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    VISITING BEAUFORT...

    If you are fortunate enough to visit a small town in
    Beaufort, North Carolina, you will soon discover its
    uniqueness.


    Beaufort is a waterfront town, and one of those places you could term as "charming." I
    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
    t is rich -- both in its history and the natural beauty of a seaside atmosphere.

    I would term it "nice."

    Nice in the relaxing sense.

    Nice like savoring the flavor of a fresh, delicious tuna sandwich with your special someone while allowi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    g the calming presence of a beachfront view remind you one more time of what it means to "take time to live."

    PERSONALLY YOURS BY THE SEA

    You could pass it by and not see it.

    The sign is not huge by any standard. A few words painted on
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    a wooden marker: "Personally Yours By The Sea."

    The size of the sign might easily be an indicator of the size of the gift shop it is advertising. In a word: small.

    An area less than the measurements of an average living room houses the co
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tents of "Personally Yours By The Sea, Ltd." Should you discover this somewhat hidden treasure, upon entry you would no doubt receive a warm Southern greeting from Laura Lee.


    Personally Yours By The Sea is a place of transformation.

    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ou give Laura Lee a blank picture frame, for instance, and she will transform the frame into a personalized gift.

    By combining a thought or two of your own with Laura Lee's handiwork, the frame becomes a uniquely designed souvenir or pres
    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
    ent created for the sole purpose of causing someone to experience a moment of joy each time it is viewed.

    THE POINT


    What was a blank picture frame becomes a *personal expression* of beauty for you or someone special to you.

    It just
    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
    akes...


    Some time.
    A personal thought or two.
    And a dash of creativity.


    You might say that we each own a store -- not too unlike the one in Beaufort. We are the sole proprietors of our own "Personally Yours" establishmen
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s.

    As storeowners, we have the power to use our resources in whatever ways we choose. We, like Laura Lee, may add our unique "signatures" to the lives of those we influence.

    Day by day we can design and distribute moments of delight, enc
    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
    ouragement and hope to people.

    IT ALL ADDS UP


    Laura Lee has been personalizing her gifts for about fourteen years.

    Fourteen years!


    Allow your mind to wander for a few brief seconds. How many individualized expressions of happine
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s have been crafted over the years from Laura Lee's tiny shop in Beaufort, North Carolina?

    And...


    In how many different places around the United States -- or even the world -- do you think these unique gifts can be found? (I can nam
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    at least two states that I know of for sure!)


    Fourteen years.
    And no doubt multiplied hundreds of customers.


    That's a lot of smiles for a lot of people


    It also reveals the value of...


    COMPOUND INFLUENCE


    We know
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    the value of compound interest. Consistent investments -- even of relatively small amounts of money -- made over a long period of time can add up.

    Consider the "compound influence" we can have in the lives of people.


    Our influence c
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n "travel" -- just like the personalized gifts purchased from a small waterfront town in North Carolina have traveled to the homes, places of employment, and vacation hideaways of many people in a variety of< different locations.


    WHA
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    'S THE SECRET?


    Consistency --> That's the secret of compound influence.

    Some time

    A personal thought or two

    A dash of creativity


    *Repeated again and again over time*

    "Compound Influence"


    I know
    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
    this is not a new concept. It is not unique and certainly doesn't qualify as brilliant.

    But the determination to take small, consistent steps of action in order to delight the hearts of others according to the unique motivations and gift
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    we have been given is both *needed* and *valuable* in our world.

    And with that in mind, maybe each of us should ask...

    "HOW'S THE STORE?"

    Do I have too much unused inventory?

    Am I allowing my gifts, talents and abilities to lie
    som
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    what dormant in the back room of my heart?


    Or...

    Is my inventory being consistently used to brighten the
    lives of people?


    Am I utilizing the tremendous value of compound influence
    by consistently adding my personal "signa
    .

    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
    ture of joy" to
    the people in my world?


    Yours for a day filled with beautiful moments in time,

    Lee

    P.S. Why not spend a moment or two and take an inventory--
    an inventory of your strengths, gifts or abilities?


    You don't
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ave to list all of them -- just a few.


    Once the list has been made, ask yourself this question:
    "How can I use one or more of these gifts I have been given
    to create a moment of joy for someone I care about?"


    Just a though


    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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