Safety Strategies for Viral-Vectored Products

Duration: 60 Minutes
Viral-vectored drug strategies include vaccines and gene therapy as well as using viral vectors to transduce genes into cells used to manufacture a biologic product. These products and processes carry with them safety considerations not typically seen with "traditional" biologics. This webinar is for those who are developing a virus-vectored product or process and wish to proactively navigate quality and regulatory considerations for their program.
Safety Strategies for Viral-Vectored Products
Instructor: Paul W. Price
Product ID: 501347
Objectives of the Presentation
The key learning objectives will be:
  • Product safety consideration
  • Understanding the Quality/Regulatory environment for vectored products
  • Building safety strategies into product development
  • Cell-substrate characterization for product safety
  • Design of Analytics
  • The importance of planning
Why Should you Attend
This webinar will review safety considerations for viral-vectored products (e.g. gene therapy and vaccines) as well as products manufactured using viral vectors and will review quality/regulatory implications. The webinar will also discuss effective strategies for including safety into product design, including: Cell-substrate characterization, adventitious agent testing, immunogenicity, toxicity, and target specificity.

Areas Covered
Areas that will be covered include:
  • Safety considerations for viral-vectored products
  • Quality/Regulatory environment for vectored products
  • Effective strategies for including safety into product design
  • Planning
  • Cell-substrate characterization
  • Adventitious agent testing
  • Immunogenicity
  • Toxicity
  • Target specificity
Who can Benefit
  • Scientific Leadership
  • Management
  • Senior Scientists and above
  • Functional Area Managers responsible for vectored product development
  • Directors
  • Project Managers
  • Quality/Regulatory Managers
  • Principle Investigators
  • Senior Staff
  • Biotech Investors
Topic Background
Viruses reproduce by transporting their genomes inside the cells they infect where they coopt the host's transcription and translation machinery to make copies of itself. Understanding how they work has enabled molecular biologists, beginning with Paul Berg in 1970, to engineer viruses to transduce cells with specific genetic material. The science has since evolved to where virus vectors have become tools to deliver genes to cells for the manufacture of proteins, to deliver vaccines, and as vehicles for gene therapy. Developing virus vectors brings unique safety considerations. For example, a traditional virus clearance protocol will have serious deleterious effects on the vector. This webinar will review product safety considerations and discuss strategies for incorporating safety testing into vector product development.
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Paul W. Price, Ph.D. is a Senior Consultant at Biologics Consulting with over 25 years' experience in the Biotechnology Industry. Paul is part of the CMC-Analytics and Formulations Team, and also serves with the Early Development and Biosimilars Task Forces. He assists clients with design and implementation of biologics development and manufacturing projects; design, development, qualification and validation of process and release analytics; developing Project Management strategies for product development including Risk Management, Quality Oversight, and Technology Transfer; and Identification, management, preparation, and submission of Government Contract and Grant Proposals.

Paul's career has included work at Biocraft Laboratories and Barr Laboratories, Beckman Coulter, Inc., Abeome Corp., and Paragon Bioservices, as well as working as an independent consultant. As Principle Scientist at Paragon, he lead the planning and implementation of biologics development projects, including vaccines, viral-vectored products, monoclonal antibodies, protein therapeutics, and diagnostics. In addition, Paul held the position of Director of Government Grants and Contracts, where he oversaw the development, management, and submission of Government contract proposals and Grant applications. He is a SME in immunology, infectious diseases, microbiology, virology, and cancer, as well as biological assay development, Risk Management, and Quality oversight.

Dr. Price holds a B.S. in Marine Biology and a M.S. In Microbiology from Fairleigh Dickinson University, he earned his Ph.D. in Biology (Immunology) from Georgetown University, and completed post-doctoral studies at the University of Maryland, School of Medicine.
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