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    For any organization to succeed it must have good employees to power it, but employees can’t do it all by themselves, they need help. Employees today come from all types of diverse backgrounds with different types of education and experience. When you bring these different types of backgro
    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
    unds and experience together as a team it can have a profound impact on the success of your organization.

    A team by definition is a collection of individuals trying to work together to achieve a common goal or objective. It is a grouping of individuals with their own talents, prejudices,
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    mbitions, and fears. The output of any team comes from the interactions of its individual members.

    The success of any team is dependent on making the different parts work together. Many companies run into trouble with their teams because they don’t understand that each individual person h
    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 his or her own strengths and weaknesses. For a team to be successful it has to be lead, motivated and nurtured. You can’t just assemble a team, turn it on like a machine and then walk away.

    A successful team starts with good leadership to inspire the team to creative and innovative acti
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    n. For this reason, the best team leaders are infectious self-starters. They are active, energetic, and excited about the task. Great team leaders are also doers and good listeners.

    One of the first roles of a team leader is to help others understand the larger issues at stake. A team th
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    at appreciates the importance of its goals will be inspired to greater action. By bringing a broader perspective to the team, you will not only inspire it, you will also help it perform more efficiently. A broader perspective helps the team perceive different possible paths towards its go
    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
    ls.

    It’s important to understand that a proper goal begins with the leader’s vision of a task that is desirable and doable. For example, if you want your organization to increase market share by becoming more customer oriented. You know that other companies have done it, and they became
    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
    ore competitive.

    Your job is to sell that vision to the team. You have to inspire the team to believe in the goal, and to believe it can achieve it. For example, you could tell your team something like: “Based on your experience and knowledge, find out what we can change so that our compa
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    y always puts the customer first. This is your task.”

    Successful teams live and breathe the short term. They plan longer term, but act for the present. So always begin with the main goal that your entire team is striving for. Then break that goal down into short-term, doable steps.

    For t
    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
    eam goal setting to be the most effective a long-term goal should not be more than six months and a short-term goal should not be longer than one month. If any of your team goals are pushing past six-months you should break them down into a shorter period. When you work with shorter peri
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ds, your team is continuously knocking down fresh goals and objectives, staying motivated and on track. Short-term goals also allow for adjustments. Things change and circumstances or knowledge may require goals to be amended. Changing directions is much easier within a shorter time period
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a


    To be an effective team leader you must understand that people are imperfect human beings with a collection of prejudices, ambitions, and personalities that affect their relationships with other people. On real teams, different personalities will clash and despite talented team members a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    d worthwhile goals, internal conflicts destroy many teams.

    One of your most important responsibilities and challenges as a team leader is to adapt your style to the different personalities of your team members. For example, if you are dealing with an analytical person, forget intuition an
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    d emotion. You have to present your case analytically, clearly, and logically to this type of a person.

    Expressive people, on the other hand, need to get the feel of a project. They need to be emotionally involved. If you are dealing with an expressive person, be open and honest. It’s alr
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ght to move quickly because expressive people work better when they are in a hurry.

    No one can be completely flexible. So don’t try to be a chameleon changing with every person’s personality. Just remember what type of type of person you are talking to.

    Change is all around us and happen
    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
    every day. People generally are resistant change and don’t like it. Teams are no different. Since they are made of a collection of different individuals, teams generally don’t like change.

    To enable your team to accept and enhance the inevitable changes that will occur constantly and sud
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    enly you must plan for change. Don’t let change sneak up on your team. Let the team plan how change should occur, on what time schedule, with which members.

    Sometimes changes occur that the team cannot control. For example, if the company is either bought by or merges with another company
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    . In these cases, the key is communication. The team will be asking questions such as: What is going to happen? How will we be kept informed?

    When it comes to change good leadership is essential. You must provide a vision and create positive expectations. The team will support change if t
    .

    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
    e positive results of the change are clearly explained, especially if you keep the team motivated with ongoing support.

    Teamwork is vital for success of any organization. Becoming part of a team is a natural part of most people. The majority of employees get there intrinsic rewards and va
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ues in an organization from the teaming process. People are social animals that prefer to work together in teams rather than individually. You help your team succeed by being a strong and effective leader.

    Copyright©2006 by Joe Love and JLM & Associates, Inc. All rights reserved worldwide


    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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