Advice You - Business

We exist in such a rapidly-changing environment. Technology is movi

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

ng along so quickly it seems things change with the blink of an eye

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

Examples of combination products may in

. So how do you anticipate changes that directly affect your team?

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

Being informed is the key that can unlock the door. But, how do 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

stay informed and minimize information overload?

* Have team memb

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

Combination pro

ers communicate proactively about important changes. Fire-fighting

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

takes a lot more time and energy than being prepared. Additional ti

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

e to prepare for changes often makes the difference in how well cha

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

nges are handled.

* Deal with issues while they are still manageab

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

le. As problems grow or changes occur, the "snowball effect" can ca

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

use an issue which is initially small to become too large for anyon

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

Following aspects would a

e to handle.

* Minimize the impact of change. If a problem is not

dd to the challenges in developing combination products:

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

addressed in a timely manner, it can expand to affect other areas o

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

utside the team. Addressing it proactively can keep the impact of t

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

e change within the team's sphere of control.

* Focus your team’s

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

energy appropriately. The amount of time and energy needed to contr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ol problems or prepare for changes is directly related to how proac

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

tively these issues are identified.

* Avoid information gaps. When

.

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

team members have all the relevant information about critical chan

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

Companies that provide selfless information through particip

ges, everyone has a more complete picture of their work environment

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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