commercializing diagnostics


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

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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 Mya weighs in on the issue of LDTs: the FDA says it has the authority to regulate LDTs, but so far has issued no draft guidance.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.

Why BioGeeks Care About Lab Developed Tests

There has been a lot of whoop-ti-do about when the FDA will close enforcement discretion loopholes in regulations governing Laboratory Developed Tests. The FDA claims it has the authority, just hasn’t gotten around to rule making since 2006. CLIA and CAP regulations putatively cover these tests. Private health care payers and Medicare already reimburse for many of these tests under existing CPT codes.

Our Take on Personalized Medicine World Conference 2012: The Road to Commercialization

This week we attended the <a href="http://pmwc2012.com" targe=_blank">Personalized Medicine World Conference 2012 in Mountain View, CA. Though sequencing continues to dominate the show, this year there was much more focus on the commercialization of existing technologies for better, more tailored health outcomes. Some news that came just after the conference gave a nice punctuation to the feeling that personalized medicine is here to stay.

Sequencing (of course)

PMWC 2012: A Preview with Dr. Larry Marton

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Guest:

Dr. Laurence Marton, Program Committee Chairman, PMWC 2012 Bio and Contact Info

Theme-Road to Commercialization Listen (7:24) Theme-Road to Commercialization

Difference from Previous Conferences Listen (8:36) Difference from Previous Conferences

Industry Has Reached a Point of Exponential Growth Listen (4:05) Industry Has Reached a Point of Exponential Growth

Genesis for PMWC Listen (2:28) Genesis of PMWC

There are several conferences on Personalized Medicine each year. Perhaps the best attended is the Personalized Med World Conf taking place in Mountain View California, on Jan 23-24. We invited an advisor to the conference, Dr. Larry Marton, to speak to us about the focus of the upcoming show and what we can expect from this year’s lineup.

Dr. Marton is an advisor to the Personalized Medicine World Conference and joins us now to preview the upcoming conference. Dr. Marton serves as a consultant to industry and to governmental, not-for-profit, and academic institutions. Before moving from academia to industry, Dr. Marton was Dean of the University of Wisconsin-Madison Medical School and previously Chaired the Department of Laboratory Medicine at UCSF.



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