Mendelspod Podcast

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. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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 is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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 is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe

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? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.mendelspod.com/subscribe