regulation


Creating the Foundation of Genomics: Marc Salit, NIST

What is a human genome? Well it’s the three billion letters of our DNA. But how is it measured? How do we know when we have it accurately represented?

These are questions that will have to be answered as precision medicine takes hold; for we must have defined standards that will be the basis for regulatory policy, commerce, and better research. These are also the questions that are foremost on the mind of today’s guest.

Marc Salit is the leader of the Genome Scale Measurement Group at the National Institute of Standards and Technology or NIST. In today’s show, he explains how NIST played a pivotal, foundational role in enabling the ‘Century of Physics.' Now Marc and NIST are looking for the right set of standards to enable the already-upon-us “Century of Biology.”

The human reference genome is an example of a standard that Marc and his team are developing. Currently they are piloting what they call “Genome in a Bottle,” a physical reference standard to which all other human genomes can be measured. How far is the team to having a complete reference genome, and what is an example of the way they are working with the FDA to ensure safe and meaningful genomic tests? Join us as we peer in at the foundation of genomics.

Still Unhappy with FDA’s Plan to Regulate LDTs, Professional Lab Groups Go Direct to the Senate

It's no secret that America's molecular testing laboratories by and large are worried that the FDA's plan to regulate laboratory developed tests, or LDTs, will severely harm patients. Now they have a new proposal which they are taking directly to Capitol Hill.

Roger Klein is the Medical Director of Molecular Oncology at the Cleveland Clinic. He’s also serving as the spokesperson for the Association for Molecular Pathology (AMP) on the controversial topic of regulating LDTs.

Several weeks ago Roger was in Washington arguing before the Senate’s HELP Committee presenting them a newly drafted proposal that he, AMP and other professional groups feel to be a better solution to regulating LDTs. Currently the FDA is on a path to issue their final guidance for LDTs in a way that treats these lab tests as medical devices.

Klein and the professional lab groups are highly concerned that the FDA’s proposed regulation will be too restrictive and will curtail an industry just as it is blooming. Their proposal: to beef up the existing CLIA regulation so that it includes determining a test’s clinical validity. So far, CLIA has been concerned only with the analytical validity of a test.

But wait a minute, haven't we heard these arguments before? Roger explains in today’s interview that his proposal before the Senate is much more complete than what they had in January.

Brian Kennedy and Aubrey de Grey on their Converging Approaches to Aging Research

Last week we attended the 2015 Rejuvenation Biotechnology Conference where we heard about the latest developments in aging research.

We were fortunate enough to sit down with two of the major figures in the field of aging research, Aubrey de Grey, CSO of the SENS Research Foundation and Brian Kennedy, CEO of the Buck Institute for Research on Aging. Brian and Aubrey have gone about their work in different ways but say that their approaches are now converging as the momentum behind aging research increases.

How do the two see the field since Calico and Human Longevity emerged? What developments in the past year stand out to them? Join us for an exclusive interview with two of the aging field’s visionary leaders.

The Sports Genes with Jeremy Koenig, Athletigen

Jeremy Koenig is a molecular biologist and an athlete. His interest in both led him to found a new direct-to-consumer genetic testing company called Athletigen.

Still it its early days, the company has curated several genetic markers which tell about a person’s athleticism. With their first report now available, the company makes it super easy to get started if you have already used 23andMe’s service. The athletigen.com portal will link in to 23andMe and retrieve your raw data. Within minutes you can be looking into whether you’re more of a power or endurance athlete, or whether your body will respond well to the paleo diet, among other predispositions. The report is free.

So how will the company make money, we ask Jeremy, who is also CEO. And, being a Canadian company, what regulatory hurdles does the company face? The DTC genetic testing space has been a treacherous one. The winners have been those companies which offer non health related products, such as genetic ancestry or paternity, or those which have sold large data sets to big pharma.

In today's show, Jeremy points out that the human body is the ultimate technology, and that athletes push this technology to its limits. Athletes can learn from their genes. And the rest of us can learn from studies of athletes and their genes. Will the field of sports genetics take off and open up new possibilities for research and precision medicine?

