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I was watching one of my favorite television mini-series, HBO’s Band of Brothers, and I came across a forgotten viewpoint from the production.

Although the program centered

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

around the time immediately following the Battle of the Bulge and the besieged 101st Airborn during World War II, part of the drama focused on the leadership of a lieutenant

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

Examples of combination products may in

nd his platoon. This lieutenant would simply leave his men and wander off for a walk . . . to talk to regiment . . . to get help . . . or god knows what. He was never there t

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

set direction, to discuss operations, to counsel, or even to listen. One scene has him asking questions of a soldier in a foxhole. The soldier answers and then asks the offi

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

er a question, but the soldier is talking to thin air. The officer had already turned his back and faded away . . . as if he had never been there at all.

The officer should

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

Combination pro

ever have commanded a combat team. He was possibly put there to gain experience, while seeking further advancement. He was shown with an academy ring. The implication being t

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

at he was part of a “good old boy” network. This is not unusual in business or the military. The minor sin was that he received command from favoritism or preferential treatm

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

nt. The major sin was that he assumed command without proper training.

The First Sergeant described the situation exactly: he wasn’t a bad leader because he made bad decisio

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

s, he was a bad leader because he made no decisions. A bad leader is worse than no leader. A leader has responsibilities and the people under that leader should have expectat

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

ons of ability. When an attack was imminent by the platoon, the sergeant complained to an officer up the chain of command. There was no one else to send, but the captain took

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

aside the lieutenant and explained exactly what was to be done: keep advancing and take the village. The attack came and as soon as the platoon came under fire, the lieutenan

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

Following aspects would a

t froze and gave confusing orders to his men. The advance was stopped.

The captain took another lieutenant from another platoon and sent him as a replacement in the thick of

dd to the challenges in developing combination products:

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

the battle to bring order to the attack and finish the advance. Within minutes they took the village.

Now, of course, sometimes it is better to make no decision, while you s

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

rvey the job, the market, the industry, or your employees, but when decisions are needed, the leader must step up and make decisions. In the case of the lieutenant, his indec

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

sion cost lives, including his own.

“Leadership is action. In its most basic form, leadership involves moving people from one place to another, either physical

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

y or figuratively. And if you’re going to get people moving, you’d better be sure you know where you’re headed. You have to make decisions about your desired destination and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ow you’re going to get there. You need to make the right decisions, you need to make them stick, and you need to accept the consequences.”
-- John Baldoni from his book

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

80 Ways to Walk the Leadership Talk

You could say the lieutenant accepted the consequences and died, but he didn’t even do that. He merely shut down. He died as

.

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

a consequence, but didn’t really accept the consequences.

A leader needs to make decisions, and he should be trained to make them. There is nothing wrong with a bad decision

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

Companies that provide selfless information through particip

based on sound judgment (unless it becomes a pattern), but no decisions based on no judgment, is unforgivable. No decisions can cost time; cost money; and can even cost lives

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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The holiday season is close and there is no doubt that soon everyone will be back to the usually holiday occupation, finding gifts for friends and family, and in many cases, work colleagues. It is not uncommon for people who work together to give each other gifts for the holidays.

Remember, when making your decision weigh the final price, quality of the work, and length of the warranty. All things being equal, the best choice sometimes turns out to be manufacturer-refurbished equipment.

If you are looking to leave your old career or job behind to start up your own business, then you are already half way there. The idea of you having something more has already been planted in your head, now all you have to do is have the courage and determination to follow through on your business ownership goals.

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