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Cosmic...OK, it was between the Emerson quote and this one by Teddy Roosevelt. Such a great day, I decided to post this one as well:
"It is not the critic who counts, not the man who points out how the strong man stumbled, or where the doer of deeds could have done better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood, who strives valiantly, who errs and comes short again and again, who knows the great enthusiasms, the great devotions, and spends himself in a worthy cause, who at best knows achievement and who at the worst if he fails at least fails while daring greatly so that his place shall never be with those cold and timid souls who know neither victory nor defeat."
Theodore Roosevelt
Have a great evening everyone...
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1USGrant...I had almost forgotten that IBM and Moffit are giving the keynote address at the upcoming BioFlorida Conference where Richard Gabriel will be presenting.
When I posted that message, any relationship with Moffitt was mere speculation. Great to see this news today.
Conference is April 1, 2004. Could be interesting...
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Cosmic...Doesn't it feel great to finally see this company get recognition for it's hard work and dedication to a cause? Wow!
Congratulations! A job well done, including all employees (current and former), scientists, AND much maligned management.
And to you at DNAPrint, that have worked hard and persevered in the face of financial struggles, scientific doubters, and impatient investors, this quote by Ralph Waldo Emerson sums it up best:
What I must do is all that concerns me, not what the people think. This rule, equally arduous in actual and intellectual life, may serve for the whole distinction between greatness and meanness. It is the harder, because you will always find those who think they know what is your duty better than you know it. It is easy in the world to live after the world's opinion; it is easy in solitude to live after our own; but the great person is one who in the midst of the crowd keeps with perfect sweetness the independence of solitude.
Now show'em what'cha got!
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Teamlasvegas...Thanks for posting that Moffitt PR. I especially liked this part:
In the new pharmacogenomics alliance, Moffitt physicians and scientists are teaming with DNAPrintTM to identify genetic variants that underlie poor patient response to various chemotherapies and also to implement new clinical tests at the Cancer Center.
Ovanome????
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froggy...How do you know that there will be "no money changing hands here."
Might I refer you to the DNAPrint website under Products/Pharmacogenomics:
FDA rules regarding pharmacogenomics testing are still evolving and we are seeking additional guidance from the FDA on this issue. Until OVANOMETM is FDA approved or deemed to not require FDA approval, we plan on generating revenues through physician guided Investigative New Drug studies.
Physician guided new drug studies...isn't that a large part of what they will be doing at Moffit? Aren't we working with the Associate Center Director for Clinical Investigations?
IMO, though not assured, there is a distinct possibility that some revenue would be generated during the course of this work.
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bag8ger/Miss Scarlet...The current score: Biologists 1; Engineers 0 lol
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jbmccoy57...Where have I seen this before???? Oh, I know:
http://investorshub.com/boards/read_msg.asp?message_id=2626058
I love it when a plan comes together...lol JMHO of course.
Thanks for reposting that article.
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frog...Actually I am in the pollution contol business. And I'm finding that it applies even here, or so it seems...lol
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OT: Miss Scarlet...Can't help it. I think it goes all the way back to high school biology.
You know, even after you pith a frog, a very mild electrical stimulus will make him twitch...lol I see it holds true whether he is awake or "dreaming".
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MattG...Where was the press release about Genetic Identity selling AncestryByDNA, or Genelex selling the product?
Who is John Galt?
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frogger...LOL, I'll leave it to the board to decide for themselves who's spinning.
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ps I'm a Biologist working in Technical Sales. My job is to educate engineers, and trust me, with some it is an exceedingly difficult task.
eb...George Frudakis sold the building about six months ago. I came across the transaction while checking the local real estate listings. DNAPrint occupies it under a lease agreement..eom
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bag8ger...Perhaps he missed the lilypad altogether! lol
I posted the link as evidence of yet another AABB Accredited lab that is offering their test. For me it was positive news. I guess it depends on your perspective.
But I am a firm believer that there is purpose to every happening. Maybe while in the pond he will get the opportunity to add some water to his glass...lol
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froggy...You seem to have "jumped" to a conclusion.
The statement on the website says "assist in validating..." I didn't see a statement that said the government "accept(s) DNAP results as proof of Native American ancestry", as you state in your post.
