Tackling regulatory hurdles in biopharma can either be like an equestrian event, where rider and horse majestically bound over obstacles in their path or like bumper cars at a carnival where the driver is bounced off course by other vehicles they didn’t even see coming. While graceful trotting across the often-muddy regulatory grounds is the desired course, navigating hurdles doesn’t come naturally and requires a fair bit of training by instructors who have real experience. This is what the M Lab™ Collaboration Centers brings to the table when assisting clients with the best approaches for gamboling over regulatory barriers—especially in bourgeoning biopharma markets such as Asia. In this podcast, we will hear from two members of the Merck team stationed in the APAC region who will describe how the M Lab Collaboration Centers have been instrumental in training personnel to work with local regulatory agencies to move biotech companies forward.

This is part four in the five-part podcast series tackling diverse issues such as next-generation bioprocessing, bioproduction training in emerging markets, cell and gene therapy manufacturing challenges, and viral safety assurance in upstream and downstream. Make sure you check back regularly to hear the latest GENcast session.

 

 

Panelists:

Miles Shi

Associate Director, Asia Vaccine and Viral Therapies Segment Development

Merck

 

Charles Park

Manager, Manufacturing Science and Technology

Merck