As Arena International’s Preclinical Development Operations Summit gets underway in Boston, MA, this week, Clinical Trials Arena will shine a spotlight on preclinical development. Running throughout this week, CTA will post articles uncovering the most pressing issues in early phase trials.
Be sure to visit CTA tomorrow when CTA staff writer Guglielmo Migliori provides regulatory considerations for preclinical trials. On Wednesday, Steven Kates of Lakewood Amedex offers advice on how sponsors should manage their vendors. On Thursday, Harold Smith, University of Rochester, speaks to CTA Editor Henry Kerali about the funding gap in early phase trials, and on Friday, CTA will round off the week by looking at the landscape for preclinical development.
In the meantime, catch up on some CTA’s most recent stories delving into the challenges concerning early phase trials… (click on the headline to finish reading).
Biomarker Considerations for Early Phase Clinical Trials
The average cost of drug development is $1 Billion over the course of 10 years. In recent times, there has been a need for personalized medicine treatments. In many therapeutic areas, patient therapy can be ineffective, oncology and Alzheimer drugs, in particular, are the two most ineffective. Personalized medicine would enable the ability to take advantage of the fact that many tumors are driven by certain genetic mutations.
Biomarkers are important for the success of clinical trials, and for that reason, it's beneficial to adopt the 5R framework: Right target, Right tissue, Right safety, Right patients, Right commercial potential, and Right culture. Take for instance the Crizotinib (Pfizer ALK inhibitor) Approval Success Story: Two single arm studies (n=119 and n=136) in four years with shorter time, fewer patients, and less money.
When It All Goes Horribly Wrong: How Do We Protect Volunteers in Our Early Phase Trials?
In August 2015, Portuguese pharmaceutical company Bial-Portela & CA. SA. began a first-in-human (FIH) clinical trial of its experimental fatty acid amid hydrolase (FAAH) inhibitor known as BIA 10-2474. According to the protocol, the two primary objectives of the study were to evaluate the safety and tolerability of both single and multiple ascending doses, and to investigate the effect of food on the safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) of the molecule. In January 2016 the study was stopped after five participants in the highest dose group experienced serious neurological adverse events. One man died of his injuries. The trial was conducted by Biotrial, a CRO in Rennes, France.
Industry Viewpoints: It’s not about Size, It’s about Competent CROs
Meet Astrid Myrset, Director of Clinical and Preclinical Research at AlgiPharma in Norway. In this Industry Viewpoint, Myrset speaks to CTA about why it's important for small companies to work with professional CROs that can adapt to them. What's more, Myrset shines a spotlight on the challenges of vendor selection and management processes.
Clinical Trials Arena: What are the key attributes that you look for in a CRO?
Astrid Myrset: The primary requirements in our search for a CRO are competence and capabilities. This applies not only for competence to run clinical studies in general, but also related competence to disease indication, regulations and GMP. If they are competent, then the key attributes that we search for are clear accountability and good communication lines, so that we do not waste time and our clinical sites get the best service.