This online whitepaper article explores the 2020 regulatory changes in U.S. FDA guidance1 and recommendations, compared to existing EU EMA2 and Japanese PMDA3 guidance for in in vitro drug–drug interaction (DDI) assessments.
Advancing the next generation of pluripotent and multipotent stem cell candidates
Cell therapy breakthroughs, such as chimeric antigen receptor T-cell (CAR-T) therapy, have made a significant impact on the oncology landscape, but many potential breakthrough cell-based therapies are emerging in other therapeutic areas, such as neurodegenerative diseases and macular degeneration. “What we see in the cell-based therapeutic research area today represents …
Are you ready for BIMO inspections?
The time to answer “yes” to the question “are you ready for an FDA Bioresearch Monitoring Program (BIMO) inspection?” is not near or at the end of a trial……it’s at the beginning. And in the middle. And of course, at the end. Inspection readiness is an ongoing and vital component …
DART: Secrets and advice on running successful studies
What is DART? DART stands for ‘developmental and reproductive toxicology’ and is the acronym commonly used in place of the term reproductive toxicology. DART studies assess a chemical’s effect on several aspects of reproductive capacity in laboratory animals. These include mating performance and fertility, sexual maturation, and offspring growth and …
Working with a CRO – tips from the sponsor’s perspective
Congratulations! You’ve just selected the contract research organization (CRO) that best fits your goals, timeline, budget and philosophy. You’re confident that the project team, study and company will be successful! What’s next? Whether you are expecting a “turn-key” solution from your chosen CRO or are partnering with them for a …
Transforming pharmacovigilance operations through automation and cognitive technologies
Traditionally the pharmacovigilance (PV) function has been responsible for collecting, assessing and reporting adverse events (AEs) and related drug safety information to regulators. Because PV is so process driven, companies have had to invest in safety systems to organize data and optimize efficiency. Yet these closed systems, including home-grown systems, …
Inflammatory Bowel Disease clinical studies and the importance of patient centricity
In today’s exceptionally crowded clinical trial environment of inflammatory bowel disease (IBD), patient-centric practices can help your study of Crohn’s disease (CD) or ulcerative colitis (UC) stand out to both patients and sites. Learn about your options to increase your trial’s patient centricity, encourage recruitment and promote ongoing patient retention. …
Enabling rapid response drug development
In an age where new chemical entity drug development can average 15 years to complete and only 0.1% of drugs advance from early drug discovery to approval, a different approach is needed to address a pandemic like COVID-19. “Drug repurposing” and the request of an Emergency Use Authorization (EUA) are …
EU MDR and IVDR implementation and deadlines – Proposal for EU MDR application delay
The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …
GDPR: What is it and what does it mean for your clinical studies: Part II
This two-part blog serves to summarize Covance Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Covance Medical Device and Diagnostic Solutions through a review of the …