Business Plan: a Medical Affairs perspective

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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.
  • Key words are, PLANNING, EXECUTION, MONITORING & FOLLOW-UP

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.

“Without planning, the jungle’s law would prevail” (John Fitzgerald Kennedy)

Tommaso Salanitri
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.