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Sydney, Australia was the destination. Quantas Flight AF008 (LAX to Sydney nonstop) was the particular flight. 58H was my seat assignment

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

—in Economy? Yes, Economy happens.

I'd tried all my best techniques with the counter attendant but to no avail. Wearing a suit to

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

Examples of combination products may in

ppear the perfect upgrade candidate, smiling, commiserating with her obviously heavy workload, volunteering to move up to business or fir

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

st class to help better distribute weight throughout the aircraft. Nothing worked.

No one gets what they want every time, even Mr. Negot

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

ator. However, the real lesson here is never give up.

While the obvious objective of an upgrade was not obtained, the seat between mysel

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

Combination pro

f and the fellow next to me was however, blocked (unoccupied) by the counter attendant. And it was a full flight.

Every adversity offers

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

an equal or greater opportunity! The reputation of this mantra helped me to accept my fate, Seat H, Row 58 in Economy.

Polite introducti

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

ons were exchanged between myself and my fellow occupant (Bob) of Row 58 (Right side Economy on a 747-400 aircraft).

Through three meal

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

ervices, two bar services, and four feature films, we became better acquainted.

It turns out Bob was a writer from The New York Times tr

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

aveling through Sydney to Papua, New Guinea. His assignment was to write an article on travel and leisure.

By exchanging information and

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

references, Bob and I made a great deal on our (LawTalk is our company) new legal lifestyle magazine. In return, I provided him with sugg

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

Following aspects would a

stions on how to navigate through Customs and Immigration in Sydney, and what sights to see before he traveled north to the jungle.

We n

dd to the challenges in developing combination products:

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

egotiate everyday. And, we never know when the use of our give-and-take talents will result in an unforeseen long term benefit.

The Sout

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

ern Cross Hotel in Sydney is a great place. The staff at the Southern Cross is so congenial that I choose to stay there each time I trave

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

l to Sydney.

"This is a suite, isn't it?"

I received a suite for the same price as a regular room.

Always ask for an upgrade

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

when you book your hotel reservation and again when you check in.

After a week of heavy negotiation on several business deals, it was ti

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

Professional from academic institutions, pharmaceutical industries, health care indust

me to go home. Seat 58H was bad enough. On my return flight, I convinced the counter attendant to allocate me seat 48H (Bulkhead exit row

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

. More leg room! (I thought.) Unfortunately, 48H is also the area where people congregate waiting for an opportunity to use the bathroom.

.

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

"Be careful what you ask for because you just might get it!" was my new mantra.

Remember, world-class negotiation techniques

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

Companies that provide selfless information through particip

re powerful tools but we should always keep in mind that we use these techniques door-to-door, one person at a time.

Bio

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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