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ENCODE Critic Goes into TV Business and Other Life Science Predictions for 2014

Author: 
Theral Timpson

It's here.  2014 is no longer that strange number we'll deal with at a later time.  Fortunately this year, I got hold of a crystal ball, and here's a timeline with the predictions I saw for our industry.

Jan 14  Luke Timmerman came out as an entrepreneur to his audience during the annual JP Morgan conference.  

“Growing up in Wisconsin meant traditional values, and the calling of journalism was higher than that of business.  So even though I felt the natural urges to be a businessman, I repressed those urges and opted for journalism," he said in the hotel hallway out in front of the Xconomy press suite.

Many in the life science venture capital community praised Timmerman for speaking out openly for entrepreneurs.  Including Tom Perkins, who said that in an age when entrepreneurs are overly harrassed by the government, it’s a breath of fresh air.  

It's thought by some of Timmerman's close colleagues that it might have been fresh air which brought about his forthright announcement.  Last June Timmerman climbed Mt. McKinley, the tallest peak in North America.  

Timmerman says he will still be writing his regular Monday BioBeat column at Xconomy, but commits to pass any stories about the various companies he’s founded to his colleagues.  He pointed to fellow life science journalist, David Ewing Duncan, as an example of other journalists who have come out as entrepreneurs.  For many years a writer for the Atlantic, New York Times, Discover Magazine, Duncan recently founded an environmental genetic testing company.

Finally, it’s rumored that tensions flared at the office of BayBio, the Bay Area life science trade group, when it was discovered that Timmerman’s first openly founded company will be in Boston. Sources say that BayBio CEO, Gail Maderis, has been encouraging all Bay Area entrepreneurs to "come out of the closet" and "speak out" for local business.

The San Francisco Bay Area is already considered to be the least closeted of the Biotech clusters.

March 15  Dan Graur has chosen this auspicious day to announce that he has gone into television.  

It appears that after writing the criticism of ENCODE last year, On the Immortality of Television Sets, Graur and his colleagues became interested in the idea of eternal TVs.  

"As it turns out, there’s a business here,” said the professor.

It is not known whether Dr. Graur will be making televisions or becoming a TV star.  Both seem equally likely.

Ewan Birney, leader of the first phase of the large ENCODE project who took the brunt of Graur's criticism put out a congratulatory tweet:  “Happy for @DanGraur.  Hope he's as ruthless in television as he's been on Twitter.”

April 1  Elsevier buys PLoS for $1 billion.  Much discussion about the future of open access flames over Twitter.  The spokesperson for PLoS assured researchers that this move will only advance the cause, as their are no plans to change anything about PLoS.

It’s rumored that PLoS founder, Michael Eisen, and his brother have moved their revolutionary zeal into another area, that of microbial rights.  The movement is of yet little understood.  In a recent tweet, Michael Eisen writes  “there they go again, calling themselves human when they are mostly microbe.”

April 20  Self proclaimed Indie Scientist, Ethan Perlstein, opens first day of the Deconstructing Man Festival,  a counter culture event for the life science industry based on the popular Burning Man Festival in the Nevada Desert.

Held for the first time, the festival took place in Golden Gate Park in San Francisco.

“I couldn’t be more pleased with the turnout," says Perlstein in one of his thousands of interviews with mainstream media.  “After all I’d said about the NIH grant system being unfair, to have Dr. Collins show up in blue jeans and sing his number one hit song, Sequester Blues, was the highlight for me.”  

Not everyone was happy with the appearance of Collins at Bio’s own indie festival.  

“Uh, it would have been nice if, uh, we could have had at least one, uh, powwow without the powers that be, you know, here, you know,” said one independent scientist in the group, a joint hanging from his mouth.

It’s been confirmed that Bernard Munos, a leading critic of big pharma, held a special meeting in his tent and ordained future Apostles into his "High Order of Innovation."  Though the meeting was secret, a source in the tent  said that each of the Apostles of Innovation had to swear that they would do all they could to lower the price of drug development.  What was unconfirmed is whether it's true that Munos was seen later that  night with his shirt off doing a striptease dance.

“Who would have known that Munos was such a great strip dancer, unless we had put on this festival," said Perlstein with a DNA bandana tied around this forehead.  “And Steve Burrill.  When he showed up in his giant RV and walked out wearing purple instead of his traditional pink, the crowd went wild."  

When asked what was the purpose of Deconstructing Man, Perstein said that he hoped the biopharma community could finally open up a bit and let their hair down.

“It’s important for those who are carrying man’s future and possible immortality in their hands . .  it’s important for them to loosen up a bit,” said Perlstein.

June 6  In federal court, a judge has decided the case, ACLU vs. Craig Venter,  in a decision mostly against the genomics maverick.  It is ruled that Venter cannot patent the speed of light.  However, the judge held open the option that though Venter’s patent on earth was invalid, the patent might hold up on Mars.  The case is expected to go to the Supreme Court.

September 24 George Church was seen riding an Asian elephant in Chang Mai in northern Thailand today.  While Church confirmed in an interview with Der Spiegel that the Asian elephant is the one species capable of assisting in the cloning of the extinct wooly mammoth, he would not confirm whether the DNA of dead famous scientists, such as Charles Darwin and Gregor Mendel, was being used to create a new “super generation” of top rate scientists.

November 26  Despite having regulators swarm around the company all year, CEO of 23andMe, Anne Wojicki, announced today a new home kit for collecting “personal” microbes from your own feces.  The kit must be sent back to 23andMe for the microbes to be isolated and held in storage.  Already a superstar among the libertarian sector of life science, Wojicki further announced that the personal microbes were available to be returned to their owners and could be sold and traded with other customers via the 23andMe website.  In the spirit of openness and sharing and accomplishing more great science, Wojicki said she didn’t “see why the microbes couldn’t be traded and sold elsewhere, such as on eBay and Amazon."

“The internet is the future, folks," said Wojicki on the day before Thanksgiving.  "While we are working solidly with regulators, we're not going to slow down this personal omics revolution. We’re all part of a giant mega organism and the longer we take sharing our microbes, the longer it takes to solve problems of disease and world hunger, and important stuff like that.”

The announcement further inflamed the controversy over the regulation of personal omics.  It is anticipated that the  FDA will consider the home kit and microbial service subject to regulation, but it is not known when they will have the will to enforce such regulation.