“One of the things my coach said to me as an athlete in college - I was a hundred meter sprinter - he’d say, 'Jeremy, we are all wearing different bodies, and you need to embrace yours. Don’t think that you need to do what the best sprinters in the world are doing right now. You need to do what’s good for Jeremy.' I think everyone needs to take stock of their own DNA,” says Jeremy.

 

Myriad Settlements Mark End of an Era: Antoinette Konski on Gene Patents

This past month one of the most successful genetic testing companies, Myriad Genetics, has been settling one gene patent case after another. Also, the FDA has been attempting to regulate some very complicated lab testing. So we figured we better talk to a lawyer about the devil in the details. We’ve chosen Antoinette Konski of the law firm, Foley and Lardner.

Antoinette agrees that the Myriad settlements indicate the end of an era with gene patents. So how is she advising her life science clients in securing IP?

Antoinette is also interested in the regulation of diagnostics. What does she have to say of the FDA’s recent move on LDTs, particularly with regard to next-gen sequencing tests?

Not a Stenographer to Power: Luke Timmerman and the New 'Timmerman Report'

Just less than a year ago, the national biotech editor at Xconomy, Luke Timmerman, left his post. Yeah, he just left it. Gone was the regular Monday column that helped us all absorb the newest trends in biotech. Gone were the lists of companies to watch out for that made sense even if we weren't up to date on Luke's sports analogies. One day the columns were here, then they were gone. Luke said he was busy with a biography of Lee Hood, the guy who brought us automated DNA sequencing. But we all knew Luke just wanted to go climb more mountains.

This week Luke jumped back into the game with the new Timmerman Report, his own venture. Today he tells us what he’s up to with the new life science media site and why he just couldn’t resist the biotech beat.

Working in a dramatically changing media landscape, Luke favors "old school journalism". Using the tried and true subscription model, he says the new platform offers him ultimate editorial independence.

“If somebody doesn’t like what I write, I just lose a $99 subscription. There’s really not much more to consider than that," he says. "This is a journalist owned and journalist run company, and I’m going to run it according to my own editorial sensibilities."

We wish Luke much success and look forward to having his independent voice back on the biotech beat.

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!

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.

Current Version of LDT Draft Guidance Means Much Fewer and Lower Quality Tests for Patients, Says Elaine Lyon of ARUP

Guest:

Elaine Lyon, Former President, AMP; Medical Director of Molecular Genetics, ARUP Laboratories Bio and Contact Info

Listen (4:37) What is at stake here?

Listen (6:16) Is your message being heard?

Listen (8:03) Current guidance would shut down two thirds of current tests

Listen (2:33) What would be the best outcome with guidance?

Today we begin a Special Report on LDTs Series. LDTs, or Laboratory Developed Tests, have been used in healthcare for years to aid in diagnosis and treatment of illness. In the age of genomics, the number of these tests has boomed and become ever more complex. It was not until last year that the FDA, who had long been suggesting it, put out the first version of a draft guidance, or terms of regulation for LDTs. Implementation is expected to take about ten years.

Last week the FDA held a community feedback workshop at the NIH and heard from dozens of stakeholders from around the country. Today we’re joined by one of the speakers at the workshop, Elaine Lyon, the Medical Director of Molecular Genetics at ARUP Laboratories. Elaine was the President of AMP or Association of Molecular Pathologists for 2014.

Elaine joined us on the program last year just before the FDA issued the guidance to make the argument that actually what her lab performs are LDPs or Laboratory Developed Processes and not tests. Because they are processes that require a medical professional, this service is more akin to the practice of medicine and therefore not to be regulated by the FDA, she believes.

Nonetheless, guidance has been issued, and it looks like it will go forward. Elaine and other stakeholders around the community have given their input. Will they be heard? What is Elaine’s best hope for an outcome that will work for laboratories across the country and satisfy the FDA?

Stay tuned for interviews with Liz Mansfield of the FDA and the feedback of other stakeholders in this ongoing series.



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