commercializing diagnostics


The Silicon Valley Fantasy Trip: Sci-fi Author Kim Stanley Robinson Talks Life Science

Guest:

Kim Stanley Robinson, Sci-Fi Author Bio and Contact Info

Listen (3:30) Creating plot when science wants to be boring

Listen (3:22) Genetics and the distant past

Listen (5:09) The mental voyage

Listen (6:35) Why don't we value diagnostics?

Listen (4:58) Medicine has always been utopian

Listen (4:28) The Silicon Valley Fantasy Trip

Listen (9:12) The open question of aging

Since first interviewing sci-fi author, Kim Stanley Robinson, I find myself wondering what he might think about this or that topic that comes up on Mendelspod. So we invited him back to weigh in on themes that continually resurface here on the program.

For example, what are his thoughts on why we value therapeutics so much higher than diagnostics? And what level of regulation is appropriate? Should there be government imposed controls on drug pricing?

Stan is never short of a well reasoned answer. In today’s interview he takes on what he calls the Silicon Valley Fantasy Trip and the naivety of futurists—who he reminds us are also sci-fi writers—such as Peter Diamandis.

“Two or three billion people on this planet go to bed hungry every night and don’t have basic healthcare, don’t have toilets,” he says. "So the researchers on the edge of biotech are like the games the French aristocracy were playing right before the revolution, and they got their heads chopped off. Here’s what you have to say to them, ‘Get real. Just because you’re a trillionaire doesn’t mean the world is in good shape.'”

We start the interview with a chat about two of Stan’s recent works, Shaman and Galileo’s Dream.

Podcast brought to you by: Chempetitive Group - "We love science. We love marketing. We love the idea of combining the two to make great things happen for your marketing communications."

Faces of Leadership in Diagnostics: Mara Aspinall

Guest:

Mara Aspinall, Founder, DxInsights

Bio and Contact Info

Listen (2:43) DxInsights and EPEMED

Listen (3:53) Diagnostics 5.0

Listen (2:43) International School of Biomedical Diagnostics

Listen (3:43) FDA Guidance on LDTs: the right time? the right move?

Listen (3:53) Angelina Jolie: a teaching moment

Listen (4:17) What translational gap?

Listen (1:56) Educating payers

You could call her Ms. Dx Education. Mara Aspinall has served as CEO of diagnostics companies big and small, but she’s also spent a great deal of time building a diagnostics community. Some of the early meetings of the Personalized Medicine Coalition took place in her home.

Recently Mara has stepped up her efforts in diagnostics education: that of the industry players, of physicians, and also of the next generation. She’s a co-founder of DxInsights, a new non-profit focused on better education that has already put on their first conference. DxInsights recently announced a partnership with EPEMED, or the European version of the Personalized Medicine Coalition, to create a new Knowledge Center. She is perhaps most proud of helping to create a new International School of Biomedical Diagnostics which has enrolled their first graduate students this year. This school is a first of its kind, pulling faculty expertise from various organizations in Southern Arizona as well as Dublin City University.

“We have medical school students requesting that sequencing--and what I call “Diagnostics 5.0”-- be a part of their curriculum, and it has not been,” she says in today’s interview.

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Mara is a supporter of the FDA’s recent move on LDTs, saying that the current system for diagnostics has not been working. She thinks new regulation that levels the playing field among the various players will help to spur business and innovation because it offers a more predictable path to market.

We end with her thoughts on physician and payer education.

Podcast brought to you by: Slone Partners - Premier talent. Delivered.

Faces of Leadership in Diagnostics: Bonnie Anderson, Veracyte

Guest:

Bonnie Anderson, CEO, Veracyte Bio and Contact Info

Listen (5:58) What is the secret to your success?

Listen (4:30) Building the case for reimbursement

Listen (5:14) How did you go about finding a commercially viable pathway?

Listen (6:03) Challenges to adoption

Listen (2:27) What are you anticipating on the regulatory front?

Listen (6:41) A woman of influence

Today we’re pleased to launch a new series, Faces of Leadership in Diagnostics, underwritten by the executive recruitment firm, Slone Partners.

We begin with the leader of a company that has been going from one giant success to another. Bonnie Anderson is the CEO of Veracyte. She has been awarded the “Women of Influence” award by Silicon Valley Business Journal and named one of the best Bay Area Life Science CEO’s by the San Francisco Business Times.

In 2013, Bonnie led Veracyte through a successful IPO, and this year the company has won contracts with two major payers, United Healthcare and Cigna, for their breakthrough Afirma Thyroid Analysis test. This gene expression based test is saving thousands of patients from undergoing unnecessary thyroid surgeries.