Ms. Wojicki wouldn’t confirm whether the name of the company would be changed to 23BillionandMe.  At one time during the press conference, the attention turned from Ms. Wojicki to one of the reporters in the room.  It was Luke Timmerman of Xconomy who said that he was not a part of the founding team of 23andMe.  

“But I’m not opposed to the idea of starting up a competitor company,” added Timmerman.

 

What are your predictions?  Write them in the Comments Section below.

5 Most Popular Interviews: Mendelspod 2013

Author: 
Theral Timpson

With a new year staring us right in the face, today we review our 5 most popular interviews for 2013.

1.  Debating Encode: Dan Graur, Michael Eisen

Our most popular show of the year by far included two guests back to back, Dan Graur and Michael Eisen weighing in on the ENCODE project. I can clearly remember the Saturday morning early in March that my colleague Ayanna called me way too early saying, "you gotta get on Twitter." I did and was glued to the debate marked #ENCODE for hours.  Rifts within the scientific community are always good for the journalism business, and this one delivered the traffic. I'm still running into folks at conferences who say, "oh, you're the ones who did the interview with the scientist who went after ENCODE."

At stake was not just the worth of the $400 million ENCODE project (a multi-phase follow up to the Human Genome Project), but the value of doing Big Science in general, and perhaps even most important, the characterization of the human genome. (We've learned that scientists can be possessive over the human genome. Something to do with a "duty to the universe.") In 2012 over 30 papers were published as the first phase of the ENCODE project was completed. These papers were accompanied by a large media campaign about the "death of junk DNA." The lead authors of the ENCODE project were claiming that, contrary to what was previously thought, most of the genome was in fact functional, that even though 80% of the genome doesn't contain genes, it still plays a role in health.

Six months later, Graur and his colleagues published "On the Immortality of Television Sets," a sharply worded and sarcastic takedown of ENCODE. The Graur paper deconstructed the ENCODE claims and, judging by Twitter, had the agreement of most scientists in the field. What many took issue with was the tone of Graur's paper. Was it right for a scientific publication?  Fortunately for us, Graur's interview presence was just as engaging as his prose.  

Credit for the show's popularity also goes to the second guest, open access publishing guru, Michael Eisen. He was happy to take up with Graur in his criticism of Big Science and question the worth of such a big project as ENCODE. Not the least bit shy himself, Eisen lamented a shift to the "Sovietization" of science. He cited the then recently announced Brain Mapping Project as well.

2.  Father/Scientist Finds Gene Responsible for Daughter's Unknown Syndrome:  Hugh Rienhoff Talks Personal Genomics

Apparently this headline had everything our audience loves, except perhaps more talk about ENCODE.  First of all: personal genomics.  Anyone who is searching around in their own DNA or that of a family member is basically a hero in our industry.  That Hugh Rienhoff did before many others further built up his notoriety.  

This show turned out to be a scoop for us, which I wasn't aware of until about halfway through the interview.  Hugh had just found the gene causing his daughter Beatrice's unknown syndrome, but he hadn't yet been to press.  

Hearing directly from patients, or families of patients, was something our audience clearly liked this year, and we followed up Hugh's show with more patient interviews.  This will be a strong theme in 2014.

3.  Making a Difference: Janet Woodcock, FDA

I was surprised to see this show pop up in our anayltics as third on this list. We've found that the biggest names in the industry don't always draw the biggest crowd.  Still, Janet was very open in her answers here and explained the FDA's newly adopted program of fastracking "breakthrough status" drug candidates.  

This was our first interview with someone from FDA. Since then we've had Liz Mansfield from the device division join us in another popular show.  Obviously folks want to hear directly from the horse's mouth when it comes to regulation.

4.  Hunkapiller Chips away at PacBio's 'Perception Issue'

I was quite happy with this show.  Early each year we produce a series on the latest in NGS, and this year the new CEO of PacBio, Mike Hunkapiller, set the tone for the series around the importance of 'long reads'.  The PacBio instrument had suffered several years of being seen as low accuracy.  But in this interview Hunkapiller pointed to limitations with short read technologies (Illumina, Ion Torrent) saying that actually, the PacBio machine had high accuracy.  

In fact, the importance of long reads became the theme in NGS over the year.  BioNano Genomics entered the market offering genome mapping technology and the opportunity to better capture structural variation.  And upstart Nabsys was the darling at AGBT with their 'positional' sequencing.  (Nabsys promised a product launch in 2013, and unless they plan on a holiday launch, haven't delivered on that.)  Furthermore, Illumina picked up Moleculo, a company offering a solution for getting longer reads from the Illumina platform.  I'm proud that we were able to catch the 'long read' message early in the year with Mike's show and keep our listeners up with the very latest in the field of NGS.  Stay tuned for 2014's series beginning in January.

5.  Science and the "Great Delusion" with David Brin, Sci-fi Author

This was easy.  All we had to do here was just get this interview.   Ok, we did show up at Brin's house in San Diego and turn on the camera.    Author of many popular sci-fi books, including one made into a movie by Kevin Kostner, Brin has been captivating audiences with his tremendous intellectual chops and entertaining delivery.  Never one to shy from any question, no matter how probing or how far into the future, Brin delivered a tour de force here.  

I remember that day in San Diego when we filmed Brin. The interview was quite the ride.  Interviewing Brin is like being in the cockpit of the millitary's top fighter jet.  One can go anywhere, and quickly.  After the interview, both Ayanna (behind the camera) and I applauded.  What else to do?

I'm going to also list our interview with another sci-fi writer here, author of the popular Mars Trilogy, Kim Stanley Robinson.    KSR, as he's know among sci-fi fans, also delivered a great interview and came in just after Brin's in terms of audience downloads. 

One final note. This list all came from early in 2013 and in fact the numbers favor the older shows.  Many of our interviews have staying power, so the longer they've been up, the more hits.  Another way to compose the list would have been to look at how each show did over a week's time period.  If we had done that, we'd also be talking about the recent controvery over the FDA letter to 23andMe (here and here) and a show we did with the self described "science indie".

Happy New Year to our audience, and thanks to all our 2013 sponsors for underwriting some memorable programs!

 

Parody of a Thought Leader

Author: 
theral Timpson

Time for a bit of pre-holiday fun.

At Mendelspod, we say that we feature "thought leaders" from around the life science industry. But what is a thought leader?

David Brooks of the New York Times offers his version this morning, and I must pass it along. Superbly observed, full of delicous phrases.  A fine bit of comedy. 

FDA Tells 23andMe to Stop Marketing: Death Knell for DTC Genomics 1.0?

