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In the article Getting Involved in the Global Development Market (available in full in Latest News at www.globizdev.com) I commented that while tendering skills are critical, in isolation of other key activities success is a lottery.

Preparation must

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

remain as a key and ongoing activity if organisations and individuals are to expect success from their tendering involvement.

While there is no doubt that some of this preparation may require investment if site visits and the like are to occur, as the

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

Examples of combination products may in

need to, not all preparation is costly.

So often, when working with some of the smaller organisations that seek activity in sub-components of larger projects, the tendering effort is stressful, time- challenged and often without system.

This can be m

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

anaged by planning in advance.

As discussed in Getting Involved in the Global Development Market, tender responses, even for sub-components, invariably require details of your team, approach and methodology, management, price and past experience. 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

the often tight timelines for the tender response, it is critical that time is spent on ensuring the best possible solution to the project’s requirements at the best possible price. Hence, time should be mostly devoted to new thinking, not admini

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

Combination pro

strative compilation of past information.

There is no doubt that a successful track record of implementing or involvement in similar activities will be assessed and contribute to your success or failure for any tender. But this does not mean taking t

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

o weeks to find and compile a list of past experiences is time well spent – this can be done now and on an ongoing basis.

All tenders are likely to request a range of information that demonstrates your experience in past, similar activities. Informat

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

ion required invariably includes the activity name, location and duration, client, project value, key personnel by name and title, and a synopsis of the activity.

Collating this activity is obviously going to be a challenge if it requires seeking out

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

personnel and past team members for information, relying on memory etc. The solution is to encourage the habit of compiling relevant information as soon as a project or activity commences, and keeping the information current.

This can be made even e

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

asier by capturing information from the beginning of a project consistent with how a future tender might require the information presented.

Major agencies require a Project Data Sheet (PDS, or similar name) for each project example that you are pres

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

nting with your tender. This is usually one page per example, and captures all the information required in the assessment of your tender. I have prepared a word document that is consistent with information that would be required by the World Bank,

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

Following aspects would a

ADB and AusAID etc, and any sub- components within project from those agencies. This can be downloaded from the Latest News page at http://www.globizdev.com/articles/latestnews.php (it is listed as PDS Template.doc).

So what do I do now I have the P

dd to the challenges in developing combination products:

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

S Template?

Simply stated – start using it!

If you have a number of project examples in different formats, then consider updating the information to use this format. If you have yet to compile capability information, then this would be a useful form

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

at to start populating.

Importantly, as any new project or activity commences, set up a new PDS immediately and update it regularly.

Can I use each PDS just as it is for any tender I submit?

Remember that while this template is consistent with what is

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

currently asked, it is important to check exact tender requirements before submission to ensure compliance.

Secondly, each tender has different considerations because each project is different, so a generic response is seldom successful. Similarly,

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

each project you have undertaken would have contained a range of activities, approaches etc. So, before just adding a PDS example to a tender submission, consider what the tender’s (project’s) focus is, and ensure your PDS examples demonstrate this

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

Professional from academic institutions, pharmaceutical industries, health care indust

Occasionally a slight re-write to place greater emphasis on a key aspect of relevance is important.

What if I do not tender for activities?

The information that the PDS template captures is useful for submissions direct to client, or as a data capt

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

ure tool for drawing information from for developing capability documents, case-study information and the like.

Preparation is the key.

Whether preparing a tender for a complex project, or a proposal direct to a client, it is important that time is s

.

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

ent coming up with the best possible approach to ensure implementation creates the best outcomes. Taking time away from this critical aspect of tender and proposal development to prepare Project Data Sheets is not time well spent.

Download the PDS

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

Companies that provide selfless information through particip

Template, a word document, in Latest News at http:// www.globizdev.com/articles/latestnews.php

http:// www.meldunn.com.au

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Should you be looking for a nursery job and have found nothing suitable so far, it would be a brilliant idea to use the Internet as an employment means. Of course, you cannot always get hired just by browsing the Internet!

I want to start things off by saying that I come to the table not only bringing a problem, but also the solution. Most of us are skeptics and are concerned that the money recently handed out will not be used to improve the patient care in our healthcare system. Even with the best intentions, the money may get diverted to areas, which may have little impact on the real systemic healthcare problems. As you read this article, you will discover there is a way to ensure that the changes and investments of the dollars have the desired outcome on healthcare. It only requires passion and a solid strategic plan for implementation.

Have you ever sat in front of your computer looking for a document – knowing it was there – the question is: “Where?” The answer gets amazingly complicated if the document is an attachment someone sent to you from someone else’s e-mail account!

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