Vaishali Shukla
Vice President, CGT & API Global Expansion Eli Lilly & Co.
Vaishali Shukla, PhD, is Vice President of Cell & Gene Therapy and API Global Expansion at Eli Lilly and Company, where she leads global efforts to scale advanced therapy manufacturing and supply networks. With more than 20 years of experience in the biopharmaceutical industry, she has worked across areas including early clinical development through commercialization of cell and gene therapies, biologics, peptides, ADCs, and small molecules. In her current role, Vaishali oversees strategy for API and CGT manufacturing expansion and plays a key role in enabling the global delivery of advanced therapies with quality and consistency.
Seminars
Automated manufacturing is emerging as the industry’s clearest path to lower COGs, broader patient access and sustainable commercial success.
In this focused session, evaluate where automation delivers the greatest value in your manufacturing process, how to integrate it into your existing framework and how to align with regulations. Through case studies and in-depth discussions, combining industry leaders involved in automated manufacturing and key regulatory experts, gain insight into the decisions, trade-offs and lessons shaping automated manufacturing programmes to de-risk execution and ensure a smooth and economical road to market.
- Analyzing the impact of automation on cost of goods to optimize resource allocation and support sustainable clinical and commercial manufacturing
- Integrating automated platforms within GMP manufacturing and quality systems while maintaining data integrity and oversight
- Interpreting updated cell therapy GMP and advanced manufacturing technology expectations to leverage regulatory flexibility without compromising compliance
- Exploring the adoption of automated manufacturing process to enhance consistency, output and decrease variability
- Examining integration and flexibility challenges in automation to inform realistic implementation strategies
- Analyzing the impact of automation on cost of goods to optimize resource allocation and support sustainable clinical and commercial manufacturing
- Exploring rapid sterility testing methods, including ATP release assays and NGS-based microbial detection, to reduce traditional 7-day timelines
- Implementing rapid QC testing to accelerate vein-to-vein time without compromising safety and regulatory compliance
- Highlighting emerging technologies demonstrating rapid, reliable testing to support clinical and commercial qc workflows