Author: 
Eric Schuur

The FDA on Friday published a letter addressed to 23andMe’s CEO, Anne Wojcicki, telling the company to cease marketing it’s Saliva Collection Kit and Personal Genome Service (PGS). In the letter, Alberto Gutierrez, Director of the Office of In vitro Diagnostics and Radiological Health, describes the many interactions the Agency has had with 23andMe, informing the Company of the need to comply with the regulations and attempting to assist the Company in doing so. He also describes how 23andMe did not fulfill their promises to provide information to the Agency. I’m kind of surprised that 23andMe did not work with the FDA, since it ought to be no surprise that the FDA would order 23andMe to stop, given their apparent lack of compliance. Hopefully we will find out more about why the Company thought they could ignore the FDA.

Two additional thoughts that this development seems to support: the final bell for DTC genomics 1.0 and FDA is going to regulate genetic tests. 23andMe was really the last prominent player in DTC genomics left standing, after Navigenics and deCode were purchased by big Life Sciences firms with no apparent interest in consumer genomics. It sort of confirms that the space of unregulated genetic testing with medical information packaged alongside is rapidly diminishing in size and probably won’t exist in this form for long. It seems likely that these technologies and products will end up being regulated and available largely via prescription. Score one for the medical profession. However, there may well be a next chapter written and it could have some interesting twists. Say, for example, a 23andMe equivalent offers that service from an international location. I think it will ultimately be hard to hold a lid on consumer genetic testing.

5 Myths of Genomic Medicine

Author: 
Theral Timpson

No topic has been more popular at Mendelspod than that of genomic medicine.  This is partly an editorial decision.  But it also comes to us from every direction.  And it is very exciting to hear stories of new knowledge about human biology being translated into precision healthcare.  We have featured the major players in the NGS tools industry and some of the newcomers working on “next next gen”.  We’ve featured data analytics companies and some of the new genomic interpretation and reporting groups who are setting up shop.  We have interviewed professors talking about their latest discoveries linking biomarkers to disease.  

It’s easy when listening to these guests to get caught up in a personalized medicine wonderland.

One guest has stood out over the past two years.  Cliff Reid, CEO of Complete Genomics, has a powerful vision of personalized medicine that is undeniable.  But he also commands an exceptional grasp of “on the ground” realities.   The implementation of research into the clinic is not always as straight forward as we hear.   

Cliff was a cofounder of the company and started with the vision to sequence a million genomes.  This meant more than research.  The business model for the company depended upon doing clinical genomes.  They had the fastest human genome sequencing technology, accuracy as good as any other platform, and a steadily dropping price.  Running low on cash, the company sold last year to the Chinese sequencing and informatics company, BGI.  Still, Cliff’s goal is the same: to sequence a million clinical genomes.  And with the resources, infrastructure, and international footprint of BGI, Cliff can see even further into the horizon of genomic medicine.  

I recently heard Cliff speaking on a panel titled “The Genome Moves to the Clinic” at the Burrill Personalized Medicine conference.  His  answers stood out boldly and often ran counter to the prevailing winds of the conference circuit.  I met with Cliff this past month for a couple chats to get a more comprehensive view of his thoughts on the topic.  Together we came up with these five myths of genomic medicine:

1.  Genomes will be housed in EMRs.  

Cliff turned heads at the Burrill conference when he said, point blank, that the genomic data won’t be kept in electronic medical records.  It has been the accepted notion that at some point one of our great software companies--IBM, Google, Oracle--will bring phenotype and genotype together, will put a person’s omics profile together with their EMR.    A doctor will come in the patient room, pull up the record, and see everything about the patient in one place.  In fact, Cliff says, doctors are scared to death of this prospect.  Why, I asked him.  

Because of a group that we don’t talk about much in this industry, but with whom doctors are very familiar--the twelve person jury.  Genomic data is powerful.  But doctors don’t yet know how to use it.  Let’s say the patient’s genomic profile resides in his/her medical record, Cliff reasons.  Then the patient comes down with some illness or has an existing disease that hasn’t been diagnosed .  This patient later gets it in his/her head that the illness could have been predicted or diagnosed based on the genomic profile in their EMR--which could be true.   How responsible is the doctor?  Genetic researchers don’t think about malpractice suits from day to day.  Doctors do.

2.   Genomic data is huge and will require an enormous, expensive storage facility.

Cliff gives a talk titled, “All of the world’s genomic data fits in my garage . . . and always will.”  He expects to be booed off the stage at bioinformatics meetings.  Here’s the gist of it:

The NSA is building a storage facility to house their data so big that it has to be located in the desert of Utah.   But this needn’t be the case for Complete Genomics.  Sequencing data is big now, Cliff says, because it’s raw data.  But companies such as Complete are developing a new level of confidence in finished data--that is, the significant information gleaned from the raw data.  And the raw data will not be needed.  Check out these numbers:

If Cliff’s goal is to clinically sequence a million genomes, how much storage is needed?  One genome generates 20 gigabytes of raw data.    So one million genomes equals 20 petabytes.  A data center that size can fit into Cliff’s current average size garage.  (I  know where you think I’m going.  When genomic medicine goes mainstream, Cliff’s garage will grow accordingly too.  No.) 

In a few years, the finished data for a clinical genome will take up just 20 megabytes.   That’s a decrease of one thousand times, from 20 gigabytes to 20 meg.  Now scale up the sequencing of one million genomes to one billion genomes.  That’s one thousand times increase.  Which means the finished data will again be 20 petabytes.  It still fits in Cliff’s garage.

And what about the need to go back to the raw data to question a conclusion?  Cliff says it will be cheaper to just sequence again.  The ultimate storage for raw data already exists, he says.  It’s stored in molecules, not bits.

3.  Genomic medicine will first take hold in the U.S.

We can’t even implement Obamacare, let alone a new practice of medicine.  Research hospitals in the US are certainly the leaders.  And it might seem wrong that the American taxpayer who has funded the majority of research not be the first to benefit.  But it may be a smaller country in Europe, or say Asia where there is a national health service and a culture more open to risk taking.  

Cliff says that in America the risk profile introduced by genomics causes a great deal of caution.    This is not to say that there are cultures without ethics.  But let’s take the notion of privacy, for instance.  George Church has been campaigning tirelessly to get a group of people who will share their genomic data with his Personal Genome Project.   Participants must sign what’s called an informed consent form.  It’s been a painstakingly slow process.  

