Useful Advices - Business

Leading organizational change requires a manifesto for change. Your manifesto begins by saying the following:

1

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 understand that all progress requires change but all change is not progress.

2. I understand that all chang

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

Examples of combination products may in

e comes from leadership but not all leaders can drive change.

Okay, if you truly get that the next step is to a

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

nswer these two questions:

1. What problem am I trying to solve?

2. What will success look like when I solve i

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

t?

It’s important that you answer the two questions above. They are the key to your change success. Because you

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

Combination pro

must know that the bridge between what problem you are trying to solve and what success will look like when you

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

do will hinge on the execution of the following steps:

1. You must stop BS’ing yourself about where your organ

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

ization is today. You must admit where you are and deal with it.

2. You must be brutally honest about where you

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

want to go.

3. You must be realistic about the level of financial commitment that exists in your organization

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

for the change you are leading. How real is the support? Is this support in keeping with what you know to be tru

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

e about your organization spending money? Get real.

4. You must be realistic about the level of emotional commi

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

Following aspects would a

tment that exists in your organization for the change you are leading. Senior support of the changes must exist

dd to the challenges in developing combination products:

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

or you fail. Get real about whether your leaders have thought through the pain of change and are realistically w

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

illing to endure to the end.

5. You must know and accept that you cannot succeed at driving change in your orga

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

nization without the unwavering support of the highest person in your organization that is impacted by the chang

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

e you lead. Get real, if you don’t have their support you fail.

6. You must have the above five items in place

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

Professional from academic institutions, pharmaceutical industries, health care indust

and then I must have detailed plans that I execute daily, make changes as necessary and continue to do so until

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

I succeed.

You must commit to live by the wise words of Alfred E. Newman of Mad Magazine fame when he said, “Ju

.

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

st because everything is different doesn’t mean anything’s changed”. You must commit to insure that doesn’t happ

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

Companies that provide selfless information through particip

en on your watch. Make a difference and make your changes happen. That … is your manifesto for change!

Ed Kugle

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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