Advice You - Business

Part 1: Are You Prepared to Face a Journalist? As a former journalist I am aware of how difficult it might be for some people to face the press and send their messag

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

e right. I’ve heard so often nasty comments against my line of work, I faced negative responses, even had to beg for an interview and hardly get those stubborn “I don’t do in

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

Examples of combination products may in

terviews” VIPs answer my questions. I knew back then why I had to struggle so much to make people understand I was not the enemy. I know it now as well.

How many times were

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

ou misquoted? Too many? Often? Always? Never? Depending on how you answer this question you’ll know whether you were able to send your message right or not.

As odd this migh

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 sound, sometimes it’s not the fault of the journalist. When you have to face the media “in person” and you give “live” answers you have a few factors that

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

Combination pro

ill determine how your message is perceived: body language, voice inflec

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

tions and face expressions. While for skilled psychologists and behavior scientists these are quite clear messages, a journalist might “read” these messages wrong an

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

d make not so accurate presumptions.

The moment you are being interviewed you become part of the media – you become the news. The reporter

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

ou talk to, in most of the cases, is not always the one who will write the story. He or she is just collecting data to hand over to an editor. Way too often

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

the reporters are not familiar with your field of expertise. They are supposed to document their work and research a bit prior to an interview, but how many do you think that

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

really do the hard work? No so many, to be frank, especially not those who get their questions from the managing editors and all they need to do is come back with your answer

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

Following aspects would a

s. To such reporters you are speaking in a foreign language.

Another problem: the reporter might, or might not care about the subject he/ she has to cover.

dd to the challenges in developing combination products:

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

The lack of emotional concern will definitely influence the reporter’s ability to get your message right and to underline the points that really matter.

So

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

ere come some questions for you: are you ready to face a reporter? Do you understand that he/she might know zip about your business? Are you prepared to accu

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

rately answer fast paced questions in a short time? (Journalists are always in a rush!) Are you prepared to see your business or personal values and views shaken to their cor

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

by someone who has obviously other understanding of what really matters? Because, believe it: journalists know what matters for the public and this is

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng>the only thing they care about. After all, it’s in their own interest to “sell” the news. And they’ll look for the “sensational” that sells. Bein

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

g so focused on instant success they might ignore the long-term elements from your message. They’ll also overlook any of your statements they might consider “tacky”, “blah-bl

.

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

h” or irrelevant for their target audience.

If you feel this is unfair, you might be right. From your point of view. From the journalists’ point of view though, this is fair

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

Companies that provide selfless information through particip

. As you, they try to run a successful business, which is a rather unfortunate turn of actions. The media was supposed to serve the public and not some profit hungry entities

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 - Dealing With the Press: An Ultimate Challenge

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