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The Future of Personalized Medicine with Mike Snyder and Eric Topol

Author: 
Theral Timpson

Mike Snyder from Stanford and Eric Topol of the Scripps Institute held a live chat today on the future of Personalized Medicine hosted by Science Mag.

California Industry Groups Come Together for CALBIO 2012 and Focus on Patients

Author: 
Theral Timpson

“Biotechnology is a big word with a simple meaning--hope.” 
John Crowley, CALBIO 2012 Keynote Speaker, CEO of Amicus Therapeutics, Father of two children with Pompe disease

The biotechnology industry is in trouble. And one place industry leaders are finding inspiration is in reconnecting with patients.

“If it’s right for patients, it’s almost always right for your business,” stated George Scangos, CEO of Biogen Idec in his opening keynote speech to the crowd at CALBIO 2012. The conference, produced for the first time by California’s two biggest industry organizations, BayBio and BIOCOM, focused on the theme that the needs of patients must be the driving force for the industry.

The John Crowley Story

Few can tell a more remarkable story about patient driven medicine than John Crowley, a keynote speaker at this week’s conference.

In 1998, two of Crowley’s children were diagnosed with Pompe Disease, a fatal disease. At the time John Crowley was just 31 and consulting for financial institutions. Borrowing $100,000 on his home and 401(k) plan, he started his own company, Novazyme, devoted to finding a cure for his two children. And he found success. Novazyme developed an enzyme that showed promise, and Mr. Crowley sold the company to Genzyme for $137.5 million, one of the heftiest sums ever for a product untested in humans.

As it turned out, getting the product tested on his own kids wasn’t as easy as you might think for the entrepreneur and developer of the cure. Genzyme’s CEO, Henri Termeer, thought a father’s love would prove a powerful catalyst for the program, and Crowley was made a VP over the Pompe program. Still it took several years to finally bring the drug to his two failing children.

“It ripped me apart,” Crowley is quoted in a WSJ article in 2003. “Many times, I’d be talking aloud about programs and budgets, and at the back of my mind be thinking, ‘Oh my God, this is not good for Megan and Patrick.”

A powerful story for the role of patients to drive innovation, Crowley eventually was able to have the two children enrolled in a trial, and the enzyme he’d developed saved his kids from certain death.

“Hard not to get teary eyes hearing John Crowley talking about his kids at #calbio2012,” tweeted SF Business Journal’s Ron Leuty, reflecting the mood in the room packed with about 1,000 attendees.

The Crowley story is one about the depth of a father’s love, but also about success in the bio industry. (The story also made it to Hollywood in a CBS movie, Extraordinary Measures, with Harrison Ford acting and producing.)

When Drug Research Is Personal

Not everyone’s story is as dramatic as Crowley’s. But the theme of drug research being powered by patients and relatives of patients is an ongoing and strong theme.

On hand for lunch the second day was Representative Brian Bilbray, a U.S. Congressman representing California’s 50th district that includes some of San Diego. In a Q & A session with BIO’s CEO, James Greenwood, Rep. Bilbray talked about the impact of his being father of a 25 year old daughter recently diagnosed with melanoma. “It does affect me and my work,” he said. “Brianna (his daughter) is becoming the patient advocate in Congress. We changed regulations during the AIDS crisis and we can do it again.”

Melinda Cathbert is an entrepreneur, student, and mother of a son with autism. She volunteered at the conference, and I caught up with her after a panel. She offered some insight into why patients or relatives of patients can lead business to success.

Melinda is the founder of a biomarker company focused on autism, SmartDx. Melinda said that as a mother of an affected child she “had a unique perspective. There’s so many unintended consequences that come up [in business] that you have to have extra insight.” Melinda feels that watching a disease at close range gives just that insight.

Melinda is a driven woman. She showed me an app she has developed (still in alpha phase) which will help consumers make healthy changes to their daily habits. I suggested she go to Steve Burrill or another VC firm. It wasn’t but a few hours, and I saw her with Mr. Burrill showing off her app.

“Many folks say, I’m not going to get my career bogged down with a problem when a drug doesn’t work out, I’m moving on. But you have to hang in there long enough to solve the big issues. I have a twenty year commitment to the field of autism. I’m not going to jump ship.”

John Crowley didn’t jump ship, and it saved his kids lives.

Patient Advocacy and Disease Foundations

A major component of the conference was the presentations and panels populated by members of various disease foundations, including The Michael J. Fox Foundation, The Leukemia and Lymphoma Society, Susan G. Komen For The Cure, and others. More and more these foundations are become major contributors to R & D research.

The Myelin Repair Foundation has supported the discovery of 24 new research tools to advance research for potential multiple sclerosis therapeutics. The Melanoma Research Alliance awarded over $30 million to 73 research programs.

Disease foundations are supported by large patient networks. Like relatives of patients, they could be said to have a longer term commitment to a disease than say a big pharma or biotech. In addition, the foundations can help promote reform at the FDA on behalf of patients.

Dr. Robert Fisher is an advisory board member for The Epilepsy Therapy Project at Stanford University. In a panel on the role of patients in drug discovery, Dr. Fisher pointed to a growing trend of more sensitivity to the patients on the part of drug companies.

“It used to be as soon as the trial was over, it’s bye bye to the patient,” said Dr. Fisher. Even though the medication was helping the patient, drug companies would tell them “check back in three or four years.” Now Dr. Fisher says that for an academic research institute such as Stanford to sign off on the IRB, there must be more commitment to the patient. In addition, Dr. Fisher pointed out that more and more patients are now included on FDA panels. “Regulators listen more to patients than doctors,” he asserted.

This year is the first time BayBio and BIOCOM have come together for their annual conference. Together, they represent by far the largest concentration of biotechnology on the planet. CALBIO is the result of the pooled resources of the two large industry organizations and delivered a concentrated message. This year that message was simple.

Biotechnology equals hope.

“It reminded us why we all do what we do,” Gail Maderis, CEO of BayBio, said to me on the way out. Gail herself was diagnosed five years ago with MS.

Academic-Industry Partnership to Study DTC Genomics

Author: 
Eric Schuur

A few days ago this GenomeWeb story discussed a study being performed by researchers at Brigham and Women’s Hospital and the University of Michigan on the motivations for getting and effects of DTC genomic testing. The study will look at the attitudes and motivations of 1000 people who order tests from 23 and Me or Pathway Genomics before testing. These results will be compared with the subjects’ attitudes toward their health and changes in their behaviors following testing to ascertain how people use genetic information.

Two interesting aspects to this study are the academic-industry collaboration and the window into social attitudes toward genetic information. The ability to complete this research will require the industry participants to cooperate, which in turn required give and take from both academia and industry to accommodate the needs of both parties during the planning process. These two groups are often at odds, so it is heartening to see a partnership that recognizes that both parties are motivated to make positive contributions to the greater health good. The road to this agreement is described in this paper by Lehmann and colleagues.

