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Kathy Sierra's story will frighten women bloggers world wide. Kathy has received a series of death

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

threats which have forced her to cancel a public appearance at ETech in San Diego and suspend he

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

Examples of combination products may in

r blog. Besides the threats the campaign also included a post that featured a picture of her next

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

to a noose. Kathy has been receiving death threats for four weeks now.

I have spent a while on

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

er blog 'Creating Passionate Users' reading some of her recent posts. Her style is informative and

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

Combination pro

friendly. There is not threatening tone or abusive comments against anybody. Even her post about

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

the death threats and her decision to stop blogging and not to attend the conference is factual. I

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

really cannot see anything that could have started somebody or a group of somebodies off on this h

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

ate campaign.

Of course what the web allows is just that. Somebodies. It is the ideal territory f

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

or stalking and anonymous threats. This is where the nasties come out to play. It must somehow pro

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

ide vicarious pleasure, otherwise why do this to a really pleasant and friendly person who writes

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

Following aspects would a

a blog? It must provide some form of satisfaction that they, the attackers, are able to frighten p

dd to the challenges in developing combination products:

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

eople to such an extent, they are unable to leave their home anymore.

A question has been asked a

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

nd commented on, inspired by these incidents against Kathy Sierra and that is whether these attack

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

are predominantly targeted against women? Could this be considered a kind of cyber rape? If one r

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

eads the report on Kathy's blog, some of the threats describe some explicit violent sexual acts wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ich the authors are imagining they are inflicting.

I'm going to leave it at that. Don't want to s

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

art some sort of nasty attack directed at me. A shame really that we feel we need to gag ourselve

.

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

s. Kathy, I am really sorry this happened to you. I hope they catch the people behind the threats

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

Companies that provide selfless information through particip

and verbal attacks and that you may feel safe again sharing your invaluable opinions and expertise

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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