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    It might have been your best friend, your partner, your boss, your brother or even your lover. It burns deep inside. You can’t sleep for the anger, the shock and dismay. You may find yourself still not believing it’s happened to you. But it has!

    When those we have entrusted with our money, our plans, our strategies, our loyalty or even our love betray us, we feel violated deep inside. We feel crushed. We wonder if we can ever recover from this.

    It is at this moment of realization that you will make some of the most important decisions of your entire
    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
    life. The three most critical choices you will make – whether you realize it or not are: (1) what to focus on; (2) what to believe; and (3) what to expect from this point forward. These three choices will determine the final impact this betrayal has on your life.

    A LESSON FROM MICKEY

    Most people don’t know that Walt Disney suffered a great business defeat early in his career. While living and working out of his uncle’s garage, Walt Disney had created a cartoon character called “Oswald the Lucky Rabbit” and signed a contract with Universal Studios to
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    create animated short films about the little fury critter that would be shown before the main feature film at theaters. The short films enjoyed great success, but in his youth and naivete, Walt did not realize that he had signed away the rights to the character. When his contract came up for renewal, Universal Studios refused to renew the contract and announced that it owned the exclusive rights to produce films using “Oswald The Lucky Rabbit.” Walt was devastated.

    Starting over from scratch, Walt desperately needed to come up with a new character. The
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    garage he was living in was infested with rats and mice. Instead of sulking in his misery, instead of turning bitter, instead of filing a lawsuit, Walt focused on what he had left - his gifts, talents and abilities - and his incredible imagination. Walt actually made a pet out of one of the mice and kept it in a cage on his desk. Drawing inspiration from his miserable surroundings, Walt created a cute little mouse character that he named “Mickey Mouse.” And the rest, as they say, is history!

    THREE CRITICAL CHOICES AT WORK

    What made the difference? W
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    alt Disney made the same three critical choices that heroes have made for thousands of years in order to turn tragedy into triumph.

    HE CHOSE HIS FOCUS

    First, Walt chose his focus. Instead of focusing on his bitterness and anger, instead of focusing on his miserable rat and mouse infested environment, he focused on the next most immediate steps he needed to take in order to survive. He chose to move forward. He chose to focus on what was in front of him, not what was behind him. He focused on the few resources he had left. He poured himself into his w
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ork and he started over.

    HE CHOSE HIS BELIEFS

    Second, Walt chose to believe. He could have decided his career as a cartoonist was over, and that he could never make it in Hollywood. He could have chosen to believe he could not compete against the “big boys” and disappeared into oblivion. After all, at that time, the only movies being made in Hollywood had real live actors, not cartoon characters. There was no full-length cartoon movie industry at that time, and no one knew whether there was even a viable market for full-length cartoon movies. Despite
    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
    all this, Walt chose to believe, and he chose to keep believing every new day that the sun came up. Through this tenacious belief, and hard work, he single handedly created a whole new industry. HE CHOSE HIS EXPECTATIONS

    Third, Walt chose his expectations. He knew he could create cartoon characters that audiences would love because he had done it before. Failure was not an option. He expected to succeed, and this gave him the motivation to keep moving forward.

    Remember, “they” may take away your office, your status, and your income. But they can’t
    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
    take away your determination to succeed, your inherent abilities, your intelligence or your creativity. These are the very things that have brought you all of your past successes. These gifts, talents and abilities haven’t gone anywhere. Wherever you go, they are still with you!

    LEFT FOR DEAD IN THE ANDES MOUNTAINS

    In 1985, Joe Simpson broke his leg on his descent of a 20,000 foot mountain in the Peruvian Andes. Then after a second fall left him dangling in mid-air off a cliff, his partner, Simon Yates, cut the rope that tied them together. This rope
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    was Simpson’s last and only hope for survival. Simpson dropped into a long, narrow ice tube that went straight down. His body came to rest precariously on a narrow ice bridge between two much deeper vertical drops. He had two choices. He could either sit there until death slowly overtook his freezing body, or he could plunge into the dark unknown to meet death on his own terms. He had one ice screw left, which he banged into the wall of ice. Then he threaded his rope through it and somehow managed to tie a crude knot in the end of it. This became hi
    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
    s anchor as he lowered his body into the deep, dark, icy unknown.

    To his surprise, his body eventually came to rest on a flat surface of snow. Then he saw a thin ray of light shining from the opposite side of the cavern. There was a forty-five degree slope of ice leading up to where he could just barely see a pinpoint of daylight. This was the way out – if only he could reach it.

