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Advice You - Leading Change - Listen More and Talk Less
"Well Dave, here's how it is. Thanks to Oracle, we have most of the parts we need for all of the products. However, we don’t ha
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
ve all of the parts we need for any of the products."
That quote came from the Director of Purchasing regarding the new Oracle
That quote came from the Director of Purchasing regarding the new Oracle
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
system the company had just implemented. Honesty was long overdue. We were working in a $500 million dollar tech outfit at the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ime, when the VP of Op's flew into town to stop the riot. He was going to set everyone straight and tell us straight up ‘how it
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
was’.
He started the meeting with this gem.
"I've heard all the noise in the system. I've checked it out. And I want you to k
He started the meeting with this gem.
"I've heard all the noise in the system. I've checked it out. And I want you to k
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
now it stops today! Oracle is our system, it works fine and this is the end of it."
We all wished he was right. But he was abo
We all wished he was right. But he was abo
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
t as right as Bush and his WMD’s in Baghdad.
But the truth never stopped this guy, so he rambled on with authority.
"Just why
But the truth never stopped this guy, so he rambled on with authority.
"Just why
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
are we not making the new products that are on order? Why are our shipments always late? We cannot have this anymore. It stops
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
oday!"
He was pretty exercised and excited and they seemed like fair questions. I mean the company had invested around $30 mil
He was pretty exercised and excited and they seemed like fair questions. I mean the company had invested around $30 mil
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
lion or so to get this Oracle thing on the street. It had been two years since this guy kicked off the Oracle project. So quest
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ons like he now posed seemed fair. Things were pretty quiet for a time.
That's when he got his priceless answer from the Direc
That's when he got his priceless answer from the Direc
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
or of Purchasing.
"Well, Dave, here's how it really works. Thanks to Oracle, we have most of the parts we need for all the pro
"Well, Dave, here's how it really works. Thanks to Oracle, we have most of the parts we need for all the pro
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ucts. However, we don’t have all of the parts we need for any of the products."
The entire project team had been telling this
The entire project team had been telling this
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
guy we call Dave, for months that things weren’t what the consultants from Oracle were claiming. They were telling him but he w
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
sn’t listening. As time went on he became more obsessed with the timeline than he did the truth. That is a killer. He had stepp
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
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
d out on that proverbial limb and told the CEO that all was well in Zion. He was dead wrong. You have to listen to the right pe
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ple. You have to listen to understand, not just nod your head.
You must be a listener to lead change successfully. Anything le
You must be a listener to lead change successfully. Anything le
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ss and failure is loaded on the southbound train screaming towards you at this very moment. It's a bullet that's been fired and
.
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
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
it just hasn’t arrived yet. Dave ended up getting shot in the process, don’t let that be you.
As the change leader - make sure
As the change leader - make sure
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
you listen. It's been said, "To change, you gotta' change". I might add, "To change successfully, you gotta' listen."
Ed Kugle
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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