personalized medicine


CoDx the Only Way Forward for Big Pharma: John Palma, Roche Molecular

Guest:

John Palma, Director of Medical Affairs, Roche Molecular

Bio and Contact Info

Listen (6:54) On demonstrating clinical value of CoDx

Listen (4:45) What is the lead time for CoDx from discovery to market?

Listen (4:11) International considerations

Listen (4:38) CoDx the only way forward for big pharma

Listen (6:54) Are you seeing more companies opt for the CoDx way?

John Palma is the Director of Clinical and Scientific Affairs at Roche Molecular. His job is to demonstrate the clinical value of the companion diagnostics that are developed at Roche. In today's interview, John gives us a "view from the trenches."

How does his team decide when to move forward on a promising biomarker? What is the lead time for CoDx compared to Rx? What are the considerations in going international? What does success look like? John addresses some practical realities for those moving pharma in the direction of personalized medicine. Will a CoDx business strategy be able to save big pharma? John says it's the only way forward.

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

FDA Makes Two Strong Moves in Direction of Personalized Medicine

Two statements by the FDA this week--one a letter to the DTC genomics company, 23andMe, the other a press release announcing the clearance of Illumina's MiSeq platform for a diagnostic assay--signal an agency on the move.

Disruption, Dissent, and Diversity at Burrill's PM Meeting

Last week Burrill and Co. put on their 9th annual Personalized Medicine Conference.  The Burrill meetings are known for straight talk on business matters, in depth panel discussions, working lunches, star speakers, and of course, Steve Burrill.  While this year’s meeting followed in that path, there was more diversity, more disagreement, more complexity. 

IPOs, and more IPOs

Burrill kicked off his usual state of the industry talk with a caveat that echoed throughout the show,  “healthcare doesn’t follow normal laws of economics.”

Quality Is the Key, Says Veteran of Personalized Medicine

Guest: Dr. Larry Marton, Program Chair, PMWC

Bio and Contact Info

Chapters: (Advance the marker)

0:40 Building one of the first molecular diagnostics labs at UCSF

6:47 Where are we at with personalized medicine today?

11:27 What can we do to better quality assurance in the industry?

19:01 Using PMWC as a neutral place for dialogue between disparate groups

23:47 If you practice medicine better than the community, you can be in trouble

29:14 What can those in the industry do to better engage the medical community?

Our guest today has been focused on personalized medicine since before it was called that. Larry Marton is the former chair of the Department of Laboratory Medicine at UCSF. Helping to form the department back in the late 70's, Larry and his colleagues set out to transform a standard clinical laboratory into a place for cutting edge molecular research, a place where basic research could be done and translated into medical practice.

Today he's retired from UCSF, but "busier than ever before." He serves on various boards and is the program chair for the Personalized Medicine World Conference which takes place each January in Mountain View, CA. Anyone who has been to this conference knows the depth and breadth of Larry's contacts and influence in the industry. He says the PMWC is an important conference because it plays the role of "neutral broker" between the various stakeholders in the field: entrepreneurs, researchers, investors, regulators, physicians, and patients.

Larry's core message is that we must improve the quality of new clinical tests which have been translated from research. It is the key to demonstrating clinical relevance, he says. There are issues with sampling, with analytics, and with compliance. What can those in the industry do to better the quality assurance? And how can the industry better engage the medical community? A veteran shares his insights.

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."

Garry Nolan: Trailblazing Single Cell Analysis

Podcast brought to you by: Fluidigm - The leader in single-cell genomics and maker of the C1™ Single-Cell Auto Prep System. The path less traveled just go easier.

Guests:

Garry Nolan, PhD, Professor of Microbiology and Immunology, Stanford University School of Medicine Bio and Contact Info

Listen (6:41) Why is the focus on the single cell so important?

Listen (5:18) Low hanging fruit from bulk analysis already picked

Listen (6:29) What has been the response to your work?

Listen (6:25) Commercializing work as diagnostics at Nodality

Listen (6:38) Biggest challenge is to simplify

Making a big decision several years ago that his lab would have the single focus on the single cell, Gary Nolan has become a global leader in a new discipline. In today's show, he shares his conviction that the next frontier in biology is to expand the number of parameters wherein the individual cell can be studied. "The low hanging fruit from bulk analysis has already been picked," he says. Gary is a founder of two companies, Rigel Pharma (publicly traded) and Nodality, wherein his research is being commercialized. Is 2013 the year of single cell genomics, we ask this trailblazer.

