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Several years ago I worked with a young couple who wanted to purchase their first home. They had a toddler and a new baby on the way and were anxious to move into their new home befo

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

re the baby came. The husband’s family was helping them with the purchase and they needed a house with a guest unit for his parents to stay in when there were visiting.

After lookin

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

Examples of combination products may in

g at many properties over a period of almost three months we finally found the perfect property for them. The main house had three bedrooms and two bathrooms which would suit the fam

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

ly perfectly. There was also a large den where the husband could set up his musical equipment. Additionally, there was a separate guest house with one bedroom and a bath. The parents

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

would be very comfortable there and everyone would have some privacy. The lot was on almost half an acre and the backyard was like a small park where the children would be able to p

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

Combination pro

ay. The price was right and we opened escrow after a short period of negotiation.

On the day the escrow closed I took the couple over to the property for a final walk through with t

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 sellers. This couple had moved out of the area so this would be the first time they would be meeting in person. They liked each other right away and I followed along with the list

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

ng agent as they shared information about the house. They told my buyers when they had installed the carpet in the master bedroom, what to look for when they moved a large piece of f

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

urniture in through the front door, and how helpful the gardener was when the weeds got too thick in the backyard. We went from room to room in the main house and then walked through

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

the guest house. It was a Friday afternoon, a warm day in May, and I was thinking about how much I loved selling real estate. Bringing people together like this made the job worthwhi

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

le.

It was just about then that I saw the wife look a little pale. I thought maybe it was the baby kicking her or that she was becoming tired. I leaned in and heard the seller speak

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

Following aspects would a

ing.

“And the Hell’s Angels across the street are perfectly nice neighbors. On Sunday they have the club over, but you can’t hear anything if you stay inside of the house. Sometime

dd to the challenges in developing combination products:

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

hey have 30 or 40 motorcycles lined up in front of the house. It’s pretty loud, but we just stay in the house on Sunday afternoons. They are very nice people…”

I was frozen with fea

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

r and speechless. Hell’s Angels? Thirty or forty motorcycles? I looked quickly to my buyers to watch for their reaction. My life flashed in front of me. They would want to cancel the

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

sale. No, it had already been recorded earlier that day and it was Memorial Day weekend. Memorial Day weekend! Hell’s Angeles everywhere. My buyers would have to work around the moto

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

rcycles in the street to get their moving van into the driveway. I was in a panic but I maintained my composure and smiled sweetly. Could they tell that I was biting my lip? My reput

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

Professional from academic institutions, pharmaceutical industries, health care indust

tion would be ruined. I began to feel faint.

My buyer’s are still living in this house. The children are eight and five and there is a third child on the way. They love the house, h

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

is parents stay regularly in the guest house, and the neighbors, who happen to be Hell’s Angels, are wonderful people. I had overreacted to the situation. Luckily, I did this inside

.

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

f my head and not out loud in front of everyone. I did learn some important lessons that day that I will never forget. Don’t jump to conclusions. Everyone has a right to be who they

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

Companies that provide selfless information through particip

are. Be kind and accepting of other people. These lessons have served me well over the past several years and they apply to all situations in my life, not just to selling real estate

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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