Clearly, the payoff for this study will be answers to questions around why people are interested in this type of testing anyway and what effect it has on their lives. A big concern from the health policy world has been that dispensing this type of information without expert interpretation might lead to a range of ill effects on the recipients. Happily, this so far has not been the case and for the most part I don’t believe ill effects will be observed in the future.

What I am curious to see is what the motivations for so-called “recreational” user are, if those can be identified in this study. Similarly, it will be interesting to infer from these results how seriously people take genetic information. My sense of it is that these results will reflect back in interesting ways on the usefulness of a variety of other genetic and genomic testing services, primarily involving the risks of disease. This study will hopefully provide a really interesting window into what we as a society really think of genomics.

Why BioGeeks Care About Lab Developed Tests

Author: 
Joe Kaufmann

There has been a lot of whoop-ti-do about when the FDA will close enforcement discretion loopholes in regulations governing Laboratory Developed Tests. The FDA claims it has the authority, just hasn’t gotten around to rule making since 2006. CLIA and CAP regulations putatively cover these tests. Private health care payers and Medicare already reimburse for many of these tests under existing CPT codes. And the American Clinical Laboratory Association suggests that HR 3207 now making its way through Congress will do a better job at monitoring and controlling these tests than the FDA.

I’d like to put this controversy in perspective from the point of view of a bio-entrepreneur eager to create value at the bench in life sciences, emulating the success of the garage computer tinkerers who gave us PCs, mobile Apps, Apple, and incredibly clever software solutions. Laboratory Developed Tests offer the bio-tinkerer a path to implement innovations, provide medical value, and generate wealth, unencumbered by bureaucratic obstacles.

Licensed physicians decide the relevancy of test results in their professional exchanges. Just as physicians have the right to prescribe drugs off label, they should have the right to review results of research and decide for themselves if this information helps them manage their patients.

Lab Developed Tests are developed internally at a laboratory whose use is confined to the same laboratory that develops the test. That is, until the test catches on. These tests are developed to answer an unmet medical need for monitoring, prognosis, or diagnosis of a disease condition. Their development is driven by an unmet medical need, a recognition of a biological relationship that, if measured, is informative, and by the ability to implement such a test in a lab setting when commercially available tests aren’t available.

Tropoinin for acute coronary syndrome, hsCRP for Heart Disease, staining protocols, ESR rates, genetic tests for rare diseases, Pap smears are all examples of Lab Developed Tests used either in the hospital or in pathology evaluations. What sounds trivial is in fact a big deal. LDT test revenues are the fastest growing segment of the commercial reference laboratory testing market.

There are over 7 billion lab tests performed in the US each year. Total revenues exceed $52 billion a year over the last few years. More than 1400 tests are offered by more than 95 different laboratories.

Lab developed tests offer clinical diagnostic test developers a quicker go to market path than the traditional FDA 510(k) or PMA approval routes. After establishing their relevance during ‘proof of concept’ that lead to more wide spread acceptance, such tests could be commercialized using the traditional pathways.

Why throw a monkey wrench in the works now?

Why restrict innovation in an arena occupied by licensed physicians? Why interfere with the pathologist/clinician/patient relationship when generating information that could be useful for managing a patient?

Most importantly, why interfere with the development of potentially disruptive breakthroughs that will drag medicine, kicking and screaming, forward? With the shortfalls in federal spending for research, the high cost of drug and medical device development, the plethora of new technologies, availability of information, and existence of talent, why not let creative people be rewarded for generating creative solutions to unmet medical needs?

The Future of LDTs at TriCon 2012

Author: 
Theral Timpson

Along with greater outcomes for patients, the movement now known as Personalized Medicine has also held great promise for new business.

In the winter of 2005-2006 (if we can call it winter in Silicon Valley) I was caught up in the hype and became a partner in a new start-up that was to offer all kinds of predictive genetic tests. We even secured the name ConsumerGenetics.com, a domain highly sought after at the time. There was to be a revolution in the way health was delivered to patients. In fact, we would bypass the doctor and go to the consumer with important health information. And best of all, the products weren’t regulated by the FDA. It was just a matter of setting up a lab, combing through the literature for the latest findings on specific genes which could predict the probability of certain disease, putting up a website, and we were in business.

This naivety landed me in a piece by Andrew Pollack of the New York Times entitled <a href=http://www.nytimes.com/2006/09/12/business/smallbusiness/12genetic.html?pagewanted=all" target="_blank">The Wide, Wild, World of Genetic Testing.

OK, so it turned out a bit more complicated than that.

In 2009 we got a letter from the FDA.

Consumer Genetics is offering a test that is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h) because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. . . You should be aware that FDA does not consider your device to be a Laboratory Developed Test because the test is not developed by and used in a single laboratory . . . You should take prompt action to respond to this letter.

Now the FDA has decided to regulate LDTs as well. This was the focus of a track last week at the Molecular Medicine Tri Conference in San Francisco. Though the FDA has decided to regulate the tests, they still have no draft guidance. Others from industry were on hand to debate the direction of the industry.

Speaking for the FDA

Speaking for the FDA was Elizabeth Mansfield, Director of the Personalized Medicine Staff in the Office of In Vitro Diagnostic Devices. Her first point: there has been a ‘loophole’ for LDTs or what used to be called “home brew” tests. It will be closed.

To a pretty packed room for 8 a.m., Director Mansfield made her second point right away. The FDA hasn’t completed the guidance and there was no date when it would be available. Excusing anyone in the room who came just to hear that, she launched into an historical update on the FDA’s policy in regard to Laboratory Developed Tests. Her salient points:

1 - There is no need for new rules. The FDA already has the authority to regulate LDTs. 2 - The goal is to adopt a transparent approach and seek to avoid any surprises. 3 - FDA doesn’t want to interrupt medicine. They will be more relaxed toward rare diseases. And in the case of emergencies such as bio threats, they will issue EUAs or Emergency Use Apps. 4 - There will be some type of registration and listing. 5 - High risk tests will be evaluated first. 6 - There may be new classifications. 7 - For now the FDA is using enforcement discretion.

“We don’t want lab testing to stop,” Dr. Mansfield assured the crowd.

There was some time for Q & A.

“What about a predictive test for Alzheimer's--what’s the risk there? Is it high or low? Not sure the intended use.” A fellow from Genomic Health stepped to the mic. “Do you understand the conundrum?”

Mansfield is used to such questions. “There is no conundrum. This is science. We’ve been classifying risk since 1976,” she replied succinctly. “Furthermore, it’s not possible to classify without knowing the intended use.” Correctly sensing that the questioner wasn’t happy, she added, “did I answer your question?”

“No, but that’s ok,” he submitted.

“Sorry,” she followed up.

A second question came in. “You have a great database of adverse events. Doesn’t this help provide draft guidance for LDTs?”

Mansfield: Not many adverse events are reported for LDTs. Labs are not required to report. You’d be surprise at how few adverse events are reported.

Another question. “How is the FDA going to deal with new technology such as NGS?”

Mansfield: Not a problem. We deal with new technology all the time.

