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State of Biotech Turns to State of Disbelief with Fraud Allegations against Steve Burrill

Author: 
Theral Timpson

Earlier today Nathan Vardi at Forbes broke the news that one of biotech’s most notable investors, Steve Burrill, was ousted from his own company’s fund and has been sued for fraud by a former managing partner.   The news hit the biotech community like a major earthquake, particularly in the Bay Area where Steve has been advising and funding bitoech companies since the the founding of Cetus and Genentech. 

Reporting from documents just filed with the California State Court in San Francisco, Vardi writes that thirteen investors to Burrill Life Sciences Capital Fund III, including the Treasury of the State of North Carolina, Oregon Investment Fund, Unilever, Monsanto, and Celgene removed Steve as general partner of the fund in March.  

And why?  The investors in Fund III claim that the Glass Ratner Advisory Capital Group audited the fund and reported that nearly $20 million had been paid to “various designees and affiliates” beyond what had been earned in management fees.

Steve Burrill at One Embarcadero Center 

Steve Burrill has built up a venerable name in biotech, having participated in getting the first biotech companies off the ground, funding some of the winners over the years, and publishing financial data and other industry news in the The Burrill Report.  

We’ve featured Steve on the program each of the last three years to review his annual State of Biotech book which covers the latest trends in everything from the R & D crisis in big pharma to the new digital health apps.

While I’ve heard various opinions about Steve--most of which go something like “Steve is all about Steve Burrill” and “Steve is a brilliant guy, but too heavy handed”--allegations of fraud and dishonesty have never been among them.  If true, these claims would stain what has been a phenomenal career.

The Forbes scoop has been tweeted right and left today, but with no more comment than:

“Wow.”

“Whoa!”

“Big.”

“Yikes.”

@ArthurKlausner wrote the most in his tweet:  Stunning News about Steve Burrill -- hope there’s an “explanation.”

Alex Lash of Xconomy put out a piece this afternoon with the same details from the Forbes article and a link to the fraud lawsuit against Steve filed by Ann Hanham, former managing partner at Burrill and Co.  

A story like this takes some time to digest.

I emailed Steve this morning for comment, but so far nothing has come back.  

And I’ve reached out to some of our local advisors, but no one wants to go on record yet.

Steve Burrill has been an advisor to Mendelspod, and agreed to an in-depth interview shortly after we got up and running.  (It doesn’t take long to run into the Burrill brand in this industry.)  He’s been very approachable and even  offered up his rolodex, saying he’d reach out to anyone we wanted to get to the program.  We’ve partnered with Burrill and Co.’s media division, attending and reporting on their always high level conferences.  Last year Burrill and Co. partnered with the Buck Institute on a conference on aging that was a first of its kind.  I’ve valued all of my chats with Steve, both formal and informal, over the past few years.  He’s offered great advise and pointed us to key trends.

At Burrill's Personalized Medicine conference last Septemeber, as I reported here, there was quite a break in tone from previous conferences.  After that we couldn’t reach some of our steady contacts in the media division.  On December 3rd, Luke Timmerman, biotech editor at Xconomy wrote a piece, Burrill VC Fund Splits into New Firm, Biomark, after Short Marriage.  Timmerman interviewed Steve and partner David Wetherell for the piece and even probed them to see if there were any “disagreements” over startegy with what was called the Burrill Capital Fund IV.  

“No,” came Wetherell’s answer.

Well, it turns out there were already problems with Fund III.  According to the Forbes piece, Burrill and Co’s managing partner, Ann Hanham “discovered that a substantial portion of the money that had been raised from Fund III limited partners had gone missing.”  Hanham’s number?  About $20 million.  

In what appears to be the most damning evidence against Steve are quotes from an email he himself wrote urging Hanham and her colleagues not to report the missing funds to the investors.

“We can earn our way out of trouble,” Steve wrote.  “What we need is revenue to solve our problems n just timely enough to meet any capital calls which might be needed . . . Each of u are part of the solution.”

I've heard it said around the industry that Steve doesn’t hire anyone who will give him trouble.  Perhaps that all changed with Ann.

So far it’s a "she said" story without the "he said."   But with some big consequences.  The investors of Fund III have heard enough to be convinced that they are done with Steve.

Steve has been using the title, CEO of Burrill Media.  As Timmerman reported back in December, Steve had let go some of the media staff and made contractors out of the rest in what he called a "rightsizing."   For example, Danny Levine has moved on to create his own company, but still produces the weekly podcast for The Burrill Report.  

I interviewed Steve just last month to go over his annual book (which came out on time), and Steve carried on pretty much as usual.  I noticed in his email signature that his address had changed from the 27th floor of the prestigious One Embarcadero Center building to a “Suite 120” in The Presidio.  A fire engine siren sounded during the interview.  With the address change, I obvserved to Steve that he must be down on the ground floor now.

“Yes.  I’m very grounded now,” he replied.

 

Some Glimpses into the Challenges of Data Visualization Panel Event

Author: 
Theral Timpson

Big Data might offer tremendous breakthroughs in healthcare and personalized medicine.  But with the new amounts of terabytes and petabytes flooding organizations today, old architectures aren't able to keep up.

