Advice You - Business

What do innovation, manufacturing, exporting, training and the environment have in common? The opportunity to share in a generous grab-bag of Government sponsored incentives and f

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

unding! Governments around the world offer commercialisation grants worth millions of dollars to develop bright ideas, substantial export market development grants, incentives for

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

Examples of combination products may in

the manufacturing industries, generous tax breaks for research and development, employment subsidies, tariff reductions and a whole raft of other benefits to make life easier for

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

nterprising business people.

So how do you find the funding that’s right for you?

A good starting point for would-be grant seekers is the internet. In Australia

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

for example, www.grantslink.gov.au, lists almost 300 grant opportunities, sorted into 12 categories for easy reference. The AusIndustry site is another useful resource and each St

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

Combination pro

te and Territory has an on-line government grants portal, which lists all available grants and funding opportunities. In the United States, grantseekers can refer to http://www.gr

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

nts.gov to electronically find and apply for their share of more than $400 billion in government grants; and in the United Kingdom, www.businesslink.gov.uk is a good starting poin

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. Secrets of writing a winning proposal

While submitting a grant or funding proposal does not guarantee that you will be successful in obtainin

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

funding, there are ways to increase your chances of winning, by presenting your application in the best possible light. Because funding programs are generally very competitive, y

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

u must plan and research your application well in advance, to ensure that you are able to answer the questions on the application form comprehensively and accurately. Familiarise

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

ourself with the funder’s requirements beforehand; and make sure you leave yourself enough time before the closing date to prepare any supporting documentation such as business pl

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

Following aspects would a

ns, letters of support and budgets. Never hesitate to speak to the funder’s contact person if there is anything you are not sure of -- it could make the difference between winning

dd to the challenges in developing combination products:

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

a grant or missing out.

The best grant applications are written both strategically and persuasively -- strategically because the government funding process is, above all, politic

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

lly-based; and persuasively because you need to sell your project or need to the funder. When writing an application, ensure you refer back to the exact terms of the relevant ques

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

tion in your response, keep to any specified word limit; and provide exactly the information required, in a clear and succinct manner. This will enable the assessment panel to jud

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

e the degree to which your application addresses the required criteria and compare it with the submissions prepared by other applicants.

Review your application carefully and com

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

Professional from academic institutions, pharmaceutical industries, health care indust

lete any final checklists before submitting it to the funder, with the required number of copies and attachments. Ensure you allow time for it to arrive, or be postmarked, dependi

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

g on the funder’s requirements, by the due date. The next step

Successful applicants are required to sign comprehensive funding agreements befor

.

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

proceeding with their project and funding is usually paid retrospectively when evidence is provided to the funder that you have achieved each required milestone.

If you are not

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

Companies that provide selfless information through particip

uccessful, don’t hesitate to contact the funding body for feedback, which you can use to make your next application even stronger and significantly improve your chances of success

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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