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The team members are in place, many of whom will have been pillaged from other projects and you need to set them to work. The first priori

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

ty when managing a bid is to have the customer's bid documentation reviewed. No one person is an expert on all aspects, which is why you h

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

Examples of combination products may in

ve a team comprising members from all different disciplines and that is how you divide up the paperwork. The technical specification will

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

be reviewed by your technical expert, the contractual terms and conditions by the Commercial Manager and so on.

You will need to set a tim

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

scale for this, and all other, activities because invariably, bid periods are far too short for the amount of work that needs to be done.

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

Combination pro

few days should be sufficient for your team of experts to come up with an answer to those burning questions "Do we want this job?" and "Ar

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

e we capable of doing this job?"

Yes, believe it or not, just because your favourite customer has invited you to tender for a project, you

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

don't actually have to accept his invitation so the very first team decision is the Bid/No Bid. You should, as a company, have a procedure

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

in place which lays out guidelines for making this decision and some of the questions you will have to answer will be as follows:

- Is th

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

s the company's core business?
- If it's not core business, do we want to get into this area?
- Can we respond to the Invitation

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

o Tender (ITT) in the required timescale with a feasible bid?
- Do we have the resources to bid and carry out the project, if won

The

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

Following aspects would a

re will be more questions that this but these are the major ones that senior management will need to be answered in order for your bid/no b

dd to the challenges in developing combination products:

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

d decision to be approved.

The first two questions will require the input particularly of your Marketing Manager. This person will, if he

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

's done his job properly, have found out from your customer where a favourable response to this bid could lead. Bidding for a low value pi

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

ot project may not seem much in itself but if a successful bid leads to a full development contract, followed by several phases of producti

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

n or implementation, then that is a different matter. Your Marketing Manager will know how this project relates to others coming along, he

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

Professional from academic institutions, pharmaceutical industries, health care indust

will know about the politics surrounding this bid, your customer's expectations, the general feel in the marketplace and the probable comp

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

tition. He will be able to work out, to a degree, the likelihood of your winning this bid, taking into account the opposition and all sort

.

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

s of other factors. In general, it will be the Marketing Manager who leads the presentation of the bid/no bid decision to your board of di

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

Companies that provide selfless information through particip

ectors, showing anything that may have an affect on the outcome of the bid.

In the next article, we will discuss the management of the bid

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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Too often a business assumes that IP based solutions are the best choice to satisfy their communication requirements. Particularly with convergence issues. But...don't get caught making a hasty decision. There are viable options...and factors to consider before making a final choice.

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