Advice You - Business

Performance contracts. Performance management - useful or major challenges? They are easier if they are kept simple, through strong and trusting relationships built and people effec

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

tively managed through daily informal contacts - yet someone, sometimes isn't listening at all! Take a look right here...

I wonder what you think of the 'invitation' to a performan

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

Examples of combination products may in

e review shown below. It is real, though some of the details have been amended, for the safety of recipients!

As you read it, please see it through the eyes of someone who expec

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

ed a 3-monthly review and has not set eyes on their appraiser more than once in six months!

"Saturday, October 22nd, 2005 07:13PM

6 month contr

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

ct review for managers

please note the following dates for your contract review. they will be held in your base office (jackie, will you contact me and let me know which office

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

Combination pro

you are in on the nominated day).

PLEASE HAVE READY FOR THE REVIEW:

1) AN UP TO DATE SCORECARD

2) A WRITTEN SUMMARY OF YOUR PERSONAL CONTRIBUTIONS YOU HAVE MADE TO THE SUCCESS OF

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 BUSINESS IN YOUR AREA/S. (INCLUDE AS MUCH SUPPORTING STATISTICAL EVIDENCE AS YOU CAN).

3) YOUR 3 KEY PRIORITIES THAT YOU ARE GOING TO DELIVER BY END OF MARCH TO SUPPORT THE GRE

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

EN LIGHTS ON THE SCORECARD.

*i will have a 'dim' view of anybody not coming having prepared!!!!*

-julie jones:3pm tues 22nd nov.

-jeff stanton:3pm friday 18th nov

-jackie smythe

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

9am thurs 24th nov

-josia long:5.30pm tuesday 22nd nov

-davy thomas: 10.30am thurs 17th nov

-rita singh:10.0am thurs 17th nov

WILL REGIONAL CO-ORDINATORS PLEASE MAKE SURE MANAGE

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

S GET THIS E-MAIL.

THANKS

STEVE"

Add to the mix the following ingredients:-

The poor senior manager is writing this at 7:13pm on a Saturday eveni

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

There is a new e-mail system and not only did the recipient not receive the e-mail, nor did their regional controller!

Jackie Smyth's name is spelt wrong - it

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

Following aspects would a

was directed correctly though, because her name has been entered on the system wrongly as well (but she hadn't been told how to access her mail - she did get told abou

dd to the challenges in developing combination products:

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

the 24th of November on December 1st!).

There is a big conflict with lower-case and upper case (upper case is shouting - RIGHT!) - it is shown how it really

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

was written.

There is a huge chunk of work here putting numbers together - what is the value of that, when these numbers are available on the internal systems?

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

key priorities before the contract discussion?

...and that threat - 'a dim view...' eh?

How does the phrase "...not coming having prepared..." work?

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

the day set, for at least two of these recipients (both of whom didn't receive their e-mails because no-one told them how to access them), the senior manager didn't show

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

Professional from academic institutions, pharmaceutical industries, health care indust

p anyway - and there were no apologies!

So...

Questions for you...

How would you feel on the receiving end of this?
How might you do it differently<

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

b> - you can stop when you get to 20 changes you might make.
What does it say about the sender?
What does it say about the organisation who employs someone like

.

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

his and pays them in excess of ?60K pa?
How do you think the culture (morale and motivation) is?
Above all, what can each and every one of us learn from t

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

Companies that provide selfless information through particip

is example (so at least something good comes out of it)?

And remember, sleep well, this happens in a very small number of organisations, so fear not.

Or does it?

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 - Performance Contract Review - Is this the Way?

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