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When the Barrier to a Breakthrough Drug is You Can’t Make It




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Despite all of their promise, newer medicines, especially those based on advanced technologies, have been met with unprecedented challenges in scaling up manufacturing, quality control and commercial launch.

Hear how developers have approached different aspects of the manufacturing process to bring new and innovative treatments to patients.



  • Alessandro Maselli, president and chief executive officer, Catalent (sponsor speaker)


Part 1: BioNTech’s Plans to Bring mRNA to the World
How can mRNA be manufactured in Africa? What are the logistical challenges of new, personalized mRNA cancer vaccines? A look at BioNTech’s plans.

  • Sierk Poetting, Ph.D., chief operating officer, BioNTech
  • Allison DeAngelis, biotech startups and venture capital reporter, STAT (moderator)


Part 2: BioMarin’s Plans to Make a New Gene Therapy
BioMarin’s hemophilia gene therapy, Roctavian, will present specific challenges when it comes to manufacturing. The company has been investing for years to solve them.

  • C. Greg Guyer, Ph.D., chief technical officer and executive vice president of global manufacturing and technical operations, BioMarin
  • Matthew Herper, senior writer, medicine; editorial director of events, STAT (moderator)


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