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  • Advice You - If Not This Time - Perhaps Later

    Ever worked hard on a proposal and not been awarded the contract? When it happens to me, I
    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
    say ‘Thank you’. My follow-up notes read like this:

    ‘Thank you for the opportunity to get
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    o know you better and offer my services to you. I hope we have a chance to work together in
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    the future. In the meantime, I wish you the best of success. Feel free to contact me when I
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    may be of assistance.’

    This note creates good feelings for everyone. The prospect may cont
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ct me in the future. If someone else asks about me, he may give a positive comment or an ac
    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
    tive referral.

    Consider the different reactions in these two examples.

    I interviewed a co
    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
    sultant but decided not to hire her at this time. She went totally silent, no longer respon
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ing to my messages. I wonder if she felt I owed her the business since we met once to discu
    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
    s it? Or that I should not have chosen another consultant, or could not simply change my mi
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    d?

    This short-term reaction can have a long-term impact. I often refer people within my bu
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    siness network. Her cordial reply would have secured my positive word of mouth.

    I met twic
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    with a financial planner, but made a decision not to use his services. He called me to exp
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ore my reasons and accepted them with grace. He asked if he could stay in touch in the futu
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e. I gladly agreed. He asked me for referrals when appropriate, which I also agreed to do.
    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

    Key Learning Point
    ------------------------------------------------------------
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    --------------------

    Your prospect may become your client in the future, and inf
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    uence your reputation in the present.


    Action Steps
    ---------------------------
    .

    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
    ----------------------------------------------------

    When you make a proposal an
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    you don't get the business, make an extra effort to leave a positive impression at the end


    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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