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mingwan0...And speaking of connections, remember this? This is an excerpt from the meeting minutes from the TiEMalasia meeting in July where DNAPrint was originally listed on the agenda. We all know that DNA Phenomics made a presentation instead, but I was always curious about these other two companies that presented on the same evening:
AP Genomics is a genome-science technology developer focused on translating the findings of cutting edge R & D into clinical and commercial applications. DNA Phenomics Asia-Pacific specializes in discovery and development of diagnostic tests and services for growing market in personalized medicine. Last but not least, Southern Domain Technologies Sdn Bhd is a pioneer in Biometric Solutions for Identity Management using Iris Recognition.
http://www.tiemalaysia.org:8080/tie/news.htm
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mingwan0...Spoken like a "true" DNAP long. IMO, and keeping in mind that this is really a first step by the regulatory community on the road to personalized medicine, I didn't even dream that "Ancestry" would be mentioned in this document.
I worked for the government for a good number of years. What they are BEST at is CYA. They don't make ANY public policy until there is a mountain of evidence supporting it's implementation. And as far as the evidence is concerned, what do they have that would cause them to embrace ancestry as the key.
Again, IMO, this is a very good step. As a DNAP investor I do believe that ancestry will be found to be one of the keys to the accurate inference of drug efficacy and adverse events. But scientific consensus for such a conclusion doesn't exist at this time, and until it does we'll have to settle for small steps.
But as a small step, it is my opinion that this one was bigger than most.
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DougS...I recall that some time back, a member of this board had e-mailed Orchid with questions concerning their relationship to DNAP. It seems to me the answer direct from Orchid was that they own an option on certain IP.
I don't recall the poster but it was several weeks ago.
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Here's a couple more examples:
B. Specific Uses of Pharmacogenomic Data in Drug Development and Labeling
As the field of pharmacogenomics advances, it is likely (and desirable) that sponsors will begin to use pharmacogenomic tests to support drug development and/or to guide therapy. Sponsors may choose to submit pharmacogenomic data that have not achieved the status of a valid biomarker to an IND, NDA, or BLA to support scientific contentions related to dosing, safety, or efficacy. For example, a sponsor may wish to provide supportive data demonstrating that changes in drug-induced gene expression differ between species that have different toxicologic responses to a drug, thus correlating changes in certain gene expression patterns with a specific toxicity. A pharmacogenomic test result also might be used to stratify patients in a clinical trial or to identify patients at higher risk for an adverse event.
When pharmacogenomic results are to be used in decision making in an animal safety trial, or during clinical development in a human trial as part of the protocol, the submission algorithms described below suggest that full information on the test system should be submitted to the IND. In contrast, results from earlier feasibility studies done under the same IND (or outside the IND) to establish the potential usefulness of the pharmacogenomic test (e.g., from samples taken during a dose-response study) should not normally be submitted unless they provide support for the use of the test in clinical decision making.
If a pharmacogenomic test shows promise for enhancing the dose selection, safety, or effectiveness of a drug, a sponsor may wish to fully integrate pharmacogenomic data into the drug development program. This could occur in two ways:
1. The pharmacogenomic data are intended to be included in the drug label in an informational manner.
For example, such data might be used to describe the potential for dose adjustment by drug metabolism genotype or to mention the possibility of a side effect of greater severity or frequency in individuals of a certain genotype or gene expression profile. In such cases, the pharmacogenomic test result may or may not be considered a valid biomarker, and an FDA-approved or widely used commercial pharmacogenomic test may not be available. Given this level of complexity, at the current time, sponsors should consult the relevant FDA review division for advice on how to proceed in a specific case. However, in all such cases, when a sponsor intends to include pharmacogenomic data in the drug label, we expect that complete information on the test and results would be submitted to the Agency as envisioned under §§ 314.50 and 601.2.
2. Dose selection, safety, or efficacy of a drug as described in its label will be contingent upon the performance of a pharmacogenomic test or tests. For example:
• In the later phases of clinical drug development, patients will be tested for drug metabolism genotype and dosed according to the test results.
• Patients will be selected for efficacy trial entry based on genotype (of patient or tumor) or gene expression profile.
• Patients will be excluded from the trial based on genotype or gene expression profile (e.g., marker for adverse event).
In all of these cases, the FDA recommends co-development of the pharmacogenomic tests and the drug and submission of complete information on the test to the Agency (in many cases, data on the test itself may be submitted to an IDE). The FDA plans to issue further guidance on co-development of pharmacogenomic tests and drugs in the near future.
If a new pharmacogenomic test will be used in therapeutic decision making (choosing or dosing of drugs), we recommend that sponsors consider obtaining premarket review by the Center for Devices and Radiological Health (CDRH) in conjunction with their drug development program. By studying or considering diagnostic issues in conjunction with the introduction of new drugs, or changes to existing therapeutic claims, it is often possible to provide simpler and more consolidated studies.
