Expediting Biologics Drug Development: Strategies to Accelerate Preclinical Development Timelines

Register Free: https://www.biopharminternational.com/bp_w/strategies

Event Overview:

Sponsors developing innovative biologic therapies face key challenges to bring their compound to the clinic quickly. An investigational new drug (IND) submission is a key milestone for every drug development program. This webinar will discuss the best practices to expedite biologics drug candidates quickly from discovery to IND submission including safety assessment and chemistry, manufacturing, and controls (CMC) programs with real-world case studies, including how the CMC development timelines were adapted to expedite COVID-19 therapeutics into clinical trials.

Key Learning Objectives:

• Key considerations for developing and manufacturing of biologics drug
• Comprehensive preclinical strategies to improve drug development outcomes
• Innovative solutions and risk-based approach to expedite IND submissions, especially for pandemic response initiatives
• Strategies to save significant time and money to help meet IND submission and early-phase clinical trial goals and milestones

Speakers:

Xuejun (Sherry) Gu, PhD, Vice President, CMC Management (US), WuXi Biologics

Jing Shi, PhD, Executive Director and Global Head of Large Molecule Bioanalytical Services, WuXi AppTec Laboratory Testing Division

Time and Date: Thursday, December 3, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET

On Demand Until Dec. 3 2021

Register Free: https://www.biopharminternational.com/bp_w/strategies