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Main Subject - Don't Settle for Vague Answers
I arrived at the golf course to check in, and much to my surprise, the pro shop attendant said, “We don't have a
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
reservation for you or the other person you mentioned.”
Shortly thereafter, my playing partner, Chuck (who had
Shortly thereafter, my playing partner, Chuck (who had
; 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
ndeed called earlier for reservations), straightened things out.
Sitting in the clubhouse after the round (with
Sitting in the clubhouse after the round (with
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ust enough sweet shots to keep one optimistic about the sport) Chuck told me he had an inkling a mix-up would occ
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r. He said his call to the pro shop went like this:
Chuck: “Can you get two people on at 12:30?”
Attendant: “Th
Chuck: “Can you get two people on at 12:30?”
Attendant: “Th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t shouldn't be a problem. Come on down.”
Chuck: “So we have a confirmed time at 12:30?”
Attendant: “We'll work
Chuck: “So we have a confirmed time at 12:30?”
Attendant: “We'll work
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 out. Come on in.”
Because the attendant was being somewhat evasive, vague, or just plain lazy, he didn't give
Because the attendant was being somewhat evasive, vague, or just plain lazy, he didn't give
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
a commitment although Chuck asked for one, but stopped short of saying, “Look, do you have my name written in the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
book at 12:30?”
We then related that situation to a similar fault some salespeople suffer from: not being speci
We then related that situation to a similar fault some salespeople suffer from: not being speci
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
ic enough, and accepting fuzzy answers.
Vague Responses
Get No Action
For example, Chuck has several sales peo
Vague Responses
Get No Action
For example, Chuck has several sales peo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
le working for him, marketing mechanical contracting services. Chuck will usually ask the reps after a major pros
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
ect meeting, “How did it go? Are we going to get the job?”
Sometimes they'll respond in a manner like the golf s
Sometimes they'll respond in a manner like the golf s
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
op attendant: “It looks pretty good. They were favorable toward us.”
He'll then ask the rep, “Did you come righ
He'll then ask the rep, “Did you come righ
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
out and ask them if they were going to use our bid in the overall contract?”
“Well, no . . . but I think they'
“Well, no . . . but I think they'
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
re leaning in our direction.”
Well folks, Chuck's company doesn't send out work crews (or invoices) based on so
Well folks, Chuck's company doesn't send out work crews (or invoices) based on so
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
eone who's just leaning. They need to know for sure. And that's the way it is with my company, and probably yours
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
When people speak in terms of specifics, things happen. If prospects and customers aren't asked for a definite d
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
cision or course of action, it's easy for them to shelve the issue.
“Are we going to do this?”
“When will we se
“Are we going to do this?”
“When will we se
.
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
the purchase order?”
“How many do you want?”
Find out precisely where you stand. Leave no doubt as to where yo
“How many do you want?”
Find out precisely where you stand. Leave no doubt as to where yo
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
both stand after the call, and you'll find that follow-up files become less clogged, and your wallet gets fatter
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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