Spencer Todd

Designer drugs are constantly evolving, and in order to keep up, you need access to the most recent spectral data. The new release of #MassSpectra of Designer Drugs 2024 remains the most comprehensive MS collection for your lab. Learn more https://ow.ly/JkVB50RbeAE #forensics #wiley #gcms

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Designer drugs are constantly evolving, and in order to keep up, you need access to the most recent spectral data. The new release of #MassSpectra of Designer Drugs 2024 remains the most comprehensive MS collection for your lab. Learn more https://ow.ly/GLKt50RbeyQ #forensics #wiley #gcms

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Designer drugs are constantly evolving, and in order to keep up, you need access to the most recent spectral data. The new release of #MassSpectra of Designer Drugs 2024 remains the most comprehensive MS collection for your lab. Learn more https://ow.ly/8poW50RbeFg #forensics #wiley #gcms

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Please check out our improved regulatory science tools catalog, I promise it'll be worth it! #OSEL #CDRH #FDA #regulatoryscience #medicaldevices 

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The LDT Final Rule was viewed by many in the in vitro diagnostics space as a costly burden. Navigating FDA premarket review, oversight, and quality compliance isn't easy. But using the LDT pathway to go fast and break things, as companies like Theranos once did, is not sustainable. Particularly as IVDs advance in their complexity, personalization, novelty, and influence on critical healthcare decisions. The good news is that there are genuine market incentives for pursuing an FDA submission. The FDA can play an important role in enabling differentiation, uptake, and product-specific coverage for IVDs with superior clinical evidence. This white paper includes case studies demonstrating these market access benefits for those IVD developers that decide to proactively pursue FDA approval.

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Designer drugs are constantly evolving, and in order to keep up, you need access to the most recent spectral data. The new release of #MassSpectra of Designer Drugs 2024 remains the most comprehensive MS collection for your lab. Learn more https://ow.ly/2EGR50RbeCZ #forensics #wiley #gcms

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National Institute of Justice Grant Meeting National Safety Council Recommendations: Accurate Rapid Tests and Laboratory Confirmation Procedures for Fentanyl and Prevalent Opioids in Oral Fluid 9 Delta Analytical, LLC (‘9-Delta Analytical’) and Orfila Diagnostics Inc. dba nform (‘nform’) are proud to announce a research grant award from the National Institute of Justice (NIJ). This grant (Award # 15PNIJ-23-GG-04233-RESS) was awarded under NIJ’s FY2023 Research and Development in Forensic Science for Criminal Justice Purposes solicitation. Under this framework, a total of $434,500 in funding has been allocated to support: ·        Development of an inexpensive, visually read testing device which allows the operator to rapidly identify the presence of fentanyl and/or other opioids in oral fluid taken from the subject, and ·        Development of environmentally friendly confirmatory laboratory procedures for the remaining specimen. The development of a “Made in America” rapid oral fluid drug testing device will be carried out by nform, a subrecipient of this award. The development of environmentally friendly laboratory confirmation methods for quantitation of drugs in oral fluid using liquid chromatography with tandem mass spectral detection (LC-MS/MS) will be performed by 9-Delta Analytical, the primary recipient of this award. 9 Delta Analytical and nform view these research and development activities as one of many critical steps to help address the ongoing opioid crisis in the United States.

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National Institute of Justice Grant Meeting National Safety Council Recommendations: Accurate Rapid Tests and Laboratory Confirmation Procedures for Fentanyl and Prevalent Opioids in Oral Fluid 9 Delta Analytical, LLC (‘9-Delta Analytical’) and Orfila Diagnostics Inc. dba nform (‘nform’) are proud to announce a research grant award from the National Institute of Justice (NIJ). This grant (Award # 15PNIJ-23-GG-04233-RESS) was awarded under NIJ’s FY2023 Research and Development in Forensic Science for Criminal Justice Purposes solicitation. Under this framework, a total of $434,500 in funding has been allocated to support: ·        Development of an inexpensive, visually read testing device which allows the operator to rapidly identify the presence of fentanyl and/or other opioids in oral fluid taken from the subject, and ·        Development of environmentally friendly confirmatory laboratory procedures for the remaining specimen. The development of a “Made in America” rapid oral fluid drug testing device will be carried out by nform, a subrecipient of this award. The development of environmentally friendly laboratory confirmation methods for quantitation of drugs in oral fluid using liquid chromatography with tandem mass spectral detection (LC-MS/MS) will be performed by 9-Delta Analytical, the primary recipient of this award. 9 Delta Analytical and nform view these research and development activities as one of many critical steps to help address the ongoing opioid crisis in the United States.

