Cambridge Healthtech Institute ’s 4th Annual

Gene Therapy CMC and Analytics

Regulation and Analysis of Vector-Based Gene Therapies

August 26-27, 2020

 

One of the biggest challenges for AAV and lentivirus gene therapy products is establishing an appropriate CMC and analytical strategy to support product manufacture, release, stability, comparability and characterization at different stages of development.

 

Cambridge Healthtech Institute’s Gene Therapy CMC and Analytics meeting uncovers the practical challenges facing the analysis, characterization, and quality of viral vector-based gene therapies for clinical and commerical supply, with dedictated sessions on CMC strategy, regulatory requirements, orthogonal analytical strategies, new analytical methods, particle detection, stability, and the impact of machine learning on advancing vector safety and quality.

 

Cover will include, but is not limited to:

 

  • CMC and analytics
  • CMC requirements from Phase I-Phase III
  • Analytical development of gene therapies
  • Potency assay development and validation
  • Gene therapy analysis and characterization – MS, NMR, HPLC
  • Particle sizing
  • Plasmid production, aggregation, and purity
  • Stability testing – ancillary materials, lipids, carbon source of producer
  • Comparability following process change
  • Formulation, stability, and delivery
  • Gene editing/CRISPR techniques in gene therapy
  • Gene editing and delivery
  • Vector design, selection, and development
  • Delivery strategies for gene therapies – viral and non-viral delivery systems
  • Determining whether the vector is full or empty
  • Molecular biology – RNA, DNA, Synthetic, Peptide
  • Nanoparticles

 

If you would like to submit a proposal to give a presentation at this meeting, please click here.

 

The deadline for priority consideration is February 14, 2020.

 

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

 

For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-247-6266
Email: dbarry@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



Premier Sponsors:

NanotemperTechnologies

Vironova