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Ever notice that negotiations usually go much better when there is a history of trust from previous successful negotiations? That is no accident. The good will that is built up over the ye

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

ars allows the other party to accept your positions at face value. However those negotiations can get flat and you might want to try something new as well. Here are some tips to build on

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

that long term relationships during negotiations.

Look To The Past For Inspiration.

Usually I say look to the future, and that the past is called the past for a reason. That is because t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e usual negotiations are unsuccessful and the past may be a source of frustration and pain. However, when there is a history of successful negotiations, the negotiations themselves are a s

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ource for study. Try to analyze what has worked and what might need improvement. Even if you are pleased with the results, what could make the negotiations better? For example, you could a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

k questions like the following:

1. Was I prepared enough?

2. Did I give in too soon?

3. Were any mistakes made?

4. What worked and would I use that technique again?

5. What did not wo

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

rk and how can I improve?

Look To The Past for Pitfalls or Drawbacks

Even though successful negotiations predict further successful negotiations, negotiations with the same parties for s

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

everal years do have some drawbacks or pitfalls. The negotiations can be predictable and even boring and the parties can become complacent. The parties anticipate what the other side is g

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ing to do so that there is no element of surprise. When it is time to close the deal, they are more likely just to split the difference. Negotiations repeated over the years can go flat.

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

As they say, familiarity can breed contempt. If the parties know each other’s moves, they can predict where the negotiations are going. Sometimes the negotiators just go through the motion

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

and don’t put much thought into the process. Each person has a role and they just go back and forth as they always have. Sometimes the expectations are fairly low and that can affect the

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

bottom line

Try Something New

You might want to assign some different people to the negotiating team or pick a new chief negotiator to shake things up. You might want to add a new formul

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

a for the payment of fees. You might try to ask for something new this year, something you really want. You might start in a different order. Start with the important items if you have bee

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

starting with the easy items. Maybe you want to start all over again and start from scratch and build a new contract. This is fairly drastic but might be worth a try. If you are happy wit

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

h last year’s contract, then you might want to think of some brand new provisions. If you don’t ask, you don’t get.

Be Prudent

Even though you may want to try something new, be prudent o

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

how you implement it. Don’t risk everything just for the sake of trying something new. Experiment by trying one or two minor changes and see how it works. Don’t allow years of successful

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

negotiations to be jeopardized for the sake of innovation. You will need to assess the situation to see if the tried and true is still working or whether the parties have become complacent

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

and need some new strategies at the negotiation table.

In conclusion, a long term negotiations are usually built on mutual trust and will likely predict good future negotiations. However

.

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 will up to you to decide whether the parties are complacent and caught up in a routine or are already at their peak performance. You may have to try something new to put some new zest

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

in the negotiations. Or you may want to continue the techniques that have worked in the past. The point is that there should be a review to determine the strategies for future negotiations

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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When seeking for a job, it is important that you are ready when you face your future employer. The most challenging part is the interview. To prepare for this, you can practice how to answer interview questions. Most interviewers have similar sets of questions. So being prepared will make the battle a lot easier. Below are some guides on how to answer interview questions.

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