Mendelspod Podcast

Today we bring you a story which you probably wouldn’t have heard at last week’s AGBT conference at Marcos Island. While PacBio and 10X Genomics were getting most of the buzz at the annual show on all things sequencing, it could be the new BGI/Complete Genomics platform that steals the show later this year, says David Smith, a cancer researcher at the Mayo Clinic. In his research, David uses sequencing to analyze the connection between the human papillomavirus (HPV) with oropharyngeall cancer.

For many years, the trend in biotech was for drug development companies to pursue one or maybe two drug candidates, or assets, as they’re called in industry parlance. Go lean and attract the attention of big pharma or investors in the late stage trials. But today’s guest says there is more innovation when the biotech organization invests in a technology platform that produces multiple drug candidates. Paul Hastings is the CEO of OncoMed, a company developing drugs that target cancer stem cells. He’s built OncoMed in what he says was the old model.

In today’s special studio interview, the health tech duo, David Shaywitz and Lisa Suennen, walk us through the changing paradigms around healthcare. They offer their thoughts on some of the new digital health and peer-to-peer social platforms which are becoming integrated in daily clinical care.

One of those attending the recent White House gathering where Obama announced the Precision Medicine Initiative was a woman who has worked tirelessly as a patient advocate for over twenty years. She’s an award winning scientist and the CEO of the Genetic Alliance: Sharon Terry joins us to kick off a new series, Personalized Medicine and the Consumerization of Healthcare.

Today we bring you a story which fits nicely in the vein of personalized medicine. But this time with a twist. We talk with the CEO of Protagen, a company that has developed a platform to find new biomarkers for disease, particularly autoimmune diseases such as SLE, or Systemic Lupus Erythematosus. But the platform is based on the hunt for genetic mutations. Rather the company is using antibodies, or proteins to better define disease and disease populations. The company is able to stratify auto-immune diseases better than we’ve done with genomics.

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?

David Schwartz was focused on long read sequencing and the structural variations of the genome—the big picture—long before the current trend. His lab at the University of Wisconsin at Madison developed optical mapping and posted the first optical map of the human genome several years ago. And last year, they published the first optical map of a cancer genome.

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.

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?

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.

Guest: John LaMattina, Senior Partner, Pure Tech Ventures Bio and Contact Info Listen (6:27) Comparing drug approvals: 2014 with 1996 Listen (7:10) More rational drug development?

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?

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?

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

Guest: Anna Barker, Co-Director, Complex Adaptive Systems Center, ASU Bio and Contact Info Listen (3:21) Andy's challenge Listen (4:39) The year of immunotherapy

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

Guest: Carolyn Compton, Professor of Pathology, ASU Bio and Contact Info Listen (4:54) A historic new consensus Listen (6:33) CAP committed to enforcement

Guest: Geoffrey Ginsburg, Director, Duke Center for Applied Genomics and Precision Medicine Bio and Contact Info Listen (6:58) Genomic medicine occuring across the lifespan

Guest: Thomas Quertermous, Director of Research, Division of Cardiovascular Medicine, Stanford University Bio and Contact Info Listen (7:45) Close, but not quite there

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