BTS Research is pleased to share with its clients the results of the FDA audit which was concluded on December 4th, 2019.
Following a 14-day onsite inspection, the FDA concluded their inspection of a 2-week GLP Rat Intravenous study and a 26-Week GLP Oral dog study for two of BTS’ clients. The FDA affirmed that the studies have been performed under the Good Laboratory Practice for Nonclinical Studies regulations [Title 21, Code of Federal Regulations, Part 58].
“We are very pleased with the inspection results especially that the inspection came at a time when BTS Research was in the middle of downsizing their facilities footprint, moving into their new lab and doing a financial restructure.” Mr. Sami Abunadi, President & CEO said.
“We couldn’t have done that without the dedication and the quality of work the BTS Team possess”. Mr. Abunadi added.
BTS Research is a Discovery through IND preclinical CRO located in San Diego offering Inflammation, metabolic, Cancer and Device research in all regulated species (Rodents, Rabbits, Dogs, Pigs and NHP’s).
The downsizing came after major clients of BTS Research concluded their long-term programs in 2017 and their old facility went through a major obstructive construction.
San Diego, Ca.
January 21st, 2020
BTS Research is finishing 2018 on a high note
BTS Research is pleased to report this year’s USDA inspection has been completed with 0 findings. Since BTS incubation in 2001, aside from minor recommendations from USDA that were addressed immediately, BTS enjoys a clean track record with all regulating agencies with no violations.
BTS Research has partnered with BioLaurus Inc. , an advanced molecular imaging group to bring new research capabilities to our pharma research clients.
The gold standard for pre-clinical research has long been the non human primate (NHP) but access to NHP and advanced research capabilities has become ever more challenging. To meet this challenge there are two prerequisites ; the first requirement is a world class facility and staff and the second requirement is advanced molecular imaging capabilities and expertise in imaging and analysis.
Molecular imaging offers unique benefits most important of which is in vivo whole animal PK/PD. Other benefits include:
- Longitudinal study design with time points over seconds to days.
- Translational alignment between preclinical and clinical research models
- Transformative true functional in vivo imaging verifies GLP tox studies.
- Disease staging that reduces dramatically the variability of disease models by placing only animals with the same disease stage on study.
- Imaging assay development based on in vitro and in vivo iterative optimization allowing seamless research cycling.
- Real time bio-distribution that can detect on/off target distribution in all organs and tissues resulting in 3D images and with multiple time points over time, 4D results.
Molecular imaging studies require a variety of expertise from animal handling to surgical expertise, to animal scanning to image analysis. Putting all these moving parts together may seem daunting but that is precisely why pharmaceutical drug discovery and drug development researchers come to BioLaurus. BioLaurus makes advanced molecular imaging accessible. Over the ten-year existence of BioLaurus our researchers have developed the expertise to conduct a wide range of NHP studies including
- Blood brain permeability studies
- Brain PK/PD and receptor occupancy analysis
- Stereotactic implantation
- SPECT (nuc med) Autologous Platelet survival curves and organ sequestration
- T cell biodistribution and trafficking
- Experience with small molecules, Anti Sense Oligonucleotides, and biologics
- Ultrasound vascular and cardiac imaging including strain analysis
- Flow cytometry to ; qualify cells for in vivo injection, track cells , and Receptor Occupancy analysis.
With many cities and states now approving cannabis products, and without a doctor note, the American population at large is being invited to be a part of an uncontrolled drug influence clinical trial without a sufficiently regulated method to question the right dose determination hence consumers and non-consumers are subjected to possible danger.
Now that the cannabis is much more widely dealt with and accepted, many new industries are forging their way with little guidance from the Federal agency regarding how to handle a substance that is well known to be toxic and addictive to be allowed in the industry hands – more importantly as an FDA scheduled substance without current Federal oversight is a concern.
Many brave individuals and trend setters have embarked on either making their mark in the industry or by writing their respective expectation for the Cannabis Industry like the EPA, the Bureau of Cannabis Control, and the ISO 17025. But The FDA has not formed an official stance on the subject.
The fact that this industry most likely will never go away, and that Marijuana is now grown in fields and cropped all over the states. In addition to the international attention that has been met in Canada and other countries, the FDA should at this time, look at how the cigarette, Alcohol labels were historically established and how drugs doses determinations are studied – in combination.
With high concentration of the CBD and other extracts from the plant and with variation of the genetic crop and what the active material does, the brave few that have extracted these active ingredients and made it to the shops, have only their wits to go on besides the state recognized regulations. Why do so when the EPA has been studying crops for decades and we know that there is a variation from strand to strand.
When dealing with plants, it is commonly understood that crops undergo their own optimized growth path, which includes gene’s, pesticides and growing methods. Now, taking a crop that is known to be extremely influential and, in some cases, potent, and allowing it to be processed without acceptable set limits from the FDA is very risky.
The risk we are talking about spans from traffic accidents (just like in driving under the influence), to cognition, to the now diversely present active ingredients from Cannabis Water to cosmetic materials or foods. Soon, people will start preferring a Cannabis influencing beverage over a beer, wine or hard liquor.
To really be able to use the cannabis product safely, one should know how the cannabis will affect their behavior and their health. This can only be done with two primary mechanisms at minimum. 1) Identifying the strand that will be used and maintained and 2) to conduct adequate scale clinical studies that allow the streamlining of the dose determination.
With a significant undertaking of this scope, the FDA would have no choice but to consider allowing this industry into the “large pharma” hands and the clinical trials industry at large, who can and have the ability to conduct such tests. In addition, the FDA should require a clinical medical test for dose determination for all unclassified and determined dose levels or well-studied strands.