Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — OPCO Fireside Chat 2020
22 slides from Simulations Plus's conference presentation, Dec 18, 2020
Slide 1: OPCO Fireside Chat December 17, 2020
OPCO Fireside Chat December 17, 2020 Nasdaq: SLP
Slide 2: Safe Harbor Statement
2 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 or contribute t
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 Discovery Phase 1 Phase 2 Phase 3 NDA Cheminformatics EOP2 Pre - NDA IND Pharmacometrics PBPK Preclinical Regulatory Interaction Post Approval Approval Cognigen | Lixoft DILIsym Services QSP/QST
Slide 5: Technology Overview: The Machine Learning / PBPK / QST(P) Marriage
Technology Overview: The Machine Learning / PBPK / QST(P) M arriage… Permeability, solubility vs. pH, pKa(s), logD vs. pH, Fup, blood:plasma ratio, tissue Kps, CLint, C L filt Local & systemic exposure, drug distribution, parent and metabolite levels, patient variability 5 Machine Learning Inputs fo
Slide 6: GastroPlus By the numbers
: By the numbers… 6 Peer - reviewed journal publications 73% 10% 6% 6% 6% % Revenue by Client Type Pharma/Biotech Generics CROs Chemicals Nonprofit % Revenue by Geography 49% 1% 23% 26% • GastroPlus® client base: ~160 commercial companies and >90 nonprofit organizations • >60 commercial companies li
Slide 7: Clients Driving Software R&D: Funded Collaborations
Cosmetics Europe: Dermal model extensions Est. end date: 2QFY21 Clients Driving Software R&D: Funded Collaborations Large Pharma: Virtual BE trial simulator Est. end date: 2QFY21 FDA: Dermal model extensions Est. end date: 4QFY21 7 Themes: • Whole - body mechanistic absorption • Advanced formulation
Slide 8: >70 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 w
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 clinica
Slide 11: Establish Dissolution Safe Space in Adult and Pediatric Populations (TAMIFLU)
Establish Dissolution Safe Space in Adult and Pediatric Populations (TAMIFLU®) 11 • 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 ex
Slide 12: DILIsym Services Inc., an SLP Company
DILIsym Services Inc., an SLP Company • DILIsym Services, Inc. offers comprehensive program services: – DILIsym software licensing, training, development (consortia) – NAFLDsym and IPFsym software licensing, training, development – QSP / QST simulation consulting projects – Consulting and data inter
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 Exposure Drug Effects DILI Liver Biochemistry/ Pathophysiology Efficacy Mechanistic representation of underlying biochemistry describing pathophysiology is foundation of QSP models PD effects and in
Slide 14: NAFLDsym v2A Overview
NAFLDsym v2A Overview Multiple interacting sub - models, including • Steatosis • Lipotoxicity • Inflammation • Fibrosis • Biomarkers • Weight gain/loss Numerous simulated patients (SimPops) included to account for pathophysiologic and clinical heterogeneity Clinical data from literature used to esta
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 • Predicts drug - induced liver disease • Includes mechanistic representation of normal hepatic biochemistry So how can DILIsym help my organization? • Predict DILI liabilities beforehand and save $$$ • Choose the lead candidate most likely to succeed f
Slide 17: DILIsym Utilizes Various Data Types to Inform Decisions
DILIsym Utilizes Various Data Types to Inform Decisions • Dosing Protocols, fasting/fed state, meal times • Anthropometric data - Body weight, age, ethnicity • Pharmacokinetic data - Absorption, extra - hepatic clearance, metabolites PBPK Modeling • Compound Properties - Tissue partition coefficient
Slide 18: Important DILIsym Application Examples
Important DILIsym Application Examples NORMAL 18
Slide 19: Important DILIsym Application Examples
19 Important DILIsym Application Examples
Slide 20: Important DILIsym Application Examples
20 Important DILIsym Application Examples
Slide 21: Important DILIsym Application Examples
21 Important DILIsym Application Examples
Slide 22: SimulationsPlus Q&A
n S+ SimulationsPlus SCIENCE + SOFTWARE = SUCCESS Q&A SimulationsPlus ymservee io