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  • Useful Advices - Web 2.0 Feels Like Dot-Com All Over Again

    The web 2.0 movement is certainly mainstream at this point. A quick look
    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
    at the VC investment data shows that this is no longer a fringe movemen
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t. Having lived through the dot-com experience, running an Internet star
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    t-up at the time (which made it through to this day), I have a few obser
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    vations about this latest craze.

    The number one objection I have to Web
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    2.0 is the lack of definition for the term itself. Whenever there is a
    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
    "buzz" about something people can't quite define, I tend to believe it's
    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
    not real. Or at least, the idea is still in a formation stage. We heard
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    this in the 90's, "the Internet is changing the very fundamentals of bus
    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
    iness." But when you asked people how, they couldn't really answer. Thei
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    r only reply was: "You'll see." Well, we certainly saw. Business is busi
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ness, and always will be. There needs to be a return of x percent in y y
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ears, or investments generally are not offered.

    Will Web 2.0 bring new
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    and interesting ways to make money? I think so. I'm quite intrigued by t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e possibilities. But my money is on the sidelines at this point. I think
    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 the money that's out there now is somewhat foolish. Maybe foolish
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    is a little harsh. It's the early-adopter money. It's a typical investme
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nt pattern, really. The early money will largely be lost, but is necessa
    .

    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
    ry to help define how to use a new technology. The 1% who make it throug
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    h the first few years will see incredible returns. The other 99%, well..


    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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