Diagnostics and the Evolution of the FDA: Mya Thomae, Myraqa

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Mya Thomae, Founder and CEO, Myraqa Bio and Contact Info

Listen (9:22) What's least understood about the regulation of diagnostics?

Listen (2:22) How well is the FDA evolving from the old blockbuster drug model?

Listen (6:58) Regulatory advice fo diagnostics developers

Listen (9:32) How do you see the LDT issue playing out?

Listen (5:12) Are diagnostics way undervalued?

Listen (2:24) From music performance to regulatory affairs

Mya Thomae is an expert in the regulation of in vitro diagnostics. On today's show, she shares with us the advice that she gives her clients seeking FDA approval for their diagnostic products. Mya weighs in on the issue of LDTs: the FDA says it has the authority to regulate LDTs, but so far has issued no draft guidance. This is creating an unfair playing field for those producing CoDx, which are regulated. Has the FDA been waiting for the election to issue guidance? Does Obama's reelection or the recent 'Spygate' and meningitis outbreak really affect the FDA? Ms. Thomae travels often to Washington and offers her informed views.

Genomics Around the World with Chris Barbazette, Affymetrix

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1:08 Population specific genomics

7:03 Personalized medicine and diagnostics abroad

16:15 Agbio

20:02 Are arrays still more widespread than sequencing worldwide?

27:11 What's the most obscure place where you've promoted arrays?

31:00 Personal path to international markets

34:57 Worst airport story ever

Chris Barbazette is Affymetrix's VP for International Markets. He travels the equivalent of the distance around the globe each month. He joins us to talk about what's going on in genomics in such places as Saudi Arabia and China. Are arrays still the most important genomic technology abroad? Where's the most obscure place he's been for work? These are some of the questions we ask in this fun overview.

BioConference Live 'Clinical Diagnostics': A Preview

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Greg Cruikshank, President, BioConferenceLive Bio and Contact Info

Listen (8:28) Greg Cruikshank previews changes and highlights

Whitney Green, VP, Molecular Diagnostics, Roche Bio and Contact Info

Listen (7:16) Whitney Green talks about Roche strategy and participation in the conference

On May 23-24, BioConference Live will be producing their 3rd annual Clinical diagnostics online conference. The event brings together clinicians, researchers, and medical experts from around the world to learn about recent advances in clinical diagnostics and medicine. The show is free and the venue a click away on your computer. Attendees can earn CME and CE Credits at no charge by watching live video presentations. Users can browse the virtual exhibit hall and interact with vendors such as Roche Diagnostics, Siemens, and Cardinal Health. Today we’re joined by some guests to preview the conference. First we’ll talk with the founder of BioConference Live, Greg Cruikshank. Then to the the VP of Roche’s diagnostics division, Whitney Green.

Personalized Medicine: Histone biomarkers with PrognosDX

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Kamran Tahamtanzadeh, CEO, PrognosDX, Bio and Contact Info

Macro environment very important Listen (8:13) Macro environment very important

<img src="/images/speaker.jpg" alt="Not just about a few markers/> Listen (2:27) Not just about a few markers

What does the service tell a doctor? Listen (5:25) What does the service tell a doctor?

Histones studied only recently? Listen (7:56) Histones studied only recently?

From scientist to businessman Listen (3:25) From scientist to businessman

Poet and painter Listen (2:03) Poet and painter

Histone like a soccer ball Listen (3:44) Histone like a soccer ball

Today we bring you the story of a company which is moving us closer to the promise of personalized medicine. Joining me is Kamran Tahamtanzadeh. He’s the founder and CEO of PrognosDX, a new company in Palo Alto, CA aiming to improve the treatment of cancer through epigenetic technology, specifically with histone biomarkers. Kamran was formerly with Ventana Medical Systems (now Roche) and MetriGenix.

Proteomics with Caprion's Martin LeBlanc

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Martin LeBlanc, CEO, Caprion, Bio and Contact Info

Proteomics overshadowed by DNA sequencing? Listen (1:07) Proteomics overshadowed by DNA sequencing?

Caprion and CellCarta Listen (7:17) Caprion and CellCarta

Novel drug targets and biomarker candidates Listen (4:34) Novel drug targets and biomarker candidates

Promise of proteomics and protein diagnostics Listen (3:10) Promise of proteomics and protein diagnostics

Proteomics and genomics Listen (7:11) Proteomics and genomics

A Human Proteome Project? Listen (2:57) A Human Proteome Project?

Proteomics outlook Listen (4:49) Proteomics outlook

As part of a series on Personalized Medicine, today we explore a leading company in the field of protein biomarker discovery, Caprion Proteomics. Caprion’s proprietary technology, CellCarta, enables comprehensive measurement of protein expression differences across large sets of biological samples. They have been providing protein biomarker and target identification services to over 30 major pharma industry clients in all of the major disease areas. Here to talk to us about the field of proteomics and his company is the CEO of Caprion, Martin Leblanc.

Personalized Medicine World Conference 2011

This week I attended the 3rd annual World Conference for Personalized Medicine held at Microsoft’s Computer Science Museum in Mountain View, California. A museum for the history of computing seemed appropriate for a new industry which has been dramatically impacted by the accelerating pace of technological innovation. The most oft quoted theme in the conference: that the price of sequencing an entire genome has dropped at breathtaking speed over the last few years. Just four years ago, the price for a genome sequence hovered in the tens of millions of dollars.