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  • Main Subject - Business Relationships - Promises are for Keeping

    It's a small thing, but it is so vital. In your business relationships, forget
    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
    ting little things promised, causes erosion of trust and belief in you and all you st
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    and for.

    And ultimately, those little things add up to a lot for your people. And th
    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 affects you and in the end, your business success.

    Integrity is very important to
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    me, and I try hard to 'do unto others as I would wish them do unto me'. It hasn't
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    always worked that way for me though.

    There have been times in my previous caree
    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
    - times that I can remember vividly (and cringingly!) even now - when promise
    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
    s were not kept, things were borrowed, never to be returned and where I was not on th
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e best end of wheeling and dealing that are part of corporate politics.

    For me, crea
    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
    ing honourable relationships with my people has always been important. It is a two
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    -way street. Once when my wife was very ill, my management team told me not to co
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    me in, despite it being a very busy time.

    I told them, thank-you, and I would come a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    d go, in the comfort that they thought enough of me; of us; to tell me to do that.

    I
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    didn't need to ask, but what they said to me at that time came from an environment o
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    f fairness, honesty and trust had grown over time. They knew that if it had been them
    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
    I would have offered the same.

    It was as if, as Steven Covey says, in 'The Seven
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    Habits of Highly Effective People', I had enough credit in my 'emotional bank ac
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    count' to tide me over.

    I'd never realised that I had that credit, but looking back,
    .

    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
    my standards and values were daily deposits gained partly from keeping my promises. Y
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ou get back what you give out.

    There's no better time to start than right now


    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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