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    A majority of my work as a consultant involves getting in front of potential audiences via speaking. M
    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
    y speaking engagements, which range from forty-five minutes to all day, vary according to the objectiv
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s of those purchasing my services. In other words, I have no canned speeches that I pull out, and I ne
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ver give the same speech or presentation twice. However, this is not usually the case. In fact, most s
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    eakers today take the same speech content and deliver it repeatedly to different audiences. It is beca
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    se of that propensity for regurgitation of past material that I believe most companies can benefit fro
    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
    m the following guidelines to use when searching for your next speaker.

    Print out these questions, 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
    answer them prior to hiring any speaker. Not only will it help you hire the RIGHT speaker for your co
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    pany needs, but it will make you look like a million bucks in your boss’ eyes!

    1. What specifically d
    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
    o you hope to achieve through hiring this speaker? (Increased sales? Motivation? Decreased turnover? H
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    gher fees in your sales staff?)

    2. What is the potential speaker’s main area of expertise? (Sales, Ma
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    keting, Management, Leadership Development, etc)

    3. Can this speaker provide references?

    4. Does the
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    potential speaking candidate listen to what you think are your company needs?

    5. How engaging is the
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    potential speaker? (If your initial conversation with them is as inspired as watching paint dry, move
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n. It’ll get worse in person)

    6. What are their fees? (And remember that most of the time, you get wh
    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
    at you pay for)

    7. Do they provide a satisfaction guarantee? (Quality speakers want you to be complet
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ly satisfied with the results of your work together and won’t hesitate to guarantee your satisfaction
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    s such)

    These seven points will enable you to discern good potential speaking candidates from lousy o
    .

    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
    nes. Your time, and your company’s time, is too valuable to waste. Put effort in initially and ask the
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    tough questions. Your boss will thank you.

    Copyright (2005) Leif H. Smith, Psy.D. All Rights Reserved


    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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