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One hundred and eighty years ago, the first railroad started hauling freight. That company is now part of CSX. In 2006, its 36,000 employees operated a fleet of 100,000 railcars and locomotives, moved hundreds of thousands of tons of cargo along a 22

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

,000-mile network of track, and produced exceptional revenue and income results for its shareholders.

For such companies, crisis looms on a daily basis – crashes, derailments, chemical spills, and so forth. Obviously it’s the nature of the beast, no

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

Examples of combination products may in

less so than with any transportation industry. Earlier this year, CSX responded to a crisis with the kind of creativity that would earn it respect in a critically important community and help bullet-proof its brand as industry kingpin.

In January 20

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

7, a CSX train derailed in Bullitt County, Kentucky. No one was seriously injured, but the local populace endured considerable inconvenience. In particular, highway detours forced motorists to take alternate, traffic-clogged routes.

CSX took a simpl

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

but conspicuous step. It gave $100 or more to anyone with valid ID who could simply explain how they were inconvenienced. It’s called “running to the crisis” and the effect here was to minimize lawsuits and maximize public understanding. CSX showed

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

Combination pro

– it didn’t just tell – its concern and desire to make amends.

The media responded warmly. The Courier-Journal in Louisville (January 23, 2007) even quoted University of Denver marketing professor John Burnett, who agreed “the reimbursemen

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

s could make CSX's reputation in the community stronger in years to come.”

Yet it’s important to realize such effective stratagems don’t happen by accident, but are instead typically implemented by companies already predisposed to creative communica

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

ions solutions. It’s all about stockpiling risk management resources and identifying salient action points early on. To help bullet-proof your brand, consider the following proactive strategies:

Know your vulnerabilities. Identify likel

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

exposure and assume the problem will occur at some point. As plan for these eventualities, write out message points, blog postings, articles, and web content geared to the likely occurrences. The difference between risk management and

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

crisis response is preparation.

Dark sites. Create an online template now in anticipation of likely crises. Derailments and spills may be inevitable, so have a blog or website ready to post once the problem occurs.

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

f course you’ll need to fill in some details, but that’s a lot easier than starting from scratch. The sites should chronicle all that the company is doing to prevent derailments and ensure diverse railroad-related safety practices. Muc

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

Following aspects would a

of that content can be written well in advance. Include user-friendly (i.e.., reporter-friendly) pictures and diagrams that can be easily download.

Optimization. Have the technical assistance at hand to ensure t

dd to the challenges in developing combination products:

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

at whatever you post online reaches the maximum audience of search engine users. As a result, when an event occurs, reporters will find your point of view first.

High-authority Blogs. Know the most credible industry

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

bloggers now. Convince them of your community commitments now, not when you’re perceived as having no choice.

Key Reporters. Ditto both general and local reporters. The better you all know each other, the more credib

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

e you’ll be when you need them. For both bloggers and reporters, broaden the list – not just railroad industry watchdogs and journalists but, for example, chemical industry and environmental sources as well.

Brainstorm. I

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

eas like the $100 awards should be discussed and vetted well in advance. As CSX has a standing reimbursement policy that varies from situation to situation, the Bullitt County reimbursement was evidently not just a bright idea tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

someone was fortunately able to come up with when needed.

Media-train. Press comments by CSX spokesperson after the derailment were irreproachable. Equally effective comments can be developed during pre-crisis train

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

ing sessions and their delivery rehearsed for maximum impact.

Public interest leadership. By identifying and lobbying for industry-related improvements, the company takes the lead and is perceived as doing so. For

.

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

a railroad company, such leadership suggests ongoing collaboration with the regulators, and that the company is not just an object of their ongoing and wary oversight.

As additional crises challenge CSX – from Congressional inqui

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

Companies that provide selfless information through particip

ies to executive pay fracases – such brand-protection strategies can help create a protective shield for the company brand. High-exposure industries like the railroads must go beyond simple contingency plans. They must evolve risk management cultures

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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