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There seems to be no gray area when it comes to trusting and being trusted. Many things affect our decisio

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

n to trust - past experience, new information, attitude towards risk - but one thing is certain: if trust

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

Examples of combination products may in

s betrayed, it is more likely to be withheld in the future.

Are you fostering a culture of trust in your

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

organization? By trust, I mean believing that people will say and do the right things for the right reason

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

.

According to many studies, organizations with a high trust factor are far more likely to have superior

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

Combination pro

financial performance, so besides being something nice to have, there are serious economic implications fo

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

a work environment grounded in mutual trust. In his book "The Speed of Trust", Stephen M.R. Covey explain

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

s this using two very simple equations: "When trust goes down, speed will go down and cost will go up. Tha

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

's a tax. When trust goes up, speed goes up, cost goes down. That's a dividend." Think about it. For examp

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

le, when you micromanage the work of someone you've hired specifically for their expertise, time is wasted

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

on unnecessary conversations, rework, multiple reviews, and jumping through approval hoops. That time - yo

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

Following aspects would a

urs and theirs - costs. Productivity is greatly diminished and the speed of decision-making resembles the

dd to the challenges in developing combination products:

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

ast runner in a marathon - finally there, but who cares anymore?

A recent study by Watson Wyatt Worldwide

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

indicated only 49% of employees reported having trust and confidence in the performance of senior managem

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

nt, down from 51% in 2004. The results aren't surprising given the rash of widely publicized corporate sca

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

ndals. Trust, according to Covey, is about character as well as competence. In a recent interview in Workf

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

Professional from academic institutions, pharmaceutical industries, health care indust

rce Management he said, "You can do a lot about this. You can establish trust. You can grow it. You can re

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

store it."

If a survey was taken today in your organization on the three important aspects of trust, how

.

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

o you think people would answer these questions about you?

Integrity: Are you telling me the truth?

Cred

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

Companies that provide selfless information through particip

ibility: Do you know what you're doing?

Sincerity: Do you care?

The answers will either be "YES" or "NO.

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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