The pharmaceutical industry is undergoing extensive change. Global uncertainty, growing pressures over operational practices and pricing, combined with reducing healthcare costs and ensuring the reliability of treatments mean that strategizing for the future has become more challenging. Pharmaceutical leaders are widely adopting engineering simulation to create significant opportunities from these challenges. Pharmaceutical companies are utilizing simulation to help plan and make long-term decisions with better accuracy. Applying engineering simulation throughout the development cycle can make all the difference in bringing new treatments to patients while meeting safety standards and product deadlines.
Join us for an overview of how modeling is used in the pharmaceutical industry followed by an update on the regulatory opportunity and best practices for using modeling and simulation results. This will be followed by an overview of the importance of systems modeling and a demo of the ANSYS systems modeling simulation platform. The seminar will conclude with a few examples and case studies.
Why You Should Attend:
Learn how computational modeling can help you understand and optimize existing unit operations
See how simulation apps can standardize and automate key analyses
Gain an understanding of how multi-scale simulation can provide additional insights regarding the efficacy of drug delivery platforms
Get the latest information on the regulatory pathway and opportunities for modeling and simulation
Who Should Attend:
This conference is designed for professionals from pharmaceutical companies with responsibilities in the following areas:
Process development engineers
Process R&D engineers
Drug delivery scientists and engineers
Please register early to reserve your spot. Lunch will be provided.
10:00 - 10:30 AM
10:30 - 10:40
ANSYS Welcome and Introductions William Schulz, Regional Director - North California, ANSYS
10:40 - 11:20
Industry Keynote Michael Bolger, Ph.D., Chief Scientist, Simulations Plus, Inc.
11:20 - 12:00
Overview of ANSYS in the Healthcare Industry Including Regulatory Update Marc Horner, Ph.D., Vice Chair V&V 40, Principal Engineer, Healthcare, ANSYS
Understanding and Optimizing Spray Dryer Performance Using Simulations Aravind Kishore, Senior Applications Engineer, ANSYS
1:30 - 2:00
Computational Modeling of Human-Device-Drug Interactions Marc Horner, Ph.D., Vice Chair V&V 40, Principal Engineer, Healthcare, ANSYS
Michael B. Bolger, Ph.D. Professor Bolger is Chief Scientist at Simulations Plus, Inc. in Lancaster, CA. His formal education has been in Biology, Chemistry, Pharmaceutical Sciences, and Pharmacology at UC San Diego and UC San Francisco. He was a professor of Pharmaceutical Sciences for 23 years at the University of Southern California School of Pharmacy and retired from USC in 2004.
From 1987-1993 he was a cofounder and Director of Medicinal Chemistry at CoCensys Inc. He studied the chemistry and use of novel neuroactive steroids for treatment of anxiety, epilepsy, and sleep disorders. Drug candidates emanating from seven of Dr. Bolger’s patents have been tested in Phase I and II clinical trials for petite mal epilepsy, sleep disorders, and migraine.
Dr. Bolger joined Simulations Plus, Inc. in 1996. He programmed the first version of a software program called GastroPlus® for simulation of mechanistic oral absorption and physiologically based pharmacokinetics in 1997. GastroPlus is currently used by all the major pharmaceutical companies, biotechnology, generic drug companies, and many of the global drug regulatory agencies. He currently works with a team of scientist / programmers at Simulations Plus, Inc. in the development of software
programs for estimation of biopharmaceutical properties and simulations of absorption and bioavailability. He was elected to the rank of Fellow of the American Association for the Advancement of Science in 1996. In 2017 he was appointed to the NIH Scientific Advisory Committee on Alternative Toxicological
Dr. Michael Bolger, Ph.D.
Simulations Plus, Inc.
Dr. Marc Horner is a principal engineer leading technical initiatives for the healthcare industry at ANSYS, Inc. Marc Joined ANSYS after earning his Ph.D. in Chemical Engineering from Northwester University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory, science, and clinical applications. These include Vice Chair of the ASME V&V40 Sub-Committee and Chair of the AAPS Process Modeling and Simulation Focus Group (PMSFG). Lastly, Marc is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.
Marc Horner, Ph.D.
Vice Chair V&V 40, Principal Engineer, Healthcare at ANSYS