Speaking for Industry - Hologic

Mansfield was followed up by Stephen Day, Director of Medical Affairs at Hologic. Day was determined to point out the inconsistencies in the current system. The FDA regulates what are known as ASR’s or Analyte Specific Reagents which are really the components for test kits. Labs have gotten away with passing their products off as ASRs for RUO (research use only) and not submitting them as IVDs (In Vitro Diagnostic kits).

Though there are strict definitions for ASRs, there are hundreds of tests which don’t fit these definitions on the market passing off as ASRs. This is overlooked by the FDA. For example, an ASR can be a set of primers, or a single probe but not more. Many products which are on the market consist of multiple probes and targets such as those for HPV. In a random check, Dr. Day searched online for just such a test. On a site he didn’t name he found a test for HPV with multiple targets passed off as an ASR. Adding to the confusion, at the bottom of the website, the product was marked “For IVD Use.”

There are also IP issues with LDTs, Day noted. A manufacturer cannot sell its test with multiple primers to a lab, yet if the lab goes ahead and develops their own primers, there is violation of a patent. Many labs feel a “damned if you do, damned if you don’t” frustration at the present.

Dr. Day was obviously calling for more clarity, though he ended his talk with the diminutive “I just wanted to share what I’ve been thinking about.”

Speaking for Labs - ACLA

Next up was Peter Kazon who consults for the ACLA (American Clinical Laboratory Association). Kazon confronted Mansfield and the FDA directly. He went over a couple bills that are presently before congress which both propose that LTDs come under CLIA guidance rather than FDA. And that if the FDA did continue with regulation, they did, in fact, need new rule making.

“What would the FDA inspect in a lab,” he asked, “which is already inspected by CLIA?”

Under one bill before congress, HR 3207, labs would be required to register tests with CLIA. CLIA and the CMS could both prevent the tests from being offered. But, most importantly, said Kazon, there would be less impact on innovation. Companies would not be faced with the heavy regulatory burdens of the FDA.

I chatted with Dr. Stephen Little from one such company by the name of Qiagen after the session. Little and his colleagues at Qiagen know well the regulatory burden to launch tests. They go through the FDA for IVD approval. They have also found success working with pharma to offer CDx. They do not, however, offer any LDTs.

Is there an un-level playing field, I ask. “Yes,” Dr. Little replies. “We either need to see the burden lowered on the tests we’re offering, or see it come up for LDTs.”

Speaking for Industry - Asuragen

The final speaker on the track, Carol Berry, is a VP at Asuragen. Her company develops IVDs and LDTs side by side and has a CLIA certified lab. “Not all LDTs are equal,” she repeated during her presentation. Focused mainly on walking the audience through the ups and downs of developing a diagnostic, Berry didn’t offer an opinion about regulation other than to say that the CLIA process is extensive and thorough.

Will DTC (Direct to Consumer) tests be considered LDTs in future FDA guidance? Will products marked RUOs continue to be allowed on the market for clinical use? These and many other questions remain as companies continue to produce tests and hope to get around the FDA’s current policy of enforcement discretion.

Carol Berry from Asuragen urged the audience to look at the bigger picture. “According to the AACR, 3,000 biomarkers were discovered this year, but none have become tests. It should not be about safety, but about life saving improvements. After all, LTDs are driven by the acceptance of physicians and patients.”

“That’s just ridiculous,” exclaimed Little to me privately. “Just because some doctor or some group of patients thinks a test is ok, then it’s ok?”

In some form, regulation is coming for LDTs. While the FDA is clear that they don’t want to stifle innovation, the they feel that they have the authority to regulate, and it’ll take congress to stop them. A statement put out by the FDA listed on one of Peter Kazan’s slides read:

. . that the use of LDTs has contributed to enhanced standards of medical care and that significant regulatory changes in this area could have negative effects on the public health.

Though there are still many questions about the future of LTDs, Dr. Mansfield does have answers. She has agreed tentatively to give an interview at mendelspod and reply to the issues brought up by the other speakers. It was too bad that the organizers at the TriCon didn’t have a panel at the end of the discussion where the speakers could go back and forth among each other and with the audience.

Consumer Genetics, the company I co-founded in 2006, is still around offering a simple prenatal gender test. I’m no longer involved.

Watch for Dr. Mansfield’s interview among others in an upcoming series, “Commercializing Diagnostics.”

Watson and 21st Century Healthcare: Burrill's Digital Health 2012

Author: 
Theral Timpson

Look for an upcoming series at mendelspod.com on digital health with some of the companies listed below.

Last year a super computer won the TV game show Jeopardy. Is IBM’s Watson going to conquer the world of healthcare as well?

Yesterday was opening day at Burrill and Co’s Digital Health Conference, one of two conferences in the Bay Area this week presenting a window into the future of medicine. (The other, FutureMed, is a weeklong program taking place at Singularity University. Separate blog to follow.)

Barry Mason, VP of Global Healthcare Payers at IBM Healthcare and Life Sciences gave a keynote, “Putting Watson to Work." Mason told the crowd of entrepreneurs, investors, and doctors that the supercluster computer which can process 500 gigabytes of data, the equivalent of a million books, per second is coming to a clinic near you.

Here’s how it will work. The godlike Watson will live in the cloud. A doctor or nurse will upload your symptoms, family history, and other phenotypic data to the big computer in the sky. Watson will then combine this data with hundreds of thousands of data points from medical literature and clinical best practices and, within a few seconds, deliver a diagnosis.

A doctor just can’t keep up with all the new data like a super computer can.

IBM is collaborating with Wellpoint (<a href="http://www-03.ibm.com/press/us/en/pressrelease/35402.wss" target=_blank">press release), one of the nation’s largest health insurers, to bring the Watson technology to select clinics early this year.

“With medical information doubling every five years and health care costs increasing, Watson has tremendous potential for applications that improve the efficiency of care and reduce wait times for diagnosis and treatment by enabling clinicians with access to the best clinical data the moment they need it," said Manoj Saxena, general manager, Watson Solutions, IBM Software Group in the press release announcing the agreement.

But will Watson be used just in the clinic, or is he coming to our living rooms? Will we soon be logging on to some consumer friendly interface with the cloud-based super computer from our laptop to find the right answers for health and wellness?

Watson heralds the major themes that are changing the world of healthcare and which dominated the Burrill Digital Health Conference: consumerization, new business models, and the changing role of doctors.

'Consumerization'

Healthcare is increasingly being tailored for consumers, not patients. At the Consumer Electronics Show (CES) in Las Vegas last month, a keynote was given by Qualcomm CEO, Paul Jacobs, who devoted 25% of his talk to healthcare. Healthcare at a consumer show? (We recently had Paul Billings, CMO of Life Tech, <a href="http://mendelspod.com/podcast/billings-proton" target=_blank">on the program. He was at the CES as well where he was demonstrating the new Ion Proton which will sequence a person’s genome for $1000 in a few hours. Billings told us this is the first time a Genomics/Life Science company had presented at the show.)

Don Jones is the VP for Health and Life Sciences at Qualcomm Life. He gave the other keynote. Looking at Qualcomm’s business and market, it is not surprising that Don is unabashedly pushing the ‘consumerization’ of healthcare.

