March 2021
In this issue
The latest complimentary webinars, industry podcasts and articles, bioanalytical assays, and more!
The Altascientist
Exploring microsampling applications, benefits, and considerations in preclinical, clinical, and bioanalytical research during early phase drug development. Includes two case studies!
Making Early Phase Drug Development More Efficient
Engaging with a single partner through the critical early stages can make all the difference.
Timely PK Analysis Supports Data-Driven Decisions
Exploring the benefits of including pharmacokinetic analysis between cohorts in first-in-human studies.
Industry News
Keep up to date on the latest news from and about Altasciences.
CONTINUE READING
- Webinars
View the latest on-demand webinars and catch up on some of our favorites, including a new presentation on navigating the abuse potential evaluation of CNS-active drugs for European and American submissions. - Podcasts
HListen to discussions about the principles of the 3Rs in preclinical studies, large molecule bioanalysis, Altasciences’ unique approach to scientific project management, and research support services. - Up Close and Personal with…
Meet Dr. Gaetano Morelli, Chief Medical Officer at Altasciences. - Blog
Learn more about protocol design concepts in Phase I ethnobridging clinical trials.
WCCT Global (an Altasciences Company) Clinic Expansion
Laval, Quebec, March 23, 2021 – WCCT Global, an Altasciences company, announced the expansion of their clinical pharmacology unit and laboratory earlier this year. Today, Altasciences confirms the unit dosed its first study participants.
The expansion added 5,000 square feet of configurable clinical trial facilities. This further ensures participants have access to a socially distanced, comfortable space in which to complete study procedures. An additional 700 square feet of lab space was also added. Read the original press release.
“We are thrilled to be able to provide more functional space for our study participants and staff, and create a dosing environment that can support blinded administrations of medications. This expansion increases unit capacity, operational efficiency, and freedom of movement. We look forward to showcasing our brand-new expansion to our clients and for our subjects to have added comfort during their participation at our site,” said Dr. David Nguyen, Chief Medical and Operations Officer at WCCT Global, an Altasciences company.
Chris Perkin, CEO of Altasciences, adds: “The dosing of the first participants in our West Coast clinic expansion is an important milestone in the evolution of our clinical trial offerings, for both long-term stays and outpatient visits. We are excited to see it come to fruition, and contribute to Altasciences’ continued growth to support early-stage drug development.”
Altasciences acquired WCCT Global on February 12, 2021, adding a third clinical location to existing facilities in Kansas City, U.S.A. and Montreal, Canada. Read the acquisition press release.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Altasciences Qualifies Quantitative Serological Assay for Detection of SARS-CoV-2 IgG Antibodies
Laval, Quebec, March 17, 2021– Altasciences, working with the National Research Council of Canada (NRC), has qualified a quantitative serological assay for the detection of SARS-CoV-2 IgG antibodies, to support vaccine development in studies from discovery to Phase II.
The development of this assay represents an important endpoint in vaccine development, serving to ensure an antibody immune response is generated against the vaccine, and the response ultimately correlates with neutralization of the COVID-19 virus.
Dr. Lynne Le Sauteur, Vice President, Laboratory Sciences, shares what makes this assay qualification unique: “This assay is different from other developments in that it is quantitative, giving an indication of the magnitude of the antibody response, where other assays typically provide qualitative yes/no results. The assay was qualified in a GLP laboratory, using a source of spike protein that is reliably and robustly produced in Canada. We are proud of the success of this qualification, which could not have been achieved without seamless teamwork, scientific expertise in vaccine assay development, and the source of study subject patient serum from Altasciences’ clinics (both with and without SARS-CoV-2 infection) that were needed to qualify the assay. It was a truly collaborative achievement.”
Altasciences has over 260 laboratory sciences experts specialized in bioanalysis, ligand binding assays, mass spectrometry, immunology, biomarkers and molecular biology generating the quality data needed for successful preclinical to clinical drug and vaccine development.
Altasciences worked with the NRC to test various antigens and select the best reagents for the assay. In addition, the NRC produced and characterized the spike protein of the SARS-CoV-2 virus that was used in the testing.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
Bioanalytical Methods for Vaccine Assessment
Altasciences performs robust, bioanalytical assessments according to GLP and GCP regulations for a wide range of vaccine types, including: adjuvanted recombinant proteins, virus-like particles, and nucleic acid- or vector-based vaccines.
We apply our extensive expertise in diverse and complex biological matrices by utilizing broad platform capabilities, for the development of optimal, phase-appropriate methods that meet your unique vaccine program needs, such as:
- Flow Cytometry
- ELISA
- Cell-Based Functional Assays
- Meso Scale Discovery
- Real-Time PCR (qPCR) & Digital Droplet PCR (ddPCR)
Contact our scientists today.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
- Fact Sheet: First-in-Human (FIH) Trials
- Webpage: Preclinical Drug Development Solutions
- Fact Sheet: Comprehensive Research Support
Altasciences’ Commitment to the 3Rs
In this on-demand podcast, Dr. Christina Cruzen, Attending Veterinarian and Chief Animal Welfare Officer, discusses how Altasciences’ commitment to the 3Rs remains a priority and how it pushes us to continuously advance our animal welfare program.
Here are some examples of recent advancements made to the program:
- Partnered with North American 3Rs Collaborative
- Increased the role of the animal behaviorist to help guide specific study needs
- Established a more robust technical review process by involving a new cross-functional committee
- Further refined procedure cages to better fit animal needs
Listen to this podcast to learn more about how Altasciences’ prioritizes animal welfare to ensure the wellbeing of the research animals in our care.
Questions? Speak to an expert.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
Altasciences Conducts Preclinical Studies in Support of Verve Therapeutics’ Gene Editing Approach for Cardiovascular Disease
Laval, Quebec, March 12, 2021 – Altasciences is proud to have conducted preclinical studies for Verve Therapeutics that support the development and advancement of Verve’s gene editing approach to treating cardiovascular diseases. Altasciences’ Seattle team performed intravenous preclinical studies, including supporting analyses of pharmacodynamic markers and whole liver DNA editing, in non-human primates, that show that a single intravenous infusion of Verve’s gene editor achieved a 59% reduction in blood low-density lipoprotein cholesterol (LDL-C) at two weeks, which has been maintained beyond six months post treatment. No adverse events were reported during the study and in studies of primary human hepatocytes, clear evidence of on-target editing was observed.
“We are excited to have supported the advancement of Verve’s gene editors for cardiovascular disease, and to have contributed to the development of an entirely new approach to treating heart disease, which remains the leading cause of death among men and women worldwide,” says Mike Broadhurst, General Manager of Altasciences’ preclinical facility.
More information on Verve Therapeutics’ program can be found here.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com