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Few researchers take witnesses seriously if they claim more than one incidental encounter. Herein lies th

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

e double standard.

Bigfoot researchers often claim repeated encounters.

I would venture a guess that ab

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

Examples of combination products may in

out 90% of Bigfoot researchers don't live in their "research areas." They live elsewhere and go

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

on expeditions to state parks or other areas where sightings have occurred in the past. They haul a bunc

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

of gear into the woods, huddle in their tents, and wait for Bigfoot. Then, voila! Bigfoot appears.

Ever

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

Combination pro

y time the researchers go out, they have some kind of Bigfoot-related experience. They find footprints, h

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

ear eerie vocalizations and/or tree thumping, or discern the sound of something "large and bipedal&q

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

uot; tramping around their campsite. Yet if a nonresearcher claimed to have such experiences on a regular

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

basis, the researchers would laugh.

I live in my research area, a remote area surrounded by thousands of

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

acres of forest. I walk through the forest every day. Sometimes I'll find evidence of Bigfoots several d

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

ays in a row. Often I go weeks or months without finding or hearing anything. I see the occasional deer o

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

Following aspects would a

r rabbit. But mostly I see and hear the forest.

When a witness reports to me that she has had multiple s

dd to the challenges in developing combination products:

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

ghtings, I listen. I would be a hypocrite if I believed my own experiences yet discounted those of a stra

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

nger. I talk to the witnesses, get a feel for their personalities, and decide whether or not I believe th

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

em. That's research. So why do other researchers apply a double standard?

I can think of several reasons

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

—jealousy, fear, arrogance. Witnesses are not stupid. They can tell when a researcher has applied a

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

Professional from academic institutions, pharmaceutical industries, health care indust

double standard. They hear the unspoken assessment: My experiences are real because I'm a researcher; you

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

rs are bogus because you're a country bumpkin (or a hysterical woman, or a flaky hippie, or whatever).

B

.

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

igfoot researchers need to remember the Golden Rule—do unto others as you would have them do unto y

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

Companies that provide selfless information through particip

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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