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  • Subjects - Poor Business Planning; Lost Opportunities

    Business planning is a bore to most organisations. It is seen in many cases as an annual chore to be completed under duress of the chief executive officer, board or other stakeholders.

    It should be seen however, as an opportunity to clear away the co
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    bwebs of day to day management and supervision. It is the one time that the leaders of the organisation are able to reflect on their current operating environment and plan for the future.

    Much of the apparent drudgery of business planning comes from
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    he poor, if any, processes adopted in business or corporate planning. Business planning does not have to be complex, but it does take process, thought and data.

    The bulk of business planning should be completed over two to three days away from the da
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    y to day management. Prior to the “away days” preparation in the form of an analysis of current performance against financial, employee, customer and community KPIs and the development of a model of financial inputs and outputs can be completed.

    A wo
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    thy starting point for a business planning session is to reconfirm what business the organisation is in. This somewhat obvious step is often revealing as organisations tend to slide from their original purpose over time. Alternatively, the environment
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    in which they operate changes enough to make their business model irrelevant.

    Business planning processes are well documented. They tend to follow a well worn path of planning. The path is usually Mission/Vision, current performance, SWOT, goals, str
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    ategies, marketing and sales plan, operational plan, research and development plan, people development plan, funding plan, financial projections and action plan.

    To make the most out of an away day, the leadership team needs to come prepared with an
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    xcel spreadsheet of profit and cash flow over the last four years and a prospective balance sheet. Also, an excel model of the component parts of sales, direct costs, indirect costs, capital investments, depreciation schedule, interest taxes and finan
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ing sources and costs is required.

    If the skills required to create these models are not available in the organisation, they should be hired. The importance of having accurate financial data on business planning cannot be overstated.

    Although, it is
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    equally important to recognise that business planning should not get in front of the data available. That is, if the data available is only at the high level, the planning regrettably must be at high level. The corollary of course, is that the action
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    plan must include activities to improve the granularity of the data.

    The first day of an “away day” concentrates on understanding the current performance. Leaders ensure that they understand the inter-relationships of the existing marketing, sales, o
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    erational, research and development and people development activities. They must understand the strengths, weaknesses, opportunities and threats in the markets in which they operate.

    Government departments and ministries are not immune from this nece
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ssity of analysis. They may not receive payment for many of their services, but they do have services, customers, cost and people development activities which interact not only with other ministries and departments but also with the public and public
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ompanies.

    The second day of an “away day” concentrates on the “so where do we want to be” discussion and brainstorming. This should be a day free from restrictions of the present. It should concentrate on using the strengths of the organisation or el
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    minating the weaknesses of the organisation to achieve the goals and vision of the organisation.

    The third day of the “away day” concentrates on the capacity constraints that would either stop some of the strategies and tactics developed on day two f
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    rom ever being realised or are needed to be developed to be able to reach the goals and vision. The capacity enhancements will include capital investment, recruitment, process re-engineering, competency development, data gathering and performance mana
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ement, to name a few.

    The key to this part of the planning is to be realistic about the time required to develop and the resources to manage the development of the capacity. The resources will include money and people and occasionally systems, which
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    equires policy and process documentation and people and money.

    After the “away day” the leaders should communicate the outcomes to their subordinates and ask them to model and understand the ramifications of adopting any of the planned items. The sub
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    ordinate feedback and output from the away days is discussed and prioritised with timelines, people requirements, financial and funding implications being used to cull out activities to a final plan.

    Business planning is not a chore. It is the obliga
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ion of every leader to plan their business and communicate it to their subordinates. Without it, organisations operate in a dark and foreboding forest of opportunities lost through ignorance of the past, and present and lack of planning for the future


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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