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  • E-Folder - Sorry, You May NOT Have a List of My References

    A few weeks ago there was a substantial article in one of the major business weeklies about a consultant to Fortune 500 CEO’s.

    Originally from India, this gentleman seems like a genui
    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
    ne “guru.”

    One or two of his clients’ names were dropped in the article, and they are quite prominent.

    But absolutely nothing else was said about the CONTENT of his consulting, or ab
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    out his specific advice. He insists on maintaining utter confidentiality.

    The article went on to say his clients appreciate his discretion, and this aspect of his service is one of 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.

    e main reasons he seems to stay so solidly booked.

    As a long time management consultant, myself, I find his approach very interesting and highly appealing.

    As consultants, what we do
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    for our clients is really no one’s business, but theirs.

    If clients felt everything they did with us or revealed would be blabbed about, they would either do projects so mundane as to
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    be meaningless, or avoid getting outside assistance, altogether.

    Recently, I wrote an article indicating that client references should not be disclosed until the final step in negoti
    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
    ation is reached, and our prospects are otherwise convinced they want to work with us.

    By delaying the disclosure of references we accomplish at least five things, assuring that our c
    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
    lients aren’t needlessly bothered by strangers or by our competitors, or theirs.

    But now, in light of this other consultant’s successful approach, I’m considering not supplying refere
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ces at any time.

    Will this discourage clients from working with me? Perhaps some, but I’m not sure I wish to do business with them, anyway.

    Here is my reasoning:

    (1) I’m a prominent
    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
    name in my field, a brand name. If I weren’t, my inquiries probably would not have heard about me.

    (2) A huge storehouse of information is publicly available about me. With 12 publis
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    hed books and well over 1,000 articles available at everyone’s fingertips, people can have a significant, first-hand experience with my ideas without leaving their cubicles or corner o
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ffices.

    (3) They’re not hiring a cashier or a regular employee. They’re dealing with a professional who has five degrees and a number of licenses and certifications, all of which can
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e validated, again, without dusting their derrieres.

    (4) Every program is unique, and at best, they would get a hint about the success OTHERS achieved, which is not predictive at all
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    of what they can expect, given their unique cultures, circumstances, requirements, and budgets.

    (5) They’re really asking my clients to sell them and to make their decisions for them,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and this is unrealistic and unfair to everyone. If prospects so doubt the wisdom of their own judgment, they are probably so insecure, nervous, and tentative as to be undesirable clie
    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
    nts from my viewpoint.

    (6) I guarantee my results. So even if I am wrongly retained, this is an error that can be corrected swiftly and painlessly. Which would you prefer: to hear a p
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    st client singing my praises, someone who could actually be my next door neighbor or tennis buddy, or to be assured that you will get results or you don’t pay? Which would you rather r
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ely upon?

    By the way, I do have a long and distinguished client list, consisting of names you’ve heard and admired, and names you should have heard about, and one day will.

    But if yo
    .

    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
    u’re seeking me out to do a quick speech or a few weeks of work, do you think I should ask a half-million dollar reference to counsel you?

    Frankly, I don’t have many “little” referenc
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    es to supply, so if I’m making myself available to do your project, perhaps you should pat yourself on the back, and have the wisdom and good manners to simply say: “Happy to have you!


    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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