Main Subject - Business

I once worked for a boss who was never wrong, never made a mistake or a bad decision. All you had to do was ask him.

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

To his staff he was Teflon-man. Nothing stuck to him and everything came sliding toward us.

Accountability was not a

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

Examples of combination products may in

concept he practiced unless things turned out well and then, he claimed the credit. But if they didn't, he immediate

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

ly embarked on endeavors to identify someone responsible. Being called to his office typically meant he was looking f

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

or information and trying to decide whom to blame.

Justify. Justify. Justify. Like a battle cry, he commissioned rep

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

Combination pro

rts, graphs, charts and enhanced documentation whenever his boss questioned him. He found it easier to dig his heels

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

into a position than admit he might have been wrong or change his mind. Working for someone I couldn't respect eventu

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

ally led me to transfer departments.

But it still baffles me. People do make mistakes, they do trip up sometimes and

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

they do, on occasion, speak or act in error. And while there's nothing that says we should be happy about it when we

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

do it ourselves, trying to act like it didn't happen, covering up our mistakes, or trying to justify inaccurate posi

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

ions leads nowhere.

You see, unlike that early boss of mine, people who are winning at working speak up and admit wh

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

Following aspects would a

en they've made a mistake. They take accountability for fixing resulting problems. And even if they have to gather th

dd to the challenges in developing combination products:

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

eir courage and swallow hard, they acknowledge when they're wrong.

I learned in twenty years in management that play

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

ing it safe, isn't. One of the biggest mistakes you can make if you want to be winning at working is pointing fingers

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

, blaming others or offering excuses. Own your decisions, choices and actions. Admit when you're wrong. Fix your mist

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

kes. Then learn from them and move on. These are the signs of confident, accountable, initiative-filled people. And t

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

Professional from academic institutions, pharmaceutical industries, health care indust

hese are the people you want on your team.

There's a story I love about the famed British economist, John Maynard Ke

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

ynes, who was confronted by a young man after one of his lectures. The man insisted Keynes give him an explanation of

.

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

why he contradicted himself with something written years before. "Well", Keynes replied. "When I'm wrong, I change m

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

Companies that provide selfless information through particip

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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