Surely, the test might be useful as corroborating evidence, to "assist" in validating NA. I see nothing nefarious in that statement.
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dnapfan...Or extreme loss...lol
And yes, those types of returns are certainly possible. Last June the price appreciated 600% in a matter of days based on positive PR. This past fall it doubled in a week or two time.
Many here believe in the long term value of DNAPrint's technology and are looking for still bigger gains.
But as I said at the outset, both extreme gains AND extreme losses are possible when taking extreme risk...
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MattG...Quite simply, the text on the site tells you:
New cutting edge technology in genetic testing is now available. Whether your goal is to assist in validating your eligibility for government entitlements such as Native American Rights or just to satisfy your curiosity, our Ancestry DNA Test is the only scientific method available for this purpose in existence.
If A=B, and B=C, then A=C. If this statement is true (our Ancestry DNA Test is the only scientific method available for this purpose in existence), and AncestryByDNA exists (as we all know), then by deduction, the test IS AncestryByDNA.
BTW, and they ARE correct. It is the only existing scientific method for this purpose.
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dnapfan...I would think that someone that just dropped $8,000 on a stock might already know the answer to those questions. Tell me, on what did you base the statement that you "expect to be getting a great return"?
Good Luck in the Long Haul,
W2P
Looks like another site offering DNAPrint ancestry testing:
http://www.dnatestingsolutions.com/html/ancestry.html
And they're located right in Tampa, FL, go figure:
http://www.dnatestingsolutions.com/html/contact.html
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A little more on the Affy/Beckman Coulter collaboration:
http://10kwizard.ccbn.com/fil_list.asp?TK=AFFX&CK=913077&FG=0&alld=ON&BK=FFFFFF&...
Clinical Applications Initiatives
We believe that our GeneChip® technology can be effectively applied to complex molecular diagnostic testing. We have formed collaborations and intend to further partner with, or license technology to, established diagnostic and medical device companies to develop, obtain regulatory approval for, and commercialize probe arrays and instrumentation for broader use of probe arrays as components that can be incorporated into diagnostic products and other clinical applications. We believe that to support large central laboratories, additional instrumentation and automation will need to be developed to allow for handling the large volume testing anticipated in the clinical diagnostic setting. To further our clinical applications strategy, we have established a number of collaborations with leading academic researchers, pharmaceutical and biotechnology companies.
For example, we are non-exclusively collaborating with Roche to develop and commercialize GeneChip® laboratory tests for DNA analysis, genotyping and resequencing applications, as well as for RNA expression analysis, in a broad range of human disease areas. Using our GeneChip® technologies, Roche intends to develop and market tests for diseases such as cancer, osteoporosis, cardiovascular, metabolic, infectious and inflammatory diseases. We and Roche believe that developing diagnostic products for cancer and other human diseases will establish new standards for genetic clinical testing. Ultimately, these products will allow physicians to better diagnose and treat human disease.
In addition, we have collaborations with several academic research centers, including Boston University Medical Center and the Whitehead Institute for Biomedical Research, to discover and test molecular signatures for specific indications, as well as to develop and test new methods necessary to meet the requirements of diagnostic applications.
In bacteriology, we have a non-exclusive collaborative development agreement and an associated supply agreement for probe arrays with bioMérieux to identify the species and drug resistance profiles of those bacteria causing human infection. The agreements also allow for non-exclusive development of DNA probe arrays for certain viral clinical diagnostic tests and in the fields of food and industrial testing.
We have also entered into a series of agreements with Beckman Coulter that give Beckman Coulter the right to develop probe array-based diagnostic products that would use some elements of our GeneChip® technology. Under these agreements, we agreed to grant Beckman Coulter licenses to commercialize probe arrays manufactured using certain of our technologies other than light- directed synthesis. Under the arrangement, Beckman Coulter would pay us transfer prices and royalties on sales of these products.
And if we dig further we discover that the new series of agreements actually involves a NEW entity called:
Array Automation, Ltd. (Joint venture with Beckman Coulter, Inc.)