Take the genome, for instance.  We know that there is a ton of valuable information in there.  But how does one go about looking at it?  Doctors have very little time as it is, and decision making becomes a burden becuase it takes days to get answers to questions, if at all.  And what about the opportunity to get genomic data to the lay person as 23andMe was doing?  

On June 5th, about sixty of us turned the Oakland office of Omicia into an event venue for networking and a discussion, "Delivering Genomic Medicine: Challenges in Data Visualization and Reporting."

Panelists were Martin Reese, the CSO and founder of Omicia; Michele Cargill, a genetic scientist at InVitae, and Adam Baker, a product designer at the new start up, Iodine.   The audience, including Omicia's new CMO, Paul Billings, and a group of 23andMe folks actively drove the discussion on what is clearly a hot topic.

Some pictures and takeaways:

-While visualizations of the genome have come a long way, genome interpretation companies still have to find new, simpler ways of presenting their data.

-Doctors want a simple, green-yellow-red light kind of answer to their question. They don't have time to go through long reports.

-Online reports are best.  They offer the chance to show a simple report up front with the possibility to click through for further information if needed/desired.

-Genetic counselors have a critical, but not very fun job.  The science is often vague, and patients' knowledge of genetics is limited.

-Success in genomic reporting will depend in large part on the user interface. 

-You don't have to dumb down the presentation. Yelp and Expedia are examples of complex data sets that are navigated by millions every day.

 

Panelists Martin Reese, Michele Cargill, and Adam Baker with Moderator, Theral Timpson

Matt Landry, Nola Masterson

Paul Billings

Ashley Dombkowski 

The event was sponsored and co-produced by Chempetitive Group, a life science marketing company that is "introverted about marketing and extroverted about science."

Why Hasn't Clinical Genetics Taken Off?

Author: 
Sultan Meghji

Insiders to genomics are looking around and, generally over a tasty adult beverage, bemoan the lack of forward progress on the clinical side of adoption. Why haven clinical adoption rates gone up faster? What’s making this hard? I’ve become frustrated over the last few years, raising a significant amount of money across a number of companies, all trying to speed up the scale of adoption in the non-sick population. Looking back, looking around and seeing how the current landscape of startups and new activities in clinical genetics are being run, I’ve come to the following conclusions.

1.      Why should I (the patient) care about my genetics?

It’s expensive. It’s confusing. It doesn’t give me any actionable information. We’ve seen how quickly the alpha consumers are taking up activity trackers and other actions-oriented technologies; the lack of an equal demand in clinical genetics is a clear indication.  The general population just doesn't see the point in utilizing clinical genetics and are not asking for it.

2.     The case hasn’t been made to the physicians

The vast majority of front line caregivers acknowledge the technological advances but just aren’t convinced that genetics would make a useful differentiation in healthcare. The current environment has placed an onerous burden to change the standard of care, with the exception of a new pill to replace the old one, usually at a pricing premium. Not too long ago I was talking to the #2 at a major regional medical center (an oncologist by training and practice) and the quote from him I took away was, “..clinical genetics doesn’t matter to me in my practice. There is no proven utility to the vast majority of our patients.” 

3.     The front line caregivers need to be (re)educated

Given that most front line caregivers do not have an education around molecular biology, the entire dialogue around genetic information needs to start at scratch and there isn’t a common platform to do that.  Any easy way to discover this is to ask your primary care physician if (a) they took molecular biology in college and (b) how many molecular tests they’ve ordered this year. For far too many the answers are “no” and “zero”. 

4.     The hospitals, clinics and labs which the physicians have access to don’t offer full service, cost effective solutions

Another interesting question to ask your PCP is what tests are actually available now. Is there a test that they can order right off the menu from their office/lab/hospital/clinic? Again, for the vast majority of doctors, even if they had an educated and motivated patient and an educated, motivated and willing doctor, the local infrastructure doesn't support this. The one shining light of hope is for people with chronic or specific issues, especially around cancer. 

There is a tremendous amount of effort being put into “4” and the other supporting systems, but until 1, 2, and 3 are resolved we’ll never see the broader impact we hope for.  There are a few interesting movements out there, but right now change can be measured generationally. A ray of hope comes from the current pain in the public educational system where k-12 is using resources like the Khan Academy, which has a nice introductory set of content on genetics.

In an environment where most PCP’s are between the ages of 50-55 (AMA), coupled with the increasing age of the general population, we find ourselves in a situation where most people inside the medical ecosystem do not understand genetics.  This is true both on the patient and the provider side.  The ecosystem is currently focused on financially oriented activities (ACA, playing nicely with Medicare/Medicaid and the health insurance providers) vs. actually integrating new useful technologies.  

Inside the industry, we still talk about the lack of adoption as a scientific or techincal issue, when actually this "last mile" issue is with doctors and the average person just not seeing the value. We need to do a much better job of educating the general populace as to the value of genetics in their daily lives. 