Now consider a country like Denmark where there is a national health system and where all the citizens of the country have an electronic medical record.  Just with that, Denmark sits better poised to implement genomic medicine.  Add to that a Danish cultural phenomenon.  All of these medical records are open to the public.  This is a country where the population shares their tax filings!

Or, let’s go to rural China, where Cliff has spent time recently.  Rural China? I ask.  Surely the latest in precision medicine will be introduced in the huge metropolises we see covered in smog.  No, Cliff says.  There is an opportunity in rural China.  There is no medical infrastructure there yet.  Think about India when cell phones were introduced.  The  Indians had never pulled copper cable.  They went directly to cell phone towers.  The same might be true for the introduction of a new way of medicine into great portions of China that bypasses sluggish bureaucracies and inefficient infrastructure. 

4. Medicine is first delivered by doctors.     

This is a myth often laid bare by Eric Topol, and we see more and more questioning it.  Still, Cliff insists that it’s not that well understood.

Genomic medicine will be incorporated into practice and will ultimately be implemented by doctors, yes.   But not at first.  There are passionate patients who have become experts at their own genomic status or that of someone in their family.  Parents of children with rare diseases are acquiring the equivalent of a PhD in genomics, determined to find a diagnosis and treatment.  

Jay Lake is a sci-fi writer struggling to survive colon cancer.  Thousands of fans read his daily blogs which for the last few years have been mostly about his cancer.   Since one of his fans told him of genome sequencing, Jay and his father, a former U.S. ambassador, have found their own way to get Jay’s genome sequenced and interpreted.  They have pushed clinics and physicians to be up on the latest in genomic research.    In our interview with Jay, he said genomic medicine is not clinical yet, it’s individual.  Jay and others like him are the pioneers of genomic medicine.  They are patients delivering medicine to doctors.  

5.  A revolution in genomics will change the face of healthcare.

Genomics is not the big revolution.   The revolution with the big “R” is in social media, Cliff says.  Even though this is the age of science, meaningful discovery still moves at a slow pace.  We jumped forward with GWAS, for example, then back again.  We had Herceptin and Gleevac a decade ago.  As predicted by Moore’s Law, the technology moves forward fast, yet making sense of the data is slow.   According to Cliff, if there’s any revolution that will change medicine, it’s not the science of biology as much as the phenomenon of social media.  It is changing the way humans interact.  It is changing our culture and turning existing hierarchies on their head.  Patients are talking with each other.  They are talking directly to researchers, and as seen in the previous myth, they are developing a different relationship with their physicians.  

Remember the four “P’s” of Lee Hood’s P4 Medicine, Cliff insists.  Don’t underestimate the “P” for ‘participatory.’  We haven’t yet nearly hit the tipping point on this one.

A couple runners up to this list were the issues of regulation and incidental findings.  Here, Cliff’s thinking is not so revolutionary.  Regarding regulation, he says it’s inevitable.  This sentiment was backed up today by a  letter sent by the FDA to popular DTC company just down the way from Cliff’s office, 23andMe.  And on the topic of incidental findings, Cliff says that “it is beginning to settle down” with the recent recommendations of the ACMG.

Cliff acknowledges that DNA sequencing is only part of personalized medicine.  Proteomics will be much more challenging to deal with.  Other ‘omics’ will become the limiting factor.  Still, genomics is charting the way.  Cliff is part of team laying down the first railroad tracks of a new approach to medicine. And we’re not always sure just which way the tracks will run. 

FDA Makes Two Strong Moves in Direction of Personalized Medicine

Author: 
Theral Timpson

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.

The most surprising part of Friday’s letter from the FDA to 23andMe was the neglect on 23andMe’s part to follow through on their own submissions to the FDA. Rather than putting forth any new doctrine, which I admit first went through my head when I read the headline today--that the FDA was finally mustering the will to issue guidance on LDTs, the letter reads quite boringly.

In Friday’s letter, it is stated:

“Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.”

So nothing new here. But the letter continues with some incrimination of 23andMe and what appears to be hubris on the part of the popular DNA testing service:

“Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS.  As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”

Fourteen meetings and hundreds of emails. Was 23andMe gambling when they launched their big marketing campaign this year? Were they betting, as some guests on our program have concluded, that the FDA does not have the political will to regulate the genetic tests? The company’s strategy seems quite unclear, with one foot in regulation yet going on with business as usual, indeed ramping up business as usual with price incentives and an assertive marketing campaign.

So far, there has been no response from Anne Wojcicki and her team other than a brief statement by the press officer:

“We have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns.”

There's bound to be a backlash of opinion on Twitter and in the blogosphere, but so far there's not much. I looked for a response from three big fans of the DTC testing company. Daniel MacArthur offered nothing other than the headline everyone else was tweeting. John Wilbanks tweeted that he’s waiting for 23andMe to respond, and when they issued the short statement above, said he too is surprised by 23andMe's efforts, or lack thereof:

"@JohnWilbanks: Response from @23andme in the wild: they’ve been failing to respond on time. Bad FDA strategy. Surprised"

Dan Vorhaus (@genomicslawyer) only retweeted Fierce’s John Carroll’s headline.

"@JohnCFierce: Whoa, FDA gets mighty cross with 23andMe, tackles Ann Wojcicki. - Want to see what angry regulators look like?"

It's still early. 23andMe has become popular in the industry as the debate over regulation continues. But perhaps, and I say hopefully, the needle is moving.

23andMe’s Anne Wojcicki often talks about the fun side of her company’s product in her talks around the conference circuit: are your ancestors from where you think they’re from? how much Neanderthal do you have in you? does your urine smell like asparagus? and so on.

But the service offers more than just the “fun” information with their PGS, Personal Genome Service. In their letter, the FDA gets specific about the tests offered for healthcare decisions, such as the BRCA testing:

“For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.”

Indeed, in an interview here, genetic counselor, Ellen Matloff related a sobering statement that she knew of women who had bought the BRCA tests (not particularly from 23andMe) and proceeded to undergo mastectomies when, indeed, it turns out the women didn’t need to. Matloff has been involved in genetic counseling at Yale since "before the book was written." She came right out and said that “DTC genomics were not accurate, protected, or helpful.”

Will this lead to more FDA action on LDTs in general?