“It’s no longer the patient, it’s the consumer,” said Mr. Jones. “And consumers want access to their data. The consumer is saying to the doctor, ‘if I can’t get the data, I don’t want your service.’” And Qualcomm Life will be there to connect the consumer to the clinic. Already the giant communications company has an FDA listed device hub, the 2net, which connects medical devices in the clinic to the internet and by extension, to the new self empowered patient . . eh, consumer.

Nowhere can this new empowerment be seen better than in the dizzying array of healthcare apps being launched at lightning speed. There were two panels with 16 of them presenting in rapid fire over the two days. Here are a few of them.

-<a href="http://mc10inc.com" target=_blank">MC10 is a company developing conformal electronics. One of their products will be a tattoo with sensors to collect data from the body.

-<a href="http://zephyr-technology.com" target=_blank">Zephyr has a shirt that looks like the tight gear worn by cyclists, what Zephyr calls the BioHarness. The shirt contains bluetooth sensors that will “enable loved ones to stay in their home longer while family, friends and medical practitioners can remotely monitor their physiological state.”  So it’s not just about doctors monitoring a person’s health info, but friends and family as well.

Many of the companies promoting their new ideas came from practical situations.

-Matt Berry, the CEO of <a href="http://orcahealth.com" target=_blank">Orca Health, is the son of an orthopedic surgeon who specializes in spinal injuries. Matt saw what his father provided patients for their education on complex body structures and said, “hey Dad, I can design you something better.” He’s created apps containing some pretty cool animated graphics that show a patient just what’s going on in their body.

-<a href="http://wesprout.org" target=_blank">WeSprout is a pediatrics hub in the model of Facebook. Parents can go to the website and share stories and information about their children’s health and well being. M. Jackson Wilkinson, the founder and CEO for WeSprout, is the former lead designer for LinkedIn. He also happens to be married to a pediatrician. At lunch, Jackson told me that WeSprout is made up of 2 1/2 people. “My wife is that 1/2 person. She devotes about 10 hours a week to the business.”

-<a href="http://alivecor.com" target=_blank">AliveCor has an app and a sensor which clips on to the iPhone. With this sensor on your phone, you can place the phone to your chest and receive an ECG reading. The founder of AliveCor, Dr. David Albert, and inventor of the iPhone ECG, is a cardiologist himself. He reminded the crowd that the cost of healthcare has to go down, and that we are forced to come up with cheaper devices. The newest product from the company, the icard ECG, is expected to sell for $100. It will replace the traditional big expensive machines.

“We’re not going to be epatients, but rather ipatients-for informed,” said Dr. Dave, as he’s fondly called in the mHealth community.

-The holy grail of medical devices for consumers and doctors alike is the mythical “tricorder” of Star Trek fame. In the fictional Trek universe, the medical tricorder is used by doctors to help diagnose disease by quickly scanning a person’s body. Walter De Brouwer is working on just such a device. In 2011 he set up <a href="http://scanadu.com" target=_blank">Scanadu, a deep-science research lab at NASA Ames in Silicon Valley, to make the mythical tricorder.

In a panel discussion, Mr. De Brouwer was short on details of the upcoming device, but full of factoids on consumer behavior.

“The issue over privacy is exaggerated,” he said. “Most consumers will opt in for tracking by a device for a discount in their insurance. And they don’t want to watch the device. They want the device to watch them. Consumers are very lazy.”

Asked what healthcare will look like in 2020, De Brouwer said, “We’ll know what’s going on in our bodies in real time. And the info will be actionable.”

-Enter <a href="http://proteusbiomed.com" target=_blank">Proteus. They begin selling their smart pills, the Helius, through Lloyds Pharmacies in the UK later this year. The pills have electronic sensor embedded in them and are taken along with a medication. The pills convey information to a patch worn on the body about whether the medication was ingested, as well as sleep patterns, and physical activity. The product comes with a mobile health app to track the data and allow sharing with others.

New Business Models

Very keen on early technologies in healthcare, Burrill has a special VC division devoted to digital health. According to Derek Wong, a member of the Burrill VC team, the division is “actively looking.” In each panel, Burrill, or other moderators pushed the guests to explain and anticipate their business model. Answers were not always the most clear, yet clear themes emerged. FDA regulation and payer reimbursement could prove formidable barriers and companies must decide whether they are traditional medical device companies or consumer companies, or both.

Perhaps the most articulate about their model was Dr. Dave from AliveCor. The company recently raised $3 million in a round of financing got mostly from both Burrill and Co. and Qualcomm Life. “We’re a hybrid,” said Dr. Dave. “We are both a traditional med device company and a consumer company.” AliveCor has achieved CE marking and will shortly be pursuing FDA 510(k) approval. With their high level of support in funding and expertise, AliveCor will be a company to watch pioneering the new hybrid model. I asked Dr. Dave whether they are pursuing large med device partners such as GE Healthcare or J & J or whether the company was determined to go it alone and chart new territory. And whether they’re pursuing doctors or consumers as a market. “Yes” was his simple answer.

Another app on display in the lobby to the conference, <a href="http://digisight.net" target=_blank">SightBook, is being promoted to doctors and consumers as well. The app--available now at the Apple App Store-- allows you to test your vision with an iPhone. Simply hold the phone 14 inches back from your face and tap the letter that you see. In a few minutes you’ll have your vision score. The company that makes the vision testing app, DigiSight Technologies, has already determined to partner with doctors. “That’s the path to reimbursement,” said Ed Kenner of DigiSight. “Our app to the consumer is free.” DigiSight is not selling the product yet, but intends to offer a premium service to eye docs. They anticipate the service would be covered by insurance under existing CPT codes.

“There is another model which we’re pursuing as well,” said Mr. Kenner. “Doctors want data. The SightBook app generates a lot of data. For $5/patient, we’ll provide them the data in electronic form.”

A more traditional approach can be seen in the path of <a href="http://agamatrix.com" target=_blank">AgaMatrix. Director of Worldwide Commercial Development, Stuart Blitz, said at the conference that his company had received the FDA’s first clearance for an iPhone glucometer, the iGBStar. In addition, the company is pursuing large partners in the healthcare space to expedite their business plan. Motorola is an investor. And while AgaMatrix manufactured the glucometer, Sanofi submitted and received clearance for the iBGStar from the FDA.

“We are a serious healthcare company,” Proteus’ CEO, Andrew Thompson told me. “We have our CE and FDA approvals. “We’re not like <a href="http://fitbit.com" target=_blank">Fitbit and others who are more or less toys. They’re not really designed to impact care.”

Doctors or Advisors?

And what of the role of doctors? In his provocative, business oriented keynote, Don Jones of Qualcomm said that “the consumer will become CEO of his own health. Then he will fire his doctor and hire an advisor.”

Is Jones thinking of the advisor, Watson? Or is he envisioning a more collaborative kind of doctor in a more modest role?