In today’s interview, Bonnie explains the secret to her success at Veracyte. Rather than beginning as a company with a cool technology, Bonnie says they started by looking for a clinical area where there was a huge unmet need.

"What we realized early on, was that the science is so rich today, and the tools available just keep getting better,” she says. “The assumption we made was that we would be able to figure out the scientific answer. But the challenge was in finding the commercially viable pathway where we could start, and then have a runway of expanding that same strategy across many indications so we could build a scalable, viable company."

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Easier said than done. We ask Bonnie just how she and her team went about finding that “commercially viable pathway.”

Bonnie is a co-founder of the company, coming out of retirement after an already successful career in diagnostics. She explains her leadership style and describes the unique company culture she has fostered at Veracyte that has made the company a shining beacon in the tough space of diagnostics.

Podcast brought to you by: Slone Partners - Premier talent. Delivered.

Proteins Are Where It's At: Chip Petricoin, George Mason University

Guest:

Emanuel "Chip" Petricoin, Co-Director, CAPMM, George Mason University 

Bio and Contact Info

Listen (4:00) Beyond the genome

Listen (5:30) Challenges to mapping the proteome

Listen (10:35) A new level of resolution for studying protein activity

Listen (6:05) 95% of cancer patients treated at the community level

Listen (8:12) Taking the latest in tumor profiling to patients everywhere

Today we continue our series on the democratization of tumor profiling with Chip Petricoin, Co-Director for Applied Proteomics and Molecular Medicine at George Mason University.

Chip says we must now go beyond the genome to the proteome and metabolome to really understand the biology of disease. Chip is particularly interested in hard to treat cancers such as pancreatic cancer.

The proteins are where the action is, insists Chip. Proteins are the drug targets for approved therapies. They comprise most of the biomarkers looked at in routine therapy. And proteins form the pathways and networks that everyone has been talking about.

“There’s no such thing as a gene pathway,” Chip says in today's interview. "Genes don’t form pathways. Genes don’t move. Genes aren’t the software of the cell. Genes are the blueprint. Proteins form the pathways. They do the work."

What are the challenges in characterizing the human proteome, and what new strategies are researchers like Chip using to get at a new level of awareness of protein activity?

Chip's work is being commercialized at two companies. The first, Theranostics Health, is developing a diagnostic that will measure protein activation. Perthera, the second company, uses not only genomics, but also proteomics to profile tumors. Chip explains how Perthera is taking the latest research that, until now, has been accessible only at major research hospitals and makes it available to community oncologists everywhere.

Pioneering Use of the Microbiome: Colleen Cutcliffe, Whole Biome

Guest:

Colleen Cutcliffe, CEO, Whole Biome
Bio and Contact Info

Listen (2:32) Do we know enough about the microbiome yet to commercialize it?

Listen (5:58) The Complete Biome Test

Listen (6:50) A higher resolution platform for developing new diagnostics and therapeutics

Listen (3:12) What are the low hanging fruit?

Listen (2:25) Going forward what is the biggest unknown for you?

There is an intense research effort underway to find out more about the human microbiome. But do we know enough yet to commercialize it?

Whole Biome is one of a handful of new startups in the microbiome space. It was founded by three former employees of PacBio who decided, yes, they knew enough to begin offering a product, the Complete Biome Test.

One of those founders, and the CEO of Whole Biome, Colleen Cutcliffe, joins us to tell their story.

As entrepreneur trainer Steve Blank said here in a recent interview, startup phase is that time period where a company searches for a successful business model. That certainly applies to Whole Biome. Colleen says that early on, the team saw that there was a gap in bacterial strain resolution that they could fill with a tool, meaning they could offer a much clearer picture of a person’s microbial community than what has been available to researchers.

“Before we even began developing that tool,” Colleen says, "we went out and we talked to people who were key opinion leaders in the field and had been thinking about the microbiome and different diseases for a long time. And we said, hey we feel this is a gap. Do you think this is a tool that would be useful? And they all said, that would be a great tool. And if you start a company around that, we’d love to work with you. And we started the company and went back to them and asked would you like to work with us now. And every single one of them is partnered with us.”

Just what will be their business model? And what are the low hanging fruit Colleen and her team are pursuing? She answers these questions and more in today’s interview.