As I mentioned above, one of my first thoughts on seeing the headline this morning was whether the FDA finally summoned the will to issue guidance on LDTs. For 23andMe is not the only company offering such tests. Myriad Genetics, who built a solid business on the BRCA testing, still has not gone the regulatory route on the popular breast cancer tests. Myriad’s sales have spiked sharply this year, part of what has been called the “Angelina Jolie effect”, an uptick in market awareness since the famous actress went public about her testing and mastectomies.

We’ve recently had to the program a couple guests who have made strong arguments for the FDA regulating these tests. Hank Greely is a law professor at Stanford who teaches a course on the FDA and has done a lot of work on regulation and bioethics. He says that regulation is necessary here and makes the case that the relation of regulation to business has a strong history in the US going back to the time of the railroads. He suggests that “carefully drawn regulation can be helpful to industry.”

And in an interview with Dan Hayes, an oncologist at the University of Michigan Cancer Cetner, we heard pretty much a plea with the FDA to buckle down and regulate diagnostics. Dan outlines the “vicious cycle” that the diagnostics industry finds itself in, leading to low prices and poor quality tests. One of the reasons for the vicious cycle is that the FDA hasn’t so far issued guidance on LDTs.

Dan asks that the industry grow up and look at diagnostic tests as they do therapeutics, and says that if we want to move forward then “the days of doing LDTs are past.”

In our interview with Liz Mansfield of the FDA a couple weeks ago, I chose not to spend much time going after her on the topic of LDTs. It’s been done and done. She did say that she and those working in the agency had a “tremendous amount of authority” to do their jobs. And she said that the FDA was already deep in the process of looking into new types of tests which have resulted from cheaper sequencing technology. Last week, the FDA announced the clearance of Illumina’s "next generation" MiSeq platform for a diagnostic assay, hailed by many, including NIH Director Francis Collins, as an important step forward for personalized medicine. It's also a demonstration of the FDA's ability to move forward with the new technologies appearing. But Liz also acknowledged there were times when they needed the go ahead from “higher forces”. LDT guidance “is wrapped up in some politics” she said, “and in that case FDA reviewers and managers don’t have a lot of authority. It’s really beyond our ability to say it’s ok to publish it.”

Perhaps we can look at the two correspondences from the FDA this past week, clearing the Illumina platform and slapping of 23andMe, together. One is a go ahead, the other a get-with-the-program or cease. Are we seeing a gradual incremental approach here, and if so, who will be next?

The Most Important Omic is Econ-omic: Synthetic Biology Conference Turns Two

Author: 
Theral Timpson

Deoxyribonucleic acid.  DNA.  We can read it.  We can write it.  It’s been the foundation of life for billions of years.  Surely there’s lots of money to be made with it, right?

That’s what a group of leading scientists, creative entrepreneurs, and investors with an appetite for risk are banking on.  They’re known as the synbio community, and many of them gathered last week for the 2nd annual SynBioBeta conference.  These folks are tinkering with the DNA of about anything you can think of.  Special bacteria manipulated to produce alternative fuel.  Seeds for custom fruits, vegetables, and grain that are more hearty, disease resistant, colorful, flavorful.  Beauty products.  Specialty oils.  Plants that glow in the dark and may some day be used to light your neighborhood streets.  Sterile male mosquitos that stop the spread of malaria and other diseases.  The possibility to revive ancient life forms that have gone extinct.  Who here wants to see wooly mammoths roaming in Alaska?  In the headlines this morning, we read that Craig Venter is seeking to electronically transmit DNA code between Mars and Earth.

In the past, synthetic biology has been the domain of well funded public research laboratories or large corporations.  Everyone knows about Monsanto and GMOs.  But now, as with anything related to computing, the ability to tinker with DNA is being democratized by every more efficient and inexpensive technology.  Startups are blooming in the space nurtured by an expanding group of investors.  Projects once thought the domain of big science are now crowdfunded on KickStarter and IndieGogo.  Calling all biohackers to a community lab near you!

Will the easy availability of DNA reading and writing technology lead to an economic boom with an array of new products and services limited only by our imagination?  The synbio community is betting “yes.”    

Meeting in the Mission Bay District of San Francisco, the SynBioBeta crowd hails mostly from Silicon Valley, and they look to the hightech/IT industry as a model of growth and innovation.

“Matter is programmable.  Biology is the new software,” said Andrew Hessel, one of a long line  of speakers at the conference giving quick talks.  Hessel is a well known guru in the space who recently went to work for the rapidly growing 3D design company, Autodesk.  

“What do we want to build, not what can we build is the new question,” asserted keynote speaker Steve Jurvetson.  He’s one of the top investors in synbio and a board member of Tesla Motors.

The conference's organizing team is led by a young scientist, John Cumbers, who’s gigs during the day at NASA Ames.   Working his way through school inspired by ideas of terraforming Mars, Cumbers is outspoken about NASA’s synbio program and determined to nurture the business side of the community with the annual conference.  

And he’s succeeding.  This year he and his team doubled the attendance of the conference over last year and persuaded some big names in the investing community to take the conference in a strong business direction.  There were more investors than new companies he told me in an email today punctuated with exclamations marks.  

If last year the goal was to gather the community in one place and launch the conference, this year it was business, business, business.

“The most improtant ‘omic’ is ‘economic,” said speaker Harry Yim, quoting Syndey Brenner.  Yim is a director of engineering at Genomatica, a new company producing sustainable chemicals.

Investor Panel at SynBioBeta

Give Me Some Products

No doubt, this annual shindig is a full day of hype.   Some companies who presented last year are no longer to be seen.  But there is obvious traction, as evidenced by a panel of investors deliberating on just what gives them that special feeling inside.

“Don’t talk to me about technology.  Give me products,” said panelist and investor, Una Ryan.

She’s the chair of the new Bay Area BioEconomy Initiative and a strong voice for women entrepreneurs.  Her main point is a good one.  Many of the startups in the industry have struggled with commercialization.  They usually begin with some cool technology but are unable to convert to useable products.  

This is changing.  One of the big news items for the industry this year was the successful IPO of Intrexon, a sythetic bio company that has been in stealth mode.  Intrexon is working on several fronts from biofuel to new types of drugs and this year formed a new consumer focused subsidiary called BioPop, for Biological and Popular Culture.  BioPop came from the buyout of Yonder Biology, makers of the Dino Pet, a bioluminescent pet on display at the Smithsonian National Museum of Natural History.  A glowing pet is not exactly an iPhone.  But who know's what will come of it?

