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Every project manager dreads the day when he or she has to make the long walk to the executive sponsor’s office to ask for more money. Unforeseen delays, scope changes and excessive c

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

onsulting costs are often cited as reasons for the increase, and shallow excuses that these costs could not be divined when the project’s budget was originally developed abound.

Legit

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

Examples of combination products may in

imate or not, these costs are frequently approved. What’s another 5% to preserve the millions already invested? What becomes unjustifiable is when these budget increases become a rec

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

urring ritual, and project costs and timelines double or triple over original estimates. Even more shocking is that justifications are often based on “fuzzy math,” with elusive “man d

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

ay” estimates and the like serving as justification.

Many executives and project managers have some vague idea of a project’s burn rate, which boils down to a calculation of the cost

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

Combination pro

to run the project for a given period of time. What is lacking in this figure is usually a comprehensive analysis that provides burn rate information down to a granular level, providi

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

ng the cost side of a cost-benefit analysis. It’s easy to take consulting costs for the last month, divide by working days and produce a burn rate, but to use burn rate as a legitimat

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

e project management tool requires a more complex model.

At a minimum, burn rate analysis should include the following:

Consulting and contractor cost calculations on a per-t

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

eam or functional area basis. Consulting costs can vary widely based on a particular skill set or area of expertise, so a “universal average” simply does not cut it. This figure shou

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

ld be based on the smallest unit of measure tracked in your project plan, generally a daily or weekly average. Be sure to include any additional costs that may be incurred through ove

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

rtime work.

Cost for salaried employees working on the project. All too often, these resources are considered “freebees” as the project does not write a check each month to

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

Following aspects would a

an outside vendor. However, pulling fulltime resources onto a project incurs replacement costs to fill their former position which should be included in a burn rate calculation.

dd to the challenges in developing combination products:

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

Travel expenses for both contractors and fulltime employees may generally be calculated based on a project average. More sophisticated analysis can track these costs on a per-tea

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

m basis, and include additional adjustments for working weekends or schedule changes that might incur additional travel costs.

Facilities costs such as additional real-estate

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

, workspace setup and technology requirements should be factored into the burn rate on a per-person basis. I’ve visited projects where spiraling resource requirements have necessitate

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

d renting modular office space, or constructing new facilities in old warehouses, etc. All significant costs not properly accounted for in burn rate analysis.

After gatheri

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng the required information to cover the basic points above, a model can be built for the entire project, tying costs to headcount on a daily or weekly basis. With this model a new fi

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

nancial urgency can be injected into a project. If a key manager makes a decision that extends the project by one week, no longer is there some vague understanding of what that decisi

.

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

on will cost. With a through burn rate analysis, an accurate price tag can be placed on any decision that will affect a project’s timeline. With accurate costs known in advance, exec

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

Companies that provide selfless information through particip

utives and project managers can focus on determining what benefit will be derived from a scope or timeline decision with full knowledge of the financial repercussions of that decision.

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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