Isn't This What CASIS Is Supposed To Be Doing?
NASA: Notice of Prospective Space Act Agreement and Intent to Transfer Sponsorship of Investigational New Drug Application
“The National Aeronautics and Space Administration (NASA) has identified a potential pharmaceutical industry partner named Epiomed Therapeutics, Inc., having its principal place of business in Irvine, California, which is interested in assuming responsibilities for the further development and commercialization of a pharmaceutical dosage form for intranasal administration of scopolamine (INSCOP). NASA has been actively engaged in the clinical development of this agent and is now seeking a Space Act Agreement (SAA) Partner whose role will include production of the formulation under FDA stipulated GMP GUIDELINES for clinical trials.”
Keith’s note: No mention of CASIS – anywhere. Isn’t this the sort of thing CASIS is supposed to be doing?
It would be good to hear who in NASA identified this potential partner. My guess is that one of the NASA-JSC ISS managers made this happen. Good for them. Unshackled, and CASIS aside, my bet is that the ISS team at JSC could make major inroads to ISS utilization, like this one.
Sounds from the company description like it might be related to the salmonella virulence issue that might have been discovered by JSC personnel.
I thought that CASIS ‘owned’ half the ISS national lab resources and is free to go out and find commercial partners, participants and sponsors, and NASA owns the other half of the ISS national lab resources, and brings in their own partners or sponsors.
So its a race to see who can find and enlist the most and most valuable users.
I think earlier, some months ago, there was a post that described that CASIS was responsible for the commercial half and NASA-JSC the operational half of the ISS. The halves were not supposed to tread on the other’s half of the business.
The JSC SAA and new drug application make sense in part, if you view the development of scopolamine as an aid for astronauts on the ISS; operational need. And it is a bit fascinating that the effort is about metabolites science, as Doc pointed out.
I don’t think NASA-JSC has many if any scientists on staff that have salmonella expertise, so I can’t imagine JSC researchers discovered salmonella. Most of the papers on the web list Arizona State University as the salmonella virulence leader.
Unless the researchers are trying to prevent the little salmonella bacteria from throwing up, I don’t think there is any relationship between the salmonella and the scopolamine R&D efforts.
It would be nice if someone from NASA-JSC or even ASU would put a post on this board to elaborate on the facts.
Nice dream there Mike. Be careful about comparing CASIS to a Fermi, Sandi, Livermore, or any Battelle run lab, or at least don’t do it in front of any of those lab folks; they may laugh or push-your-face-in.
I think Duane Ratliff’s presentation at the Denver ISS Conference summarizes what CASIS’s execution plan is quite well. Visualize their activity more as (a) a teacher loves STEM outreach and then (b) maybe runs a matchmaking service at night and (c) has a little pot of money they can use to entice and pay for some first dates. Down the road, if any of it works, (d) teacher gets comp’d in some way shape or form.
Duane’s pages say it well: “Open the Opportunity” (whatever that means), “Develop Relationships” (that would be the matchmaker thing), “Translate the Benefits” (decide who gets the “stuff”, which is the fun part!), “Publicize and Educate” (which you can do for centuries). They can also “Incentivize Participation”, granted they only have a what’s left from a little $15M to do that with. The last one is the most fun, because it’s handing people money and hell that’s a great friend maker.
The Livermores don’t have quite the same behaviors and agendas.
Duane’s presentation lacks any obvious substantive mechanism or means by which seriously big funding will be acquired, although they do ask for handouts (termed: donations). You know, like homeless people do on a street corner. Well, all dot.orgs do that, right?
As CASIS moves forward given the plans presented in Denver, it’s probably reasonable to conclude that CASIS will eventually run back to NASA and ask for a lot more annual funding. Tens or hundreds of millions more per year would help. I think Lori and Gerst and Charlie could see this coming, so they probably already have those budget monies marked for 2013 and soon 2014.
Probably the thing that will remain most active is “outreach”. Plan on three to five years of non-stop outreach.
I’d like to know at least a bit more detail about how the ISS is different from Livermore, et.al.? Just an interested non-scientist. As to why they are different, that would be a different subject, one supposes.
Factoids: scopolamine is a secondary metabolite from the Nightshade
family of plants and is used to treat addiction, motion sickness, and
major depression. It’s also a street drug known as
“Dragon’s Breath,” which either kills you or causes a loss of free will – another zombie drug.
Gosh Doc, I almost lost my cookies just reading your scopolamine summary.
Keith,
Your note makes me wonder if I’ve been under a major misconception. There is nothing the article about this SAA being done on the National Lab, on the ISS, or even in space at all. It’s just a NASA SAA. I though that CASIS was just responsible for ISS National Lab utilization. Yes / No?
Steve
Steve,
You are correct. A commercial partner is taking the NASA research forward commercially. As part of that effort, they will be assuming sponsorship of the Investigational New Drug (IND) application originally filed to support the earlier NASA effort.
Not ISS related.
Courtney
Scopolamine is one of a number of medications NASA has used for years to treat/prevent Space Motion Sickness. It is used on astronauts. Astronauts fly to the ISS. Research was being done so as to find better ways to administer the meds. Application of SMS meds has clear operational applications to anyone visiting the ISS. That is why NASA started this research in the first place. By your logic if possible commercial applications are not directly space-based then there is no ISS relevance – yet the intent of CASIS is to foster exactly that sort of application. Once again NASA is confused as to what it is doing and why it is doing it.
Hi Keith – thanks for your comments. I meant “not ISS related” to mean that the partner will not be utilizing the ISS to support its commercialization efforts and, therefore, won’t be working through CASIS to use the ISS National Lab capability.
Why is CASIS doing golf ball research on ISS? How is that “ISS related”?
Keith,
Let’s drop the term “ISS related,” because I think that’s where we’re not communicating. The question is: If the work to be done in the SAA is not being performed in the US National Lab on the ISS, is it not then outside of CASIS, who I understood to be responsible only for utilization of ISS US National Lab facilities? My original post pointed out that the article doesn’t say anything about any of the work included in this SAA being done in the National Lab, or on the ISS, or even in space. Perhaps it is being done, in whole or in part, in the Lab, but there is no indication of that, which I could see, in the article. My understanding was that CASIS has no responsibility for on-Earth facilities, just the US National Lab on the ISS. Is that right or wrong? Thanks,
Steve