Vincent Laufer, MD, PhD on LinkedIn: Good morning ! (2024)

With the forecast in regulatory affairs remaining tumultuous in the wake of Loper Bright and Relentless, efficient monitoring of relevant legislative, regulatory, judicial information is vital for timely allocation (or re-allocation) of institutional resources. So, I wanted to share a bevy of tools that Open Chromatin Group has been using to help read the tea leaves, as it were. All of the below enable (at minimum) keyword-based email alerts. Additional functionality varies widely among them, however. Here I try to succinctly summarize website capabilities, cost, and scope of info. provided.Governmental Websites (Free)1. Congress.gov's Bill Tracker. This free service enables basic keyword tracking limited to legislative developments.2. GovTrack.us adds tracking of general topics in addition to keywords. Again limited to federal legislative affairs. In addition, GovTrack also allows monitoring of developments in a bill's progress - amendments, voting records, etc.3. The Federal Register: Akin to a daily journal of developments in the Executive Branch. Alerts by email or an RSS feed.Tools and Newsletters from Professional Organizations4. Typically free (or free for members) these tools tend to offer targeted monitoring of regulatory affairs in their sphere. For instance, the American Association for Clinical Chemistry (AACC) may offer much more targeted than anorganizations than CAP, which may in turn be more narrow than the Regulatory Affairs Professionals Society (RAPS).Free Third-Party Tools5. Google Alerts: If tracking news articles and press releases is as useful to you as tracking legislation, then Google Alerts may be a better option, as it indexes all new-comers to the interwebs.Freemium and Premium Legal Database Licensing6. Legiscan offers a Freemium model. Basic data access and query functionality is free, while the paid tier unlocks more sophisticated features. Taking query complexity as an example, the Paid-tier enables the use of Boolean and Proximity operators. The customizable a legislative calendar is a nice touch as well.7. Finally, Premium services such as Bloomberg Law, Westlaw, and LexisNexis are a staple for legal professionals and law schools. These high-end tools are the most comprehensive, enabling more advanced tracking of all 3 branches of govn't at both federal and state levels. Combination with business and intelligence info. and AI-powered tools help facilitate advanced strategic planning.*Perhaps the most important tidbit:* All-in-all, the premium sites win out, but are pricy. If you're in an academic medical center, check if your institution provides access to employees in the medical (as well as law) school!Hope some of these are new or interesting to you, and please let me know if you don't see your favorite tools here Michael Fraser Shannon Bennett Miriam Bergeret, MSc Scott Wallask Xander van Wijk, PhD, DABCC, FADLM !

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Towards a file standard capable of incorporating epigenetic mods.But, the vcf still fails spectacularly at the n+1 problem. Much work is needed in this area to ensure sublinear scaling and population scale information storage and retrieval

Does anyone have experience creating a website front-end from a wireframe such as is produced by Axure using (enterprise-scale) AI?All my prior experience suggests to me that, in the presence of enough structured information regarding the target database, an appropriately trained enterprise-scale #transformer could be used to create a well-articulated web application.If you have direct experience doing this, please reach out to me here or at vlaufer@med.umich.edu

The following post is not legal advice, but rather is my opinion (alone) on continued discussion of the now doomed "final rule." In the weeks since Loper Bright v. Raimondo and Relentless v. Department of Commerce, I have been surprised to see regulatory professionals continue to post memoranda from #FDA regarding guidance for its "final rule"; for instance see this one: https://lnkd.in/gW86Tn_J. In this post, I will argue that no further consideration of the implementation of the final rule is warranted: **the position of the FDA in enacting the final rule is so weak as to set expectation that it will not see the light of day in any jurisdiction.**While this may seem a strong stance, the evidence for the stance is even stronger:I. Amicus briefs filed by states themselves would be heard by SCOTUS, which has already given clear indication of its stanceDespite the expedited certiorari process, both cases were supported by many more amicus briefs than are typically seen, **including multiple filings by US States**. While certain courts' views may have been harder to predict, regarding #SCOTUS itself, the final rule is very likely to be viewed by the Court as exactly the type of Chevron-era overreach that was just cast aside. In other words, a ruling to the effect that FDA cannot proceed with this rule without a legislative basis might be expected, and abundant indication of this is found in the majority opinions themselves.II. Recent Language from Congress itself in the 2025 Congressional budgetAs pointed out by Xander van Wijk, PhD, DABCC, FADLM, https://lnkd.in/gWvDBRMh, Congress itself has now specifically directed the FDA in its 2025 budget proposal to suspend efforts to implement the final rule.Paraphrasing language from the budget, Congress in effect said that there **is** a legislative basis for the regulation of LDTs, provided to FDA in 1988 (CLIA). As such, FDA *should wait for further legislative action rather than go forward trying to implement this final rule.* I think the most likely interpretation of this is one that indicates Congress fully recognizes what Loper Bright is.To close, for these reasons and others, I have arguing now for 3 weeks that continued discussion of the final rule is counter-productive.Even for those of us who have a fiduciary obligation to ensure ongoing clinical testing for our patients who need it most - no further attention need be paid to the final rule: it's doomed. Rather, reasonable efforts to lead edge of change in this area might focus instead on influencing legislation to effect any changes that we see to made to LDTs - a direction that Michael Fraser & others have already begun to write about.Welcome any/all comments!

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Haydar Celik, PhD how much spatial transcriptomics do you think we need to include to (largely) obviate staining ?

Lovely to see #ONT tech at the bedside of patients in dire need. Will stay tuned Andrew Beggs

Chen Yang - The findings in this article contains such strong support for WGS for childhood cancer. Different than from the use-case we discussed in the past, but very interesting findings - thought I would share. Enjoy!

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For unit testing LLM-powered workflows

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