20 年的创新
Simcyp was founded in 2001 by Professors Geoff Tucker and Amin Rostami-Hodjegan as a spinout company from the University Of Sheffield, UK, creating a new technology, the Simcyp population-based Simulator. Simcyp joined with Certara in 2012 and has experienced dynamic growth, delivering groundbreaking scientific achievements in the field of physiologically based pharmacokinetic (PBPK) modeling.
Simcyp innovation has been demonstrated on numerous fronts:
- Created a world-renowned and trusted technology for virtualizing R&D and accelerating the development of hundreds of novel drugs;
- Strengthened drug labeling by providing dosing recommendations for special populations, including pediatric, pregnancy, organ impaired, and other diseased patients and bridging between populations
- Educated hundreds of scientists across commercial, academic, and regulatory organizations;
- Provided numerous grants to academic scientific teams including Simcyp licenses at no cost to hundreds of academic institutions;
- Enabled key technology to be leveraged for drug development decision-making, saving time and R&D investment for sponsor companies;
- Groundbreaking use of PBPK in regulatory filings including >200 label claims using the Simcyp Simulator.
Simcyp 协会
35 of the world’s leading biopharmaceutical companies are members of the Simcyp Consortium, which is a pre-competitive group dedicated to teaching, using and progressing PBPK in drug development. The members of the Simcyp Consortium collaborate with Simcyp scientists to guide the scientific development of the Simcyp Simulator, determining annual software development priorities, thus ensuring that the software continues to meet and exceed industry needs. Leading regulators, including the US FDA, European, Canadian and Japan pharmaceutical agencies, use Simcyp for research and drug review.
业界领先的 Simcyp 一体化 PBPK Simulator 平台，用于从早期开发到临床、监管批准和上市后的药物开发中的虚拟决策。The Simcyp PBPK Simulator predicts how the drug will move through the body and how a drug is affected by other medications, ethnicity, age, genetics and disease-state. 它用于减少、引导和/或消除试验，并为新患者群提供剂量建议。
There are 500 peer-reviewed articles by and about Simcyp with >8,000 Simcyp citations.
Education and Collaboration
The Simcyp team conducts internationally recognized, cutting-edge research and development that is published and presented at industry-leading conferences and publications. The Simcyp division maintains strong scientific collaborations, providing sponsored academic teaching and research licenses to more than 120 universities and research institutions around the world. Certara’s in-house expertise also allows the team to provide scientific, software development, project-related consultancy services, and education programs around the world.
Each year, the Simcyp Consortium presents two annual awards to recognize research excellence, for teaching the next generation of scientists, and to give back to the scientific community. The awards are for ‘most informative scientific report’ and ‘most effective teaching application,’ using the Simcyp Simulator. Award winners receive financial support from Simcyp.
Simcyp研讨会
Certara 的 Simcyp 部门对基于模型的药物开发的各个方面都提供了实践研讨会。The full weeklong workshops cover the incorporation of population variability into the mechanistic prediction of PK and modelling of PBPK whereas the 2-day focused workshops cover in-depth some of the major topics in model-based drug development. We also offer customer-specific training, which can be tailored to your specific requirements.
Simcyp 协会成员