Array Automation is a joint venture between Affymetrix and Beckman Coulter, Inc. The joint venture was incorporated in July 2003, with the primary purpose of product research and development in the field of non-photolithographic arrays of polynucleotide sequences and instruments. July 2003
Here's a little more detail on their relationship:
Other Collaborations
Beckman Coulter, Inc. In July 1998, we entered into an arrangement with Beckman Coulter, Inc. ("Beckman Coulter") that involved the execution of a series of agreements including an asset purchase agreement. Pursuant to these agreements, which were implemented and became effective in June 1999, we purchased Beckman Coulter's array business. Under the agreements, we agreed to grant Beckman Coulter licenses to commercialize probe arrays manufactured using certain of our technologies other than light-directed synthesis, and the parties agreed to enter into an original equipment manufacturer supply agreement for products that use our GeneChip® array technology. Under the arrangement, Beckman Coulter agreed to pay us transfer prices and royalties on sales of these products.
Array Automation Ltd. The Company is currently a partner in Array Automation, LLC ("AAL"), a joint venture with Beckman Coulter, Inc. ("Beckman"). In July 1998, the Company entered into an asset purchase agreement with Beckman. As part of the asset purchase agreement, the Company agreed to establish a joint venture with Beckman. AAL was incorporated in July 2003, with the primary purpose of product research and development in the field of non-photolithographic arrays of polynucleotide sequences and instruments. (Please see Note 10 of the Notes to the Consolidated Financial Statements.)
And of course, to be complete, we need to see what's in Note 10 to the Consolidated Financial Statements:
ARRAY AUTOMATION, LLC
The Company is currently a partner in Array Automation, LLC ("AAL"), a joint venture with Beckman Coulter, Inc. ("Beckman"). In July 1998, the Company entered into an asset purchase agreement with Beckman. As part of the asset purchase agreement, the Company agreed to establish a joint venture with Beckman. AAL was incorporated in July 2003, with the primary purpose of product research and development in the field of non-photolithographic arrays of polynucleotide sequences and instruments. In accordance with the agreement between the Company and Beckman, 100% of the losses generated by AAL are allocated to Beckman. Future net income generated by AAL, if any, is allocated 51% to the Company and 49% to Beckman, after Beckman has recovered all of the cumulative losses it has recorded.
Based on the application of FIN 46, the Company has concluded that AAL is a VIE and the Company is not the primary beneficiary. Accordingly, the Company will account for its investment in AAL using the equity method. Since the cost basis of the Company's assets contributed to AAL were of zero value, the Company's investment in AAL is also recorded at zero value. As a result, the Company will not record any impact of AAL's operating results in its consolidated statements of operations until, and only if, Beckman has recovered all of the losses that it will absorb pursuant to the terms of the joint venture agreement. If AAL is terminated with a cumulative deficit, the Company is not obligated to fund any such losses. In addition, the Company does not have any obligation to provide funding to AAL, guarantee or otherwise have any obligations related to the liabilities of AAL or its investors.
Just something to keep an eye on given the fact that Beckman Coulter owns the original Orchid option on DNAPrint SNP based technologies.
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OT: Maybe or maybe not?
I've held a fascination for Affymetrix since the 2003 introduction of their 10K mapping array. In reading their recently filed 10K, this statement stood out as potentially significant:
http://biz.yahoo.com/e/040315/affx10-k.html
Company Outlook
In general, as management looks ahead to 2004, the outlook for our Company continues to be favorable for a number of reasons. We anticipate that continued improvements in access to capital markets will favorably influence sales in the biotech arena, that the current regulatory market appears poised to leverage genetic information tools to improve the approval process for new drugs, and that we will see continued standardization on our technology platform for both existing and new applications. Although it is difficult to predict product demand in 2004, we expect continued growth in the total number of probe array and related supply sales as the number of experiments on GeneChip technology continues to grow. Additionally, due to the strong adoption of our new line of DNA analysis products in the second half of 2003, we anticipate that these products will make a meaningful contribution to our array growth in 2004. Management also expects that we will continue to demonstrate strong operational leverage as we grow into our infrastructure.
Going forward, management is focused on growing the business and increasing its profitability. A key driver will be increasing the breadth of scientific and clinical applications of our technology, while also industrializing, automating and standardizing our technology to open new markets and drive revenue growth. The aim of our automation efforts is to reduce the cost per experiment, minimize operator variability and dramatically improve experimental throughput. We believe that our automation solutions will enjoy the same success in the high-throughput markets as our bench-top systems have in the research markets. In addition, we are industrializing our processes through collaborations with industry leaders such as Beckman Coulter, Caliper Life Sciences and others.
