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I was making arrangements to attend a conference in Los Angeles, California.

As a frequent flyer, I receive award coupons offering a 50% discount from normal hotel

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

rates. I contacted the call center of a major hotel chain to make my reservation.

The reservations clerk was friendly and very helpful. She took my name and conta

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

Examples of combination products may in

ct numbers. She confirmed the dates, my room preference and credit card number. She asked if I was a ‘Premium Club’ member, which I was not. So she registered me fo

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

r Club status over the phone.

Then she remarked, ‘Mr. Kaufman, now that you are a Premium Club member, I can offer you an even lower rate for an upgraded room on a

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

higher floor. And a fruit basket will be waiting for you upon arrival.’

I was surprised and delighted. My special room rate was just $100 per night.

Signing off

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

Combination pro

rom this great telephone experience, I said: ‘Thank you for your help. I am looking forward to staying at the hotel during the conference.’

‘The conference?’, she

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

quickly replied, ‘What conference are you attending?’

When I told her about the event, she said, ‘Oh. If you are attending that conference, you have to use our con

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

ference rate of $124.’

I laughed and assured her I was happy with the special rate and Club status she had already confirmed.

‘Oh no,’ she repeated. ‘If you are c

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

oming for the conference, you must use the special rate. We have a block of rooms already reserved for you on a lower floor. And I’m afraid you don’t get the fruit

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

basket.’

A lower floor, higher rate and no fruit basket? I protested. But my protest was in vain. She checked with her supervisor, who concurred. ‘I’m sorry, but t

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

at’s our policy,’ she said without much concern.

I surrendered to her insistence, listened sadly as she cancelled my Premium Club reservation, but declined to have

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

Following aspects would a

her book me back into the hotel at the higher conference rate. I hung up the phone in disbelief.

Then I called right back and reached a different reservations cle

dd to the challenges in developing combination products:

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

rk and made another reservation, again using my frequent flyer award coupon and my new Premium Club membership number. This time I kept my mouth shut about attendin

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

g any conference.

I paid $100 per night when I went to Los Angeles. I enjoyed the Towers room and a complimentary fruit basket upon arrival. No thanks, though, to

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

this hotel’s absurd policy and customer-unfriendly procedures.

Somewhere deep within the marketing department of this hotel chain, yield-management professionals c

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

refully calculate the maximum rate they can squeeze from participants at each international conference.

Meanwhile conference participants are also thinkers…real, l

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

Professional from academic institutions, pharmaceutical industries, health care indust

ive customers! Yield managers, are you listening?

Key Learning Point
--------------------------------------------------------------------------------

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

r>
When your policies cross, collide or contradict, your customers will find out. Clean up the confusion!

Action Steps
-------------------------

.

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

-------------------------------------------------------

Review the many ways your customers can confirm, order, book, engage, hire, rent or purchase your

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

Companies that provide selfless information through particip

products and service. Look for mismatches and inconsistencies in the policies and procedures. Get them back in line so your company and your customers stay aligned

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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