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Dear Email Alert Readers,
This free service by Florida Funding Publications
provides information critical to grant seekers and fundraisers. Visit our
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for more information on the grantseeking world.
Remember each alert comes with several
HOT GRANTS due in a given month. Scroll below for 3 Hot Grants. PLEASE NOTE DUE DATES!
***2005 FOUNDATION GUIDE
ANNOUNCEMENT***
For those of you who ordered the
Complete Guide to Florida Foundations, we again thank you for your
patience. The book is on schedule for a late March shipping. Below we
have compiled some of the statistics, numbers, and information about the
new book. We are sure you will be happy with the addition of more than
800 new Florida foundations as well as almost doubling the
amount of assets.
For those of you who haven’t ordered,
read the stats and order NOW (order form available on-line)
***Click
HERE for the Complete Guide Stats, including total number of foundations
and assets!***
THE 2005
COMPLETE GUIDE HAS BEEN SENT FOR PRINTING…EXPECT YOUR COPY SOON IF YOU
HAVE PLACED AN ORDER.
Florida Funding Staff
In this update:
I. News
1) WIDENING OF US1 STALLED
2) DRUG DEVELOPMENT AND RESEARCH (for those involved in medical
research field)
II. Order The Complete Guide to
Florida Foundations, 18th Edition, 2005
III. Hot Grants: March 2005, Part
III
I.
NEWS
Trial
delayed on challenge to plan to expand 18-mile stretch
nvironmentalists' challenge in federal court of plans to overhaul the
18-mile stretch leading to the Florida Keys was canceled Monday.
A clerk for Senior U.S. District Judge James Lawrence King apologized,
saying an unspecified ''medical emergency'' forced the delay. Joyce
Williams, King's courtroom deputy, would not elaborate but said the trial
could be rescheduled as early as this week.
The $270 million, three-year project, scheduled to begin within weeks,
is intended to widen shoulders, replace an aging bridge and add a
concrete divider to what is now a two-lane road with two four-lane
passing sections.
State transportation officials say the work will cut down on head-on
collisions and speed hurricane evacuations on the road, notorious for
horrific and frequently fatal head-on collisions. The narrow two-lane
Card Sound toll road is the only alternate to U.S. 1 traffic.
The Sierra Club, Friends of the Everglades and
the Florida Keys Citizens Coalition oppose the plan and want it delayed
for more study. They say the project will destroy 100 acres of wetlands
and likely spur a new wave of Keys development.
IVAX: The inside
story of how a drug is developed
or almost three decades, the concept of a ''soft steroid'' floated through
the mind of Nicholas Bodor, a drug researcher at the University
of Florida.
His goal was an anti-inflammatory steroid that could benefit patients
with asthma, allergies or arthritis but that didn't have the typically
harsh steroid side-effects of bloated ''moon faces'' or stunted growth in
children.
''This is an old problem,'' sighs Bodor.
In 2000, he joined IVAX, the Miami
drug maker, and started work on a molecule he thought could do the job.
Thus began an expensive corporate odyssey that will last a decade, even
in a best-case scenario.
This story chronicles the development of a drug with the prosaic
scientific name of etiprednol dicloacetate from early lab and animal
studies done in Budapest,
along with research on asthmatic sheep at Mount
Sinai Medical Center
in Miami Beach, to current
human trials now going on in Mexico
that may soon expand to Poland
and Bulgaria.
There are at least five years more work before this drug will go to
market, and it's possible at any time that the trials could fail and the
project could be abandoned.
The tale of this drug is a riveting example of the central debate
swirling through America's
drug industry today.
Critics say our unregulated prices are the highest in the world and
should be cut.
Drug makers say they need to charge hefty prices because they provide
them with the money and incentive to take huge risks to develop new
drugs. Only one in five drugs that start human clinical trials reach
market, according to the trade association PhRMA.
''This can be a tough path for a drug company, but the benefits for
the public are so large,'' says IVAX President Neil Flanzraich. ``The
system we have is not perfect, but it's a good system. It works.''
Critics of the drug industry disagree. One of the most vocal,
physician Sidney Wolfe of Public Citizen's Health Research Group, says
drug makers often ''are overstating the cost'' of developing drugs. He
believes that's proven by the fact that big drug makers frequently enjoy
profits of 17 to 20 percent a year, about twice those of the rest of the
economy.
