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You definitely need to have a comprehensive, realistic budget. It's a critical component of your nonprofit's annual marketing and communications plan and, like the work plan, serves as a map to ensure you reach your goals. The budgeting process helps you to determine whether your

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

plan is realistic. If not, you know you have to cut the plan to focus on ultimate priorities and retool the budget.

But, it's always a challenge to determine your nonprofit marketing and communications budget, and to justify it to the powers that be. On popular approach is to a

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

Examples of combination products may in

llocate a certain percentage of the organization's budget to marketing.

In the for-profit world, it's fairly standard to determine a marketing budget by allocating 10-20% of projected gross revenues to marketing and communications. However, things aren't so black and white in th

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

e nonprofit world with our dual bottom line of people and dollars. You can take the percentage approach OR the flat dollar approach.

What's most important is that you establish a detailed marketing and communications budget prior to the start of each fiscal year, and track costs

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

(by strategy and program or project) and results AS YOU GO so that you can analyze cost vs. benefit. The budget should be integrated into your annual marketing and communications plan, with a dollar cost allotted to each strategy (direct mail, email, paid advertising, media rela

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

Combination pro

ions, etc.) and program or project, each of which should be broken out by its various components (consulting, evaluation, printing, postage, etc.).

Each organization's plan (and budget) will cover a unique set of components. Don't forget to budget for the tasks - such as researc

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

hing your audiences and evaluating outcomes - that give you the information to make your selected strategies as successful as possible.

The Percentage Approach

This approach is favored by those who believe that marketing and communications expenditures should d

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

irectly reflect a nonprofit's evolution and the size of its budget. Personally, this is the approach I prefer. The advantage of developing a budget based on your organizational finances is that it's organic. Communications spending grows as does your organization. Of course excep

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

tions are made for special needs such as the launch of a new program, introducing new leadership, or tackling an urgent advocacy campaign.

The average allocation is from 9-12% of your annual organizational budget (start with 10%). Advocacy organizations tend to allocate a higher

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

percentage (12% or higher) of their organizational budgets to communications, since much of their advocacy work is communications based.

Here's a highly-simplified example of a budget shaped by the percentage approach:

2% Purchasing all advertising and pro

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

otion media, including newspaper, radio, TV, and direct mail (postage).

+

4% Producing (design, artwork) and printing all communications. This includes newsletters, brochures, web sites, press kits, etc.

+

1.5% Producing special events.

+

3.5% Salaries, consultan

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

Following aspects would a

ts and freelancers.

= 11% Total percentage of the organizational budget going to marketing and communications.

The Dollar Approach

Others in the field consider a flat dollar approach to be more relevant (and safer) than the percentage approach since you

dd to the challenges in developing combination products:

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

r total budget has to cover utilities, rent, taxes, health insurance, etc.

Defining the dollar figure is challenging the first time round but becomes much easier once you have records of several years' marketing expenditures to work from. Start out with a quick-and-dirty calcula

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

tion based on last year's costs and revise it to reflect special campaigns, inflation, etc. Or, if this is your first year out, estimate the costs of what you think you'll be doing based on what you know today. Contact colleagues in the field and prospective vendors to get your p

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

rojections as accurate as possible. Either way, you'll end up with a baseline budget.

Frankly, I've heard a lot about this method as a viable alternative to the percentage approach, but have never seen it put into practice.

What Budgeting Does for You

Whicheve

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

approach you take, you'll find that a formal budget is a great aid in decision making. To begin with, your marketing communications budget (and plan) will help you distinguish between needs and wants. You'll see clearly how much you have to spend to reach your goals and, via tra

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

Professional from academic institutions, pharmaceutical industries, health care indust

cking results, will gain a sense of what strategies work best to achieve which goals. For example, based on your budget framework, you may decide to promote your advocacy campaigns via direct mail and email, media relations, and paid advertising in order to match legislative time

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

frames. However, you may decide to hold off on enhancing your already strong membership campaign with the launch of a members-only web site.

So start your budget process today, even if you're in the middle of your fiscal year. Make sure that you track costs by category and maint

.

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

ain a spreadsheet of actual vs. projected expenses. By next year, you'll have an accurate map of expenditures that will serve as a great foundation for next year's planning process and a sure means of ensuring you make the most of your marketing and communications budget.

Do kee

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

Companies that provide selfless information through particip

p in mind that your budget will have to be adjusted each year to reflect increasing costs and changes in your organization. For example, launching a new program requires an increased marketing budget for the first year or two so you'll need more dollars or do less on other fronts

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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