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  • Useful Advices - You Snooze, You Lose

    I recently attended at leads group that I have been a part of for several weeks. As I went into t
    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
    he room, I found that most people sit in the exact same spot each week. I began to wonder if they
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    really liked that particular seat or where just uncomfortable moving around the room. The psychol
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    gy behind it (and from years of training people), is that people like routine and will sit in the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    same seat unless forced to do otherwise. Now how many people do you think they will get to know i
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    n this group? Probably the ones on either side and just across the table. A very small network. <
    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
    r>
    Now let's take this one step further. I made a choice to sit at the opposite end of the t
    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
    ble with a new group. I was privileged to talk to 5 new people. They knew who I was but were not
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    oo sure about how I could help their business as they only heard snippets from the other end of t
    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
    he table. Nothing could be better said. In sales, networking is crucial and getting to know more
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    han just a couple of people in a group is essential.

    It so happened that a person in my
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ew circle discovered that someone at the other end of the table had an incident where her experti
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e would solve the problem. Because she had not made the effort to get to know the other person, s
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    he thought that if they needed her, they would call. Hmmm, something is definitely wrong with tha
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    scenario.

    A few keys to getting business from a networking group include:
    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
    Sit in a new place with new people each meeting.
  • Get to know each person around y
  • ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    u (set outside meetings to learn even more).
  • Don't wait for the business, call when
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

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