commercializing diagnostics


FDA Will Take Time to Digest Comments on LDT Guidance, Says Liz Mansfield

We’re very pleased to have Liz Mansfield of the FDA on the program to finish up our current Special Report on LDTs Series. Liz is part of the team at the FDA working on the new guidance for the regulation of LDTs, and she was at the recent meeting the FDA held to receive community feedback.

Today we get into some of the details of that feedback. Did Liz and the FDA hear any new issues that they had not already considered? What about the BRAF testing that was mentioned in the meeting? Is there a risk that patients will lose access to some important tests?

In a recent interview in this series, Amy Miller of the Personalized Medicine Coalition urged the FDA to push out their timeline for guidance. In this very open and candid interview, Liz responds that there is no set date for final guidance. “We will take the time it requires to go through them [community comments], analyze them, and decide what we need to do in response and finalize the guidance,” she says. "There is no rush to do that."

Podcast sponsored by: This Month in Biotech - Coming January 30th!

Future of Personalized Medicine at Stake, says Amy Miller of PMC about LDT Regulation

Amy Miller is the Executive Vice President for the Personalized Medicine Coalition (PMC) and joins us in our Special Report on LDTs Series. Though the PMC does not have a position on whether the FDA should regulate LDTs, Amy says that the stakes could not be higher.

“We see the future of personalized medicine is at stake. We urge the FDA to get this right the first time so that personalized medicine can continue to improve the quality of care that patients currently have access to,” she says at the outset of today’s interview.

Amy and her organization represent stakeholders from every side of the current debate on LDT regulation. They hear from industry, payers, providers, and labs. Amy is asking the FDA to step back, take time to respond to the recent community feedback conference, and publish supplementals that will provide more clarity to the guidance, such as how risk will be determined. Amy and the PMC would also like to see the FDA “harmonize” their language with that of CLIA, the current system in place for lab regulation.

“I absolutely think the timeline has to be pushed out,” she says. “The community needs another crack at that framework."

An Exciting Time for Mass Spec: Paul Beresford, Biodesix

Guest:

Paul Beresford, VP of Bus Dev, Biodesix Bio and Contact Info

Listen (4:47) VeriStrat - a test for non-small cell lung cancer

Listen (4:39) What do you anticipate on the regulatory front?

Listen (6:01) Evolution of the Dx model away from cost plus

Listen (3:39) New legislation

Mass spectrometry has been a valuable research platform for many years. But clinical uptake of the technology has proved illusive. Until now.

In today’s program, Paul Beresford says that his company, Biodesix, out of Boulder, Colorado has been able to improve mass spec to a clinical, commercially viable level. The company already has a proteomics based test on the market, VeriStrat, a predictive and prognostic for non-small cell lung cancer. And this is just the beginning. Announcing a new round of funding this week, the company intends to use the platform for other cancers and tests.

Working for eight years at Ventana Medical Systems before his current stint at Biodesix, Paul offers a seasoned perspective on the challenges facing all diagnostics companies. Asked about how we as an industry can raise the value of diagnostics, Paul says that the “value-based play for diagnostics is actually getting better” and sees help on the horizon from Congress.

“Legislation is moving forward so that these [high value diagnostic] tests will essentially be priced through a market assessment versus Medicare just picking a price,” he says.

The Sad State of Biospecimen Science with David Rimm, Yale

Guest:

David Rimm, Professor of Pathology, Yale University School of Medicine Bio and Contact Info

Listen (4:16) An unsexy science

Listen (5:36) A lack of certifications

Listen (6:20) Most pathologists not aware of the problem

Listen (2:48) Pathologists not reimbursed for providing research samples

Listen (7:44) Still no Tissue Quality Index

The next stop in our journey to better understand the impact of poor biospecimens on biomedical research takes us to Yale where we talk with pathology professor, David Rimm, about the new science of biospecimens.

In past interviews we’ve established the importance of better standards in the collection, handling and storage of biospecimens. David has developed some rare and unique training at Yale for the students of pathology, but still, he says that biospecimen science has not really taken off.

“Most scientists and pathologists are not aware of this problem,” says David, referring to the issue of sample degradation.

How is it the case that billions of dollars are spent studying samples that were not collected with any standards? Why are there no certifications for pathologists in this regard?

One thing that would help immensely and has been long hoped for is an assay that would tell whether a sample is still good, what David calls a Tissue Quality Index. Perhaps a researcher or pathologist does’t know where a sample came from or how long it’s been in storage. This Tissue Quality Index would be a scoring system for determining whether the sample could still be used for an application. David got a grant to develop the score, but didn’t quite get there with the one grant. He applied for another grant, but it was turned down. Regrettably, he says, it’s just not an important topic for traditional funders.

The holy grail of biospecimen science, a Tissue Quality Index, remains still to be grasped.

Podcast brought to you by: Quintiles - bringing people and knowledge together for a healthier world.

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Faces of Leadership in Diagnostics: Surbhi Sarna

Guest:

Surbhi Sarna, Founder, CEO, nVision Medical

Bio and Contact Info

Listen (4:43) Filling a void in female health innovation

Listen (4:31) Addressing the leading cause of infertility

Listen (7:41) Creating the pap smear for ovarian cancer

Listen (5:22) An early start

Facing health difficulties at a young age, Surbhi Sarna determined early in life that she wanted to change the status quo for female healthcare.

“I’m generally not very good at accepting things the way they are,” Surbhi says in today’s interview.

Several years ago, she tapped into that impatience to create nVsion Medical. Backed now by venture capital, the company is running clinical trials for a new imaging device to address the leading cause of infertility—fallopian tube blockage. The company is also working on tests to diagnosis ovarian cancer early.

“Our long term goal is to create the pap smear for ovarian cancer,” she says after painting the bleak outlook those with the disease face today.

Surbhi has been listed as one of Forbes Magazine’s 30 under 30 in Science and Healthcare. Today she tells her story.

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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.

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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.

Why We Are Underwriting 'The Faces of Leadership in Diagnostics’ at Mendelspod

It’s no secret that the diagnostic industry is changing. Outside pressures like reimbursement and regulation, and internal forces like innovation, have produced tectonic shifts and allowed new landforms to rise from the ocean that is the diagnostic industry.

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.



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