gene patents

Nathan and Laura join Theral for our final review show before the summer break. Have you already headed out on vacation? Take us along and stay current with the top stories in genomics.

This month it's gene patents (yes, Congress is really reviving that debate), another gene therapy with another astronomical price tag, and remembering Dr. Henry Lynch of Lynch Syndrome fame.

Direct-to-consumer (DTC) genetic testing has had a bumpy ride.

Back in 2010, Pathway Genomics and Walgreens made a deal to sell DTC genetic tests in thousands of Walgreens drugstores. Within 48 hours of the deal being announced, it collapsed. The FDA sent a letter to Pathway basically asking them what the hell they were doing. Walgreens quickly elected to put the kibosh on the partnership.

Since then, Pathway has reinvented itself as an “information technology company with a genetic testing lab on the side,” according to today's guest, Ardy Arianpour, Pathway’s Chief Commercial Officer.

Late last year Pathway announced a partnership to use IBM’s supercomputer, Watson, to power a new “killer app” called Panorama. This will be a “smart" app available later this year, Ardy says, that will incorporate data from wearables and biomedical literature (through Watson), and be able to recommend certain genetic tests that the company will offer.

However, this time Pathway is being more careful about selling the genetic tests. While the app will be available to every consumer, all genetic tests provided by Pathway must be ordered by a physician. The app becomes then really an educational tool for consumers which might lead them into discussions with their doctors. Ardy says Pathway is developing a separate app for physicians as well.

It's a new day for DTC genetic testing. The FDA just approved for the first time a DTC test offered by 23andMe. Might Pathway's Panorama app with accompanying tests find the right balance between protection of the consumer and the freedom to access our own genetic data?

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?

Guest:

Dan Graur, PhD, Professor, University of Houston Bio and Contact Info

Listen (3:09) Study of biology overtaken by hype

Listen (4:55) Scientist vs. technician

Listen (6:34) Public unaware that all they eat are GMOs

Listen (3:58) Do you have a role as a scientist to reach out to the lay audience?

Listen (2:27) What was your reaction to gene patent decision?

Listen (1:43) Thoughts on clinical genomics

Listen (2:04) Twitter and the Very Angry Evolutionary Biologist

We're happy to welcome Dan Graur, Professor of Biology and Biochemistry at the University of Houston, back to the program. Dan and his colleagues caused a stir in the world of genetics with their publication "On the Immortality of Television Sets," a sarcastic and witty criticism of the ENCODE Project and ensuing claims about the death of "junk DNA."

In today's interview, Graur says that he's always been a critic of bad science. He sees a trend where technicians and tools folks are masquerading as scientists.

"What happened in recent years," he says, "is that we have a huge influx of people who are not versed in the basics of population genetics and molecular evolution, and such. They are all essentially people who know how to write computer programs, who believe that science is not driven by questions, but it's driven by a sort of high tech natural history--the data will tell us what is in there."

Is not biology an information science? Does not the new biologist need to be a bioinformatician as well? Graur says we do not need to reinvent the wheel when it comes to basic science. (We'll be pursuing this question in an upcoming series, "The Bioinformatician Bottleneck")

Graur is currently working on a book about GMOs for the lay audience. He also shares his thoughts on gene patents, clinical genomes, and that marvelous "time waster", Twitter.

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

Guests:

Ellen Matloff, C.G.C., Director, Yale Cancer Genetic Counseling

Listen (5:05) Genetic counseling before the book was written

Listen (6:10) Myriad actions unprecedented

Listen (4:32) 30-40 % of all genetic tests ordered in error

Listen (5:12) Patents needed for business incentive?

Listen (3:09) Too few genetic counselors? Just Myriad propaganda

Listen (4:02) What is the Myriad database?

Listen (5:26) Why is the gene patent decision so personal for you?

Listen (2:32) DTC genomics not accurate, protected or helpful

When Ellen Matloff heard news of the recent Supreme Court decision invalidating some of Myriad's BRCA patents, she was overcome with tears. Tears of relief.

The first genetic counselor at Yale's School of Medicine, Ellen has had a front row seat to the long saga of gene patents, particularly the BRCA patents of Myriad Genetics. In today's interview Ellen recalls the days when the BRCA genes were first made known and explains the huge benefits the gene tests provided to her patients.

Then Myriad cracked down on their patents in a way Ellen calls "unprecedented" and "surreal."

Getting snubbed at every turn by Myriad--and then by her own peers for taking a position against gene patents has made this journey very personal for Ellen. Today she tells her view of gene patent history and gives her take on the burgeoning world of clinical genomics.

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."

Guests:

Christopher Mason, PhD, Assistant Professor, Weill Cornell Medical College

Listen (5:59) ENCODE and the functional genome

Listen (6:00) 59,000 genes in the human genome

Listen (9:00) Huh? Genes can be patented?

Listen (2:36) Did the Supreme Court get the right balance in Myriad case?

Listen (6:26) Genome Liberty - opening up the flood gates for genetic testing

Today we continue our exploration of the recent Myriad gene patent case and what it means for research and the life science industry.

Chris Mason, a professor of genomics at Weill Cornell Medical College, has always greeted the idea of gene patents with disbelief. Working in his lab to "understand the human genome down to every base and every base modification," Chris has been involved with the Myriad/ACLU case from the beginning, serving at times as an expert witness.

In today's interview, Chris discusses his involvement in the case which included some basic scientific training of the lawyers at the ACLU. He also shares his thoughts on the outcome of the big decision. Did SCOTUS strike the right balance? And what practical implications will the decision have?

One of the outcomes is a new company, co-founded by Chris, called Genome Liberty. The company launched last week with the goal of "opening up the flood gates for genetic testing."

Chris is passionate not just about "genomic liberty", but about basic genomic science as well, citing a "duty to the universe" to get it right.

"It's my favorite thing to do," he says in the interview, "to make sure that any new text that is published is obsolete within a year."

Podcast brought to you by: Ingenuity Variant Analysis - Identify causal variants from human sequencing data in just hours.

Guests:

Charles Mathews, VP, Boston Healthcare Bio and Contact Info

Listen (3:51) Response to Myriad ruling

Listen (8:20) What is your number one message to your diagnostic clients?

Listen (9:16) Diagnostics model becoming more like pharma model

Listen (6:17) How can diagnostics startups be better focused on reimbursement from the beginning?

Listen (4:21) Are you seeing more whole genome testing?

Continuing our series, Commercializing Diagnostics, we speak with Charles Mathews, VP at Boston Healthcare. Specializing in reimbursement issues, Charles is a consultant for diagnostics companies. Recorded just hours after the Supreme Court handed down its unanimous decision invalidating Myriad's gene patents, the interview begins with a discussion on the case and what it means for the diagnostics industry.

Charles points out that while Myriad really paved the way in the industry, few diagnostics companies have been able to "carve out" such IP. In fact he sees a possible silver lining with the ruling, saying that it really matches the way the the science is headed, where there are fewer and fewer single markers and more next gen sequencing and multiplexing assays. These new tests with complex algorithms will be better in a world without individual gene patents, he argues.

Mathews' biggest message to his clients is that they must focus on reimbursement at the beginning. No longer is it about a single biomarker or new technology, but rather clinical efficacy. Evidence of clinical impact is much more important, he says, than hiring a host of IP lawyers. How can a start-up be better focused on reimbursement? And is he seeing more whole genome testing? These are questions Charles faces each day.

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

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

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.