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When I think of trust, things like integrity, faith, belief and confidence come to mind. As an employee I want to feel secure that

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

I will be heard, understood and accepted. As an employer I want my staff to do the right thing, to believe in me and be confident 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

my decisions. As a customer I want to know that the company I am doing business with will provide the services or products they pr

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

omise, with integrity and confidence. Trust supports our business efforts and breeds success. Without trust it is hard to imagine t

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

at a business could succeed.

So why is it such a challenge to maintain trust in the workplace and the community we serve? There ar

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

Combination pro

many reasons but the almighty ego is high on my list of culprits. In business, competition can be healthy, or not. Inflated egos c

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

an instigate un-healthy competition; it is not long before the resulting malcontent begins to foster a loss of trust. When trust is

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

lacking in the work environment the business agenda can be easily overlooked. When trust is lost (or was never there to begin with)

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

we risk losing the edge we need to thrive. It is hard to figure where loss of trust begins (and it is unimportant as well because i

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

t requires that we assign blame, which only makes things worse) but one thing is for sure once trust begins to fade in one area of

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

business it tends to evolve into a widespread issue. You know how it goes; you do not trust me so I do not trust you and so on and

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

Following aspects would a

so on.

The bottom line is this: if you are fortunate enough to work in a trusting work environment, take the time to understand wh

dd to the challenges in developing combination products:

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

y it is that way and do whatever you must to keep it that way. If not, make every effort to restore trust. Start by letting go of y

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

ur ego (this process is infectious; get it going and it will multiply nicely); forget about trying to figure out who is responsible

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

and just get back to the basics. As leaders of course, we must be mindful of the needs of our employees, our customers and our busi

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

ness goals. We know and we must respect that our goals are heavily dependent upon the way in which we utilize our human resources a

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

Professional from academic institutions, pharmaceutical industries, health care indust

d interact with our customers.

Fostering an environment in which trust thrives is an investment in the long-term success of your b

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

siness. It is an investment you cannot afford to pass up. Trust is a two way process; it is as important to you as a leader as it i

.

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

s to the most subordinate employee or the most infrequent customer.

Take advantage of your position as a leader. Be a role model;

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

Companies that provide selfless information through particip

nsure that trust is relevant, viable and expected in your workplace. In turn you will be rewarded with the trust you desire as well

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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