regulation


Training the Next Generation of Bioinformaticians: Russ Altman, Stanford

Guest:

Russ Altman, Dept Chair, Bioengineering, Stanford University

Bio and Contact Info

Listen (5:32) A bioinformatician bottleneck?

Listen (4:19) Does the engineer or coder have enough basic biology?

Listen (5:04) Have we been overly reductionist?

Listen (5:16) Beautiful but useless algorithms

Listen (4:13) New breakthroughs in natural language processing

Listen (3:39) A new regulatory science

For our last episode in the series, The Bioinformatician Bottleneck, we turned to someone who has not only done lots of bioinformatics projects (he's been lead investigator for the PharmGKB Knowledgebase) but also one who is training the next generation of bioinformaticians. Russ Altman is Director of the Biomedical Informatics program at Stanford. He's also an entertaining speaker who's comfortable with an enormous range of topics.

It's been some time since we had Russ to the program, so we had some catching up to do. What are his thoughts on the recent philosophy of science topics we've been discussing? Are the new biologists becoming mere technicians? What is meant by open data? Etc. He warns of being too black and white when it comes to reductionism or antireductionism. And agrees that the new biologist needs quite a bit of informatics training. But he's not worried that all bioinformaticians have to be better biologists, saying that there's a whole range of jobs out there.

What's Russ excited about in 2014? The increased ability to do natural language processing, he says.

"We have 25 million published abstracts that are freely available. So that's a lot of text. Increasingly we're having access to the full text and figures. I think we're near the point where we'll have an amazing capability to do very high fidelity interpretation of what's being said in these articles," he says in today's interview.

Russ finishes up by talking about a new West Coast FDA center in which he's involved. The center is focused on a program for a new emerging regulatory science, which he defines as the science needed to make good regulatory decisions.

"This area of regulatory science," he says, "has great opportunity to accelerate drug development and drug discovery."

I saw Russ at Stanford's Big Data conference after our interview and asked him at what age he decided against Hollywood and for going into a life of academia and science.

"Who says I did?" he retorted without hesitation.

Podcast brought to you by: Roswell Park Cancer Insititute, dedicated to understanding, preventing and curing cancer for over 115 years.

Applauding FDA Action against 23andMe, Stanford's Hank Greely Calls for More Guidance on Genetic Testing

Guest:

Hank Greely, Professor of Law, Stanford

Bio and Contact Info

Listen (5:00) What's the best argument for FDA regulation of genetic testing?

Listen (10:50) A health exceptionalist

Listen (7:06) What about a Consumer Reports for genetic testing?

Listen (5:05) A device or a report?

Listen (3:13) Tools in command

Listen (3:43) The genoscenti vs. the general public

Hank Greely is a law professor at Stanford who teaches a course on the FDA and keeps a close watch on the genomic revolution. Hank is concerned with the ethical, legal, and social implications of new biomedical technologies.

We're excited to have Hank join us as part of our series, Regulation and Genomic Medicine. He has developed one of the most clear voices on the question of whether the FDA should regulate genetic testing.

"The best argument for regulating 23andMe is that they're providing health information that is not very good," he starts out in today's interview.

We threw the best arguments against regulation that have come up in this series at Hank. For example, one researcher compared the state of bioinformatics and genome interpretation today with that of the early days of the computer. Was the computer good enough in the 80's, the researcher asked. No, but we still used it, he said.

Hank accepts this argument and agrees that the U.S. has been a more libertarian country than many countries around the world. But we make an exception for health, Hank says. Computers weren't used in the early days, he points out, for guiding cars through traffic.

But is the FDA being overly paternalistic? Are 23andMe's predictions really any different from using data from the Framingham studies?

"In health, I am much more paternalistic than I am with anything else," Hank says. When the information is of really weak power and dubious accuracy, I get still more paternalistic."

Hank is quick to point out that he's not for banning astrology, something that he calls "completely useless." He takes issue with the fact that 23andMe has sold itself as a health company.

"When something wraps itself in scientific and medical guise, and is presented as being scientifically correct, we have the right to demand that it actually is."

What about letting the market bring up the value of genetic testing on its own? Is a genetic test really a device or is it a report done by a professional? And are we doing too much sequencing for sequencing sake? Hank isn't one to avoid tough questions. At the same time, he doesn't deny that some truly impactful technology is here.

