In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases.
Certara supported the first FDA approval of an oligonucleotide therapy as well as 23 subsequent programs. Watch this free webinar to learn how we can help you accelerate your drug development program. Our experts explained how clinical pharmacology, pharmacometrics, and regulatory science solutions can help oligonucleotide drug developers overcome key challenges.
—- Time Stamps —-
0:00 Intro to oligonucleotides
10:35 Oligonucleotides: Transitioning from animals to humans
35:34 Clinical pharmacology considerations
Dr. Virna Schuck is a Senior Director in Clinical Pharmacology and Translational Medicine at Certara. She has over 16 years of experience in Pharmaceutical Development, working across the Discovery and Development phases. Prior to joining Certara, Dr. Schuck held positions of increasing responsibility at Novartis, AstraZeneca, and Millennium Pharmaceuticals. Dr. Virna Schuck has a bachelor’s degree in pharmacy and master’s in Pharmaceutical Sciences from the Federal University of Rio Grande do Sul – UFRGS- Brazil, and a PhD in Pharmaceutical Sciences from the College of Pharmacy, University of Florida.
Dr. Suzanne Minton is the Director of Content Strategy at Certara. She has 8 years of corporate marketing experience with expertise in scientific content strategy and communication. Dr. Minton also spent 5 years conducting biomedical research on HIV and cancer. She holds a BS in biology from Duke University and a PhD in pharmacology from the School of Medicine at the University of North Carolina, Chapel Hill.
Dr. Martin Beliveau has over 10 years of modeling experience in clinical pharmacology. He joined Certara Strategic Consulting in 2007. Before that, he was a pharmacokinetic scientist and Study Director at Charles River Laboratories. His entire career has been in the area of pharmacokinetic analysis, modeling and simulation for regulatory submissions and decision making. His work covers areas a wide range of indications with a particular focus on translational medicine, first-in-human predictions and biodefence.
Dr. Martin Beliveau received a PhD in Public Health from the Université de Montreal under Dr. Kannan Krishnan in physiologically-based pharmacokinetic modeling in 2004. Aside from his modeling/simulation activities, Martin enjoys reading a good Spider-Man story.