This workshop will examine CMC development of oligonucleotide therapeutics through interactive discussions. Review the key CMC concepts for oligonucleotide therapeutics and the successes and challenges for the platforms that have already progressed to product approval. Explore the use of oligonucleotides in complex and emerging modalities and assess the next generation of manufacturing platforms. Assess oligonucleotide impurities, their guidelines and how these should be controlled and addressed through interactive discussions. Delve into the regulatory expectations by phase of development and how to plan for the end goal, and understand how this can be applied to future projects
 
				 
             
         
                                
                                
                             
							
								
							
							
							    
        FEATURED SPEAKERS
        
               CEO and Founder, MikeWebbPharma Ltd
   Mike Webb PhD was the VP of Development Chemistry and Analysis for GSK in the UK and was heavily involved in developing GSK’s oligonucleotide pipeline. Since leaving GSK in 2016 he has been consulting with Big Pharma and Biotechnology companies in the development, analysis and manufacture of therapeutic oligonucleotides from pre-clinical to marketing submission.
  
	    
        
			
		
                
            
		
						     
							
							
							
													
							
								
							
							
							
							
                         
						
						 						
						
					    
						    
					            
  
  
  
  
  
  
  
        Workshop agenda
        
			
            
            
                 Key CMC development milestones for oligonucleotide therapeutics –Complex and emerging modalities / manufacturing platforms
 
    
Review of key CMC concepts for oligonucleotide therapeutics
    CMC challenges and successes for the platforms that have already progressed to product approval
    Review of the ‘next generation’ manufacturing platforms and use of oligonucleotides in complex and emerging modalities
    Leveraging CMC synergies between ‘legacy oligonucleotides’ and complex /emerging modalities and acknowledging the new frontiers in the CMC development path
     
 Addressing impurities and their control
 
    ICH Impurity guidelines
    Oligonucleotide Impurities: ID and control strategies, and Formation and fate
    We thought the analytics for 20’mers and siRNA were complex. When you multiply the chain length by 5 – and / or conjugate the oligonucleotide, what is the multiplier for the complexity of impurity control?
    Mass spec-based impurity method vs. orthogonal chromatography methods, or all of above?
    Connecting Module 3 and Module 2 in demonstrating impurity control
     
     
    
  Attending to Regulatory expectations by phase of development  
 
    
Planning for the end goal – NDA vs. BLA – oligonucleotide manufacturing platform
    Pre-IND and Phase 1
    Phase 2/3
    Late stage, pre-marketing
     
 Key Takeaways and Discussion
 
    
Delegates will have the chance to discuss and benchmark concepts and challenges of oligonucleotide development and CMC based on learnings from first 3 sessions
    Outlook into the future of oligonucleotide therapeutic development
     
 
			
			
          
						     
					     
					    
							
                                
                 
                    
            
                
                    
                        
							
                        
                    
                        
                            
                                
                                CEO and Founder
                                MikeWebbPharma Ltd
                                CEO and Founder, MikeWebbPharma Ltd
                                Mike Webb PhD was the VP of Development Chemistry and Analysis for GSK in the UK and was heavily involved in developing GSK’s oligonucleotide pipeline. Since leaving GSK in 2016 he has been consulting with Big Pharma and Biotechnology companies in the development, analysis and manufacture of therapeutic oligonucleotides from pre-clinical to marketing submission.
 
                         
                     
               
            
                 
            
		
                             
					     
					    
					    
					    
					    
					    
				     
			     
		     
	     
     
    
    
    
    
    
    
    
    
    
  
    
    
    
    
    
    
    
    
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