Advice Pool - Relationships

"The little foxes are ruining the vineyards. Catch them, for the grapes are all in blossom." —Song of Solomon 2:15

Often, when we evaluate our own contribution to our relationships, we focus on

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

the big things: Well, I must be a good husband / wife / partner (choose one!) because I don’t cheat / gamble / run around / lie / resort to physical violence (choose one or more!), and we congratu

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

Examples of combination products may in

late ourselves. And it is true that we are wise to avoid these major problems.

But there are also “the little foxes” that seem to be so harmless - even cute - which can do major damage to our rel

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

tionships. Foxes are members of the dog family, which we think of as being carnivorous; however, foxes eat, in addition to meat, vegetable matter, especially fruit. Imagine the damage to a vineya

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

rd that a litter of little fruit-loving foxes can do!

You know the couple: always the life of the party. Always the center of laughter. Such fun they are. We’ve all heard, “And then do you know

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

Combination pro

what Mary did? She has this bad habit of (your choice, again!).” And often, what Mary has done gets a laugh, especially when Bill’s delivery is wonderfully humorous, and she giggles and rolls her

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

eyes.

And sometimes, Mary has a brilliant, funny comeback with which she gets in her jab at Bill, and the comedy is on. And if you asked them, wanting to be good sports, they would respond with,

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

“We don’t mean it. We’re only teasing!”

However, over time, the repeated litany of our shortcomings gets old, and on the day when our self-esteem is in need of a boost - not a put-down, we feel

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

hurt. We may or may not say anything; we may so quickly bury the hurt that we are hardly aware of having experienced it - after all, what’s one tiny nip from one tiny fox?

But eventually, we are

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

leeding inside from multiple tiny bites; the hurt is deep - and it came from one who is supposed to be our champion and support. This “harmless” teasing is a fox that has sharp teeth indeed. And

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

the catch-22 is that if we speak up to complain, we are being poor sports.

One definition of fox, when it is used as a verb, is to baffle or to confuse. And this is most appropriate here. At the

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

Following aspects would a

start, our relationships make us feel so good (why else would we get into them?), but over time, the magic goes, and it is true that in a healthy, normal relationship, the excited intensity with w

dd to the challenges in developing combination products:

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

ich we begin mellows to something warm and caring.

But that’s just the point: when the relationship has cooled from its white-hot beginnings, but doesn’t feel warm and caring any more, we become b

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

affled or confused as to just what went wrong. We are both still good people; we are both still committed to the relationship, but somehow, there’s a shadow over us, a wall between us, and we can’

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

figure it out.

A good place to start is to ask ourselves if our partner has fallen into this pattern of “teasing” with nips of pointed little fox teeth, and it’s often easy to see this fault, par

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

ticularly when we are smarting from a hurt. But the next step is to ask ourselves if - just perhaps - we have fallen into that same pattern and are contributing to our partner’s pain.

A wise man

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

Professional from academic institutions, pharmaceutical industries, health care indust

nce said that his definition of love is to find someone to adore, and then to actively adore that person - often, out loud, verbally, physically, in every way possible. Imagine the healing and the

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

validation that would come from hearing often how wonderful we are, how beautiful/handsome, how strong, how delicious, how sweet, how supporting, how . . . fill in your own adjective here. Now i

.

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

agine the healing and validation your partner would feel from the same treatment.

Ask yourself just what harvest you want from the vineyard of your relationship - tiny, spoiled, sour grapes, or ju

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

Companies that provide selfless information through particip

icy, delicious, sweet fruit that delights and nourishes - both you and your partner.

Only you can make the choice to keep those little foxes out of your vineyard and to actively adore your partner

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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