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A colleague of mine has a problem. We belong to the same association and he's been trying for quite some time, without success, to get support for one of his

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

proposals.

His lack of results came to mind when a reader asked for ideas about making internal proposals more effective. As she noted in her message, it's

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

Examples of combination products may in

necessary to make a business case for proposals, including costs and returns.

She's right, and I agree wholeheartedly. In fact I just finished a proposal 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.

an organization I work with and had it accepted on that sort of basis.

But, I think all good proposals start where my colleague has trouble. They start wit

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

a clear and concise statement about the project: "This is what I recommend, this is the issue (problem or opportunity) it addresses, and these are the conse

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

Combination pro

quences (benefits) of doing what I recommend."

I frequently come across situations where ideas don't fly because the person making the proposal hasn't prepa

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

ed that kind of analysis and statement. While the virtue of the ideas seems apparent to him or to her, it's not at all apparent to others. I've referred to i

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

t elsewhere as the 'Everybody knows' syndrome.

To do the analysis, and later write the statement, start with a description of the action that you want taken

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

In just a few words, write down the what you want to see happen, and how it changes the status quo. For example, I recently went to a meeting with a proposa

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

l that went like this: Change the duration of our event to four weeks from the current duration of six weeks, to reduce our costs during a slow period.

Next

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

name or list the people or functions involved. Who will take the action? Do you want just one person to act, or several, or many? And, if it involves a mult

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

Following aspects would a

i-stage action, set out the stages. For example, "I would like this committee to formulate a recommendation we can put to a vote at the annual meeting."

Fol

dd to the challenges in developing combination products:

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

ow that with a list of people and organizations affected by the action. Be thorough in this consideration; it's all to easy to forget the peripheral players.

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

And very often peripheral players make a critical difference to our plans.

Now, is there a timeline or sequence of events that needs consideration before a

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

decision can be made or implemented? Almost everything we do in large modern organizations is interconnected to other people and resources. And, what about c

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

ontingencies? Does your proposal depend on something else happening?

Having thoroughly explored the proposal and its implications, we now turn to costs and

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

Professional from academic institutions, pharmaceutical industries, health care indust

enefits, the business case. What are the tangible and intangible costs? In the intangibles column, make at least a mental note of the emotional costs that ke

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

y stakeholders will pay. The same is generally true of benefits, or the returns if we're talking about financial components. Remember the important role emot

.

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

ons often play in decisions.

In summary, then, take a strategic approach to internal proposals, an approach that identifies the issues, the players, and the

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

Companies that provide selfless information through particip

consequences. This exercise allows you to be clear and concise because you have thought your way through the proposal carefully, and you know the key issues

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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