Session 6: Introduction
Session 6: Pharmacogenomics in the global landscape: Pharmacogenetics and Ethnicity Speaker: Stephen Spielberg, FDA, USA Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:08:22More inScience Technology
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Session 6: Introduction - Video
Session 5: Panel discussion
Session 5: Pharmacogenomics: impact and needs from health care view point to facilitate patients #39; access Panel discussion Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:20:56More inScience Technology
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Session 5: Panel discussion - Video
Key themes from the consultation and next steps
Session 1: Pharmacogenomics: regulatory and methodological implications in early clinical development Speaker: Priya Bahri, European Medicines Agency Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:38:13More inScience Technology
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Key themes from the consultation and next steps - Video
Session 5: IVDD revision
Session 5: Pharmacogenomics: impact and needs from health care view point to facilitate patients #39; access Speaker: Fabio Faraulo, European Commission, Belgium Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:20:09More inScience Technology
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Session 5: IVDD revision - Video
Session 5: Companion diagnostics
Session 5: Pharmacogenomics: impact and needs from health care view point to facilitate patients #39; access Speaker: Stuart Hogarth, Department of Social Science, Health and Medicine King #39;s College London, UK Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:24:57More inScience Technology
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Session 5: Companion diagnostics - Video
Epistem Pharmacogenomics provides high quality biomarker and personalised medicine Information to pharmaceutical and biotechnology companies from very limited quantities of RNA (down to a single cell input). We specialise in advancing drug development programs for oncology, inflammatory and fibrotic disease indications through our innovative plucked hair analysis and laser capture microdissection techniques as well as offering GCLP accredited laboratory gene expression and DNA genotyping services. In addition to our expertise in assessing limited quantities of RNA, we also have extensive experience in developing patient stratification companion diagnostic assays using our point of care Genedrive platform.
Epistem's proprietary amplification technique, RNA-Amp, allows robust gene expression information to be derived from as little as a single cell input
Epistem provides a unique plucked hair biomarker platform to drug development companies targeting intracellular signalling pathways in oncology and other therapeutic areas.
Epistem offers Laser Capture Microdissection (LCM) services and subsequent gene expression and DNA genotype analysis. This technique is an ideal method for obtaining molecular analysis of specific cell populations.
Epistem provides global (microarray and NGS) and focused (qPCR) mRNA and miRNA gene expression profiling services.
Epistem provides laboratorybased services(microarray, NGS and qPCR) and Point of Care (Genedrive)DNA genotyping tests.
Epistem Pharmacogenomics amplification technology is ideally suited for assessing fluid or tissue based samples that have limited quantities of RNA.
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Epistem Pharmacogenomics
Session 6: Pharmacogenomics in the global landscape: Pharmacogenetics and Ethnicity
Speaker: George Patrinos, University of Patras, Greece Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:04:11More inScience Technology
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Session 6: Pharmacogenomics in the global landscape: Pharmacogenetics and Ethnicity - Video
Session 3: Concept paper on key aspects for the use of pharmacogenomic methodologies...
...in the pharmacovigilance evaluation of medicinal products Session 3: Post-approval pharmacogenomics: impact on Risk Management Plans and Information Speaker: Qun-Ying Yue, CHMP-Pharmacogenomics Working Party and Pharmacovigilance Risk Assessment Committee member Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:23:17More inScience Technology
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Session 3: Concept paper on key aspects for the use of pharmacogenomic methodologies... - Video
Session 2: Methodology and adaptive designs and in confirmatory clinical trials
Session 2: Methodology and adaptive designs and in confirmatory clinical trials Speaker: Martin Posch, University of Vienna, Austria Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:1 0ratingsTime:19:20More inScience Technology
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Session 2: Methodology and adaptive designs and in confirmatory clinical trials - Video
Session 5: HTA of Companion diagnostics
Session 5: Pharmacogenomics: impact and needs from health care view point to facilitate patients #39; access Speaker: Elisabeth George, National Institute for Health and Clinical Excellence (NICE), UK Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:19:04More inScience Technology
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Session 5: HTA of Companion diagnostics - Video
Welcome note
Speaker: Marisa Papaluca, Secrtion Head, Scientific Support and Projects, EMA Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:03:11More inScience Technology
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Welcome note - Video
Session 2: Reflection paper on methodological issues associated with PG biomarkers...