The FDA on LDT Draft Guidance Notice to Congress

Guests:

Liz Mansfield, Deputy Office Director of Personalized Medicine, OIR, FDA
Bio and Contact Info

Katie Serrano, Deputy Director of the Division of Chemistry and Toxicology, OIR, FDA
Bio and Contact Info

Listen (4:08) What was submitted to Congress?

Listen (5:09) Why is CLIA not enough?

Listen (4:07) Does the FDA have the resources for this?

Listen (5:54) How will risk be determined?

Listen (2:13) How will you approach panels and whole genome tests?

Listen (2:33) Is NIPT on your radar?

Listen (1:32) What about laboratory developed processes or LDPs?

Listen (1:19) What should labs be doing now?

On July 31, the FDA notified Congress that they will be publishing draft guidance for laboratory developed tests or LDTs.

This means the potential regulation of lots and lots more lab tests. Thousands of diagnostics for diseases like cancer or heart disease or a rare disease.

As with most actions of the FDA, this news has its fans and critics. There are those who feel that a hands off policy of the FDA has fostered innovation and better testing. And there are those who say that some of these tests carry such high risk that they should be regulated as a device or a therapeutic. In any case, others argue, the playing field should be level among test providers.

Here to walk us through what is happening and what will happen is Liz Mansfield and Katie Serrano, both from the Office of Invitro Diagnostics and Radiological health at the FDA.

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

NIH Goes Lean with Steve Blank

Guest: Steve Blank, Author, Entrepreneur, Educator

Bio and Contact Info

Chapters: (Advance the marker)

Intro

0:59 What are you up to with the NIH?

4:39 The scientific method for entrepreneurship

8:14 Do scientists resist learning about business?

10:50 "I’m from the U.S. Government, and we need your help!"

17:55 Have you had to adapt your approach for the life sciences?

23:33 What is good for investor returns is not necessarily good for the country

27:33 You were supposed to be retired. What happened?

Steve Blank is a serial entrepreneur who has been teaching his trade at Stanford for some years now. We’ve had some of his student entrepreneurs as guests at Mendelspod.

Steve comes from the world of high tech and always told his students that his approach, dubbed the Lean LaunchPad, doesn’t apply to the life sciences. Until last year.

In a course at UCSF that began in October of 2013, Steve began adapting his ideas for startups in the areas of therapeutics, devices, and diagnostics.

After the class was over, Steve says in today’s interview, he got a call that went, “Hi, you don’t know me. I’m from the US Government, and we need your help.”

Steve is an avid blogger, and customarily puts out summaries of his teaching experiences. It turns out some folks at the National Science Foundation were reading all of his blogs about the UCSF class. They persuaded Steve to bring the class to government and see if he couldn’t help grant recipients have better results in business.

Steve laments that we’ve had no formal mechanism for teaching scientists how to turn research into commercial products.

"Essentially, in giving out these SBIR and STTR grants, we were giving out cars without requiring drivers’ ed. And we are surprised that the cars keep crashing!” he says.

Now, the NIH wants in on the training. This fall Steve will begin a pilot program called I-Corps, or Innovation Corps Team Training Program, to aid in the commercialization of new products and services from SBIR and STTR award projects.

How has Steve adapted his training program for the life sciences? And what resistance is he encountering from scientists? And hey, wait a minute, isn’t Steve supposed to be retired after selling off his eighth and last company for $329M—what happened?

Filmed at his ranch in Pescadero, California, today’s interview catches Steve relaxed and eager to share what he’s learned over the years.

Podcast brought to you by: Chempetitive Group - "We love science. We love marketing. We love the idea of combining the two to make great things happen for your marketing communications."

Rethinking Biomarker Development with Anna Barker

Guest:

Anna Barker, Co-Director, Complex Adaptive Systems Center, ASU

Bio and Contact Info

Listen (7:54) Have we been overly reductionist in the study of disease?

Listen (6:32) Applying new knowledge about complex adaptive systems to biomarker development

Listen (7:09) The National Biomarker Development Alliance

Listen (3:05) What do you think of the 'Snyderome' model?

Listen (5:44) Confident that FDA will regulate LDTs

Southern Arizona is emerging as a hotspot in the world of diagnostics. And one of the leading lights there is Anna Barker, who has been bringing folks together to think about biomarkers for a long time. As the former deputy director of the NCI, she assembled many different groups including the Nanotechnology Alliance for Cancer and The Cancer Genome Atlas (TCGC). She's now at Arizona State University where she co-directs the Complex Adaptive Systems Center and seeks to establish a new paradigm in the way we look at the biology of disease.

Beginning with some philosophy of biology, Anna takes us into her latest thinking on complex systems.

