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  • Useful Advices - Joint Ventures - Part XI

    JV With Those Who Already Have Business Relationships – I mentioned at the start of this section that some
    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
    of the best companies to JV with are those whom you already have a preexisting relationship with. What if
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    you don’t have any?

    You can JV with those people who do! Put an ad in your local paper. Go online and net
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    work with people who do have these relationships. Then cut them in on the deal and let them introduce you.
    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’s the difference between a cold intro and a warm or hot one.

    Start Small – Do you have a big idea for
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    deal but no relationship with the potential partner company? You can always start out small, with a test
    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
    to validate your experience and the results before moving onto the big deal you had in mind. By the time y
    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
    ur small deal is validated, you know have that relationship to move to the next level.

    Let Them White Lab
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    el You – Let’s assume you are an IT consulting firm, and you decide to JV with hardware companies to acces
    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
    their customer base and have them endorse your services. The trouble is, you want to JV with several hard
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    are makers, and each one wants you to use only their hardware. How do you get around that and still have a
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ccess to all of their lists and endorsements?

    One way is to let them “white label” your services. In othe
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    words, when you consult for their customers, you represent that hardware company. So every time you go ou
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t, you change “shirts and hats,” so to speak. That way each hardware company has you representing them. Ba
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ically, they would sell your services as their own.

    Think of it as a “private label rights” situation, 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
    re you sell your works to other companies that they can in turn repackage as their own. If you’re looking
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    to drum up more business, this one approach alone could bring you more than you can handle. In other words
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    you may have to hire more staff. It’s that powerful.

    Listen, do you think all of the “Geek Squads” and s
    .

    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
    uch are all owned by the companies dispatching them? No, many are contracted. These are large-scale corpor
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    te deals, but nothing says you can’t do something similar on a smaller scale to start.

    to be continued...


    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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