The regulatory landscape for gene therapy is constantly changing and global harmonization has yet to be aligned. An understanding of the regulations and guidance documents reflecting global regulatory agencies’ current thinking will help to better understand the key challenges. This is an exciting time in the industry with products being developed at an accelerated rate.
This webinar will discuss the current state of regulatory issues around gene therapy product development, key challenges for manufacturing controls and other insights in navigating the path to commercialization.
Register for this webinar to gain insights into:
- Regulatory guidelines, with highlights from FDA’s gene therapy guidance documents issued in 2020
- Challenges of following the traditional regulatory framework while trying to keep up with demand for cutting-edge treatments on accelerated timelines
- Regulatory strategies with accelerated clinical plans — a comprehensive CMC plan and why early regulatory agency interactions will ensure long-term success
- Establishing manufacturing controls and developing the appropriate analytical methods
- Keeping up with gene therapy product development while identifying key challenges with high cost of goods, long lead times, manufacturing capacity, scale-up hurdles and increasing demands for plasmids (pDNA)
- Future trends: how the global pandemic is shaping and/or repurposing emerging therapeutics
Dawn L. Wofford, Director, Regulatory Affairs, Cytovance Biologics
Dawn L. Wofford is on a mission to help biopharma companies navigate the global regulatory landscape by delivering compliance and regulatory solutions from product development, clinical trials, product realization, commercial manufacturing and post-marketing activities. Trained as an archaeologist/anthropologist, she has a unique 15-year background in Regulatory Affairs and Quality Compliance in the biologics, tissue, pharmaceutical and medical device industry. Dawn’s therapeutic areas of expertise include cellular therapy, regenerative medicine, ophthalmology, oncology, hematology, and maternal health.
Dawn is currently the Director, Regulatory Affairs of Cytovance Biologics, a CDMO in Oklahoma City. In this role, she promotes a culture of quality excellence by implementing innovative solutions through the regulatory roadmap of the product’s lifecycle. Dawn received a B.A. in Anthropology/Archaeology and a B.A. in Sociology from Hawaii Pacific University. Dawn is a certified Quality Auditor (ASQ), a certified Manager of Quality/Organizational Excellence (ASQ) and participates on various industry working committees for the Pharma & Biopharma Outsourcing Association (PBOA), International Society for Pharmaceutical Engineering (ISPE) and Parenteral Drug Association (PDA).
Who Should Attend?
This webinar will appeal to the following pharmaceutical and biotechnology professionals:
- Gene Therapy Product Development Professionals
- Development Scientists
- Regulatory Professionals
- Quality Professionals
What You Will Learn
In this webinar, participants will learn about:
- An overview of gene therapy product development
- Navigating the regulatory landscape
- Overcoming hurdles from clinical trials, manufacturing and regulatory challenges
- Understanding emerging regulatory requirements
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation, such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle, including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.