    He bent over and dug a small foothold for each of his boots, which were equipped with crampons (metal claws) for climbing. Then he pounded his ice axe into the wall of ice ab
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ove him and slowly lifted his bad leg, then his good leg into the footholds, while pulling his body up with the ice axe. Each time he put weight on his bad leg, searing pain exploded up and down his leg. He would scream and curse out loud. Then he would repeat the process.

    It was at this moment that he made a critical decision. He chose to focus on the pattern rather than the pain. Simpson says, “The flares of pain became merged into the routine and I paid less attention to them, concentrating solely on the patterns.” He was so intent on focusing on
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    the pattern that he refused to even look up to the object of his climb for fear that it would remind him of the little progress he had made and how far he still had to go. He knew where he was going, but it was more important to focus on the pattern. The pattern was working – one inch at a time – but it was working. After what seemed like an eternity, he popped his head up through the snow to see a ring of spectacularly beautiful mountains and blue sky. He had made it. But now he had to figure out a way to get down the rest of the mountain with a broke
    dd to the challenges in developing combination products:

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

    Simpson was forced to experiment and find different patterns of behavior to determine the most efficient and least painful way to get down the 20,000 foot mountain. He tried walking, but fell repeatedly. Nevertheless, he tried to fall forward in the direction he knew he needed to go. When he could not stand, he crawled, then tried to stand and walk again. He walked, fell and crawled over and over again for several days and nights without food or water.

    His focus made the difference between death and survival. He would pick a spot in the distan
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ce and focus on it. Then he would give himself a deadline by which he had to get to it. When he finally got there, he would pick out another spot in the distance and repeat the pattern. It was a slow, agonizing process and his body got weaker and weaker as he went. But, through the sheer force of his will and the voice inside his head that kept commanding his mangled body forward like a cruel drill sergeant, after several days, he finally got close enough to his campsite where his shouts could be heard.

    What can we learn from Joe Simpson’s epic tale of
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    survival and Walt Disney’s incredible comeback?

    CHOOSE YOUR FOCUS

    First, when you find yourself reeling from a shocking act of betrayal, make a conscious choice to focus on the immediate next steps needed for survival – rather than on your bitterness and anger. If you dwell on your anger it will consume all of your creative energy and brain cells – the same brain cells that you will need to come up with your next move.

    Second, focus on the resources, skills, gifts, talents and friends you have left – even though they may be few.

    Third, don’t throw goo
    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
    d money after bad. Don’t pursue litigation unless you absolutely are being forced to do so. When you choose to litigate rather than recuperate, the only ones who get rich are the lawyers. Most lawyers joke that the winner in any lawsuit is the one who has lost the least amount of blood in the fight. History shows there are no real winners except the lawyers. Turn the energy generated by your anger into a new resolve to succeed against all odds. That’s the best way to get even.

    CHOOSE YOUR BELIEFS

    Make a conscious choice to believe there is a way out
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    . There is always a way out. You can survive this and even prosper on the other side of this tragedy. But first you have to make a very deliberate and conscious choice to believe it. Then you have to pursue it.

    CHOOSE YOUR EXPECATIONS

    Joe Simpson and Walt Disney both survived severe acts of betrayal because they expected to survive. They had their doubts at first, but with each slow and deliberate step forward came another glimmer of hope. They gave themselves hope by getting up and moving forward after each temporary setback. If you just sit there
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    and wallow in your misery, history will record that this setback was your final resting place. If you get up and keep moving forward, history will record that it was only a temporary setback.

    If you expect to survive, your brain cells will suddenly awaken with excitement. They will stand at attention and await your orders. They will find a way because they have been ordered to find a way. Expect to prosper again one day. Expect to rise from the ashes of this tragedy. Create a self-fulfilling prophecy, and then bring it to pass. You can choose to wr
    .

    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
    ite the final chapter if you want to, but you have to choose to want to.

    GET ON THE HERO’S PATH

    Heroes throughout history, like Walt Disney and Joe Simpson, have created a well-worn path for us to follow by their examples. It is up to us to choose to follow their footsteps. This is the first and most important choice you can make. Will you wander blindly in your bitterness, depression and anger, or will you choose to follow the heroes’ path?

    “Better to light a candle than to curse the darkness.” — Confucius

    If you choose to follow the hero’s path, re
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    member, the three most critical choices you can make today - right now - this very moment are: (1) what to focus on; (2) what to believe; and (3) what to expect - from this point forward. Take conscious control of your focus, your beliefs and your expectations and you can determine the final impact of this tragedy on the rest of your life. Get on the hero’s path and eventually you will go places where only heroes have trod.

    Daniel R. Castro, author of CRITICAL CHOICES THAT CHANGE LIVES: HOW HEROES TURN TRAGEDY INTO TRIUMPH

    Copyright 2006 Daniel Castro


    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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