Wolfe thinks many new drugs have no real purpose ''other than to earn
the drug companies money.'' He points to Nexium, a mirror of Prilosec, a
drug for acid reflux now available in generics, as a pointless expense.
IVAX's etiprednol is certainly not a Nexium. If it does work and is
safe, it could offer a significant new benefit for many patients.
On the profit front, IVAX, which offers generics and branded products,
has a margin of 10.8 percent, not 20, but the company won't say how much
it's costing to develop etiprednol.
THE COST OF DEVELOPMENT
Its executives point to a commonly cited industry figure of $800
million as the cost of developing a new drug -- an amount that Wolfe and
other critics say is greatly exaggerated.
In fact, Flanzraich says it will cost considerly less than that to
develop etiprednol, but when pressed for details, he says simply that
IVAX is spending ``many millions.''
The firm's financial statements reveal IVAX spent $140 million last
year in research and development, but that includes a thick pipeline of
drugs, only one of which is etiprednol.
The firm prides itself on not wasting money. It out-sources much of
its development work and does most of its research overseas because it's
cheaper.
''We have a very lean organization,'' says Edmundo Stahl, vice
president of pulmonary clinical research.
''They're using state of the art technology, but their labor costs are
about one-third of the United States''
because basic research is done in Budapest,
says Andrew Forman, an analyst for the financial services company Advest
who does not own IVAX stock. ``And their clinical trials are much less
because they conduct them in places like Mexico.''
Founded in 1987 by dermatologist Phillip Frost, IVAX has always been
interested in branded drugs, but during much of the 1990s its main
business was generics.
Generics don't require huge research expenses, but they also don't
yield the profit margins of branded drugs, and in 1999 the firm decided
to broaden its reach, and rewards, by launching a new effort in the
branded field.
To achieve its goals, IVAX purchased the Hungarian Institute for Drug
Research, which had 200 research scientists who had worked for the former
Communist government's national pharmaceutical institution.
THE KEY PLAYER
Within a year, IVAX added three top drug developers: Bodor, the
Gainesville scientist; John Howes, a veteran of a previous Frost company
who had been running a small drug development firm in Gainesville that
handled Bodor's discoveries; and Stahl, a physician with 20 years
experience in clinical development with big pharma firms.
Bodor was the key player. Of Hungarian descent and educated in Romania,
he had been a professor and drug researcher at the University
of Florida for 20 years.
Bodor became IVAX's chief scientific officer. He serves as the
language-cultural-scientific bridge between the Hungarian researchers and
the American administrators.
Bodor already had a patent on the etiprednol molecule, which he had
filed for in 1997, starting off a 20-year period of exclusivity.
Eventually, this patent was transferred to IVAX, and the firm undoubtedly
will file other patents associated with the drug and its formulation, but
a clock on the molecule's exclusive use by IVAX had started ticking long
before the drug will be ready for market.
In 2000, the Budapest lab
began working on the etiprednol steroid. The first step was to
manufacture it in large enough quantities so it could be used in lab and
animal experiments.
Most people think of steroids as being connected with athletes'
scandals, but, in fact, body-building anabolic steroids are only part of
a large group of molecules with a distinctive carbon-atom ring structure.
Etiprednol is a corticosteroid, produced by the adrenal glands or made
synthetically. Corticosteroids are anti-inflammatories, which among other
things can shrink inflamed lung tissue in asthma patients or inflamed
nasal tissue in people who suffer from hay fever.
SIDE EFFECTS
Such steroids work well and are widely used in medicine, but many
patients avoid them or complain of the unwanted side effects, including
bone growth problems, which can effect not only children but also
post-menopausal women with osteoporosis.
The problem is that a steroid taken in a tablet form that breaks down
in the stomach means a slow action in which the drug metabolizes with
negative side effects.
Etiprednol needed to hit the body fast -- such as through an inhaler
into the lungs -- and then dissolve. ''There is no way this works as a
tablet,'' says Howes. ``It doesn't survive in the blood stream.''
For an arthritis application down the road, it might be injected into
a joint.
Howes says that Bodor had already proven the fast breakdown qualities
of etiprednol with animal tests. ``So that was not an issue. But we had
to demonstrate efficacy and safety.''