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Check out Sitero's new E-Learning platform to take on demand training in a variety of Research Compliance topics. More classes are being added every week. Learn more here: https://loom.ly/kgWPnr4 #Sitero #ResearchCompliance #Bioafety #Training

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Don't Miss Out on Tomorrow's Webinar!! FDA LDT Rule: Essential Strategies for Protecting Your Lab’s Future!! "Essential Actions Every Lab Should Take Now to Calculate the Cost-Benefit of LDT Compliance," TOMORROW! September 12, 2024 - 1pm ET, a 90-minute Dark Daily Premium Webinar with Live Q&A. Our expert speakers have been carefully selected to provide you with comprehensive guidance on the FDA's LDT rule. With years of experience working directly with federal regulators, they'll help you navigate the challenges and ensure your lab's continued success: Emily Johnson, JD, Member of McDonald Hopkins provides general understanding of the FDA LDT Rule; what’s clear, where more agency guidance is needed, and ‘must do’ steps labs must take to keep their LDTs compliant. Sheila Walcoff, JD, CEO of Goldbug Strategies, provides strategic FDA regulatory and policy advice and a wealth of knowledge in the LDT regulatory environment Valerie Palmieri, CEO of MOMENTUM Consulting is a seasoned executive in scaling and transforming high-growth biotech companies and possesses deep experience and business knowledge of the clinical laboratory industry. Don't get caught off guard. Learn the steps you need to take NOW to protect your lab's LDTs, streamline compliance, and minimize costs. Register now at https://hubs.ly/Q02Pw2Px0

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A nice and useful #FridayRead: #spatialtranscriptomics by #GeoMx Digital Spatial Profiler reveals high intratumoral heterogeneity of Small Cell Lung Cancer (#sclc) as one of the major factors of poor response to #neoadjuvant chemoimmunotherapy. Available online since April 17, 2024, in the Online First Collection of Clinical Cancer Research. In the same collection you can read also an article on Facts and Hopes of #immunotherapy for this very aggressive #cancer: https://lnkd.in/dyAT22GM Both articles authored by Jon Zugazagoitia et al (people from the #spatialbiology crowd know that Jon is a pioneer of #GeoMx use...). #cancerresearch #geneexpression #lungcancer #gotoyourpathologist

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Trying to stay on top of the latest NPS recommendations for forensic toxicology testing? The The Center for Forensic Science Research & Education has you covered with their quarterly reports! Check out how Cayman Chemical's Forensic Chemistry Division assists by providing the standards that you need for Tier 1-3 recommendations. https://lnkd.in/ev_FKwi2

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Fayetteville Secures $30 Million to Address PFAS Contamination; Support Needed for Bioremediation Solutions The Fayetteville Public Works Commission (PWC) has secured $30 million in state and federal funding to address PFAS contamination in the city's water supply. This funding is in addition to more than $60 million already secured for the development of an $80 million Granulated Activated Carbon (GAC) facility, which is expected to be completed in 2028. This facility will significantly increase Fayetteville's ability to filter PFAS from its drinking water. In addition, PWC was awarded $1 million for its Operation Clean & Clear program to inventory water service lines to comply with recent updates to the U.S. Environmental Protection Agency's Lead & Copper Rule. Meanwhile, PWC is upgrading its P.O. Hoffer Water Treatment Plant to expand its powdered activated carbon (PAC) filtration system. This temporary solution will help reduce PFAS levels in drinking water until the GAC system is operational, which is expected to be completed by 2026. https://lnkd.in/dSqxBfPm While this funding is commendable, it is critical to also support innovative #PFAS bioremediation projects. Activated carbon absorption, while effective, is costly and requires a combustion process that is both #energy intensive and a significant source of #CO2 emissions. Therefore, I urge consideration of #bioremediation initiatives such as ASPIDIA that offer sustainable and cost-effective alternatives for PFAS remediation.

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The talented group of scientists from Mercer University and Centers for Disease Control and Prevention, Atlanta, GA, used our microneedle array devices to perform the delivery of Adjuvanted Microparticulate HPV16 Vaccines and summarized their results in the following publication: Vo, Trinh Phuong, Gitika Panicker, Kimberly Braz-Gomes, Ashwin C. Parenky, Ira Rajbhandari, Mangalathu S. Rajeevan, Elizabeth R. Unger, Martin J. D’Souza, and Mohammad N. Uddin. 2022. "Enhanced Immunogenicity of Adjuvanted Microparticulate HPV16 Vaccines Administered via the Transdermal Route" Pharmaceuticals 15, no. 9: 1128. Based on the results of the study, the quantitative benefits of using AdminPatch microneedle array devices are: • Enhanced Immunogenicity: The AdminPatch microneedle array devices were used to deliver an HPV16 vaccine, which demonstrated enhanced immunogenicity in preclinical models. The microneedle delivery of the vaccine elicited robust immune responses, which were significantly higher than those observed with intramuscular injection. • High Encapsulation Efficiency: For the microparticulate (MP) vaccine formulation, the encapsulation yield was notably high at 80.5 ± 0.85%, indicating efficient incorporation of the HPV16 antigen into the microparticles, essential for maintaining the vaccine's integrity and immunogenicity. • Significant Immune Activation: The microparticulate vaccines, when administered intradermally using AdminPatch, showed a substantial expansion of crucial immune cell populations. Specifically, there was a significant increase in CD4+, CD45R, CD27, and CD62L cell populations in vaccinated mice, demonstrating the vaccine's effectiveness in activating both innate and adaptive immune responses. • Robust Antibody Production: The study reported a marked elevation in HPV16-specific IgG antibodies in the group receiving the microparticulate vaccine compared to those administered antigen solutions, highlighting the enhanced immunogenicity offered by the microparticulate form and the AdminPatch delivery system. • Effective Memory B-Cell Generation: In the lymph nodes, memory B-cell counts were significantly higher in the microparticulate vaccine groups, with 27.2% and 25.5% for different formulations, compared to only 7.7% in the positive control group, indicating a strong, sustained immunological memory response. • Enhanced Seropositivity with Optimized Formulation: Adjustments in the vaccine formulation, including changes in polymer matrix concentrations and adjuvant types, led to increased seropositivity. Specifically, using a prime dose of 20 µg HPV16 VLPs/mouse, which is two times greater than the initial formulation, enhanced the immune response, indicating the system's adaptability for improved outcomes. These points underscore the AdminPatch microneedle array devices' effectiveness in delivering microparticulate vaccines, enhancing immunogenic responses, and offering a promising strategy for improved HPV vaccination protocols.

