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  • Advice You - Business Experience Verses Business Education

    Many years ago I had a friend who was extremely intelligent, had a photographic memory, and finished university with
    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
    top marks in business administration. He had all the credentials to get a great job.

    Sounds good for the most part,
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    wouldn’t you say!! Maybe even a nice boy who you would want to marry your daughter!! Shortly after finishing school 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.

    e landed a job working for the owner of this large company, whose business did millions a year in revenue.

    The perso
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    he worked for was old world, very little formal business education, and built a wonderful business from scratch. He
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    was shrewd person with tons of business experience under his belt. After working there awhile my friend decides that
    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
    he can really make a difference in this man’s business.

    Here is what he actually did:

    He goes into the employer’s o
    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
    fice and asks if he could speak with him, the man says sure. He starts explaining that the way he is running the busi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ness is wrong. He enlightens him by reciting certain paragraphs out of the text books he studied at school, and tells
    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
    him that is the way a business should be run.

    The Employer’s reaction:

    The Employer looks at him and says: I can s
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e you are a very bright boy who has studied hard at school and learned everything about business. The question I have
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    to ask is, if I am doing business wrong … how come I have been in business for 30 years , never finished high schoo
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    l, supported my family, sent my kids to university. The difference with experience is you do not always believe what
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    you read!!! You need to use your gut sometimes to know what is really right. I thank you for the education, but if i
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    is all the same to you, I would like to continue the way I have been.

    My opinion

    I am a firm believer in education
    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
    especially if you are going to be a doctor, a lawyer, or even a business person. When people study to become a docto
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    r they must intern to get the practical experience needed to practice. Business is very different and can not be lear
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ed strictly through books and exercises.

    If I was considering going into business for the first time, had very littl
    .

    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 experience, here is what I would like to happen for myself. I would hope to work for someone prior, who had years o
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    f experience, who would be willing to take me under their wing, and teach me real world business, and how to be savvy


    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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