Regulatory Affairs
Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD
Many of my colleagues and I are members of the Cross-Company Abuse Liability Council (CCALC), where I have been a co-chair for the past seven years, and a member for 15.
Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development
The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
Top Life Science Resources for Fall 2024
There’s a lot of life science content out there, so for your convenience, we’ve curated a selection of expert insights, tips, case studies, and scientific and regulatory information. Catch up on what you might have missed below!
Regulatory Comparisons for Starting First-In-Human Clinical Trials
Exploring the Advantages of Canada for Early-Phase Clinical Trials
Where you decide to conduct your early-phase clinical trials could have a significant impact on your costs and timelines. There are lots of factors to consider when making that decision—in some cases, performing clinical trials in Canada and the U.S. simultaneously can be the right step towards optimizing your program. But as sure as maple syrup is great on pancakes, and mustard is better on hot dogs, some things are simply just a better fit.
Top 10 Life Science Resources - October 2023
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!
Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines
Drug Development Timelines: How Health Canada’s 30-Day Regulatory Review Process Could Provide an Advantage
We want novel therapies to be approved fast, while being safe for us. Regulatory agencies around the world strive to balance the critical elements of speed and safety; at the same time, a rigorous review process is a must.
Five Reasons to Choose Canada for Your Clinical Trials—From the Webinar Demystifying the Conduct of Clinical Trials in Canada
Canadian research facilities are becoming a popular choice for American and European sponsors, carrying out hundreds of clinical trials each year.
ISSUE NO. 31 — The Advantages of Conducting Early Phase Clinical Research in Canada
Timely completion of necessary studies is a critical element of drug development, bringing important treatments to patients in a safe and cost-efficient way. 
A consideration with a measurable impact on early-phase clinical studies is the location where trials are performed; this is especially true for first-in-human (FIH) trials.
Conducting early-phase clinical research on novel compounds in Canada can provide significant advantages versus other locations.
In Issue 31 of The Altascientist, we take a deep dive into these advantages, covering:
- Canadian CTA trials–time and cost savings
- Regulatory review process predictability
- Business efficiency cost savings
- Clinical trial participants
LAUNCHING CLINICAL TRIAL APPLICATIONS (CTAs) IN CANADA
To initiate a clinical trial in Canada, a Clinical Trial Application (CTA) specific to the given study is submitted to Health Canada (HC) for approval, along with submission of study materials to an Ethics Review Board. The studies conducted under a Canadian CTA can be used to support an IND in the U.S., or a marketing authorization application in the EU, the UK, and any other regulatory regions, such as Asia and Brazil.
Studies in Canada are conducted in accordance with the International Conference on Harmonisation (ICH) guidelines, are of high quality and compliant with regulatory and ethical standards, and are routinely used to support drug applications by global regulatory agencies, including the U.S. FDA and European Medicines Agency (EMA).
A well-planned clinical program designed to meet all the regulatory requirements for the jurisdictions where you plan to request market authorization can be conducted cost-efficiently, safely, and in a timely manner in Canada. In fact, the majority of studies conducted at Canadian early-phase CROs are used for ex-Canadian submissions.
ALTASCIENCES’ EXPERTISE IN CLINICAL STUDIES IN CANADA
Altasciences has a clinical pharmacology unit (CPU) in Montréal, Québec, Canada, and the expertise to ensure efficient, compliant trial conduct. In 2022, Altasciences submitted 45 innovator CTAs (30-day default review) which represents almost 30% of the total Health Canada CTA submission volume for 2021-2022. We also submitted 46 bioavailability/bioequivalence (BA/BE) CTAs, which corresponds to 25% of the total Health Canada BA/BE CTA submission volume for 2021-2022.
In addition to designing, conducting, and reporting on clinical trials, Altasciences provides preclinical, bioanalytical, data management, and biostatistics solutions that bring additional efficiencies and savings. Altasciences’ integrated offerings in manufacturing are also a benefit, as your program is developed, analyzed, and approached holistically from the start.
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.