Welcome to thePhoenix User Group Meeting

* Scheduled in Korea Time ZoneSEPTEMBER 10, 20209:00 – 9:05 AM Welcome to the 2020 Phoenix User Group Meeti ng

Tomoo Shinya, General Manager, Asia Pacifi c, Certara

9:05 – 9:15 AM Certara OverviewJieun Choe, Chief Strategy & Marketi ng Offi cer, Certara

9:40 – 9:55 AM The Phoenix Platf orm Evoluti onChris Mehl, Associate Director, Pharmacokineti cs Soft ware, Certara

9:55 – 10:20 AM Phoenix WinNonlin What Is New & Product RoadmapChris Mehl, Associate Director, Pharmacokineti cs Soft ware, Certara

10:20 – 10:35 PM Coff ee Break & Win your gift card15 minutes

10:35 – 11:00 PM Example of NCA Business Rules Used with Parameter Rati o Tool Chris Mehl, Associate Director, Pharmacokineti cs Soft ware, Certara

12:05 – 12:10 PM Wrap Up and Closing Remarks Tomoo Shinya, General Manager, Asia Pacifi c, Certara

11:00 – 12:05 PM Phoenix WinNonlin Bioequivalence Use Case Chris Mehl, Associate Director, Pharmacokineti cs Soft ware, Certara• Parallel• Crossover• Replicate design• FDA reference scale template

9:15 – 9:40 AM [Keynote] Sharing experiences for Model Informed Drug Development (MIDD) in KoreaHwi-yeol Yun, Ph.D. ,Associate Professor,College of Pharmacy, Chungnam Nati onal University

AGENDA: SEPTEMBER 10 - 11, 2020

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SEPTEMBER 11, 2020

OUR SPEAKERS

9:00 – 9:05 AM

9:05 – 9:30 AM

9:30 – 10:05 AM

10:05 – 10:40 AM

12:05 – 12:35 PM

12:35 – 12:40 PM

Tomoo Shinya General Manager, Asia Pacific, Certara Tomoo is the general manager Asian Pacific at Certara since 2013. He has been working at software/ hardware companies for over 20 years where he has gained extensive experience in the pharmaceutical industry.

Jieun Choe Chief Strategy & Marketing Officer, Certara Ms. Choe is Certara’s Chief Strategy and Marketing Officer where she is responsible for spearheading strategic planning and all aspects of Certara’s marketing efforts, including branding, integrated marketing, market development, and market research. Previously, Jieun served as Certara’s Senior Vice President of Strategic Ventures where she developed and executed innovative, strategic initiatives for the company in collaboration with business units and key opinion leaders. She specializes in consumer insights and developing and implementing differentiated business strategies to position companies for growth.

Before joining Certara in 2016, Ms. Choe was Chief Marketing Officer at Triumph Learning and prior to that Executive Director of Marketing at Kaplan’s Precollege Division. She has also held strategic planning and product management positions at Guidant and Boston Scientific. Jieun earned her Bachelor of Arts degree in Public Policy and Economics from Stanford University and an MBA at Stanford University Graduate School of Business.

Implementing a Dose-Titration Study Design in Trial Simulator Dr. Keith Nieforth, Senior Director, Pharmacometrics Software, Certara

Wrap Up and Closing Remark Tomoo Shinya, General Manager, Asia Pacific, Certara

10:20 – 10:35 PM

10:55 – 12:05 PM

• FDA approval case study• NLME vs. NONMEM

* Scheduled in Korea Time Zone

Welcome to Day Two of the 2020 Phoenix User Group Meeting Tomoo Shinya, General Manager, Asia Pacific, Certara

[Keynote] Model-informed drug repurposing: COVID-19 and beyond Kashyap Patel, PhD. Director of Pharmacometrics, Certara

Next Generation Data and Model Repository – Integral Cindy Liang, Associate Director, Enterprise Software, Certara

Overcoming CDISC Roadblocks with PK Submit Kevin Trimm, Senior Director, Product Strategy & Services, Certara

Coffee Break & Win your gift card 15 minutes

Phoenix NLME Use Case Dr. Keith Nieforth, Senior Director, Pharmacometrics Software, Certara

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Chris Mehl Associate Director, Pharmacokinetics Software, Certara Mr. Mehl is the Associate Director, Pharmacokinetics Software for Phoenix WinNonlin and IVIVC Toolkit. Prior to this role Chris was an instructor at Certara University. His educational background is a BS in Molecular Biology from the Ohio State University, and an MS in Pharmacology from the University of Wisconsin. He has conducted over 200 training courses with Certara products, such as Phoenix WinNonlin, IVIVC, NLME, and Trial Simulator. These include workshops at the US Food and Drug Administration, universities, customer sites, and courses open to the public.