STUMBLING BLOCK
Other scientists and other drug makers have looked at soft steroids.
The basic stumbling block has been that these steroids break down so fast
that they don't have any healing powers -- or that the doses required to
be effective are so high that they're toxic.
In Budapest, the drug was
first tried on rats and mice, then later dogs, to determine if it worked
as an anti-inflammatory. At the Mount Sinai
Medical Center
research building on Miami Beach,
the drug was given to sheep who had been sensitized to a parasite to
approximate asthma in humans. Because etiprednol was meant to be inhaled,
the animals were given the drug as a spray they breathed in.
The Budapest researchers
also worked on standard therapeutic indexes -- giving animals
extraordinarily high doses, many times higher than would ever be used in
humans to test the upper limits for body damage.
Altogether, says Bodor, ''there were 57 different studies'' of
etiprednol before it got to humans. These basic tests showed that the
drug was effective in animals and caused no physical harm at very high
dosages. All of this data is recorded and kept because it will ultimately
be needed for the drug's final approval by the Food and Drug
Administration.
In October 2002, after almost three years of lab work, IVAX filed
papers with the FDA requesting to start human trials of etiprednol as a
hay fever remedy. The FDA had no objections and in December 2002 the
company first gave etiprednol to humans, using a company in Austin,
Texas, that specializes in such early
trials.
This Phase IA trial involved using a nasal inhaler to administer a
single dose to several dozen healthy young men (not women, to avoid any
harm to their reproductive organs). The sole purpose was to show
etiprednol did no damage to humans. Blood and other tests were run to
prove that.
When this simple trial showed no problems, a Phase IB study was
conducted in the spring of 2003 by giving multiple dosages to several
dozen healthy volunteers, again only measuring safety.
COMPLICATIONS
Etiprednol again showed no problems, but complications were
developing.
Howes says one basic issue was shelf life. Etiprednol was being made
in a liquid solution and dispensed through a nasal inhaler as a fine
mist. The FDA insists that over time, the drug has to stay within certain
narrow parameters -- between 95 percent and 105 percent of its original
intensity -- and the industry shoots for a two-year shelf life for most drugs
for economic reasons.
As time went by, researchers were concerned a liquid version might not
provide enough shelf life. It was better, they decided, to make
etiprednol as a dry powder, giving it greater stability over a longer
time, and then dispense the power through an oral inhaler.
Meanwhile, says Stahl, executives debated what should be the first
usage of the drug. IVAX already had one hay fever remedy under
development, so why should it waste money developing two? What's more,
asthma seemed to be a bigger potential market.
The result: Eleven months after IVAX first asked the FDA to approve
tests for hay fever, the company went back and said it wanted to test
etiprednol for asthma. Another Phase IA and IB were required, this time
using an oral inhaler.
Again, Austin was the site of the testing. Those tests went well, and
in September, IVAX representatives started Phase II by meeting with
doctors in Mexico to discuss using etiprednol on their asthma patients.
''This is the key time,'' says Stahl.
After five years of preparation, etiprednol was finally given to
humans with asthma to see if it worked and was safe. If it was,
researchers needed to find the right dosages.
This is slow work. Doctors/investigators must be found and paid for,
and then the doctors must select the patients. After five months, only 50
some patients are enrolled. Eventually, Stahl hopes to expand Phase II to
300 asthma patients in Poland and Bulgaria.
Working with doctors and patients in other countries can be cheaper
than in the United States, but all of their experiences must be
documented for later submission to the FDA.
This phase is expected to last well into next year. In the meantime,
studies in Budapest will see if etiprednol causes cancer in laboratory
rats. These carcinogenic studies by themselves can cost $2 million or $3
million, says Howes, and will last three years. Similar studies will see
if etiprednol has any effect on the reproductive organs of animals.
MOVE TO PHASE III
If everything goes well with Phase II, IVAX researchers will meet with
the FDA and learn what regulators think is missing from its studies. At
the end of next year, the company may then move into Phase III, using as
many as 1,500 patients around the world to examine whatever the FDA wants
and to study some patients for up to a year to examine long-term effects.
And if that goes well -- the ifs are piling up -- in 2009 IVAX
could prepare an application for final approval from the FDA.