"I expect that within 10-15 years there's going to be whole genome sequences in the electronic medical records of most people in this country. If we learn to use them well, interpret them well, convey the information to the patients well, they hold real potential for improving public health. If we do it poorly, they could make things worse."

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

Steve Burrill on Drug Pricing and Capital Markets

Guest:

Steve Burrill, CEO, Burrill and Co

Bio and Contact Info

Listen (3:20) What is going on with capital markets?

Listen (6:48) Drug pricing an easy target but only 11% of healthcare cost

Listen (11:02) Public misunderstands true cost of drugs

Listen (4:21) Which companies excite you today?

Listen (6:00) Where do you stand on FDA's approach with 23andMe?

Listen (4:30) More facts on aging crisis

Burrill and Co has just published their yearly overview of the biotech industry, this year called Biotech 2014: Transforming Healthcare. CEO Steve Burrill joins us today to give his personal takeaways on recent trends.

In 2013, the Burrill Select biotech stock index was up 61%, the biggest gain for any year going back to 1994 when the index was established. This March though, biotech stocks took a tumble. Why the fall? Steve links it directly to the recent controversy over drug pricing, particularly that of Gilead's hep-C drug, Sovaldi.

"Gilead's stock, along with that of some other major biotech companies, dropped and this took off a bit of the market cap and some of the excitement around the industry," Steve says.

Burrill goes on to address the current pressure to lower drug pricing, where it's coming from, and how biotech companies can respond. He says that the general public has a big misunderstanding about drug pricing. The cost of drugs only accounts for 11% of total healthcare spending, and yet drug companies are disproportionately beat upon to lower pricing.

"The real pressure," he says, "is on the doctor community, the hospital community, the broader healthcare community that's consuming 90% of the costs not the 10% that the pharma products are."

Steve doesn't think Gilead will give in on pricing, but will continue to make special deals with various payers and hospital groups, such as their recent agreement with Kaiser. Big pharma and big biotech have become "very sophisticated in working with the various payer communities to both determine outcomes and assign value propositions," he says.

We finish the interview with a discussion about how much FDA regulation is needed for genetic testing. Steve also shares more facts about the aging crisis for healthcare systems around the world.

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."

They're LDPs not LDTs Argues Elaine Lyon of ARUP

Guest:

Elaine Lyon, President, AMP; Director of Genetics Division, ARUP

Bio and Contact Info

Listen (5:53) How do you determine clinical validity?

Listen (5:41) Whole genome or exome?

Listen (5:41) LDPs not LDTs

Listen (5:40) Having both CLIA and FDA regulation too onerous

Listen (3:25) Not convinced that FDA cleared means a better test

Listen (2:32) Opting out of incidental findings

Elaine Lyon has become a key figure in genomic medicine. As the Medical Director of Molecular Genetics at ARUP Laboratories, she's at the bench developing clinically relevant genetic tests. Serving a term as President of AMP, or the Association for Molecular Pathology, she is a popular speaker on the diagnostics conference circuit and is certainly able to talk from an overall industry perspective. She joins us as part of our series Regulation and Genomic Medicine.

Beginning with questions about her work in the lab, the interview quickly moves on to Elaine's thoughts on regulation. Recently, Elaine co-authored a paper arguing that we should not be calling the tests laboratory developed tests, or LDTs, but rather laboratory developed processes, or LDPs. Her point is that the test is not the product, but rather the report that's delivered to the physician. She says we should be focusing on the process of genetic testing because a lot depends on the professionalism of the lab tech doing the test. As a process, Elaine continues her argument, the products are not actually in the domain of the FDA.

As guests have noted on this show before, the diagnostics industry has suffered from low quality testing. There are the three issues of analytic validity, clinical validity and clinical utility. It's been argued that regulation by the FDA can improve the quality of the testing. Elaine is doubtful of this argument.

"I am not convinced that simply having an FDA cleared test means it's a better test," she says.

She feels that more regulation is just too onerous. Rather than having two separate governmental regulatory bodies--CLIA and the FDA--examining and approving the testing, Elaine says that we should enhance CLIA.

