regulation


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.

Making a Difference: Janet Woodcock, FDA

Podcast brought to you by: See your company name here. - Promote your organization by aligning it with today's latest trends.

Guest:

Janet Woodcock, MD, Director, CDER, FDA Bio and Contact Info

Listen (6:48) Is the FDA changing their approach?

Listen (4:34) Message to pharma: work together

Listen (5:08) How does a submission get breakthrough status?

Listen (2:29) It's a privilege to work somewhere you can really make a difference

Listen (2:47) What feedback lets you know you're doing a good job?

Recently named one of Fierce's 25 most influential people in biopharma, Janet Woodcock is changing things at the FDA. With her influential position as Director of CDER (Center for Drug Evaluation and Research) she is pushing for the use of more biomarkers and combination therapies. With targeted therapies, "it's easier to see that they work, and they require a smaller number of people in trials to demonstrate they're effective." This is not just talk from Woodcock. Last year the agency approved more drugs than in any of the previous 15 years. Woodcock speaks in the interview about her role as prod to the bio-pharma industry. She regularly urges them to work together and share more of their pre competitive work.

A couple weeks ago, Janet made headlines announcing the FDA's new "Breakthrough Status" program, a process for streamlining submissions with a special potential to make a big difference. In today's show, Janet explains what it take to get this designation, saying that potentially a drug could be approved after a Phase I trial. Woodcock has spent many years at the FDA and talks about the secrets to her success. "I have to use my own individual judgement about what is right for the people who are my customers, the patients."

Clinical Trials Go Open Source with Marc Desgrousilliers, Clinovo

Podcast brought to you by: Assay Depot - the world's largest cloud-based marketplace for research services. With Assay Depot, you can easily find the perfect research service provider and manage your project from anywhere in the world.

Guest:

Marc Desgrousilliers, CTO, Clinovo Bio and Contact Info

Chapters: (Advance the marker)

1:26 Why does open source make sense for clinical trial software?

7:47 What are the objections to adopting open source?

11:12 Will adoption speed up clinical trials?

14:15 Is this the future?

18:16 Do FDA regulations pose special challenges?

22:04 BONUS: Swimming with sharks, literally

We've been tracking the open science movement here at Mendelspod with shows on open access publishing, platforms for collaboration and sharing data, and genome sharing for research. But what about open source software? Does this trend so strong in the IT world translate over to the life sciences. Marc Desgrousilliers, CTO of Clinovo says yes. Marc comes from the world of IT, spending several years at Microsoft where he led the development of Windows' network management. Marc is passionate about open source and the benefits that come from using software that is developed by the larger community. First of all the software has no licensing fees. (Clinovo makes their money on services that go along with the software.) Users are not dependent upon one software vendor. In addition, Marc points out, when software is designed by a large community free of charge, the user/designer volunteers tend to me very passionate about upgrades and development of the software. Are there special issues related to FDA regulation for open source software? Marc tells of his experience with the Clinovo software and of the validation they provide.

FDA Clearance Sends dHealth Pioneer Into Overdrive: Dr Dave, AliveCor

Podcast sponsored by: "Your Organization Name Here" - Build your brand at Mendelspod. Click here for details.

Guest:

Dr. Dave Albert, Founder, AliveCor Bio and Contact Info

Listen (8:43) Device cleared for medical community, not yet OTC

Listen (6:24) If I could, should I buy this device?

Listen (5:14) Fusing consumer health with traditional med device

Listen (5:09) Was this clearance a new exercise for the FDA?

Listen (4:40) How will you get around misaligned incentives for physicians?

Listen (1:49) Are there any downsides to piggy-backing on a smart phone?

Over the past year we've been closely following AliveCor, the new digital health pioneer. Cardiologist, David Albert, came up with a simple device that fits on the iPhone and can immediately give a person a readout of their ECG. His company, AliveCor, has generated a fair amount of buzz, not least of which is the notice they get from Steve Burrill in many of his talks. It's become a part of Steve's spiel about how healthcare is changing. Steve will stop, pull out his iPhone, put it on his chest and then watch the audience ooh and ah. The company has a stellar lineup of supporters/advisors. I mentioned Steve Burrill, who is an investor. Eric Topol, author of The Creative Destruction of Medicine, is a big fan.

Last week the company received the coveted FDA clearance to sell the device into the medical community. They'll now pursue an OTC clearance so that you and I could buy one for those scary days after a relationship break up or an earthquake and check our own heart stats. Is this company, a fusion of the new consumer health movement and traditional med device, an example of many companies to come? Dr Dave joins us to answer this question and others.

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.

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.



New to Mendelspod?

We advance life science research, connecting people and ideas.
Register here to receive our newsletter.

or skip signup