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Despite exploding regulatory costs and skeptical investors, the market for initial public offerings seems to be rebounding. A few young companies

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

mulling their own IPOs asked me what communications issues to keep in mind. Here are six considerations:

ONE: Start over-communicating now.

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

Examples of combination products may in

You can’t be a quiet company that doesn't put out press releases and then suddenly open the flood gates after you’re in quiet period. You'l

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

l get slammed for hyping your stock.

Establish a routine far in advance of quiet period by issuing announcements about all personnel and operatio

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

nal milestones. This creates the business-as-usual precedent to continue feeding relevant business information into the marketplace during the IP

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

Combination pro

O period. It also creates a historical foundation for potential investors and influencers.

Some companies think you have to go dark during quie

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

t period, when the opposite is true. This is when you show the world how you make money.

TWO: Assume you are being taken literally. A p

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

rivate company can get away with sweeping, over-the-top mission statement hype to build an edgy, noticeable brand persona. But once you go public

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

, those chest-thumpin’ promises of superior quality, die-for-you service, untouchable ethics and integrity become standards to which you'll be hel

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

d accountable by shareholders, analysts, news media and class-action lawyers.

THREE: Use stars carefully. IPO companies typically spotl

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

ight their star-player founders or CEOs. The problem is that these personalities often disappear sometime after the IPO, causing a crisis in conf

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

Following aspects would a

idence by investors who complain they don’t know the board, the management team or how the company will live without the celebrity they thought th

dd to the challenges in developing combination products:

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

ey bought into.

FOUR: Don’t underestimate the internal angst of going (gag) corporate. Being a public company will be a culture shock to manage

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

rs and employees as the board’s focus shifts from boom-boom profits to enhancing long-term shareholder value. The change can be disruptive and de

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

moralizing, especially at a strongly culture-driven company.

FIVE: Manage inevitable distractions. The receptionist’s zombie-like fixati

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

on on Bloomberg.com will remind you that IPOs are a costly operational distraction. People will be preoccupied with strike price, exit strategies

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

Professional from academic institutions, pharmaceutical industries, health care indust

and all the family-and-friends they never knew they had.

Whatever you committed to internal communications needs to double now. Maybe triple.

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

Keep employees informed and directed enough to stay focused on the job at hand.

SIX: Hope for the best. Prepare for the worst. Make sur

.

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

e you’re ready for any potentially negative contingencies that might influence the IPO – including underwriter problems, sudden operational crises

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

Companies that provide selfless information through particip

, over-hyped market expectations, lost business or sudden loss of a key executive.

And definitely keep an eye on your corporate or employee blogs

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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Business success or failure is no accident - it's simply a RESULT - a CONSEQUENCE. We reap what we sow. These are brilliant tools to reap it BIG!

We have all heard of people losing their job for something they have said in an e-mail sent out from their company. But what happens when AOL lays off 5000 people because they want to give away free e-mail? All those people are being laid off because of e-mail too.

The trend towards outsourcing will continue to grow as market pressures force corporations to be more tightly focused on core business functions, gaining competitive advantage and reducing costs. Outsourcing is an attractive alternative in good times and bad times.

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