At the time of the IPO, Intrexon CEO, Randal Kirk told Forbes’ Matt Herper, “I’ve been a biotech investor for 27 years, and Intrexon is by far the best thing I’ve ever seen.  Kirk became a billionaire with the sale of his two previous drug companies, New River Pharmaceuticals and Clinical Data.

Biology Is the New Software

Reese Jones is a long time angel investor.  He told the crowd that he’d been involved in high tech back in the “Homebrew” days, and that the new biology space has the same feel.   (Recall the article in Wired a couple years back where Bill Gates said if he were a teenager today, he'd be hacking biology.)

Moore’s Law, the observation that over time, the number of transistors on integrated circuits doubles every two years, was the most popular model at the conference.  The graph was used time and again to give an inevitability to the coming rise of synthetic biology.  

I asked Reese, Una, and the panel of investors if there was a threshold--for instance, the price of synthetic genes--that they were using as a positive signal for investing.

Una replied that she didn’t think there should be such a threshold and again returned to the theme of “give me products.”  Reese said he’s looking for the time when the reading and writing of DNA is as cheaply done as nature can do it.  That is, for free.

“We can predict the breakthroughs, but just not the companies that will be born,” said Michael Fero, the co-founder and CEO of TeselaGen, which develops software for large scale production of DNA assemblies.

The Wooly Mammoth in the Room

The elephant in the room, or let's say wooly mammoth (which, if it is indeed revived, would have to be born by an elephant) at any synbio conference will almost always be PR.  The promise of new products that will save humanity on planet earth is not without its detractors, and I was happy that the investor panel did not avoid the topic of regulation and PR.  We’ve covered this subject in many interviews at Mendelspod, so here I’ll just say that the concerns, and I believe mostly fear, on the part of average citizens about synthetic biology, most notably GMOs, is very real.

The panel of investors were asked by an audience member how regulatory uncertainty plays into their assessment of risk, and all of the panel came off as quite settled in their views.  There is uncertainty, they agreed, but this hurdle exists for any new industry with promise and one shouldn’t be afraid.  

Una was the most outspoken.  “I’m frankly tired of this cowardly approach to regulation,” she said.  

She’s an advocate of the industry beginning with self regulation and then having a proactive part in creating any government standards.  She was also pretty vocal with her distaste for the term 'synthetic biology.'  She finds it is too entrenched in academia and spooks the public.  She'd like to hear about just 'biology.'

In his keynote, Steve Jurvetson got some chuckles out of the audience when he talked about “motherless meat.”  The phrase does sound better than the more typical “lab meat” and reflected the investor’s awareness of the importance of words in selling such new products.  

Steve said he’s not currently a vegetarian but that he thinks he may be some day.  "I’ll be looking back wondering how I ever ate animal meat," he said.  

It’s true.  Our ethics do change over time.  (See slavery, polygamy, paternalism.)  And perhaps the best ethical defense of a strong snybio industry came again from the investor panel: The biggest risk is in not pursuing it, they all agreed.

Part of a final panel on alternative funding sources, Anthony Evans is the creator of the Glowing Plants Project (see our interview here), a project he funded through KickStarter.  The project is enormously popular with the synbio community as it raised over $450,000 from every day folks demonstrating a certain mass appeal.  Those who pitched in will receive seeds or plants according to their contribution.

Anthony said the biggest goal for the project is to give people something in their hands they can touch and feel, to reach out and build more public awareness.

The conference ended with a chance to go into a dark room to see for ourselves the glowing plants which everyone is discussing.   The single, small aradopsis was not blinding with light, but it does glow,  an apt symbol of the conference and the fledgling industry.  

 

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

Author: 
Theral Timpson

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.”

In the past two conferences, Steve has insisted on a bit of doom and gloom in his talks to balance the hype which can bloom at such industry meetings.  Burrill and Co has invested in personalized medicine and the hurdles have been depressing.  Science marches to its own drum.  And so do payers.

But this year Steve was compelled to acknowledge the drama of an aggressive IPO market which has seen companies go for ever higher starting bids, then see their stock jump 50, 100% in the first day of trading.  Steve suggested Foundation Medicine, who IPOd at $18 and closed the first day up 96%, is the company to watch in the genomics space, much as the industry has looked to Genomic Health in the past.  

It’s rare to see below Steve’s well earned cool when he talks about money.  Afterall, he worked on the business plans for Cetus and Genentech and has been witness to the rise of the biotech industry.  Still, his incredulity at the current IPO market was obvious as he returned again and again in disbelief to the fact that Foundation Medicine, founded in just 2010 and who lost $22.4 million as of 2012, would be valued at over a billion dollars.  

CoRx?

The big takeaway from Steve’s presentation for me was his claim that we should be using the term “companion therapeutics,” rather than “companion diagnostics.”  

“The value will be in the diagnostics side,” he said, accompanied by a slide showing the rise of generics and biosimilars.

The value will be on the diagnostics side--huh?  Did I hear that correctly?  Did he mean the same diagnostics which have run into such regulatory uncertainty and reimbursement hurdles?  The diagnostics which can’t even get CPT codes, and when they do, still don’t find reimbursement from Medicare?  (See this year's debacle.)

First of all, Burrill explains, 55% of drugs do not work.   He says we are “moving to an outcomes world,” and that the information about each person’s unique biology will be where the value is.  Therapeutics will follow from diagnostic type data.

Steve often points out that Google, Facebook, and Twitter don’t charge for their service.  That this is part of their value, and they get paid for this value in other ways.

“What if you were on the board of Google before they put out their innovative search engine and you were asked if the company should charge a penny or a dollar for each search?  You would have voted to charge, no?”

This question of how diagnostic companies will capture value is a gauntlet Steve throws down at the feet of the industry.  Now get up in a panel, or a talk, he seems to be saying, and show what innovative way you’re going to capture value.

Scott and Reid

Most ready to take up this challenge was genomics super star Randy Scott, serial entrepreneur, founder of Genomic Health.  His new company, InVitae, has raised $40 million and offers a CLIA panel of around 200 of the most common genetic tests for $1,500.  Next year the panel will be 500 to 1,000 tests.  And be cheaper.  You see where the company is going.

As a keynote speaker, Scott had the podium for 45 minutes to say how InVitae would bring genomic salvation to planet earth.

“We’re at the dawn of the medical internet,” he began with a contagious enthusiasm, an attitude surely indicative of long days spent with San Francisco's "can do it all" techies.