When asked to define the difference between doctor and advisor, a panel including Dr. Dave didn’t have much to offer. Dr. Dave off-handedly said the “only difference is a degree.” Panel moderator, Mehran Mehregany tried to dilute Jones assertion about doctors becoming mere advisors. “Don Jones means to be provocative in a deliberate way.” Mehregany went on to simply to say that distance health is changing the role of the doctor.

Perhaps Mehregany will be training the future digital health doctors/advisors. He is heading up the first ever certified graduate program in wireless health at the Case Western Reserve School of Engineering.

“The disruption comes from shifting the way consumers have access and healthcare sustainability,” said Proteus' Andrew Thompson. “At the end of the day, we give patients more options.”

At the beginning of the conference, Steve Burrill began with his usual State of the Union-like address. Burrill talked of the vast opportunity for “eHealth to reset the healthcare system.” But he also challenged the group of entrepreneurs and investors. “Everyone loves a new toy, but will your app be around in two years?” And what of regulation, he cautioned, telling of a company, <a href="http://proventys.com" target=_blank">Proventys, which "was tanked due to problems at the FDA." Burrill also acknowledge how difficult is it to get patients to change their habits. He pointed out that though there has been gigantic amounts of effort and new regulations to discouraging smoking, the percentage of the American population of smokers has only dropped from 26 to 21 percent.

To me this is the crucial issue. As we’ve seen with personalized medicine, a person can receive great genomic data and health risk predictions, but what does it do for us? The answer is always a healthier lifestyle--more exercise, better diet. How many of us who have received our 23andMe reports have changed our daily lives? How many who buy up a shirt with sensors or download a new app for detecting our heart rate will truly change our behaviors?

For this reason, my favorite app of the day had to do with biofeedback. <a href="http://brainbot.me" target=_blank">BrainBot, Inc. offers an app and a gadget to monitor mindfulness. In real time, with a sensor which monitors the brain, a person can see their level of mindfulness. A simple, constantly moving wave on a graph and some gentle prerecorded reminders can help a person stay focused and relaxed.

I’ve experienced the positive results of biofeedback. For a period I struggled with chronic migraines. One of the methods I used was to hold a very fancy gadget called a thermometer in my hand and then, through the mind, raise the temperature by 3 degrees. I learned to move blood flow through my body and into my extremities through concentration. The feedback from the thermometer let me know when it was working. When the body receives this feedback it responds in a positive loop for a desired goal. Draining blood from the brain down into my hands and feet would relieve my migraine.

At the heart of the quantified self movement is this kind of loop between our behaviors, tracking the behaviors, and then gradually changing them. This is the real work in better health and living. Apps and new technologies which provide this real change will go a long ways toward moving us to a 21st century model of healthcare. One which is less about treatment and more about prevention through better living.

Look for an upcoming series at mendelspod.com on digital health with some of the companies listed above.

Our Take on Personalized Medicine World Conference 2012: The Road to Commercialization

Author: 
Theral Timpson

This week we attended the <a href="http://pmwc2012.com" targe=_blank">Personalized Medicine World Conference 2012 in Mountain View, CA. Though sequencing continues to dominate the show, this year there was much more focus on the commercialization of existing technologies for better, more tailored health outcomes. Some news that came just after the conference gave a nice punctuation to the feeling that personalized medicine is here to stay.

Sequencing (of course)

The conference began with presentations by two emerging startups with new sequencing technology: Genia and NABsys. (Look for our upcoming interviews with both companies.) The Genia story is particularly fascinating. Founded in 2009, the company has been working on what they call the ‘holy grail’ of sequencing technology, single molecule and electronic. So convinced is the management team at Genia, who all come from the world of high tech, that they’re calling their technology ‘last gen sequencing.’ “It’s not that there won’t be newer developments, it’s that we’re working with the ultimate model,” said the CEO, Stefan Roever, in his presentation.

Full interview with Stefan and Roger

Though Roever is German, he spent time in Silicon Valley when he was a boy. His dad worked for IBM. He feels that he’s come full circle co-founding Genia in Mountain View with an IT team who previously worked at Maxim Integrated Products in Sunnyvale. Roever came to DNA sequencing through a chance meeting with Genia’s CSO, Roger Chen, at a Starbucks in Mountain View.

“I asked Roger what he was doing,” relates Stefan Roever in our interview, “and he said he was working on this new sequencing machine in his garage. I asked him if he had investors and a business plan. He said no, and we began working together.”

Now the company has their first chip back from a fab in Taiwan. The technology is based on ‘natural nanopores’ which are created by the chip itself with a lipid bilayer. “We use nature to do what we couldn’t do in the world of high tech,” says the always enthusiastic Chen, who is fascinated by the ability of biology to create smaller more complex structures than man has been able to duplicate.

With single molecule technology, the DNA sample goes directly on the chip without the need for amplification or time consuming prep. When ready, the chip will be disposable, sell for $100, and be used with a reader that itself costs less than $1,000. And not only extremely affordable, the small portable system is said to be able to read millions of bases per second with higher quality than current technology. When will this ‘last gen sequencing’ be ready? The company plans sending the chips out to a group of “friendly beta customers” as soon as later this year.

Roever’s claims no doubt turned a lot of heads. What is intriguing about Genia, is not only that they would have a technology that would take sequencing to the clinic, but they talk about the development of the new product with so glibly.

“This is not new technology. We’re just operationalizing a technology that is widely available in the high tech world and bringing it to bio,” Roever says in a matter-of-fact tone.

The other significant news with sequencing, I thought, was the fact that <a href="http://genomichealth.com/" targe=_blank">Genomic Health is moving to the ever more popular technology. They have been one of the most successful companies to take genomics into the clinic with their 21 gene PCR-based OncoTypeDx(TM). With sequencing they plan to beef up their tests with more known mutations. PCR will be used as a quality control.

Listen to our interview with Cliff Reid, CEO, Complete Genomics

Practical Gains and Challenges

The theme of the conference was “Road to Commercialization” and despite the presentations about some pretty whiz bang sequencing technology, I thought there was less hype this year and more practical stories.

The morning of Day 2 was a several hour panel discussion on Rx/Dx, or companion diagnostics, populated by representatives of three major drug companies and two diagnostics enterprises. Leading the discussion, Scott Patterson of Amgen asked very practical questions such as when to contact a diagnostics company during drug development or what is the life cycle of Dx compared to that of Rx?

David Parkinson of <a href="http://nodality.com/" targe=_blank">Nodality, winner of the PMWC 2011 award for most promising company, had the most to say. He talked about basic assumptions that were driving the new industry. “The value,” he said, “is in knowledge of disease. Not only in small or large molecule creation.” This statement led to a discussion about the need for a new classification of disease based on biological pathways. Up to now, diseases have been classified by organ or by symptom.

