Advice You - Business

When I was writing this blog the snowball effect seemed to talk hold of me and so it was split into two parts!
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
>

The has been much press about outsourcing over recent years. Call centres to India were the initial hole
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
in the dam. As this hole expanded to allow more trade it sucked in medical billing processes, content for publications
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

, x-ray and even private tutoring for children.

The use of technology and collaboration tools have helped t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
minimise any pains with transition to outsourced skills and the management of them but technology is not the answer t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
o everything.
The concept of virtual teams can increase our productivity. If you are happy to work more than 7 ho
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
urs a day then you could start with you virtual team in Mumbai and finish your day with your colleagues in Vancouver o
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
r San Francisco, stopping a couple of times in Europe on the way. Sacrificing a few hours of nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
p://www.channel4.com/bigbrother/">mundane TV watching could prove to be an investment in your future.

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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
a target="_new" href="http://www.winningbysharing.net/aboutauthor.asp">Leon and I were talking with Charles Carlet
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
on and Dennis Warren from Jyve Pro last night. Among many other things, we discussed how their technology is the reali
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
sation of a concept that Leon had two year previous and then wrote about in his dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ngbysharing.net">book (so it is possible to predict the future ;) ). We focussed for some time on how Jyve Pro wil
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
l initially be launched into the a market place which is typically has high throughput, with an low/average compensati
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
on.
Arguably this is a good place to start as it may be possible to secure a large subscriber base with little ef
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
fort and many would speculate that the subscriber base, and not the revenue, should be the first "quick win". But what
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
about legal advice, accountancy advice as examples. The subscriber base for these alone must be huge. Not only that bu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t it is high value too. I think there will be considerable kudos to the first legal firm to provide instant, 24/7, voi
.

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
p, by the minute advice to clients. Think about this in the context of the first paragraph above. The law firm doesn't
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
need the staff to deliver the service, just the network. The network can be anywhere.

...to be continued..

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 - Outsourcing, Virtual Teams and Cybermediaries - Part 1

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