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As a commissioned officer, you outrank all warrant officers and all enlisted Soldiers including Noncommissioned Officers. That said, if you go around as a seco

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

nd lieutenant acting like you own the show, and order your experienced NCOs to do stupid stuff just because you outrank them, you deserve what you get.

Most s

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

Examples of combination products may in

cond lieutenants' act cocky to make up for the fact they don't know much, and are at best nervous, and often scared to death to suddenly be in charge. If you a

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

t cocky, you will be sorely treated by your NCOs, and other unit experts. They will give you plenty of rope, and let you hang yourself. If you ask your NCOs' a

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

dvice during private planning sessions, and then discuss the decision you plan to make, so you learn from them, but you make the final decision, then you will

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

Combination pro

o better.

Everyone's leadership style varies, but a team building and consensus style during planning, can go a long way to getting the respect of your experi

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

nced NCOs. If you get their respect, you will be in charge. But you have to earn it; you cannot demand it, just because you outrank them. They will respect you

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

r rank, but not you. Under those circumstances the only thing you will learn is failure.

An NCO cannot "order" a commissioned officer around. If the officer a

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

lows that, he has abdicated his authority. Does a captain ask his senior NCOs for advice? You better believe it! NCOs are your experts on Soldier training and

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

elfare; warrant officers are your experts on technical issues. You must learn who you can trust, and who may need more guidance, but you must use them for guid

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

nce and execution. You cannot do it all yourself.

About your first year, as a new second lieutenant, you will attend the basic officer's course for your speci

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

Following aspects would a

alty. That can take anywhere from 3 months to a year depending on how technical it is. That is why you are "not in charge of anything" for a year. The OBC trai

dd to the challenges in developing combination products:

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

ers are usually senior NCOs in your field, and they are "in charge" during OBC. If you listen to them with respect, they will treat you with respect and help y

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

u learn how to be a good junior officer. If you are arrogant, expect to be ignored, and therefore learn very little.

My experience as a second lieutenant was

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

a great OBC with terrific professional NCOs that helped me learn my Branch (Chemical) and how to be a good officer and handle being in charge. My first job was

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

as a platoon leader and I had high responsibility immediately. I had to prepare my unit to deploy to the National Training Center at Fort Irwin. I planned with

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

Professional from academic institutions, pharmaceutical industries, health care indust

my NCOs and asked the 1st Sergeant for advice, but in the end the load and movement orders were mine. And the unit executed them. I had responsibility for 147

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

Soldiers and $3 Million worth of vehicles and equipment on that move.

Please don't believe the negative rumors you hear. Try to keep your ego in line, then li

.

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

ten and learn. Use your team in the problem solving and planning stages. Then make decisions when they need to be made, and don't vacillate. Treat all your Sol

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

Companies that provide selfless information through particip

iers with respect, even the goof-offs. But punish the goof-offs appropriately. If you do, you will earn well deserved respect, and you and your unit will go fa

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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