Risk assessment is a complex process intended to protect human health. In drug development, this process includes identifying drug candidate-related hazards in relationship to dose and exposure via traditional in vitro and in vivo frameworks. Nonclinical studies in pharmacology, pharmacokinetics and toxicology are designed and conducted under conditions that closely mimic the clinical setting to facilitate proper risk assessment. The introduction of novel model-informed approaches can further translate this information to predict clinical pharmacokinetic and pharmacodynamic (PK/PD) outcomes for supporting clinical development. A well-designed risk assessment strategy, plan and analysis ultimately ensures patient safety relative to potential therapeutic benefit.
In risk assessment for drugs designed to treat neurological diseases, there are additional challenges. These include overcoming the barriers of drug delivery to the central nervous system (CNS), verification of CNS drug exposure and mitigation of safety concerns unique to the CNS such as seizure risk or off-target adverse effects on neurotransmitter pathways. Therefore, novel and intelligent designs for a risk management strategy for CNS drug development are essential. This strategy may be informed by various types of data that include in vitro and in vivo findings, as well as data from multiple types of modeling: e.g., physiologically-based pharmacokinetic (PBPK) modeling, in vitro in vivo extrapolation (IVIVE) and more.
Join this webinar on CNS risks in the context of drugs intended for neurological use and explore case studies and perspectives on their current and future challenges.
Marcus S. Delatte, PhD, Vice President, Regulatory Strategy, Allucent
Dr. Delatte served as a Senior Pharmacology/Toxicology Reviewer at the US FDA for 12 years. He is an established expert in translating nonclinical data to inform clinical program design, including dose selection, safety monitoring, inclusion/exclusion criteria for clinical protocols, and informed consent forms. Dr. Delatte has extensive experience in creating and implementing strategies for regulatory pathways in the US, as well as preparing and creating strategies for formal FDA meetings. His expertise and experience span multiple therapeutic areas including psychiatry, neurology, pain, rheumatology, infectious disease, immunology, cardiovascular, pulmonary, and oncology.
Devin Welty, PhD, Vice President, Clinical Pharmacology, Allucent
Dr. Welty has over 30 years of extensive experience in preclinical and clinical pharmacology leading organizations and project teams from early discovery to approval and commercialization in multiple therapeutic areas and modalities. Dr. Welty’s primary therapeutic area of experience includes neurology, ophthalmology, and rare diseases. He has extensive experience in pharmacokinetics, pharmacodynamics, and systems pharmacology and adopting model-informed approaches for candidate nomination and clinical development. He has experience with small molecule, biologics, and cell and gene therapy products, and has supported > 50 IND/CTAs and >20 NDA/MAA/BLAs.
Alison Wakeford, PhD, Scientist, Allucent
Dr. Wakeford has over a decade of experience in cannabinoid, psychostimulant, and entactogenic pharmacology, including thirteen manuscripts on nonclinical drug abuse liability across all three classes of drugs. Her nonclinical expertise includes both rodent and nonhuman primate experimental design and analysis of these compounds, with a specific focus on central nervous system (CNS) effects.
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers and Heads involved in:
- Preclinical/nonclinical research
- Research and development
- Regulatory affairs
- Medical affairs
- Scientific affairs/consulting
- Clinical pharmacology
- Clinical development
- Project management
- Clinical operations
- Clinical research
- Biostatistics and data management
Additional Audience Information:
- Small and medium-sized biotech and pharmaceutical companies
- Academics from drug discovery centers or groups
- Venture capital and other life science investment groups
What You Will Learn
Attendees will gain insights into:
- Understanding approaches to assess anatomical and functional neurotoxicity in animal species
- Integrating various types of data to create a toxicity profile and manage risk
- Reviewing case studies to understand the intricacies of assessing and managing CNS risks
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.