Summary - Relationships

Falling in love is so much fun. It just feels so good.

If only the high lasted t

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

he entire relationship. The high naturally subsides. In long term relationships t

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

Examples of combination products may in

is will usually lead to disillusionment.

Hitting the wall

Just about eve

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

y couple I see in my office or on the phone have hit the wall of disillusionment.

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

It often gets expressed in these words:

"Who are you and what have you done with

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

Combination pro

the person I fell in love with?"

If you do not get anything else from this artic

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

e, get this - the is a normal process and event in long term relationships.

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

What to do

The most important thing is not that this disillusio

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

ment happens, but how you handle it. Here are some important strategies for how t

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

respond to hitting the wall of disillusionment.

1. Realize, get it, that thi

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

is normal. When you do this, you can take away the panic and power.

2. T

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

Following aspects would a

ink back to what first attracted you to this person in the beginning of the relat

dd to the challenges in developing combination products:

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

onship. This goes under the heading of "when you are up to your ass in alliga

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

ors it's hard to remember that your original intention was to drain the swamp."

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

You need to shift your focus here by getting reacquainted with the positives of t

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

is person.

3. Talk about it. What we don't talk about, we act out. While

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

Professional from academic institutions, pharmaceutical industries, health care indust

t may be difficult, have the conversation. You can start by saying "I'm really wo

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

ried by how far apart we are. Can we talk about this?"

If you cannot talk this o

.

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

t on your own, it's time to find a good relationship coach or counselor.

Remembe

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

Companies that provide selfless information through particip

, hitting the disillusionment wall is normal. What counts is what you do about it

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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Summary - Relationship Advice: D is for Disillusionment

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