Sheri Smith

What kinds of study changes and amendments need @IRB review? Check out Advarra's most recent #blog to get a refresher on the basics of what to send for review by the IRB.

19

A single day lost in development could make or break your chance at market leadership. Don't let slow methodologies delay your market entry. Download our expert whitepaper to avoid costly delays. #drugdevelopment #needforspeed #marketfirst #cuttingedge #massspec

7

🧠Learn How ISS Nexus Helps You Harness Real-Time Data for Clinical Trial Success💡

7

🧬 Join the American Pharmacogenomics Association for a FREE online event to discuss hot topics in PGx. ☕️ Here's what you can expect: ✅ Discuss the latest PGx developments ✅ Explore the impact of new legislation ✅ Ask your burning questions Date: Thursday, May 16th Time: 7:30 AM - 8:30 AM PST 🔷 Reserve Your Spot and Register here! https://lnkd.in/g9AVfw_w #pharmacogenomics #genetics #personalizedmedicine #coffee #webinar

10

Last chance to register for tomorrow's upcoming RRD webinar, "Quality Systems Approach for Early-Stage Biopharma Companies," presented by Nnamdi Nwachukwu. Learn best practices for getting to your first in-human trial, and ask your Quality questions at the Q&A. July 18th at 1:00 pm ET. Register here: https://lnkd.in/gKfnHiH9 WEBINAR OVERVIEW The probability of success for a clinical trial can be greatly increased with proactive planning concerning the systems and logistics that will be used the house the clinical data. Proactive planning around systems and regulatory compliance can reduce risk and avoid unnecessary setbacks and missed milestones. Quality by design planning directly relates to the clinical and financial performance of clinical stage biotech companies. TOPICS TO BE COVERED: Clinical Trials Chemistry, Manufacturing & Controls Information Systems & Validation Document & Quality Management Systems Knowledge Management & Training Auditing & Compliance #biopharma #drugdevelopment #qualitysystems #qualitymanagement #thisisrrd

6

New Series Alert! Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, leads a panel discussion about CDK4/6 inhibitor use in high-risk early breast cancer with experts Naomi Dempsey, MD; Joyce O'Shaughnessy, MD; and Hope S. Rugo, MD, FASCO. Tune in to learn about trial updates, best practices in managing toxicity profiles, and financial challenges to navigate while optimizing patient outcomes. Watch here: https://bit.ly/4eGWTru #BreastCancer #ManagedCare

3

We want to call your attention to a timely new series on AJMC® Peer Exchange® peer-to-peer panel discussions featuring authoritative insights, opinions, and perspectives on important issues facing today’s managed care professionals. Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, leads an expert panel discussion on the use of CDK4/6 inhibitors in high-risk early breast cancer. With insights from renowned experts Naomi Dempsey, MD; Joyce O'Shaughnessy, MD; and Hope S. Rugo, MD, FASCO, this series covers crucial updates, best practices in managing toxicity profiles, and navigating financial challenges to optimize patient outcomes. Don't miss out on this opportunity to learn about: - Factors influencing decisions to prescribe CDK4/6 inhibitors - Analysis of the monarchE and NATALEE trial results - Sequencing considerations with CDK4/6 inhibitors - Differences in toxicity profiles between abemaciclib and ribociclib - The impact of different endocrine therapies on toxicities Watch the series here: https://bit.ly/4eGWTru #BreastCancer #ManagedCare #CDK46Inhibitors #Oncology #PatientCare #MedicalUpdates

2

Happening at 12PM - Abstract Number 960! Don't miss insights from our cell and gene therapy scientist, Katie Knapp! 🧬 Learn about GMP Testing Potential for Replication Competent Adeno-Associated Virus Across Multiple Serotypes! Meet our team at ASGCT booth #2253 this week! #eurofins #testingforlife #vectorology #virology

51

2 Comments

Join us for a free webinar, part of our Background Screening 101 series! Demystifying Drug Screening Wednesday, June 12 at 11am PT Register here: https://lnkd.in/gJUgdgXw Join us for an essential overview of what you need to know when it comes to drug screening: ➡️ What is drug screening? ➡️ Why is drug screening done? ➡️ What kind of drug, clinical or medical tests can be done? ➡️ Which industries or job profiles need drug screening? ➡️ How much does it cost?  ➡️ ... and more!! Let's clear up the confusion and make drug testing less overwhelming.  Sign up here: https://lnkd.in/gJUgdgXw Navin Chugh #hr #backgroundscreening #backgroundcheck #drugtesting #drugscreening

6

Mythic Therapeutics, Inc. announced promising initial results from the Phase 1 KisMET-01 study of MYTX-011, a novel cMET-targeting ADC, in treating advanced or metastatic non-small cell lung cancer (NSCLC). The study, presented at the ASCO Annual Meeting, showed MYTX-011 was well-tolerated with no dose-limiting toxicity and demonstrated nearly dose-proportional pharmacokinetics. The study continues to assess safety, tolerability, and preliminary anti-tumor activity, with further efficacy data to be presented in the future. The findings offer hope for patients with diverse cMET expression levels. #HemiBio Brian Fiske https://lnkd.in/epvx2gPC

3

Oncology clinical research sites often encounter intricate challenges in budgeting for complex trials. Join us to review common billable items often overlooked in budgeting processes through the SCRS Site Invoiceables Toolkit. Gain practical knowledge to empower your site to navigate budget negotiations. Register here ⇢ https://lnkd.in/d-reDKKD

4

📊 According to the latest 2024 CRA Impact Report, CRAs are reallocating an average of 8.35 hours per week thanks to Site Enablement Platforms! Curious to see how you can do the same? Download the Report: https://bit.ly/3xo59LY

6

Industry leaders, the FDA has released a guidance draft document on data integrity for in-vivo bioavailability and bioequivalence studies. This document is now open for comments. Data integrity is a critical component to ensure the accuracy of data submitted for INDA and NDA's, and the FDA guidelines on this are very welcoming. Certain data handling practices in CROs have always been questioned by authorities, making this guidance document a crucial step in ensuring the integrity of data in the industry. Share your thoughts and comments on this important topic. QvalFocus #IndustryLeaders #DataIntegrity #Bioavailability #Bioequivalence #FDA #CROs Follow us at #QvalFocus for current trends and jobs in the industry.

17

The Elevate Compliance Podcast is here! Listen and watch the interview with Amie Granger, RDH of POM Medical here! https://lnkd.in/ggaT7kUV

1

Have you checked out our Regulatory Affairs Resource Library? If you're pursuing #FDA drug development pathways, these resources provide insight into the various programs and designations to help you identify applicable, advantageous regulatory tracks. https://ow.ly/AzWw50RmznJ

25

In the fourth edition of our neurosciences blog series, Parexel expert and former regulator, Simona Stankeviciute, M.D., shares valuable insights on several best practices and creative approaches to assist biotech companies in developing effective trial design strategies and planning for successful regulatory submissions. Read the full article here: https://lnkd.in/gBnixZw2 #Alzheimers #Regulatory #ParexelBiotech

19

1 Comment