Join Us Next Week for a Discussion about the Challenges of Data Visualization and Reporting in Genomic Medicine

Author: 
Theral Timpson

Next Thursday, June 5th, Mendelspod teams up again with Chempetitive Group to bring you an evening of networking and a special panel discussion.

"Delivering Genomic Medicine: Challenges in Data Visualization and Reporting"

When:  Thursday, June 5th

   Networking:  5 30 pm

   Panel Discussion:  6 15 pm

Where:  Omicia Inc, 1625 Clay St, Oakland, CA  94612

Price:  Free (Register here)

What is a genome?  And how does one go about looking at it?  Furthermore, how can it help a doctor make a quick call for a patient?

Source: AmericanProgress.org

Remember after the Human Genome Project was completed when Science Magazine offered that insert foldout in one of their issues that was a full color representation of the entire genome?  We hung it on our walls and showed it off to our friends.  But what did it tell us? 

Helpful and accurate visualization of biological data--from genomics to lipidomics--will be a key step in translating discovery to everyday use. Doctors use X-ray and other images to help diagnose a patient's illness. How can genomic and other omic data be visualized in a way that will offer quick and accurate insights into a person's "health state" (as Stanford's Mike Snyder likes to call it)?

This is the question we'll be putting to a panel of experts next Thursday,  folks who are working every day to help the rest of us better understand the latest gigabytes of biological data.   We'll be housed at the trendy new office of the genome interpretation company, Omicia, in downtown Oakland where we'll be surrounded by work stations and data scientists up to their elbows in data.  There is limited seating, so if you haven't already, register now.

See you June 5th in Oakland!

Stanford’s Big Data in BioMedicine Conference Turns Two

Author: 
Theral Timpson

With Silicon Valley blazing on as number one hot spot for high tech and the Bay Area claiming the same for biotech, it makes sense that Stanford, sitting there mid-peninsula basking in all that brilliance, should command a leading role in bioinformatics.

Today, Stanford’s Big Data in Biomedicine Conference kicked off with a star lineup and even a whiff of glamour.  The conference room at the Li Ka Shing Center was packed with attendees looking up on a stage lit with colored lighting, backed by giant screens, and filled with elegant white leather chairs.  Cameras and lights filled the lobby, with interviews being done on the side.  The conference is being tweeted (#bigdatamed) like a presidential election!   

Along with a contingent from Oxford University, speakers included representatives from the White House, NIH, and the FDA.  Stanford  is well connected with the national funders and policy makers.   Though beginning with some of the hype from last year (the first time is always the most exciting), by the end of the first morning the conference had settled down in a somewhat grounded pace when some good questions were addressed:  whether there is enough "science" in data science.  Questions of privacy and quality were lightly touched on.  

I was disappointed to see that none of the panel topics for the entire three days--which range from integrating genome scale data to machine learning--included bioethics.  Stanford has some great speakers on bioethics, such as regular Mendelspod guest, Hank Greely.  Big data certainly holds big promise for improving healthcare, but new technology always brings up big unforseen consequences.  Addressing those thorny issues like privacy, equality, and safety head-on would have kept the conference more balanced.

Todd Park is the second CTO ever for the U.S.  And having him come directly from the White House adds some glamour, yes.  But Mr. Park’s keynote was more Easter service than scientific conference, more cathedral than campus.  Using lines like “there has never been a better time to innovate in healthcare than now” and “we are so blessed to be living in . . .”, Mr. Park “god blessed” the crowd of scientists praying that “the force be with you.”  Hm hm.  Bring on the data, please. 

And yes, the next speaker, Colin Mahony, used the term “nirvana,” alluding to that big data heaven that we all dream about.  But from there on the conference came back to earth with slides and graphs of . . . . data.  

Mike Snyder, perhaps the most biologically studied person in history, gave an update on his iPOP, or integrated personal omics profiling project.  He didn't offer much new today other than that he’s had some progress in tracking epigenetic changes--not easy--and some characterization of his microbiome.  Steve Quake and Stanford newcomer, Julia Salzman, rounded out the session leaving plenty of time for a panel discussion with Q & A.

Snyder’s ongoing project of looking at hundreds of thousands of his own biomarkers over time, often referred to as the Snyderome, provoked a great question from panel moderator and bioinformatics super star, Atul Butte.  There’s been lots of progress on the various omes, but isn’t the most challenging one the time-ome (anyone for temporome?), or the ability to continually access samples and build the data set over time, Atul asked.

This is of course the key to Snyder’s project, so he launched into more details of his “longitudinal” study. It was Steve Quake who delivered the provocative line.

“I think of time as my friend,” Steve said.

It’s when you look at the data points over time that you’re able to find an anomoly or a signal, Steve reasoned.

Panelist Colin Mahony chimed in with an excellent observation as well.  When you look at the various slides that the speakers use to present their data, Colin observed, time is usually the only constant.  Time can provide “the best primary key” to work around in building data sets, he concluded.

Julia Salzman delivered what was for me the biggest WOW moment of the morning with her talk on “circular RNA.”  

