Too hot to hold?: “Hot Trends in Life Science Tools” event reflects competition in biotech

Biotech is on fire with new tools

The October 1, 2014 “Hot Trends in Life Science Tools” event at Bio-Rad hosted by the Women in Bio San Francisco chapter highlighted the excitement of emerging biotech resources and profiled some of the women that are pioneering these technologies. However, each of the panelists has challenging competition to consider, as the scary side of great ideas is that they rarely come from only one source. The approaches these companies are taking, or will take, to carver out their niche in the rapidly growing biotech market should provide good parables for anyone considering entering the biotech startup world.

Dr Rachel Haurwitz, President and CEO of Caribou Biosciences, was the panelist that most represented how a hot idea in biotech spreads like wildfire and how focusing on a specific application of your tool can keep you relevant.

Caribou is in the CRISPR system genome editing game. When the CRISPR system was first described in Science in 2007 it was esoteric and best left to PhD molecular biologists. However, people wanted it and the demand sparked a race to simplify the system into a tool for anyone. Today, a search on Science Exchange brings up ten providers offering CRISPR contract services. To do-it-yourself, Addgene provides extensive resources and kits are available from Clonetech, OriGene, System Biosciences, Life Technologies, and more.

As a small startup, Caribou is avoiding being engulfed by the CRISPR blaze by focusing on a narrow market in a sexy field: epigenetics. Modifying epigenetic markers adds additional complexity to genome editing that the large kit makers are not ready to address, but that academic and industrial researchers need. This niche is giving Caribou time to grow and evolve. It also may make them attractive to those big companies.

Jessica Richman, President and CEO of uBiome, may face a similar challenge. uBiome is in the hot field of microbiomics and companies are popping up all over to stake early claims. Microbiomics is so nascent that the majority of these companies are in extreme stealth-mode; however all biotech startup expositions and competitions seem to include at least one, if not several. Watch closely, the microbiomics explosion will soon provide plenty of marketing and business development lessons.

Microbiomics and Dr Natalie Wisniewski’s PROFUSA, Inc., which is focused on implantable devices for monitoring tissue oxygen levels, also brought to mind the issues with “quantified self” product competition. Quantified self is commonly associated with “wearable” devices, like FitBit, Nike Fuel, and old-fashioned pedometers, but it can encompass any type of self-monitoring. Buy-in for these products is extremely low outside of tech bubbles like San Francisco according to TechnologyAdvice but more and more continue to flood into the market. Furthermore, NBC News reports consumers bore of them quickly with 40 percent of owners abandoning the product. This does not bode well for products that rely on a consumers attention span.

As an implantable device, PROFUSA is, according to Wisniewski, “what comes after wearables.” It has a medical application, but they will still face the wearable challenge of making continuous monitoring records useful to doctors. A The Daily Beast article highlights how these devices can be valuable tools, but concedes that most doctors have no interest in the data, which can come in an indigestible deluge. Without the acceptance of the medical community, and until doctors and insurance providers start requesting this information, self-monitoring devices may struggle.

As the title “Hot Trends in Life Science Tools” suggests, biotech is full of scorching new ideas; but it never hurts to remember that to keep a company vibrant takes as much innovation as that first idea.

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The world of fecal microbiota transplants

Poop pills or bacteria pills

Not to be confused with these poop pills, FMT requires transplantation directly into the colon

This is the link to my most recent post for uBiome on fecal microbiota transplants (FMT).

A little taste:

Fecal microbiota transplant (FMT) is the therapeutic process of transplanting feces from a healthy individual to an ailing recipient. Despite the obvious “ick” factor of receiving healthy poop from your sister, husband, or friend, people suffering from debilitating Clostridium difficile bacterial infections are overlooking the ick in hopes of a C. difficile cure. Currently the only indication for which FMT is approved by the FDA is C. difficile colitis and there is contention as to the efficacy of FMT for C. difficile treatment.”

Thank you from California Academy of Sciences

Oral swabbing for uBiome by Cal Academy

Angus Chandler, Academy postdoc, and Sean Edgerton, graduate student at SFSU, demonstrate oral swabbing

Check out my blog post on the wonderful thank you letter we received at uBiome from the California Academy of Sciences.  Visit both uBiome and the Cal Academy at Bay Area Discovery Days November 1, 2014.

The real problem of irreproducible data

               

You have to know what is real before you know what is relevant. In science we trust that published means “real”. We may debate the impacts of different conditions and ooze skepticism over significance measurements and choose, sometimes less than tactfully, to object to an author’s conclusions, but overall we trust the data are real for the experimental conditions and that repetition of the experiment under the same conditions would yield the same outcome.

However, in a Catch 22 the data on reproducibility disagree.

In a collection of articles in the open source Nature special issue on data reproducibility, the most optimistic studies show 25 percent reproducibility of academic research. One article from Glenn Begley and Lee Ellis led to the development of Begley’s Six Rule for Reproducibility, which include blinded studies, full disclosure of all results, and reagent validation. Based on these rules, the optimistic 25 percent of reproducible studies are probably coming from far less than 25 percent of total academic labs. I know very few researchers that can honestly read all six rules without a little shame. 

On July 9th, Oxbridge Biotech Roundtable (OBR) hosted a panel discussion on this issue of data reproducibility. The panel included Dr Liz Silva, the MIND Program Manager at UCSF and the former Senior Editor at PLoS ONE; Dr Tim Gardner, founder of Riffyn; Dr William Gunn, Head of Academic Outreach at Mendeley; and Dr Corey Goodman, a partner with venBio.

Goodman opened the conversation with the first question he asks of founders pitching their science to him: “who has reproduced this?” The rest of the discussion focused on the problems, like an increasing rate of article retraction, and potential causes, such as intense pressure to publish, funding shortages, and increased oversight. Somewhat frustratingly, very few solutions were offered.  Gardner made a compelling argument for an incentivized approach to solving the problem. He suggested that two factors hold back scientists from solving the reproducibility issue: our culture and our lack of tools. We operate in “a culture of noise” in biology and accept that irreproducibility is unavoidable. However, if we employed adequate documentation tools similar to other industries it could greatly diminish the issue. Through incentives, like lower costs and timesavings by eliminating unnecessary, faulty repetitions, we can develop and adopt new tools and change the culture. (Gardner discusses this more in the Podcast referenced later.) When asked about automation as another tool in this solution, the panel felt it might be in the future, but currently there are other more pressing issues to address. (This could also be a reflection of the fear of the outdated bench scientist, but that is a topic for another day.)

Another potential, but more dogmatic approach, is a mandated NIH requirement for reproducibility standards. However, this reeks of additional strain on an already stretched system and more delays in publication, which will only compound the stresses that contribute to irreproducibility in the first place.

More adaptable and agile solutions are being developed through the Reproducibility Initiative. This partnership between Science Exchange, Mendeley, PLoS, and Figshare was briefly touched upon, but has the potential to revolutionize the way research is conducted as we incorporate tools, such as those being developed by Riffyn, and commercial replication services become cheaper and more convenient.

Overall this is a discussion that needs to continue and it requires total engagement from the entire scientific community. There is no clear solution but isn’t this the kind of problem we live for?

(To solicit more thoughts on solutions and the topic in general from two of the panelists, Silva and Gardner, I was asked to conduct an impromptu interview for a Podcast. By impromptu, I mean this interview was conducted on about five minutes notice.  I even forget Liz’s last name!  Anyway, it is clear I am not ready for the evening news.  As soon as the Podcast is up I will add the link here, so stay tuned!)