The Tucson-based Critical Path Institute is working to create a standard-setting body to evaluate the performance of diagnostic medical tests before their submission to the U.S. Food and Drug Administration.
This project has been approved by the C-Path board of directors, and initial funding for the project has come from a $2.16 million grant from Science Foundation Arizona. U.S. Rep. Gabrielle Giffords, D-Ariz., has also appropriated another $2 million in the 2009 fiscal year budget to supplement the grant from SFAz.
C-Path has hired PricewaterhouseCoopers to create a business plan for the new non-profit agency, and has received a federal trademark for its name, United States Diagnostic Standards.
This week, C-Path started approaching diagnostic companies to get commitments. The drug institute also is planning a new facility for the project and hiring employees.
To get a drug approved by the Food and Drug Administration, it may take 15 years and $1 billion, but the process is well-defined, according to Dr. Raymond Woosley, the president and CEO of C-Path. However, there is no such pathway for diagnostic tests, he said.
Companies like Ventana Medical Systems, which markets tests for cancer, have had difficulties getting these tests through the FDA system, Woosley said.
United States Diagnostic Standards, or USDS, will help streamline the process, filling a national need to advance the field of personalized medicine — the evolving process of matching patients to specific treatments based on genetic data.
“We think this is a huge unmet need, and, by filling it, will create jobs in Arizona, but more importantly it will really break the logjam so that we can get personalized medicine available to people in a more reliable fashion,” Woosley said.
Woosley pointed to institutions like United States Pharmacopeia (USP) and Underwriter Laboratories that have set standards in their industries and have seals of approval.
“We don’t have an Underwriter Laboratories or USP for diagnostic tests,” Woosley said. “So that’s why we got a grant from SFAz to see if such an entity would be viable, and then start it in Arizona.”
The new standards agency would take a product closer to final FDA approval by establishing performance standards for each test.
Initially, USDS is working closely with Ventana Medical Systems to establish standards for a diagnostic test the company has developed for lung cancer.
The business plan for United States Diagnostic Standards calls for a further $24 million in investment over the next five years for USDS to break even, Woosley said. He estimates it will be six to nine months before the facility is operating.
“It’s not a business because if it started making a profit, people wouldn’t value our seal of approval,” he said.
The non-profit status of USDS and its neutrality are essential for companies and the FDA to trust the results it produces, according to Dr. Gary Greenburg, a program officer at SFAz.
Greenburg sees this new national lab as very important to Arizona because it will raise the profile of Arizona and Southern Arizona in the diagnostic and bioindustry community and hopefully spin off new technology as a result.
“SFAz believes that the USDS will also help attract high-wage professionals to Southern Arizona, as well as acting as a magnet to attract and foster diagnostic and biotechnology companies,” Greenburg said in an e-mail.

October 30, 2008, 10:28 p.m.
RYN GARGULINSKI
Tucson Citizen

Tucsonan Ariel Hernandez Frayre will always remember Valentine’s Day - but not for its chocolates and roses.

That was the day in 2006 when the U.S. Army veteran’s truck in Iraq was blasted by an improvised explosive device.

Four men were on the truck; all survived. Three ended up in a troop clinic. Two received Purple Hearts. One, Staff Sgt. Hernandez Frayre, had to wait two years for the honor to come.

After he left Iraq in 2006, Frayre’s medical records were lost in a computer failure, said U.S. Rep. Garbrielle Giffords, who helped iron out the mess.

“She made one phone call and that was it,” Hernandez Frayre, 28, said at a ceremony outside Giffords’ office Thursday.

“It’s a great honor. I don’t know what to say,” he said. “I’m very excited.”

Several family members attended, including 4-year-old daughter Elizabeth, who helped pin the medal on her daddy.

Tucsonan Michael Ryan of the Military Order of the Purple Heart was also on hand. He knows all too well about waiting for an award.

He received his Purple Heart 35 years after he was injured in Vietnam. His records, too, had been somehow overlooked.

Ryan’s medal came with the help of former U.S. Rep. Jim Kolbe, Giffords’ predecessor.

“I remember no one was there except my wife,” Ryan said of the moment he received his medal. “There was no hoopla.

“I wanted to be here for support.”

Along with Ryan, Hernandez Frayre is now among the ranks of the 189-member strong Tucson chapter of the Military Order of the Purple Heart, which meets monthly.

Thursday’s gathering on a sunny lawn in Tucson was a far cry from where the family was two years ago.

Knowing the situation at home in early 2006, Hernandez Frayre didn’t tell his family he was wounded in the blast.

“I didn’t know about the injury when it happened,” said his wife, Megan Hernandez, 27. “I was already stressed out.”

While Hernandez Frayre was overseas being treated for injuries, his and Megan’s twin sons - Angel and Daniel - were in intensive care, born four months premature.

The worried father was allowed to come home when one of the babies developed pneumonia and a collapsed lung.

Thursday, Hernandez Frayre was honored and his military service made known.

“We are glad he’s home,” said his dad, Mike Mason.

Though Hernandez Frayre has finished his time in the Army, he hasn’t finished serving his country. He now works as a Border Patrol agent.

Born in Hermosillo, Mexico, Hernandez Frayre moved to the U.S. with his mother at 14.

Four years later, he enlisted in the Army and has since become a naturalized citizen.

“The voters of Arizona CD 8 are seeing the politically ineffective side to GOP Congressional candidate Tim Bee. The guy can not make up his mind….
Let me preface my remarks by saying that Tim is a really nice guy. In fact, his easy going niceness is part of his political problem. He has a terrible time making up his mind if doing so will offend someone. I learned this first hand while serving in the Senate with Tim. I learned quickly that you never could count on his support.

