Date: Tuesday, April 29, 2025
Time: 11-12 ET
Solutions: Preclinical, Early Clinical, Late Clinical
Therapeutic Specialties: Complex Biologics Services
Summary
Oligonucleotide therapeutics are transforming drug development, but their complex pharmacology and regulatory landscape present unique challenges. Join Certara and Ionis Pharmaceutical experts as we explore a model-informed approach to accelerating oligonucleotide drug development.
In this webinar, we’ll cover:
- Essential foundations of oligonucleotide therapeutics – what they are, how they work, and why they matter
- Regulatory strategies for success from day one – ensuring alignment with evolving global expectations
- How model-informed drug development (MIDD) accelerates and de-risks oligonucleotide programs – smarter decisions through data-driven insights
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Clinical Pharmacology Leader, Ionis Pharmaceuticals
Pratap Singh, Ph.D., is currently an Executive Director and Franchise head within the Clinical pharmacology department at Ionis Pharmaceuticals, a company that has been pioneering RNA-targeted therapeutics since its founding in 1989.
At Ionis, Pratap oversees clinical pharmacology, ADME, translational, and PK/PD/QSP modeling efforts for a number of clinical and discovery stage projects. Prior to joining Ionis, Pratap spent a number of years at Pfizer, Gilead and Alexion, and over the years (including 18 years in industry and 6+ years in academia), he has gained an end-to-end “early-discovery-to-regulatory approval” experience in advancing diverse therapeutic modalities including antibodies/ADCs, small molecules, oligonucleotides, siRNA, fusion proteins and Bispecifics.
Pratap Singh received his Ph.D. from The Johns Hopkins University at the Department of Chemical and Biomolecular Engineering where his research work contributed to the discovery of novel anti-androgens for the treatment of hormone refractory prostate cancer.
Director, Clinical Pharmacology
Francine de Castro is Director in Clinical Pharmacology and Translational Medicine, working on the development of new therapies with a focus on complex biotherapeutic drugs including oligonucleotides. Contributing to the optimization of therapeutic strategies and innovation in drug development, Francine collaborates with multidisciplinary teams to advance biotechnology-based therapies, supporting strategic decisions to ensure the safety and efficacy of new treatments. With a strong academic foundation and experience in engaging with the industry and regulatory agencies, she stands out in the application of clinical pharmacology to innovative therapies.
Associate Director, Clinical Pharmacology, Certara
MarieCecile Secouard, PharmD, has been an Associate Director in Clinical Pharmacology at Certara since early 2022. She is a pharmacist by training with a Master of Science degree in Pharmacokinetics from the University Paris Descartes, France. MarieCecile has 12 years of experience working in the pharmaceutical industry as clinical project manager and clinical pharmacology project leader. She has experience with small molecules and biologics from phase I to post-approval in neurology, oncology, cardiology, and pediatric diseases. Extensively involved in the development plan of an antisense oligonucleotide in the past, she is part of the Complex Biologics Integrated Practice Area at Certara.
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