Gil Y. Roth

President
Pharma & Biopharma Outsourcing Association (PBOA)

Articles by Gil Y. Roth

  • CMO/CDMOs: Challenges and Opportunities

    Thursday, December 07, 2017
    “All predictions null-and-void if Trump wins the US Presidential election:" That’s how I closed out last year’s ‘Looking Ahead’ piece. Suffice to say, my crystal ball is C-R-A-C-K-E-D, and my backup Magic 8-Ball’s answer to everything is, “Reply hazy...
  • CMO/CDMOs: Looking Ahead

    Friday, September 30, 2016
    The number one trend from last year’s edition demands a repeat (see - (http://pharma-bio.org/pdfs/CPhI%20annual%20report%202015.pdf - page 46). The CMO/CDMO sector remains fragmented, and business logic dictates that the sector needs to consolidate (...
  • CMOs and GDUFA: Shaping a New World

    Friday, July 31, 2015
    In July 2012, the U.S. Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which contained the Generic Drug User Fee Amendments (GDUFA). GDUFA has noble goals in its first five year term (FY 2013 - FY 2017): ...
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