And just what is it that they are collaborating with Beckman Coulter and Caliper:
We collaborate with both Beckman Coulter Inc. and Caliper Life Sciences in the development of automation for GeneChip technology applications for use in drug discovery and development.
Interesting...
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mingwan0...Perhaps he was TOO familiar to DNAPrint investors...lol
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Interesting choice of ADR's that Eudragene has chosen to tackle first. Mr. Paul McKeigue, familiar to all DNAP investors, is leading the effort, but as you can also see many countries are involved:
http://www.Eudragene.com
Here's an excerpt:
EUDRAGENE
European collaboration to establish a case-control DNA collection for studying the genetic basis of adverse drug reactions
This project is funded with support from the European Union from 2003-06 (Project number: QLRT-2001-02757)
Coordinator: Paul McKeigue <paul.mckeigue@ucd.ie> Professor of Metabolic and Genetic Epidemiology, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK
Tel: +44 20 7927 2633
Objectives
The specific objectives of this study is to establish a collection of DNA samples as a resource for studying genes which influence serious or adverse drug reactions (ADRs). Identifying genes that influence susceptibility to adverse reactions will advance understanding of the basis of adverse drug reactions and may also lead to the development of tests that can predict individual susceptibility to adverse reactions, with obvious benefits to human health.
At least 500 cases of each ADR will be collected, together with an equal number of healthy volunteers. The co-ordinating centre will manage the database, and will make samples freely available to academic and industry-based researchers throughout Europe. The collection will be extended to include more ADRs after the first 1-2 years, based on problems of current concern.....
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Published this month in "Annals of Human Genetics":
http://www.blackwell-synergy.com/links/doi/10.1046/j.1529-8817.2003.00084.x/abs/
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mingwan0...Yes, and his upcoming publications are equally interesting:
PUBLICATIONS
In preparation
Fernández, J.R., Redden, D.T., Goran, M., Gower, B.A. (manuscript in preparation) Association of genetic admixture markers with insulin-related phenotypes.
Fernández, J.R., Jones, A., Albu, J., Shriver, M.A., Allison, D.B. (manuscript in preparation) Genetic admixture and body fat in Puerto Rican elderly women
Fernández, J. R., Holt, J., Beasley, T. M., Allison, D. B. (manuscript in preparation) Decomposing race: supporting the use of genetic admixture in explaining racial differences in complex traits.
Looks to me like Shriver and his fellow scientists are out in force providing scientific validation of the concept of using AIM's and admixture to discern complex phenotypic traits.
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This is probably old, but is worth looking at again:
http://www.demko.com/m030710.htm
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Looks like DNA Phenomics is "emerging" from somewhere...lol At least Windhover is selling their profile for $25 as of February 2004:
http://216.239.39.104/search?q=cache:v-RfGpAYyD0J:sis.windhover.com/windbuy/lpext.dll/windbuy/iv/200...
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And don't forget that while Richard Gabriel is presenting to the BioFlorida folks on April 1, 2004, Zach Gaskin will be presenting March 31, 2004 at the Bode Technologies/Promega sponsored STR Megaplex and Advanced Research Technology Workshop in Virginia Beach, VA:
http://www.bodetech.com/documents/syllabus.pdf
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OT or maybe not:
http://story.news.yahoo.com/news?tmpl=story&cid=586&e=3&u=/nm/20040321/wl_nm/malaysia_el...
Big Win Gives Malaysia's Abdullah Mandate for Change
Sun Mar 21, 4:58 PM ET Add World - Reuters to My Yahoo!
By Simon Cameron-Moore
KUALA LUMPUR (Reuters) - Malaysian Prime Minister Abdullah Ahmad Badawi's resounding victory over an Islamist opposition in parliamentary and state polls on Sunday has given him a mandate for change that will start with his cabinet.
When Abdullah took over in October from veteran leader Mahathir Mohamad, he was widely seen as a transitional leader.
But after one of the biggest wins in Malaysia's history, Abdullah should master his notoriously factional United Malays National Organization (UMNO).
