Main Subject - Business

How do you, or would you, communicate in a chaotic environment?

That question was put to me by a reader who works in big, frantically-paced telecommunic

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

ations company. Many projects operate at the same time, and many connections exist among the project teams.

In this environment, teams work independentl

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

Examples of combination products may in

, but at the same time depend on each other for critical information. Without that information, time is wasted and progress slowed.

In a broader sense,

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

he challenge is to create communication systems that gather, process, and disseminate critical information. With this information, teams can work more ef

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

iciently and effectively.

The reader reports that one solution emerged out of a technical forum organized around a very large project. He says that whil

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

Combination pro

participants exchanged technical information, a lot of value came from the process, as well as the content.

Specifically, many participants got to know

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

each other, sharing their experiences and insight. This opened up person-to-person channels that had not existed before. New, informal networks developed

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

and participants found alternative ways to get information.

Therefore, he suggested that quarterly conferences might be a good idea, because they provid

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

a mechanism for further developing and extending these networks.

My suggestions complemented his experience and thoughts. I recommended that each team

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

evelop an information requirements list at its planning meetings. After articulating such a list, team members can begin identifying where and how they w

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

ll get this information. In other words, start with objectives, a strategic approach.

Teams should ask: What information do we need? Why do we need it?

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

Following aspects would a

here and when can it be found? Who will get it, and from whom? This takes the information shopping list to a new level, without necessarily adding a lot

dd to the challenges in developing combination products:

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

f time to the process. With the specifics identified, gathering the information should be quicker and easier.

On a related topic, technology opens up a

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

umber of interesting opportunities for better communication in such an environment. Email, discussion groups, and internal databases offer ways to get an

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

give critical information.

On a smaller and less chaotic scale, I've set up several closed, Internet discussion groups for associations with which I vo

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

unteer. They provide excellent forums for discussion between meetings or other get-togethers.

Perhaps the biggest challenge is to create electronic mech

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

Professional from academic institutions, pharmaceutical industries, health care indust

nisms that actively draw out information, rather than just passively route it to the participants. One way of doing this might be to set up groups in whi

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

h requests for information are posted and answered.

While such a process might not work for some organizations, the thrust behind it should work for mos

.

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 is, we can build effective communication systems when we start with a strategic approach, working backward from our objectives to the things we wi

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

Companies that provide selfless information through particip

l do.

In summary, even in chaotic environments, we can develop systems that lead to good communication, allowing us to get and give critical information

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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