Useful Advices - Business

My mother wanted to be sure that her condo in Florida was in my name. When she checked with the condo administrator she found there was a Quit Claim Deed dated 1990 on file that said just the opposite. The

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

condo was taken out of my name and put in the name of both my parents.

The advice from the condo administrator was to get another Quit Claim Deed to make it in my name again. How could we do that? She dire

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

Examples of combination products may in

cted us to the self help desk in the court house.

My mother is 93 and court houses are usually big and require lots of walking. She uses a walker so that didn’t seem like something she could do. Besides I w

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

anted it done correctly and we really didn’t know what we were doing. I suggested we call a lawyer.

Reluctantly (“It will cost too much!”) she agreed that I could make the call as long as I found out how mu

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

ch the fee would be first.

I called an attorney and asked him his hourly rate and an estimate of how much it would cost to file a new Quit Claim Deed. He asked these questions:

Had I considered the imp

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

Combination pro

ct of this change on my estate?

Had my mother ever gifted me anything before?

What affect would this have on my mother’s taxes?

What affect would this have on my taxes?

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

He added that he would tell me his hourly rate but he couldn’t tell me how long it would take him. His questions showed me that this was more complex than we had originally thought. His final comment reall

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

y resonated with me. He said he would only do the work if he was allowed to do it correctly. He wasn’t interested in doing just the Quit Claim Deed unless he was satisfied that that was all we needed.

I wa

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

s impressed with his questions all of which led me to the conclusion that if I wanted to get this taken care of I needed an attorney to do it. Since my parents and I have been pretty thorough about estate

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

planning together, I decided to wait to look in my home file that contained both my mother’s plan and mine.

It turned out that I had a deed done in 1990 with a date a month later than the Quit Claim Deed giv

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

ng me the property. It seems my parents had originally done something by themselves (Sometimes “It will cost too much!” makes it cost more.) and then had a lawyer look at it. Whatever they had done, was not

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

Following aspects would a

what they had intended to do. The attorney fixed what they did with the Quit Claim Deed and then created a deed in which the property was in my name. The problem was resolved then and we didn’t need to do

dd to the challenges in developing combination products:

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

anything now.

If however there had been a problem, I definitely would have gone back to that attorney. The questions he asked made me see first that I had a complex problem and that he was someone who coul

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

d handle this complexity. Second, I now realized that there were a lot of considerations for me and for my mother. What I needed was someone who could help us see the implications of making this change to ot

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

her parts of our lives. Finally his closing statement told me the terms that he would accept my case. He left the ball in my court to call him.

Take Action
1. Think about your discussions with

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

a potential client. Clients don’t always know what they need. Ask questions that help you to see the scope of the work and let the clients feel the complexity. Make a list of those kinds of questions now to

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

Professional from academic institutions, pharmaceutical industries, health care indust

get a sense of what they would be for your type of work.
2. Clients don’t think about the impact one change can have on other aspects of their lives or their businesses. Make a list of questions from

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

your type of work that will help them to see this.
3. Make sure you know who the decision maker is and find the influencers too. Ask questions that allow you to build a relationship with both the influ

.

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

encers and the decision maker. Make a list of these types of questions.
4. What are your standards? How do you let clients know how to do business with you? Write a list of questions and statements t

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

Companies that provide selfless information through particip

o let clients know what it takes to work with you and helps you determine if the client is right for you. This helps you attract only those clients who are perfect for you and those who will respect you.

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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