Another basic assumption in the industry has to do with how therapeutics and diagnostics are paid for. “What if we change the payment system to payment only if a patient benefits,” Parkinson asked, speaking of incentives. “This will lead drug companies in the right direction.” Many of the existing drugs on the market, especially those for treating cancer, have high failure rates because they are ‘one size fits all.‘

Ted Snelgrove of <a href="http://crescendobio.com/" targe=_blank">Crescendo Biosciences, a new company developing tests to characterize the biology of rheumatoid arthritis, brought some great experience to the panel. He helped develop and market Genomic Health’s OncoTypeDx(TM). Ted pointed out that in marketing the new tests for Crescendo, he is mindful that there are 2,000 pharma reps for every 10,000 doctors in the field. Why do it yourself, when a partner in pharma is already in the space, he asked.

Snelgrove also pointed out that he has found a sweet spot of 30% in what he called the ‘discordance impact.’ This means that a test which changes treatment decisions 1 in 3 times is most likely to succeed. If it is lower, say 10%, the benefit doesn’t justify the use. Yet if the test is affecting treatment say 50-60% of the time, doctors just don’t believe it and therefore don’t use it. “Rx has been much easier to teach to doctors than Dx,” he observed to a round of chuckling throughout the panel. David Parkison of Nodality was quick to suggest the “carrot and stick” approach. Because of their presence and success in the clinic, big pharma is able to offer the carrot. When that doesn’t work, getting Dx written up in physician guidelines can be the stick that does the trick.

Out with a Bang

Each year there are more and more examples of the move to medicine which is tailored to a person’s biology. Perhaps one of the strongest bits of news came at the end of the day, not at the confernece, but over the wires: <a href="http://news.businessweek.com/article.asp?documentKey=1376-LYGF8K1A74E901-3MIQF1UMSJP1QKGJJJFIIH98RA" targe=_blank">Roche announced a hostile takeover of Illumina. Though a deal is by no means inevitable, the move by the Swiss drug giant is widely seen as one that will enhance their ability to create drugs and diagnostics which are more personalized. Sequencing has dominated conferences on personalized medicine and many have questioned whether the rapid evolution of the technology was outpacing its practical use. Perhaps there is an answer to this question in the move by Roche. The practical use of sequencing by several companies at the conference and the news that Genomic Health is transitioning to sequencing as a platform for their tests goes toward removing the question about whether the age of the genome has arrived in medicine.

The organizers of the PMWC, Tal and Gadi Behar of Silicom Ventures, do an outstanding job with the conference. Each year, the top names in the field appear and present to a growing audience, which this year numbered over 900. The growing conference now boasts three tracks, including the run through of companies competing for the most promising company award. (The 2012 award was given to Auxogyn, a company focused on improving the percentage of in vitro fertilization procedures that result in a live birth with their Eeva(TM) system.) I wonder how long the conference will keep it’s current name. With personalized medicine becoming more and more the standard, one can see the time not far off when the names of the tracks of this year’s conference turn into independent stand alone conferences: Emerging Technologies, Into the Clinic, Rx/Dx Opportunities, Evolving Regulation, and Reimbursement Dilemma.

DTC Genomic Testing—What’s it good for anyway?

Author: 
Eric Schuur

What is the fuss over DTC genomic/genetic testing all about anyway?  DNA is just a sequence of letters, isn’t it?  Lots of people are experiencing angst over the fact that these upstart companies would have the nerve to sequence part of people’s DNA for them.  I mean, it’s just a bunch of letters, isn’t it?

Seriously, I have to admit, I, as a molecular biologist, have experienced a degree of self-righteous indignation that these so called entrepreneurs would debase the field of genomics and medical genetics by offering to sequence anybody’s DNA for a price.  It seems beneath all of the effort and concern that has been invested in developing the field.  All of that hard-earned knowledge being sold off the shelf like a cheap tabloid.  That was the feeling, anyway, and I imagine some amount of that type of sentiment contributes to the resistance to the development of the DTC genomics field.

However, the reality is that those letters are attached to a lot of other information that may have health implications.  There are several serious genetic diseases (ironically, most discovered prior to the genomic era) whose sufferers (or carriers) traditionally receive genetic counseling to learn how to cope with the situation.

Beyond these known disease situations, the hype of the genomic age has led to lofty expectations for genomics.  Those letters are our shorthand for the substance (DNA) that gives us our individuality and which when altered is may give rise to disease, tell us who our relatives are, and potentially make us weller-than-well (if only we can change it a little bit).  We’ve bought pretty heavily into the idea that we are our DNA and therefore, revealing it is, in a sense, giving ourselves away.  There is an ever-growing body of genomic information that pins many hopes and dreams and futures to those four letters.  So, it’s not surprise that feelings run high when it comes to genomic information.

So, DNA/genes/genomics is loaded with expectation, but what’s DNA sequence information really good for when one takes a hard look at it?  How is it being used now?  We can start with a partial list of uses that have been found for DNA sequence information:

  • Disease risk assessment
  • Disease diagnosis
  • Preconception screening
  • Forensics
  • Genealogy
  • Recreation

The fuss that these upstart companies have created has revolved around health information for the most part.  That would be the first three items on the above list.  These companies are seeking to sell their customers their own DNA sequence information, along with an assortment of linked information regarding the health implications of the DNA sequence in question.  It’s the health information being sold along with the sequence information that has caused the kerfuffle with the FDA and the medical profession.  And, for some understandable reasons…

Long before we even knew what DNA was, enterprising companies and individuals were taking advantage of our sensitivity around health issues, selling remedies and other noxious (or inert) substances to solve health problems.  This profitable, but unethical, behavior was addressed through creation of the FDA, whose job it is to keep the nation’s healthcare resources safe.  So, here we have what might be called the modern day version of the snake oil salesmen (at least in the estimation of some): the DTC Genomics companies.  Not surprising, then, that the FDA might feel compelled to step in, as it appears they are likely do.  Similarly, many in the medical community have allowed as to how they would prefer that their patients not have access to their DNA information.  Also not surprising, since for known genetic diseases the medical profession has heretofore controlled this information  However, as it currently stands, the genomic profiles being sold by DTC genomic companies are pretty innocuous, so it doesn’t stand to reason to restrict the type of genomic information the DTC companies are selling.

My view is that we stand at a crossroads of sorts.  Down one road we regulate human DNA sequencing as a medical procedure, bequeathing control of the resulting information to specialists licensed to dispense that information in carefully predetermined ways.  This is a suitable model when the dispensing requires extensive training to avoid injury to the receiving party, as in the case of prescription drugs or cardiac catheters.  For genetics in the current information-rich environment and age of patient empowerment, I believe that there are a limited number of situations in which harm would come to a person who knew their own DNA sequence.  And, even those cases (e.g. Tay Sachs disease) it is questionable if the actual harm is sufficient to bar access except under carefully controlled conditions.

The other road might be one in which one can obtain the sequence of their genome, if they are so motivated and can afford it.  It is likely that reasonable quality services will be available to provide this information soon (currently there are concerns about quality with many of the providers; note to DTC genomics companies: you would do well to pay attention to the quality of your sequencing if you want to survive).  The latter three items on the list above would be supported by relatively simple, low hurdle access to sequencing services.  In fact, my guess is that FDA regulations or no, in the near future a motivated person will be able to get their genome sequenced.  Somewhere.

