The Promises and Pitfalls of Gene Therapy for Rare Diseases On-Demand Webinar The Promises and Pitfalls of Gene Therapy for Rare Diseases The state of gene therapy faces much uncertainty as recent regulatory and clinical setbacks have…CertaraApril 29, 2021
The Rare Disease Drug Dilemma: Great Value, High Price, Limited Access? On-Demand Webinar The Rare Disease Drug Dilemma: Great Value, High Price, Limited Access? This webinar will explain how pricing has evolved for the rare disease drug market and…CertaraFebruary 19, 2020
Innovative Solutions for Fast-Tracking Drugs for Rare Diseases On-Demand Webinar Innovative Solutions for Fast-Tracking Drugs for Rare Diseases This webinar discussed which pharmaceutical payer strategies work and which don't in our rapidly changing…CertaraAugust 10, 2019
A Randomized, First-in-human, Healthy Volunteer Trial of Sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway Publication A Randomized, First-in-human, Healthy Volunteer Trial of Sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway CertaraMay 8, 2018
Obeticholic Acid—From PK Model to Drug Label On-Demand Webinar Obeticholic Acid—From PK Model to Drug Label Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to…CertaraJune 1, 2017
Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage Publication Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage CertaraDecember 1, 2016
Rare Disease and Orphan Drug Development Brochure Rare Disease and Orphan Drug Development There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…CertaraAugust 3, 2016
Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development Publication Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development CertaraJuly 1, 2016
Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia Publication Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…CertaraApril 1, 2016
Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys Publication Chemotherapy of Second Stage Human African Trypanosomiasis: Comparison Between the Parenteral Diamidine DB829 and Its Oral Prodrug DB868 in Vervet Monkeys Human African trypanosomiasis (HAT, sleeping sickness) ranks among the most neglected tropical diseases based on…CertaraFebruary 15, 2015