Main Subject - Business

Just two weeks shy of the fourth anniversary of September 11, our country experienced another epic disaster, Hurricane Katrina. Our political leadership was challenged to respond. The contrast

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

in results will be studied for years by political historians. Here are three cases of disaster leadership. What can we learn?

New York: 9-11-01

Mayor Rudy Giuliani emerged from 9-11 as a leade

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

Examples of combination products may in

r of epic proportions. He has become a noted author and speaker on the subject of leadership. While the 9-11 disaster shined the national spotlight on NYC, Giuliani's previous achievements were

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

erhaps more impressive than anything he did in the wake of the tragedy. From my prospective, he personally polished the big apple in miraculous fashion. His achievements include the quieting of i

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

nfamous, incessant horn honking by NYC cabbies. And, he cleaned up a graffiti laden subway system and maintained the newly established cleanliness. Two municipal miracles! If his health had not

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

Combination pro

prevented him from running, I don't believe Hillary Clinton would currently be a New York senator. Mayor Giuliani had accumulated up too much political capital in his state.

Chicago: January, 1

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

979

Those of us who were in Chicago during the 1979 blizzard and the rein of Mayor Michael Balandic witnessed what slow response to a natural disaster can do to a political career. The Chicago

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

emocratic machine's successor to Richard J. Daily was subsequently defeated by Jane Byrne who preyed upon the incumbent's arrogance and indifference to unplowed streets and closed airports during

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

the crisis. The blizzard exposed the ineffectiveness of the Democratic Machine's political patronage system. The defeat of a machine-backed Chicago mayor was previously unthinkable. Some believ

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

that the blizzard of '78 altered the history of Chicago politics enabling both Mayor Byrne and Harold Washington to serve in the office. I contend that Michael Balandic's political problems ste

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

mmed as much from arrogance and integrity shortfalls as the blizzard itself.

New Orleans 2005

If there is an American city that is historically more politically corrupt than Chicago, it might b

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

Following aspects would a

e New Orleans. So whatever Mayor Ray Nagin can accomplish might also be considered miraculous. To be fair, his task of restoring normalcy to his city dwarfs the issues faced by either Giuliani

dd to the challenges in developing combination products:

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

r Balandic. Heavily armed, released prisoners and street gangs that turned the streets of The Big Easy into Bayou Baghdad, compounded by a natural disaster that cut lines communication, public

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

utilities and transportation in a poverty-stricken, welfare state. Mayor Nagin has had to overcome the incompetence of a Federal disaster support team led by the disposed legal council for the I

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

ternational Arabian Horse Association. The ineffectiveness of political patronage is exposed by mother nature once again.

What leadership lessons can we learn from these three municipal crises?

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

There's the obvious need for improved preparedness: An ounce of prevention is worth a pound of cure. When challenged, ineffective systems will eventually be exposed. Any grandstander can asse

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

Professional from academic institutions, pharmaceutical industries, health care indust

s blame after the fact. What else is there?

When faced with a crisis, a leader chooses either to react or respond. Those who effectively respond gain the respect of their followers.

* Mayor Gi

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

uliani was all about results: before and during the crisis. Now he's cashing in. He's earned it.

* The late Mayor Balandic attempted to substitute deception and denial for the real thing. The

.

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

oters weren't fooled.

* Mayor Ray Nagin's story is still being written as his unique city is being reopened, restored and rebuilt. Judging from his tireless response, I like his chances, thoug

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

Companies that provide selfless information through particip

h this task will likely outlive his term in office.

Leadership, simply stated, is getting results through others. In the end, that is how the skills of these three or any of us will be evaluated

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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