Planning a successful Phase I hybrid trial requires aligning the right therapeutic area, the right molecule, the right study design and endpoints, as well as considering regulatory requirements.
TORONTO (PRWEB) March 13, 2020
Join Paul Rothenberg, MD, PhD, Executive Director, Product Development Strategy, Covance Inc. and Amitava Ganguli, BSc (Hons/Pharm), MBChB, MRCP (Edin), Senior Medical Director, Medical & Scientific Affairs, Clinical Pharmacology Services, Covance Inc. in a live webinar on Thursday, March 19, 2020 at 1pm EST.
For novel drugs, demonstrating clinical “proof-of-concept” (POC) is a critical milestone on the road to success. Preparing a comprehensive development plan (CDP) – one that integrates early clinical trial designs and program strategy with other key disciplines (e.g., pre-clinical, regulatory, CMC, commercial) – can shorten overall timelines, reduce costs and increase success rates. Creating a thoughtful CDP that includes Phase I hybrid trials (with enrolment of healthy subjects and patients with the target disease) can help attain the earliest possible clinical POC. Planning a successful Phase I hybrid trial requires aligning the right therapeutic area, the right molecule, the right study design and endpoints, as well as considering regulatory requirements.
This free webinar explains what a CDP is and how pharmaceutical companies create and use CDPs, focusing on the central role of clinical pharmacologists in devising efficient drug development programs. We will explain what Phase I hybrid trials look like and how they provide an important advantage in early drug development.
For more information or to register for this event, visit Optimizing the Success of Phase I Hybrid Trials: The Role of a Comprehensive Early Development Plan.
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