financially. I mean you didn't get into your business to always do your books did you? (And
if you did, maybe you want to try bookkeeping as a business!). Chris Barrow aka
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
ractice.com>The
Million Dollar Coach always reckons the first thing any self-respecting
entrepreneur should do, is get a PA. In these days of VA's (virtual assistants) it's becoming a
do-able option for all.
Look For Taucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
lent
With your mind set on what you want, look out everywhere
for people who can help. If you are small business owner, that might not be for a
little while, but keep your eyes open, both within your own business, your family
and your acquain
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
tances. Anyone, anywhere - be alert!
Build Networks
Get out there and make sure that you listen to people
who might use some of the experts you need. This means that if you have to choose,
you have already got testimonials up front.nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
This makes it a lot easier. Recommendations
work! Many local specialists, when they are worth their salt, get more than enough
clients through recommendations rather than need to advertise.
Seek Recommendations
Again, it's about keand 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
eping your eyes and ears
open. You need a whiz with computer experience. By talking about it and listening
hard, you may well find the help you need. Didn't you know that your cousin
Myrtle's step-brother is learning all about HTML at college
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
- shame on you!
Set Quality Standards
By being very clear about what you want from
the help you get, you are much more likely to get it. You will save yourself a
lot of time and probably money by getting really specific (so, dot 'iding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
's and 't's very
carefully). It's very interesting how what comes out of our mouths is interpreted
in so many different ways than we might expect (hint - it's always your fault, not
theirs - so get over it).
Measure Performance
Indd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
with the standards you agree with your help,
be they a member of your own team, or an external contractor, it is vital that you
have a way of measuring performance on a regular basis. Keeping your requirements
SMART (Specific, Measurable, Agreed, R
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ealistic and Timescaled) will make this much
easier. And don't be afraid to require penalties from external contractors if the
fail to deliver.
Take Some Risks
Sometimes you have to wing it. So, if you take as
much care as is practions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
tical, you can take a few risks with those who you have to
help you. So don't be afraid to give more responsibility to one of your team,
especially if they show promise - give them the opportunity, support and your
confidence and often they will del
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
iver way beyond what you expect.
New Blood
If you are missing an ingredient with your internal or
external help, don't be afraid to get someone new in. It helps everyone
if the right person is in the team, and there are a lotping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
of folks out there who
can do a great job. Anyone doing a poor job knows it and is not helping you at
all. For outside help, if you have even a hint in your gut that it isn't working,
be tough and get it fixed - or get out - dragging bad deals on i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s a very bad deal
for you.
Give Accountability
And finally, make it very, very clear who you
are holding accountable for the help you hire, whether it is in your business of
from outside. You have a name to an accountabilit.
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
y and that's that. They
are where the buck stops. Internally, it can be through one-to-one meetings and
milestones, externally, well, much the same although maybe a little more formally.
Set them up with agreed 'T' - timescales and make them
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
stick.
Being aware of the help you need well in advance, will make a big difference for
you - you can focus on the aspects of business you bring value to and, while
we're on the subject of value, have fun and get a life for yourself as well.
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
