Altasciences

Is your organization starting clinical research and looking for a way to conduct it in a safe, timely, and cost-effective manner? Is the program designed to meet regulatory requirements for the multiple jurisdictions where you plan to request market authorization? Consider conducting your early clinical development in Canada. Many biotechnology and pharmaceutical companies have moved their initial clinical research to Canada to get earlier access to first-in-human data, high-quality clinical research, and reliable study participants. Plus, it can help keep costs down. Here are some of the advantages your organization can expect when moving your early phase clinical research to Canada. Start First-In-Human Trials Earlier Access to FIH trials in Canada is slightly different than in America. You can start FIH clinical trials before obtaining Investigational New Drug approval. That means your contract research organization can conduct study participant recruitment and screening at the s...

Early phase drug development pathways may seem rigid, but there can be some flexibility when it comes to the steps you take in certain phases. Some studies often associated with Phase 1 do not necessarily have to be done before starting Phase 2. The reverse is also true, in that some elements of Phase 2 can actually be performed by you or your contract research organization during Phase 1. This can help you access vital bioanalysis data earlier in the drug development process. As Phase 1 studies have become increasingly complex, early access to trial results and comprehensive data related to safety and drug pharmacology can help better inform decisions. This information can also help support funding opportunities and solidify your overall program. Here are four things you need to know about the flexibility you have during Phase 1 clinical trials. Early and Clinical Pharmacology Study Timing During a drug development program, exploratory therapeutic studies are required milestones, a...

When it comes to drug development and manufacturing, pharmaceutical companies rely on CROs and CDMOs to streamline the research process. After all, developing a new drug or drug variation is a highly regulated and lengthy process. Partnering with a CRO with pharmaceutical CDMO capabilities offers numerous benefits, including access to clinical equipment and facilities and the ability to help your business scale at a faster, more cost-effective rate. Now that partnerships are becoming the norm across the pharmaceutical manufacturing landscape, choosing the right CRO/CDMO partner requires a careful approach to ensure you find the right, most experienced option. Here are a few of the top factors you should look for when selecting a CRO/CDMO partner for your next drug development program. A Wealth of Experience in Drug Development and Manufacturing One of the most important considerations to make when choosing a CRO/CDMO is to search for a partner with a wealth of experience in drug dev...

If your organization intends to develop drugs for the Asian market, you may need to repeat Phase 1 studies in regions outside of North America or Europe—or with your current CRO if they have the right participant populations. This research can help you determine whether the drug’s pharmacokinetics are the same in different ethnic groups. If your organization wants to demonstrate biosimilarity in drug products between Asian and non-Asian populations, consider performing Asian ethnobridging trials. When you decide to incorporate ethnobridging into your project during early clinical development , you can save time and help your budget. Here’s how.  What Is Ethnobridging? Ethnobridging means using a local target population for a study during Phase 1. Instead of needing to repeat studies in the target region, your organization can recruit participants in “global” safety and efficacy trials using a Phase 1 ethnobridging strategy. The Phase 1 development won’t have to be rep...

Toxicity studies during drug development are essential. They play a vital role in helping drug sponsors make informed decisions. Your organization wants tests supporting data-driven decision-making to help move your drug development further along toward manufacturing and clinical trials. Your CRO partner can leverage the preclinical data in planning for and designing your first in human clinical trials . Here are six things you need to know before starting repeat-dose toxicity testing.  How Long Does a Repeated-Dose Toxicity Test Take? Once the design of the repeated-dose toxicity test is finalized, the tests usually range from 2 to 6 weeks. Using bioanalysis to identify biomarkers and other key translational endpoints during preclinical toxicology studies can help reduce the risk to clinical study participants and greatly benefit your research. It helps to have a team well-versed in selecting species, treatment group size, frequency, duration of treatment, administrati...

When choosing a contract research organization to help with your company’s clinical research, you must ensure they have the right capabilities. Ideally, your CRO also offers pharmaceutical CDMO capabilities for over-encapsulation and creating blinded study materials. These are vital during clinical trials. A CRO/CDMO that can run the study and create the dosage form can drastically reduce your timelines. Here is everything you need to know about over-encapsulation and why it might be worth partnering with a CRO with CDMO services and expertise in this area for your next clinical study.  What Is Over-Encapsulation? Over-encapsulation is a cost-effective, popular technique involving blinding a solid dosage form into a capsule shell. This eliminates bias from comparative clinical studies while maintaining the study’s efficacy and integrity. Without adequate blinding, clinical trial participants may be able to tell the difference between a placebo and the real drug. Thi...