Elaine warns that at a time when labs are not getting reimbursed like they used to, adding FDA regulation will increase the cost of genetic testing. This may mean that labs won't be able to offer these tests at a time when the technology is dramatically better.

We end with a discussion about the recommendations coming out of the recent ACMG meeting.

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

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.

The Whiplash Culture of DTC Genomics with Anne Wojcicki, 23andMe

Guest:

Anne Wojcicki, CEO, 23andMe

Bio and Contact Info

Listen (5:39) What was your personal reaction to the FDA letter?

Listen (5:34) What is the appropriate level of regulation?

Listen (3:30) Results roulette?

Listen (1:06) What is the path forward with the FDA?

Listen (4:17) How do you go about deciding next steps?

Listen (3:48) Audience: What about international options?

Anne Wojcicki is a fighter. Seen by many in our industry as a leader in delivering genomics to the masses, she now has a more complicated job as CEO of 23andMe.

On November 22 of last year, the FDA sent a letter to Anne and her team in Mountain View telling them to stop marketing their popular genetic testing service. It's a day, Anne says, she'll remember well.

In one of the few interviews she has given since the letter, Anne shares her reaction to it.

"There was a lot of shock. And I think it took a while to settle in to really understand what the implications of the letter were," she says at the top of the interview.

Though some see her as standing strong for the right of the average person to see their genomic profile, yet others in the industry feel Anne and her company are undermining the potential of personalized medicine by delivering an inferior product. Today we ask Anne just what she thinks is the appropriate level of regulation and what is her response to those who say that the 23andMe test is merely genetic "results roulette."

Confirming that the company is working diligently to comply with the requests of the FDA, Anne says she leans on a team that has become used to a "whiplash culture." And while she admits that the company could do a better job of labeling the product, she nevertheless asserts that the "current regulatory process was not ready for us." She's of the opinion that the company can again offer the health related testing.

Today's show reveals a CEO who remains undeterred in her mission while acknowledging a more complex way forward.

"This is not the simple path. It's a fight. And I'm really honored to be part of that fight and driving a change. But I have more headaches than I used to," she says at the conclusion.

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

Finding the Sweet Spot in Regulating Genomic Medicine

New technologies and the possibilities they bring to improve human life always come in fits and starts.

Genomic medicine is no exception.  The overdriven tools space of next generation sequencing has created a bursting spring season in genomics research.  New studies linking “this” biomarker with “that” phenotype bloom with a force of nature leading some to make bold predictions about man’s ability to conquer his own form.  We can smell eternity.

Cliff Reid on Regulation and Genomic Medicine

Guest:

Cliff Reid, CEO, Complete Genomics

Bio and Contact Info

Listen (3:55) What do you make of recent crackdown on genetic testing in China?

Listen (5:19) Self pay model better for health care

Listen (2:08) What is the right level of regulation?

Listen (5:22) A two-tiered approach to delivering genomic information

Listen (2:00) How has your focus changed since the buyout?

Listen (3:48) FDA regulation not the only way to raise quality of genomic testing

Listen (2:11) What's your reaction to Illumina announcement of $1,000 genome?

Listen (4:13) What is the cost for genome interpretation today?

In a recent blog, 5 Myths of Genomic Medicine, we quoted Cliff Reid, CEO of Complete Genomics, as saying that the mainstream adoption of genomic medicine might well happen first in a country outside the U.S. and very likely in China where there is more appetite for risk.

Well, a month ago or so, many of us were surprised to read that China is cracking down on genetic testing. So for our first show in a new series, Regulation and Genomic Medicine, we invited Cliff to come back on the program and tell us what he knows about the recent regulatory actions in China and how Complete's parent company, BGI, is responding.

What is the right level of regulation back here in the U.S.? And what is Cliff's reaction to the recent letter sent by the FDA to 23andMe stopping the sale of health related genomic information?

In his answers, Cliff hints at a possible two-tiered system for delivering genomic data: one avenue through the clinics that is regulated by the FDA, the other directly to consumers in a 'interpret the data on your own' kind of way.

What's are his thoughts on Illumina's claim to the $1,000 genome, and how costly is human genome interpretation today? Cliff is forthright, provocative, and prescient.

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



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