4 ms·

Is $120k going to be enough to even make a dent in a biotech startup?! It's years and years and years of hard work before you may even get denied by the FDA. Wi

by NDizzle 13y ago

Is $120k going to be enough to even make a dent in a biotech startup?! It's years and years and years of hard work before you may even get denied by the FDA. With all this funny money flying around who has the patience to wait 10 years to maybe see a return?!

mkempe 13y ago
There is a need for biotech startups that help navigate FDA regulations. Think process & documentation for medical solutions, like shovels for gold-miners. I've been doing consulting work at healthcare manufacturers. The environment is insane -- constraining, slow, unproductive, depressing. And it's used as a huge moat.
- mkempe 13y ago
  Down-voting my comment will not make the FDA regulations go away. You will not bring any biotech products to [edit: medical] market unless you comply with the FDA (or somehow manage to eradicate it). Health-related products and services are heavily controlled -- in ways completely at odds with the common practices of Internet startups. If you haven't yet had to comply with these regulations, you may want to find out how onerous they are. Here is one example: Quality System (QS) Regulation/Medical Device Good Manufacturing Practices [1], covering: Quality System, Design Controls, and Human Factors. They audit your compliance with their regulations. You have to document everything you do, every decision you make, every change you make. That is not how startups commonly operate. [1] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
  - technotony 13y ago
    Who say's biotech products have to go via the FDA? There are all kinds of potential markets with lower or non-existent barriers to market, eg my company which makes Glowing Plants. These are the areas which make more sense initially as you really can take a lean startup approach to them.
    - mkempe 13y ago
      Of course, some biotech is not aimed at humans. Anything aimed at humans will have to satisfy the FDA, in the US.
    - dnautics 13y ago
      how's that going? You guys said you would deliver in april, but it looks like it's been pushed back to june. There are also very few lab-related blog posts, despite a promise by Mr. Drory in the reddit thread that all intermediate results, both good and bad would be disclosed. Also, he said a budget would be disclosed. I haven't seen one on the site yet. http://www.reddit.com/r/technology/comments/1e5rti/whats_wrong_with_the_glowing_plant_kickstarter/ http://www.reddit.com/r/technology/comments/1e5rti/whats_wro... >This will be totally transparent project - we will introduce a novel concept called "constant peer review" - In academia no one publish things that didn't work - we will publish everything. >We take being a good Steward of our backers funds as #1 priority. Our budget will also be publish online and you can see where the money went. Neither of these two things has happened yet.
      - technotony 12y ago
        Are you a backer? We've been sharing this information in the backer updates. Some of this is also to be found on our youtube channel. With respect to the budget we currently have $230,000 left in the bank. We'll publish the financials when we are ready to ship.
  - fasteo 13y ago
    This is THE hardest problem to solve in a biotech start-up. In the mitochondrial field, companies are going through orphan-drug designation and fast-track approval processes. This is probably to only advantage researching for niche - rare - diseases: You can save lots of money/time to get the drug in the market. If you can then find some off-label use for you drug, much better.
- danieltillett 13y ago
  I agree with this, the problem is biotech companies rarely have enough money to pay for good advice.
- antifragile 13y ago
  I don't believe it's possible to tackle the gatekeeper or incumbents and win. You have to bypass them altogether before revisiting them. You have to, in Bill Gurley's words, have an orthogonal solution to the problem. My words, you have to be 100% disruptive. Or, you seek fast-track, accelerated approval, breakthrough therapy, and/or priority review, but then you will likely come across and have to compete against the incumbents, who've by the way woken-up on the orphan disease problem too. Truth is, we have bigger problems than orphan diseases in the world. Biotech startups should be tackling major diseases and focusing on transformative innovation, by questions the fundamentals.
antifragile 13y ago
Categorically, yes. But, you're only likely to succeed if you for one, question the fundamental assumptions on which things are built. Anything less is incremental, or so far down-track in clinical trialing that it wont get funded or wouldn't be sufficient, respectively). Questioning assumptions is fairly straight-forward because so much out there is high quality but seriously questionable bull. Not seeking to cast derisions, just that biology, by its very organic nature, is volatile and often uncooperative. The problem of course is that now we are talking about obtaining deep-domain knowledge, which can take some time, absolute minimum 5 years to read everything, condense and connect-the missing dots. My project, for example, has taken me literally a dozen years, in part, because I hadn't realized I'd started! http://www.reuters.com/article/2012/03/28/us-science-cancer-idUSBRE82R12P20120328 http://www.reuters.com/article/2012/03/28/us-science-cancer-... Accessed 28/04

by NDizzle 13y ago

mkempe 13y ago

There is a need for biotech startups that help navigate FDA regulations. Think process & documentation for medical solutions, like shovels for gold-miners. I've been doing consulting work at healthcare manufacturers. The environment is insane -- constraining, slow, unproductive, depressing. And it's used as a huge moat.

