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  • Advice You - Best Practices: Achieving Success by Knowing Your Audience

    How do you show leadership with your presentations?

    Identify who your audience is and what their needs are before you start preparing your presentation: What do you need to address in your presentation in order to meet the audience's expec
    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
    tations? Your audience may be, for example,
    • your clients
    • your team
    • your direct management
    • your senior management
    • your service providers
    • the auditors


    Identify the considerations for the different types
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    f audiences:

    If you are presenting to your clients, consider what they need to make them more comfortable in working with you and your team. What are their key concerns? Is it their budget and your costs? Are your services helping them meet th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ir objectives with their clients and management? What can you do to help them out with their objectives? If you identify a list of your audience's concerns at the beginning of your presentation, that will set their minds at ease. They will feel that you h
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ve acknowledged their concerns and will therefore address those issues. They will listen better to your presentation as a result.

    If you are presenting to your team, your objectives may be team building, budget cuts, changes coming down the line,
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ew procedures. Your presentation should include key items for them to focus on and key steps to move forward. Consider if you want to identify the key steps or if you want to solicit input from your team. Soliciting input has the benefit of getting your t
    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
    am to buy-in to the next steps.

    When you are presenting to your direct management, it may be easier than presenting to senior management since you are more aware of the style of your direct manager. You can understand their priorities and f
    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
    rame of reference. You know whether they are detail-oriented or if they just want the bottom line. Since you may not work with your senior management as often, you might not know what to expect. Speak with your management or others who have presented to s
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nior management so that you can better prepare yourself. If the presentation is financial, you need to show them that you have a command of the budget. You can do this by presenting both the high-level directions and by being very prepared to show and dis
    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
    uss the details behind the high level. Make sure you include cost-saving measures that you are implementing or pursuing, the efficiencies that you have or will implement. You want your senior management to feel confident that you are addressing their conc
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    rns and issues proactively.

    If you presenting to your service provider, your presentation may be about the status of work, next steps, budget, issues. Your audience would typically allow more time for the presentation since they want to meet your
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    eeds and satisfy your concerns. Having samples to discuss in more detail would be very useful.

    With auditors, presentations are typically very, very detail oriented. But never skip the high level overview to ensure that you are addressing the righ
    dd to the challenges in developing combination products:

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

    Consider other items that can affect your presentation:

    For a successful presentation, also plan for the following:

    • how many presentations are going to be given along with yours? Try to not exhaust your audience.
    • when in
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the day are you presenting? If it is at the end of day or before lunch, be prepared to cut your presentation short. Prepare your verbal presentation to summarize slides that are not presented.
  • how much time is your presentation allotted for? That wi
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ll indicate how much detail is expected. Always prepare a high level presentation, speak to the audience with the details in mind, have extra slides ready just in case. When you practice for your presentation, make sure you are fluent with where the slide
    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
    are and their sequence so you can change directions quickly at presentation time. When presenters are not prepared for this, they feel letdown after their hard work. And worse, the message that they want to get across to the audience is somehow lost in t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e shuffle. If the message is lost, the presentation is not successful.

    The results show your leadership skills:

    By addressing the considerations listed above, your presentation would be addressing "what is in it for the audience?"
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nd in turn, "what feedback do I need back from the audience?" to achieve your objectives.

    By summarizing the presentation and presenting 'Next Steps', you are reminding the audience of the key points of the presentation and the next steps n
    .

    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
    eded to progress forward. The discussion with your audience around ‘next steps’ is critical. It will ensure the commitment or buy-in from the audience and from you as to what needs to get done. Once agreement occurs around what the next steps should be, t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    en there can be a feeling of closure. A comfort level is felt by you and your audience that progress will continue. You leave your audience feeling that you have achieved the command of the material as well as the ability to make a successful presentation


    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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