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E-Folder - How Much Money Do You Need For Your Business?
As much as I can get! This would be the answer readily shouted out by most entrepreneurs. The fact is though, both over and underestima
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
ting the amount of capital needed to fund a business can have serious negative consequences.
Underestimating what you need can cause pro
Underestimating what you need can cause pro
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
blems ranging from having to go through the whole time consuming fund raising process again, to having to shut down the company because f
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nds have run dry. Having to go back to the original investors and ask for more money often undermines the entrepreneur's credibility wit
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
h the investors and can cause a significant dilution in the founder's ownership.
Obtaining more than enough capital may seem like a bles
Obtaining more than enough capital may seem like a bles
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ing at first, but it can breed a lax attitude toward expense control. "If you have it, spend it," is not an advisable motto for a new co
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
mpany. If the investment takes the form of equity, raising too much money means that the founder's share of the business was reduced mor
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
than was necessary--and this violates one of the maxims of entrepreneurship: hold on to those equity points!
Typical advice given to e
Typical advice given to e
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ntrepreneurs is to do a cash flow projection, or cash budget, and then add 10%, 20% or even 50% to this amount, for "contingencies." The
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
e contingencies are all the things that can go wrong in a start-up venture, all the unfavorable events that can negatively affect results
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
.
Contingency planning is a skill that does not come easily to all entrepreneurs--even those with a finance background. How do you get
Contingency planning is a skill that does not come easily to all entrepreneurs--even those with a finance background. How do you get
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the cockeyed optimist (what you absolutely must be to even conceive of the idea of the starting a company), who expects the best, to pla
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
for the worst?
To stimulate contingency planning, it helps to look at the reasons why entrepreneurs so consistently run out of money; a
To stimulate contingency planning, it helps to look at the reasons why entrepreneurs so consistently run out of money; a
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
mong these are:
Not realizing how expensive it is to introduce a new product, especially consumer products, on a national basis.
Not re
Not realizing how expensive it is to introduce a new product, especially consumer products, on a national basis.
Not re
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
lizing how long it takes to introduce a new product, or for the market to truly accept the product.
Delays in regulatory approval, munic
Delays in regulatory approval, munic
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
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
ipal zoning, or patent approval.
Assuming that a small start-up company will get the same forbearance on payments and favorable terms th
Assuming that a small start-up company will get the same forbearance on payments and favorable terms th
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
t a large one will.
An entrepreneur with an early stage company must be prepared for one or more of these situations to occur. Continge
An entrepreneur with an early stage company must be prepared for one or more of these situations to occur. Continge
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ncy planning doesn't mean simply adding a percentage or dollar "cushion' to the amount of capital being sought from investor or lenders.
.
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
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
It is a way of thinking--a recognition that the entrepreneurial road is always rocky. Envisioning what might go wrong does not equate to
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
entrepreneurs losing faith in their product or their company; it means they accept these difficulties as steps on the path to prosperity
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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