Main Subject - Business

Replying to all e-mail messages and private messages from online networks within 24-48 hours is a nice ideal. A

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

ctually, replying to all of them eventually is a nice ideal. But it's simply not always possible.

Unfor

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

Examples of combination products may in

unately, when people don't get a response, sometimes they feel that:
a) they're being personally slighte

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

or the recipient is mad at them
b) that the recipient is simply being rude
c) that the recipient

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

poorly organized

None of the above are true for me, as I'm sure is the case for many other people. If I don't

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

Combination pro

eply, I'm not rude, mad at you, or disorganized -- I'm just very, very busy.

This is a general issue -- I'm ju

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

st using myself as an example. For the month of August, for example, I'm booked 18 full days at clients.

That

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

eans my typical day consists of:
- 10 hours at the client (including travel time & lunch)
- 1 hou

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

prep for the next day at the client
- 4 hours personal time (meals, hygiene, exercise, family, relaxati

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

n/entertainment)
- 1-2 hours on my About.com work (average)
- In the remaining 7-8 hours a day, I

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

have to work on marketing The Virtual Handshake, handle my e-mail and online communities, and sleep
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
i>.

That gives me around 1-2 hours a day to handle all my correspondence and online communities. When I got ho
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
e tonight, I had 254 messages, of which 108 are NOT bulk mail. I can cut that down to less than 100 in j
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
st a couple of minutes, but even that, at an average of 1-2 minutes per message, is more than I have time to ha
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
dle right now.

Not everyone is this busy with their work, but a lot of people are. What I see all too often in
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
online networking communities is a lack of empathy/respect for that fact. It's not entirely a case of "haves" v
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
s. "have-nots" -- there are a lot of successful people with plenty of time on their hands, too.

So, if you hav
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
time on your hands, enjoy it. Be glad you do. But please be respectful of the time of those who don't, and don
.

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
t take it personally or hold it against them when they don't have time for you. It's no reflection on you, or e
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
en on your relationship with them. Sometimes people are just really, really busy. I am, and that's a good thing

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Main Subject - I'm Not Rude, I'm Not Mad, I'm Not Disorganized - I'm Just Very, Very Busy

Related Articles: