All of Mats Olsen's Comments + Replies

Hi Matthew, thanks for engaging and for your thoughtful comments/questions. 

  1. In non-pandemic times, yes. Australia has less requirements for a IND-type submission (GMP certificate only needed prior to enrollment, not at submission); you only need the HREC approval (IRB equivalent) and no national regulatory approval (just a rubber stamp); and depending on the indication and competitive pressures you usually get faster enrollment. 
  2. Agreed. I was talking more about regulatory speed to get into FIH.
  3. You can still get a pre-IND meeting with US regulator
... (read more)

As an ex-Alvean and also 15-year industry veteran I can maybe weigh in, particularly because I think this ties in to what was Alvea's main value proposition: speed for pandemic response. There were some aspects that enabled Alvea to go faster than a "from-scratch", hypothetical vaccine program: Alvea based its DNA-Omicron vaccine on an existing, approved vaccine platform (ZyCoV-D), and applied to SAPHRA instead of FDA/EMA. 

But even trying to account for that, Alvea went faster than any company I'd seen that wasn't in early COVID pandemic-speed (with t... (read more)

3
Matthew Stork
5mo
Thanks for that additional context Mats. I did want to follow up on US vs ex-US P1 trials. 1. At this point, Pfizer and Moderna have consistently gotten mRNA vaccines into US trials in ~2 months after receiving a new sequence. Are the timelines to starting a trial in Australia/South Africa/elsewhere considerably shorter? 2. As a comment, big pharma does perform vaccine trials in the global South, although this is more about seasonality than speed. Pfizer performed a major P1/P2 trial for their RSV vaccine in Australia, because the timing of RSV season in Australia matched well with the development timelines for the drug. 3. One of the main arguments I see in favor of US or EU P1 trials is that the FDA/EMA are the most sophisticated regulatory agencies, and will provide more useful feedback on your development plan than other agencies. This is particularly relevant if you intend to eventually market a drug in the US, since the FDA only accepts foreign trial data if the study was conducted according to FDA requirements. Since Alvea wasn't really targeting the US market, this is less of a consideration. Still, what do you make of this argument? 4. I'd also mention that once you get to the P3/BLA stage, filling in a country with a less sophisticated regulatory agency can be a burden. My own experience is that FDA/EMA/Japan are more willing to let sponsors deviate from official guidelines if there is a good scientific justification. Meanwhile, other agencies lack the expertise to assess drugs on the merits and will fall back to saying that you must follow the guidelines. For instance, I've been in the maddening position before of having agencies in small countries repeatedly cite FDA guidance to argue that we need to make some change to our plans, despite the fact that our drug was already approved by the FDA without said change!
6
OscarD
5mo
Thanks, that was useful and interesting to read, and makes more sense now!

Just a quick update on this project (8 Oct 2023):

We decided to close the project in 2022 for two main reasons:

  1. We looked at engagement metrics and calculated how much throughput of volunteers and projects we would need to achieve a take-off trajectory on this metaproject and concluded it would take much active effort, partnerships and acceptance of the wider EA community.  Given that this was a volunteer project we thought the odds of this happening were low.  
  2. CEA also communicated with us that they were considering including something similar in
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1
Joe Rogero
6mo
I'd like to discuss a similar "metaproject" I have in the works. Currently my goal for a "minimum viable product" is just the list, with volunteer matching added later if it works, but also including smaller "quick win" projects and immediate contributions that could be made. Would you be willing to share further and discuss lessons learned on this one? 
2
pseudonym
6mo
This failure mode seemed similar in nature to this listed mistake on the CEA website. Specifically: OTOH, it may not have caused harm in this case if 1) or others were sufficient reasons to close the project without 2), or if this wasn't a project that could have been done better than CEA.

Great initiative. Whoever ends up in this role, we at impactcolabs.com would love to connect as we could both help identify potential candidates as well as help identify needs within EA orgs. We find that many EA orgs have volunteer needs that might be best served by a PA-type FTE. We will hopefully share more about these findings and the status of our 2.0 platform soon.

1[anonymous]2y
Nice initiative! Have you seen https://eawork.club? Certainly not as fancy as impactcolabs.com but seems clearer and easier to navigate to me, so potentially still a source of UX ideas.