Apparently scientists have already been aware of RNA molecules that circle back on themselves, biting their own tail.  But these molecules--unlike their linear siblings-- have been dismissed as non-protein coding, and therefore not interesting.  Julia said that by being “willing to look at data that was in the trash”, her team discovered that circular RNA has implications for disease and could be used as a diagnostic tool.  She went so far as to say that with this discovery, biological textbooks are now obsolete.  That sounds like a big deal!

The issue of quality was raised.  But unfortunately the discussion followed a specific instance of sequencing, and the general question of how to clean up huge amounts of data was not addressed.    A recent guest bioinformatician at Mendelspod said her biggest challenge was not with storage or compute power, but in improving the quality of the data.

A small debate broke out between Snyder and Quake over big science vs. small science when the NIH representative speaker, Philip Bourne, asked what the NIH could do more for bioinformatics projects--other than give more money.  Quake said that we have some great data sets out there produced from big consortium projects already. Now money should go to good ideas at the individual research level.  Snyder argued that the ongoing large ENCODE project had been beneficial and proved that big data sharing projects could consist of individual researchers pooling their RO1s (smaller grants) together, sharing their data, and benefiting from more real time interaction.  A hybrid of big and small science.

A top question at Mendelspod this year has been whether with the increased data storage and data mining abilities, research has become more data driven than hypothesis driven.  And is anything lost in that?  I presented this question to the panel.

Mike Snyder asserted, with examples,  that “the biggest discoveries in science were not hypothesis driven.”  

So the question was asked, if there is plenty of data, then what is the "scarcity" for generating better questions.  

Steve Quake couldn't resist sharing a local joke:  "how do you define data scientist?  any statistician who lives in San Francisco.”   Then Quake threw out a serious challenge:

“We have a scarcity of ideas, not data.”  

The big data conference continues through Friday and is being broadcast live at https://bigdata.stanford.edu

For Twitter stream, search #bigdatamed.

Delivering Genomic Medicine: Challenges in Data Visualization and Reporting - Panel Event Set for June 5th in Oakland

Author: 
Theral Timpson
Mendelspod and Chempetitive Group are pleased to team up and bring you another evening of networking with a panel discussion, "Delivering Genomic Medicine: Challenges in Data Visualization and Reporting." Join us after work in Oakland on Thursday, June 5th for drinks, bites and discussion.
 
Since the FDA shut down 23andMe's health related products late last year, a separation has grown in the genomics community between those who think 23andMe is good for personalized medicine, and those who think the DTC company has been harmful. The former argue that 23andMe has simplified genomics for the masses through their marketing and PR campaigns and through their online reports. Those opposed warn that the data and the reports are over simplified.
 
When talking about how to understand, interpret, and report genomic data, one of the challenges is presenting to various levels of users.  There are the patients--or consumers as some like to say, the doctors, lab techs, and, of course, other researchers.  The secret behind translating research into better clinical outcomes depends not just on Big Data, but how it looks.
 
 
We'll be talking with some data experts who are finding their own ways to look and report on genomic data:
 
-- Martin Reese, CEO, Omicia - Omicia is now targeting clinics with Opal, their new software which helps clinicians "understand, interpret, and report" on genome sequence data.  Martin has been around bioinformatics since the mid-90's and worked directly on the Human Genome Project with what later became UCSC's Genome Browser.  
 
-- Michele Cargill, Geneticist, InVitae - Michele has a strong passion for democratizing genomics.  She believes that genomic data should be shared in a kind of Web 2.0 She joined Randy Scott's new company, InVitae, after working as a geneticist at the former DTC company, Navigenics.
 
-- Euan Ashley, Asooc. Prof. of Genetics, Stanford - Euan is directing the new Clinical Genome Service at Stanford Hospital.  He refer's to the problem of visualization in genomics as looking for a "needle in a needlestack."  Benefiting from a strong genomics research community at Stanford, Euan is attempting to put some of that research into healthcare benefits.
 
-- Theral Timpson, Host & Producer, Mendelspod.com - Founded in 2011, Mendelspod is a premier media source advancing life science research by connecting people and ideas. Mendelspod goes beyond quick soundbites to create a space for probing conversations and deep insight into the topics and trends shaping our industry's future and the future of our species.
 
This event is brought to you free thanks to underwriting from Chempetitive Group, an international life science marketing agency that gets it. From PR and design to creative and marketing strategy, Chempetitive Group has a love of science and a passion for strategic marketing.
 
Join us June 5th in Oakland at the hip new offices of Omicia where we'll have time for networking, food and drinks before and after. Event begins at 5:30 p.m. and the program begins promptly at 6:15 p.m.
 
Register soon as there is limited seating capacity!

Finding the Sweet Spot in Regulating Genomic Medicine

Author: 
Theral Timpson

New technologies and the possibilities they bring to improve human life always come in fits and starts.

Genomic medicine is no exception.  The overdriven tools space of next generation sequencing has created a bursting spring season in genomics research.  New studies linking “this” biomarker with “that” phenotype bloom with a force of nature leading some to make bold predictions about man’s ability to conquer his own form.  We can smell eternity.

Selling information about our bodies--biomarkers, for instance--will be big business, maybe bigger than pharmaceutical remedies.  Genomic knowledge brings power.  Will it also bring profit?

