commercializing diagnostics


Dietrich Stephan Hits the Refresh Button with SV Bio

Guests:

Dietrich Stephan, Founder, CEO, SV Bio Bio and Contact Info

Listen (5:24) What makes this the right time for SV Bio?

Listen (6:03) What does the SV Bio product look like?

Listen (2:38) Healthcare IT behind by several decades

Listen (6:52) How are you selling your product?

Listen (6:11) Whole genome pricing level still uncertain

Listen (5:02) The big ambition

On January 15th of this year a new company, Silicon Valley Biosystems, or SV Bio, was launched in the clinical genome interpretation space. And just this past week the company's lab gained CLIA certification. Founder and CEO, Dietrich Stephan was the creator several years back of Navigenics, a direct-to-consumer approach to personalized medicine. Navigenics was acquired by Life Technologies in the summer of last year. Stephan is quoted in Bio-It World as saying he “wanted to hit the refresh button and do the necessary inventing around rare variants now that the time is right.” Today he joins us to share his ambition for what he considers THE scalable platform and tell us why the time is right for SV Bio and genomic medicine.

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

and by: Roche Molecular Systems: A proud sponsor of today's podcast.

"Not about Owning Genes:" Diagnostics in the Wake of Gene Patent Ruling with Charles Mathews

Guests:

Charles Mathews, VP, Boston Healthcare Bio and Contact Info

Listen (3:51) Response to Myriad ruling

Listen (8:20) What is your number one message to your diagnostic clients?

Listen (9:16) Diagnostics model becoming more like pharma model

Listen (6:17) How can diagnostics startups be better focused on reimbursement from the beginning?

Listen (4:21) Are you seeing more whole genome testing?

Continuing our series, Commercializing Diagnostics, we speak with Charles Mathews, VP at Boston Healthcare. Specializing in reimbursement issues, Charles is a consultant for diagnostics companies. Recorded just hours after the Supreme Court handed down its unanimous decision invalidating Myriad's gene patents, the interview begins with a discussion on the case and what it means for the diagnostics industry.

Charles points out that while Myriad really paved the way in the industry, few diagnostics companies have been able to "carve out" such IP. In fact he sees a possible silver lining with the ruling, saying that it really matches the way the the science is headed, where there are fewer and fewer single markers and more next gen sequencing and multiplexing assays. These new tests with complex algorithms will be better in a world without individual gene patents, he argues.

Mathews' biggest message to his clients is that they must focus on reimbursement at the beginning. No longer is it about a single biomarker or new technology, but rather clinical efficacy. Evidence of clinical impact is much more important, he says, than hiring a host of IP lawyers. How can a start-up be better focused on reimbursement? And is he seeing more whole genome testing? These are questions Charles faces each day.

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

and by: Roche Molecular Systems,: A proud sponsor of today's podcast.

Commercializing Diagnostics: Building Value in a New World with Mark Trusheim

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

and by: Roche Molecular Systems,: A proud sponsor of today's podcast.

Guests:

Mark Trusheim, Founder, Co-Bio Consulting Bio and Contact Info

Listen (11:54) Science blossoming, but still a long ways to go

Listen (6:41) The economics of diagnostics

Listen (3:41) Why the indignation over Myriad gene patents?

Listen (5:11) Finding IP protection for innovative diagnostics

Listen (7:54) ACA a new opportunity for payers to improve misaligned incentives

Listen (7:10) From one-off tests to whole genome, proteome testing

Continuing our series Commercializing Diagnostics, we’re joined by an economist who has been the CEO for a diagnostics company and now consults. Mark Trusheim is the founder and president of Co-Bio Consulting and Executive in Residence and Visiting Scientist at the MIT Sloan School of Management. He’s also a Special Government Employee for the FDA’s Office of the Commissioner.

The world of diagnostics is in great flux. The science is blossoming and technology is evolving at lightning speed. Whole genome sequencing threatens to overtake "one-off" tests. Gene patents are up in the air and regulation is uneven between IVDs and LDTs. Furthermore, a new healthcare law, the ACA, offers payers new opportunities to address misaligned incentives in the practice of medicine. How does a diagnostic company create value with a test and then protect that value in such a changing landscape? Running longer than our typical 30 minutes, Mark's interview will put you on the front row of the diagnostics show.

Note: Today's show was recorded before the recent Supreme Court decision on gene patents.

Revaluing Diagnostics with Alan Wright, Roche Diagnostics

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

And by: BioConference Live: Register for free to the upcoming online Clinical Diagnostics Conference May 29-31.

Guests:

Alan Wright, MD, Chief Medical Officer, Roche Diagnostics Bio and Contact Info

Listen (9:05) Why do you think diagnostics are undervalued?

Listen (5:46) How are you going about raising the value for Dx?

Listen (8:20) Are the payers proving willing partners?