Eric Topol and His "Creative Destruction"

Podcast brought to you by: The Burrill and Buck Aging Conference Explore how innovative approaches from regenerative medicine to digital health stand to change our notion of what it means to grow old.

Guests:

Eric Topol, MD, Cardiologist, Genetic Researcher, and Technologist Bio and Contact Info

Listen (6:22) Patient stories heard at Future of Genomic Medicine Conference

Listen (4:34) Medical community's response to book

Listen (6:02) "I just wish I could go back and start medical school again"

Listen (4:30) Eradicate fee for service

Listen (3:05) Craig Venter: Quality of sequencing has gone down

Listen (4:29) "De"personalized medicine?

Listen (0:58) Excited about rollout of sensors

Eric Topol joins us to discuss what was perhaps the most talked about book in the life sciences in 2012, his "The Creative Destruction of Medicine." In his book, Topol tells of the now arriving era of individualized medicine and the rise of "homo digitus," or digital man. In today's show, Topol dives into some key topics from the book such as how to deal with misaligned incentives in healthcare. "I just wish I could go back and start medical school again because this is truly an era . . a renaissance, an enlightenment in the medical space," says Topol when asked about what he advises young people.

Dr. Topol recently hosted the Future of Genomic Medicine Conference at The Scripps in San Diego, and he begins the interview giving some highlights of patient stories.

Highlights of the 5th Personalized Medicine World Conference

This week the always spectacularly organized Tal Behar and her team put on the 5th annual Personalized Medicine World Conference (#PMWCintl). I want to mention a couple highlights from the conference: prenatal diagnostics and cell profiling.

Prenatal Diagnostics

Lee Hood: Salesman for Science, Part II

Podcast brought to you by the upcoming Personalized Medicine World Conference taking place in Mountain View, CA, January 28-29. Over 100 speakers in three tracks will discuss how best to navigate the changing landscape of personalized medicine.

Guest:

Dr. Lee Hood, Founder, Institute for Systems Biology Bio and Contact Info

Listen (11:04) Pharma's core problem - good at making drugs, poor at finding drug targets

Listen (2:11) Are scientists the world's new rulers?

Listen (2:35) The Montana Factor

Listen (3:38) NIH funds Small Science

Today's interview covers some very broad topics and comes in two parts. It could only be done with an industry Titan, a scientist, an entrepreneur, a visionary, and a great salesman. Our guest is Lee Hood, founder of the Institute for Systems Biology.

I've been looking forward to having Dr. Hood to the program since we started, and delighted that it worked out now. During the interview, you'll hear Lee's take on some of our common topics here at Mendelspod. First, I explore Lee's foresight in bringing together biology and engineering. This has proved a beautiful marriage and led to Lee's direct involvement in the design of the automated DNA sequencer. This discussion has further implications for Dr. Hood, as this was the first of several paradigm shifts he's been part of. In fact, paradigm shifts have been a study of his and a theme throughout his career. He says an early mentor at Caltech urged him to "be on the cutting edge."

It's not easy being at the cutting edge, breaking paradigms. Dr. Hood had to leave the university system to found his dream environment for research and education, the Institute for Systems Biology. Dr. Hood talks about that step as a defining moment for him and his ideas. He explains the core ideas on which the Institute is founded and relates them to the broader picture of healthcare. Rather than healthcare, he predicts we'll call it the wellness industry.

Another favorite topic at Mendelspod is the role of the scientist in society. More and more,scientific discoveries and technology dictate the course of human life. When asked whether scientists are the world's new rulers, Dr. Hood tells the anecdote of his brief flirtation with the idea of running for senator in Montana.

It's obvious that Lee's home state played an important role in his life. He attributes his confidence to the independence he felt at the behest of his mother and the opportunity to hike and experience the wilderness. He was exposed to an academic setting in highschool and recalls that often academic pursuits were combined with trips into the wild.

Finally I ask Dr. Hood a question that came from the audience about whether tax dollars should fund bad science. His answer is nuanced and thoughtful. He warns of being to cynical of 'bad science' or non-reproducable research. He goes on to make the point that there is Big Science and Small Science. He calls the NIH a funder of small science.

Dr. Hood's experience is vast. He's a great thinker. He's an innovator, concerned with a big vision. He's also been able to sell his vision, achieving remarkable success. We've split the interview into two because I just couldn't bring myself to stop Dr. Hood after 30 minutes. A listen through to both shows brings one very close to understanding what our industry is all about.

(Editor's Note: On 12/21/12, Dr. Hood was awarded a National Medal of Science.)



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