In the meantime, medicine continues it’s steady march.  Streams of new genomic tests based on biomarker studies are finding their way to patients, sometimes through established channels, sometimes in new avenues,  often leaked through the cracks.   Streams and rivers must be watched closely when it rains.  When linked to human health, they must be regulated.

So far the translation of genomics into routine clinical use has been regulated mostly by CLIA, the Clinical Laboratory Improvement Amendments overseen by CMS, the Centers for Medicare and Medicaid Services.  

When a biomarker test is used in conjunction with a therapeutic, the FDA or Food and Drug Administration has insisted on an approval process for the biomarker test.  The FDA calls such biomarker tests medical devices.

But can all genomic and other ‘omic information be converted to simple, easily commercialized tests like Roche's HER2 test?  Furthermore, should this information and the clinical interpretation of it be regulated by two different government regulatory bodies?

These questions remain unanswered and form the basis of a new series at Mendelspod, Regulation and Genomic Medicine.  

The deluge of genomic data has found routes outside of traditional healthcare channels.  Through ubiquitous internet connections, the data is being made directly available to the masses.  Some say that healthcare is becoming more democratic and that we are seeing a fundamental shift from treated patients to smarter consumers.

Last November, however, the FDA put a monkey wrench in this democratic genomic current by stopping the direct-to-consumer company, 23andMe, from selling their health related genomics tests to consumers.  And with much backlash.  Some have charged the FDA with being “paternalistic” and a “killer of innovation.”  Others are relieved by the FDA’s action, contending that this so called “democratization” of genomics is eroding the quality and therefore the potential value of genomic testing.

Our first guest in the series is Cliff Reid, the CEO of Complete Genomics.  With an eye on delivering whole genome tests and reports to clinicians, Cliff has been of the opinion that routine clinical genomics might first take off in a country outside the control of the US FDA.  His company was recently purchased by the Chinese genomics firm, BGI or Beijing Genomics Institute.  Practically then, Cliff talks of the opportunities in China where regulation has been limited, if not primitive.

However, last month China cracked down on NGS based genetic testing.  Cliff explains that the new regulations are an important step forward for China and remains bullish on the opportunity there.

Back in the U.S., Cliff envisions a two-tiered system:  a highly regulated clinical avenue on the one hand coupled with democratic opportunities for consumers to get their own data on the other. 

The FDA says they are not opposed to consumers having their own genomic data, but are concerned over how the data is interpreted.  Cliff envisions consumer sites that aid in interpretation and get around FDA concerns.

Our second guest will be Anne Wojcicki, CEO of 23andMe, the company recently targeted by the FDA.  In her interview, Anne says her vision of delivering genomics data out to the masses remains undiminished.  She says the company is working closely with the FDA to get their test back on the market.   Is this a straightforward process, or does she see it as a major setback?  Ms. Wojcicki sounds confident about satisfying the regulators at the FDA.  She says she draws inspiration from her employees who “have always known they were in a ‘whiplash’ culture.”  For Anne, there may be setbacks and the way forward ambiguous, but the target remains clear.

Our third guest is working on the front lines of genomic medicine.  Elaine Lyon is the senior medical director of molecular genetics at ARUP Laboratories.  She’s also the new president of AMP, or the Association of Molecular Pathologists.    After discussing the impact of next gen sequencing on the lab, Elaine has some well informed thoughts as to the sweet spot of regulation.  

First of all, she says that her product is not a simple test, but the report that is delivered to the clinician.  Elaine feels that the professionalism of laboratory technicians is overlooked.  Much preparation and study is needed to be able to run these tests and interpret the results in a way that doctors find clinically relevant.  

This is why Elaine supports a change in terminology.  A lot has been said and written about whether LDTs, or laboratory developed tests, should be regulated by the FDA or whether CLIA is enough.    Elaine says that, in fact, they are not LDTs, but really LDPs, or laboratory developed processes.  And how does the FDA go about regulating a process, Elaine asks, which includes a highly trained subjective interpretation of the results? 

Elaine is concerned that having both FDA and CLIA regulation will be too onerous for labs.  “We’ll just end up not offering the tests,” she says in her interview.

The remaining two guests are yet to be interviewed.  We plan to speak with someone from the FDA to reveal their latest thinking.  And we aim to represent the diagnostics industry, members of which are increasingly making FDA approval part of their business plan and strategy up front.

What is this sweet spot for regulating genomic medicine?  Will Cliff Reid's two-tiered suggestion be the way forward?

We found this suggestion written on April 1st provocative, even if made in fun.

Spreading "Particle Fever"

Author: 
Theral Timpson

On July 4 of 2012, we all watched with suspense for the outcome of one of the biggest and most expensive experiments in the history of science: the discovery of the Higgs Boson at the Large Hadron Collider at CERN in Switzerland. What many of us were not aware of at the time was that an entire generation of physicists were hanging in there to see whether their careers had been in vain.

David Kaplan was one of those physicists. A professor of particle physics at Johns Hopkins University, he knew what was at stake. Fortunately for us, four years prior to that big day, Kaplan had the foresight and creativity to team up with another physicist, Mark Levinson, to document the historic discovery.

