Expediting the Delivery of Your Innovative Biologics to the Clinic and Beyond

Learn about the latest strategies and cost-effective innovative technologies that can help reduce your time to clinic, streamlining CMC development while maintaining product quality and regulatory acceptance. This webinar highlights lessons learned from multiple case studies that pertain to navigation of the record-breaking DNA to IND timelines established during COVID-19 mAb development that can be applied today to all biologics development programs.

Register Free: https://www.biopharminternational.com/bp_w/innovative-biologics

Event Overview:

Speed is one of the major factors to ensure success throughout the CMC development and manufacturing of biological products whether moving from gene synthesis to IND submission, or through late-stage development towards a BLA filing. The acceleration of preclinical activities into first-in-human clinical trials has never been as important as it is now, in a post-COVID-19 era, for companies to beat their competition and meet market demands.

Biologics development efforts during the COVID-19 pandemic propelled neutralizing COVID-19 monoclonal antibodies (mAbs) into the clinic at an unprecedented speed, while demonstrating and maintaining product quality and consistency. Innovative acceleration strategies used during the development of these COVID-19 programs can now be broadly considered and holistically applied to biologics development across all disease areas to further shorten CMC timelines.

Notably, during the pandemic, WuXi Biologics shortened the traditional 12–18-month biologics development timeline from DNA to IND to a remarkable 3-6 months, and also enabled a neutralization mAb to go from DNA to Emergency Use Authorization (EUA) in just 14 months. To date, WuXi Biologics has supported over 40 COVID-19 projects, including 6 approved products (globally) for commercial use.

Based on the vast experience derived from the aforementioned COVID-19 programs in addition to enabling over 480 IND approvals and 30 successful BLA/MAA or EUAs across multiple countries, Dr Sherry Gu will share the collective insights and perspectives from WuXi Biologics for how companies can accelerate CMC development timelines. This webinar will review the strategies and innovative technologies spanning cell line development, analytical and biosafety testing, process development and clinical manufacturing, including key regulatory considerations. These insights demonstrate the ability to expedite timelines, as made possible by WuXi Biologics, that ensure success for clients.

Key Learning Objectives:

• Strategies for expediting biologics into the clinic from initiation of cell line development to IND filing.
• Recommendations to accelerate development, and lessons learned from COVID-19 programs that can be holistically applied in standard programs to maintain product quality and regulatory acceptance.
• Innovative technologies and platforms that support and enable the acceleration of CMC development timelines.

Who Should Attend:

• Researchers, development scientists and engineers seeking advanced strategies and methodologies for early-stage biologics development.
• Director-to-VP level biotech and pharma managers and executives exploring ways to expedite development and obtain a competitive advantage by accelerating entry into clinic trials.
• Biologics developers looking for new ways to speed development while maintaining product quality and ensuring regulatory acceptance.

Speaker:

Sherry Gu, PhD
Executive Vice President and Chief Technology Officer
WuXi Biologics

With over 27 years of biopharmaceutical industry experience, WuXi Biologics’ Executive Vice President and Chief Technology Officer, Dr. Sherry Gu has established extensive expertise in cell line, upstream and downstream development and portfolio management while in her various roles at WuXi Biologics and in her well-established career in the biopharmaceutical industry.

Dr. Sherry Gu joined WuXi Biologics in 2017 and built a strong CMC team in the US and EU. She was instrumental in establishing WuXi Biologics’ global footprint and business growth by leveraging the company’s strong technical capabilities, robust global capacity, and service flexibility. Dr Sherry Gu received her PhD in Biochemical Engineering from Massachusetts Institute of Technology. She worked for 2 years at Bristol Myers Squibb and 18 years at Eli Lilly and Company. During her time at Lilly, she made significant technical contributions, including establishing the mammalian cell culture platform that enabled multiple Lilly bioproduct approvals, including Dulaglutide, Ixekizummab, and upcoming Galcanezumab. She also held several significant leadership roles, including Director of Cell Line and Upstream Development, Director of Downstream Development, Program Team Leader, and AutoImmune Portfolio Leader, which helped her gain a deep understanding of drug development throughout the product lifecycle.

Register Free: https://www.biopharminternational.com/bp_w/innovative-biologics