Congratulations to Ipsen on positive Phase IIIb results from the ELSPIRE trial evaluating IQIRVO® (elafibranor) in patients with Primary Biliary Cholangitis (PBC). The trial met its primary endpoint with statistical significance, with 85% of patients treated with IQIRVO achieving ALP normalization versus 23% on placebo — a result with meaningful implications for how the field … Read more
By Nick Spittal, Chief Operations Officer, Velocity Clinical Research How many times have you heard the term AI this week? Sponsors are investing in it, CROs are building for it, and tech vendors are popping up left, right, and center to sell it. Sites are fully in the crosshairs, with hundreds of hours of procurement … Read more
By Andrew Reina, Chief Revenue Officer I spent the better part of two decades on the CRO side of clinical research, which gives you a particular vantage point. You see how sponsors evaluate site networks, what they ask for, and (more tellingly) what they don’t. Historically, this is a transactional relationship; a site’s job is … Read more
There is a phrase William Beacham, MD reaches for when people ask how he ended up an OB-GYN: congenital gynecologist. It was his father’s speciality, too, and his grandfather was a physician. Four of his father’s five brothers also went into medicine. So, by the time Dr. Beacham was making his own choices, there was … Read more
Since 2020, Velocity Clinical Research has supported trials that contributed to 61 FDA-approved products — and we couldn’t be more proud of what that represents. Those 61 FDA-approved products span an extraordinary range of therapeutic areas: cardiovascular disease, obesity and diabetes, Alzheimer’s disease, respiratory conditions including RSV and COVID-19, dermatology, liver disease, migraine, multiple sclerosis, … Read more
Congratulations to Zydus Therapeutics on the US FDA granting Priority Review to their New Drug Application for saroglitazar for the treatment of Primary Biliary Cholangitis (PBC)! Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG — Velocity Principal Investigator and EPICS-III Study Investigator — was featured in the Zydus Therapeutics announcement highlighting the Phase 3 results of … Read more
Given his time again, Robert Buynak, MD, FACP, may well be a train driver — but as a young man, he wasn’t sure how to go about it. Academically gifted, he was raised in the true spirit of the American Dream: “My mom’s family really pushed academics,” he recalls. His mother, born in Croatia during … Read more
Shishir Khetan, MD has always been interested in science and how the body works. His mother was an OB-GYN and, while she never practiced in the U.S., would talk about medicine here and there — a discourse that helped influence his own interest. “My first real interaction with anything medical was volunteering at a local … Read more
Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG, was featured in the recent Mirum Pharmaceuticals announcement that the VISTAS Phase 2b study of volixibat met its primary endpoint in patients with primary sclerosing cholangitis (PSC) and cholestatic pruritus. PSC is a rare, chronic liver disease with significant symptom burden and no approved therapies. In the VISTAS … Read more
Advarra’s announcement of a new risk‑based AI governance framework features Raghu Punnamraju, CTO of Velocity Clinical Research, underscoring Velocity’s role in advancing responsible AI in clinical trials. Velocity is a founding member of the Council for Responsible Use of AI in Clinical Trials, a cross‑industry group convened by Advarra that brings together leaders from biopharma, … Read more