Tuesday May, 7 | Boston, MA
Morning Welcome Coffee
08:00 AM
Workshop A
Optimizing Delivery Platforms for Next Generation RNA Therapeutics & Overcoming Targeted Delivery Challenges to Achieve Their Full Therapeutic Potential
9:00 am - 11:00 am
Workshop Leaders:
Anthony Saleh
Chief Executive Officer
MiRecule
Dinesh Chandra
Associate Director, Interventional
Oncology
Johnson & Johnson
Vignesh Hariharan
Senior Postdoctoral Associate
University of Massachusetts Chan Medical School
Workshop B
Enhancing CMC Process Development to Streamline Next Generation RNA Therapeutic Development in Line with Regulatory Expectations
11:30 am - 1:30 pm
As the unprecedented efficacy of RNA in the treatment of various diseases has catapulted RNA-based therapeutics into the spotlight, it is crucial to design robust protocols for scaling and manufacturing these drugs to ensure regulatory approval and enable commercial use. With streamlined chemistry, manufacturing and control strategies, next generation RNA-therapeutics can be manufactured more efficiently and efficaciously to accelerate the development and manufacturing timeline.
Join this workshop to discuss:
- Obtaining a comprehensive understanding of which steps and variables need to be controlled in the manufacturing process
- Ensuring consistency of specificity, safety, stability and strength of the therapeutic drugs in both a clinical trial and commercial setting
- Driving R&D success by minimizing bottlenecks in process development, manufacturing scale-up, qualification and validation, quality assurance and quality control approachesImproving CMC strategies to increase chances of regulatory success
Workshop Leaders:
Jim Nolan
Vice President of Tech Ops
Sali Biomedicines
Giles Besin
Chief Scientific Officer
Orbital Therapeutics
Dharini Shah
Senior Director
Sanofi
End of Pre-Conference Workshop Day