Advice You - Business

Have you ever asked for a report based on data in a database? Or have you ever been asked to create such a report? Starting a report can sometimes

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

feel like a mind reading trip into uncharted territory. I have spent over 5 years creating reports and I found it was often necessary to go back a

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

Examples of combination products may in

nd redo reports because communication was not clear. Sometimes the party requesting the report didn't know what they really wanted. Sometimes the

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

party creating the report does not ask enough questions before starting. Over the years, I have come up with starter questions that provide a plan.

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

Using these I have more often created the needed report on the first draft.

What question are you trying to answer?
I have often had mana

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

Combination pro

gement ask for something specific without first telling me what they wanted to know. When the objective is not set forth at the onset, often what m

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

anagement requested does not give them the answers they were seeking. This is usually due to the fact that people were jumping ahead to the result

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

nstead of actually asking the question. Management does not always know the data source and may be unaware of possibilities available to them or th

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

e best means of proving or disproving something. Getting an answer to this question has resulted in vast changes to the final report as originally

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

requested.

What timeframe of data do you wish to consider?
It is important to know if you just want current information or if you are loo

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

ing for historical trends. Do you just want to consider open orders/tickets or do you want to look at everything entered in the last three months?

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

Following aspects would a

You may even need to consider, if you are evaluating data over time, how to compare it: by quarter, by month, by week, by day.

How do you want

dd to the challenges in developing combination products:

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

to qualify the data returned?
Are you looking to group things by customers or by products or by dates? Do you only want records meeting a ce

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

rtain criteria? Is there anything that needs to be excluded?

What details do you wish to include?
This one can be tricky. Too many deta

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

ls can make a report large and cumbersome, but too few will cause additional reports to be run. You want to have enough information so that if 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

need to drill down on the data occurs, you'll be ready.

What summary information do you wish to see?
While the details usually remain in

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

Professional from academic institutions, pharmaceutical industries, health care indust

the background for drill-down purposes, the summary is the one page view. Often visual charts can be used. This is also the place for basic statis

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

ics such as subtotals, totals, or averages.

If you start with questions in these five areas, you'll be able to get the report done right the first

.

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

time. There are, of course, always additional questions to ask. Some may be triggered naturally by one of these first five. Ask as many questions

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

Companies that provide selfless information through particip

as you can without becoming an hindrance to the process. Just like in any other business area, it will save time if you measure twice and cut once

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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