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Procopio Webinar: Sciences Patent Enabled?

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U.S. Supreme Court Will Decide This Year In this year’s foray into patent law, the Supreme Court will decide whether Amgen’s patent that claims antibodies by functional antigen binding and does not disclose the full range of antibody sequences is invalid for not meeting the enablement requirements of Section 112(b). Join us for this webinar..

Conversation with Thought Leaders – Accelerate with Agile in Life Science

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  Many think you can’t use Agile in Life Sciences due to regulatory requirements. We’ll discuss ways that you can, even beyond software development. While waterfall methods assume you know the steps leading to your end-product, Agile methodologies work well when you have evolving requirements at the outset. The iterative process allows you to obtain..

CCC – Best Practices When Using XML Articles in AI, Machine Learning, and Text Mining Projects

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  Drawing insights from massive sets of data with AI can increase productivity, efficiency, and production, while reducing costs. That’s why most digitally forward-thinking companies increasingly incorporate artificial intelligence, machine learning and data analytics into their processes across the R&D pipeline. To get the most ROI from these AI investments, end users – data scientists,..

PBSS – INQOVI by Astex – Otsuka for the treatment of myelodysplastic syndromes (MDS)

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Decitabine is a hypomethylating agent (HMA) and was approved by FDA for treatment of intermediate/high-risk MDS for IV infusion in 2006. Oral administration of decitabine, or other HMAs as single agent, has proven challenging as high first-pass due to metabolic degradation by cytidine deaminase (CDA) results in low bioavailability. Cedazuridine, a synthetic analog of tetradrouridine,..

PMI Live – VACCINE CLINICAL TRIALS WITH RNA: SEQ ENDPOINTS TO MEASURE GENE EXPRESSION – LESSONS LEARNED

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RNA-Sequencing (RNA-Seq) is a revolutionary technology that enables researchers to assess gene expression changes in thousands of genes over time. Results provide deep insights into mechanistic processes such which innate and adaptive immune system processes are activated following vaccination and when. However, the analysis of this data is not trivial requiring special statistical and computational..

Public Health & Its Access to Historically Excluded Communities, Pt. 4 Actualizing Change

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In jurisdictions as large and diverse as California, the understanding of health equity and how to apply best practices could not be more pressing. Improving and assuring racial equity above racial equality has been shown to reduce inequity in healthcare outcomes through community-level investment, equitable leadership development, and most importantly increased access to timely and..

$1000

Success Stories and Lessons Learned from Recent FDA Approvals: VOXZOGO (vosoritide)

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By BioMarin Pharmaceutical Inc. VOXZOGO is a recombinant C-type natriuretic peptide (CNP) analog that has been modified to resist neutral endopeptidase degradation and enhance half-life. In 2021, VOXZOGO was approved for treatment of patients 2 years of age and older with Achondroplasia and open growth plates in the EU and under accelerated approval by US..

Optimize Your Value Story Through Integrated Evidence Generation – From Bench to Patient

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Location: Live / Online 8 AM PST / 11:00 AM EDT (North America) Innovative new treatments with the potential to improve patients’ lives face unprecedented obstacles, including greater complexity and cost, more stringent evidence requirements to secure patient access beyond regulatory approval, a greater diversity of stakeholders and decision-makers, and competition for share of voice...

Patient Engagement in the Digital Age: Leveraging Technology to Improve Communication Between Patients and Stakeholders

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Location: Live / Online 8am PST (N. America) / 11am EDT (N. America) / 4pm BST (UK) / 5pm CEST (EU-Central) Shifting expectations in the healthcare industry have put a considerable focus on scientific innovations driven by the end user. This new structure, combined with ongoing commitments to maintain scientific integrity, has created a new..