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Track 2 Session 1: Innovative Clinical Perspectives
Session Chair(s)
Sachin Mangalvedhekar
VP GCP and PV Quality
Glenmark Pharmaceuticals, India
Technological advances enable faster access to innovative and transformative medicines. This session will touch upon several innovative approaches, namely: Adaptive Design and Platform Clinical Trials, Perspectives for Conducting PK Studies for Novel Delivery Systems and Regulatory Challenges for Novel Delivery Systems and Adaptive Clinical Trials Adaptive Design allows modifications to the trial procedures based on interim data analysis. These modifications can be made without undermining the trial's integrity or validity. The key feature of adaptive design includes flexibility, efficiency, and ethical approach. Platform Clinical Trials are a type of adaptive trial that test multiple interventions within a single, overarching trial infrastructure. The key features are multiple interventions, shared control group, seamless transition, and ongoing data analysis. As there is increasing interest in accelerating the drug development and innovations in clinical trials the adaptive design and platform clinical trials have emerged and they are gaining traction in recent years. The integration of novel delivery systems with PK studies is pivotal in advancing drug development, ensuring that new therapeutic approaches are both effective and safe. This synergy aims to enhance patient outcomes and foster innovation in the pharmaceutical industry.
Speaker(s)
Innovation in Clinical Research: Adaptive Design and Platform Clinical Trials
Sachin Patil
Expecto Health Science Private Limited, India
Director and Head Project Management
Novel Delivery Systems: Perspectives for Conducting PK Studies
Kiran Marthak
Veeda Clinical Research Limited, India
Director, Medical Affairs, Phase 1 and Regulatory Affairs
Regulatory Challenges for Novel Delivery Systems and Adaptive Clinical Trials
Maharukh Rustomjee
Amaterasu Lifesciences LLP, India
Managing Partner
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