Advice You - Business

A reader wrote me with the following questions: "I was researching potential local funders for my project and I found one that i

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

s a perfect fit. Their mission aligns with ours and many of the programs they have funded in the past are in the same area of intere

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

Examples of combination products may in

st as ours. However, their website says they do not accept unsolicited proposals! How can I let them know I think my project would b

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

e perfect fit? Here is my answer to their dilemma:

First of all, congratulations on doing your homework. An alignment between

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

your mission and that of potential funders as well as an established interest in funding projects similar to yours are two signs th

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

Combination pro

at this is a strong candidate for funding. However, the fact that they do not accept unsolicited proposals certainly puts an obstacl

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

e on the road to grant money. There are a few ways to work your way around that obstacle.

Do not bother sending a proposal in the h

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

ope that they will realize what a perfect match you are. If their policy is not to accept unsolicited proposals, they most likely do

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

not even read those that arrive. More so, you run the risk of appearing as someone who can’t follow directions, which is never and

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

impression you want to leave with someone you are asking for financial support from.

Foundations that do not accept unsolicited pro

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

osals are often those that have certain “pet” projects they like to fund, usually chosen by Board members. To be considered for fund

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

Following aspects would a

ing, you must become one of these favorite projects. The only way to do this is through their Board members.

The best way to get th

dd to the challenges in developing combination products:

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

e news of your project to a Board member is via networking. Do some research to see who is on their Board, and take those names to y

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

our Board to see if anyone has an “in.” You may also want to look at past grant recipients to see if you have contact with them and

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

ask them for an introduction. Be sure not to threaten the secure funding of your colleagues- instead adapt an attitude of collaborat

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

ion, rather than competition.

If all this networking fails, you could simply call the Foundation up and ask what the best way to le

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

Professional from academic institutions, pharmaceutical industries, health care indust

t them know about your project is. If they stress again that they do not accept proposals, let them know the reasons that you think

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

you are a great fit and ask if you could send a letter of inquiry - a 1-3 page letter summarizing your program. This letter should i

.

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

ntroduce your program by emphasizing the ways that your program is a perfect fit. Write in detail, but keep it concise. Your goal is

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

Companies that provide selfless information through particip

to peak the curiosity of the reader and make them want more information, which will require them to invite you to submit a proposal

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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Why is it that in some situations, our personal performance is so good while in others we struggle and cannot seem to get into the groove where we do our best work? Is it because we forget, from one day to the next, the important details of our profession or what it takes to excel? Of course we all know that this is not the reason we sometimes follow up a great personal performance with one that leaves something to be desired. The answer to these questions lies more in the inconsistent application of basic mental skills that underlie our ability to perform – whether the performance is in the boardroom, on the sales floor, or on the golf course!

Managing a business small, medium or big requires you to pay your taxes, as well as your employees taxes. Managing a payroll can be an arduous and taxing job, no pun intended. There are laws that require us to pay taxes and everyone have to comply with that. But keeping up with the payroll can give many people sleepless nights.

If you want to spend your life helping people live better lives, then you should consider applying for health care jobs. You don’t have to go to college or study for seven years and become a doctor to help other people. There are jobs that are as important, and require less time in school.

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Advice You - Break Into The Vault-How To Win Grant Money From Private Foundations

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