Karen Knudsen MBA PhD’s Post

Curious about how the legislative process works? #Becker’s LaToya Sheals, JD, MPA is teaming up with State Representative Michele Rayner for a pre-session legislative workshop tomorrow in Tampa! LaToya will break down the steps—from drafting and passing legislation to bringing state funds to our community through appropriation projects. Don’t miss out! Secure your spot by clicking the link below. #LegislativeSession #FloridaPolitics #LegislativeWorkshop.

Consequences for not following natural law come in many shapes and forms https://lnkd.in/gpt-dHrv

The World In Brief digest of The Economist on 6 May gives prominence to the intellectual property challenges of BioNTech, most famous for developing one of the world’s first Covid vaccines in partnership with Pfizer. The two companies are being sued in a Delaware federal court by GlaxoSmithKline (GSK), which claims that in producing the vaccine they violated GSK’s patent rights. Moderna, another vaccine developer, has made similar claims in a trial that began in London in April. BioNTech and Pfizer deny all the claims but the court cases are likely to be long and costly for all concerned. These are particularly high profile and complex examples of a vital consideration for IP-rich companies not only in biotech but across all technology sectors: the need to understand and document the prior art landscape within which they are innovating, to ward off future claims of infringement and to establish Freedom to Operate (FtO) across key global markets. TTN’s subject matter experts, many of them former patent examiners, are well qualified to help businesses deal with the challenges of this requirement and to help them ensure that where possible their innovation and R&D is directed into “white space” areas that have relatively little patent coverage. #intellectualproperty #intellectualpropertyrights #ip #patent #patents #innovation #invention #trustedtechnologynetwork #ttn #ipbackedfinance Source: https://lnkd.in/dVaNYawR

New menopause drug:- 5.3 Preclinical safety data Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Repeated dose toxicity Repeated administration of fezolinetant to rats and monkeys showed the effects consistent with the primary pharmacological action (oestrous cycle disruptions, the lack of ovarian activity, decreased uterine and/or ovarian weight, uterine atrophy). These effects were observed at high exposure levels (> 10-fold of the anticipated clinical exposure at the human therapeutic dose of 45 mg). Furthermore, in rats, secondary effects were seen on the liver and thyroid which are considered to be an adaptive response to the enzyme induction and in the absence of functional impairment and accompanying necrotic changes were considered non-adverse. The finding of thyroid follicular cell hyperplasia is considered secondary to the liver enzyme induction due to the increased thyroid hormone metabolism, resulting in the positive feedback to the pituitary for the stimulation of thyroid stimulating hormone production and increased thyroid activity. It is generally accepted that rodents are more sensitive to this type of liver-mediated thyroid toxicity than humans, thus these findings are not expected to be clinically relevant. In monkeys, thrombocytopenia, sometimes associated with haemorrhagic episodes and regenerative anaemia, was seen following repeated administration at high dose levels (> 60-fold of human exposure at the human therapeutic dose). Genotoxicity Fezolinetant and its major metabolite ES259564 showed no genotoxic potential in the in vitro bacterial reverse mutation test, in vitro chromosomal aberration test, and in vivo micronucleus test. Carcinogenicity An increase in the incidence of thyroid follicular cell adenoma was noted in a 2-year rat carcinogenicity study (186-fold of human exposure at the human therapeutic dose). The increase is considered to be a rat specific effect secondary to the induction of hepatocyte metabolic enzymes and does not constitute a clinical carcinogenic risk. Additionally, increased incidence of thymomas, which slightly exceeded the historical control range, was observed in both species. However, these findings were only noted at exposure levels significantly in excess (> 50-fold) of the clinical exposure at the human therapeutic dose, and therefore are not expected to be relevant to humans. 😔 Veoza, INN-fezolinetant European Union https://ec.europa.eu › health › anx_160974_en PDF Breast-feeding Veoza is not indicated during lactation. It is unknown whether fezolinetant and its metabolites are excreted in human milk.

Melanoma: Through Thick and Thin (thelinkbetween.ca)

Questions on the Corporate Transparency Act⁉ 💡 Here is your chance to Ask The Experts as they provide an overview of what’s required, next steps to take, and answer pre-submitted questions during our webinar on May 7th. Register here and submit your questions: https://lnkd.in/gpXtGuAa Powered by WealthManagement.com and Trusts & Estates, in partnership with the American Cancer Society

Sharing Mike Borella's important deep dive into the shallow end (ouch!) of the examination pool, where allowance rates languish in the single digits. "But the elephant in the room is why the USPTO allows LAREs [Low Allowance Rate Examiners] to continue as examiners for years or decades. The USPTO appears to have very little oversight of examiners, especially senior examiners. If the USPTO is unable or unwilling to provide this oversight and to at least explain why so many LAREs and other examiners with low allowance rates exist, an independent oversight board should be established to conduct such a study and provide recommendations to the Department of Commerce." Such a study is long overdue! A 2021 Department of Commerce OIG report determined that "the USPTO does not have a reliable means of measuring or controlling examiner consistency." https://lnkd.in/gF6xiXDZ In 2015, Kate Gaudry proposed that the USPTO identify and monitor outlier examination statistics. https://lnkd.in/g4kD4p3t And in 1996, I recall my mentor Robert Budens prided himself on his super low allowance rate - about ten applications allowed over the prior three years. I remember he had poster of the USPTO's official seal tacked to the back of his office door. With a black sharpie marker, Robert had crossed out the term "patent" and written over it "rejection" so that the seal read "US Rejection Office." USPTO management must have valued Budens' mindset, as he was promoted to GS-15 expert level position in about 1996 and given control over the HIV/AIDS docket to reject. Note claims to treat HIV/AIDS, a disease deemed untreatable by the USPTO, were specifically listed in the SAWS memo and flagged for further delay, denial and extra scrutiny. Examiners must have supported Robert's mindset, too, as he was repeatedly elected President of POPA and up til ~2014, worked closely with management to craft performance plans, employee policies and labor practices that continue to shelter patent examiners with super-low allowance rates. https://lnkd.in/gdMXQy9W

Enjoyed my conversation with Nyah Phengsitthy from Bloomberg Law regarding general 340B issues and the 340B request for information issued by Senators Thune, Stabenow, Capito, Baldwin, Moran and Cardin. It's an interesting read and a nice overview of the issues at hand. Check in out here if you're interested: https://lnkd.in/gqRR-den

🎙️ Tune in to our latest LegalCast episode for a comprehensive update on the Camp Lejeune litigation! Attorney Nevin Wisnoski of Napoli Shkolnik joins host Mark York to discuss key legal issues, recent court decisions, and challenges faced by plaintiffs and attorneys. Learn about the denial of jury trials, settlement options, and ongoing efforts to expedite case resolution. Don't miss this insightful discussion on one of the most significant environmental mass tort cases in history! #LegalCast #CampLejeune #LitigationUpdate 🏛️✨ https://lnkd.in/g3pZv7vy

Navigating the Complexities of 280E, 471(c), CHAMP, and Strategies for Psilocybin Service Center's In this enlightening conversation, Justin Botillier, CEO of Calyx CPA in Medford, Oregon, alongside Michael Brooks, who is venturing into Oregon's burgeoning psilocybin industry, delve deep into some of the most pressing questions faced by psilocybin service centers today. https://vist.ly/wet7