Dr. Keith Nieforth Senior Director, Pharmacometrics Software, Certara Dr. Nieforth is the Associate Director, Pharmacometrics Software, which includes Phoenix NLME, Pirana, and Trial Simulator. Keith has more than 20 years of global drug development experience and held a variety of positions within Clinical Pharmacology at Roche, from direct project support roles supporting successful NDAs, to membership on the global Clinical Pharmacology Leadership Team as systems expert for the department.

In addition to his expertise in quantitative and systems aspects of drug development, Dr. Nieforth has a passion for understanding and optimizing the human aspects of successful systems implementation.

Keith has a Bachelor of Science in Pharmacy from The University of Connecticut, and PharmD from the Massachusetts College of Pharmacy.

Kevin Trimm, MSc. Senior Director, Product Strategy, Software, Certara Mr. Trimm is Certara’s head of software product strategy and is responsible for establishing the vision, strategic objectives, and road maps for Certara’s analytical and regulatory software. Prior to joining Certara in 2017, Kevin held a number of positions in contract research firms, including the global head of Pharmacokinetics and Statistics at Charles River Laboratories, where he gained extensive experience in software development, validation, and deployment in highly regulated environments. Kevin was also the co- founder of the consulting firm Montreal Pharmacokinetics Inc. that was later acquired by Certara. Kevin received his undergraduate degree from the University of Waterloo, and holds graduate degrees in Neurobiology and Experimental Medicine. Kevin has a passion for finding innovative technology solutions to complex business problems.

Kashyap Patel, Ph.D. Director of Pharmacometrics, Certara Kashyap Patel is Director of Pharmacometrics at Certara Strategic Consulting. His research interests include mechanistic PK/PD modelling of anticancer, antiviral and antimalarial drugs. Kashyap has over 10 years of postdoctoral experience in pharmacometrics and drug pharmacology. He has a broad range of expertise in pharmacokinetic and pharmacodynamic modelling, bioanalytical assay development and validation, cell culture and in vitro or in vivo evaluation. Past appointments include Modelling & Simulation (Monash University) and Cancer Pharmacology (University of Auckland).

Cindy Liang Associate Director, Enterprise Software, Certara Ms. Liang is the Associate Director, Enterprise Software, which includes Certara Integral and PK Submit. Prior to joining Certara, Cindy has over 10 years DMPK experience in the pharmaceutical and CRO industry, including preclinical and clinical environments. She started her career as a DMPK scientist at Merck Research Labs, then went on to hold key positions at international CROs. In addition to scientific experience and expertise, Cindy has additional significant professional experience with business operations, quality assurance, and business development. Cindy holds a Master’s degree in Pharmacology and is a trained Pharmacist.

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Chandramouli Radhakrishnan, Ph.D. Support Analyst, Phoenix, Certara Chandramouli Radhakrishnan is a support and training scientists at Certara. Chandramouli graduated with a doctoral degree from The University of Queensland, Australia, in Clinical Pharmacology. With his experience, he was able to increase awareness on Certara Softwares (Phoenix Winnonlin, NLME, IVIVC, PK Submit, Trial Simulator, and Integral) in teaching and academic research, as well as in Industry across South Asia Pacific and provide global support.

Takanori Ogawa, MS Senior Application Scientist, Certara Mr. Ogawa joined Certara in 2010 through the acquisition of Bellkey Science Inc., which was a distributor company of Phoenix products in Japan. During his time at the companies, he has provided scientific support for PK/PD modeling and simulation (M&S) analysis to scientists in the pharmaceutical industry, academia, and regulatory agencies of Asian countries such as Japan, Korea, and China. He also has conducted over 250 training courses in those countries. In the courses, he teaches scientific theory and practical applications in addition to software hands-on exercises so that attendees can readily practice the M&S approach to their own R&D project. He earned an MS in Environmental Science from the University of Tsukuba.

Hwi-yeol (Thomas) Yun, Ph.D. Associate Professor, College of Pharmacy, Chungnam National University Hwi-yeol (Thomas) Yun, Ph.D. is Associate Professor at College of Pharmacy, Chungnam National University in Korea. Hwi-yeol’s specialty is pharmacometrics-related techniques including proficiency in advanced and population PK/PD modelling & simulation, and a population PK study for dose optimization of immunosuppressant (cyclosporine and tacrolimus) in transplantation patients. He is also strong at Preclinical in vivo/in vitro PK/PD test techniques.

Hwi-yeol majored Biological Pharmacy/Pharmacokinetics and earned his Ph.D. at College of Pharmacy, Chungnam National University. After earning his Ph.D., he worked in Drug metabolism & pharmacokinetics laboratory of JW pharmaceutical and also he was pharmacometrics advisor at Clinical Pharmacy, Seoul National University during that period. Before he joined Chungnam National University as a professor, he was a post-doctoral fellow of pharmacometrics research group in the department of pharmaceutical biosciences, Uppsala University, Sweden.

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About CertaraCertara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past six years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.

For more information, visit www.certara.com.