Advanced Specialty Research in Nampa, Idaho, is a local trial site organization that typically works with small to mid-sized biotech ventures and contract research organizations as well as big pharmaceutical companies to test novel new therapies in this generally rural region west of Boise, Idaho. However, the trial site organization was recently selected by multinational pharmaceutical company Pfizer to participate in an important study investigating the impacts of the Pfizer/BioNTech COVID-19 vaccine in pregnant women. A high profile study, this trial site organization gains more profile along with the rapidly growing Boise, Idaho region.
Reported on recently by local KTVB 7, director Jennifer Poralla described how the study generally works. This study targets pregnant women and seeks to better understand the safety and efficacy associated for the pregnant mom and the forthcoming baby.
This Phase 2/3 randomized, placebo-controlled, observer-blind clinical trial (NCT04754594) evaluates the safety, tolerability and immunogenicity of 30 µg of BNT162b2 or placebo administered in two (2) doses 21 days apart in approximately 4,000 healthy pregnant women 18 years and up vaccinated at 24 to 34 weeks’ gestation.
Ms. Poralla reports that the study includes extensive monitoring and data derived from an electronic diary given to the participants.
The Trial Site Organization
Advanced Specialty Research (ASR) LLC works on a number of investigational advancements, bringing the state-of-the-art breakthroughs to an area far from major academic medical centers. For example, the trial site organization is conducting a study of a new plant-based Medicago COVID-19 vaccine not yet available to the public. Past the Phase 1 safety phase, it is now undergoing testing with the public.
The staff includes two physicians (investigators), including Dr. Gary Gregerson and Dr. Ryan Owsley as well as Dr. Bill Laitinen. Running at least six (6) trials spanning a range of therapeutic areas, the trial site is located about 20 miles west of Boise surrounded by agricultural areas; although, the total Boise region now includes nearly 750,000 people.
Managing the trial site location and day to day affairs is Jennifer Poralla who has been with the site now for seven years. On the recent news interview, Ms. Poralla noted, “They come in and they have a full safety lab done on them to make sure they are appropriate for it and then at that point we bring them back in and do the traditional vaccine just like you would if you were out at the pharmacy. You would come on day one and get a vaccine and 21 days later you get another one. Then we follow you and the baby for a year.”
Participants are closely monitored through an electronic diary they are given by ASR, along with routine visits. Notes from the participant about how they feel after getting the vaccine along with tests provides extremely valuable data.
Rapid Growth in Boise Region
Boise has continued to grow with migration from California and other locations as people seek a better, higher quality of life. The city and surrounding suburbs have grown rapidly over the last couple of decades. Idaho’s capital city and university town, Boise has a good vibe when visiting the downtown district on a warm summer evening.
Recent news reveals the desirous nature of this area. A recent study by the Boise Regional Realtors uncovered that the rapidly appreciating real estate prices were the result of low housing supply and steady and strong population growth. This region has tremendous lifestyle advantages, which people in ever growing numbers have now discovered.
With a growing population comes the potential for various research efforts and ASR appears to be well situated just 20 minutes to the west.