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Mutations: Facts and Figures

Let's start off where naturalists usually begin - with something like a bacteria. Never mind how those three million nucleotides got together and organized into a living system. Let's just say the bacte

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

ria-like life form is a given.

How is the bacteria suppose to change? Answer: by mutation. Immediately we run into a problem. Mutations are very rare. Even more discouraging, the simpler the organism, the fewer the mutations. And n

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

Examples of combination products may in

thing alive is more simple than a one-celled bacteria type of organism.

On the average, one mutation would show up in every 500,000 of these creatures. That's a slow start. But coming up with a mutation is only the first of many hu

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

dles. The second hurdle is finding a beneficial mutation. (See: Those Elusive Beneficial Mutations.) Geneticists claim 0.1 per cent of them are beneficial. Okay, lets go with it.

Cranking out the numbers shows that on the average

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

one out of every 500,000,000 (500,000 X 1,000) single-celled organisms may have a beneficial mutation. Which brings to question: How long did it take these life forms to build up to a population of 500,000,000?

Evolution by mutatio

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

Combination pro

n is full of hazards and complications. Here is one: Most animals don't live long enough to reproduce. Something, usually another animal, comes along and kills them before they reach maturity.

Infant mortality varies greatly from s

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

ecies to species. We know that as far as sea creatures go, only a few, just a small percentage, survive to mate. In general, the smaller the creature, the less chance it has to make it to adulthood. How does that affect evolution? 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

simply adds another hurdle to the list.

All mutations are rare; much rarer are the positive mutations. Now we see that the majority, probably the vast majority of those already extremely rare mutations are dead on arrival. Predato

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

s, disease, fire, drought, famine, floods, and other natural disasters destroy them before they have an opportunity to pass on their innovative trait.

Let's think positively. Say we have a one in five hundred million positive mutan

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

t who avoids predators, disease, etc. Is he able to pass on his positive mutation? Not necessarily.

Many mature males are barred from finding a mate due to a local dominant male who keeps all available females for himself. That is

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

rue for seals, antelopes, baboons, and many other mammals. Obviously, if the positive mutation winds up in a male who can't mate, the beneficial trait will go no further.

Any other roadblocks? Yes, most animal populations are genet

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

Following aspects would a

cally stable. Why? Mates with medium characteristics or traits are favored, while those with unusual traits are shunned. So the majority of individuals in practically all species show intermediate height, weight, and appearance. The

dd to the challenges in developing combination products:

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

range and distribution of traits remain approximately the same from generation to generation. This stabilizing influence is very common.

Some insects, birds, mammals, and other organisms practice "reverse discrimination" and prefer

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

mates who are rare. The beautiful bird plumage in the Paradise Islands is a striking example. But that is the exception.

There is another very strong force for countering chance. Any large population of animals has a natural tende

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

cy towards stabilization. A solitary genetic contribution, even a beneficial one, is likely to be swallowed up in a massive gene pool. In the long run, all mutations - good or bad - have no affect on a large population. That is why

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

erd animals remain so constant.

Scientists call it genetic homeostasis. The only place where any mutation stands a chance of surviving is in a small, isolated, peripheral population.

All of this throws a wrench into evolution's ge

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs. Mutations of any sort are rare; mutations which might help evolution are much rarer still; and the bearer of those good-for-evolution mutations are likely to be destroyed by "mother nature" before the innovation can be passed on

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

.

Even if the animal survives to mate, the odds are against his offspring living long enough to permanently establish the new trait in the gene pool. If the bearer is a male, chances are the positive mutation will go no further unl

.

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

ss he happens to be the dominate male in the area.

If one of those ever so rare positive mistakes hits a large population, it sinks without a trace. Even if the beneficial mutation winds up in a not-so-large gene pool, the animals

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

Companies that provide selfless information through particip

ill more than likely consider it extreme and discriminate against it.

We will continue our study with an analogy of evolution by mutation called "The Language of Life": see Evolution:The Devil Is in the Details (Part Five of Six.

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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