Advice You - Business

Ask any marketing person to name the bane of his or her professional existence and they’ll likely say one word: proposals.

Why?

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

How bad could it be, right? Well the process of answering a proposal can be laborious at best and haphazard at worst. At times

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

Examples of combination products may in

construction firms spend more time preparing a bid than they do a proposal. And yet proposals are required for large, popular job

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

s that will likely add a hefty figure to your bottom line. What steps should you take in responding to these requests? Here are

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

five key steps:

1) Determine your proposal team. While your marketing person will help you assemble and write proposals, the te

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

Combination pro

am should also consist of your best project managers and someone from your executive staff to assist with content.

2) Banish the

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

“fire drill” method of responding to a proposal. Inform your staff that it’s their job to pay attention to the rumors heard on th

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

street about pending proposals. Watch for them. Let your team know they might be expecting one to come their way. As soon as y

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

ou have an idea about when a future proposal might be made a reality, let everyone on your proposal team know, especially your mar

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

keting person, so they can begin any research and preparation.

3) As soon as the RFP is in your hot little hand, gather your team

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

and decide how (and if) you want to proceed. Take a long hard look at the project. Is it right for your firm? Don’t ever respo

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

Following aspects would a

nd to a proposal “just to keep your name in the ring” for a project your firm really doesn’t even want.

4) Once you’ve decided th

dd to the challenges in developing combination products:

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

at you’re going to respond to the proposal, gather your team and divvy up the work. Be careful with assumptions here. Don’t hand

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

off a pile to your marketing person and tell them the responses they need to develop are all “boilerplate.” (In fact, cast out t

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

is term from your mind – proposals are rarely boilerplate in the true sense of the word.) Realistically determine who would be be

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

st in answering each section.

5) Immediately set up a time to meet again with your proposal team and wrap up any questions still

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

Professional from academic institutions, pharmaceutical industries, health care indust

unanswered. If all questions are sufficiently answered, gather your team once more to read the proposal. This basic step is rare

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

ly done in construction firms. Your marketing person should be reading for continuity, tone, and if each question is answered in

.

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

the manner in which it is asked. Each member of your proposal team should help proof the document for content and flow.

With the

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

Companies that provide selfless information through particip

se steps your firm will take a more proactive approach with proposals and you and your staff will have a better chance to win them

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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