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Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

Recently, artificial intelligence (AI) has been front and center of newspapers, trade journals, and social media. It gleams in the limelight the same way as a host of other past innovations. Like many scientists, I look at innovations as an advancement. However, little did I know what the business outlook on innovation was until I … Continued

The Best Biosimulation Software, Technology & Services Blogs of 2022

We are grateful for all our loyal blog readers. Can you believe that it’s been eight years since we started blogging about our challenges and accomplishments in model-informed drug development, scientific informatics, regulatory science, and market access? Before plunging headfirst into 2023, we wanted to stop, reflect, and share our 2022 highlights with you in … Continued

Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label

Physiologically based pharmacokinetic (PBPK) modeling and simulation has become an established approach to assess drug-drug interaction (DDI) liabilities involving CYP enzymes, with transporters and/or absorption-related mechanisms evolving in its acceptance by regulators. In addition, the use of PBPK modeling in specific populations such as organ impairment populations has been recently highly encouraged by the US … Continued

Ghent University wins the 2021/22 Certara-Simcyp Grant and Partnership Scheme

PRINCETON, N.J., January 9, 2023 — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that Ghent University (Belgium) submitted the successful bid for the 2021/22 Grant and Partnership Scheme (GPS). Funding will now be provided for a two-year Postdoctoral Fellowship research project titled ‘Optimisation of therapy in patients with chronic kidney disease: … Continued

Collaborative Digital Technology Enables Patient Centric Healthcare

For life science companies, being provider-focused is out. Patient centricity is in. Two factors are driving this trend: Thus, life sciences companies are adopting more agile systems and promoting innovative business models in response to pricing pressures and declining drug profitability. They are also incorporating the voice of the patient in decision making from drug … Continued

Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued

Questions Regarding the Public Release of Clinical Information Draft Guidance – Part I

Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide. Nirpal Virdee, Synchrogenix’s Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public … Continued

Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II

Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health … Continued

10 Blogs that Rocked Our World in 2020

Introduction 2020 was a year that none of us will ever forget. The COVID-19 pandemic upended our lives in ways big and small. From the challenges of working at home with small children underfoot to the heartbreak of losing more than two million irreplaceably precious people to this global viral scourge, 2020 was the year … Continued

Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

Accelerate The Simcyp PBPK Simulator enables you to accelerate your clinical development by avoiding and/or replacing clinical trials with PBPK modeling. Quickly perform early PK first-in-human dose assessments to triage potential compounds with best chance of success. Test alternative formulations in silico with the Simcyp Simulator. Advise Advise clinical trial design to reduce the study … Continued
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