The Office of In Vitro Diagnostics in CDRH is willing to meet with sponsors to discuss both scientific and regulatory issues with regard to new pharmacogenomic diagnostics and has both formal (IDE) and informal (pre-IDE) processes for helping to evaluate protocols.
And this which is DIRECTLY relevant to Ovanome:
Much of the concern about FDA actions in this area is based on the perception that pharmacogenomic testing is likely to give very definitive answers about safety and effectiveness in subpopulations. This may happen sometimes (e.g., in oncology) and in such cases, rapid development of a diagnostic test is highly encouraged. However, this is unlikely to be the ordinary case. In most instances, genotype or gene expression profile is likely to be one of a number of factors, so that probability of an adverse event or a favorable response would be increased, but the outcome not inevitable. For this reason, genetic markers can ordinarily be handled like other predictive markers in the clinical arena.
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mingwan0 and others:
I believe this guidance is an excellent move forward. Here's a couple of excerpts from the guidance document that you'll find particularly interesting:
V. FORMAT AND CONTENT OF A VGDS
This section provides recommendations on the format and content of VGDS reports and data. The FDA invites submission of exploratory pharmacogenomic data on drugs or candidate drugs whether or not the drugs are currently the subject of an active IND, NDA, or BLA. Exploratory genomic data may result from, for example, DNA microarray gene expression profiling experiments, expression biomarkers from single or limited gene expression profiles, genotyping or single-nucleotide polymorphism (SNP) profiling of clinical study participants, or from other studies using evolving methodologies that are intended to facilitate global analysis of gene structure or gene function.
The purpose of the VGDS process is to provide the FDA access to emerging pharmacogenomic data so that a foundation can be built for developing scientifically sound regulatory policies. The Agency intends to gain experience and to develop an aggregate genomic knowledge database from multiple VGDSs that could be used to rationally facilitate the use of pharmacogenomics in drug development and to share what general knowledge is learned from the data repositories, where appropriate. The VGDS process will also provide a forum for scientific discussion of exploratory data within the FDA outside of the application review process.
And there is this:
Currently, as discussed above, only a few pharmacogenetic tests for certain drug metabolizing enzymes are considered valid biomarkers in humans. Considerable concern has been expressed about how the FDA will evaluate newer types of pharmacogenomic data (e.g., results that may predict increased risk of adverse events, or point to an enhanced probability of response). In fact, the FDA has considerable experience dealing with these issues in other contexts. Examples of how pharmacogenomic studies fit into this experience include the following.
• Descriptions of drug metabolizing phenotypes and discussion of their impacts on dosing are common in drug labels. Extrapolation of this information to pharmacogenetic testing is straightforward.
• There are many conditions or co-factors that may increase an individual’s susceptibility to an adverse event (e.g., co-morbid conditions, metabolic susceptibilities such as renal or
hepatic failure, or interacting drugs).
FDA’s usual approach in such cases has been to request that information be added to the drug label that describes the possible interaction and advises on precautions. Were a sponsor to discover a new pharmacogenomic test that could possibly distinguish patients at greater risk for a serious adverse event, it is likely that both the sponsor and the Agency would have great interest in exploring the correlation in the appropriate populations. However, if the sponsor also moved forward on developing the drug in the overall indicated population, the FDA would evaluate the safety database on its merits. If the sponsor decided to develop the drug solely in populations from which certain patients were excluded based on pharmacogenomic testing, the FDA would recommend co-development of the pharmacogenomic test (as a diagnostic) and the drug because the FDA would be unable to approve a drug for which the safety profile was predicated on a pharmacogenomic test that was unavailable.
It is most likely that, in the near future, pharmacogenomic markers that predict drug toxicity will be identified and developed on a parallel path with overall drug development. In other words, the drug would be developed in a conventional manner with a parallel effort to identify appropriate predictors of toxicity. If the drug’s risk-benefit profile were acceptable, the drug could be approved prior to the completion of efforts to refine and develop the relevant pharmacogenomic tests. When and if a test's predictive value were to be established and the test were to become commercially available (either as an approved device or as a service), the drug label could be changed to reflect the data.
• The FDA has similar experience with tests used to target populations likely to respond to therapy.
Several decades ago, broad indications for use were described in labels. Over time, as more exact diagnoses were developed, narrower indications were sought by sponsors, based on the clinical trials conducted. A similar evolution occurred in the field of anti-HIV therapies as drug resistance testing became available. We encourage sponsors to continue to develop pharmacogenomic tests that are predictive of subpopulations with enhanced response to therapy.