My concern  is what we might lose if we over-regulate DTC genomic testing.   The latter three items on the list have emerged in recent years.  What else might be added to the list in the future?  What uses for DNA sequence data are not on that list?

What is DTC genomic testing good for anyway?  I don’t think we know the answer to that question yet.  Should we follow the Silicon Valley paradigm, let go of the information, and see what millions of “users” out there do with it?  Should we “crowd source” genomics?  Maybe there is someone out there with a marketing degree, a penchant for spreadsheets, and the interest in genetics who can offer a creative solution for the problem of missing heritability of SNPs.  Maybe a user group will surprise us by producing a creative solution to one or another vexing biology or health problem that has stumped the collective brain power of us professionals?  We may not know what DTC genomics is good for unless we give it a chance.

Art and Science: CAST Labs Launches with Soiree

Author: 
Theral Timpson

In a former life, I was a musician. I studied orchestral conducting and was working my way up to conduct the New York Philharmonic. Or so I thought. The reality is I wasn’t a superstar musician, and it turns out I have a knack for BSing over Skype. I now spend my days interviewing scientists and business execs in the life science industry.

Naturally, I was intrigued when a former professional ballerina from France, Sylvie Leotin, recently set up CAST Labs. The name is an acronym for Connecting Art Science and Technology. Sylvie just put on her first two events, a seminar at Stanford and a dinner/discussion/performance.

After her life as a ballerina, Sylvie came to Silicon Valley and became? What else? A computer engineer. Then she went on to entrepreneurship. Being proficient at different disciplines has become rare in our age of specialization. Fields of thought and scientific discipline become ever narrower and the amount of knowledge needed just to keep up with one of them can be overwhelming. I recently interviewed Ron Davis, a veteran scientist at Stanford, and he remarked that when he was young, he read all the literature there was in the life science field. It was expected. That’s not only utterly impossible today, but keeping up with one’s narrow field of say neuroscience or within that, electrophysiology or computational neuroscience, is almost impossible.

Are the renaissance men, the Leonardo da Vinci’s of the world, a thing of the past? If we are to become excellent at our work, does this come at the exclusion of other activities? Does striving in both art and science mean that one will end up as Salieri from the movie Amadeus, a "mediocrity"?

CAST Labs Launch

As part of her project, Sylvie is asking a wonderful question. Does creating art improve the way one does science or develops technology? (Everyone is thinking about Steve Jobs and I can’t help but think what his answer would be. Have you see the plan for the new Apple headquarters?) To put it scientifically, does working in our right brain aid our use of the left brain?

CAST’s first event was a seminar at Stanford entitled “What can a scientist learn from ballet?” I missed this event but happily made it to the second event later in the week, a dinner, performance, and discussion.

The evening heated up with some live jazz, led by pianist Howard Lieberman and concluded with some very slick tango dancing (see end of video). Dinner entertainment was a couple arias from Mozart’s Marriage of Figaro and Puccini’s la Boheme, sung by Indre Viskontas. Both Lieberman and Indre perform on the side. Lieberman is an electrical engineer and the Chairman of the Silicon Valley Innovation Institute (who co-hosted the evening.) And Indre is a neuroscientist. After dinner, the two were joined by artist Michael Killen for a panel discussion with Sylvie, as moderator.

Canvassing a wide range of topics, Sylvie pushed the idea with her guest panel, and the audience, of what being an artist can do for science. We heard that art opens the brain to think differently. That being creative in an art leads to new ideas and innovation in other fields.

Asked whether art is more inspiration or perspiration, Indre conceded in her case, perspiration. “Art is being ready, through hard work and application for when the inspiration happens,” said the young diva/scientist.

Sylvie provoked panelist and artist Michael Killen (his 24 foot long painting called Sustainability will be hung in a new building at NASA Ames next year) with the a book Proust Was a Neuroscientist, by Jonah Lehrer. In the book Lehrer argues that many 20th and 21st century discoveries in the field of neuroscience are really re-discoveries of insights of artists. For Killen, who came to Proust later in life, reading Proust’s Remembrance of Things Past was a revelation. “I began reading this book, and was struck time after time, thinking that Proust was on to this long before science.”

Perhaps it was Howard who best summed up the evening by turning around Sylvie’s question, what can art bring to science and technology. Howard noted that science and technology are changing art. Conceding that the last century has been one of high specialization, Lieberman observed that now most artists are amateurs due to the phenomenon of the internet. “Things are reversing. We’re going back to the day a hundred years ago. Back then everyone had a piano and if you wanted entertainment you provided it yourself. We’re going back to the days of amateur artists. And science is the one that let the genie out of the bottle.”

How true. Look at the e-books, the awesome videos on YouTube done by amateurs (far outnumbered by the crap, for sure) and the insightful blogs we look at each day. Science and technology constantly change art. Movies, photography, animation--entire art forms exist as a result of new technology. The piano, my chosen instrument, was a technological wonder in it’s day.

Renaissance Persons

Still, does being an artist improve one’s ability in scientific endeavor?

For da Vinci, they seemed to go well together. My business partner, Ayanna, dug up some other examples that are more recent.

Gerd Maul was a scientist who studied nuclear physics and later vaccines. He was also a great artist working in photography, silk-screen printing, and sculpture. He saw no separation between art and science, according to an article in The Scientist written after Maul’s death last year. “He saw art in his science and science in his art,” says Louise Showe, Maul’s colleague and friend. When his university, the Wistar Institute in Philadelphia, was prepared to trash an old electron microscope, Maul made use of it instead as an art piece in his backyard.

Another example is Carl Djerassi, an emiritus professor of chemistry at Stanford University. Djerassi is best known for contributing to the development of the first oral contraceptive pill, now known as simply ‘the pill.‘ Djerassi is known around Silicon Valley as the former president of Syntex Laboratories, one of the first bio ventures in the area. Djerassi also writes novels and plays. His success in science and technology has enabled Djerassi to form a marvelous art collection, some of which he donated to the San Francisco Museum of Modern Art. In his writing, what he calls “science-in-fiction,” he explores the ethics of new scientific research. His novel, Cantor’s Dilemma, recounts a fictitious scientific breakthrough and the race for a Nobel prize. Djerassi “exposes many uncomfortable truths about how credit for scientific discoveries is given, and how competition, politics, and ego play a major role in many scientific inquiries” writes Dave Watts in his review the book in The Tech. Watts says the book “should be read by everyone who wants to know how science really works.” And who better to write about that world than one who lived it?

Science in Context

When I first moved to Silicon Valley, I was surprised to see such a wealthy region devoid of major art institutions I’d come to know in Los Angeles. The San Jose Symphony was allowed to go bankrupt in the Dot Com Bust and the only museum worth one’s time on a Saturday is the Tech Museum. In this hub of innovation are scientists and engineers too busy to be bothered with art? In this world of start-ups and venture capital is their time only for one focus-that of technology? Without art, will science and technology be meaningful?

I’m glad to see Sylvie begin her endeavor to bring more art to the scientists and technologists in the Valley. I personally cannot live without music. Well, let me be more scientifically accurate. I don’t want to live without music, without making music. Nothing can bring me to a fresh perspective like music.