This is a great initiative! I help run Impact CoLabs that hosts many organization and projects in need of different types of expertise, tech expertise being a very common one. If you ever have free time, please reach out at info@impactcolabs.com as we can connect you with high-impact projects in need. We welcome you (and anyone else) to also fill out a volunteer profile so organizations can find you directly as well. Thanks again for doing this with you free time!

Thank you for the feedback! You found a blindspot that most of us at Impact CoLabs and those we asked to review this post had, namely that we all had a concept in our mind for what a project platform was. I have adjusted the snapshot to hopefully aid in explaining the concept in general, but please let me know if this still doesn't address your issue.

Thank you for the kind words and the great feedback! You make a great point about 'volunteering', we will discuss that internally. I'm generally in agreement with your comments but would love to explore some of the nuance! Look forward to hearing form you, if you reach out and don't hear back, please message me here to make sure we are being responsive.

Hi Denis, thank you for your message and your offer to contribute, it is welcome. Since we are just starting out we still haven't built all the capabilities we have envisioned. For example, and as mentioned above, we were planning a list of tractable problems and project ideas to guide potential project leaders, as well as a list of past/failed projects or lessons learned from projects to ensure the community as a whole is not just spinning its wheels (e.g. this metaproject has had similar iterations in the past..). But your idea for a wiki that not onl... (read more)

2
Dawn Drescher
3y
Hi Mats! That sounds splendid! Meanwhile I’ve set up my wiki, started thinking about the structure of the template I’d like to use for the project pages, and have started reading up on your Google Docs. It’s impressive how thoroughly you’ve already evaluated your project concept! My “idea foundry” project itself will have its own page in its wiki with more information on my future plans. That’ll make it easier to reflect on whether the whole thing is sustainable. I haven’t thought about it sufficiently myself. I’ll only publish individual pages once I have proofread them for possible info hazards and have gotten feedback from some trusted friends too. Yeah, and there are also a lot of ostensibly brilliant project ideas in various lists that I think are subtly deleterious. No one has attempted to realize them yet (at least the ones I vaguely recall and to my knowledge) but a project database with just a bit more detailed thinking may help to keep it that way. (Or else may inspire someone to come up with a way to realize the project in a way that avoids the subtly deleterious bits.) Totally. It feels like so far I’ve been wholly unconvinced by some 95+% of project ideas I’ve read about, so those should not end up on your platform. It would just be valuable – or essential – to be able to promote the top of the shortlist to potential founders. I’m worried about that too. I’d be willing to risk it, pending further thinking. An alleviating factor is that the detailed reviews would be reserved for a small shortlist of projects. Most of them would just get a quick stub summary and the reason why I didn’t prioritize them. I’ve read that you’re perfectly open to (for-profit) social enterprises and of course early-stage project in need of cofounders. But I see the term “volunteer” a lot in the materials. It has these particular associations with low commitment, low responsibility, no salary, nonprofits, etc. Is it the best synonym for the job? None of the alternatives I

A group of us developed coviddash.org which was referenced in the NYTimes and had about ~30K visitors, directing between 10K-20K to vaccine trial screening websites or to the sites themselves. We had sites thank us for patients so we know we our counterfactual impact on trial enrollment was >0, but we are not sure of the total number we actually directed. If we accelerated just one vaccine for just one day though we probably helped save a few hundred lives. We were not funded by any EA org but some of us are EA-aligned.

I plan to write a more detailed... (read more)

Thanks Jan! Yes, we even reference your post in our detailed write-up and agree that vetting will be critical and a bottle-neck to maximum positive impact, particularly related to x-risk. Currently we have implemented a plan that we believe is manageable exclusively by a small group of volunteers, and have included a step in the process that involves CEA's Community Health team. Having said that, we don't think that is an ideal stopping point, we hope to expand into other forms of vetting pending general interest in the project, vetting volunteer intere... (read more)

Fantastic analysis, wish I had this prior to making my decision. Back in the day both Fidelity and Schwab had a $5K minimum and Fidelity had a $50 minimum contribution whereas Schwab had a $500 minimum, which is why I went with Fidelity. Glad to see they made these improvements.

Going off of Dan's comment, if a Fidelity (or Schwab) account is at $25K or more, would you recommend switching over to Vanguard given the better fees and investment options?

2
MichaelDickens
3y
Unless you're putting a lot of work into optimizing your DAF investments (like I describe here), Fidelity is pretty much just as good as Vanguard.