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In 206 BC, during the Second Punic War between Rome and Carthage, Publius Cornelius Scipio was initially given the responsibility of securing the Spanish peninsula for the Roman Republic. In the final, definitive battle for Spain, Scipio faced the superior numbers of Hasdrubal Gisgo's combined

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

army of Carthaginians and their Spanish allies. Hasdrubal organized his forces with his superior, veteran Carthaginians in the center with the Spanish allies on the wings. This tactic was typical of Roman warfare also since they tended to place their untested allied forces on the edges of the b

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

attle.

However, at the Battle of Ilipa, Scipio placed his well trained Roman legions on the wings and placed the entire contingent of allied non-Roman troops in the middle of his lines. They marched to battle to confront the Carthaginians who were unaware of this major tactical change. Once Ha

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

drubal's forces were in battle formation, Scipio ordered his legions to advance towards the enemy lines at a 45 degree angle, and once they were near the enemy flanks, they were to turn and attack Hannibal's Spanish allies. Scipio's allied forces were ordered to hold the center and not to engag

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e the Carthaginian forces across from them.

Scipio's legions smashed thru the Spanish lines, eventually causing a rout. The complete disorder on the wings of the battlefield caused the Carthaginian forces to flee without putting up a fight. These same Carthaginian forces under Hasdrubal eventu

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

Combination pro

ally fled Spain and rejoined with Hannibal in North Africa. Spain was conquered and Scipio was heralded a great general by the Roman Republic. These Spanish victories were the reason why Scipio was granted command of the Roman armies sent to North Africa that ultimately defeated Carthage.

The

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

eason why I relate this tale is because Scipio never lost sight of the objective. His duty was the capture and pacification of Spain. He was well aware that Hannibal was wreaking havoc in Italy but smashing the Carthaginian forces in Spain was not his duty. The Carthaginians were secondary to 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

he goal and therefore, irrelevant. By smashing Hannibal's Spanish allies, Scipio removed their ability to defy Roman power in the region. He realized that in Spain, the Carthaginians were impotent without their allies. By smashing the Spaniards, Scipio denied the Carthaginians their allies and

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nipped any immediate rebellions against Roman rule. It would be another 50 years before another significant rebellion started in Spain.

Therefore, when dealing with trouble, it is often wiser to eliminate your enemy's allies first. Cut the strength out from under them in order to deny them suc

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

or and assistance. Send your strongest forces to deal with the allies first. This will sufficiently weaken them so that you can crush them at your leisure. The added benefit is that if you remove all the allies first, there is less rebellion afterwards.

"Always mystify, mislead and surprise th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e enemy if possible." -General Thomas "Stonewall" Jackson

The other tactic is too keep all your enemies too busy to plot against you. Set them to different tasks where they will not work together. Always give them the same information. Never tell one more than another. Never tell them anything

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

of value. Send them along roads with no end; this will ensure that they never know your goals or desires. Give them time consuming, meaningful work. Set for them high goals and push them to achieve. Give them the tasks that have always been talked about but never started because of their compl

dd to the challenges in developing combination products:

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

xity. They should be sufficently afraid of failure and public humiliation that they will spend their time on the task and not on you.

Monitor them carefully. Divide and conquer. Work to turn one to you. Find the weakest link and bend him to your purposes. Find commonality with that indivdual a

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

nd show him how you are truly not different. Convert him and make him spy for you. Never trust this spy with any useful information. You can never be sure if they have turned completely. Be wary of the information they provide.

Do not permit enemies to linger. Their poison will eventually infe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ct more people. The sheer power of repetition will create the illusion of truth. They will fight with rumor, innuendo and outright lies. In 2003 I tried to make peace with an open enemy. He informed me in no uncertain terms that he would continue to work against me. He and his cohorts poisoned

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

ood people. And when I refused to give them a position of merit or trust because I could not trust them, they all quit the company and tried to take as many people as they could with them. Because I did not act decisively and I thought I could win them back I risked destroying everything. The f

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

allout of this poor decision still rears its head on occassion.

So if you are unable to stop their plotting then eject them without mercy. In order to do this properly, however, you must be convinced that your course is the proper course. If, for a moment, you believe that they might be correc

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

t, then stand aside and allow them the right to lead. You will be testing the limits of your power with this move. There will be upheavals that will cause ripple effects thru the organization for some time. You must be strong to weather the storm and to keep your department on course. They must

.

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

never see you waver or show doubt. This will prove your weakness and you will lose.

And if you do manage to crush them, you will poison this enemy against you forever, there can never be a reconciliation. Strike without mercy and know that you will carry that burden with you for the rest of yo

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ur days. But, if this strike carries no psychic penalty then you must realize you are no longer fit to lead. Your inability to resolve the dispute, and the fact that this does not weigh on your soul, means you are fully given over to the arrogance of office. Step down now before you are toppled

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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We are seeing a drying up of consumer dollars in our markets. But remember the dollar is only an instrument of trade; it is merely a leveling point for evaluation. The dollar creates intrinsic value in everything we desire based on the value we and everyone else in a market sector places on that item in relation to a predetermined unit price of a fixed and stable instrument.

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