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    My golf game progresses in direct proportion to two things:

    The quality and quantity of practice time I put in.

    Staying on a regular coaching schedule with my golf teacher.

    Ab
    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
    out three years ago I was consistently shooting in the high 90's and ready to melt the clubs into a paperweight. Today I'm in the low 80's and dip into the 70's.

    I don't say thi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    to boast (Ok, maybe just a little), but to compare this improvement to what it takes to be successful in sales.

    Success in golf, sales, or most any endeavor that requires skill
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    relies on knowledge, practice, and coaching. Regardless of how much I improve, I'll always use a coach. Particularly when I'm temporarily out of sync. It amazes me how my coach
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    an watch me hit just a few balls, have me make a few minor adjustments, and have me once again striking blazing rock­ets 300 yards down the center of the fairway. Well, maybe, 25
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    yards with the wind and a good roll on a hard sun-baked fairway, while leaning a bit to the right.

    The point is that even though my mind thinks it knows what I should do with m
    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
    y swing, the muscles doing the work often say “Huh?” But my coach helps me get back in the zone, and gives me suggestions for practice drills.

    And I see the same things happenin
    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
    with sales profes­sionals.

    Sure you can get somewhat better on your own, if you have the desire, are willing to research new ideas, and work independently. But we all have thos
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    blind spots in our rear view mirrors that we don't even know exist. Therefore, to make a quantum leap, get a coach.

    You should seek out the best you can find. Typically it's yo
    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
    ur manager or supervisor, or maybe it's an accomplished sales rep you respect. Maybe a knowledgeable pro outside of your company. Ask them to review your calls-either on tape or
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ive-on a weekly basis.

    Why You Need Coaching

    We don't know what we don't know. You might be doing something wrong, but not even know it. A friend of mine hasn't progressed much
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    in his golf game during the past couple of years. Not surprisingly, he has never, ever taken lessons. He has said, “I don't know what I'm doing wrong, and wouldn't know how to fi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    x it if I did.”

    oPractice does not make perfect. Practice can be a dangerous thing. Because, if you continue committing the same mistakes, they become habits. Perfect practice m
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    kes perfect.

    Suggestions for Productive Learning Sessions

    Maximize your time together. The best use of time is to have a coach listen to tapes of calls. Dead time between calls
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and non-contacts can either be edited out or fast-forwarded through. (Our Recorder Link product plugs into your phone and your tape recorder, clearly taping both ends of the call
    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
    . It's $20.95. Call us at 800-326-7721 to order.)

    Discuss positives, then suggested changes. When I coach-whether it be telephone calls of sales reps making over $100,000 or my
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ids' basketball, baseball and softball teams-I use the same format. Praise the person and the positive performance first to reinforce it, then make any suggestions, explain why,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nd demonstrate personally or give examples. On calls I start by asking what they liked, I then state positives I observed, next ask what they would have done differently, and fin
    .

    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
    ally I'll make my suggestions. I suggest you and your coach work something similar.

    Reflect on the coaching session. Learning takes place after an event, when you ponder it and
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    reak down its components. Discuss for several minutes what you covered.

    End with an action step. Be certain you receive an assignment to work on during the time between sessions


    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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