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You may have the MBA but if an internal critic constantly berates you, or you have feelings of self-doubt, low self-confidence, fears of rejection or othe

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

r negative emotions your chances of success may be quite limited.

More and more executives are beginning to realize that the next frontier in maximizing

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

Examples of combination products may in

their chances for success is to start focusing on building personal internal skills that go beyond the business training that they have already received.

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

To drive the point home, a metaphor to describe how negative emotions adversely affect personal and career performance is in order. As you know, when you

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

r car is not finely tuned it tends to work less efficiently and to break down more often thereby accumulating more downtime.

Similarly, having to deal wi

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

Combination pro

th unwanted negative emotions has the same effect on one’s physical and emotional health and ultimately on one’s performance. The chronic wear and tear of

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

these negative emotions is what I call stress.

We often think of stress as being caused by external circumstances. For instance, how often have you hear

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

d “ My boss just stresses me out”? In fact, the truth is that the origin of the stress is “all” internally generated. Yes, that’s right, “all internally

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

generated”. One way to see this is to recognize that different individuals respond to “stressful circumstances” very differently.

Different responses to

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

“stressful circumstances” are largely due to the fact that individuals perceive these situations differently based on conscious and/or unconscious beliefs

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

that they may be projecting into the situation at hand.

A simple example will serve to illustrate this. Individual “A” fails to get a meeting with an im

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

Following aspects would a

portant new client and immediately begins to berate himself for his poor performance. Individual “A” believes he is a failure if he doesn’t get buy in fro

dd to the challenges in developing combination products:

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

m every new client.

Individual “B” however may see the situation as follows: “Well it’s likely that this client isn’t ready for my services yet so I’ll t

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

ry again in a couple of months”. Individual “B” believes that the failure to connect with the client is not a reflection on his competence rather an issu

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

e of timing.

The effect of the different beliefs on individuals “A” and “B” are as follows:

Individual “A” feels like a failure, his sense of self-estee

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

m and self-confidence plummet. This can lead to preoccupation with future failures followed by anxiety and poor concentration. All this affects future per

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

Professional from academic institutions, pharmaceutical industries, health care indust

formance and success. Ultimately, we have a self-fulfilling prophecy occurring i.e. “I believe I’m a failure, therefore I fail”.

Individual “B, on the ot

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

her hand has moved on to the next client without any significant difficulty. He may in fact have thought about how he might creatively assess which client

.

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

s are more likely to be receptive, thereby boosting his sense of confidence.

Hence the impact of negative emotions are clear. What’s important is that it

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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