Listen (5:15) Society has two big decisions to make regarding Dx

Listen (2:53) How does patentability play into the difference between Rx and Dx?

There is an un-level playing field in the world of in vitro diagnostics. First of all, they are valued much lower than a therapeutic despite the amount of research and development that goes into refining a great diagnostic. Second, regulation is all over the board. A diagnostic may or may not be approved by the FDA. Something has to be done to level off this field if we are to see important innovation and the promise of personalized medicine fulfilled.

At least, that's the way our guest for today sees it. Alan Wright is the new Chief Medical Officer for Roche Diagnostics and he address an issue with which Roche has long been struggling. Alan is the former Chief Scientific officer for Caremark and so has a unique perspective from the developer and the payer's points of view. What is entailed in raising the value of diagnostics is the thrust of today's show.

Garry Nolan: Trailblazing Single Cell Analysis

Podcast brought to you by: Fluidigm - The leader in single-cell genomics and maker of the C1™ Single-Cell Auto Prep System. The path less traveled just go easier.

Guests:

Garry Nolan, PhD, Professor of Microbiology and Immunology, Stanford University School of Medicine Bio and Contact Info

Listen (6:41) Why is the focus on the single cell so important?

Listen (5:18) Low hanging fruit from bulk analysis already picked

Listen (6:29) What has been the response to your work?

Listen (6:25) Commercializing work as diagnostics at Nodality

Listen (6:38) Biggest challenge is to simplify

Making a big decision several years ago that his lab would have the single focus on the single cell, Gary Nolan has become a global leader in a new discipline. In today's show, he shares his conviction that the next frontier in biology is to expand the number of parameters wherein the individual cell can be studied. "The low hanging fruit from bulk analysis has already been picked," he says. Gary is a founder of two companies, Rigel Pharma (publicly traded) and Nodality, wherein his research is being commercialized. Is 2013 the year of single cell genomics, we ask this trailblazer.

Dx from the Payer's Perspective with Ira Klein, Aetna

Podcast brought to you by the upcoming Personalized Medicine World Conference taking place in Mountain View, CA, January 28-29. Over 100 speakers in three tracks will discuss how best to navigate the changing landscape of personalized medicine.

Guest:

Ira Klein, MD, Chief of Staff, Office of the Chief Medical Officer, AETNA Bio and Contact Info

Listen (8:55) How do you determine when to pay for a Dx?

Listen (3:45) Are you opposed to covering a test before FDA approval?

Listen (2:56) How do you help physicians keep up with new Dx technology?

Listen (8:43) The problem of misaligned incentives

Listen (4:19) Are diagnostics way undervalued?

Our last show in the series, Commercializing Diagnostics, is from the payer's viewpoint. Reimbursement has become the biggest challenge for Dx companies, so we ask Ira Klein from Aetna to talk about the issues: How does Aetna go about deciding whether to cover a diagnostic? Do they always wait and follow the FDA's lead? What about the unregulated LDT's out there such as CardioDx's CAD test? Formerly a physician himself, Dr. Klein takes us into his world and explores the issues he faces as medicine changes. A fan of the new healthcare law, Klein sees diagnostics and personalized medicine as having a positive impact on the challenges of escalating costs and an aging population. Are diagnostics way undervalued, as Roche's Walter Koch asserted on the program? Tune in for Ira's answer.

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

Podcast Sponsor: Ingenuity - iReport, the quickest way to get biological meaning from your expression data. www.ingenuity.com/get iReport/

Guest:

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.

A Biomarker Strategy for Every Drug: Walter Koch, Roche Molecular

Podcast brought to you by the upcoming Personalized Medicine World Conference taking place in Mountain View, CA, January 28-29. Over 100 speakers in three tracks will discuss how best to navigate the changing landscape of personalized medicine.

Guest:

Walter Koch, PhD, Vice President, Head of Research, Roche Molecular Diagnostics Bio and Contact Info

Listen (4:07) Why hasn't the sequencing of the human genome led to more therapeutics?

Listen (8:48) Every drug in development at Roche has to have a biomarker strategy

Listen (4:53) Barriers to clinical adoption vary by disease area

Listen (6:33) Dealing with unlevel regulatory playing field for CoDx and LDTs

Listen (6:02) Whole genome tests and the FDA

Listen (2:32) Diagnostics undervalued

We often use the term 'big pharma.' Will we one day be writing about 'big diagnostics' as well? As part of our series Commercializing Diagnostics, we're joined by the head of global research at Roche Molecular Systems, Walter Koch. Walter joined Roche in 1998 when the first drafts of the human genome were coming out. In today's interview he admits to his naivety at the time the human genome sequence was completed about how soon we'd realize therapeutic results. Walter dives into Roche's drug development and companion diagnostic strategy and in the end looks forward to clinical genome sequencing. Walter was formerly at the FDA and puts in his two cents about how to deal with the unlevel playing field between the regulation of CoDx and LDTs.



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