Advice Pool - Self Improvement

Wouldn't it be great if everyone in your organization trusted each other? You'd quick

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

ly get to the source of problems without wasting time on turf protection or covering

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

Examples of combination products may in

up mistakes. Many mistakes could be avoided because people would easily ask for help

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

and acknowledge the limits of their expertise. The bottom line? Your organization wou

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

ld be much more successful.

But that's not the world most people work in. We are oft

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

Combination pro

n wary, wanting others to trust us but unwilling to trust them first. So we carry on

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

with protecting ourselves, playing corporate political games, and other low trust, c

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

ounter-productive strategies. That's why your leadership is important. As a leader, y

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

ou can turn this story around.

Trust is a risk game and the leader must ante up firs

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.

Recently an executive was discussing with me his challenges with one of his subor

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

inates. The executive had met one-on-one with his subordinate and was hoping the conv

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

Following aspects would a

ersation would help improve the relationship. "I could tell he didn't trust me enough

dd to the challenges in developing combination products:

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

to offer up much about his frustrations and challenges. So I decided to open up with

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

him about my own challenges. It felt risky to put myself out there. But then he did

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

begin to open up. I think we're on a path toward a better working relationship." The

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

xecutive made a choice to take the risk of talking to his subordinate about the chall

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

Professional from academic institutions, pharmaceutical industries, health care indust

enges that he felt vulnerable about. The result? Progress in a difficult relationship

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

. Increased trust. Ultimately better performance for the organization.

It won't feel

.

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

comfortable to take these risks at first. But leadership isn't about comfort - it's

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

Companies that provide selfless information through particip

about results. If you want a more trusting organization, be the leader. Ante up first

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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Advice Pool - Leadership: Trust and Risk

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