Regulatory Strategies for Gene Therapy Product Development

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

Speaker

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).

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