Subjects - Business

The purpose of any selection process is to discriminate (albeit fairly) among jo

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

b candidates. Your goal is to select the right people, with the right skills, a

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

Examples of combination products may in

the right time for the right position. Have you hired anyone recently? If so,

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

how well did you do? How many of these ten questions can you answer ‘yes’ to?

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

Did YOU:

Avoid hiring in a hurry just to get a body on board

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

Combination pro

i>Know what you really needed – not what looked good on paper?

Get the

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

word out to a variety of sources so that the best candidates could apply?

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

Pay attention to the right things during the interview – the required compet

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

ncies?

Prepare for the interviews ahead of time and do your homework a

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

out what to look for?

Ask focused questions to draw out the candidate’

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

skills, knowledge and experience?

Develop a system to compare candida

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

Following aspects would a

tes so as not to get into legal hot water?

Have real proof that the ca

dd to the challenges in developing combination products:

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

didate can do the job – get behavioral examples?

Make a timely decisio

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

and not procrastinate for fear of making a wrong choice?

Use both you

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

head and gut in determining the best candidate for the position?

<

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

>Scoring:

8-10 ‘yeses’ indicates you’re the tops. Keep up the good work.

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

Professional from academic institutions, pharmaceutical industries, health care indust

4 –7 ‘yeses’ is OK. Brush up in certain areas.

0-3 means you have work to do.

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

ake this a top priority to develop your staffing skills.

Great hires are always

.

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

the result of good preparation, good information, and good decision making. You

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

Companies that provide selfless information through particip

an probably teach a turkey to climb a tree – but it is easier to hire a squirrel

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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