Category Archives: News
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.
SAN DIEGO–(BUSINESS WIRE)–BTS Research, a preclinical services Contract Research Organization, is delighted to announce the addition of Mark T. Crane as Vice President of Business Development. Mark will be taking on the Company’s Marketing, Sales, and Business Development efforts pushing BTS’s business growth model and fostering positive relationships with new and current clients. Particularly, Mark will be pushing BTS’s Toxicology capabilities that aid in the regulatory approval of clients’ drug developmental programs including GLP studies.
“Mark’s combination of industry knowledge, sales training and management skills will enable BTS to move to the next level in size, scope and market leadership”
Crane joins BTS Research from Sinclair where he served as Vice President of Business Development and Marketing. He has held similar positions at SNBL, Ricerca Biosciences, Bridge Pharmaceuticals, ITR, Quest Pharmaceutical Services and MDS Pharma Services.
Crane’s extensive expertise in management, business development and marketing in the preclinical market will be of significant value to the BTS team and the clients. He has an excellent track record of growing preclinical business at exceptional rates.
“Mark’s combination of industry knowledge, sales training and management skills will enable BTS to move to the next level in size, scope and market leadership,” said Sami Abunadi, President & CEO of BTS Research. “Since 2011, BTS has seen double digit growth in their Toxicology offerings year after year and has reached a point where a seasoned industry expert is needed to groom and foster this growth. As a well-recognized industry executive, Mark has proven leadership skills that will be invaluable as we continue to grow our business and add key contributors to the management team.”
About BTS Research
BTS Research provides in vivo and in vitro preclinical research for pharmaceutical, biotechnology and medical device industries worldwide. As both a GLP and non-GLP CRO with extensive experience in discovery research models through IND enabling developmental studies, BTS provides clients with valuable research, direction, best practices and regulatory compliance requirements which ultimately helps them in achieving their goals. BTS is considered instrumental in bettering the lives of humans and animals and is instrumental in value creation for its partners.
For BTS Research:
BTS Research is not only one of the leading CRO pharma companies in San Diego, but also a front runner in global research. BTS Research offers its clients that are looking to hire research pharmaceutical companies in Southern California exceptional services in pharmaceutical/bio pharmaceutical, biotech, academic research, medical device development, and other related industries. BTS Research, one of the major pharmaceutical companies in Southern California and a leading San Diego pharmaceutical CRO that provides customers with biomedical research and toxicology research needs. BTS Research is customer focused and derives its success through dedicated employees, integrity, quality, and strategic partnerships with industry leaders. Customers have praised the dynamic services, friendly environment, and rigorous in-house training. As one of the leading pharmaceutical companies in Southern California, our trained scientists are prepared and equipped to perform the latest and most advanced research assays. A key component in working with a CRO like BTS Research is their understanding of drug metabolism, mechanisms, pharmacokinetics, and epigenetic changes. BTS Research provides many difficult or cost efficient quantitative analysis experiments that are out of reach to many researchers. Outsourcing research needs to this San Diego CRO provides access to cutting-edge research technology and industry leading scientific design. When searching for pharma companies in San Diego or contract research services, it is important to choose a company with a strong background in study design, execution, experimental reproducibility, and a proof-of-concept testing.
San Diego Contract Research Services
BTS Research is a high-quality contract research services that provides interdisciplinary biological studies in areas of pharmacokinetic and toxicology, inflammation, autoimmunity, oncology, would healing, stem cell regeneration, as well as CNS and metabolic disorders. High quality quantitative analyses of drug screens and biological studies are conducted in carefully designed experimental conditions to eliminate confounding factors. BTS Research has consistently demonstrated high quality in vivo and in vitro experimental designs. One of the few San Diego pharmaceuticals, BTS Research offers PK/PD modeling and data which is frequently included in IND applications. BTS Research contract research services deliver careful and controlled animal husbandry. The majority of staff at BTS Research is AALAS-certified and provide the highest quality and standards of care necessary for successful research. Our clients have access to state-of-the-art in vivo research in normal or immunodeficient mice or rats, as well as hamsters, rabbits, canines, pigs, cats, and two non-human primates. Additionally, our staff is qualified and trained to comply with institutional and academic requirements, in addition to regulatory compliance, SDA and DEA registration, AAALAC accreditation, OLAW assurance, and OSHA compliance. For more information on pharma companies in San Diego, or this San Diego pharmaceutical, contact us.
