Actual - Real Estate

Believe me: Clearwater is the lifestyle you've always dreamed of. It's a small town of friendliness, affordable housing, good schools and growing business opportunities. It's a true—officially voted—beach lover’s paradise, it's the new 9-million dollar Cleveland streetscape, the new

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

multi-million dollar beach walk, the new downtown marina with gorgeous water taxi that will take us back and forth from the white sand beaches and all the new shopping and restaurants of downtown. What more can we ask for? Apparently our Mayor Frank Hibbard dared to ask for much mo

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

Examples of combination products may in

re than that and to many that was very politically incorrect.

It will probably take a miracle to grant our mayor's wishes, but given that it is over a decade since there has been a good miracle in Clearwater, (ever since the Blessed Virgin Mary briefly chose to appear on the dark-t

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

inted window panes of an office building on the side of US19 highway back in 1996. This made Clearwater world famous almost overnight) I think it’s time for another, and I hope I could help.

I would be happy if he gets what he asked for. I like him. I only had a few chances to meet

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

him personally, but every time I left thinking, "He is good for Clearwater". It could be that he is young, the youngest to get that office at 34. It could be that he is more a business man than a politician, he is polite, good looking, and you know what? He is one of the people. I

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

Combination pro

go to a high society benefit, he is there in his tux. I go to the groundbreaking of the Station Square condos, he is there with the hammer in his hand helping to start demolition, one of the guys. Member of the Leadership Florida class of 2007, city’s representative on the Clearwat

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

er Marine Aquarium Foundation, Secretary of the Pinellas County Metropolitan Planning Organization, President of the Mayor’s Council of Pinellas County and a member of the Board of Directors of the Florida League of Mayors. Sunday school teacher, family man.

Mayor Hibbard transmits

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

a real love and dedication for this city and its people. I like him. You might think my humble opinion is rather unnecessary and I should go back to write about real estate. At any rate, if you are still with me, I feel there is more I need to say on this subject. This is not just

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

about local politics, this is about new developments, this is about turning this city into a vibrant, beautiful, alive community that everyone truly enjoys. And that is my field, too, so my opinion here becomes quite important.

Mayor Hibbard has been a driving force behind a lot

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

of good changes for Clearwater. Not only did he help get the new Causeway bridge finished against all odds, he was one of the first promoters of property tax cuts to show citizens that redevelopment has rewards, and he supported the key project of the downtown marina. On top of it o

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

ne of his biggest accomplishments over the past two years has been his ability to build consensus on the council. Hibbard himself admitted that it has been a challenge to help meet the needs of a diverse population in the city and all the different views on what the city wants to be

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

Following aspects would a

come. Leadership, political savvy, administrative skill, the ability to attract business, jobs and tourists. Those are just a few of the qualities a successful mayor needs and Hibbard showed us he has them all.

So what did he asked for that sparkled so much criticism?

He came up w

dd to the challenges in developing combination products:

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

ith the idea of switching to a strong-mayor form of government. Concentrate power in one high office, rather than diluting it between a city manager and council. A form of government that could bring in new business, improve city services and rejuvenate civic pride. He would also g

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

ain broad authority over day-to-day management of the city budget. The city will be equipped to succeed in fast-changing times. Scared yet? Don't be. Yes, Mayor Hibbard has broached the subject of change in Clearwater government. But that is just common sense for a better Clearwater

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

. Something that many other cities have already done.

All he has really done is show the courage to ask for the authority to carry out the responsibilities of his job, that shows even more to the citizens that he is a true leader; and sometimes, as a fellow citizen suggested in a l

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

etter, "Leaders need to lead in the deep water as opposed to the political safety of the kiddie pool. We should consider reacting in gratitude for and contemplation of the suggestion, rather than being fearful and suspicious of an individual servant of Clearwater." Well said.

It ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

kes absolute sense to try the strong-mayor approach. If the elected mayor doesn't measure up, it will be the voters who castigate him, not politicians who say one thing and do another. If the elected Mayor does not do a good job, you the voter can remove him and replace him with som

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

ebody different at the next election, and there is a greater chance that you will see change. Think about this: under the old system, you could never vote the city manager out of office for not doing a good job.

I have not personally discussed the mayor's ambitions with him, so I d

.

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't know what he might aspire to, but I look at the job he’s done, inspiring developers, investors, retailers, businesses, and citizens alike. I hope each one of you will be able to judge correctly in case we will be ever called to vote on this issue, no matter what criticism you w

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

Companies that provide selfless information through particip

ill read in local newspapers. He does have an authentic desire to carry out major projects and reforms that are genuinely needed. To me it does not seem like all he wants is personal power.

Actually, I cannot help but wonder... maybe he is aspiring to a better Clearwater after all.

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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