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  • Advice You - Negotiating Ethically Is Not For Sissies

    Negotiating isn't easy, no matter what your style. Negotiating to get what you want takes brains and backbone, regardless of whether you're gunning for your negotiating counterparts, or focusing on designing equitable solutions. You have to think through what you want and the most effective way to get it. And you have to have th
    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
    e moxie to follow through with your plans. Sometimes just asking for something takes nerve. After all, some of us were taught as children not to ask for anything; instead, we were to wait until it was offered. That courtesy may have won you points with your second-grade teacher, but it'll kill you in the real world. We usually h
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ve to go after what we want. And to get what we want, we have to be shrewd negotiators, even when we try to maintain high ethical standards. As a matter of fact, negotiating on a mature, adult-to-adult basis is even more demanding than slipping around and trying to manipulate or trick the people you're negotiating with.

    First o
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    f all, being open and honest takes guts. It takes nerve basically to say to the people you're negotiating with, "I want to play fair. How about you?" or "This is what I want. How about you, and how can we both get what we want?" You're challenging them to meet you on your level, and you're asking them to focus on more than their
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    individual needs. You can get some strange reactions because people aren't used to an open approach to negotiating. Some people don't want to negotiate that way, which brings me to a second reason ethical negotiations can be so challenging. Making sure that you don't get manipulated by someone who is not so honest takes savvy.

    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    strong>How to Avoid Being Manipulated

    A difference in standards can cause serious problems when negotiating. Just because you follow all the principles I outline through Negotiate Like the Pros, that doesn't guarantee that everyone you negotiate with will be as mature and fair-minded as you are. (I know that once you'v
    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
    e learned all my negotiating secrets, you're going to be mature and fair-minded, right?) You have to be prepared to run into less-than-honest bargainers, people who have their eye on the prize and have no qualms about running over you to get it.

    These people have no interests in forging mutually beneficial agreements. They are
    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
    nly interested in what's good for them, and they don't mind abusing others to get it. They are the hardballers. They want to play rough. They don't care if there's such a thing as principled negotiating. They think they can get more by bullying the people they negotiate with. They believe they're stronger than their opponents an
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    d think they can walk away with the spoils if they go for the jugular vein.

    Don't misunderstand me. Not every person you meet at the negotiating table is going to be an unscrupulous rogue. Some people don't share your high standards for negotiating because they don't know any better. Before reading this book, what were your att
    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
    tudes toward negotiating? Did you see it as a "me-against-my-opponent" proposition? Did you feel like the only way you could win was for someone else to lose? Some people don't realize there's a better, easier way to negotiate.

    I have a system for negotiating that can handle any of the problems that inevitably crop up when I'm
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ith people from either group.

    Defense Tactic 1: Maintain your standards.

    If a person approaches negotiations aggressively out of ignorance, I can eventually win him or her over to my style. Most people don't want to be enemies. They just don't want to get ripped off. If you can demonstrate to them that you're
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    interested in a fair deal, they will usually drop the aggressiveness routine and start to work with you.

    Defense Tactic 2: Protect yourself by not fighting back directly.

    When you meet with the people who don't want to play fair, you can protect yourself - and you don't have to resort to trickery or manipulat
    dd to the challenges in developing combination products:

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

    If you think about it, most sharks are propelled by three basic drives - greed, self-centeredness, and an exaggerated ego. And any of those three drives makes them extremely vulnerable to a smart negotiator.

    Roger Fisher and William Ury call this approach "negotiation jujitsu" in their book Getting to Yes. Jujitsu
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    is a form of martial arts that focuses on deflecting attacks rather than engaging the enemy. If someone is running toward you aggressively, you don't stand your ground and hit back when they run into you. You step to the side and let them run past.

    Defense Tactic 3. Call in a third-party arbitrator.

    Rarely in
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    my experience as a lawyer and a businessman have I ever had to call in a third-party arbitrator because the people I was negotiating with insisted on using less-than-honorable techniques. It almost never reaches this point. But probably most of us have been involved in situations where we needed someone who was completely impart
    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
    al and had no links to anyone in the negotiations to help guide the negotiating process.

    The benefit of bringing in a third party is that they can shift the negotiations from positional bargaining to bargaining based on interests. A third party can look at all sides objectively and weave together a plan that takes into account
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    everyone's interests.

    Defense Tactic 4. Bail out.

    When all else fails - you can't persuade the other party or parties to negotiate honestly and openly, and a mediator doesn't work - abandon the negotiations, at least for a while.

    Maybe a deal just wasn't meant to be. Sometimes you get a gut feeling telling y
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    u to get out of a certain negotiating situation. Go with it. Remember, you will be negotiating from a much stronger position if you are willing to walk away from the bargaining table. Maybe both parties need more time to think about what they want and what they are willing to give for it.

    In Conclusion

    Negoti
    .

    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
    ating is a complex process, even under the best of circumstances. Every person involved in a negotiation brings to the event a different background, culture, perceptions, values, and standards. Breaking through these differences can seem impossible, yet it is crucial to creating a mutually beneficial agreement. Maintain your sta
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    dards throughout negotiations.

    If you can't win cooperation, chances are you will gain nothing from the negotiations. When you encounter people who aren't negotiating ethically, try to bring them up to your level. If the other party doesn't respond to your attempts to do so, be willing to walk away. You won't have lost anything


    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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