Particle Fever is the result of their collaboration, a stunningly beautiful documentary now in theaters. I cannot recommend the film highly enough to our audience. True, the film is about physics, not biology. But the theme of doing science at the highest level rings out for a hundred minutes, offering inspiration, explanation, and stunning images.

“Imagine being able to watch as Edison turned on the first light bulb,” says the film's website.

Official Trailer "Particle Fever"

I read the write-ups on the discovery of the Higgs back in 2012, but I was unaware of just how much was hanging on finding the particle. As the film explains, the Higgs boson lies at the center of what’s called the “standard model” of physics. Without the Higgs, our current understanding of physics would come unraveled.

Many of the themes we see in biology are present here as well. How much money should be spent to pursue basic science? What is the goal of such science?

One particularly satisfying scene was a talk by Kaplan at the Aspen Institute promoting and explaining the work at CERN. After his talk, Kaplan takes questions. An economist in the audience asks what will be the monetary reward in finding the Higgs boson. Kaplan replies, “perhaps none. But it might just lead us to understand everything.”

The film features real time interviews with six physicists, some working at CERN, others following from their classrooms. There is enough explanation and a terrific array of animations and illustrations to bring us deeply into the world of these physicists and see just what was at stake.

I was struck by the pure poetry that came from these scientists as they attempt to explain physics and how far our species has gone in defining and understanding our universe.

One of the star players in the film is Savas Dimopolous, a professor at Stanford. In an unscripted interview typical of the film he explains how mathematics has enabled humans to go great lengths in answering the fundamental questions of life.

“With mathematics,” he says, “it’s as though Nature is whispering to us.”

The documentary delivers a drama and plot as thick as any Hollywood action flick. For not only was the whole world watching to see whether the Higgs was there, there was another question, how much mass would the particle have.

Whether the particle would be light or heavy has vast implications into the future of the study of physics and our understanding of the universe. On the one hand, a light particle indicates a “supersymmetry” in the universe where all elementary particles are related. This theory shows a certain beautiful connectedness in the universe and teases us to go on discovering particles. On the other hand, a heavy Higgs boson indicates a multiverse situation, where constants in one universe may differ drastically and randomly from the constants in another universe. If this is the case, the study of physics may be at an end, as we cannot go into other universes to discover new particles.

10,000 scientists from over 100 countries engaged in the single pursuit of the Higgs boson. Going into the film, we already know that the particle will be found. But we’re on the edge of our seats as the implications of the discovery unfold. Nature, herself, offers the finest of plots.

One Less Voice on the BioBeat - Luke Timmerman Ends Stint with Xconomy

Author: 
Theral Timpson

Monday mornings won’t be the same in biotech.

Luke Timmerman announced last week that he’ll no longer be writing his Monday morning BioBeat column or serving as National Biotech Editor at Xconomy.

Timmerman’s voice has stood out in our industry for consistency, optimism, pragmatism . . .  and great sports analogies.  

 

Source: Xconomy

In a farewell article, Timmerman writes:

“I was hired to help take our life sciences coverage to a new level.  I’m proud to say Xconomy is a must-read news site for people in the bioetch and pharmaceutical industries.”

It’s true.  I can confirm that Luke’s column has been a part of my Monday mornings since we started Mendelspod.   Most of what we read in life science media is regurgitated press releases.  Luke wrote his share of these.  But his Monday morning column stood out.  It was obvious Luke put some thought into each week’s column, writing on topics he found fascinating and relevant.  

Recent headlines for the BioBeat column read:

The Big Guys Have Lost their Iron Grip, and It’s All Good - A piece about the relationship of big pharma and smaller biotechs.  Luke argued that there’s been a recent shift in the balance of power where smaller biotechs have more options.  

The $1K Genome?  So What?  Illumina Is on a Quest for World Domination - Here Luke actually downplays the milestone of the $1K Genome saying that there’s a lot more than this headline going for Illumina.

Molecular Diagnostics Are in a Rut.  The Industry Needs the FDA  - A gutsy headline that stands on its own.

These columns could only be written by someone who has been covering biotech for some time.  Someone who has seen the peaks and valleys--several of each--and who maintained a healthy dose of passion for the industry to go along with the reporter’s “been-there-seen-it-all” skepticism. 

Curious to know more about Luke and how he got to his place on top of  biotech journalism, I interviewed Luke at the end of 2012.  He struck me as an old school journalist in the best sense of the term.  A writer who worked always toward the ideal of journalism and willing to put in the hours to know his field and develop his craft.  In today’s world where everyone on Twitter can be journalist, Luke seems cut from another cloth.

I remember going to an Xconomy event where it was like sitting in Luke’s office and overhearing his conversations.  Luke interviewed one biotech CEO after the other, not shying away from difficult questions.  His command of the history of each company and the drugs they had commercializied or were working on blew me away.  He could name these compounds from memory and many of the drug targets.

In a phone chat last week, Luke said the Monday BioBeat column was a personal challenge.  He wanted to "plant a stake" and come up with a  “really meaty, impactful piece of journalism” once a week.  Consistency builds readership.  