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I was pleased to be asked to contribute to an article about the new FDA LDT rule in Diagnostics World, and want to share a link: https://lnkd.in/e4b-trJ9 Please reach out if you have any questions! #FDA #LDT #LDTs #Diagnostics MCRA

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Is Formaldehyde the Missing Link in AD Pathology? The Differential Aggregation of Amyloid-Beta with APOE Isoforms In Vitro https://lnkd.in/e66ducjd

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This past weekend I was involved in a vigorous discussion about "what is full-length in single-cell RNA-Seq" on this platform. It started with a user posting public data analysis pointing out the PacBio Kinnex single-cell RNA kit might be selectively biasing towards smaller cDNA and therefore, not really sequencing the "full-length" cDNA in single-cell RNA-Seq. After much back and forth, the user thoughtfully revised the two-part series and re-posted them. The comments were therefore lost, but I thought I want to re-write them here about my 2c on "full-length" definition. IMHO "full-length" is always going to be a debatable term in cDNA synthesis. Years ago, I defined for PacBio Iso-Seq that the bioinformatic definition is "seeing the 5' and 3' cDNA primer on the two ends of a single read". That is what the `lima` tool does for Iso-Seq data, identifying and trimming away such reads, and we call those reads "full-length (FL) reads" while the expanded definition in the report is "reads with 5' and 3' primer detected". Whether a bioinformatic FL read represents the biological 5' and 3' end of an mRNA is going to depend on factors like RT processivity, secondary structures, priming artifacts, etc. With bulk transcriptome, we optimized the cDNA synthesis (Iso-Seq express 2.0 kit) to work with an 8-fold concatenation (Kinnex full-length RNA kit) to achieve best yield with an average cDNA length of ~2kb. For 10x cDNA on Kinnex single-cell RNA kit, we typically see a cDNA size of 600-800bp. I was the product manager for the original MAS-Seq and now Kinnex single-cell RNA kit. The choice to use a 16-fold concatenation for 10x single-cell cDNA (though it is now also compatible with other single cell platforms) was based on observation that we did not see an improvement in cDNA length distribution with lower concatenation factors. There is a balance between the concatenation factor, cDNA size, and concatenated product length. If there are longer single-cell cDNA distributions due to higher quality samples or better single-cell runs, lowering the concatenation factor might benefit the captured transcript lengths. While named after its target and (importantly) supported applications, the three Kinnex kits (https://pacb.com/kinnex) were meant serve as general kits for 8-fold, 12-fold, and 16-fold concatenation. Theoretically there are ways to modify your amplicons to become compatible with Kinnex, and if you're interested, do reach out to me! Finally I think it is rare that a user posts on social media a thought piece but revises their writing after taking in discussion. (it's almost like LinkedIn can serve as peer review!?) so thanks a lot Simone Picelli :) The revised two-part series is here: (part 1) https://lnkd.in/gDTXghBZ (part 2) https://lnkd.in/gTZqfhPG

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Struggling with understanding the FDA's calibration standards? If the thought of receiving a 483, Warning Letter, or Consent Decree has ever troubled you, know that you're in good company. Navigating compliance can seem like an overwhelming task, but it doesn't have to be. Tune in with Matt Thompson, Sr. Director of Pharma Services, for the accessible webinar titled "FDA Findings – Requirements for Calibration." Uncover valuable insights into FDA guidelines, examples of where others have gone wrong with compliance, and practical tips to enhance your operational procedures. Don't gamble with your compliance efforts—arm yourself with the essential knowledge to safeguard your enterprise. Access the Webinar Here 👉 https://gag.gl/QDecmC #FDA #Compliance #Calibration #Pharma #Webinar #metrology

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