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Useful Advices - Sticky Conversations
Can you just feel the sickness in your stomach right now? That feeling when you know that you have to have a conversation that you are NOT looking forward to, but know you need to have. It plagues you for days before you have to face the inevitable and then the moment
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
arrives when you make contact with the person, and there they are.. waiting for you to initiate conversation.
Usually, the conversations start friendly. You talk about the weather or your weekend or something work oriented that you both can agree on. This is a great t
Usually, the conversations start friendly. You talk about the weather or your weekend or something work oriented that you both can agree on. This is a great t
; 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
ctic.. to find something that you both agree on BEFORE you attack.
Okay, attacking is NOT a good word here. That is exactly what you don’t WANT to do. But, it is going to be your natural instinct. You have probably been steaming on the inside thinking of everything w
Okay, attacking is NOT a good word here. That is exactly what you don’t WANT to do. But, it is going to be your natural instinct. You have probably been steaming on the inside thinking of everything w
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ong that your opponent has done. You’ve been thinking of what he or she is going to give you as a rebuttal and you have every cleaver answer ready to go.
But instead of attacking, you need to PRACTICE exactly WHAT you are going to say. And even though you can barely C
But instead of attacking, you need to PRACTICE exactly WHAT you are going to say. And even though you can barely C
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
NTAIN yourself and want to just blast the person, you MUST REMAIN CALM. You MUST remain in a place where an equal exchange of ideas can take place. You must tell yourself that you HAVE to stay calm, and agree to listen with out interrupting.
Visualizing being calm is
Visualizing being calm is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
elpful and visualizing yourself having a good conversation is even better. It can help pave the way for a fruitful conversation. Then, after you’ve finished the small talk, and that awkward silence takes place, then it’s up to you, to ask a question: “so, perhaps we sh
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
ould discuss this issue at stake?”
Remember at this point, whoever ASKS the questions controls the conversation. If you ask the question, “can you tell me what happened from your point of view?” then you are off to a good start. Then, follow up by taking notes and ask
Remember at this point, whoever ASKS the questions controls the conversation. If you ask the question, “can you tell me what happened from your point of view?” then you are off to a good start. Then, follow up by taking notes and ask
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
ng MORE questions. Do this so your opponent can see that you are really listening to him or her and value what you have to say. The most controlled person is going to want to JUMP in and add their two sense, but you MUST not! You must just listen, look them in the eyes
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
with all of the sincerity you can muster up, and you must listen to his or her complaint about you.
When they are done with their 15 minute monologue that may or may not be salted with epiphanies about yourself that you were dying to know, then you HAVE to take a brea
When they are done with their 15 minute monologue that may or may not be salted with epiphanies about yourself that you were dying to know, then you HAVE to take a brea
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
h, a deep one and then… WAIT.
YES… WAIT. Let the clock tick. This is essential for letting your opponent know that you are giving serious thought to the assaults that you just endured. You are carefully considering the awful things that you instigated, and then you ar
YES… WAIT. Let the clock tick. This is essential for letting your opponent know that you are giving serious thought to the assaults that you just endured. You are carefully considering the awful things that you instigated, and then you ar
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
thinking carefully about how to respond.
Then you do. You might want to throw in one or two more questions to gain clarity just for good measure, but more than likely, you’ll have the major complaints listed and are now ready to respond.
But.. before you respond… do
Then you do. You might want to throw in one or two more questions to gain clarity just for good measure, but more than likely, you’ll have the major complaints listed and are now ready to respond.
But.. before you respond… do
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
you need to apologize? Do you need to tell the person that you’re sorry that you hurt their feelings, damaged their reputation, embarrassed them in front of others, or ANYTHING else. Apologizing is an EXCELLENT strategy for gaining respect from an opponent. If you don
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
t have any apologizing to do… then FIND something to apologize for. It’s VERY important that you take some of the blame.
Next, thank the opponent for opening up to you and sharing with you. Tell them that you want to gain their respect and trust and want to word every
Next, thank the opponent for opening up to you and sharing with you. Tell them that you want to gain their respect and trust and want to word every
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
hing as carefully as possible.
Then you start your rebuttal. Tell the person that you want to do a good job. You both have the same goal at stake of keeping the company growing and moving in the right direction. (or list a common goal that you both share) and it’s obv
Then you start your rebuttal. Tell the person that you want to do a good job. You both have the same goal at stake of keeping the company growing and moving in the right direction. (or list a common goal that you both share) and it’s obv
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
ous that you are both passionate about the topic.
Then start slow, and talk about how you arrived at your decision. Do NOT point fingers. Just talk about the goal of making your company great.. or how you arrived at your decision. If you are giving a rebuttal to a ser
Then start slow, and talk about how you arrived at your decision. Do NOT point fingers. Just talk about the goal of making your company great.. or how you arrived at your decision. If you are giving a rebuttal to a ser
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
ous allegation that is true, then confront your fears and tell the person that you are working on this issue and ask for them to be patient with you. Most people will understand human error and give you a break – if you admit it. If you defend yourself completely and t
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
ake no responsibility, then you might as well hang up your gloves. You are going to lose respect and probably in the long run, you’ll lose the game.
Sticky conversations are not fun to have, but they can further the action faster than anything else. Rather than people
Sticky conversations are not fun to have, but they can further the action faster than anything else. Rather than people
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
sitting around stewing all day long, gossiping in the halls about each other, then having those conversations can challenge people to come to the table with ideas, conversations and new solutions.
Each time you have a sticky conversation, you’ll gain strength. You’ll
Each time you have a sticky conversation, you’ll gain strength. You’ll
.
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
ee that it’s MUCH better to have the conversation than let it simmer underneath the surface. Facing the uncomfortable does more than just solve an issue, it can help you get comfortable with the person, and make them into your advocate.
There is no better solution to
There is no better solution to
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
ind than to transform from an enemy to an advocate. That is the ultimate and while it might not be easy, it is simple. Just prepare in advance, be prepared to humble yourself, and in the process you’ll gain respect from your opponent, and even more respect for yourself
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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