“It’s very easy to get caught up in all kinds of little tasks and wake up in a month and realize you haven’t done a piece of journalism in a while,” he said. 

I asked him if there was a column or two in the past few years of which he’s especially proud.  After some um-ing and ah-ing, he came up with a piece from last December, 12 Things the Pharma Industry Can Do to Rebuild Real Public Trust.

“I remember when I wrote that,” he said, “and I thought I’d be really happy if pharma even considered one of these things."

Luke honed his chops at Bloomberg and moved to Xconomy to be part of a new paradigm in media.  He says social media drastically changed journalism while he was at Xconomy.  He has written regular posts about who to follow on Twitter and today has nearly 12,000 followers.

Again from his farewell column:

"This has been quite an adventure in online journalism entrepreneurship. At other companies where I’ve worked, the readers were there, regardless of what you wrote or didn’t, but they seemed more like a set of composite demographic characters than actual people; it was hard to identify with them.

"Xconomy, as a startup, was something altogether different. When I joined it was still in the midst of being built and defined. Reporting and writing were just the start. It forced me to stretch in all kinds of new directions. This job required being an entrepreneur, ambassador, proselytizer, recruiter, staff mentor, editor, conference impresario, name badge stuffer, and computer anti-virus technician."

Overall thoughts on the industry as he changes focus?  Luke says he’s encouraged about big pharma becoming more transparent.

“I’m seeing signs of movement in the right direction.  I do think pharma wants to become better corporate citizens that they’ve been in the last 15-20 years.”

So what's next for Luke?  He told me that over the years he’s developed a passion for getting the word out about our industry to the wider public.  He’s  going to devote his full attention to a biography of the industry giant, Lee Hood.  Luke feels that a biography is a great form for educating the general public on the possibilities of genomic medicine and other trends. 

“People like reading about other people,” he said.

Erik Clausen, a managing partner at Chempetitive Group, has been in life science PR for over twenty years.  He’s worked with Luke and been a regular reader of the Monday column.  I asked him over email if he’d heard about Luke moving on, and he gave this reaction:

“Save for a few individuals, the media that covers the life sciences operated at a slower pace (or at from less-informed position) than their brothers and sisters tasked with covering the tech or other sectors. That is, until Luke Timmerman brought an informed tenacity to Xconomy that made the outlet, his peers, colleagues and (frankly speaking) CEOs and PR flacks better at what they do. He set the bar a bit higher. His ability to accurately grasp and relate both the science and business aspects of this industry are paralleled by only a few journalists, but not surpassed. And, his talent for infusing a point-of-view into his work is a testament to his passion for discovery and a compliment to his predecessors in print journalism.”

Luke’s Xconomy column will be missed, especially those yearly biotech picks based on sports stars.   Good luck, Luke - looking forward to reading the book.

 

The Clinical Sequencer

Author: 
Theral Timpson

A Feburary 7th article in the online version of Nature magazine began with the line, "Genomics finally came of age as a clinical discipline on November 19, 2013, when the US Food and Drug Administration (FDA) approved Illumina's MiSeqDx next-generation sequencing (NGS) system for clinical use."   

Now, some may argue with this and say genomics was coming of age with the BRCA test from Myriad back in the nineties, or with the use of NGS for cancer treatment, or the rise of prenatal diagnostics.

And some may say that the science just isn't here yet.  There are very few applications.  I was talking recently with a member of the team at Health and Human Services last week who helped draft Obamacare.  She said that most folks in healthcare and most of congress is certainly not aware of KRAS, BRAF, EGFR, etc.  The science is very new and there must be many many more clinical trials.   Furthermore, we've inherited a healthcare system that was designed for infectious diseases and lacks the infrastructure and expertise in molecular medicine. 

But we can all agree that the clearance by the FDA of an NGS platform is a milestone and goes another step to fulfilling the promise of genomic medicine that began many years ago.    

Last week, I moderated a panel discussion, “The Clinical Sequencer,” at Select Bio’s conference in San Diego, NGS: Research to Clinic.  Daniel Grosu, VP of Clinical Development and Medical Affairs at Illumina, played a large role in getting the MiSeqDx platform FDA approved.  He joined us on the panel among with a terrific lineup of four other experts in the space.  I think highlights of their comments deserve to be written down.

Daniel Grosu, VP Clinical Development and Medical Affairs, Illumina

Daniel was brought on at Illumina in 2011 as their first Chief Medical Officer (a position which is now filled by the former head of the NCI, Rick Clausner).  Daniel said that the process of getting approval for MiSeqDx took about eleven months total.  Because the FDA had not approved anything like this before, they had to figure it out as they went along.  For example,  PCR and Sanger sequencing were used to verify the quality of the Illumina NGS platform, even though neither of these technologies have FDA approval in this particular context.

Daniel was keen to explain that there were really two approvals at the FDA.  One was for the MiSeqDx Cystic Fibrosis Assay and the other was for the open platform with reagents.  

