Mendelspod Podcast

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

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 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:Anna Barker, Co-Director, Complex Adaptive Systems Center, ASUBio and Contact Info Listen (3:21) Andy's challenge Listen (4:39) The year of immunotherapy 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:Surbhi Sarna, Founder, CEO, nVision MedicalBio and Contact Info Listen (4:43) Filling a void in female health innovation Listen (4:31) Addressing the leading cause of infertility 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:Carolyn Compton, Professor of Pathology, ASU Bio and Contact Info Listen (4:54) A historic new consensus Listen (6:33) CAP committed to enforcement 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