IMO, ALL DNAP shareholders should print and read this document. Our time is coming folks, but business in this field requires that we march a the pace of the regulatory community. They may not move as fast as we'd like, but they are moving and it's just a matter of time now.
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mingwan0...You may be confusing the Agency Notice with the actual guidance document. Try this link, I think you may find it more substantive:
http://www.fda.gov/cber/gdlns/pharmdtasub.pdf
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ann441j...Odd isn't it? Or is it just me...
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ann441j...I know that the link to the NHGRI grant list works. But did you scroll down to Shriver's grant and attempt to access the abstract?
If you are able to access it, please copy it and post it here. I know it was possible at one time, but doesn't appear to be the case now.
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Makes me wonder how long it was after we had this discussion that the link was deactivated:
http://investorshub.com/boards/read_msg.asp?message_id=1545409
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This is pretty odd. At one time you could click on the link to Shriver's grant and see that Affymetrix Mapping Array was being used in this 1000 marker study. That link is now dead.
http://www.genome.gov/Pages/Hyperion/Grant_info/Grant_search/query.cgi?sort_key=principal_investigat...
Another window now closed. Interesting...
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mingwan0...Sorry, misread the message...I read "would like to see..." as "would YOU like to see..." Quite a difference! lol
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mingwan0...Ok, now you're just messing with me! lol I'll warn you though, I'm in a rare mood today...let's see whatcha got.
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mingwan0...Coincidentally, Affymetrix recently released data for 120,000 SNP's from their (and Perlegen's I presume) private database:
http://biz.yahoo.com/prnews/031009/sfth119_1.html
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Straw5...I'm pretty sure iHub would frown on us posting our respective lists..lol
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OT: Jim...mango, jingo, lingo, tango, bingo...loco poko! lol
Need I say more? Have a great evening!
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OT: stak..."(unless you consider RB an information source!)"
If you're looking for fresh research subjects for your Master's Thesis, "Behavioral Anomalies Among 21st Century Psychopaths, Sycophants, and Sociopaths", then it's an EXCELLENT source of information. lol
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stak...Have you seen the complete PP document? Just curious.
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From the DNAPrint Website:
Our scientists have identified several Single Nucleotide Polymorphism (“SNP”) markers whose haploid alleles are predictive for non-response to the Taxol and Carboplatin drug combination, a drug combination manufactured by Bristol-Myers Squibb for the treatment of ovarian cancer.
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.
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Thanks Team and High_Hopes...This is the paragraph I was interested in:
The team plans to prospectively validate and market the predictive genetic test, called OVANOME, for a personalization of chemotherapy and an improvement in the overall first-line response rate for Ovarian Cancer chemotherapy.
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Team...Can you provide the link to this old PR? I'd like to take another look at this. TIA
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bag8ger...Mail me at work_to_play@hotmail.com.
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Theo...DNA Phenomics has NEVER listed forensics as part of their repertoire. That's one of the keys for me and that's what makes it all the more interesting..lol The fingerprint graphic, overlayed with the DNA Phenomics logo. Like I said, interesting.....
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seagull43...Either we just touched a nerve, or the shareholder update is complete...lol
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early_retirement1...Very nice find. So let me get this straight...Mark Shriver, DNAPrint Scientific Advisory Board Member, shareholder, collaborator, and consultant is going to use the following as one source for genotyping his SNP's:
"B- A new genotyping chip developed by Affymetrix, which allows for the simultaneous analysis of 10,000 SNPs.
That would be the "new" 10K Mapping Array developed this year by Affymetrix. Now THAT is interesting.
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bag8ger...It's probably just a "left coast" thing. It'll probably take a couple of years until your computer catches up to us here in the great Midwest! lol
BTW, you said you typed in dnapasiapacific.com. I hope you meant dnaprintasiapacific.com...
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bag8ger...I'm not understanding what you're talking about. What column to the left?
I posted those two links. If you click them NOW they take you to DNA Phenomics.com.
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OK, here you go boys and girls
http://www.dnaprintasiapacific.com/
http://www.dnaprintasia-pacific.com/
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Grateful...Probably as soon as it starts working again!
Just kidding, couldn't resist...lol I do wish I knew the answer to that question.
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Grateful...Nice! Funny thing is, this one gives the same result:
http://www.dnaprintasia-pacific.com/
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OT: Miss Scarlet...I have a confession to make, I'm not Catholic either! lol
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Team...Nice work. eom
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Arch...Mark Green is very much aware of DNAPrint. He is my and my brother's Congressman...lol My brother has corresponded with Mark concerning DNAPrint and their accomplishments. And from the replies he received, it was apparent that Mr. Green had read and appreciated the information my brother provided.
