Advice You - Business

Being on an improv comedy stage can be a very scary thing. You have nothing prepared in advance, you have an audience just

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

waiting to laugh (or not!), and you have other performers who will have their own ideas about what to do.

Many improvise

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

Examples of combination products may in

s, especially new ones, will feel a great deal of stress wondering what their partners are going to do. Well meaning perfo

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

rmers will get wrapped up in their own thoughts trying to figure out what’s in their partner’s head so they can help suppo

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

t them. Non-well meaning (or just oblivious) performers will stress that their partner won’t support them or that their pa

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

Combination pro

tner will do something stupid or crazy.

I was like this too for a while, until I came to a great, if obvious, conclusion:

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

the only thing I could control on that stage was myself. Ergo, there was no point in worrying about what my partner might

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

do. Whatever he did, I would flow with it.

The day I came to that conclusion is the day that my performance really took o

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

ff. All the energy and focus I had previously been putting on stress, fear, and trying to “figure out” my fellow performer

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

suddenly went to staying in the moment, paying attention, and doing the best I could with whatever was given to me.

The

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

orld works the same way. We all want to exert some level of control over all the things going on around us. This is a natu

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

Following aspects would a

ral feeling, but if you give in to it you will really be reducing your ability to do well.

Most of the disappointment, an

dd to the challenges in developing combination products:

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

er, and frustration people feel is when they do or say something and expect something specific to happen. When that thing

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

doesn’t happen, their desire for control kicks in and they get all out of whack.

The universe is tricky. No matter how we

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

l you plan, it’s going to throw something unexpected at you. People are also unpredictable. You may clearly expect them to

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

act in one way, but chances are they will do something else. The more you hold on to your desire to have them do things, “

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

Professional from academic institutions, pharmaceutical industries, health care indust

your way” the more stress and challenge you will face.

This is not to say that you shouldn’t have certain expectations. J

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

st realize that all you can control is yourself; say what you need to, do what you need to, and expect a specific response

.

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

. When that response doesn’t come, just be prepared to let go, flow, and react to it the best you can.

This is the real k

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

Companies that provide selfless information through particip

y to dealing with change: realizing that the unexpected will occur, but realize that when it happens you will deal with it

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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