Cetero Research, the leading early-stage contract research organization (CRO), is launching a series of scientific seminars, "An Accelerated Path to Proof-of-Concept in Drug Development," designed to help pharmaceutical and biotechnology researchers learn the latest innovations in Phase I and IIa clinical trial designs. The sessions will familiarize attendees with techniques and study designs to save time and money when bringing new drugs to market. The seven-city series starts on September 15 in Princeton, N.J., and ends on October 21 in San Diego.
"We know that pharmaceutical and biotechnology companies are under increased pressure to get drugs to market as soon as possible. Identifying viable drug candidates quickly allows resources to be used more strategically," said Dr. Troy McCall, CEO of Cetero Research. "Through this seminar series, we can share our expertise and best practices in accelerating the drug development process. Some of the techniques we will be discussing have been shown to cut clinical trial timelines in half and reduce costs by more than 10 percent."
The seminars will focus on three topics: combined Phase I and IIa studies to accelerate proof-of-concept, biomarker fit-for-purpose assays and advanced population PK/PD modeling/analysis. Industry experts will share information and real-life case studies about the accelerated proof-of-concept (AcPOC) study designs and how to select the appropriate level of validation for biomarker assays to ensure that studies meet the current guidance. In addition, Cetero executives will discuss lessons learned from conducting more than 10,000 clinical pharmacology studies in a range of therapeutic areas, working with both healthy participants and patient populations.
"Our case studies demonstrate how the AcPOC study design can combine multiple trials – including single ascending dose (SAD), multiple ascending dose (MAD), preliminary interaction and proof-of-concept (POC) – into one study," said Dr. Graham Wood, President of Clinical Operations for Cetero's Toronto and Miami facilities and one of the speakers in the series. "In one allergy study for a major pharmaceutical company, we went from first patient, first visit, to top-line POC results in just 16 weeks, instead of the average 32 weeks. The savings in time and money, as well as the ability to get actionable data earlier, are major advantages for our sponsors in today's environment."
Each seminar will last approximately two hours and feature three presentations with question and answer sessions. The series schedule is as follows:
- September 15 — Princeton, N.J.
- September 29 — Raleigh, N.C.
- October 7 — Chicago
- October 12 — Boston
- October 13 — Philadelphia
- October 20 — San Francisco
- October 21 — San Diego
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