The Switch to Cell-Free DNA: Strategic and Regulatory Considerations for Advanced Therapies

The Critical Decision: Switching Your Starting Material. Changing your critical input from pDNA to cell-free DNA is a strategic move that requires careful planning. Tune in to learn the essential regulatory requirements, data packages, and practical steps needed to successfully implement this switch and future-proof your product pipeline.

Register Free: https://www.biopharminternational.com/bp_w/Cell-Free-DNA

Event Overview:

Join us for a focused, insightful webinar exploring the decision to change your critical starting material from traditional plasmid DNA (pDNA) to synthetic cell-free DNA echnology. For innovators developing cutting-edge nucleic acid and viral vector-based therapies, the purity, speed, and scalability of starting materials are paramount. Host Amy Walker, Ph.D., COO of 4basebio, will lead a discussion with distinguished guest speaker Jenny Mellquist, Ph.D., about the compelling drivers for making this strategic change, from overcoming pDNA manufacturing bottlenecks to achieving higher product purity, and the impact on patient safety. We will highlight key regulatory hurdles and requirements, and outline the practical steps and data packages needed to successfully implement the switch of critical starting material.

Key Learning Objectives:

• Identify the critical regulatory considerations and necessary CMC documentation required by agencies like the FDA when substituting a core starting material.
• Review the practical requirements and data needed to successfully plan and execute the change in a cGMP environment.
• Understand the technical and logistical advantages transitioning from plasmid DNA to cell-free DNA technology for critical starting materials in advanced therapies.

Who Should Attend:

• CMC Leaders
• Manufacturing Directors
• CSO

Speakers:

Dr. Jenny Mellquist, PhD

Dr. Mellquist has over 25 years’ experience in the health care field and has held positions in government, industry, and as a consultant. Jenny is knowledgeable with all phases of the product lifecycle from early development to commercial products. Since 2010, Dr. Mellquist has been a consultant where she focuses on providing regulatory strategy for complex dossiers. She is a former FDA product specialist inspector and continues to support clients’ CMC regulatory strategy, mock audits, and provide professional and inspectional expertise to clients.

Dr. Amy Walker, PhD
COO
4basebio

Dr. Walker joined the 4basebio in November 2020 where she now serves as Chief Operating Officer and EVP of Research. Dr. Walker has a background in molecular biology and gene editing technologies, along with associated nucleic acid nanoparticle delivery platforms. She holds a Ph.D. from UCL Institute of Child Health and was awarded the prestigious Bogue Fellowship, conducting part of her doctoral studies at both University of British Colombia and McGill University, Montreal. Dr. Walker has 8+ years scientific and commercial experience in life sciences, has published scientific papers, and is named inventor on a multitude of multidisciplinary patents. She currently holds non-executive director Board positions on several high growth healthcare companies.

Register Free: https://www.biopharminternational.com/bp_w/Cell-Free-DNA