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I have a friend named Russ. He always has a maniacal gleam in his eye, like he knows a great secret or he’s just jazzed being R

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

uss. He’s a business coach. He must love what he does. His strength and presence make me think, if I hit him in the head with

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

Examples of combination products may in

a frying pan, I’d hurt my arm but he’d never feel it. Not that I would hit him. That’s just the New Jersey in me trying to 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.

ke a point.

I see Russ at one of the places where I network. I network all the time. I think I know a lot about networking.

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

But when I see Russ, I think I might be doing something wrong.

Russ just shines. You would never hear a word of complaint out

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

Combination pro

of him. Many people say, “If I were doing any better I’d be twins,” but they’re not excited. They’re just repeating what someo

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

ne else said. Many people complain about the weather and the traffic. Sure, they laugh and joke and you don’t think they’re co

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

mplaining, but they are.

Not Russ. He just seems so certain, like a rock, almost drunk on his power, drunk on whatever wonderf

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

ul thoughts he seems to be thinking. It’s a pleasure to watch him stand up and introduce himself to a room full of strangers.

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

He is a symbol to me. His greatness is the impression he makes on me. We see what we are. We see what we look for. He inspir

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

es me to be bullet-proof.

I know I am bullet-proof when I talk about my stuff, my products, my services. I try to be matter-of

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

Following aspects would a

-fact. I leave plenty of room for questions, plenty of gaps, plenty of silence, plenty of room to let people say what they’d li

dd to the challenges in developing combination products:

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

ke to say, plenty of room to let them come to me. Yes, I call and follow up, but I’m careful. Networking can bring out the tal

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

kative salesman in me. I have to go slow.

To be bullet-proof - to be impressive – to be what we prefer to be – to be comfortab

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

le in our own skin – to enjoy other people, especially when we’re business networking – that takes work. It’s a subtle skill, 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

o network and attract friends, to get great at interacting with people, to love it as much as an athlete loves his sport or a da

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

Professional from academic institutions, pharmaceutical industries, health care indust

ncer loves her dance. To be in the zone, in the moment, takes a lot of paying attention, a lot of listening, a lot of trust, in

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

yourself, in the moment, in life.

What a wonderful thing to feel. What a wonderful thing to help others feel. Trust.

We are

.

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

contagious. We attract people with what we feel. To consciously feel great, to always be happy, to always be bullet-proof, th

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

Companies that provide selfless information through particip

at is something to achieve. Then, who knows? Maybe someone will write an article about you and about how much you inspire them

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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