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  • Advice You - Personalizing a Tribute - When You Don't Know the Person

    We all know the difference between a generic “great job” and praise that really shows appreciation of t
    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
    he work we did. If you are asked to honor a co-worker, volunteer, or colleague, it’s worth the extra ef
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    fort to find ways to personalize that tribute. Even if it’s a stand-up, quick moment of public praise,
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rather than a formal speech, making it personal boosts the morale of the person honored, as well as all
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    those who are listening. And it will make you feel pretty good, too.

    But what do you do when you don’
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t know the person being honored? I am sometimes asked to write a script for an award presentation. I'm
    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
    not even giving the talk myself. Although not ideal, there are ways that I deal with this situation.

    <
    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
    b>Ask for anecdotes. If I have the opportunity, I ask the person being honored for specifics. For e
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    xample, if are awarding a great teacher, what made him or her enter the profession? What was the first
    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
    day in the classroom like? What keeps them going week after week?

    Ask around. Oftentimes, of co
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    urse, the honor is a surprise, and direct questions may not be possible. In these cases, there may be s
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    pecifics to pull from if a nomination packet was prepared, or I discreetly ask colleagues or friends. T
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    hey will no doubt have some examples of ways that the person really shines. Funny stories—as long as th
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ey are not mean-spirited to the honoree or anyone else—are welcome. For example, I had to write a scrip
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t to honor six teachers who won a prestigious national award. Their colleagues could share wry stories
    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
    that shed light on the outstanding nature of the winners.

    Look at photos. If I don’t know what
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    the person looks like, or have only seen a head shot, I try to get some photos, preferably of them in a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ction. I get a better sense of how their achievements and will be able to talk more convincingly as a r
    .

    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
    esult.

    Try to meet them beforehand. Even a short encounter will make words come alive. Even if
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    I don’t indicate why I am meeting them if the award is a surprise, the tribute will sound more personal


    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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