “integrated team”, and in many cases of the above statements and examples, Medical Affairs has to “lead” the generation of the insights, advices and gained recommendations, through KOLs and other stakeholders by building and maintaining professional relationships, and managing experts with a “peer-to-peer” approach. In fact, as per the above, Medical Affairs team has the direct contact with the most important external stakeholders (KOLs, Investigators and Scientific Societies firstly, but also with other relevant stakeholders, as Patients Association Groups, Payors, Health Economists and Pharmacologists) and through MSLs team, all these activities, can be more direct, capillary and specific. Addressing all the needed info to be collected with the right stakeholder, is highly important and it needs time. For this reason, collecting info by Medical Affairs has never to be a “spot” activity, but, on the contrary, has to be a well planned in advance – at least some months – activity, with an adequate and detailed plan of external meetings, F2F, congress attendance (to reach as many experts as possible all at once), clinical site visits together with CRAs or other Clinical Research personnel, to discuss with investigators and experts in a specific therapeutic areas, the “market disease environment”, also planning and leading Advisory Boards for obtaining medical insights and for investigating unmet needs and global uncharted market potential/access opportunities. Other topics to deeply investigate and to be included in a SWOT analysis are: •Clinical trials status of competitors and patent expirations; •Publications of competitive trials (deep analysis of these can provide valuable and differentiating strategic info); •Documenting business rules, ensuring global data is in line with domestic data parameters •Stay current on global pharma business and identify any factors that may impact business, present and future including M&A, new technologies, global markets, politics and approaches; •Presence of “disease local registries”, in addition to any eventual Regional one, managed by Scientific Societies, Healthcare Agency or Patients Association Groups for using these as a relevant source for patients information and related treatments, starting from Standard of Care (SoC). Of course, all of the above, must be completed by a full knowledge of “disease area”, main competitors and products phases of LCM, extensive knowledge of MoA of the marketed products, including development pipelines, as well; in addition to that, another relevant accountability to consider for Medical Affairs, is the deep knowledge of therapeutic algorithms, main guidelines and recommendations, local restrictions at country/regional level. At each level of Medical Affairs organization, from Medical in the field (MSLs) and office-based (Medical Advisors and Medical Managers) to Medical Affairs Director/Medical Director, all Medical team should be able to provide a highly relevant contribution, according the shared and highlighted topics. In conclusion, for completing a business analysis and having a deep market scenario picture, is important to consider, at least the following: •Understand the market: reviewing global market understanding from a local perspective; considering information on actual markets and future pipelines perspective, raising additional, relevant local knowledge and identifying and prioritize brand implications. •Identify any potential opportunities: reviewing global guidelines and opportunities to ensure alignment and identify any deviation from these; develop a SWOT for the product/brand, highlighting any critical implication from patient understanding and from the market. •Build patient understanding: assessing and defining the “patient journey”, evaluating global patient populations (with info provided by Global teams) with local insight and information obtained, to define potential local patient segments. The more detailed and accurate info are obtained, the more specific and valuable work will provide a direction and an assessment of business analysis, providing a valuable business and market scenario. Report this

Tommaso Salanitri nuovo Direttore Medico di Educom .::. PHARMASTAR

Medico e Specialista in Chirurgia Generale, con ampio background clinico e ventennale esperienza in ambito Pharma, Tommaso Salanitri approda in Educom per ricoprire il ruolo di Direttore Medico.
— Leggi su www.pharmastar.it/news/business/tommaso-salanitri-nuovo-direttore-medico-di-educom-32892

Medical teams in an evolving healthcare ecosystem

Stakeholders needs are changing and these uncertain times are accelerating changes and approaches we were just aware to make and in an era of Digital disruption and Big Data – more than in the past – Medical teams will provide value, delivering impact for the benefit of all stakeholders, mainly by leading and overseeing several strategic activities:

Having focus on Digital Health, precision medicine, integration with big data, diagnostic and therapeutic, with a complete understanding of stakeholder’s needs.  

