Chemical Manufacturing Controls (CMC) Forum

Wednesday, January 16, 2013 (7:30 AM - 10:30 AM)

What’s driving the entire drug development process?

Topic Description: 

The discovery and identification of a new molecular entity (NME) and the application of research required to show a proof-of-principle for a therapeutic agent can be rife with pitfalls, many of which can occur at different stages in the manufacture of an Active Pharmaceutical Ingredient (API). For all of the other segments that will contribute to IND-enabling programs and the clinical trials that follow, the supply of appropriate and quality levels of API can mean the difference between a highly efficient, on-time program and delayed, problem-plagued development scenarios. The efforts to produce larger and higher quality API amounts are often done with a Contract Manufacturing Organization (CMO), particularly for the small and mid-sized pharmaceutical and biotech companies which do not have their own manufacturing capabilities, but even for the larger companies which do have manufacturing but elect to outsource a campaign for capacity and/or scheduling reasons.  This symposium will identify when and where these pitfalls can and will occur and address how successful companies can proactively resolve issues that arrest efficient processes in the progression of drug development.


What You’ll Learn:

  • A better understanding of how CMC planning and delivery drive the entire drug development process
  • The differences between drug development processes of small and large molecules
  • What you need to know to before vetting and selecting a CMO or CRO
  • The “complexion” of successful manufacturing programs; what do biotechnology companies need to know to make the process succeed for quality and timeliness goals
  • Why quality and timing are so important / critical to the drug development process

Who Should Attend:

  • CEO/COO/CSO Business development directors; Regulatory directors/officers
  • Bioprocess scientists and engineers
  • Discovery scientists / Pharmacologists/Toxicologists/Molecular biologists
  • Students of all disciplines


Our Expert Panel:

 Speaker  Affiliation Topic 
Steve Frantz  MPI Research  Overview & Introduction of Speakers
Peter Korytko Preclinical Safety Consulting Pre-Clinical Consultants View of CMC Considerations
Gustavo Mahler CMC Biologics Clinical and Commercial Bioprocess Development of Biologics
Marshall Crew Agere Pharmaceutical  Small Molecule Manufacturing Issues and Challenges
Dave Barnes
VelescoPanelist
                  
Time: 
7:30 AM - 10:30 AM
Registration - 7:30 AM
Program  - 8:00-10:30 AM

Location:
Agora, An Alexandria Conference Center 
1551 Eastlake Avenue East
1st Floor
Seattle, WA 98102
 
Registration Fees:
WBBA Member- $35.00                    
Future Member- $50.00                    
Academia, Nonprofit, Student- $25.00 

Thank you to our sponsors: 

   
       


 

Peter J. Korytko
Preclinical Safety
Consulting

 












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