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:
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
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.
©2018
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:
Sahar Marshood
(209) 207-5667
bd@btsresearch.com
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.
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.
