Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — DILIsym Impact Webinar April 2021
20 slides from Simulations Plus's conference presentation, Apr 29, 2021
Slide 1: DILIsym Applications in Drug Development
DILIsym® Applications in Drug Development - Perspectives from 2 Pharma Industry Executives & an Experienced Consultant DILIsym Services Division of Simulations Plus April 29, 2021 *DILIsym®, NAFLDsym®, MITOsym®, ADMET Predictor®, GastroPlus® and SimPops® are registered trademarks, and SimCohorts™, I
Slide 2: Meet the Cast
Meet the Cast…… Dr. Vlad Coric Dr. Paul Watkins Dr. Brett Howell Dr. Lorenzo Pellegrini CEO, Biohaven Consultant Moderator COO, Palladio Bio Professor, UNC *No participants were compensated for 2 participating in this webinar
Slide 3: At Simulations Plus We Put It All Together
At SimulationsPlus We Put It All Together Science Lead Selection Pharmacology Business • Seamless collaboration • Resources available to get • Integrated, innovative the job done on time solutions to meet your needs ADMET Treatment • One-stop shopping – single DMPK Regimen vendor for all of your in
Slide 4: How We Can Help: Two Sides to the Company
How We Can Help: Two Sides to the Company 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 collaboration with
Slide 5: 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 NASDAQ: SLP 5
Slide 6: DILIsym Services Division: Mechanistic, QSP/QST Modeling
DILIsym Services Division of Simulations Plus: Mechanistic, QSP/QST Modeling Innovation: pursuing novel and creative solutions to positively impact the world Respect: promoting a diverse workforce and inclusive culture, while serving our communities Integrity: thoroughly and accurately communicate w
Slide 7: DILIsym Services QST Software Aids Decisions
DILIsym Services QST Software Aids Decisions So how can DILIsym help my organization? • Predicts drug-induced liver disease • Predict DILI liabilities beforehand and save $$$ • v8A released Q1 2019 • Choose the lead candidate most likely to succeed from a DILI standpoint • Includes mechanistic repre
Slide 8: The DILI-sim and RENAsym Consortia Partnerships
The DILI-sim and RENAsym Consortia are Partnerships Between DILIsym Services and Pharmaceutical Companies to Minimize Organ Injury Scientific Advisory Boards • Overall Goals – Improve patient safety – Reduce the need for animal testing – Reduce the costs and time necessary to develop new drugs • His
Slide 9: QST Predicts Tox via Exposure, Mechanisms, and Variability
QST Predicts Tox via the Intersection Between Exposure, Mechanisms, and Inter-Patient Variability Tox Exposure Mechanisms Tox Relevant Biochemistry 9
Slide 10: Important DILIsym Application Examples
Important DILIsym Application Examples “In summary, DILIsym prospectively predicted improved liver safety of rimegepant, zavegepant, atogepant, and ubrogepant relative to telcagepant, and these predictions have been born out in the clinical trials conducted to date. Our results support the value of
Slide 11: Important DILIsym Application Examples
Important DILIsym Application Examples 11
Slide 12: Important DILIsym Application Examples
Important DILIsym Application Examples 12
Slide 13: Important DILIsym Application Examples
Important DILIsym Application Examples 13
Slide 14: Important DILIsym Application Examples
Important DILIsym Application Examples 14
Slide 15: Important DILIsym Application Examples
Important DILIsym Application Examples Simulations including population variability support that across a wide array of patient backgrounds, acetaminophen exposure only results in significant oxidative stress or DNA effects under conditions that cause cell death 15
Slide 16: Important DILIsym Application Examples
Important DILIsym Application Examples 16
Slide 17: Important DILIsym Application Examples
Important DILIsym Application Examples 17
Slide 18: Important DILIsym Application Examples
Important DILIsym Application Examples 18
Slide 19: Take Home Message
Take Home Message……. • DILIsym has helped many drug developers and investors with key decisions and submissions • DILIsym can help your program or project as well – consulting or licensing! • Let’s chat with our panel and get their perspectives…… 19
Slide 20: Meet the Cast
Meet the Cast…… Dr. Vlad Coric Dr. Paul Watkins Dr. Brett Howell Dr. Lorenzo Pellegrini CEO, Biohaven Consultant Moderator COO, Palladio Bio Professor, UNC *No participants were compensated for 20 participating in this webinar