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  • Just Other Articles - Realistic Target Setting - Part 1

    Some of the most common worries about setting targets for performance measures are:

    * challenge 1: Striking that sensiti
    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
    ve balance between making the target achievable but also a stretch.

    * challenge 2: Creating that sense of urgency that w
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ill motivate people to hunger after the target.

    * challenge 3: Having a measure or means of monitoring progress as the t
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    arget timeframe approaches.

    I'd like to share some ideas with you, about how to lessen the burden when you come face to
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ace with worries like these.

    idea #1: don't strike a balance between achievable and stretch - do both

    What I've learned
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    is that it takes practice and confidence-building to achieve a target or goal. Why not set at least two or three targets
    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
    for any single performance improvement? The first one is shorter term and not very challenging, for the purpose of build
    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
    ing target-accomplishing momentum. The interim target is an opportunity to build more capability and confidence to stretc
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    . The last one is the stretchy target, which you might have no idea of how to reach at this point in time, but be in a be
    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
    tter position to know after you've achieved the interim target.

    idea #2: use vivid and specific language to describe the
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    world after the target is accomplished

    Numbers alone are hardly enough to motivate anyone. So handing a team a performa
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nce measure + target value + timeframe won't likely be enough motivation. Have you ever tried telling the story about wha
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    the world (or at least your part of it) is like after the target is met? Colour, sound, movement, emotion, expression, b
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ehaviour, shape, rhythm and all those other sensory experiences emblazon the meaning of the target into the minds and hea
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    rts of those setting out to achieve it. Motivation from within is the best kind.

    idea #3: make sure your measure can be
    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
    monitored at least 6 times within the target timeframe

    Design your measure so you can calculate it as regularly as is fe
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    sible, and then set a target timeframe that accommodates frequent enough feedback to increase your chances of staying on
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    track. For example, monitor your measure weekly or monthly for a 1 to 2 year target timeframe. Yes, sometimes you just ca
    .

    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
    n't get data this frequently, but that doesn't change the fact that a single point of data says nothing. Is it worth sett
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ing a target that you cannot honestly know is achieved?

    Look out for part 2, for the next 3 challenges of target setting


    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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