Slashdot is powered by your submissions, so send in your scoop

 



Forgot your password?
typodupeerror
×

Comment Re:The future is in offshore data processing (Score 1) 135

As I understand it, venture capitalists tend to be unwilling to fund clinical trials that don't result in a patent or other exclusive rights that keep free riders from unfairly benefiting from the VC's investment.

Yep, that's how it works. And diagnostic companies manage to get funded and deal with this.

There's a lot of art in the med field about how to structure things in a way that are protectable.

Comment Re:What a nonsense article (Score 2) 135

Genetic variants are different from drugs. For one things, there are billions of genetic variants.

Currently the FDA is trying to apply drug validation studies to genetic variants. That's like requiring cars to have proper horse shoes.

So, umm, this is not the case. Do you have any idea how the non-ag side of the FDA actually operates?

When you go for approval you define the criteria. "All" you have to show is that you will show statically valid evidence that your claims are plausible. Sometimes the Agency wants some specific proof (e.g. they may ask that you use a specific animal to verify a specific procedure or organ consequence) or may want an additional test because they know some classes of can compounds have characteristic issues. But in general they don't dictate anything. Oh yeah, for a treatment there are outcome criteria, but you are mostly the origin of those as well.

Diagnostics are simpler to approve than devices, which tend to be simpler to approve than drugs, which to some degree are simpler than biologics. Each division has its own specialists. And the so-called "billions" of genetic cases are a red herring -- just consider the complex consequences of introducing organic compounds into the body.

Disclaimer: I am not a geneticist, and have not gone for any diagnostic approval, though I am an advisor to a couple of companies that have. But apart from my own experience in the small molecule domain, I do know most of 23&me's regulatory team socially, and we do talk about work. So I know generally what issues they face.

Comment What a nonsense article (Score 1) 135

I have appeared before the FDA, discussing a testing protocol for a drug we were designing...when I was the CEO of a Silicon Valley VC-backed pharma company. The article even quotes a partner from NEA which is a life science investor in addition to being a tech investor.

Sure, some people try for easy wins...why not? Some people don't do their homework too -- and not just in the life sciences. And some people (looking at you, 23 & me), get the benefit of the FDA bending over backwards to try to allow them maximum freedom to experiment within the consrtraints of the law, and still don't do their homework, and cry victim when they finally have to deal with making no effort to prove the validity of their claims.

And then the article quotes one company that -- oops -- failed to do its homework.

Comment Unless you use a burner number (Score 4, Insightful) 147

I don't want to sound like an Apple shill, but the reason so many merchants and CC companies don't like apple pay is that it hides this info from the network and point of sale.

I'm even suspicious of one-time numbers from the CC company since that company knows who you are.

Comment Re: My nose smells BS (Score 1) 92

I understand the misuse but the places are culturally distinct. Even the few VCs with presence in both hire different kinds of people for their offices.

I remember talking with a taxi driver in Berlin who felt he knew the USA very well -- because he'd been to Miami six times. It's a cognitive bias I'm sure I suffer from too, but it doesn't mean it isn't worth correcting.

Comment Film interest growing? (Score 1) 213

Resurgence in the popularity of analog photography has created demand for new and old film products alike.

Yes, from a very low number to a slightly less low number, as with vinyl audio. Counterexample: Keeble and Schuchat photography in Palo Alto (perhaps the only remaining place on the peninsula where you could get film developed or buy pro gear) just went out of business in November.

Comment They should pick their targets carefully (Score 1) 742

If they boycott iPhones it will only feed Trump's vindictive streak since he doesn't like Cook. They have to pick products that would hurt his cronies. (I'm sure they realize this; iPhones make for good headlines).

I wish I were writing this as a flippant comment but one of the few Trumpisms that isn't hyperbole ("I'll build a wall". "He's a Nazi") is that he bears and escalates petty grudges.

Slashdot Top Deals

"May your future be limited only by your dreams." -- Christa McAuliffe

Working...