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Tom is a childhood friend of my brother’s. He lived about four houses from us since our junior-high days, and the guys have been friends for years. After getting his degree from Purdue, Tom went to

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

work for a steel company. The guys have another friend, Mark, who, after graduating, wound up leasing a seat at the Mercantile Exchange and later buying it.

Fast-forward several years, when Tom i

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

Examples of combination products may in

married with four sons. A couple other friends of their jumped on the “Merc bandwagon” and were doing quite well. By now Mark was a millionaire. Mark offered to help Tom get started working at 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.

e Merc. Of course, that would mean Tom would have to quit his job at the steel company, and still support four children and two adults.

I don’t recall how long he took to consider the offer. Eventua

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

ly he quit the steel company job and headed to the Merc.

My brother’s friends said that for Tom’s first two months at the Merc he looked like a deer caught in headlights.

I recalled Tom’s story a

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

Combination pro

I watched another episode of The Apprentice. Contestants who had watched other people in the role of the project manager on their teams seemed to forget everything they learned from

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

observation.

They could have made actual lists (if not on paper then at least in their minds) of what had worked and what had not worked for previous project managers, and then applied what they l

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

earned when it was their turn to lead their team.

Rather, I saw deer-caught-in-headlights expressions. Then compassion would kick in and I cut them some slack as I thought, “Well, they’re on TV, so

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

f course they’re nervous.”

But then I would think, “Hello? You’re on TV and you know it! Create a plan and act on it!”

The truth is, you don’t have to be on TV managing a team to get stuck lookin

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

like a deer caught in headlights while in a leadership role. You could be leading –

a corporate division
a small business’ distribution area
a meeting of a dozen peopl

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

in a conference room

your kid’s soccer team

and just freeze.

So what do you do when you’re in a new leadership situation and you’re feeling as if every good ide

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

Following aspects would a

just took a vacation from your brain? (Who told all of those good ideas they could leave now?)

Pretend you’re an actor. Let’s face it: Actors get paid to display emotion

dd to the challenges in developing combination products:

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

that aren’t real. The best in their field are skilled at making us believe they know something they don’t actually know or feel something they don’t actually feel. Some adult education programs of

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

er classes called “Acting for Non-actors,” which teaches acting skills for real-world social situations (such as leadership). Get the mindset of an actor to help you act more confident (until you

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

really are).

Put on your game face. Think about that deer-caught-in-headlights look you’ve seen on other people. Your “game face” should be the opposite of that look. Rather than

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

looking lost, frozen, or fearful, your game face will be purposeful and assured. Stop by a mirror occasionally to check what you see in your eyes. Make adjustments if necessary. (If you don’t want

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

Professional from academic institutions, pharmaceutical industries, health care indust

people to see you do this, keep a small mirror in your pocket and take it to a place where you will have privacy.)

Take a couple breaks in the day to write, review, or adjust a brief l

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

st of important topics & ideas. These will be topics that tend to take a vacation from your brain at the worst possible moments. Keep the list handy. By reviewing it regularly, those topics

.

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

nd ideas will be more likely to “stay” in your mind even when you’re likely to freeze up.

Several years after Tom started his work at the Merc, I was headed downtown to a client’s offi

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

Companies that provide selfless information through particip

e, walking through the train station around 11:30 in the morning. Passing me to catch a train to go home was Tom, looking confident. He was finished with his work for the day. Not bad. Life is good

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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