Drug development is a highly intricate and complex process. It requires a thorough plan. However, it doesn’t have to be complicated, and you don’t have to go about it alone. With an experienced contract research organization (CRO), you can get the help you need to navigate the requirements. The first step in the drug development process is the preclinical stage. With a reliable and efficient CRO, you can confidently make it through the preclinical stage and move on to the early clinical development phase. Here’s how.  Strategic Guidance and Protocol Development While you can partner with a CRO for stand-alone services along with preclinical and clinical studies, such as bioanalysis, biostatistics, data management, and project management, the best ones offer complete development programs. Think of the very beginning of any program as the planning process. In the discovery and preclinical stages, you need to lay out your strategy for the entire project. You need a CRO t...

If your organization is developing a drug for the first time, you may not know the required regulatory phases. Each is essential to the drug development cycle and regulatory acceptance prior to taking a drug to market. If this is the first time your organization is on its way to first in human clinical trials , whether you are partnering with a contract research organization or not, here is all the most important information you need to know.  The Preclinical Phase The preclinical phase occurs before clinical trials can begin. Researchers must conduct laboratory research and present results to the FDA. The FDA then evaluates and potentially approves the results, paving the way for the clinical trial to begin in earnest. In this phase, regulatory approval is key. If your organization has not submitted results and procedures for regulatory approval in the past, partnering with a CRO with experience may be worthwhile. Phase 1: Safety The first phase of a clinical stud...

When looking for a contract research organization (CRO) with CDMO pharma capabilities, there are certain features you should be aware of. How integrated are the teams? Does information flow freely from one team to the next, or are they stymied by handoffs and delays? What level of manufacturing do they offer? Your organization should address these questions before choosing a CRO/CDMO for your drug development cycle, so here are more details on the top factors to keep in mind.  How Integrated Is the CRO/CDMO? Ideally, all the teams of the CRO/CDMO would be fully integrated with each other. This might mean your organization is assigned a single manager who sees you through the entire drug development cycle, and that teams communicate easily. Find a CRO/CDMO that keeps a database of information that all teams can access, no matter what phase of the development cycle your drug is in. For example, the bioanalysis team would not have to wait for the clinical trial team to ...

It’s nearly time to start early clinical development , and your organization is looking for a contract research organization partner. If you are looking for a fully integrated, all-in-one organization, there are some factors to consider. There are advantages to choosing a full-service CRO instead of partnering with multiple CROs, but a single CRO needs to be able to do everything proficiently. Here are four factors to consider. Do They Have All the Necessary Resources? When a CRO specializes in one discipline, they will likely have the necessary resources to perform that service extremely well. A CRO that can take you from lead candidate selection to clinical proof of concept to commercial manufacturing requires far more resources. The CRO needs the correct medical equipment for first-in-human clinical trials, that are run in their Phase 1 clinical trial units . Ideally, they would have a substantial database of clinical trial participants for recruiting for the study. This can make ...

There has been a recent resurgence in the interest of using psychedelic therapeutic drugs as a potential treatment for mental health issues. The regulatory environment is constantly evolving and has eased some barriers to clinical research. If your organization is considering moving into early clinical development for therapeutic psychedelics, it helps to know a few facts about researching psychedelics to help your organization move smoothly to first in human clinical trials and beyond. How Psychedelics Are Made Generally, psychedelics are either naturally derived or synthetic. Psilocybin, mescaline, and DMT are all naturally occurring, while LSD is fully synthetic. Recent research includes the development of second-generation molecules that will hopefully confer the mental health benefits without potentially unwanted side effects. Types of Mental Health Issues Psychedelics Can Treat A growing body of research shows promise for psychedelics’ potential to treat depression, anxiety,...

