Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — OPCO Fireside Chat (December 2020)
22 slides from Simulations Plus's conference presentation, Dec 17, 2020
Slide 1: OPCO Fireside Chat
OPCO Fireside Chat December 17, 2020 Nasdaq: SLP
Slide 2: Safe Harbor Statement
Safe Harbor Statement With the exception of historical information, the matters discussed in this presentation are forward-looking statements that involve a number of risks and uncertainties. The actual results of the Company could differ significantly from those statements. Factors that could cause
Slide 3: Modeling and Simulation in Pharma Drug Development
Modeling and Simulation in Pharma Drug Development Software: The most comprehensive and widely recognized set of tools for in silico drug development. Ongoing development and reinvestment to incorporate the latest science and ensure a seamless user experience. Services: Highly interactive collaborat
Slide 4: Our solutions inform the entire drug development process
Our solutions inform the entire drug development process Post Discovery Preclinical Phase 1 Phase 2 Phase 3 NDA Approval Pre- Approval IND EOP2 NDA Cheminformatics PBPK QSP/QST DILIsym Services Pharmacometrics Cognigen | Lixoft Regulatory Interaction
Slide 5: Technology Overview: The Machine Learning / PBPK / QST(P) Marriage
Technology Overview: The Machine Learning / PBPK / QST(P) Marriage… Machine Learning Inputs for QST(P) Permeability, Local & systemic solubility vs. pH, exposure, drug pKa(s), distribution, logD vs. pH,PBPK in Molecule Optimizationparent and Fup, (AIDD) metabolite blood:plasma levels, ratio, tissue
Slide 6: By the numbers
: By the numbers… % Revenue by Client Type Peer-reviewed journal publications 6% 6% 6% Pharma/Biotech Generics 10% CROs Chemicals Nonprofit 73% % Revenue by Geography • GastroPlus® client base: ~160 commercial 23% companies and >90 nonprofit organizations 49% 26% • >60 commercial companies license $
Slide 7: Clients Driving Software R&D: Funded Collaborations
Clients Driving Software R&D: Funded Collaborations FDA: Ocular model extensions Est. end date: 4QFY22 FDA: Oral cavity model extensions Est. end date: 4QFY23 FDA: Dermal model extensions Est. end date: 4QFY21 Themes: • Whole-body mechanistic absorption Cosmetics Europe: Dermal model extensions • Ad
Slide 8: Approved drug product applications supported by GastroPlus simulations
>70 Approved drug product applications supported by GastroPlus® simulations 8
Slide 9: Manufacturing Process Changes and Virtual Bioequivalence Trials to Waive Clinical Studies
Manufacturing Process Changes and Virtual Bioequivalence (BE) Trials to Waive Clinical Studies • Objective: build a PBPK model for an approved drug using existing clinical data for non-engineered formulations (NFE) and perform virtual BE trial simulations vs. the particle engineered (PE) lots to wai
Slide 10: PBPK Modeling of pH-Dependent DDIs and Meal Types on Alpelisib (PIQRAY)
PBPK Modeling of pH-Dependent DDIs and Meal Types on Alpelisib (PIQRAY®) • Objective: develop and verify PBPK model to predict the impact of different meal types and co-administration with pH modifiers on alpelisib (PIQRAY®) • Simulation strategy presented outlining evaluation of pivotal clinical fo
Slide 11: Establish Dissolution Safe Space in Adult and Pediatric Populations (TAMIFLU)
Establish Dissolution Safe Space in Adult and Pediatric Populations (TAMIFLU®) • Objective: develop and verify PBPK model to predict the exposure of oseltamivir (TAMIFLU®) and its main metabolite in adult and pediatric populations • Simulation strategy presented model development in adults and extra
Slide 12: DILIsym Services Inc., an SLP Company
DILIsym Services Inc., an SLP Company “Our vision is safer, effective, more affordable medicines for patients through modeling and simulation.” • DILIsym Services, Inc. offers comprehensive program services: – DILIsym software licensing, training, development (consortia) – NAFLDsym and IPFsym softwa
Slide 13: DILIsym Services Is Using QSP and QST Modeling to Predict Efficacy and Safety
DILIsym Services Is Using QSP and QST Modeling to Predict Efficacy and Safety of Drugs in Development Predicted compound PD effects and Exposure Drug Effects concentrations at site of interactions with target often require underlying biochemistry PBPK models unique for most compounds; QSP model Effi
Slide 14: NAFLDsym v2A Overview
Multiple interacting NAFLDsym v2A Overview sub-models, including Clinical data from • Steatosis literature used to • Lipotoxicity establish quantitative • Inflammation relationships for • Fibrosis underlying biochemistry • Biomarkers • Weight gain/loss Numerous simulated Provides ability to patients
Slide 15: Collaboration with Genentech Focused on Anti-FGFR1/KLB Antibody
Collaboration with Genentech Focused on Anti-FGFR1/KLB Antibody – Helped Them Determine the Mechanisms Responsible for a Drug Effect 15
Slide 16: How the DILIsym Software Helps Drug Developers
How the DILIsym Software Helps Drug Developers So how can DILIsym help my • Predicts drug-induced organization? liver disease • Predict DILI liabilities beforehand and • Includes mechanistic eDISH save $$$ representation of • Choose the lead candidate most likely to normal hepatic succeed from a DIL
Slide 17: DILIsym Utilizes Various Data Types to Inform Decisions
DILIsym Utilizes Various Data Types to Inform Decisions Exposure Data Modeling & Simulation PBPK Modeling Simulations and Assays inform: • Compound Properties • Prediction of DILI risk - Tissue partition coefficients • Tissue penetration studies • Participating DILI mechanisms - Liver to blood ratio
Slide 18: Important DILIsym Application Examples
Important DILIsym Application Examples NORMAL 18
Slide 19: Important DILIsym Application Examples
Important DILIsym Application Examples 19
Slide 20: Important DILIsym Application Examples
Important DILIsym Application Examples 20
Slide 21: Important DILIsym Application Examples
Important DILIsym Application Examples 21
Slide 22: SimulationsPlus
SimulationsPlus SCIENCE + SOFTWARE = SUCCESS QaRA SimulationsPlus Cognigen DiLisym Services Lixoft
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