Lessons learned from the pandemic for the future of biologics

Dr. Gottlieb, who led the FDA from 2017-2019, has helped create a phased roadmap for navigating COVID-19 and has been a frequent media resource on pandemic-related topics. This LIVE interview will highlight his perspective on the lessons learned from the pandemic and it’s impact for the biotech industry.

The past, present, and future of mRNA manufacturing

With the increased interest in mRNA based vaccines and therapeutics resulting from the approval of the first mRNA products for clinical use, the industry is dedicating new focus to the manufacturing process of these innovative products. This talk will examine how mRNA manufacturing processes have developed to the current state and the approaches under exploration for future production. This will include case studies and insight based on projects completed at CPI working on diverse mRNA-LNP product types.

Capacity is not enough: smart growth as a CDMO

In this presentation, Betty Woo, Vice President and General Manager, Cell and Gene Therapy, Thermo Fisher Scientific, will interview Javier Garcia Cogorro, CEO, Viralgen, an AAV-focused CDMO. As AAV therapeutics mature and both global and market dynamics shift, client expectations and regulatory standards continue to rise and grow in complexity, pushing CDMOs to be more agile, more focused, and more connected to patients. Attend to hear this insightful discussion on the role CDMOs should play in bringing these amazing therapies to market. 

mAb early development and critical considerations for commercialization success

We’ve all learned that we need to evolve to enable a faster pace to market. However, balancing speed, risk, and future needs like commercialization is challenging. This session addresses how to accelerate post-discovery to IND milestone timelines, leading to faster first-in-human trials and a strong foundation for future scaleup and commercialization. Join us as we discuss trade-offs and the long-term implications of choices made, plus other critical considerations that impact timelines and commercialization.

Covid 19's Impact on FDA's Pre-Approval Inspections

A critical step in the commercial approval of a product is the Pre-Approval Inspection (PAI) of the manufacturing facilities. Covid-19 has impacted the agency’s ability to perform PAI’s due to travel restrictions, availability of personnel, and other covid related issues. This has resulted in the agency starting to combine bi-annual and PAI inspections together; as well as the agency asking the sponsors for a lot more facility documentation to be included in their licensing application. This trend of fewer or shorter more multi-purpose on-site inspections and requesting more documentation from the facility is something the industry should plan for moving forward. Especially since the agency will most likely continue to employ these techniques even in the post-Covid environment.

Detailing a Patient's Groundbreaking Journey Through Immunotherapy Clinical Trials

Brendan Connors was just 27 years old when he started his journey with Stage 4 Metastatic Melanoma. From Mount Siani Hospital to National Institutes of Health (NIH) and National Cancer Institute (NCI) and finally Memorial Sloan Kettering, his immunotherapy clinical trials had him unknowingly pioneering new paths for future melanoma patients. One of the first patients to leverage the combination treatment of ipilimumab (Yervoy) and nivolumab (Opdivo) to 'take the brakes off' his immune system, Brendan credits the plethora of doctors and researchers dedicated work for him being here today. Through years of treatments and trials, his new vision on life and the world has changed and he has learned to 'not sweat the small stuff' and 'live every day to the fullest'. 11 years after his diagnosis he is 'cancer free' and doing his best to 'pay-it forward' however he can.