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Have you been in this situation? One of your top managers left suddenly and you’re un

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

der the gun to replace her quickly. So you promoted her assistant. That was a disast

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

Examples of combination products may in

er. You now need to replace him but want to do it right this time and avoid another co

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

tly mistake.

This is an example of the hundreds of 'management staffing gone wrong' d

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

isasters that I’ve witnessed in working with many companies. In today’s hurry-up and

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

Combination pro

et-it-done work world, many people are unwisely promoted to management positions. Bas

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

ically, their abilities do not match or are insufficient for the new job role. Before

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

ou place someone in a management or supervisory position, take heed of these three key

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

staffing principles:

Not all competent employees make good supervisors or

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

anagers. Some might be more valuable by continuing in their role as the top sale

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

sperson, or the great programmer or the most sensitive counselor.

Interviews

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

Following aspects would a

must be focused with targeted questions. For a management position, develop specific

dd to the challenges in developing combination products:

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

behavioral based questions to decide if the person has good people skills? (Managing

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

is working with people to get results.); Communicates well? (Managing is dealing with

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

eople up, down and sideways in an organization.); Knows how to handle conflict? (Mana

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

ging is confronting and solving people problems.)

Finally, in selecting the

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

Professional from academic institutions, pharmaceutical industries, health care indust

est candidate, determine the best fit. Can this person do the job? That’s the techni

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

cal fit – the basic skills to do the job. Does the person have the desire to do the jo

.

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

? That’s the motivation fit – the commitment to perform well. Does the person fit int

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

Companies that provide selfless information through particip

o the team? That’s the culture fit – an important barometer for success.

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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