Re: Altasciences [Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of cannabinoids by Inhalation]
To whom it may concern,
Altasciences’ CEO Chris Perkin Recognized as PharmaVoice Red Jacket Honoree
Laval, Québec, August 12, 2019 – Altasciences is proud to announce that CEO Chris Perkin has been recognized as a 2019 Red Jacket honoree. The Red Jacket Award was introduced by PharmaVOICE in 2014 to honor a select and distinguished group of leaders who have been lauded by their colleagues and peers numerous times as PharmaVOICE 100 designees for their many contributions to their companies and the industry at large. Chris has been a PharmaVOICE 100 designee every year since 2015, and, as a Red Jacket honoree, will be retiring the annual award for the lifetime achievement of the Red Jacket.
PharmaVOICE Red Jacket honorees:
- Challenge us to think differently, act differently, and lead differently
- Create opportunities to make what was once impossible — possible
- Are focused beyond short-term gains and are committed to executing their long-term visions in a tightly regulated and competitive industry
- Have a persistence of vision
- Are truly transforming the life sciences industry to create better health outcomes for all
- Are inspired leaders for today and tomorrow
Throughout Chris’ career, he has demonstrated a commitment to innovation, transformation, mentorship, and philanthropy. His entrepreneurial spirit and leadership have inspired Altasciences’ employees, peers, and company, and his influence is impacting the larger sphere of the life sciences industry.
“I am honored to have been selected for this recognition, which would have been impossible without the unwavering support of the Altasciences team, our sponsors, and key collaborators. I know that, working together, we can continue making positive impacts in the ever-evolving, fast-paced life sciences marketplace,” said Chris Perkin, CEO of Altasciences and Red Jacket honoree.
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
913 304-4505
jcabana@altasciences.com
BioSpace: Movers and Shakers, Aug. 9 By Alex Keown
Altasciences – Beatrice Setnik was named CSO of Quebec-based Altasciences. She has held roles with Ventana Clinical Research in Canada, King Pharmaceuticals and Pfizer in North Carolina, and since 2014 with Syneos Health (formerly INC Research).
Altasciences Welcomes Dr. Beatrice Setnik as Chief Scientific Officer
Laval, Quebec, August 7, 2019 – Altasciences is pleased to welcome Dr. Beatrice Setnik, Ph.D. to the role of Chief Scientific Officer, supporting our internal and external clients with her expertise in all areas relating to early drug development.
Beatrice has a Ph.D. in Pharmacology and Neuroscience from the University of Toronto and since 2005 has been involved in clinical trials in Canada and the U.S.A.; with Ventana Clinical Research in Canada, King Pharmaceuticals and Pfizer in North Carolina, and since 2014 with Syneos Health (formerly INC Research). She has extensive experience in the design, conduct, and reporting of trials in a wide range of therapeutic areas, including expertise in the assessment of abuse and dependence potential of CNS-active drugs. In addition, she is an Adjunct Professor in the Department of Pharmacology and Toxicology at the University of Toronto and regularly participates in FDA meetings and workshops.
Beatrice’s wealth of knowledge and experience will ensure high-level scientific guidance and input on study designs, protocols, and medical and scientific feasibility for new inquiries for current and prospective clients.
“We are extremely fortunate to add a candidate of such caliber and talent to our team. We look forward to Dr. Setnik’s contributions which will reinforce Altasciences’ extensive offerings in early phase preclinical and clinical research,” said Chris Perkin, CEO at Altasciences.
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
913 304-4505
jcabana@altasciences.com
ISSUE NO. 9 — Cardiac Safety Assessment in Clinical Trials
Electrocardiography (ECG) is an integral part of the new drug regulatory environment.
Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity (NCE) development. Sponsors must submit all NCEs with systemic exposure to a dedicated thorough QT (TQT) study to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the QTc interval.
A positive finding of QT prolongation usually has a significant negative impact on a drug's development pathway, necessitating extensive additional ECG assessments, and potentially resulting in approval delays or even discontinuation of the program.
In Issue 9 of The Altascientist, we review:
- Electrocardiography
- Global regulations
- QT/QTc study design
- Timing of QT assessments
- A case study about a first-in-human clinical trial involving a QT assessment
QT/QTc Study Design in Clinical Cardiac Assessments
A thorough QT/QTc study is usually conducted at the end of Phase II or in parallel with Phase III studies. It would generally include 40 to 60 healthy subjects as a crossover design, or up to 240 in a parallel design format. The trial design typically involves healthy male and female subjects, in a double-blind (except for the use of a positive control), randomized, single-site, crossover study.
Depending on the pharmacokinetics of the study drug, parallel designs for TQT investigations may also be used. For crossover studies, subjects are randomized to each of the following treatment groups, with appropriate washout periods as required according to the drug’s pharmacokinetic profile.
In order to accommodate the specialized needs of cardiac assessments, important considerations include ensuring fully-trained and expertly qualified staff, working with the latest monitoring equipment, limiting blood draws or other procedures that affect heart rate in close proximity to the time of an ECG, and ensuring sufficient space around the bed for staff to perform multiple operations with ease.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Download publicationPreclinical Case Study - Assessing the Safety of Novel Therapeutics for Pediatric Indications
June 2019
Pharma Tech Outlook Top 10 CROs