Advice Pool - Reference and Education

Location: Southern Ohio Date: December 2003

Angela and a female friend had spent all day at the hospital where Angela's daughter had undergone surgery. When visiting hours ended at 9 PM, the two women set

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

off for home. Little did they know their routine journey would turn into a truly bizarre encounter with a hairy hominid.

Thirteen miles out from the hospital, Angela made a U-turn to catch a turn she'd miss

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

Examples of combination products may in

ed. After rounding the corner, the women noticed a dead cat lying on the shoulder of the road. In the next instant, a "giant, white creature" appeared in front of their car. The car struck the creature, boun

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

ing up and over its body. A terrible smell overwhelmed the women, sickening them so much that they fled the scene. Upon reaching the nearest gas station, the women made an astounding discovery—the journey ha

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

d taken 90 minutes too long.

Needless to say, Angela and her friend were dumbfounded. What had happened to those missing minutes, over an hour of time they could not account for? The women felt certain the

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

Combination pro

animal they had struck was neither a cow nor a human. Angela later found white hairs on the tailpipe of her car.

Sightings like this pose a serious problem for the researcher too. How do you deal with a wit

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

ess who claims to have missing time after a Bigfoot encounter? Many researchers would either delete the sighting report and forget about it, or shove the sighting into the Weird & Inexplicable folder where i

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

t will languish in obscurity.

What should we do with high strangeness sightings? What do these sightings mean for Bigfoot research?

After running over the creature with their car, the women experienced mis

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

sing time, a phenomenon well known to UFO researchers. High strangeness of that sort shouldn't happen with a Bigfoot encounter. After all, Bigfoots represent nothing more than giant apes. Right?

If only the

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

simple explanation fit the facts. Even if you forget that not all hairy hominids are giants, you must dismiss a wealth of strange sightings in order to squash the phenomenon into the giant-ape shoebox. Take

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

the Ohio incident I just mentioned. What should a researcher do with a sighting like that?

First, you must talk to the witness. You could read the raw report submitted by the witness and then delete it beca

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

Following aspects would a

use events like that should not happen. A truly objective researcher will do no such thing. You must interview the witness, giving her opportunities to embellish. In this case, the witness failed to take the

dd to the challenges in developing combination products:

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

bait. Her story has remained the same each time she related it to me. Her original report, which she submitted online, made no mention of missing time. Angela initially reported a normal sighting which occur

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

red here in the UP of Michigan; only after speaking with me on the phone did she feel comfortable enough to relate her other experiences.

With a witness like Angela, you have three options to consider:

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

ype="1">

The witness is crazy.

The witness is lying.

The witness is being truthful.

Can I prove Angela is not crazy or lying? Of course not. No one can prove that any witn

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

ss is sane and/or honest, no matter what the witness claims to have experienced. The researcher must form an opinion based on an interview of the witness. After talking with Angela at length, I believe she i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s both sane and truthful.

Does that mean events happened exactly as she says? Of course not. Each one of us can do nothing more than relate our experiences as we remember them, colored by our individual exp

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

ectations and perceptions. The same goes for the researcher. A witness who claims he saw a Bigfoot walk across the road in front of his car seems more credible only because the researcher believes this type

.

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 sighting has more merit than a stranger sighting.

A researcher must take risks. You must examine the evidence, interview the witnesses, and then be willing to state your conclusions emphatically in spi

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

Companies that provide selfless information through particip

te of the possibility that one day you might be proven wrong.

What should we do with strange sightings? Exactly what we do with "normal" sightings—investigate, assess, and conclude.

© 2007 Lisa A. Shie

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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