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E-Articles - Managing Monsters in Meetings - Part 4, Quiet Participants
There are many reasons why someone would decline to participate during
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
a
meeting. For example, the person may feel reluctant to speak out, m
; 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
y disagree
with the approach endorsed by others in the meeting, or ma
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
just be tired.
An effective meeting depends upon fair and equitable p
An effective meeting depends upon fair and equitable p
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rticipation from everyone.
Here's how to make it easier for quiet par
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
icipants to contribute.
Approach 1: Encourage participation
When you
Approach 1: Encourage participation
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
otice a quiet participant, ask for contributions by looking at the pers
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
on
and saying:
"How do you feel about that, Chris?"
"What results d
"How do you feel about that, Chris?"
"What results d
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
you expect from this, Pat?"
"Chris, how will this affect you?"
Somet
"Chris, how will this affect you?"
Somet
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
mes a quiet participant will test the environment with a tentative repl
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
or a
minor, safe point. Respond positively and with encouragement to
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
any response that
you receive. Then probe further to explore for more
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
ideas.
Sometimes you can encourage quiet participants to contribute by
Sometimes you can encourage quiet participants to contribute by
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
making direct eye
contact, pausing, and letting your expression say,
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
"What do you think?"
Approach 2: Change the process
Use sequential pa
Approach 2: Change the process
Use sequential pa
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
ticipation (a round robin) to collect ideas. This provides quiet
part
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
cipants with opportunities to speak. Introduce this process by saying,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
"We want to hear from everyone, so let's use a round robin. Who wants t
.
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
start?"
Use these techniques to involve all of the participants.
Thi
Use these techniques to involve all of the participants.
Thi
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
is the fourth of a seven part article on Managing Monsters in Meetings
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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