Looking for a preclinical CRO to aid in your research goals? Are you one of the many pharmaceutical companies in San Diego seeking support? California is a host for pharmaceutical companies who share a common challenge of needing to develop proper discovery animal model to help them with their proof of concept and their IND studies. These companies need look no further than their own backyard. Since 2001, BTS research has been helping clients achieve their research goals with exemplary dedication and customer service preclinical Contract Research Organization “CRO”. BTS Research fulfills the wishes of numerous pharmaceutical companies in San Diego, Australia, Europe, India, and other locations around the globe. They provide a robust suite of preclinical CRO services, including drug discovery, mechanism of action studies, and proof-of-concept for novel therapeutics. Among their team are husbandry and research experts that are well-versed in the research procedures for animal models ranging from rodents, rabbits, dogs, pigs, to non-human primates. With extensive experience in modulators, biologics, and medical devices, BTS Research provides its clients with any applicable form of expertise they might require. Their facilities are AAALAC Accredited and the staff are almost entirely AALAS certified, so clients can rest assured that their CRO partners are truly experts in their field and are conforming to all regulations and laws. Undoubtedly, BTS Research is the CRO San Diego needs to keep its many pharmaceutical entrepreneurs satisfied (be it a young company of a fortune 500).
As a preclinical CRO, BTS Research, while does not publish the names of their clients, lists among its clients some of the most groundbreaking pharmaceutical companies California has to offer. Through their experience with agencies and institutions, BTS Research provides pharmaceutical companies in San Diego and beyond with guidance through the many twists and turns of regulatory approval. With thousands of studies in pharmacokinetics and toxicology under their belts, BTS has the portfolio to support the majority of pharmaceutical companies California hosts. Their highly experienced teams maintains registration with the USDA and DEA, as well as helping clients obtain Clinical approval. As one of the top CRO San Diego hosts, BTS is also well-versed with satisfying the OSHA standards set forth by the government.
BTS Research has the capabilities to import non-human primates directly from China via a third party, allowing their clients to obtain the best animal possible for their study. If you are looking for expertise in oncology, autoimmunology, wound healing, or stem cell research, BTS Research stands as the CRO San Diego of choice that one can proudly rely upon. They are also well versed in conditions of and research relating to the central nervous system and metabolic disorders. If you are considering partnering with BTS Research for your needs, their website provides a full listing of their services, and quotes are easy to obtain through their site.
BTS Research is finishing the year on a high note
BTS Research is pleased to report their 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.
SAN DIEGO–(BUSINESS WIRE)–BTS Research announced today that they have appointed Ian Dean as their VP of Toxicology. Ian has over 27 years in the nonclinical contract research industry, with experience across UK, Canada, Asia and the US.
In addition, Ian had various responsibilities in previous CRO’s such as Huntingdon Research Centre (now Envigo), Inveresk Research International (now Charles River), ITR, Southern Research Institute, LAB (now CiToxLab) and Primetrics – Singapore. In addition, Ian has spent 10 years as an independent regulatory consultant and was an Expert External Reviewer for Health Canada’s New Drug Submissions. Ian has extensive preclinical and clinical expertise spanning protocol design, study oversight, regulatory gap analysis, audit of nonclinical and clinical bioanalysis facilities, and preparing regulatory documentation. He is a Diplomate of the Institute of Biology in Toxicology (DIBT) and a Diplomate of the American Board of Toxicology (DABT; 1995-2015).
Ian and a group of Senior Scientists and Study Directors that have been hired over the last six months at BTS are now able to cover the increasing demand for study and program oversight.
“BTS Research is now much more prepared to take on multiple programs and maintain the quality and speed expected by its clients,” BTS President & CEO Sami Abunadi commented. “We are pleased to have Ian join us along with the fantastic new and talented in vitroand in vivo scientists who have proven track record to meet this increasing demand. With the recent expansions in the lab and vivarium space, we had to increase our scientific base to be able to execute with speed and quality,” Mr. Abunadi added.
About BTS Research
BTS is a San Diego based Contract Research Organization (“CRO”) that delivers GLP and Non-GLP biological services to large and small clients in pharmaceutical/biopharmaceutical, biotech, academic research and medical device organizations in the areas of Inflammation, Metabolic Disease, Cancer, Stem Cell and Medical Devices since 2001. BTS Research is a recognized leader in providing global preclinical solutions in all regulated species from early discovery to IND enabling studies.
Antonio Civitarese PhD, MBA
Associate Director of Marketing & Alliance Management
(858) 605-5882 X 317