Get Up Close and Personal with Dr. Anahita Keyhani, PhD
Dr. Anahita Keyhani is Altasciences' Senior Director of Scientific Operations, Mass Spectrometry and Method Development.
Clinical and Regulatory Considerations for Developing COVID-19 Treatments – a Discussion with our Experts
Contract Pharma: Altasciences Names Chief Medical Officer
Dr. Gaetano Morelli Named Chief Medical Officer at Altasciences
Laval, Quebec, June 9, 2020 – Altasciences announced today the appointment of Dr. Gaetano Morelli as Chief Medical Officer, effective May 14, 2020.
Dr. Morelli is a member of the College of Physicians of Québec, Canada, with over 30 years' medical experience and over 20 years' global clinical research background. He joined Altasciences in 2013 as a GI consultant and then signed on with Altasciences in 2017, first as Medical Advisor, then Clinical PI, and now Chief Medical Officer.
“Dr. Morelli’s work and decades of experience in clinical research and hospitals have been instrumental to our studies since joining us in 2017. As Chief Medical Officer, Dr. Morelli will continue to provide key insight to our teams in North America and to sponsors worldwide, as we navigate the complexities of early-phase drug development,” said Chris Perkin, CEO at Altasciences.
Prior to joining Altasciences, Dr. Morelli was the Global Medical Director at MDS Pharma for 10 years, overseeing five clinical sites in Canada, the U.S.A., and Ireland. Dr. Morelli is an Associate Professor of Medicine at McGill University, in Montreal. He also continues to be active staff at the McGill University Hospital Center. In addition, he is Director of Gastroenterology/GI Endoscopy at one of the McGill University affiliated hospitals. He has been Principal Investigator in numerous multi-national, multi-center clinical trials.
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, 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
Dietary Biotin Interference in Hybrid LBA-LC-MSMS Assays Characterization, Impact, and Recommendations
ISSUE NO. 13 — Safety Pharmacology Studies Review — A Review
Safety pharmacology studies are defined in the International Conference on Harmonization (ICH) S7A guidance as “those studies that investigate the potential
undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.”
In other words, they are a set of tests focused on potentially adverse effects of pharmaceutical or biological agents, differing from traditional toxicology studies as they are typically concentrated on a single organ or physiological system.
In Issue 13 of The Altascientist, we take a look at the requirements, best practices, and core and supplemental study considerations, including:
- Cardiovascular system
- Central nervous system
- Respiratory system
- Species selection
- Routes of administration
- Dose level selection and duration
- Supplemental (follow-up) studies
- Safety pharmacology endpoints on traditional toxicology studies
Safety Pharmacology Endpoints
Safety pharmacology endpoints can be included in the regulatory single- or repeat-dose toxicology studies. In those instances, species selection is important, as administration by certain routes in certain species may not attain the level of exposure required.
In some cases, combination studies, where integrated approaches examine the inter-relationships of drug-mediated effects on different organs, can be a practical approach for safety pharmacology studies. One example is the addition of FOB/Irwin’s Screen to rodent toxicology studies. The additional assessments are usually performed on a subset of animals, typically from the population of animals assigned to the evaluation of potential toxicity (generally between three to five animals/sex/group).
When designing integrated studies, it is important to consider that safety pharmacology requirements must not confound the interpretation of general toxicology endpoints, and vice versa. For example, surgery for implants may introduce pathological artifacts, while the extra handling and/or novel environments can induce stress artifacts.
How Altasciences Can Support Your Safety Pharmacology Studies
Safety pharmacology may or may not be required to move your molecule forward. Altasciences' experts can provide insight for the fundamental considerations in selecting and designing a suitable program of safety pharmacology. Establishing a specific roadmap which includes the core battery (cardiovascular, respiratory, and central nervous systems) is the starting point, with supplemental studies included when there is a cause for concern. Some safety pharmacology endpoints can be included in the regulatory single- or repeat-dose toxicology studies.
Consult with our scientists for a thorough review of your program requirements, and how we can assist you with a seamless transition to regulatory submission, and human clinical trials.
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Download publicationSelectivity, Selectivity, Selectivity - a New Dimension by Differential Mobility Spectrometry
Complimentary webinar to learn how Altasciences can tackle your most challenging bioanalytical assays by combining the high sensitivity of the SCIEX 6500+ TripleQuad with ion mobility technology to achieve next level detection limits with unprecedented selectivity.