Steve Viti, senior director for regulatory affairs, says a typical
application might run 1,000 volumes at 300 pages per volume, documenting
the entire research process. The filing fee is about $600,000 -- paid to
the FDA to defray its costs of processing the application.
If everything goes right, etiprednol, with a fancy new brand name,
could hit the market sometime between 2009 and 2011, and then finally
IVAX can start earning what it hopes would be a high return on its
investment.
''This has to be one of the highest risk businesses,'' says
Flanzraich, IVAX's president. ``We don't have a crystal ball; we don't
know how it's going to turn out. And if you don't get a very high return
for all that risk, you might as well put your money in real estate.''
II. ORDER THE COMPLETE GUIDE
NOW...Shipping MARCH 2005!
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ART & 
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The COMPLETE GUIDE to Florida
Foundations 2005
18th Edition ~ 2005
COMING MARCH `05
Orders filled in order of receipt. $90 +
S&H, Visa, Mastercard & AMX. Call 305-251-2203 to order.
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~More
than 4,400 Florida Foundations
~More than $15 Billion
in Assets
~Detailed Profiles and
Indexes
~Improved Search
~An essential tool for
grant seekers since 1986
~Latest edition coming
2005!
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RESEARCH~SPORTS~COMMUNITY~SOCIAL
SERVICES~ENDOWMENTS~AND MORE!
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HOT
GRANTS
Historic Preservation Grant Deadlines
Cycle
· Historic
Preservation Small Matching Grants
Application Solicitation Period
· October 1st
to December 15th
Deadline for Application Submittal*
· December 15th
* In the event the closing date of the solicitation period falls on a
weekend or State Holiday, the submittal deadline will be on the next
business day.
Application Review and Ranking**
· March/April, by
the Historic Preservation Grant Review Panel
** Grant applications for Historic Preservation
and Historical Museums small matching grants are reviewed and ranked in
public meetings by ad-hoc Grant Review Panels appointed by the Secretary
of State. Historic Preservation and Museum Exhibit applications to be
funded by General Revenue Appropriation (Special Category) are reviewed
and ranked by the Florida Historical Commission appointed by the
Governor, President of the Senate and Speaker of the House. Grants are
awarded by the Secretary of State, based on the recommendations of the
Grant Review Panels and the Florida Historical Commission.
Community
Development (March 28)
Applications
for the Frederick P. Rose Architectural Fellowship, sponsored by
the Enterprise Foundation, are currently being accepted.
The
Fellowship creates partnerships between new architects and
community-based groups.
Architects
receive stipends totaling $120,000 over three years to
work with local community development corporations, community-based
organizations, or a tribally designated housing entity.
Applicants who are
interested in developing a partnership but have not found a partner
organization should contact Stephen A. Goldsmith.
As
director of the fellowship program he can provide a list of potential
partners who are part of the Enterprise Foundation Network.
Who
may apply: Architects working with a community-development corporation, a
community-based group classified as tax-exempt, or a tribally designated
housing entity.
The
partner organization must be a member of the Enterpise Foundation
Network.
Contact:
Stephen A. Goldsmith, FPRAF, Enterprise Foundation, 1283 East South
Temple, Suite 203, Salt Lake City, Utah 84102; (801) 364-6593; fax (801)
532-0709; sgoldsmith@enterprisefoundation.org;
www.enterprisefoundation.org/majorinitiatives/rosefellowship/index.asp
Department
of Health and Human Service
Deadline:
March
23, 2005
Centers
for Medicare and Medicaid Services
Cancer
Prevention and Treatment Demonstration for Ethnic and Racial Minorities
*visit grants.gov for more
infomation/applications for Department grants
Miami
Dade County Department of Cultural Affairs
2004-2005
Community Grants Program Guidelines
Application
Deadline: Tuesday March 22, 2005,
4pm
Contact:Mr.
Luis Ruiz Community Grants Program Administrator
Miami-Dade
County Department of Cultural Affairs
111 NW
1st Street, Ste. 625 Miami, Fl. 33128
_________________________________________________________
This Email Alert is a service of
Florida Funding Publications, authors of grants reference materials,
including the recently updated and widely used "Florida State Grant
Programs". For this and other grants reference materials, visit our
home page at www.floridafunding.com.
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