Scott is convinced that consumers want their genomes sequenced.  And that they have a right to have them.  The only question is the price.  When the price comes down far enough, it will just happen.  Everyone will get their genomic data and know what to make of it.  We’ll be living in a kind of genomic utopia.  

To be fair to Scott, he is a CEO.   His job is to hold the flag at the forefront.  And he has been successful.  Obviously he can raise money on demand.  Steve Burrill interrupted and asked how much money he’d need before the company was making money.  “$200 million,” came the answer.  That’s all?  

I get the sense that Scott, after founding and running a genomics company rooted in the current economics of healthcare, has had enough of the system.  InVitae seems to be based more on a list of personal values than of strategies.

As part of his crusade, Scott makes a moral case for an accompanying campaign to “share the data.”  InVitae has pledged to put all of their "clinically-observed" variants into a public database such as Clinvar

One in fifty of us, Scott says, is carrying a gene that is on the ACMG’s must report list.  (A controversial report published this year by the American College of Medical Genetics determining what to do with “incidental findings” -- those other things you find in the genome.)  Not only should we know these genes, Randy is saying, but we should share them.

“The future will be more about sharing data than hoarding data,” he insisted, perhaps hinting at a business model that would take the industry beyond our traditional notions of privacy and IP.

So how will value be captured from this shared data?  

Is InVitae the kind of company that in an interview here at Mendelspod this year, Cliff Reid of Complete Genomics had predicted would come into the space when he said that companies which have been wet chemistry, patent protected businesses will turn into generic database companies?

And what will be the quality level of this shared data?  Complete Genomics has yet to deliver clinical genomes, at least in the US.

Fortunately Reid was on hand at the conference.  Part of a panel immediately following Randy Scott’s keynote, Reid showed some enthusiasm for Scott’s vision but wasn’t up for drinking all the koolaid.

“It will be impossible to aggregate all the data.  There’s too many IRBs in the way,” Reid cautioned.

And Reid argued that the first clinical genomes will benefit folks in other parts of the world first.  

“Sharing is cultural,” he continued, referring to a couple European countries where medical information for every citizen is open for biomedical research.  

Reid’s experience speaks volumes.  Complete Genomics was once a darling of this meeting.  And Cliff was giving keynotes.  Now the company is owned by BGI.

Perhaps the biggest blow Reid exacted on the discussion came in his flat out statement that genomes are not going into EMRs.   His reason:  there’s no way doctors are going to risk the scary world of malpractice litigation that is sure to come.  Say that a patient has their genome sequenced, and a report of it lies in his or her medical record.  First of all, doctors don’t even know how to read such a report.  Secondly, let’s say that the patient develops a disease which was predicted in the genomic data and then pursues the doctor in court for not reporting a certain mutation.  This was one group that isn’t usually discussed in this kind of conference.  I mean the twelve person jury.

I teased Reid at the break about throwing so many curve balls after Scott scored a hit.   Assuring me of first of his optimism, Reid told of recent meetings with doctors.    

“They’re scared to death,” he said.

A Bioethicist at a Business Conference?

The other big dissent with Randy Scott’s genomic utopia came the second day from the bioethicist, Hank Greely, of Stanford.  I’ve been arguing at Mendelspod that there are some serious ethical concerns that have to be addressed before the genomic revolution will go mainstream.  So I was tickled that Burrill and Co invited Greely, an unlikely speaker at a business meeting which has usually been focused around funding, regulation, and reimbursement.  

Granted, Greely reflects the pro business enthusiasm that radiates unabashedly from Stanford.

“Whole genome sequencing is coming,” he said with an imperative stance.  

Greely engages his audience with uninhibited pacing up and down the stage, speaking extemporaneously without the aid of slides.  Giving an overview of the eithical issues surrounding genome sequencing, Greely threw out more questions than answers which centered around four areas:

  1. Analytic validity:  What will be the protocols for sequencing that will have to be approved by the FDA?
  2. Interpretation:  Who will we believe?  And, when scientists don’t even understand the genome, how will the FDA deal with it?
  3. Doctor/Patient relationship: How will doctors educate patients?
  4. Other:  What about privacy in a world where one’s clinical record could be used for forensic databases?

The most important question here is about regulation.  Greely believes the privacy concerns center around an unreasonable paranoia.  And business is already jumping at the chance to offer patients ways to learn about their genomes.  

So what about regulation?  In his talk, Randy Scott said that access to our genomes should not be regulated.  I asked Greely to make his best argument.  

“In America, there are all kinds of consumer items which are not regulated,” he answered.  “But anything to do with health, we’ve always regulated.”

Other highlights of the conference were some excellent panel discussions on the microbiome, patent/IP strategies in the wake of the Myriad decision,  and whether medical schools are preparing doctors for genomic medicine.  The quality and variety of the discussions sparked strong advocacy and dissent on important issues and underlined a remark made by Steve Burrill at the outset of the conference.

“It’s not personalized medicine anymore.  It’s just medicine.”

(Look for upcoming interviews on the topic of personalized medicine, including the patent strategies with a lawyer from Fish and Richardson and a chat about the relationship between business and regulation with Hank Greely.)

 

The Academia-Pharma Complex

Author: 
Ethan O. Perlstein

I provocatively call the nexus of government research and regulatory agencies, university biology departments and medical schools, and drug companies the Academia-Pharma Complex. This vast public-private partnership financed by US taxpayers to develop drugs is on an unsustainable path and desperately needs Open Science. Reform begins with a diagnosis of what ails us. Many roads lead to the Bayh-Dole Act of 1980, long ago in the pre-Internet Age. Bayh-Dole grants patent rights to non-government entities for inventions resulting from publicly funded research. These non-government entities include universities.

As described in a trenchant analysis in The Economist from 2005, the primary legislative intent behind Bayh-Dole was to spur (and simplify) the commercialization of publicly funded research, which prior to Bayh-Dole was stagnating inside numerous disparate federal agencies engaged in R&D efforts. Once in the private sector, discoveries would be forged into products, in this case new FDA-approved drugs. In a nutshell, here’s how it works. Professors in biology departments spend NIH-disbursed grant money on project proposals that have been positively evaluated by academic review committees. The study of biological processes invariably yields patentable results. In those instances, Professor John or Jane Q. Smith makes a beeline for the university technology transfer office, which has the Herculean task of shepherding patents into the promised land via licensing agreements that generate revenue streams to the university.

