Advice You - Business

It’s a typical day at the office. You are doing what you usually do, which is pretty much, well, everything. Your phone rings. You debate answering. Do you really need one more problem dumped

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

on you? You consider letting it go to voicemail. Then, responsible soul that you are, you pick it up and say hello.

Turns out it isn’t one of your direct reports or one of your clients or vendo

; 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. It’s a reporter. “Hi, this is Francine Smith with Your Industry Magazine.” Your heart races and your stomach feels hollow. “I’d like to ask you a few questions about what’s going on in the

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

ndustry.”

We know we want coverage. We think, wouldn’t it be great if the press called us up instead of us having to send out press releases that never get picked up anyway. We all have visions

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

of the rest of the world valuing us, our companies and our contributions. But what happens when a reporter really is on line one? A blessed few can pick up the phone and say brilliant things.

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

Combination pro

he vast majority of us panic.

When we are caught completely off guard, the cortisol kicks in and we go blank. We freeze. It’s like the man-in-the-street interview. There are a small select few

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

who are comfortable, but most people get that wide-eyed, deer-in-the-headlights look. All it takes is a camera, a microphone in our faces, or even just a reporter on the other end of the phone li

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

ne, and we lose our ability to think and speak.

So what’s one to do? The reporter’s on the line, ready to ask questions, and you are completely unprepared. Here are a few failsafe tips for just

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

that situation:

1) Buy time. Ask the reporter what the focus of her story is and when her deadline is. Sometimes the media needs a comment right that instant, and sometimes they’ve got the luxu

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

y of a few days. Just an extra hour or two is probably all you need to gather your thoughts. Don’t say you want time to think; simply suggest a later time. For instance, you might say, “I’ve go

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

a break in my schedule at 3; shall we talk then?”

2) Narrow the world and comment on what you know. No one can know everything, so adapt a reporter’s question to make it fit what you do know.

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

Following aspects would a

Be the expert on your own world. When a question is too broad for your liking or outside your scope, reign it in. For example, “The economy in general is anyone’s guess, but I can tell you what

dd to the challenges in developing combination products:

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

I see here at our company and with our customers.”

3) Stick your neck out. Make a prediction. The dirty little secret about predictions is that unless you are the chairman of the Federal Reserv

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

Bank, no one is going to go back later and check to see if you were right. You stand to gain far more by being reported on as someone with a perspective than you do by being silent, even if you

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

turn out to be wrong. Predictions are an engaging sport for media. Think of the number of articles written every January about predictions for the coming year. We read them and perceive those

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

uoted as expert resources, worthy of visibility, but no one goes back at the end of the year to see who was wrong. Those who have opinions about the future make the story; those who play it safe

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

Professional from academic institutions, pharmaceutical industries, health care indust

et cut and don’t get called again.

4) Use a cheat sheet. What are three things about your company that the general public would find interesting or want to know? What are three things about you

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

rself? What are three opinions you have? Take out a piece of paper and list them. Then stash the page in the top drawer of your desk. It’s your security blanket. Keep it right there and if yo

.

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

are ever caught off guard by a media call, pull it out. You’ll have the comfort of knowing you’ve got something to say while the cortisol dissipates and your mind catches up.

When the press cal

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

Companies that provide selfless information through particip

s, respond. See what they are writing about and when their deadline is. Don’t hem, haw and hedge. Take the opportunity presented to you and reap the benefits of being a visible, expert resource

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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Advice You - There's a Reporter on Line One: 4 Failsafe Tips for Talking to Media

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