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    With apologies to Sesame Street, how do we spot a leader in our midst? What ingredients make for a certain individual to have the style and substance to be a leader of people?

    Spotting a phoney leader is not too difficult. Phoney leade
    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
    rs intimidate or manipulate people, leading forcefully but without real confidence in themselves or a belief in a cause. They are actors on a stage, following a script and protecting their image.

    They stopped learning many years ago, b
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    elieving they "know it all". They fail to inspire people through the mastery of their craft, seeking more often to do it through their position and persona. They use rhetorical language rather than simple and direct language which speak
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s of problems or opportunities in a manner which directly connects to the people they seek to lead.

    It is obviously important for organisations to pick true leaders for development and not phoney leaders. To do so, it is important to a
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    preciate what to look for in a real leader at an early stage of their development. The qualities to look for are not about style.

    Leaders can have many different styles and different organisations require different leadership styles de
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    pendent on the environment in which they find themselves. An organisation in crisis may well appreciate a command and control style leader over a coach or a team captain type. If there is fire in the building I want one person giving or
    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
    ders and everyone else concentrating on making sure they are carried out!

    Leadership will present itself early on in a person's career in one or more of the following ways.

    They will have already displayed leadership. They will have t
    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
    ken control of a situation to get a job done. It may appear as if they have even acted out of character in that it was the environment that caused them to step up and take a lead. Alternatively, they may have been a leader in a role out
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    side of their work environment such as a social club or a church group or sports group.

    They will have a record of constructive criticism. They will not be "yes men", or "yes women" for that matter. However they will not be destructive
    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
    . They will have practical ideas that they present as alternatives to the view which they have criticised.

    Completion of projects and tasks with a clearly observable sense or personal responsibility to get the job done will separate th
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    m from those not willing to or unable to lead.

    Often, there will be a respect for family which comes through in their everyday discussion. Respect for family and respect in a family demonstrates leadership in what can be a fairly tough
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    "team" environment. Most family members are much more honest with other members in the family than is prevalent in a workplace. Dealing with honest feedback and retaining respect is a good sign of leadership.

    At times, they may have d
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    isplayed a mental toughness which others have not. Common attributes of people with mental toughness include an ability to tolerate ambiguity and uncertainty and perform in spite of it. They tend to seek solution oriented feedback from
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    which they will adjust their performance and in doing so demonstrate that they do not have to be right all the time. "I don't know, but I can find out" will not be absent from their vocabulary.

    Moreover, they will maintain clear and lo
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ical thought under pressure. They will not be prone to knee-jerk reactions. They will seek to understand the problem before they seek a solution. Under pressure they will remain focused on the goal but adapt to circumstance to find solu
    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
    tions.

    They will have the respect of their peers, although they may not be popular. Popularity is not an indicator of leadership. They may be respected for the mastery of their particular topic or their skills and will certainly be res
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    pected for an observed consistency between what they say and what they do.

    They will have demonstrated an ability to see issues in a broad context, making linkages between seemingly unrelated issues and have an appreciation of the deta
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    l surrounding an issue. High potential leaders will be able to maintain an appreciation of the detail and the broad context as they move from one issue to another.

    Above all, they will have a quality that makes many people listen to th
    .

    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
    em.

    Although in some cases it is beneficial to bring in leaders from outside an organisation to ensure the status quo is challenged, building leaders from within an organisation provides morale building benefits over an above the obvio
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    us efficiency and effectiveness benefits.

    Finding leaders early in their career and developing them through participation in projects and job assignments which challenge them is a key role for today's leaders. Are you able to spot them


    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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