Exploring new strategies, in a “disruptive” period, simplifying processes and operations. 

Using new strategies and tactics as Advanced Targeting and 1:1 Digital Engagement. 

Providing market-based strategic input to drug development and portfolio management, overseeing the effort to develop and produce Real World Evidence and Big Data. 

Embracing the power of technology to transform medical, by digital, AI, advanced analytics and developing strategic plans.  

Delivering customer experience focused on science, through a deeper understanding of physician and patient journey, medical insights, unmet medical needs and preferences from all digital and AI touchpoints, to assess and develop the best stakeholder engagement plans & actions, managing real time digital interaction tools and at the same time, providing digital services and solutions, beyond the product data and information.  

Engaging external stakeholders and communicating scientific evidence with innovative and “omnichannel” approach. 

Finally, it’s important to assess the new Stakeholder scenario and Environmental trends, according data generation, AI, RWE, Big Data, scientific exchange, next generation therapies and pricing pressures.

Medical Affairs and Strategic Value

These uncertain times are accelerating changes and approaches we were just aware to make.

In an era of Digital disruption and Big Data, more than in the past, Medical Affairs teams will provide value, mainly by leading and overseeing the following strategic activities: 

Exploring new strategies in a “disruptive” period, simplifying processes and operations.

Overseeing the effort to develop and produce Big Data and RWE.

Providing market-based strategic input to drug development and portfolio management.

Having focus on Digital Health, precision medicine, integration with diagnostic and big data, with a complete understanding of stakeholder’s needs.

Engaging external stakeholders and communicating scientific evidence with innovative and “multi-channel” approach.

Precision Medicine as one of the most relevant trends in 2020

One of the topics highlighted in the 2020 ISPOR trends report is Precision Medicine. Also referred to as “personalized medicine,” precision medicine aims to take into account individual variability in genes, environment, and lifestyle for each person. 

Precision medicine is characterized by a “growing field fueled by data” and in fact, this requires a colossal amount of big data, therefore the ability to analyze these data plays an important role.

The market for precision medicine is growing and it is expected to reach $217 billion by 2028, driven by an increasing demand for personalized treatment, technological innovation and advancement – including biomarker-based tests/kits, next-gene sequencing, and precise imaging – as well as government support and regulations.

Product launches strategy and main tasks

There are a multitude of launch preparation activities that include but are not limited to, the following: Identifying and filling the future evidentiary needs of HCPs, payers, HTAs and patient groups in the clinical development phase through the clinical trials and lifecycle plans right up until patent expiration.

Brand naming process and also leveraging the different clinical evidence, data sources, market research and consumer generated media to develop the foundational strategy for the brand.

Then, deciding on the tactical options for each local key player segment, based on solution ideation from the key “jobs to be done” work .

Multi-channel integration work to ensure it comes together seamlessly.

Message and campaign development work with requisite testing and fine tuning. Salesforce strategy and sizing, the digital strategy , the thought leader and advisory board plan.

The corporate affairs and PR plan, the DTC plan, the critical pricing, access and reimbursement work, the meetings and peer to peer approach, CRM plan and the training plan for all member of the launch team and all customer facing employees.

So many elements to a launch and not forgetting the pre-market educational and awareness work.


Medica Affairs value and leadership

The healthcare system is increasingly resource-constrained, while at the same time treatment options are proliferating, therefore access and treatment choices will ultimately require a solid understanding and convincing demonstration of medical and economic value.

In order to fully demonstrate value, Medical Affairs must continuously upgrade its understanding of what value means from the perspectives of a broad spectrum of healthcare stakeholders, from patients, to society, to industry.

Enhancing medical value will require not only a deep comprehension of product characteristics but also a robust, market-informed view of both unmet medical needs and risk tolerance.

To that end, Medical Affairs has to become more proactive about bringing insights from a broader range of external medical decision-makers and influencers into early clinical development.

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