Main Subject - Business

Working together for maximum benefit should always be part of a plan. When working together

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

the ideal situation is to have a fifty-fifty split in the work. This is actually not a good

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

Examples of combination products may in

dea; you should have one person take the lead on each project that you are working on. That

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

way there is a person that is "in charge" and the final decisions can be made. My sense of f

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

irness wants the fifty-fifty but through experience I recognize that someone has to take the

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

Combination pro

helm to make the project work. When working together each of you will have your strengths a

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

d hopefully they are not the same strengths. A really good working relationship has people w

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

ith complimentary strengths and the weaknesses are no longer a problem.

The gaps that may e

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

ist when you work on your own are covered by having a good working relationship with another

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

person such as a Power Team member. Alliances can work well this way too. I have a working

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

artner that is great with editing and picking on all the details, he is a beaver type person

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

Following aspects would a

lity and I like the big picture and making the plans. I make faces and groan if I have to ge

dd to the challenges in developing combination products:

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

t into the detail and although I can do it, it is not one of my strengths. So when I am on a

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

project that needs detail, I call in my Power Team member that can handle the detail with ea

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

se. What you need to do is find out what your strengths are so that you can plan your work a

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

propriately. At the end of the chapter is a worksheet to help you discover what you like to

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

Professional from academic institutions, pharmaceutical industries, health care indust

do and what you do not.

Finding the best working partner for any project requires a solid b

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

siness relationship before you do any work. Determine if this person is the best fit for you

.

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

and your strengths. Try not to get into a situation where you both want to lead and one of

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

Companies that provide selfless information through particip

ou wants to do the project on their own. Planning ahead will eliminate a lot of the problems

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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