Useful Advices - Business

The other day I got a phone call from a guy who wanted me to join his association.

He made a strong ca

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

se, too: reasonable dues, good people, great networking.

When he asked for the sale (or in this case,

; 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 membership), I paused for a few seconds before responding.

“Mark, my policy about saying no is, ‘I

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

on’t say it enough.’ So, for that reason alone, my answer to you is no.”

Dead silence. I smiled and

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

aited.

“Well um, uh … OK,” he stammered. “I-I guess I’m not going to challenge that.”

Dead silence.

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

Combination pro

I smiled and waited some more.

“OK well, uh, thanks for your time Scott,” he resigned.

“My pleasure!”

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

I hung up the phone.

Whoa. Where did THAT come from?! I wondered.

That was a first for me.

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

elling someone my “policy” on saying no.

And I tell ya what; it felt GREAT!

Candid, yet friendly.

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

> Honest, yet confident.
And nobody’s time was wasted.

LESSON LEARNED: people respon

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

to policies.

I actually just looked up the word policy. It means, “shrewdness or prudence, e

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

pecially in the pursuit of a particular course of action.” Which means:

You’re not being mean.
Y

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

Following aspects would a

u’re not being difficult.
You’re not rejecting someone.

You’re simply sticking to your guns.

dd to the challenges in developing combination products:

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

Telling someone, “Look, this is how I roll. This is who I am. That’s my policy.”

NOTE: I’m not talki

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

g about company policy. That’s different.

I’m talking about personal policy.

Knowing thyself. Being

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

the world’s expert ON yourself and confidently articulating that on a consistent basis.

The following

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

teps will help you put this idea into practice:

POLICY PREPARATION

1. Brainstorm a list of 10-15

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

Professional from academic institutions, pharmaceutical industries, health care indust

f your most valued personal policies.
2. Organize and type them out on a small card.
3. Carry

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

that card in your wallet.
4. Look at it regularly.
5. Next time someone challenges one of 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

policies, whip out that card and ask them physically read it back to you. (THIS IS CRUCIAL!)
6.

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

Companies that provide selfless information through particip

mile and wait for them to respond.

And they will. Every time. Because people respond to policies

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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