Certara, Inc. · NASDAQ:CERT
Certara — Technical Presentation (January 2015)
14 slides from Certara's technical presentation, January 2015
Slide 1: Phoenix WinNonlin Workflows: Estimate Preclinical Parameters for Anti-Cancer Agents
Phoenix WinNonlin Workflows: Estimate Preclinical Parameters for Anti-Cancer Agents Dr. Bernd Wendt, Director of Training and Support
Slide 2: Fact Sheet on Frontrunner Compounds
Fact Sheet on Frontrunner Compounds Development candidates Model Parameter EL101 EL102 EL103 Competitor PD (In Vitro) HIF-1α EC50 (nM) 40 13 2 223 PD (CytoTox) HG-1 EC50 (nM) 22 16 6 nd MCF-7 EC50 (nM) 64 40 15 177 MIAPaCa-2 EC50 (nM) 123 43 13 955 PD (Off-Target) hERG inhibition (at 10µM) 18 28 48
Slide 3: Fact Sheet on Frontrunner Compounds
Fact Sheet on Frontrunner Compounds Development candidates Model Parameter EL101 EL102 EL103 Competitor PD (In Vitro) HIF-1α EC50 (nM) 40 13 2 223 PD (CytoTox) HG-1 EC50 (nM) 22 16 6 nd MCF-7 EC50 (nM) 64 40 15 177 MIAPaCa-2 EC50 (nM) 123 43 13 955 PD (Off-Target) hERG inhibition (at 10µM) 18 28 48
Slide 4: Concern 1: Preclinical Experiments in Rodents
Concern 1: Preclinical Experiments in Rodents • Widely used efficacy endpoints – Percentage test to control tumor weight ratio (T/C or TGI%) – Median time to defined tumor weight • Dependent on experimental conditions – Dose – Schedule – Time Recommendation: use PKPD-models – Quantitative link bet
Slide 5: Concern 2: keeping pace with updates
Concern 2: keeping pace with updates • Too many studies – Various compounds – Various dosing regimens – Various cell lines/xenografts – Various formulations • Too many CROs – Differing output formats • Too many Analyses – In Vitro – PK – Xenograft • Not enough time… Recommendation: Phoenix Workflo
Slide 6: Agenda
Agenda: • Phoenix-Workflow: 1. Compound-specific 2. Analysis across compounds © Copyright 2013 Certara, L.P. All rights reserved.
Slide 7: Phoenix-Workflows: Key Features: 1. Data-In
Phoenix-Workflows: Key Features: 1. Data-In • Import Study Data – Prepare for modeling and simulation • Prepare Dosing Tables © Copyright 2013 Certara, L.P. All rights reserved.
Slide 8: Phoenix-Workflows: Key Features: 1. Data-Out
Phoenix-Workflows: Key Features: 1. Data-Out Use Reporter object • Extract relevant information from workflow objects – Across compounds and analyses types • Generate documents reflecting current stage of development – Streamline data to generate summary tables and plots – Automatic preparation of y
Slide 9: Phoenix-Workflows: Key Features: 1. Data-Out
Phoenix-Workflows: Key Features: 1. Data-Out • Use Model Comparer object – Extract diagnostics from related models across compounds © Copyright 2013 Certara, L.P. All rights reserved.
Slide 10: Fact Sheet
Fact Sheet • Automatically generated by Phoenix © Copyright 2013 Certara, L.P. All rights reserved.
Slide 11: Acknowledgements
Acknowledgements • Elara • Certara/Pharsight – Joe Lewis – Serge Guzy (PopPharm) – Bernd Janssen – Simon Davis – Christoph Schultes – Ana Henry – Marcel Muehlbaier – Dan Weiner © Copyright 2013 Certara, L.P. All rights reserved.
Slide 12: Q&A
Q&A © Copyright 2013 Certara, L.P. All rights reserved.
Slide 13: Training Courses and Next Webinar in the Series
Training Courses and Next Webinar in the Series • Certara offers introductory, intermediate, and advanced courses for Phoenix WinNonlin and Phoenix NLME • New Courses added in Europe – Sample listing: • Intermediate PK/PD Modeling using Phoenix WinNonlin – 16-19 March, 2015 in London, UK • Introduct
Slide 14: Contacts & Follow-Up: Thank you!
Contacts & Follow-Up: Thank you! Americas Telephone (US): 888-708-7444 Telephone (Intl): +1-919-852-4685 Email: sales@certara.com Europe Telephone: +33 1 56 95 17 10 Email: sales@certara.com India Telephone: +91 984 500 6625 Email: sales@certara.com Japan Telephone: +81 (0)50-3786-9898 Email: sales@