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    Several years ago when I started my business one of the first things I did was develop a website (in itself a sign of the times because even a
    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
    few years earlier one of the first things I would have done is develop a brochure -- or a Rolodex card – remember those?). The website deve
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    oper asked me what I wanted. I said to him, “I don’t know what I want, but I can tell you what I don’t want.”

    The wise young web developer’s
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    response to me was, “I don’t care what you don’t want. We could spend weeks talking about what you don’t want and still be no closer to what
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    it is that you do want.”

    This conversation flashed back into my mind recently when I was talking to a friend of mine. She said, “I don’t wan
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t to be in limbo any more, and I don’t want to work in isolation.” And I said to her, as I am saying to you – and as the wise young web dev
    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
    loper said to me -- “What is it that you do want?

    What is your vision for 2007? What is it that you want? Now is the time to paint a pictur
    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
    e of your future. Describe in detail what it is that you want. And allow yourself to feel how you will feel when you have accomplished this
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    vision.

    When I work with clients one of the first things I ask them is what is your vision for your company? Where do you see the business
    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
    being in three, five, and ten years? Tell me about your ideal scenario.

    I remind them that this is a vision not a set of goals – it should h
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ve feeling. I tell them to dream big. And to remember that if they shoot for the moon and miss they’ll still be among the stars.

    As you pai
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t your ideal picture for 2007, answer the following questions. And, if you really want to be successful, commit your answers to paper.
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod

    • What kind of clients do you want to be working with?
    • Where do you want to be spending your time?
    • What products and serv
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ces do you offer?
    • Do you have employees, if so how many and what role(s) are they playing?
    • What is your role with the company?
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen

    • How do you spend your time?
    • How much time are you spending working in the company?
    • What kind of revenues does the comp
    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
    ny have?
    • What is your income?
    • What resources or skills do you need to achieve and maintain your vision and how will you acqu
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ire those?
    • What do your clients say about your company?
    • What do your competitors say about your company?
    • What is your c
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    mpany’s image in the marketplace?
    • How will you know when you have achieved your vision? What will it be like?


    Now, put it all to
    .

    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
    gether. Write a 50 to 75 word description of your vision for the future – or draw a picture that depicts your vision.

    In the words of the wi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e young web developer, “What is it that you want?” What is your vision for 2007 and beyond? And, what will achieving that vision mean to you


    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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