Discover the road to success for viral vector production: strategies, insights, and regulatory considerations

Samira Shore is a distinguished leader in the CDMO industry with over a decade of experience, specializing in the development and manufacturing of monoclonal antibodies, small molecules, and viral vectors. As the head of the viral vector program design team, she provides vital technical knowledge and strategic support, empowering clients to fulfill their clinical and commercial objectives. Shore is a recognized figure in cell and gene therapy and biotechnology circles, regularly contributing thought leadership at major conferences, trade shows, and exhibitions.

Her robust scientific expertise encompasses various production and purification methods, analytics, process characterization, and cGMP manufacturing of drug substances and products. Shore has a strong track record in process development and scale-up, bolstered by her in-depth understanding of regulatory requirements for gene therapies. In her current role, she also plays a crucial part in the leadership support of commercial operations, frequently liaising with site management to ensure excellence in execution and delivery.

Anne Gilbert is a seasoned professional in the CDMO industry with over 20 years of experience. She brings a wealth of knowledge, particularly in the development and manufacturing of viral vectors and viruses, with more than 15 years dedicated to these areas. Her expertise encompasses various production and purification methods, analytics, process characterization, as well as drug substance and drug product cGMP manufacturing.

In her current role, Anne provides technical knowledge and strategic support, helping customers achieve their clinical and commercial objectives. She is a recognized thought leader, frequently participating in cell and gene therapy and biotechnology conferences, trade shows, and exhibitions. Additionally, Anne plays a crucial role in the leadership and support of commercial operations teams, maintaining regular interaction with site management and ensuring the seamless integration of scientific expertise and operational excellence. Her strong background in manufacturing, particularly in cell culture, purification, and Fill and Finish processes, underscores her comprehensive understanding of the field and her ability to drive innovation and success in the CDMO industry.

Jesse Bishop is the Head of Regulatory Affairs at Viral Vector Services, where he oversees the development, implementation, and maintenance of key regulatory submissions including site master files and drug master files. With a career spanning over 15 years in regulatory affairs, quality/compliance, and research, Jesse has established himself as an expert in cell and gene therapy CMC. He plays a crucial role in partnering with clients to develop and strategize CMC information supporting their regulatory submissions for advanced therapy medicinal products. Jesse's leadership extends to preparing and participating in pivotal meetings with major regulatory agencies such as the FDA, EMA, and Health Canada. His profound understanding of global CMC requirements from early phase through to commercialization has made him a key leader in his field.