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  • Advice Pool - Look in the Mirror

    Take a moment to step outside yourself. Now, be honest with me here… If you could be your own boss, how would you rate your own performance in the last three months? Would you
    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
    get a raise, a day off as a treat, or would a big and brawny security guy kindly escort you to the parking lot?

    In order to be an effective marketer and a progressive human
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    eing for that matter, you have to take a breather and look in the mirror. What are you doing that's working and what can you do to improve?

    See what it is you are actually do
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ing in all your busy days running from meeting to meeting, answering calls, or a zillion emails. Are you remembering your goals or your MISSION? Have you sat down and actually
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    taken the time to write out your goals and your mission?

    I read somewhere once that you should give yourself a "Company Evaluation" every month to make note of your progress
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    and see where you still need to tighten up your act. I made a similar format to the evaluation form used at one of my past jobs. I tried it on myself for a few months and it r
    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
    ally helps you re-focus and remember what your overall VISION was in the first place. It also brings your strengths and weaknesses to the forefront! Try it out and rate your
    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
    self at the end of the month to see how you did.

    Here's an example of how to do it. List your responsibilities and objectives and rate each one. 1 being the worst and 5 being
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the best:

    Evaluation of The Sweet Tooth (Pastry company):

    - Make an income of $3,000+ with orders for June: 2
    - Develop a buzz about my company: 4
    - Increase cater
    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
    ing for events to at least 5 parties per month: 4
    - Improve time management: 1
    - Manage and build an effective team: 5

    Pros: I did great with developing buzz, becau
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e of the press I received in the Daily News. Giving the editor free pies worked!

    Cons: I was late for two important meetings, because of poor time management.

    I like to writ
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e out the pros and cons of the overall performance as well. What did you do exceptionally well and why? What are the steps needed to make next months evaluation better? When y
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    u elaborate on your highs and lows…you can be your own coach to some extent. You can then set goals to make improvements instead of floating through each month with no directi
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    on. Having this on paper might help stop you from repeating the same destructive patterns. You might even want to get a folder or binder to keep them all in, so you can note y
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ur progress.

    Break It Down:

    _ Review your schedule a week in advance. (Sounds easy enough, but most of us rarely do this--even with Mr. Palm Pilot in our lives)

    _ Break up
    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
    big projects up into baby steps.

    _ Delegate, Delegate, DELEGATE! There is always someone who can help you. Just master the art of picking the RIGHT person for the task.

    _ Se
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    deadlines for every task, no matter how small. Okay…I'll admit that I'm good for thinking something is a very small project and "a piece a cake", until 10 of those small piec
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    es of cake pile up and make a big mess! So, set a deadline for the small project and get it outta the way!

    _ Know your best times of day to work. (Are you a morning person or
    .

    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
    do you like burning the midnight oil?)

    _ AND my favorite that I'm just getting the hang of:

    LEARN HOW TO SAY NO! You can't please everybody.

    Alright now…go shine up that mi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    rror, take a nice long look, and let me know if you see the same reflection next month. Hopefully, you'll see someone on a whole other level! I'll be waiting to hear from ya..


    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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