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Are you and your team, task force, committee, or any other working group struggling wi

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

th issues and divergent viewpoints? Do you attend meetings that take up hours of your

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

Examples of combination products may in

time but do not produce actionable plans at the conclusion of the meetings? I believ

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

e a majority of you answered YES to both questions.

So what is my advice to you? 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

dvice is to use an outside facilitator for your meetings and retreats. A qualified out

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

Combination pro

side facilitator will free you and your group to focus on the agenda items and will pr

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

ovide a catalyst to keep everyone focused and on track. Effective outside facilitator

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

can help bring out the best in each member of your group and help all members work to

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

gether to address issues and items on the agenda. An outside facilitator will bring 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

fresh objective viewpoint and will help your group produce actionable, results-driven

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

plans. Outside facilitators provide major benefits that include:

+ creating a safe,

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

Following aspects would a

non-threatening environment for open discussion

+ providing a neutral third party

+

dd to the challenges in developing combination products:

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

providing management of the meeting process

+ helping participants feel less intimida

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

ted

+ helping to clearly define the issues and problems without bias

+ providing ass

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

stance in dealing with rivalries within the group

+ making more effective use of the

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

meeting time by keeping the discussion focused on key issues

+ helping break down co

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

Professional from academic institutions, pharmaceutical industries, health care indust

mplex issues and problems to aid the group in working together to solve problems

+ cu

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

tivating a commitment of the group to follow-up on the action plan

+ helping to “visu

.

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

alize” what can be in the future by creating a unified vision

+ helping create accoun

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

Companies that provide selfless information through particip

tability

+ helping develop specific goals and action plans to address issues and item

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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