The volume and complexity of clinical data are growing at a faster pace than the industry can manage. Pharma companies large and small are seeing significant increases in end-of-study timelines. The number one cause for end of study delays? External Vendor Data. With over 70% of clinical data now originating from outside EDC, the overwhelming … Continued
One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued
Join us on November 15th for this webcast being held in partnership with TOPRA. In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting … Continued
Learn how to leverage the power of cloud computing to streamline your workflow! Certara’s Phoenix Hosted package provides your PK scientists with a secured and validated Certara AWS workspace allowing for much quicker transit time from compliant data sources. It enhances productivity and supports compliance requirements by managing complex time-based data, the foundation for all … Continued
For the past two years, the biotech sector saw a surge of venture funding and IPOs. Now, by contrast, the sector is cooling down along with a broader contraction in funding globally. While there is still funding available for biotech companies, investors are proceeding with more caution. For biotech companies, researchers, scientists and business leaders, … Continued
The attrition rate of drug programs in early-stage development is high, with two-thirds of preclinical programs failing to move successfully to Phase 1. How do we better inform translational R&D decisions to de-risk investments and help increase probability of success? Physiologically-based pharmacokinetic (PBPK) modeling and simulation is a regulatory-adopted, versatile tool in drug development that … Continued
Regulations in the US and Europe require and/or incentivize sponsors to evaluate their drugs (small molecules and biologics) for use in appropriate pediatric populations. It is generally agreed that that these regulations have stimulated new research efforts in pediatrics. It is essential that individuals, involved in global pharmaceutical research and development, are familiar with these … Continued
Learn how to leverage the power of cloud computing to streamline your workflow! Certara’s Phoenix Hosted package provides your PK scientists with a secured and validated Certara AWS workspace allowing for much quicker transit time from compliant data sources. It enhances productivity and supports compliance requirements by managing complex time-based data, the foundation for all … Continued
Submission publishing for investigational drug programs can be prohibitive and costly as health agencies require ever more submission types in electronic formats like eCTD (electronic common technical document). Rapidly changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult. The volume of the documentation can vary significantly and be quite an undertaking for … Continued
Cell therapies aim to treat, prevent, or potentially cure diseases. They are a relatively new and evolving area, which presents both opportunities and complexities. When developing these types of drugs, biopharmaceutical companies often struggle with three key challenges: Dose optimization. Too low a dose might exclude that patient from any future benefit, while too high … Continued
