Monday, June 07, 2010

Want to help out a biotech hackerspace AND learn about medical device regulations? Come to my class...

Yes, that's right...someone thought of a hacker-space for Biotechnology and Medical Device players! And, curiously enough, they named it "Biocurious". Yes, get over what the name reminds you about - after all, as a clever marketing ploy, it does make you sit up and notice..

Biocurious was founded by Eri Gentry, and it currently operates out of a garage while awaiting more founding support to mature into a full blown facility somewhere in the San Francisco Bay Area. Having been spoiled with hacker spaces, Maker Faires, Tech Shops and the like, yours truly, among many others has become very attracted to the idea.

Playing in the life science space is never as easy as developing a Facebook app and raking in millions, and it probably never will be. A lot of biotechnology labs and incubators have popped all over the place. They plan to take huge chunks of your company and cash, mostly because it does get that expensive sometimes.

Do-It-Yourself, cheaper...

A hacker space for life science companies is the appropriate experiment at this point. If you look at big pharmaceutical companies, they are stuck in their own rut of Ms and As with no real focus on any innovation. Venture Capital companies are minimizing risk by investing in "safe bets" while entrepreneurs pine away.

Imagine how much of an impetus it would be if you could rent a space very cheap, rent and share equipment and "schmooze" with like-minded folks. Biocurious is positioned appropriately to achieve this. You could be a serious entrepreneur, or someone who wants to make your cat fluorescent (okay, the last one is just a cruel joke), and you would find Biocurious the right space for you.

Of course Biocurious is well founded on the principles of "Safety First", open source and all that is well and good with hacker spaces.

To learn more, go here:

Education for hobbyists and entrepreneurs alike

Apart from providing space, equipment support, safety and good vibes, Biocurious also provides a framework for hobbyists and entrepreneurs to teach each other. You can see the list here:

As you can see, I have volunteered to teach a class on FDA regulations, for life science companies and medical device companies alike. So, let's take a look. I am going to copy and paste the summary of what I wrote in there later, but here's the gist.

Introduction to FDA Regulations

This is an introductory class. So, if you know little or nothing, or simply want to come and help out Biocurious with more than the suggested minimum of $10 (I am not getting any of this!), then come and have a listen.

If you are wondering what you should do after receiving a Form-483 report, this may not be for you...

The idea is not to rant about how the FDA is out to kill innovation or any of that stuff. Our goal in this class will be to develop an idea of the ways and means by which you can work within the regulatory framework from the very beginning of your drug/device/biologic/diagnostic development process.

The goal is to layout the regulatory map and discuss any questions and answers.

Although it mostly repeats, here is the class summary:

The Business of Drug and Device Development – what you need to know about regulation and the approval process

Tuesday, June 22nd | 6:00 - 9:00 PM

Srihari Yamanoor

As an entrepreneur, one of the most important balls you will juggle will be regulation. As you get more serious about your endeavor and seek funds you will notice that investors and others will seek out your “regulatory plan”. It is key to develop a thorough understanding of the regulatory process, what the FDA looks for, and the strategies companies adopt to ensure as smooth an approval process as possible.

The class will discuss the approval processes primarily focused on drugs and medical devices. We will talk about the different stages of the approval process involved in therapeutics. This will be followed by a discussion on medical device approval process. We will discuss the various classes of medical devices, how to determine the classification of your device.

Frequently, your devices and drugs will go through clinical trials in Europe, Mexico and other locations. We will discuss the need for this, how to initiate clinical trials in these locations, and how to work with the FDA throughout the process to ensure that the trials meet the standards for safety and effectiveness, essential for approval.

We will also discuss the regulatory process that is in flux at the FDA.

Cost: $10 suggested contribution. All proceeds will be used to support the lab.

Stop By!

So, once again, if you are local to the Bay Area, consider marking off June 22nd on your calendar and stopping by! If you have any questions, let me know. I hope to see you come there and support Biocurious!!

Here is the link again:


gautham said...

hey hari, an old friend of yours, mani sampath, says hi. he also asked me to talk to you for some serious career advice, me being a new graduate and jobless and all. couldnt find your mail id, so let me know if and how i can trouble you with emails. thanks.

Srihari Yamanoor said...


You didn't leave me with contact info :)

You can reach me at yamanoor @ gm**

gautham said...

thank you! sorry, i thought the link would take you to the id or something. sent you a mail. really nice blog, by the way!(i found the other one really amusing!)