mkempe 13y ago
Down-voting my comment will not make the FDA regulations go away. You will not bring any biotech products to [edit: medical] market unless you comply with the FDA (or somehow manage to eradicate it). Health-related products and services are heavily controlled -- in ways completely at odds with the common practices of Internet startups. If you haven't yet had to comply with these regulations, you may want to find out how onerous they are. Here is one example: Quality System (QS) Regulation/Medical Device Good Manufacturing Practices [1], covering: Quality System, Design Controls, and Human Factors. They audit your compliance with their regulations. You have to document everything you do, every decision you make, every change you make. That is not how startups commonly operate. [1] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
- technotony 13y ago
  Who say's biotech products have to go via the FDA? There are all kinds of potential markets with lower or non-existent barriers to market, eg my company which makes Glowing Plants. These are the areas which make more sense initially as you really can take a lean startup approach to them.
  - mkempe 13y ago
    Of course, some biotech is not aimed at humans. Anything aimed at humans will have to satisfy the FDA, in the US.
  - dnautics 13y ago
    how's that going? You guys said you would deliver in april, but it looks like it's been pushed back to june. There are also very few lab-related blog posts, despite a promise by Mr. Drory in the reddit thread that all intermediate results, both good and bad would be disclosed. Also, he said a budget would be disclosed. I haven't seen one on the site yet. http://www.reddit.com/r/technology/comments/1e5rti/whats_wrong_with_the_glowing_plant_kickstarter/ http://www.reddit.com/r/technology/comments/1e5rti/whats_wro... >This will be totally transparent project - we will introduce a novel concept called "constant peer review" - In academia no one publish things that didn't work - we will publish everything. >We take being a good Steward of our backers funds as #1 priority. Our budget will also be publish online and you can see where the money went. Neither of these two things has happened yet.
    - technotony 12y ago
      Are you a backer? We've been sharing this information in the backer updates. Some of this is also to be found on our youtube channel. With respect to the budget we currently have $230,000 left in the bank. We'll publish the financials when we are ready to ship.
- fasteo 13y ago
  This is THE hardest problem to solve in a biotech start-up. In the mitochondrial field, companies are going through orphan-drug designation and fast-track approval processes. This is probably to only advantage researching for niche - rare - diseases: You can save lots of money/time to get the drug in the market. If you can then find some off-label use for you drug, much better.
danieltillett 13y ago
I agree with this, the problem is biotech companies rarely have enough money to pay for good advice.
antifragile 13y ago
I don't believe it's possible to tackle the gatekeeper or incumbents and win. You have to bypass them altogether before revisiting them. You have to, in Bill Gurley's words, have an orthogonal solution to the problem. My words, you have to be 100% disruptive. Or, you seek fast-track, accelerated approval, breakthrough therapy, and/or priority review, but then you will likely come across and have to compete against the incumbents, who've by the way woken-up on the orphan disease problem too. Truth is, we have bigger problems than orphan diseases in the world. Biotech startups should be tackling major diseases and focusing on transformative innovation, by questions the fundamentals.

antifragile 13y ago

Categorically, yes. But, you're only likely to succeed if you for one, question the fundamental assumptions on which things are built. Anything less is incremental, or so far down-track in clinical trialing that it wont get funded or wouldn't be sufficient, respectively). Questioning assumptions is fairly straight-forward because so much out there is high quality but seriously questionable bull. Not seeking to cast derisions, just that biology, by its very organic nature, is volatile and often uncooperative. The problem of course is that now we are talking about obtaining deep-domain knowledge, which can take some time, absolute minimum 5 years to read everything, condense and connect-the missing dots. My project, for example, has taken me literally a dozen years, in part, because I hadn't realized I'd started! http://www.reuters.com/article/2012/03/28/us-science-cancer-idUSBRE82R12P20120328 http://www.reuters.com/article/2012/03/28/us-science-cancer-... Accessed 28/04