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Enhancing Data Quality: Instream Data Cleaning
Join our Director of Clinical Operations, Marwa Noaman, and our Chief Medical Officer, Vijay Reddy, M.D., Ph.D, as they explore the game-changing practice of instream data cleaning. Noaman, a seasoned industry professional, emphasizes real-time data cleaning’s impact on crucial milestones, while Dr. Reddy highlights its…
Reaching Your Milestones: D2V Clinical’s 2024 Mission
DURHAM, NC – As 2024 begins, D2V Clinical stands firmly committed to our core ethos: ‘Your Milestone. Our Mission.’ This guiding principle is the driving force behind our strategic expansions and enhancements in key areas. We’re broadening our therapeutic focus to encompass diverse medical fields,…
Connect with D2V Clinical at ASH 2023
Connect with D2V Clinical at ASH 2023 Stop by booth #3446 at ASH 2023 to meet the D2V Clinical team and discover how we can help you achieve milestones in your early-phase hematology program. Backed by leadership with 20+ years of drug development and senior FDA review experience, our agile approach eliminates surprise…
Project Optimus: Challenge vs. Opportunity
Join our Chief Medical Officer, Vijay Reddy, M.D., Ph.D., as he shares a perspective on Project Optimus, an FDA initiative revolutionizing oncology treatment development. Explore the shift from “more is better” dosing to optimized doses, maximizing efficacy, safety, and tolerability through pharmacokinetic and…
Unlocking Insights: Strategic Positioning of the PK Package
Join D2V Clinical’s Chief Development Officer, Jill Loftiss MHS, as she shares valuable insights on strategically positioning PK packages within NDAs. With 22+ years of drug development experience, Jill provides expert guidance on leveraging the timing of your PK package to enhance the likelihood of successful…
Modern Therapies: Inside Early-Phase ADC Development
Join our Chief Medical Officer, Vijay Reddy, M.D., Ph.D, as he explores the vital role of early-phase design in antibody drug conjugates (ADC) development. With a wealth of experience in drug development, Dr. Reddy’s career in ADCs began during his Ph.D. research, where he pioneered monoclonal antibodies targeting…
D2V Clinical: Raising the Bar for Early-Phase Oncology
DURHAM, NC – Dose2Value Clinical (D2V Clinical) is a full-service global CRO addressing the challenges of early-phase oncology studies faced by biotech companies. Founded by seasoned veterans from the industry and the FDA, D2V Clinical focuses on asset value creation for sponsors. The company offers vast knowledge and…
Insights from a Former FDA Reviewer on the Latest FDA Draft Guidance Regarding Dosage Optimization in Oncologic Clinical Development
Insights from a Former FDA Reviewer on the Latest FDA Draft Guidance Regarding Dosage Optimization in Oncologic Clinical Development DURHAM, N.C. (May 16, 2023) – The U.S. Food and Drug Administration (FDA) and the National Cancer Institute collaborate on the Oncology Center of Excellence (OCE) Project Optimus, which aims…