Subjects - Business

Eureka!! I always wanted to be a manager.' You have finally got the job that you a

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

lways wanted.

'Now where do I start?'

'How do I manage my friend Sarah?'

'Steve

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

Examples of combination products may in

has five years more experience than me and also went for the job - he's bound to

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

be hacked off with me.'

'I really must make sure I know more than everyone in my

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

team otherwise I won't be able to justify that I'm the boss.'

'So much to do in s

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

Combination pro

little time.'

Here are 6 tips to help you on your way as a new manager.

1. It t

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

akes time to be a great manager. You are not expected to know everything and every

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

one in a week. Spend a certain amount of time just observing what goes on. Making

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

rash decisions early on (first three months) often sets the tone for the future.

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

2. Each day make a positive step (or two) in the right direction to become a great

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

manager. Take time to understand your teams business, even if you were promoted fr

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

Following aspects would a

om within it.

3. Think ahead. You are no longer the key day-to-day implementer. B

dd to the challenges in developing combination products:

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

ook a room and have a one to one meeting with each of your team. Let them do most

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

of the talking. Discuss their business, their role, their thoughts, ideas and aspi

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

rations. Listen carefully and take notes. When you have done this take time to for

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

ulate your plan for the next six months.

4. Discuss with your team your plan. Hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing discussed things with them, how you see the future, your vision, how you would

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

like to work with them and set out your ground rules. Ask for their opinion and e

.

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

ncourage debate on this.

5. Keep to your promises unless parameters change. If th

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

Companies that provide selfless information through particip

is is the case ensure you communicate the changes fully.

6. Learn how to delegate

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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