"I'm confident to say there will be a few young faces in my cabinet," Abdullah told a news conference which followed jubilant scenes at his party's headquarters.
UMNO has led all of Malaysia's multi-ethnic alliances since independence from Britain in 1957. But the loss of more than half the popular Malay vote in the 1999 election raised questions whether it could still represent the ethnic Malay majority.
Abdullah laid those doubts to rest as he put the Islamist challenge of Parti Islam se-Malaysia (PAS) to flight in the Malay heartland states in the north of the peninsula.
Returned with a parliamentary majority of well over two thirds, the multi-ethnic Barisan Nasional coalition that UMNO heads can pass laws uncontested. The Barisan took 90 percent of the seats, with a handful of results still to come.
The success was matched in polls for provincial assemblies, with the ruling parties winning 12 of the 13 states.
Results in the last state, Kelantan, currently held by PAS, will be announced at about 10.00 a.m. (0200 GMT) on Monday after recounts in eight of the 45 seats.
Malay voters deserted UMNO in 1999 after Mahathir sacked and jailed his former deputy, Anwar Ibrahim.
But the floodtide in favor of Abdullah also seemed to wipe out Keadilan, the party that sprang out of Anwar's reform movement and which was allied with PAS.
Anwar's wife, Wan Azizah Wan Ismail, was also facing a recount in her seat, which was once occupied by her husband who is now serving a 15-year jail term for sodomy and abuse of power, and the party looked unlikely to win any other seats.
PAS had set the political agenda with its ambitions to turn a country where 40 percent of the people are non-Muslims into a strict Islamic state, governed by laws written centuries ago prescribing punishments such as stoning and amputation.
But the hardline preachers who lead PAS were unable to counteract the goodwill Abdullah generated during his first months in power through a campaign against corruption.
Hailing from a long line of Muslim scholars, Abdullah was able to command respect for his modern, tolerant views on Islam.
"We would like to promote Islam which is progressive and at the same time practices tolerance toward other non-Muslims in Malaysia," Abdullah told the post-victory news conference.
"And it seems to be an idea accepted by Muslims and non-Muslims."
The arrest of a cabinet minister and a well known businessman persuaded people Abdullah meant what he said, and there are strong expectations that bigger fish may be hauled in.
Domestic and foreign investors welcomed Abdullah's win, which had been priced into rising share and bond markets, but the margin of victory could excite more buying.
"The business community will be very happy, and so will foreign investors, because this means continuity in the pro-growth, moderate approach," said Choo Swee Kee, fund manager at KLCS Asset Management.
Interesting...
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Grateful...I believe Karin's been around since last August or September...and I believe that in time 160 kits/month will look like peanuts...lol
Remember, we are in the infancy of this technology and it's application to crime fighting. Everyone thinks in terms of violent crime, rape, and murder (and as a couple of latter posts illustrated, there are a GREAT number of those). But, there are many other types of cases where phenotypical information would be of benefit, particularly as the methods available to retrieve crime scene DNA improve.
Just a matter of time and patience IMO.
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Terry...A review of the most recent quarterly revenues shows approximately 50% gross profit on sales. The great bulk of those revenues were derived from a very similar test selling for $158.00. In addition to the test, DNAPrint provides a nice document package, a CD, a book, etc. with the results. It looks to me as if the cost of the testing itself is something less than $70.00 per sample.
DNAPrint sells contract genotyping services for $0.47/genotype. Now, the DNAWitness test is certainly more involved than contract genotyping, but ultimately it involves genotyping only 71 markers. At $0.47/genotype that would amount to around $35.00 per sample. The company has been offering to type a number of free samples with the early orders to demonstrate efficacy of the test, and as I said earlier, there is certainly more involved sample preparation, quality assurance, etc. with DNAWitness. But suffice it to say, I believe margin will be far beyond 20%.
Ultimately, I believe that COSTS will range from 20-40% of revenue (due to efficiencies of scale), leaving more like 60-80% profit per test.
In addition, I would point out that your figures for case load are U.S. cases alone. DNAPrint's forensics and genealogy will have worldwide markets.
