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    Visit the business section of your local bookstore and you'll probably find a section on "teams" or "team building".

    Listen to executives, professionals, consultants and academics, and they'll inevitably gush about the wonders of teams a
    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
    nd teamwork.

    And why not? Companies are teams, or at least they're made up of teams. A "team" being a group of people that works together to accomplish a common goal. So it only makes sense that business writers should devote attention t
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    o building, motivating and getting the best and most out of teams.

    But when we talk about teams, we're not just talking about any old group of people working together to accomplish a common goal, are we?

    We're talking about Teams with a
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    capital "T" -- tightly focused groups of interdependent individuals using their distinct yet complementary skills to tackle projects and problems. Whew -- that was a mouthful!

    These Teams do the same work as individuals or small-"t" tea
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ms, but in a more effective way. While in the past one person might have done it all, or a small-"t" team might have worked in "production line" fashion -- where each person did his or her little bit, before handing the project on to the
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    next person -- Teams work together at the concurrently.

    As such, they not only get the work done quicker, but if problems arise, they can more readily share solutions and overcome such stumbling blocks.

    But as we embrace Teams and Teamw
    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
    ork... as Teams are heralded as the answer to all workplace ills... you might pause to ask, does Teamwork always work?

    And the answer is: no!

    Structuring work around Teams... or Teams around work... will not always lead to the best poss
    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
    ible results -- whether in terms of productivity, sales, profits or any other measure of "results".

    Now, I'm not going to go into some obvious potential problems with Teams -- like people not getting along with each other. Frankly, there
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    's no faster way to hamper workplace performance than people fighting! However, this can negatively impact non-Team work environments too.

    My real objection is to companies (read: managers) rushing to deploy Teams, when one or more indiv
    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
    iduals -- working largely independently -- could more quickly and effectively do the work.

    In fact, you need to be very clear about when to use Teams and when to use teams or individuals. There are three factors to consider:

    -- Type of
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    work

    -- Scope of work

    -- Kinds of people attracted to this kind of work

    Let's consider each...

    1. Type Of Work

    When it comes to the type of work, ask yourself:

    -- Can it, must it, be done at the same time? If so, the greater the nee
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    d for a Team. If not -- if it is sequential -- the smaller the need.

    -- Does knowledge need to be acquired from one task in order to do another? If so, the more likely that one person or a group of independent people should perform the w
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ork.

    -- Does the work require diverse talents, skills or knowledge? The more varied the talents, skills and knowledge required, the less likely that one person will be able to, or should, do all the work.

    2. Scope Of Work

    How big is th
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e project? How complex is it?

    The bigger and more complex the work, the more appropriate it is to divide up the work among two or more people. Hence, the need for a Team.

    Even if the work is sequential, the sheer enormity of the project
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    might mean that you need more than one person with the same talents, skills and knowledge to work on each element. Again, you might need a Team.

    And if the work is particularly complex, you might simply need more brainpower for brainsto
    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
    rming, problem solving and "doing". A Team in other words.

    3. Kinds Of People

    Who does this kind of work? Specialists or generalists? Lone rangers or team-players?

    This is a bit of a chicken-and-egg scenario in that the type of work ge
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nerally attracts certain kinds of people, while certain kinds of people like to do certain types of work!

    For you, the question is whether or not an individual is attracted to doing everything or only some parts of the work. And remember
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    , what someone likes doing will have an impact on how he does it.

    Therefore, it's desirable to put specialists into teams tackling large projects, where they can concentrate solely on their area of specialty.

    Likewise, all-rounders or g
    .

    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
    eneralists would do better taking charge of smaller projects, that they can look after from start to finish.

    As for lone rangers versus team players -- by definition lone rangers are better suited to working alone, while team players thr
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ive in teams.

    Hopefully, these three considerations will help you decide whether to use a Team or individuals / teams. And while this "check-list" may seem like common-sense... well, we all know that common-sense isn't necessarily common


    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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