Certara Investor Day Presentation Deck
Advancing a novel, rare pediatric drug to FDA approval
mirum
Mirum, a start-up biotech, needed support to advance maralixibat,
its novel therapy aimed at treating a rare pediatric disease, and chose
to partner with Certara.
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Clinical
pharmacology
Clinical protocol
design
Regulatory strategy
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Non-compartmental
PK analysis
Phoenix Software
Represent client at
FDA meetings
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Drug interaction
modeling
Simcyp Simulator
Regulatory
submission
Approved by the FDA as the first and only medication for the treatment of cholestatic
pruritus in patients with Alagille syndrome 1 year of age and older
• Client received a rare pediatric disease priority review voucher
More than 35 scientists and regulatory experts at Certara contributed to this program
FDA
Approval
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