"We have to start thinking of a disease like cancer as a system," she says. "As you perturb one part of it, you perturb all of it. . . . We have to think more 3D."

Anna is someone who likes to go back to the basics, not only in the study of biology, but also in the business side of diagnostics.

In the interview she announces a new National Biomarker Development Alliance (NBDA) that is bringing a higher level of standardization to every phase of biomarker development. She argues that there are several decision points in the process, whether it's to validate an assay, or take it into commercial development. Right now, she says, the diagnostics community does not agree on the current standards for these decision points, or modules, and this is a problem. The aim of the Alliance is to bring the community together to agree on higher standards. The NBDA has just launched their website and is publishing their standards in an effort to better educate those developing diagnostics.

"We believe this approach will really enable us to develop biomarkers more predictably all the way through regulatory approval."

And what are Anna's thoughts on regulation? She says outright that the FDA is going to regulate LDTs.

Ms. Barker's vast experience and deep commitment to better science and better industry standards shine a light for anyone involved in translating biomarkers to the clinic.

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

And by: DxInsights: Presenting a Diagnostics Summit at the Miraval Institute May 4-6.

Dietrich Hauffe of QIAGEN on Clinical NGS

Guest:

Dietrich Hauffe, Sr. VP, Life Sciences, QIAGEN

Bio and Contact Info

Listen (3:26) What is the big vision for QIAGEN?

Listen (2:26) Business already 50 percent clinical

Listen (3:15) Will NGS replace PCR in clinic?

Listen (6:01) What can you tell us about the GeneReader?

Listen (4:38) Where are we at with genome interpretation?

Listen (5:11) How is QIAGEN's relationship with clinical labs evolving?

QIAGEN is a company on the move. Last year they picked up two bioinformatics platforms, CLC Bio and Ingenuity Systems. They bought Intelligent Biosystems the year before. That purchase was for a new next generation sequencing device. Called the GeneReader, this instrument has been designed specifically for clinical application.

Joining us today is Dietrich Hauffe, the Sr. Vice President of Life Sciences at QIAGEN. Dietrich discusses the GeneReader, which is currently being tested by select customers, and how it fits into QIAGEN's big vision for genomic medicine. The GeneReader offers clinical technicians the ability to do parallel sequencing and to have "random access" to many samples at the same time. The GeneReader will not be able to do whole genome or exome sequencing, however.

Dietrich says that the GeneReader, along with QIAGEN's broad existing product line of sample prep, PCR tests, companion diagnostics, bioinformatics offerings, puts QIAGEN in a unique position in the clinical market. By owning the entire workflow, QIAGEN is in a position to raise the quality and standards in clinical testing.

"We're very much liked for our universal approach," Dietrich says in the interview.

Today's Podcast is sponsored by Biotix - Makers of a Better Tip for Next Gen Sequencing. Find out how Biotix is setting a new standard in sample delivery here.

Is this the Omics-to-Clinic Site We've All Been Waiting for?

Guest: Jonathan Hirsch, Founder, President, Syapse

Bio and Contact Info

Chapters: (Advance the marker)

0:50 Why is Syapse the right solution?

6:12 What are you providing that hasn't already been there?

12:50 "Versioning" and preparing for FDA approval

15:44 How are you driving adoption of your service?

20:30 Scaling with a configurable platform

22:00 When will we see clinical sequencers?

26:14 What does genomic medicine look like in five years?

28:02 A PCORI grant

There are roughly two types of bioinformatics site offerings, "infrastructure" and "analytical" solutions. In our first interview of the year we focus on a new company offering an infrastructure solution, one that covers the end-to-end flow of omics into the clinic. Jonathan Hirsch is the President and Founder of Syapse and says his company is providing some services that have not been available before, particularly in the area of clinical reporting.

Recipient of a recent PCORI (Patient Centered Outcomes Research Initiative) Grant that is funded by the new ACA, Syapse is already offering their services to diagnostics labs who need a solution for reporting to physicians.

"We're in a very interesting place," says Hirsch in today's interview, "where the physicians are actually driving the adoption of IT solutions. And that's the trend that we're playing off."

How will the site scale, and how does Hirsch see genomic medicine in five years? Join us as we begin the year looking deeply into the adoption of personalized medicine.

Note: Hirsch will join Mendelspod Host, Theral Timpson, on two panel discussions on bioinformatics infrastructure later this month:

Jan 28th: PMWC 2014, Mountain View, California at 10:45 am (see details)

Jan 30th: Evening Event at Tres Lounge in San Francisco at 5:00 pm (see details)



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