感谢广大客户对本届会议地支持与参与！ 经过前期精心地组织与筹备，Certara公司与创腾科技联手于2020年5月12日至14日举办的2020 Phoenix User Group Meeting（2020年度中国区用户大会）将如期在线举行，本次活动不收取任何费用。目前注册人数已过百人，注册后您会收到三天会议的登录链接及注意事项。为了方便与会者顺利参会，请大家留意邮件通知！
Cetara公司全球专家首次齐聚云端，诚邀您出席本届大会，期待与您线上相聚！
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.
Michael K. Eckstut
SVP Software, Certara
Mr. Eckstut is the head of the Software and Regulatory Technology business at Certara. He joined Certara in 2014 to lead Certara’s Strategic Consulting Group. He has more than 35 years of business and operational experience in large, small and early stage life sciences companies as an operating executive,consultant, investor, advisor and board member.
Prior to Certara, Mr. Eckstut was part of the Global Leadership team at Archstone Consulting, a Hackett Group company where he headed the Life Science Practice and the firm’s West Region. He has also been a senior partner and head of Life Science (Pharmaceuticals) practices and board member at leading management consulting firms, Booz-Allen and AT Kearney. In addition, Mr. Eckstut was an executive in several early stage software companies, which provided tools for improving biopharma R&D and clinical trial outcomes. Mr. Eckstut holds a BS and MS cum laude in Chemical Engineering from Rensselaer Polytechnic Institute(RPI) and an MBA (as a Baker Scholar) from the Harvard Graduate School of Business Administration.
Jieun Choe
Chief Strategy and 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 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.
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 Kaplan’s Precollege Division. She has also held strategic planning and 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.
Professor Bei HU
Professor and Director
Beijing Key Laboratory of Clinical PK/PD
Clinical Pharmacological Research Center
Peking Union Medical College Hospital
Professor HU has worked in Clinical Pharmacology Research Center (CPRC), Peking Union Medical College Hospital (PUMCH) for 25 years since 1995. She graduated from Peking Union Medical College with medical doctoral degree in 1989. From 1991 to 1994, she was trained in drug metabolism and biotransformation as a postdoctoral fellow in the University of Washington at Seattle, USA. Since then, her research interests covered early phase drug development and biotransformation research of new drugs in human, including model based drug development and metabolites’ seeking and identification. As a principal investigator, Professor HU has conducted more than 100 new drug clinical trials during the past two decades.
She is the chairman of Pharmacometrics Professional Committee of Chinese Pharmacological Society (PPCCPS, in brief also named PCPC, 中国药理学会定量药理学专业委员会), vice chairman of Biochemical and Molecular Pharmacology Professional Committee of Chinese Pharmacological Society (BMPPCC, 中国药理学会生化与分子药理学专业委员会), and standing committeeman of Division of Clinical Pharmacology of the Chinese Pharmacological Society (DCPCPS, 中国药理学会临床药理学专业委员会). Professor HU also works for the Center of Drug Evaluation (CDE) of NMPA as an external consultant, and the Institute of Executive Development (IED) of NMPA as a guest professor.
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.
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.
Agenda - May 12, 2020 |
9:00 – 9:05 AM | l Welcome to the 2020 Phoenix User Group Meeting |
Tomoo Shinya, General Manager, Pacific Rim, Certara |
9:05 – 9:15 AM | l Certara Overview |
Michael Eckstut, Senior Vice President, Software, Certara |
Jieun Choe, Chief Strategy & Marketing Officer, Certara |
9:15 – 9:45 AM | l Keynote Presentation |
Professor Pei HU |
9:45 – 10:00 AM | l The Phoenix Platform Evolution |
Chris Mehl, Associate Director, Pharmacokinetics Software, Certara |
10:00 – 11:00 AM | l Phoenix WinNonlin Workflow |
Cindy Liang, Associate Director, Enterprise Software, Certara |
Plots
Noncompartmental analysis module
Summary table
Reporter tool
Q&A |
Agenda - May 13, 2020 |
9:00 – 9:05 AM | l Welcome to Day Two of the 2020 Phoenix User Group Meeting |
Tomoo Shinya, General Manager, Pacific Rim, Certara |
9:05 – 10:45 AM | l Phoenix WinNonlin Bioequivalence Use Case |
Chris Mehl, Associate Director, Pharmacokinetics Software, Certara |
Parallel
Crossover
Q&A
Replicate design
FDA reference scale template
Q&A
|
10:45 – 11:00 AM | l Phoenix WinNonlin Roadmap |
Chris Mehl, Associate Director, Pharmacokinetics Software, Certara |
Agenda - May 14, 2020 |
9:00 – 9:05 AM | l Welcome to Day Three of the 2020 Phoenix User Group Meeting |
Tomoo Shinya, General Manager, Pacific Rim, Certara |
9:05 – 10:00 AM | l Phoenix IVIVC Toolkit Use Case |
Chris Mehl, Associate Director, Pharmacokinetics Software, Certara |
Why use IVIVC: Biowaiver application
The IVIVC method
Project demonstration
Q&A |
10:00 – 10:55 AM | l Phoenix NLME Use Case |
Dr. Keith Nieforth, Senior Director, Pharmacometrics Software, Certara |
FDA approval case study
NLME vs. NONMEM
Q&A |
10:55 – 11:00 AM | l Wrap Up and Closing Remarks |
Tomoo Shinya, General Manager, Pacific Rim, Certara |
Phoenix User Group Meeting
>> 下载会议通知：
【第二轮】2020年度Phoenix User Group Meeting会议通知.pdf