Lastly, this year's accounting losses are inflated due to the Executive Management stock awards. If you focus the analysis on cash flow, you'll discover that cash burn was approximately $76,000/month beyond current revenue. At $1000/test, and 50% gross profit, 160 samples per month bring you to current break even.
Of course cash requirements will rise as the company grows and as executive salaries replace stock based pay. But in any event, it is not far fetched to imagine that forensics and genealogy revenue could, alone, provide the necessary revenue to sustain the company. IMO
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Just a sample of the types of individuals Zach Gaskin will be speaking with at the NDAA Board of Directors Meeting. According to her CV, Lynne Abraham is currently VP of the NDAA:
http://www.phila.gov/districtattorney/aboutus/DA_Bio/da_bio.html
This is good stuff folks.
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BioFlorida Website and Member Listing:
http://www.bioflorida.org/modules.php?op=modload&name=Memberslist&file=index&letter=D&am...
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For those people that are already belittling this opportunity (you know, the small thinkers of the boards), TBTF is quite an organization. They are also sponsoring a Technology Transfer Conference in May in conjunction with some familiar names:
http://www.tbtf.org/article.cfm?article=85
The university participants include: Florida A & M University, Florida Atlantic University, Florida Gulf Coast University, Florida International University, Florida State University, H. Lee Moffitt Cancer Center, Nova Southeastern University, University of Central Florida, University of Florida, University of Miami, University of North Florida and University of South Florida.
Announced speakers for the event include Andreas Stavropoulos, a director at Draper Fisher Jurvetson, a leading seed and early stage venture capital firm; and Charles Linzner, vice president and senior counsel, Bristol-Myers Squibb Company. These speakers and others will offer insight into their own technology transfer experiences and cover topics related to biotechnology, engineering, defense, pharmaceuticals, information technology and other related industries.
"For the first time, the business community will be able to forge two-way, interactive and highly-customized relationships with the Florida academic community for the purpose of commercializing advanced technologies," said Russ Alba of Foley & Lardner in Tampa. "The tech transfer conference is a leading indicator that the new economy is alive and well in the state of Florida."
Announced sponsors for the conference to date include: Akerman Senterfitt; Allen, Dyer, Doppelt, Milbrath & Gilchrist, P.A; Edwards & Angell, LLP; Enterprise Florida; Florida High Tech Corridor Council; Florida Trend magazine; Foley & Lardner; Holland and Knight, LLP; IBM; ITFlorida; Market Smart Technologies; Metro Orlando EDC; Progress Energy; Senniger, Powers, Leavitt and Roedel; Sutherland Asbill & Brennan LLP; Tampa Electric Company; Tech Solutions, Inc.; and UTEK Corporation.
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Here's a link to the Tampa Bay Business Journal article about the conference:
http://www.bizjournals.com/tampabay/stories/2004/03/08/daily21.html
The conference, sponsored by IBM, will feature 30 companies selected to give two and a half (2.5) minute presentations detailing their firm's products, services, and the type of partnership they're seeking. The program was adopted from a wildly successful annual program hosted by the Arizona Technology Council, dubbed "150 Seconds of Fury," because of the sense of urgency presenters feel to articulate a lot of important information in a very brief pitch.
The company presentations will be preceded by a keynote presentation featuring IBM Life Sciences executive Bill Kirkland and H. Lee Moffitt Cancer & Research Center vice president and CIO Ronald Doremus.
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mingwan0...And of course, there were these paragraphs as well:
Tampa, FL (Feb 19, 2004) - The H. Lee Moffitt Cancer Center & Research Institute and IBM are collaborating on a new disease-management system designed to help researchers and clinicians speed cancer screening and diagnosis. The system will help identify patients at risk and potential clinical trial participants more rapidly.
...
Moffitt’s more than 280 physicians, 600 researchers and network of 13 affiliate hospitals throughout Florida have a unique “bench-to-bedside” approach to patient care. The clinical and research teams work closely together, sharing data, designing innovative clinical trials that take into account the latest findings and determining tailored treatment options for Moffitt patients.
