Navitas Life Sciences hosts exclusive webinars to give you the latest information about clinical trials and to provide actionable insights that improve speed to market and lower costs. Immerse yourself into the webinars and learn about successful strategies and tools that can help power efficient trials.
Insights for Faster and Smarter Drug Development Decisions: More about Navitas Life Sciences
Navitas Life Sciences is a trusted clinical research organization that supports the clinical trial needs of small, medium, and large life sciences companies globally. We deliver platform-driven end-to-end clinical trials, right from clinical trial operations medical services to regulatory, pharmacovigilance, and clinical data services.
Navitas Life Sciences have been providing CRO services in US and India for over 30 years, with 550+ clinical trials across 20+ therapeutic areas including Oncology. Our trial expertise is augmented by our proprietary OneClinical® Analytics, a platform that delivers trial oversight and key data insights.
Innovation and Optimization in Early Phase Oncology Studies: Opportunity for speed, success and savings
Dr. Atul Gupta, Vice President-Medical & Scientific Affairs, Navitas Life Sciences, and Venkatesan Balu, Associate Director – Global Data Sciences, Navitas Life Sciences, will be hosting an exclusive webinar on October 6th, 2022 (Thursday) between 10 am – 11 am EST to guide you forward about managing oncology clinical trials with innovation and optimization.
Dr. Atul Gupta is a physician with over 17 years’ experience in Clinical Research, Drug Development and clinical practice. He worked as the Global Medical Lead in more than 50 studies across diverse therapeutic areas (Oncology, neurology, infectious diseases, cardiology, vaccines, biosimilars, GI, Haematology etc), across all the phases (I-IV) for drugs, devices and combination products.
He is actively involved in multiple Data and Safety Monitoring Board (DSMBs) and Scientific Review Committees (SRCs), and have been associated with successful marketing authorization approval of breakthrough therapies including PD-1 inhibitors, V2 antagonist, multiple biosimilars, vaccines and several repurposed therapies (for MDD, narcolepsy, psoriasis).
His session during the webinar will involve insights about innovation oncology clinical trial designs. The problems that exist....
Dr. Atul Gupta
Vice President-Medical &
Navitas Life Sciences
....And the solutions that are available
Venkatesan Balu has more than 15 years of experience in the domain of Biostatistics with an exposure to Phase I to Phase IV Clinical Trials in various therapeutic areas (Oncology, Ophthalmology, Infectious disease, Respiratory, Cardiovascular, cardiology, vaccines, biosimilars, GI, etc.,) and BABE or PK studies. He has the invaluable expertise in providing inputs on study design, sample size, SAP, outlier evaluation, interim analysis, complex statistical evaluation & model selection, Regulatory requirement, and discussion etc.
He is a Technical leader in drug development strategy, adaptive design, portfolio optimization, and decision-making in clinical trials.
His session during the webinar will include key insights about statistical designs in early phase oncology study
Associate Director – Global Data Sciences,
Navitas Life Sciences
Statistical designs in Early Phase Oncology
Nonparametric and Algorithm-Based Designs to Calculate MTD
- Design without dose de-escalation
- Design with dose de-escalation
Accelerated Titration Design
- Rapid acceleration phase
- Intra-patient dose escalation phase
- Assessment of dose-toxicity relationship
Bayesian Algorithm-Based Designs
- Toxicity posterior intervals (TPI)
- Beta-binomial model (BBM)
- Isotonic Designs
Navitas Life Sciences will help streamline the information overload that exists about managing clinical trials, seiving through with clarity and objective insights to provide actionable recommendations for greater cost and time efficiency.
Join our live webinar
“Innovation and Optimization in Early Phase Oncology Studies: Opportunity for speed, success and savings”
Date: October 6th 2022 (Thursday)
Time: 10 am – 11 am EST
Get Key Insights on
- How applying innovative designs in early phase oncology trials can accelerate timelines and reduce costs
- How to focus development on the most promising agents at the right doses in the right indications for the right patients.
- Simple strategies on Dose Escalation: A legacy of statistical innovation
- Expert insights on Novel endpoints to sail through dose expansion and proof of concept