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  • Summary - Relationship Advice - A Sneak Peak into a Couple's First Relationship Coaching Session

    When couples come in for their first session, they typically come ready to air their complaints and gripes about the other person
    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
    , perhaps hoping to win someone to their side.

    The first two questions I ask a couple in the first session are, "How did you mee
    ; 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 "What attracted you to each other in the beginning?"

    This surprises many couples at first, but my goal is to begin to hel
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    them focus on the strengths and positives in the relationship before we get to the problem areas.

    Let's look in on how this wen
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    in a first session with a fictional couple we will call Bob and Mary.

    Me: "How did you two meet?"

    Bob: "We met in college thro
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    gh some mutual friends."

    Me: "What first attracted you to each other?"

    Mary: "I thought Bob was a good-looking guy and he made
    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
    e laugh. He was very spontaneous and fun-loving."

    Bob: "Mary was really pretty and laughed at my jokes. We had a lot of fun toge
    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
    ther. She helped me to be more serious about the future."

    Traits that made our mate great become traits that grate

    In ou
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    search for a partner, each of us seems to be drawn to someone with complementary characteristics. The complementary characterist
    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
    cs in this case are Bob's spontaneity and sense of humor and Mary's stabilizing, future-focused view.

    In most situations, these
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    haracteristics begin to be problem areas in the relationship.

    Me: "What seems to be the struggle for the two of you?"

    Mary: "Bo
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is so irresponsible, he never takes anything seriously anymore, including me!"

    Bob: "It's just that I am so tired. of being nag
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ed all the time. She is no fun anymore!"

    Next, I ask them a series of connected questions. First, I ask them to remember when an
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    if the relationship was working.

    I then help them to identify and verbalize what specific things each partner did or said that
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    made the marriage work.

    After that, I ask what is called the "miracle question," that is, "If a miracle happened tonight while y
    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
    u were sleeping, and tomorrow morning your relationship was like you want it to be, what would be different?"

    Here's how Bob and
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    Mary responded to the "miracle question."

    Bob: "We would have fun again. Mary. would notice when I do take care of things. I wou
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    dn't feel so criticized."

    Mary: "I could trust Bob again to do what he says he'll do. I would feel like I was important to him."
    .

    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

    The miracle question allows us to focus on goals for the relationship. I usually send people home with the suggestion they conti
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ue the conversation about two things:

    1. What first attracted them to each other?

    2. How would they like the relationship to be


    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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