He also confirmed that Illumina is actively seeking big pharma partnerships for CoDx development with the now approved platform.  Earlier this year Illumina announced that they would be collaborating with the biotech giant, Amgen, to develop an NGS-based companion diagnostic for their colorectal cancer  drug, Vectibix.  

Hakan Sakul, Executive Director and Head of Diagnostics at Pfizer

Another one of those partners might be Pfizer, who’s Head of Diagnostics, Hakan Sakul joined us on the panel.  Of course Hakan wouldn’t verify wether Pfizer is partnering yet with Illumina on the newly approved platform, but he said that he’s very excited about the opportunities with NGS.  Hakan said that NGS provides some clear advantages over PCR and earlier in the day he even mused about whether NGS would replace PCR.  

Hakan pointed out that clinical sequencing offers clinicians the opportunity to do research and medicine at the same time.  With a PCR test you have to know what you’re looking for, but NGS provides a more robust tool for discovery.  This will be a challenge for regulators, Hakan said.  So far to get a diagnostic test approved by the FDA, a company like Pfizer has to choose a target, or panel of targets, which are spelled out as part of the test.  He left the question open as to how a regulator goes about approving a test where the specific target is yet to be discovered.

Shawn Baker, CSO, AllSeq

Shawn Baker keeps track of all of NGS platforms--new, old, and upcoming--for the neutral sequencing marketplace, AllSeq.  As a panelist he said he had more questions for the others than answers.  He asked Daniel Grosu about the tension that is sure to arise at Illumina now that they have a MiSeq for research and one for the clinic.  These are two very different markets.  The research market accepts and expects constant innovation and upgrades, where the clinical market must have a platform which is stable.  

Daniel confirmed that these markets were different, but said that there is opportunity to improve the clinical platform with regular upgrades.  He said that Illumina wouldn’t slow down in providing the research market with continual innovation.

I asked Daniel if Illumina planned to make a platform expressly for the clinic.  “The MiSeq,” he replied.

Nazneen Aziz, Director of Molecular Medicine, College of American Pathologists

Our fourth panelist, Nazneen Aziz of the College of American Pathologists, or CAP, has been pioneering the standards for NGS that will be necessary in pathology labs.  She said that her team at CAP is not so much focused on the instrument--it doesn’t matter what platform a lab uses--or the bioinformatics software, as much as whether the lab tech can call the disease variant correctly.  As part of the testing, Nazneen and her team have the lab sequence a known genomic segment and call the variants.  This is then compared to CAP's own gold standard for which they used various NGS platforms, including Illumina and Complete Genomics.

CAP testing also includes a profiency test for the lab techs.  Nazneen says that most pathology lab techs are sufficiently qualified to use an NGS platform.

Nathan Pearson, Genome Scientist, Ingenuity/Qiagen

It appears that Illumina will soon have some competition with their MiSeqDx platform. Qiagen has announced their own clinical NGS platform, the GeneReader, to be commercialized later in 2014.  (Stay tuned for our interview with Dietrich Hauffe, VP of Life Science at Qiagen to be published next week.)  

Our fifth panelist, Nathan Pearson, has been working in bioinformatics at Ingenuity Systems.  The company was bought last year by Qiagen.  Nathan said he couldn’t say much about the GeneReader yet, but confirmed that yes, it would come out in 2014.  Qiagen has worked with the FDA for many years and boasts an impressive lineup of approved diagnostic kits.  With an NGS instrument along with their sample prep kits, their PCR kits, and their newly acquired bioinformatics assets (they also bought CLC Bio last year), Qiagen is set to have an impressive end-to-end workflow to offer clinical labs.  Controlling the entire workflow will give Qiagen the opportunity to raise the standards for clinical sequencing.   Now the process is very modular with lab techs using various suppliers for different steps.

I asked Nathan how will we know when a bioinformatics platform is robust enough.  He replied that "it’s like the early days of the computer.  Were they ever good enough?  No.  But did they help out a lot?  Yes."  Nathan said that we are still a long ways away from knowing what to do with “the genome.”  He said that when a healthy person gets their genome sequenced it might not do much for them now, but it can do a lot for biomedical research.  He encouraged everyone in the room to get their genome sequenced and donate it to research.

Clinical sequencing is a very exciting and fast changing space.  In a year or two from now there could very well be other players who we don’t mention today, someone with a disruptive technology.  

No matter what whiz bang clinical sequencing technology that comes along, there is a big challenge that remains for the business model of diagnostic companies.  Diagnostics are just not valued highly like therapeutics.  

I've heard from industry leaders that someday we'll be saying CoRx, that the value will be in the Dx side and the Rx will supplement that.  But we're a long ways from that today.  In fact, the price for Dx  continues to drop.  Myriad, since the Supreme Court decision on gene patents, has faced a drop by half of their reimbursable price.  Why is it we don't want to pay for the tests that diagnose a disease?  They cost a lot of money to develop. (It’s not as costly as developing a therapeutic, but it is very high--in the hundreds of millions.)   Is it a cultural issue?  We don't value naming a problem like we do the solution?   I left the panel with this open question:  What is the biggest barrier to raising the value of diagnostics?  

 


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