Cases - Business

What is the best way to inform employees when you sell your business? Wait until the transaction is 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

done deal.

After many years of representing people who want to sell their businesses, experience has

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

Examples of combination products may in

taught me that complete confidentiality about any thoughts of selling are in the best interests of eve

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

ry business owner. Consequently, the best time to make any announcements about selling will be on the

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

afternoon of the day your transaction closes. That announcement should be well rehearsed and should

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

Combination pro

include a personal introduction of the New Owners.

The meeting should be planned in advance so that 1

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

00% of all employees are in attendance. In that meeting, you can explain your personal reasons for se

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

lling and that, after a diligent search, you have found the ideal New Owners.

You also can explain th

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

at you will continue to be involved in the operation of the business for a period of time in working w

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

ith the New Owners. Then, the New Owners should explain their background, the reasons for being intere

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

ted in the business and their desire to do whatever is necessary in order to grow the business and cre

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

Following aspects would a

ate more opportunities for everyone involved. Last but not least, the New Owners should indicate they

dd to the challenges in developing combination products:

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

plan “no changes” and want to meet individually with each employee to get their ideas and suggestions

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

about how to best grow the business.

Typically, any person buying your business will want to keep vi

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

rtually all of your employees, as they represent a significant portion of the value of your business.

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

Jobs will be lost only in those extremely rare instances when a New Owner intends to relocate a busin

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

Professional from academic institutions, pharmaceutical industries, health care indust

ess a great distance, and then normally after a period of both notice and transition.

The fact of the

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

matter is that virtually all employees fare better in the future because a high percentage of New Own

.

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

ers come in with additional capital and a desire to grow their new business. This growth typically sp

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

Companies that provide selfless information through particip

ells opportunity for employees who want to grow their careers and who welcome working with a New Owner

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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