At the CAST event, I found this is true for many others. And in a Q and A piece from the Washington Post earlier this year, NIH Director Francis Collins revealed that he plays the piano at night to relax and let go of his hectic routine.

This blog is part of an ongoing discussion about art and science at mendelspod. We do not produce headlines about which company’s stock was recently downgraded by Goldman Sachs or the latest discovery of an oncogene. Rather we are looking at how science and scientists fit into the larger social context. Our in-dpeth interviews seek to put a human face on the industry.

mendelspod guest blogger, Nathaniel Comfort, wrote earlier this year about why one should study the history of science. In one of the four posts on the subject, he posits that there is an aesthetic reason. For the pure beauty of science. I’m sure that da Vinci, Gerd Maul, and more would agree with Comfort. And no doubt this drives many of our scientists on. They see beauty in new discoveries of the way the world works. When this beauty is translated to another form, we call it art.

Both science and art are an attempt to understand the world around us. Perhaps art is our way to keep up with science and technology. I think that art tends to be more personal and science impersonal. Perhaps you disagree with me. What we can say is that the interaction between the two is necessary for the good of all. Sometimes this happens in a community, sometimes in one mind. At the end of the CAST dinner an older man in the audience, an architect, spoke up. “What’s missing from this discussion is any talk of imagination. The imagination is the fuel that lights the way in any endeavor.” The comment makes me think of the first tools made by mankind, created by his ability to keep an image in his mind’s eye. I think too of the first pottery and baskets. Is there really a distinction between art, science, and technology?

History as a Bridge to the Future: LSF Launches Book on Genentech

Author: 
Theral Timpson

Last month, while interviewing Steve Burrill, he introduced me to a new organization which he chairs, The Life Sciences Foundation (LSF). “What we want to do with the Foundation is to tell the real story of what happened,” he told me. “History and information are different. History is putting the information in a context that makes it useful in the future. Young people today don’t know who Cetus Corporation was.”

The Foundation

I met the CEO of the new Foundation, Arnold Thackray, at a recent event the LSF hosted, a book launch for Sally Smith Hughes’ newly published, “Genentech: The Beginnings of Biotech.” Appropriately, the event took place at Genentech Hall at UCSF and attending were many of the folks from the early days of Genentech. The terrific event represents the way the LSF can make a difference in the industry.

Thackray comes to the Foundation with a long career in keeping a history of science. Teaching first both in Cambridge and Oxford in his native England, Thackray moved to the US in 1981. A year later, he helped create the Department of History and Sociology of Science at the University of Pennsylvania, the first academic department with a focus on science in a social context. That year, he also became the founding president of the Center for the History of Chemistry at the University of Pennsylvania, which was later given the name we know today, the Chemical Heritage Foundation (CHF). Through its collection of instruments, papers, and books and regular conferences and lectures, the CHF has been fostering an understanding of chemistry’s (and related sciences) impact on society.

“History has to be made. What happens is just stuff,” Thackray says. “History is what you make out of stuff. And if you don’t make the history, someone will make it for you. And probably someone who is hostile to you.”

I’m very happy to see such an organization as the LSF. At mendelspod.com we teamed up early on with science historian, Nathaniel Comfort. He wrote a series of blogs exploring the reasons we need a history of science. Our own goal at mendelspod.com is to put a human face on the life sciences. To put the headlines we see each day in a social context. To go deeper than stock symbols and stock prices to the discoveries which propel us into new places and the stories which remind us how to go forward.

The LSF boasts some luminaries on their Advisory Board, including Venture Capitalist Brook Byers, industry titan, Craig Venter, and Jay Flatley, CEO of Illumina, so they should be able to get access to much of the history being made.

“Before memories fade and science moves on, our urgent mission is to collect and preserve the record of achievement, beginning with biotechnology.” So reads the the Foundation brochure that we picked up at the book launch. “Over the decades since DNA’s decoding, biotechnology has gone from promise to performance. . . . To tell this story is to make our case - to thought leaders in our legislature, universities, schools, and media - to remind ourselves how far we’ve come,” explains the brochure.

The Life Sciences Foundation has a website up and has compiled a nice collection of video interviews with some of the great figures in bio, including a video of Watson and Crick at the pub discussing their discovery. Some of these videos are linked from the rich collection of oral histories at Cold Spring Harbor Laboratories, a treasure I urge everyone to enjoy.

One of the videos on the home page of the LSF is an interview with Herb Boyer, early pioneer of recombinant DNA technology and co-founder of Genentech. Boyer recounts several stories from the early days of the company such as the day they came up with the name. It’s Boyer’s and Genentech’s early history that Sally Hughes presents in her book and what Thackray says is “the first serious objective history of the beginnings of biotech.”

The Event

Boyer was slated to attend the book launch event, but couldn’t make it due to an illness. Many others did make it. Tom Perkins served as the first chairman of Genentech. A deft speaker, 79 year old Perkins gave mostly a political speech decrying the idea of government investment in private enterprise (Solyndra), but did have a few stories from the early days. Of his VC firm, Kleiner Perkins Caufield and Byers, he remembers jokingly, “we tried tennis shoes and then snowmobiles, and that didn’t work, so then we tried DNA.”

Judy Swanson, widow of co-founder Bob Swanson, was on hand to tell some of her own stories and pat the Genentechies on the back. “I didn’t marry Bob for his money,” she began, “he had no money.” Judy recalled that it was very difficult in the beginning and they didn’t know how things would turn out. For Judy, relationships were very important in Genentech’s history. She said she didn’t realize in the beginning just how deep the relationships would turn out to be.”

The star of the evening, Sally Smith Hughes, is a soft spoken, modest woman who has done literally thousands of hours of interviews with the early pioneers of biotech over the years. The interviews are kept at UC Berkeley’s Bankcroft Library. For terrific archival quality oral histories, the collection is unmatched. I’ve already spent hours lost in the first person accounts of some real characters. Sally’s new book chronicles the improbable history of Genentech from the founding to the prosperous company that IPO’d in 1980. Drawing on her hours of interviews, Hughes paints rich portraits of the founders and details what she calls a “novel creation--the entrepreneurial biologist.” How did the company raise money in the low economic times of the 70’s, she asks. How does one convert regular scientific experiments into commercial success? These questions she answers in a book she hopes might “serve as a bridge to biotech for the general public.”

The book launch played out as a Genentech reunion. Most everyone knew each other and many were hugging. For one who wasn’t around in ’76 (I was a year old), it was an eye opener into a special time in the history of our industry when the stage was set for hundreds of companies to come. In her book, Hughes is certainly not hostile to her subjects, but rather brings a time that will soon be forgotten back to life. Thackray, from the Life Sciences Foundation, says they’re working on their own history of biotech book. Such projects as these will go a long way to helping us remember the stories and people who have brought us here, so we might better know how to shape our future. In soft, understated tones and graying hair, Hughes put it nicely, “to make tomorrow happen, use yesterday as one of your instruments.”



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