Why Multinational Clinical Trials are Key to Bringing Novel Therapies to Patients

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working to […]

Long-Term Follow-Up for CGT Trials: Best Practices to Operationalize

By Desmond Cabrera, Project Director, Cell and Gene Therapy With today’s cutting-edge technology, we are on the cusp of developing truly magnificent therapies using cell and gene science. However, as with any new therapy, we must always consider the patient first.   Guidelines to Ensure Patient Safety  As far back as 2001, as new cell and […]

Rare Disease Research – Why We Do What We Do

written by Richard Vesely, MD, VP, Regulatory Strategy Consulting Systemic juvenile idiopathic arthritis – can we do better? When I was a young pediatrician choosing my career path, I started flirting with the idea of pediatric rheumatology, and at the time, an older colleague told me: “Definitely choose pediatric rheumatology! It has one great advantage; Whilst […]

Managing Clinical Trial Risk Strategically: Collaborating for Success With Your Outsourcing Partners

Watch Shannon Macquarrie’s virtual session from Outsourcing in Clinical Trials West Coast conference, February 24-25, 2021. In this presentation you will learn: Decentralized trial execution strategies and the “new” norm Designing a flexible clinical monitoring strategy from the onset Considerations for navigating the post COVID-19 landscape Cost drivers that impact your outsourced clinical trial budget […]