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Advice You - The Art Of Negotiations In About 5 Minutes
There are plenty of books written on negotiations, some better than others. But what do you really need to know about negotia
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
tions to be effective at it? The answer is to understand that each of the following elements play a role in the art of negoti
; 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
tion:
1. Time
2. Money
3. Knowledge
4. Clear perspectives of what you want-define your goals.
5. Understand your limits a
1. Time
2. Money
3. Knowledge
4. Clear perspectives of what you want-define your goals.
5. Understand your limits 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.
d level of flexibility.
6. Know thy enemy-what motivates them, what are their strengths and weakness, what do they really wan
6. Know thy enemy-what motivates them, what are their strengths and weakness, what do they really wan
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
, what divides them?
7. Plan your strategy.
8. Agree on the easy things.
9. Winners and losers, go for win, win-win.
10. L
7. Plan your strategy.
8. Agree on the easy things.
9. Winners and losers, go for win, win-win.
10. L
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
mit you emotions.
Here’s the crash course:
1. Whoever has the most time has the upper advantage.
2. Whoeve
Here’s the crash course:
1. Whoever has the most time has the upper advantage.
2. Whoeve
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
has the most money has the upper advantage.
3. Whoever has the most knowledge has the upper advantage. The more information
3. Whoever has the most knowledge has the upper advantage. The more information
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
our opponent gives you, the better.
4. You must understand exactly what you want to achieve out of the deal before you can ge
4. You must understand exactly what you want to achieve out of the deal before you can ge
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
it. Think through the problem (see my article on problem solving) and develop clear written goals and objectives before you b
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
gin to negotiate your position.
5. Understand your flexibility, know with certainty your limitations, how much you can give i
5. Understand your flexibility, know with certainty your limitations, how much you can give i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
exchange for the things you want. Are you willing to pay too much for successful outcome? Put stop limits on giveaways.
6.
6.
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
Do a little discovery and find out what really drives your opponent sitting across the table from you. What are their weakness
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
s? What will they give to get what they want?
7. You cannot have a strategy if you don’t understand your opponent, see numbe
7. You cannot have a strategy if you don’t understand your opponent, see numbe
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
6.
8. Be prepared to give on the easy things and try to negotiate the easy things in exchange for the bigger things. In oth
8. Be prepared to give on the easy things and try to negotiate the easy things in exchange for the bigger things. In oth
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
r words, give them five pennies for a dime.
9. Don’t be fooled, every deal has a winner and a loser. The key is not whether t
9. Don’t be fooled, every deal has a winner and a loser. The key is not whether t
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
ere is a clear winner or a loser, the key is who THINKS they are winners and losers. Attempt to structure the deal so that yo
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
r opponent thinks he or she is the winner.
10. be a poker face: If you must laugh, laugh. If you must weep, weep. It often
10. be a poker face: If you must laugh, laugh. If you must weep, weep. It often
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ays dividends to let your attorney negotiate for you because they have no emotional investment in the deal. The key is to win,
.
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
right?
Always hold your cards close to your chest. Information is often a key to successful negotiations. The more you have
Always hold your cards close to your chest. Information is often a key to successful negotiations. The more you have
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
nd the less they have gives you the upper advantage.
To your success!
Copyright © 2006, James W. Hart, IV All Rights Reserve
To your success!
Copyright © 2006, James W. Hart, IV All Rights Reserve
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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