commercializing diagnostics


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.

In ASCO Speech, Hamburg Hints of Change to LDT Regulation

Is the FDA going to go through with the much anticipated crack down on LDTs?

In a posting at Forbes, Science and Medicine Reporter, Matthew Herper, quotes FDA Commissioner Hamburg with the following:

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.

Highlights of the 5th Personalized Medicine World Conference

This week the always spectacularly organized Tal Behar and her team put on the 5th annual Personalized Medicine World Conference (#PMWCintl). I want to mention a couple highlights from the conference: prenatal diagnostics and cell profiling.

Prenatal Diagnostics

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.

Winning Diagnostic Reimbursement and the Story of CardioDx with Deborah Kilpatrick

Podcast brought to you by: Genia Technologies - Makers of integrated circuits for "Last Gen" DNA sequencing. Biology . . . meet the integrated circuit.

Guests:

Deborah Kilpatrick, VP of Commercial, CardioDx Bio and Contact Info

Chapters: (Advance the marker)

0:40 Corus CAD™ - a diagnostic for a "huge cardiovascular market"

6:31 CardioDx - fusion between biotech, med device, high tech, and specialty pharma

10:11 The successful path toward reimbursement coverage

18:00 With Medicare approval and new funding, what is your focus now?

20:01 Diagnostics an answer to a troubled healthcare system

25:17 Selling to doctors with misaligned incentives

29:30 Personal journey from defense to diagnostics

Today we begin a series of shows about Commercializing Diagnostics. And we've chosen a company with some successes and great potential, CardioDx, based in Palo Alto, CA. They recently won Medicare coverage for their Corus CAD(™) test which can tell whether a blockage in your heart is causing symptoms such as chest pain or tiredness.

The challenge for diagnostic companies, according to Chief Commercial Officer, Deb Kilpatrick, is in demonstrating with data that the test is better than current methods. In this interview, Deb outlines the path that CardioDx took toward reimbursement and offers her insight for others pursuing what has become the holy grail for diagnostics companies. Indeed, there is now a conference devoted just to this issue of reimbursement. What next for CardioDx, we ask Deborah. This leads to a discussion about the role diagnostics companies can play in the challenges facing the healthcare system today. Will there be 'big diagnostics' along side 'big pharma?'

Personalized Medicine: A New Industry Struggles Toward Birth

Some argue that medicine has always been personal. Personalized medicine as we think of it today has become the industry that is advancing the understanding of the human body at the molecular level. Since the sequencing of the human genome, this new industry has topped the news, often with much hype but little to show. Last week, Burrill and Co put on their 8th Annual Personalized Medicine Conference in San Francisco.



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