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    Recently, I went for a drink with a group of people I know through a networking community. I ended up talking with one of them, a man I’d never felt particularly comfortable around, because he is generally quick to
    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
    anger and often has a short word for people, including me.

    I heard him say to someone that his wife was a fat slob. Before I’d even thought about it, I asked him: “So, why do you stay with her?”

    The story was long
    ; 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 sad. They had, he said, been happy together for 15 years. Then, she had stopped wanting a sexual relationship after giving birth to their second child. After 18 months he had started an affair… with her best
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    riend. They’d fallen in love, been careless and their respective spouses had found out. In the end the lovers had chosen to stay with their spouses and try to put their marital relationship back together.

    The only
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    problem was that this couple didn’t know how to do that. She had banished him from the bedroom and he increasingly felt that she was more interested in punishing him than moving on. He responded by punishing himse
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    lf and her.

    They had gone for help and the help had been ineffectual. Their friends were like a Greek chorus, constantly butting in and helping nurture their sense of grievance, telling each partner how awful the o
    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
    her was and how they shouldn’t put up with it. But still they did.

    The bottom line was that both incessantly talked about leaving, and didn’t. In fact, both wanted to rebuild the relationship and didn’t know how.

    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
    They operated on the unspoken principle that if they expressed their own pain loudly enough - and they did this principally by levelling accusations at the other – then eventually the other would hear them and empath
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ise with their pain. Needless to say it wasn’t working. Somehow they wanted their continuing rejection of the other to bring their partner closer to them.

    But of course, they couldn’t consciously admit what they r
    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
    ally wanted to happen. Instead they both told each other and themselves how much they hated the other.

    Sometimes they would let their guard down long enough to share a little of the old warmth and then the thought
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    that they were condoning the other’s behaviour would kick in. So they would revert to their habitual expressions of anger and contempt, criticism and rejection, feeling even more confused and saddened by that glimps
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e of how things once were and might possibly be again.

    I expressed my sadness for the pain they were both experiencing. I sensed the loss and abandonment and betrayal that both were suffering and wanting the other
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    o alleviate. What they both wanted, but could not articulate in a positive way, was to be together, differently.

    He looked at me in amazement. It was not what he expected to hear. “But you don’t understand”, he s
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    aid, “I really hate her now. I can’t stand her.”

    I repeated to him what a wise counsellor once said to me: “The opposite of love is not hate, it’s indifference.”

    Neither felt anything approaching indifference for
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the other. Neither was remotely interested in finding another partner. The husband was desperate to have his marriage back, be around for his children and be involved in their upbringing.

    He said that he’d tried t
    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
    build bridges and had met with constant rebuffs. He had understood the rebuffs signified her loathing for him. He’d never considered that it might be an expression of her pain.

    Both had wanted to move on. Yet ne
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ither had been able to truly hear and acknowledge the other’s hurt, and so that hurt expressed itself in hate.

    How could they do it differently? By truly listening to the other, listening respectfully without comme
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nt, until the other moves from reproaches into the underlying feelings. And then listening some more. Staying with their hurt and their guilt and the sense of betrayal, in the knowledge that that is the most powerf
    .

    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
    l way to make their agony pass.

    It may sound scary and painful, but it will actually prove a lot less painful and more effective than tearing themselves and their partner to shreds.

    Will they do it? Hard to say.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    There are no guarantees that it will work. On the other hand, if they don’t do it, there is the certainty that they will hate themselves and their partner until they can hate and hurt no more.

    (c) 2006 Annie Kaszin


    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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