iSpeak Blog

3…2…1 BioPharm Blastoff…..Are You Ready for Launch?
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It’s obvious that NASA launches require incredible coordination to be successful, but getting a drug from development to the patient is no small feat either. NASA had to control the quality of dozens of subcontractors, as does our industry. Unlike a space mission, where success is the safe return of a small crew, pharmaceutical manufacturers must ensure the safety of thousands. Launch timing is a challenge in both camps, as regulatory approval vagrancies can create ‘weather delays’ for our teams. To be sure, the environment in space is challenging, but there’s only one package being ‘shipped’ and it’s monitored continuously. We must ship thousands of packages around the world through varied and complicated supply routes, yet each one must arrive without negative impact to quality and efficacy. Perhaps most frustrating is the possibility, even likelihood, that missions will be cancelled with little warning. For space agencies, the villain is the fickle nature and politics of funding. For us, it’s the anxiety provoking reveal of late phase clinical trial data. Has your firm created the flexibility necessary to survive in this environment? Do you have novel business, regulatory, and technical tools that you can share with others? Vertical integration? Strategic business alliances? Streamlined development processes that flow effortlessly into your manufacturing plants? If so…… …PLEASE SHARE THESE at ISPE’s Biopharmaceutical Manufacturing Conference in San Francisco, California, 4 – 6 December 2017. Our theme is, “Launch Readiness: Operational Agility for Today’s Challenges”, and the content scope spans development through manufacturing and distribution; the entire supply chain. See below for a list of suggested topics and you can submit your proposals here.

  • Unique challenges of DP and packaging of biologics
  • Cold Chain infrastructure and risk mitigation
  • Faster, safer Change-Overs
    • Tech Transfer Excellence and Efficiency
  • Leveraging closed systems
    • More Science and Less Risk in Cleaning Processes
    • Focus on the science.
    • Single Use Hybrid Models to facilitate Multi-product
    • Clinical plus commercial in the same space
  • Sterile fill CMO capacity/scheduling
  • Best practices for shortening development timelines w/o sacrificing process knowledge
  • CMC/Tech Transfer
  • Microbiology, FDA's new focus
  • Ballroom design concepts
  • Leveraging CPV in filings and inspections
  • Strategies to Speed Post Approval Changes
  • Process Validation Strategies
  • Evaluation of Network Risk
  • Novel approaches to sharing the impact of uncertainty
    • Clinical supply, CMO to internal challenges
    • Tech Transfer challenges unique to CMO relationships
  • Multi-variate Analysis – don’t leave home without it!
  • Control of CQA’s through process models
  • Raw Material impact on processes
  • Process Development Strategies
  • Continuous Bio Manufacturing
    • In what economic and regulatory situation will CBM be a competitive advantage?
    • What are the enablers?
  • Operating Paradigms for Cell and Gene Therapy
  • Economics of C&GT

Feel free to expand upon our ideas. For more information, you can contact committee co-chairs Jennifer Clark or Andre Walker, or Program Manager Marianne Bock. We are all fortunate to work in an industry that enhances, and sometimes saves the lives of individuals. Sharing your successes at ISPE’s conference will expand your impact, and directly connect you with others who have overcome similar challenges.