Advice You - Business

There are many solutions for a great tender submission.

One of the great mysteries of the “open” competitive tendering process is that each of us has experienced defeat. What mystifies us is that there must have been a mistake – we had the best solution. Of course w

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

e did. So did the other three unsuccessful tenderers as did, we hope, the successful one!

So, consider this hypothetical tender, which simply asks for a proposal to “make the following equation true by only adding one line to it”:

I X = V I

Simple enough. Prepare

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

Examples of combination products may in

our team to consider what is being asked. Review all the documentation to ensure that nothing has been overlooked. And prepare your tender. You do this, and your tender response is simply:

I X (does not equal sign) V I

Compliant. One line added to the equal sign

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

to make the equation true and correct. Clearly the winning tender – or is it?

As with all projects and activities, there may be many approaches that could be implemented to lead to the same minimum requirements. And this is good and vitally important if we genuine

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

y seek solutions that create long-term sustainable benefits. Still, we can do more than just meeting ‘minimum requirements’ to ensure compliance.

We all have a responsibility to ensure that we challenge the thinking that is presented in the design, the tender docum

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

Combination pro

ntation, donor policy etc, not just to prepare a response that ‘meets’ stated requirements. If we did not do this, then the tendering process would simply come down to a price comparison, which does not necessarily translate to the best solution to the problem.

So

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

who is the “we” to take all this responsibility? Is it us as individuals? Is it the managing contractors? Agencies? Clearly, it is all of us in whatever role we are adopting as it relates to a tender or activity in question.

The tendering process should remain dir

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

ctly connected to the activity’s implementation and its results. So during the preparation of the submission some key questions need always be asked:

•Why are we doing this
•Who are we targeting
•Where will any impac be realised
•How will we know

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

•How would we measure it

And there are probably many more, all of which have something in common – starting with the end in mind.

This responsibility to ask key questions does not rest solely with those preparing the tender response. Clearly it forms part of any met

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

odology to design an activity, and it really should also be part of the tender assessment process if there is a genuine commitment to finding the best approach to any activity. I once received some ‘feedback’, and I am sure I am not alone here, that “but it wasn’t a

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

ked for in the tender”. This is unacceptable and indicates a lack of consideration to the question “why are they proposing this?” It may still have been judged to be not the desired approach, however merely dismissing alternative approaches because [possibly] it

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

Following aspects would a

wasn’t thought of in the design phase, is not being true to the cause.

So, working on an assumption that the design and preparation is sound and complete, responding to this hypothetical tender with the “does not equal” sign as your ‘approach’ will certainly ensure th

dd to the challenges in developing combination products:

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

t the needs of the ‘project’ are met. But, what if you spent some time thinking about other options, you might have considered submitting this ‘tender’ response:

I X 6 = V I

Where in the ‘tender’ did it ask for a straight line? So here is another solution to the

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

same problem that may in fact be superior to the earlier response. Our role then is to evaluate the merits of the options, and then our tender response needs to fully demonstrate why the option we finally propose will be the best solution for the activity.

We are s

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

ldom likely to be a sole tenderer, so a critical success factor is considering what the competition is doing. So by going through the above process for our hypothetical tender, we now have two options to consider. Now we are presented not only with the consideratio

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

of which option is best for the activity, but also, what might our competition be considering? This means you are in a position to consider their team, their approach and their strengths and weaknesses. And by doing this, not only can you frame your response by de

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

Professional from academic institutions, pharmaceutical industries, health care indust

monstrating why your methods, team etc are most appropriate you can demonstrate this from a comparative standpoint.

All of this requires a commitment from us as potential tenderers or team members to looking for the absolute best solution for the proposed activity.

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

And clearly it needs complete transparency amongst all stakeholders to ensure the best solution is successful, not the “best, because” option. And it equally requires a commitment from those assessing tenders and proposals to consider why alternatives or additions

.

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

are being proposed, and evaluating these on their merits.

======

Attention to detail.

It is critical for all of us in preparing proposals and tenders to maintain a commitment to having attention to detail. Nowhere in our hypothetical tender were we told that the s

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

Companies that provide selfless information through particip

lution could only be reached using mathematical symbols, and maybe you have more solutions still.

S I X = V I

http:// www.meldunn.com.au

http://www.globizdev.com

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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Advice You - Successful Tendering - There Are Many Solutions

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