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For anyone that has been trying to access the DNA Phenomics website for the last few days, it is not possible at this time. According to "Whois", Senecio has the site under "Registrar Lock". Here is a brief explanation:
REGISTRAR-LOCK: The sponsoring registrar sets this status. The domain can not be modified or deleted. The registrar must remove REGISTRAR-LOCK status to modify the domain. The domain can be renewed. The domain will be included in the zone.
What does it mean? Wish I knew...lol
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hwan...What letter?
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This is pretty interesting:
FDA Initiative and Pharmacogenomics
In a recent release, the FDA announced that pharmaceutical and bio pharmaceutical companies should take into consideration genetic testing during clinical trials and for post approval drug monitoring. Pharmaceutical and bio pharmaceutical companies will need to incorporate genetic testing in their drug discovery, clinical development as well as post drug approval monitoring in the very near future. Leveraging its proprietary ADMIXMAP, MALD/AIM, AIMs, and ultra high throughput SNP screening technologies, DNAPrintTM is strategically positioned to serve the growing compliance and operational needs of pharmaceutical companies.
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How about this one:
Forensics DNA Testing Market - Testing DNA to create a physical profile of crime suspects is a new market based on evolving technologies. Common hereditary traits such as skin pigmentation, eye color, hair color, earlobe attachment and height can be predicted through analysis of DNA sequences. DNAPrintTM believes it is the first company to use DNA evidence to successfully profile a crime suspect by predicting that suspect’s continental origin.
Earlobe attachment and height CAN be predicted...
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Nothing New? Some need to read a little more thoroughly:
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.
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david...I suspect the blue team decided it was time to take a position in anticipation of a potential run when the updated website appears. Just speculation on my part though. Nothing more.
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Early...It is interesting isn't it? BTW, I don't see anything on Senecio's website that would indicate they were involved with Bioinformatics prior to this "Strategic Alliance". So why would DNA Phenomics (a one month old company) hire THEM to install Bioinformatics Software? And whose Bioinformatics software do you suppose it is? Just a couple of questions that roll around in my mind...lol
So maybe there is no "connection". I can live with that. I prefer the word "relationship" anyway. Relationships are more flexible. Connections imply something "direct". Relationships can be either "direct" or "indirect".
Of course this is JMHO.
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mingwan0...And of course, Senecio has been spreading their wings of late:
Senecio Software Inc. Signs Deal with DNA Phenomics to Provide Software Engineering Services and Bioinformatics Support
BOWLING GREEN, Ohio & KUALA LUMPUR, Malaysia - August 7, 2003 - Senecio Software Inc. (a leading developer of advanced, multi-tier, web-based software) today announced a broad alliance entailing bioinformatics support and healthcare system development for DNA Phenomics Sdn Bhd (a development-stage company focused on the emerging field of phenomics and the discovery of genomic-based diagnostic tests).
The alliance combines Senecio's experience designing platform-neutral, all-Java, web-based systems with DNA Phenomics' genetic research and diagnostic test development. Initially, the work for the alliance will involve the installation of bioinformatics systems in Kuala Lumpur for use by DNA Phenomics' research scientists worldwide. Long term, the work will broaden to include creating components needed to deliver and analyze planned diagnostic test products using web services.
Dr. Jerry Wicks, President of Senecio Software, stated, "our research and development efforts focusing on the design and engineering of platform-neutral, web-based data gathering systems is beginning to payoff. Our software engineering strength has traditionally been in the design and development of desktop survey systems and statistical applications. Developing those technologies which enable us to push applications out to the net has allowed us to design and implement completely new methods for collecting social, demographic and medical data. Our AskAnywhere survey system will be modified and deployed for use in the clinical genomic studies planned by DNA Phenomics later this year and next."
Ezehan Kamaluddin, DNA Phenomics' Chief Operating Officer, noted, "by completing this alliance with Senecio Software, we are combining talented and experienced software engineers with our world-class lab resources to rapidly create a genomic/phenomic powerhouse in the Asia-Pacific region. Combining these assets will hasten our move into the marketplace."
About Senecio Software
Founded in 1992, Senecio Software Inc. is a privately held company based in Bowling Green, Ohio. The company specializes in the design and production of advanced, multi-tier, web-based systems used in the collection and analysis of social, health, market research, and demographic data. Given the rise in Internet-based commerce and the demand for online information processing solutions, Senecio's corporate strategy has increasingly focused on the development of customized data-gathering tools used by professional survey researchers, scientists, and market analysts. Along with designing multi-tier, web-based survey software, Senecio is developing unique data gathering tools involving remote sensing and wireless communication. Senecio Software has been the recipient of numerous research grants from the U.S. government's National Institutes of Health. Additional information about the company, its products, partnerships, and research agenda can be found at http://www.senecio.com.
http://www.senecio.com/news070803.html
It will be interesting to watch this unfold.
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