Are you insane? just because the collaborate loosely and I mean loosely you shouldn't draw assumptions that this was screened on the ONVO platform? before testing biologics on the platform one would start with small molecules... walk before you run ...know what I mean. If they are showing clinical data that means this program is years old having tested it in rodent, dog, Cyno in vivo before sticking it in humans. This was done years ago. Bad pumpers!
Jim McKim has the worst reputation of any toxicologist in the country. Ask any one from Cyprotec. Jim sold his company to Cyprotec and got sued for fraud.
Sentiment: Strong Sell
I'm very familiar with the advanced 3D liver models in the marketplace and please know that both Hepregen and InSphero models recapitulate the in vivo liver toxicity not currently seen in 2D assays. Both of the technologies have numerous studies and publications. Next week actually kicks off the Society of Toxicology meeting in San Diego where these two companies will present more data with global collaborations. The cost of these models are a substantial selling point if you consider the screening needs for pharmaceutical safety groups. As a toxicologist I see little evidence from the Onvo model and what has been published to date, that their cost justifies the models ability to better predict... in a screening capacity... human toxicity.
I get it just fine. This is not a life sciences company... they have no product revenue and won't for many years to come...Instead I classify ONVO as a baseless hype machine selling futures to suckers.
ampiprobe is a dog... compared to other rna amplification technologies. I know I've seen the technology.
I wouldn't recommend anyone take anyone's word for it...especially on this msg board. What I would recommend is you take a look at the data which is out there and conduct your own DD. I'd begin with regenemed for one. These websites have plenty of information. My guess is ONVO will likely purchase one of these smaller private companies to fill the gap between their future technology prospects and what the industry can use today.
Sentiment: Strong Sell
I suggest you take a look at the Hepregen website and see the list of publications which tout the technology and answer the questions ONVO purports to be novel for their model only. Guys this is a joke of a debate, if you only knew. Roche has a charter to evaluate different models and they have. ONVO is just one and the data that came out of the evaluation was incredibly basic. You can see the same data posted from all the advanced liver model providers that have all had similar colloborations. Hepregen for example has BI and Pfizer data sets you can see.
physiologically relevant doses are measured in units called Cmax. look it up, typically IC50's are generated during a dose response experiment, concentrations ranging from low uM to 1 mM. from these you generate an IC50 and compare that number to Cmax (physiologically relevant max dose) and the closer the ratio to "1" the more relevant. All comparative studies have done this to be honest not sure how ONVO could even make this statement. It makes me question this slight, not scientific spin they place on everything. For instance, Astra Zeneca published a poster on just subject recently. A 53 marketed compounds study with known DILI (drug induced liver injury). The non- ONVO model stacked up very well with hepatotoxicants and non-hepatotoxicants at physiological dosses. so this is plainly not true. Please don't quote snippets and miss-report what they mean. This is very unfair for the general public deciding if this investment has merit. It makes me question your motives.
Sorry but you are so wrong with your perception of what restrictions are at my place of employment. We have cell phones, iPads and even laptops. ....all with internet access. Some of us even have a sense of humor, mine happens to surround vintage 80's movies...thus Bluestar. I thought it was rather suiting and funny. Love gecko. never saw the remake though. Biotech lab personnel aren't restricted from internet access... come on....
Sentiment: Strong Sell
ONVO is keeping any characterization work very secret. So you are correct. But why wouldn't they release the details of how they can de-risk the drug development process better than the models which already are on the market and have 3 years of data behind them?
sorry I have to reply. Management team is great and the company has recruited heavy hitters...no doubt about that. I used to work for Greg at Applied bio systems. before we were acquired by life technologies. He's the best of the best. What I'm tring to convey to this board is that from a industry customer prespective we have not seen compelling evidence of superiority of the ONVO model. BTW ONVO does not sell assays they sell a liver model which one runs assays. Promega and life technologies sell assays.
She is a regenerative medicine scientist and not a toxicologist. completely different world. She probably understand liver biology but not necessarily the applications or the business aspect of these labs.
I think what you meant to say is inferior "model" not inferior "assays". neither company sells assays they cell in vitro "models" The assays are the "test" used to assess the model. Most pharma company assess for liver toxicity using ATP as the "assay" as per the FDA for new IND submissions. Since you don't seem to have a clue what is asked of these advanced liver models and what can delineate them I suggest you find someone who can give you those answers.
I encourage everyone to perfom some real due diligence and understand what answers the ONVO model delivers that some of these more advanced 3D models don't answer. Sensitivity and specificity are the keys to understanding how a "model" correlates to in vivo (human or animal) data. If the model can predict toxicity (within some certainty) in humans or animals than it's done it's job. Hepregen has done a 40 compound screen of known hepatoxicants and recapitulated in vivo data very well. I believe this was Pfizer data. InSphero has astra zenca and Sanofi and GSK with similar data sets.
I'd be glad to answer any questions you might have. I actually know Adrian Roth who did the testing for Roche and can tell you he was not happy with all the spin/ PR that was delivered to the public via ONVO management from his early assessment work. I work on the west coast for a Roche subsidiary... can you figure out who?