...for patients #39; population selection Session 2: Methodology and adaptive designs and in confirmatory clinical trials Speaker: Krishna Prasad, CHMP-Pharmacogenomics Working Party Chair Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:22:08More inScience Technology
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Session 2: Reflection paper on methodological issues associated with PG biomarkers... - Video
Session 6: Differences in strength of association across racial/ancestral groups
Session 6: Pharmacogenomics in the global landscape: Pharmacogenetics and Ethnicity Speaker: Steven Lewitzky, Novartis, Switzerland Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:25:32More inScience Technology
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Session 6: Differences in strength of association across racial/ancestral groups - Video
Session 3: Panel discussion and closing remarks
Session 3: Post-approval pharmacogenomics: impact on Risk Management Plans and Information Speaker: Krishna Prasad Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:26:37More inScience Technology
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Session 3: Panel discussion and closing remarks - Video
Session 3: New Pharmacovigilance legislation and genomics
Session 3: Post-approval pharmacogenomics: impact on Risk Management Plans and Information Speaker: Peter Arlett, Head of Sector for Pharmacovigilance and Risk Management, EMA Workshop on Pharmacogenomics: from science to clinical care (8 October 2012)From:emainfoViews:0 0ratingsTime:23:56More inScience Technology
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Session 3: New Pharmacovigilance legislation and genomics - Video
Advances In Schizophrenia Research 2009
ll4.me Advances In Schizophrenia Research 2009 Incidence and outcome of schizophrenia across the globe.- Gene and environment interactions and epigenetics of schizophrenia.- The course and outcome of schizophrenia: are there new trends?- Impact of contextual mechanisms on the incidence of schizophrenia and other psychoses.- Perspectives and conclusions.- Glutamate-dopamine interactions in schizophrenia.- Schizophrenia: Neurodevelopmental, neurodegenerative or both?.- The neuropathology of schizophrenia: novel findings and epigenetic regulation.- Molecular neuroimaging, pathophysiological mechanisms and drug discovery.- Discussant.- Molecular genetics of schizophrenia: new discoveries and controversies.- Genetic and developmental animal models of schizophrenia.- Neuroproteomic studies of post-mortem brains in schizophrenia.- Neuroimaging studies of gene effects in the brain in schizophrenia.- Pharmacogenomics in schizophrenia.- Perspectives and conclusions.- Prediction of psychosis through the prodromal syndrome.- Is schizophrenia a cognitive disorder?- Disorder of social cognition .- Impact of new strategies (early intervention, second-generation drugs) on the course and outcome of schizophrenia.- Perspectives and conclusions.- Dimensional dysfunctions.- Risk factors for psychosis all impact on dopamine.- Cannabis: clue or distraction?.- The totality of psychosis.- Perspectives and conclusionst.- Comparative efficacy and safety of second-generation antipsychotics: facts ...From:lorrainephilips754Views:0 0ratingsTime:00:11More inPeople Blogs
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Advances In Schizophrenia Research 2009 - Video
Drug Clearance - Pharmacokinetics Lect 12
This lecture covers drug clearance. View the other videos on pharmacokinetics below. (1) Pharmacokinetics Core concepts: youtu.be ---- DRUG ABSORPTION Videos: (2) Drug Absorption Overview: youtu.be (3) Bioavailability: youtu.be --------- DRUG DISTRIBUTION Videos: (4) Drug Distribution Overview: youtu.be (5) Volume of Distribution: youtu.be ------------------ DRUG METABOLISM Videos: (6) First Pass Metabolism: youtu.be (7) Phase I Metabolism: youtu.be (8) Phase II Metabolism: youtu.be (9) First Order and Zero Order Kinetics: youtu.be (10) Drug Half-life: youtu.be (11) First-order elimination rate constant: youtu.be ------------------------------------------ DRUG ELIMINATION / EXCRETION (12) Drug Clearance: [not yet posted] (13) Practice problems: [not yet posted] (13) Dosage Regimens: [not yet posted] --------------------------------------------------------------------- Factors That Affect Drug Metabolism: (14) Enzyme Induction: youtu.be (15) Competitive Inhibition Overview: youtu.be (16) Competitive Inhibition of Statins: youtu.be (17) Acetaminophen toxicity (Clinical Correlate): [Not yet posted] (18) Pharmacogenomics Overview: youtu.be (19) Slow Acetylators - Pharmacogenomics: [not yet posted]From:Areo SaffarzadehViews:1 0ratingsTime:10:36More inEducation
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Drug Clearance - Pharmacokinetics Lect 12 - Video
ScoliScore/C-GAAP Should Drive Clinical Lab Revs in 2013 By Brian Marckx, CFA
Q3 2012 RESULTS
Transgenomic (TBIO) reported financial results for Q3 ending September 30, 2012 on November 8th. Revenue fell just over 4% yoy and was well below our estimate due to relatively disappointing numbers from the Pharmacogenomics and Instruments/Diagnostics segments. While Clinical Lab revenue was dead-on with our $4.5 million estimate, the 10% yoy growth in this segment was more than offset by a very poor showing in Pharmacogenomics ($220k, -60% yoy) and Instruments ($3.2 million, -12% yoy).
As a reminder, Pharmacogenomics activity can be highly variable q-to-q, largely dependent on customer directives and not in direct control of TBIO which makes forecasting this line difficult on a short-term basis. Nonetheless Pharmacogenomics revenue in aggregate has disappointed over the first nine months of the year - which we think relates at least in part to longer than anticipated timelines (and potentially delays) of TBIO's phase III clinical trial customer(s). TBIO is still awaiting the green-light from a pharma customer to commence processing for a phase III trial - our model had assumed this work would have already commenced - we are now pushing this assumption and the related revenue back to 2013.