I'd toast you, but I'm afraid I might end up with an EMPTY glass...lol
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mingwan0...And what with the company setting up quarters in the new USF Research Park, do you suppose there is any connection to the recent IBM, Moffitt collaboration announcement? They will be giving the keynote address for this conference, and I noted the statement in the DNAPrint PR to how they are working with a Florida institution to combine it's technology with other genetic methods to help reduce the risk of cancer treatment:
http://www.moffitt.usf.edu/about_moffitt/press/press_releases/2004/20040219a.asp
Certainly would make a nice fit...JMHO of course.
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Ann...Thanks, I did a review of the website the other evening and wondered if the changes I thought I saw were changes...or if it had just been THAT long since I looked at that stuff! lol
Have a great evening,
W2P
Here's some text that's been there since the update last fall but hasn't been extensively commented on. It regards the pharmacogenomics market and Ovanome in particular:
Once funding sufficient to screen 250 patients at $1,000 per patient is received, OVANOMETM will be tested in clinical trials for monitoring and reporting on the use of Taxol and Carboplatin. Our Chief Medical Officer, Hector J. Gomez, MD, PhD will lead the clinical development process.
FDA rules regarding pharmacogenomics testing are still evolving and we are seeking additional guidance from the FDA on this issue. Until OVANOMETM is FDA approved or deemed to not require FDA approval, we plan on generating revenues through physician guided Investigative New Drug studies.
The first paragraph describes testing of Ovanome as a "Medical Device" and would fall under the regulations for Investigational Medical Devices. In this regard, it would most certainly be considered a "Significant Risk Device" as it would be used to guide critical treatment decisions. This is an important distinction, in that trials of "Significant Risk Devices" require the sponsor to file an "Investigational Device Exemption" with the FDA before they may begin. IMO, that may help explain the delay we're experiencing in initiating an Ovanome clinical trial.
The second paragraph is even more intriguing. DNAPrint is NOT a pharmaceutical company (not that I am aware of at least), and the FDA DOES distinguish between IND's (Investigational New Drugs) and IMD's (Investigational Medical Devices). This text specifically refers to IND's.
What this implies is that DNAPrint plans to generate revenues in collaboration with a biotech or pharma company planning to market a NEW biologic or drug treatment. Clinical trials, or "Physician Guided Investigational New Drug Studies" are basically experiments on live subjects (usually subjects that are well along in the disease process and have few remaining alternatives). The test would probably be used to pre-classify the patient population, without necessarily using it to make treatment decisions. But, it does become an integral part of the overall data collection effort.
In addition to generating revenue from testing during the trial, the opportunity this would present is quite significant. If clear patterns of response/non-response emerge, and we demonstrate that we were able to analyze those patterns so as to predict patient response, further rounds of testing could include testing on classified responders alone. If the drug was ultimately approved we could end up in a situation where the test may be a required element in order to market the product.
I wonder if they had anyone in mind when they penned this text...
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ann441j...I believe that much of the text on the website has been updated, either that or I'm just slowly losing my mind! lol But I don't recall this description of their Paternity Testing Service being there in the past:
Paternity
DNAPrintTM genomics, Inc. provides an affordable, confidential and accurate screening test service for paternity. Our paternity test is processed on an ABI 3700, a state of the art analyzer that measures the Short Tandem Repeat (STR) units that have been standardized. The test measures 16 loci (markers) and the 10 to 15 alleles that are associated with each loci. These alleles along with their combinations and intensity are like a fingerprint and are unique to each individual. The inheritance of these unique combinations of alleles can be tested using our ABI 3700 auto-analyzer and the results may be used to help individuals understand their genetic linkage to one another.
BTW, unless I'm mistaken, this text describes the 16 loci STR test that is the standard forensics test used for profiling DNA evidence in criminal cases. I wonder how long it will be before we are able to offer STR testing in criminal investigations?
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W2P
straw5...RCAP's entrance coincides with the announcement of the La Jolla funding agreement. They were not a trader of DNAP securities prior to December 2003. I'm not a big believer in coincidence, and certainly this is JMO, but can't help but wonder whether they are bringing La Jolla shares to market.
SCHB has been a consistent presence, but historically has traded about 10% of the DNAP monthly volume on average. YTD that number is 36%, while concurrently NITE has dropped from 40% plus to a low of 14% in February 2004. I don't have any speculation to offer concerning the causes, but from a historical perspective, I find the changes themselves interesting and worthy of note.
Later,
W2P