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    I was doing a sales training project at a company in Los Angeles when I had an oppor
    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
    tunity to hear the business owner address his sales crew.

    I usually enjoy watching
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ther trainers, but this was a special treat. Frank is self-made. He built his compan
    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 on grit and guts, and I admire him.

    Sure enough, within a minute of entering the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    raining room, I was rewarded with one of his key teachings:

    “No matter how much you
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    think you screwed-up your presentation, no matter how embarrassed you feel, no matte
    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
    r how shy you are, never leave someone’s office without asking for the order, at lea
    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
    t once,” he urged.

    His logic is that we tend to be overly critical with our perform
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ances, and just because we think we erred, the prospect may have overlooked our misc
    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
    e, altogether. Add to this the fact that most buyers won’t say yes without some guid
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    nce, and you can see how asking for the order becomes a necessity.

    Instantly, I sca
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nned my memory bank, and sure enough, I remembered a time when I failed to follow hi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    advice. I was pitching a security alarm company and I assumed we had a deal—everyth
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ing in my meeting with the two principals had gone so smoothly.

    But after leaving,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    nd then following up, I discovered that I blew it. I needed to make our tacit unders
    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
    anding completely explicit. And this is done by openly and clearly asking for the sa
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    le, by closing the deal.

    You may have heard that the ABC’s of selling can be transl
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ted into a single phrase: “Always Be Closing.” I think you can pull the trigger prem
    .

    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
    aturely, without having yet earned the deal, but it is definitely better to make thi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    mistake than to not close, altogether, or at least once!

    Dr. Gary S. Goodman © 200


    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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