The quarter did have some important positive highlights, namely the ScoliScore acquisition and new collaborations with ICE COLD PCR (with NYU and Univ of Nebraska). Management also noted that C-GAAP, TBIO's Plavix response test, has seen strong physician interest and was a substantial contributor to the 10% growth in Clinical Lab revenues. ScoliScore, as we noted in our 8/9/12 Investor Note (see below), looks like a very solid addition to TBIO's Clinical Lab business and one which we think will make a meaningful top and bottom line impact as early as next year.
The collaboration with NYU's Langone Medical Center involves the use of ICE COLD PCR in the detection of mutations in the blood related to non-small cell lung cancer and response to existing a new therapies. Similar to the collaboration with the MD Anderson Cancer Center (Univ of Texas), the NYU study will focus on circulating tumor cells (CTCs) and use TBIO's CTC capture ScreenCell devices. The collaboration with the University of Nebraska Medical Center involves the use of ICE COLD PCR in the early detection of pancreatic cancer and is being funded by a $100k NIH grant awarded to TBIO which was announced in August. The project could result in a diagnostic test for early stage pancreatic cancer which is almost always fatal if not caught early.
Revenue
Q3 revenue was $7.9 million, down 4% y-o-y and $1.1 million (13%) less than our $9.0 million estimate. The difference came from a $555k variance ($220k A vs. $775k E) in Pharmacogenomics revenue and a $607k variance ($3.2 million A vs. $3.8 million E) in Instruments/Diagnostics with Clinical Lab revenue in-line with our $4.5 million estimate.
Similar to Q1 and Q2, GM came in well softer than our estimate. Q3 GM was 48% compared to our 55% estimate. Lower than expected revenue from Pharmacogenomics continues to impact GM due to the fixed laboratory costs - while this segment should be highly leverageable with growing revenue, margins will be almost non-existent at the ~$250k and lower revenue level (this quarter was $220k). Management also noted that they've made some investments related to their Clinical Lab segment to improve efficiencies in anticipation of increased sales of C-GAAP and ScoliScore which slightly impacted margins in that business in Q3. We continue to look for GM to widen with growing revenues in Pharmacogenomics, an increase in contribution from the higher margin bionconsumables (as opposed to instruments) from the Diagnostics/Tools business and potentially (depending on reimbursement) very beefy margins from ScoliScore as well as C-GAAP.
Net Income / EPS
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ScoliScore/C-GAAP Should Drive Clinical Lab Revs in 2013 - Analyst Blog
OMAHA, Neb.--(BUSINESS WIRE)--
Transgenomic, Inc. (TBIO) today reported financial results for the three and nine months ended, September 30, 2012, and provided a business update.
Third Quarter Financial Results
Net sales for the third quarter of 2012 were $7.9 million compared with $8.3 million for the same period in 2011. Despite the decline in consolidated sales, the Company realized double digit growth in its Clinical Laboratories segment, its largest business, driven by sales of its C-GAAP test, which identifies whether or not a heart disease patient will benefit from Plavix (clopidogrel) treatment, and also due to a shift in sales mix to higher priced tests. This increase was offset by a decline in the Pharmacogenomics Services segment, due to a lower volume of projects performed for our pharmaceutical clients. We also had a decline in our Diagnostic Tools segment, which had a higher percentage of its sales go to our European distribution partner at distributor prices.
Gross profit was $3.8 million or 48 percent of net sales, compared with gross profit of $4.4 million or 54 percent of net sales for the same period in 2011. The margin decline was largely due to the significantly lower margins in the Pharmacogenomics Services segment, since its costs are relatively fixed. The Clinical Laboratories segment also had a more modest decline in its gross margin, as it is making investments to improve efficiency in anticipation of the upcoming volume growth from the C-GAAP test and the recently acquired ScoliScore test.
Operating expenses were $6.2 million during the third quarter of 2012, compared with $4.9 million in the prior year. The increase was the result of a higher bad debt provision, higher non-cash stock compensation expense, higher costs related to expansion of our field sales force to support the launch of C-GAAP and ScoliScore, and higher research and development expenses.
In summary, the net loss for the third quarter of 2012 was $2.8 million or $0.04 per share compared with a net loss of $1.3 million or $0.03 per share for the third quarter of 2011.
Modified EBITDA, which is a non-GAAP measure that Transgenomic views as an appropriate and sound measure of the Company's results was a loss of $1.8 million for the third quarter of 2012 compared to income of $43,000 for the same period for 2011. A reconciliation of Net Loss to Modified EBITDA is presented below.
Cash, cash equivalents and short term investments were $8.7 million as of September 30, 2012, compared with $4.9 million as of December 31, 2011.
Nine Month Financial Results
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Transgenomic Reports Third Quarter 2012 Financial Results
One TEST, One right ANSWER, 1PGx Pharmacogenomics
Testing your genetic background finding the right drug for the right patient, the right dosage right now!From:miketerry3Views:0 0ratingsTime:06:20More inPeople Blogs
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One TEST, One right ANSWER, 1PGx Pharmacogenomics - Video