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Answers - Business Entities Avoid These Pitfalls
In our modern society, you can get sued for just about anything. All it costs is a couple hundred dollars to file a lawsuit. If you are starting 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
business, you need to protect yourself.
Given the number of lawyers [including me] and lawsuits in the country, most business owners know it is
Given the number of lawyers [including me] and lawsuits in the country, most business owners know it is
; 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
wise to open a business entity to protect their personal assets from lawsuits. By definition, businesses offer something to the public be it servi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ces or goods. Inevitably, a problem arises. The problem can turn into a full blown dispute and then lawsuits are filed. If your business is not pr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
otected by a business entity, this can result in a judgment that can be collected both from business assets and your personal assets. In short, a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
disaster. Forming a business entity creates a shield that protects your personal assets from such judgments so long as you stay away from general
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
partnerships.
While you probably already know you need a business entity, you probably do not know there are pitfalls to avoid when forming them.
While you probably already know you need a business entity, you probably do not know there are pitfalls to avoid when forming them.
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
Knowledge is the key and knowledge I will give you. Here we go
1. Equal Equity In many situations, a business is owned by two people. When th
1. Equal Equity In many situations, a business is owned by two people. When th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ey go to form an entity, they often each take a 50 percent share. This is a mistake. Why? If a dispute arises, how are you going to solve it? Each
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
party has 50 percent of the voting shares, to wit, a decision cannot be made. In a worse case scenario, a judge may resolve such a dispute by dis
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
solving the business and distributing half of the assets to each. So much for your future business plans. If nothing else, you are looking at tota
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
l deadlock in the business.
2. How Many Businesses? Another major problem I see with businesses is they often come up with multiple ideas that
2. How Many Businesses? Another major problem I see with businesses is they often come up with multiple ideas that
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
work, but put them all at risk by using the same business entity. If you have multiple business lines, form a distinct business entity for each on
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
e. If one gets sued, the others will not be impacted or face the risk of a judgment.
3. Equity is Gold The equity in a business entity, such as
3. Equity is Gold The equity in a business entity, such as
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
shares in a corporation, should be treated as gold coins. Would you haphazardly give out gold coins? Of course, not. Yet many businesses will tra
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
de large amounts of ownership equity for relatively small sums. This often occurs at the outset of the business when money can be tight. If the bu
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
siness takes off, keep in mind it will grow in value. As it grows, you will really regret giving away 10 percent of the ownership for $20,000 to l
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oan shark Lou. If you need cash, try to get loans from people secured by stock in the business.
Once you make the decision to form a business ent
Once you make the decision to form a business ent
.
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
ity, you need to take the time to think through what you are doing. How will problems be resolved? How will ownership be handled? How much money w
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
ill you need and where will it come from? All of these questions must be addressed or you could really regret the decisions you made down the line
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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