We were called into a special session by the governor. One issue we needed to address was something called Excess Utilities which helped school districts budget for and pay for utility expenses. I was trying to garner 16 votes to support the continuation of the program. Senator Bee should have been a pretty easy YES because some of his school dsitricts in LD 30 directly were impacted by the vote. As I recall, the Vail School district desperately needed Tim’s vote.

I remember calling Tim at home the day before the vote. He assured me he was a YES. We had the necessary 16 votes. The only problem is the next day on the floor, Tim changed his vote to NO. He later told me that he did not know how to tell me he had changed his vote because Senate President Ken Bennett had put pressure on him. When I asked him about Vail, he just shrugged his shoulders and said, “Ken needed my vote.” I guess the folks in Vail play second fiddle to the senate boss from Prescott.

Holy Cow! This guy caves in all the time. We sat next to one another on the Appropriations Committee. Numerous times, after he voted (in my opinion the wrong way), he would turn to me and whisper, “I wish I could have voted your way. You know you’re right.” After awhile I started to ignore him because of his lack of political backbone.

I now read that he is unsure how he stands on the Social Security issue. I also read that after putting Proposition 102 (the Marriage Amendment) on the ballot, he is unsure how he will vote. I am not surprised by either revelation that Bee is “unsure.” The guy should be a social director at a country club, not a member of Congress. Hey, if you plan to visit DC and want to take a Capitol tour, vote for Bee! He will be great at Capitol tours”

PUBLISHED ON SEPTEMBER 11, 2003:

Easy Ride
The Tanque Verde School Board is preparing to give a key politico’s company a sweetheart deal.

By CHRIS LIMBERIS email this author
The Tanque Verde School Board is primed to bail out a company owned by influential state Sen. Tim Bee and his brother with a real estate deal for a bus yard and office next to the district’s headquarters.

The Bee Line, operated by the second-term Republican and his brother and Senate predecessor, Keith Bee, wants to switch from tenant to landlord on a parcel that adjoins the Tanque Verde bus yard and is east of the district offices at 11150 E. Tanque Verde Road.

Taxpayers already subsidized the Bee Line this year after the company fell behind on the $725 monthly rent. Tanque Verde officials also allowed the Bees to use the property after the lease expired in February.

Rather than face eviction, Keith Bee eventually paid the back rent while he simultaneously pitched the proposal for Tanque Verde to use space on the adjoining Bee property. Such an arrangement will clear the Bee buses from the district’s lot. More important, Keith Bee is hoping his company will therefore be able to circumvent Pima County zoning and building codes, records show.

Under the proposal, set for board approval Sept. 11, the Bee Line will open its own bus yard and office on two acres of residential-zoned land just north of the district’s bus yard. The Bee brothers will then free up space for the Tanque Verde school buses and lease the parcel to the district for $1 a year.

Keith Bee, a five-term senator representing the Tanque Verde Valley and other east Tucson and Green Valley areas, bought the property for $135,000 in 1999, according to county records.

Zoning at CR1 allows not a bus yard but two homes. Without the nominal lease with Tanque Verde, the Bees “would not be able to fence, grade, put down gravel or house a portable office because of zoning issues,” Superintendent Denise Ryan told the school board in an Aug. 8 memo.

By signing the nominal lease with Tanque Verde schools, the Bee brothers are hoping to piggyback on land use law that generally allows school districts to use property as they please. County officials say there is no guarantee in this case.

Keith Bee has asserted that the new arrangement will save Tanque Verde taxpayers, but one proposal had the district paying an equal $6,500 share for initial improvements, records show.

Some neighbors already have issues with Bee Line’s use of the district’s property, particularly when the large touring coach is fired up.

Among the problems cited by Carolyn Gould, director of Tanque Verde school transportation, are “complaints from neighboring houses. Diesel smoke, noise late at night and on weekends. Bee Line has been asked to move their buses in the main parking lot in the morning to ‘pre-trip,’ them. Only a few drivers are doing this,” Gould said in an 2001 assessment.

Exhaust from the coach bus, Gould said, “creates a dust storm, which keeps our district vehicles and vans filthy.”

Gould listed five other problems in the 2001 memo and confirmed in a new memo on Aug. 6 to the Tanque Verde board that “all of the problems listed are still problems today.”

Tim Bee’s position in the Senate–and his role on the appropriations committee–as Tanque Verde progresses with its controversial plan for a new high school prompted at least one board member to demand kid-glove treatment for the Bee Line.

Board member Doug Hughes unilaterally ordered Ryan and Associate Superintendent Marty O’Shea to not rile the Bee brothers while start-stop funding for the high school was on legislative tables, O’Shea said.

“Doug came into my office and told me to back off,” O’Shea said. “He told Denise Ryan the same thing. This is when we were talking to Keith Bee about the late rent and the expired lease. You know me; I like to have the document. We didn’t have a lease.”

O’Shea said Hughes, who sells school textbooks, said he was not solely focused on Tim Bee’s vote to preserve funding for the high school, but for educational funding in general.

State policy prohibits members of school boards from issuing individual orders. Directives must be approved by the full board in open session.

But it worked. Tim Bee subsequently did not recuse himself from a key vote on funding for the high school, which has caused civil war in Tanque Verde and prompted a recall drive of Board President Dr. Sherrylyn Young.
Neither Hughes nor Tim Bee returned calls from The Weekly.