Summary - Relationships

So you’re at a party, a bar, a coffeehouse or wherever and you see someone who catches

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

your eyes. What do you do? Would you just stand in your spot staring, praying and hopin

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

Examples of combination products may in

he/she will notice you and hopefully they will like what they see and approach you? Ma

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

ybe that’s why you’re still single, buddy.

Of course, it can be nerve-wracking approac

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

ing somebody. It all comes down to fear of rejection. But somebody got to do it, right?

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

Combination pro

Now gather up your confidence and go for it. Sure, the risk of them not being available

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

or not finding you worthy of a conversation is high but the chance of you hitting the

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

ating jackpot is also much higher than winning the lottery. Be confident, it’s not very

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

attractive if you stumble for words but be careful not to appear cocky. Start with sim

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

le ice-breaking lines like “Hi. Having a good time?” or anything that doesn’t seem out

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

f place. You want to avoid being too aggressive or come on too strong. Having a sense o

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

Following aspects would a

f humor helps a whole lot because you don’t want to bore them. The first few lines of t

dd to the challenges in developing combination products:

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

e conversation is the ‘make or break’ period, after that if they still appear to be int

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

erested in having a conversation then you basically make it pass the first step so keep

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

the conversation casual and get to know them. And if they start looking away or even ya

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

ning, don’t fool yourself that they’re still interested. Move on and don’t push it furt

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

Professional from academic institutions, pharmaceutical industries, health care indust

her. As the old saying goes, there’re plenty of fishes in the sea.

I know how most wom

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

n would rather not make the first move but here’s a secret. Men like being approached.

.

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 doesn’t just boost their ego but also makes things a lot easier because they might n

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

Companies that provide selfless information through particip

t have the nerve to approach you themselves. So be a little aggressive and take control

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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