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My favorite project management mantra is “Validate Critical Data”. I don’t remember what wise teacher I learned this from but it is one of

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

those sayings that rings through my head when I’m jumping into a new project. After many years it continues to be an important part of my p

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

Examples of combination products may in

roject management success (when it is done right) and an unfortunate contributor to my project failures when it is neglected. Below are som

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 keys to correctly validating critical data.

The word critical is not excess flab in this phrase. You shouldn’t try to validate all infor

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

mation – just the information that has been handed to you that effects your project approach. Usually it involves getting the right informa

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

Combination pro

tion about the project deliverables (scope), budget, and schedule. This can not be soft data.

Often a project manager will inherit much of

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

their project information. This second-hand information is highly suspect, because just like the old children’s game where the story chang

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

s a little bit each time it is retold, until it is far from the truth. The information you inherit is always worthy of validating. Other ti

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

mes, even when the information was correct initially as time passes the project environment or facts change. And the added benefit of this

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

practice is to cause the sponsor to think a bit deeper about the issue than they did initially, and have the opportunity to change their an

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

swers.

I’ve had many initiation meetings where, when asked to validate the project schedule, stakeholders admit they are not really ready

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

Following aspects would a

to do the project yet because it is dependent upon other projects that have been delayed. The process of having a friendly discussion invol

dd to the challenges in developing combination products:

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

ving the validation of all the critical data is usually quite productive and valuable. It can feel awkward the first time you do it. Don’t

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

you already know the information? Shouldn’t we be beyond this point by now? Don’t you trust the people who gave you the project descriptio

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

?

Later as the people you work with start to see that it is just a normal part of your process, the benefits of validation is appreciated.

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

The meeting usually ends with “I’m glad we talked about that because I think it’s going to be a better project now that we changed a few o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f those decisions.”

Some of our critical data comes from our project stakeholders. Other critical data may come from us, and our assumptio

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

ns that we have made about the project environment, about resources, processes, or technology. Putting the project assumptions into writing

.

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

, and getting input from others on the assumptions, is another way to validate critical data. If our assumptions are incorrect, the plan ne

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

Companies that provide selfless information through particip

eds to be changed as soon as possible. The cost of implementing these changes early in the project is always less than making changes later

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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