However, in practice a deluge of public and private funds and research scientists flow into the drug discovery pipeline but fewer and fewer drops trickle out the other end. Although I found examples of Bayh-Dole boosters, a balanced scholarly review of the law published in 2006 spelled out the flaws of a closed approach:

“By vesting such comprehensive discretion and flexibility in patenting and licensing with individual institutions, the Bayh-Dole Act provided the nation and the world with a large-scale experiment in how public institutions manage public assets as private goods. The outcomes have been positive on nearly all counts, but the Act inadvertently created a misalignment between the private interests of university technology transfer offices and public interests that benefit the innovation system at large or that enable access to IP for humanitarian purposes.”

I dug around and found more data-driven support for opening up biomedical research. First, consider the now (in)famous graph of Pharma productivity that shows the number of new drugs approved per billion US$ R&D spending DEcreasing over time. It's the opposite of the efficiency gains in computing power dubbed Moore’s Law, hence the flipped moniker Eroom’s Law. Sure, we had a bumper crop of new drug approvals in 2012. Leading the way was the groundbreaker Kalydeco, a new drug approved for the treatment of some cases of cystic fibrosis, the poster child of rare/orphan diseases. But new first-in-class drugs for many devastating diseases, e.g., psychiatric and neurological diseases, are nowhere in sight. Not coincidentally, the success of Kalydeco depended on open collaboration between academics, industry, disease advocacy groups, not-for-profit foundations and patients.

Second, consider the age of scientific independence, i.e., age at first R01 award. The R01 is the bread and butter grant for tenure-track and tenured professors in Academia that provides $100,000s per lab in public funding over multi-year increments. In 1980, the average age of professors receiving their first R01 money was 36. By 2011, the last year for which we have data, the average age had climbed to 42, where it plateaued at the end of the booming late 1990s, when NIH’s budget was doubled to around $30 billion. It’s hovered there ever since, and making matter worse sequestration has driven funding success rates to historic lows.

A prolonged and unnecessary apprenticeship exacerbates the distorting effects that Bayh-Dole has on research choices, and encourages academics to engorge grant proposals with preliminary results and skimp on truly daring, basic research aims. It’s also a serious misallocation of human capital whose enormous potential would be unleashed in an open system. According to recent stats, less than 20% of people who enter the NIH-funded graduate training pipeline emerge on the other with a tenured professorship. The downward trend was apparent even in the early 90s, when the ratio was closer to 50/50.

Think about this for a second. The very capable and creative people who run the gauntlet of graduate school, one or more postdocs, AND an assistant professor search committee are a highly selected bunch. Even in so-called good years, R01 rejection rates were around 70%, and believe it or not but decades ago ~40% of NIH grant proposals were funded. We’re squandering so much talent when we ask people who’ve endured a decade of intense, specialized training in exchange for low wages, and established scientific excellence as researchers, to hang out for an extra decade at precisely the same time when many of them are starting families, usually after delaying parenthood.

Of course, I anticipate challenges from establishment thinking as well as organizational resistance. But the first step to recovery is calling a spade a spade. I expect secrecy from Pharma, but not from Academia, which I think abuses the freedom to pursue knowledge for its own sake on the public’s dime. At the same time, I expect more innovation to originate within Pharma and not simply be hastily imported from Academia with taxpayer subsidies.

Pioneer in the Virtual World Announces Three New Life Science Conferences

Author: 
Theral Timpson

My first LinkedIn invite was sent by a young businessman named Greg Cruikshank.  He was listed as the founder of Labroots.

Not knowing a thing at the time about social media, I wanted to understand more about this site that expected me to type in my resume and share it with the whole world.  And who was Greg Cruikshank and Labroots?

Starting in the industry as salesman for several of the bigger companies, Greg turned entrepreneur  and has been pioneering the power of the internet and web 2.0 to disrupt and protect the  life sciences.  Labroots was one of the first social media sites in our industry, and their foray into virtual conferences under the name BioConference Live has been extremely successful.

“This is our fifth year, and we’re growing rapidly,” Don Cruikshank told me on the phone.  He’s Greg’s father and a partner of Labroots.

When I heard from Greg after accepting his LinkedIn request, he was asking me to join his first BioConference Live (BCL) virtual conference.  Book a virtual booth, he urged, and do lead generation without ever leaving your desk or office.

I was the marketing director for a lab consumables company at the time, and we regularly had booths at the bigger trade shows.  I didn’t book a booth that year to the first BCL conference.  But I attended.  And picked up a great deal of helpful information.  Listening to other science marketers.  Seeing the companies in the exhibit hall, and going into the chatrooms.  I was hooked.

BCL conferences are keynoted by great speakers--the same ones we hear at other conferences.  And shows are sponsored by many of the top companies in the industry, including Roche, Siemens, and Thermo.  

But the real big plus is that you can “attend” the event in the comfort of your own workstation, and if you miss any of the talks, they’re available in the archives for months.  You’re not out a week from your own schedule making travel plans, booking a trip, flying, checking into hotels and the whole bit.  Of course when you’re ready for a trip, by all means take it.  I attend many conferences in person, but I still take advantage of this two day conference.   For those who don’t want to or cannot travel, it’s perfect. You can walk through the “Expo Hall” and talk with the lead marketers of dozens of life science companies in personal or group chats.  

This year BCL is expanding by dividing their generally titled Life Science Conference that has taken place for four years into three new conferences.   (A disclosure is in order here.  I’m on the advisory board for BioConference Live as of this past year.  And why?  Because I believe in the direction of this conference, and I want to witness first hand the transformation of the traditional conference.)

The first of the new conferences, Genetics and Genomics, is taking place August 21-22.    The lineup of speakers includes George Church of Harvard, Drew Endy and Mike Snyder of Stanford, Paul Billings of Life Tech, and Charles Cantor of the blossoming  Sequenom.  

The second will be Cancer Research Discovery and Therapeutics and is set for October of this year.  And the third is a Neuroscience conference next March. 

And they are all free.

That such great content is becoming this easy to access--part of life in 2013.  Does it cheapen the content?  Does one have to attend in person to have it count? 

Don Cruikshank points to our shrinking budgets.

“We began back during the ’08 recession and the virtual conference became popular.  There are folks who want to collaborate, but can’t afford the travel.”  He adds, “it is not our intent to replace the physical trade show.’

The company also relaunched their social media platform, www.labroots.com, this year.   A longer list of resources on the left side menu including reviews and jobs and a webinar service is making it more attractive for life scientists to maintain yet another profile.

Register at www.bioconferencelive.com/1-genetics-and-genomics.html



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