If you hope to get reliable, robust data from clinical trials to better inform decision-making, your CRO will need proper handling of specimens obtained from trial participants and samples prepared for lab analysis. Their precise, timely treatment is vital to making go/no-go decisions for a new therapeutic drug. There must be a certainty to the data that comes from proper handling to give the highest accuracy of results to inform decisions. The quality of data depends on rigorous sample management. Integrity needs to be safeguarded at every step. A CRO partner conducting preclinical and clinical studies and providing bioanalytical services must ensure continuity of processes, knowledge sharing, and long-term storage of samples in a centralized location. Here is everything you need to know about choosing the right CRO for your sample management needs. Proper Collection and Storage Conditions There are many different sample types across preclinical studies and clinical trials. The CRO...

In 2017, the FDA declared that driving simulation studies are required for all drugs that may affect cognition. During early clinical development , your organization must determine whether a driving simulation test is needed for regulatory approval. If so, it’s a good idea to partner with a contract research organization that has the experience and resources necessary to carry out the testing. Here are four reasons you should consider partnering with a CRO to conduct driving simulation tests. Recruiting Database Speeds Up Recruiting An experienced CRO will have access to an extensive database of potential participants for your study, from healthy normal volunteers to patients and special populations. These potential participants may have the necessary qualifications for your study or will be easier to screen than if you simply marketed the study to the general population. The CRO can perform the screening process, helping the study get started as early as possible. A recruiting datab...

One of the essential parts of the drug development process is performing bioanalysis . You will need to perform bioanalysis before your drug can go to market, and even before it is tested in humans. You will also need bioanalysis results for regulatory submissions for your drug candidates. As such, it’s best to partner with a contract research organization with plenty of experience in bioanalysis to acquire fast, accurate results. Here is everything your organization needs to know about the importance of bioanalysis. What Is Bioanalysis? Simply put, bioanalysis is a sub-discipline of analytical chemistry. Bioanalysis is quantitative, determining pharmacokinetics, the concentration of drugs, and their metabolites. It can also determine pharmacodynamic biomarkers in biological fluids, such as blood, plasma, or urine. Analyses can also be performed in tissues, which is used to understand the elimination, activity, and toxicity of a drug. How Is Bioanalysis Performed? Before bioanalysi...

If your organization is moving to clinical trials, it’s a good idea to partner with a contract research organization (CRO). However, you will want a CRO that also has the capabilities of a contract development and manufacturing company. Partnering with a CRO that offers CDMO pharma services during early clinical development can mean a much more streamlined drug development cycle. This can help keep your drug development project on schedule and within your budget. Here are some of the advantages of partnering with a CRO/CDMO for your Phase 1 clinical trials. Make Recruiting Easier Partnering with the right CRO means you will have access to its recruiting capabilities. Your CRO partner should have access to a database of potential participants. It should have the ability to further segment this potential participant population into specific demographics that are relevant to your trial. An experienced CRO will also know how to properly market to the target population, whether it is thr...

Recruiting clinical trial participants is hugely influential for the entirety of your drug trial. Entering the recruitment phase of any trial might seem straightforward on paper, but the reality can be very different. The recruitment process can directly impact your trial timeline, as well as the proposed budget of the trial. It influences the tools and resources required to complete the trial and, ultimately, the results of the trial. When you’re conducting research on new pharmaceutical drugs, the integrity of the data is paramount. When deciding on the details for your trial and which Phase 1 clinical trial units to use recruitment strategies that will maintain your timeline, budget, and more, are essential considerations. Here’s what those strategies can look like. Establish a Clear Picture of Potential Participants When recruiting participants, numerous variables need to be addressed ahead of the clinical trial and ahead of the recruitment process itself. Your ideal candidate m...

Large molecules that have recently emerged in biopharmaceutical drug products are prone to generating unwanted immunogenicity-targeting therapeutic drugs. This can impact their safety and efficacy profile, given the fact that the drug is seen as a foreign entity, despite efforts to humanize the active component. Given the complexity of the molecules, there is a regulatory requirement to evaluate protein-based therapeutic products’ immunogenicity profile. Multiple factors can impact the bioanalysis of the immunogenicity anti-drug antibody assay that characterizes the immune response generated against the drug. Here are three challenges to be aware of while performing ADA assays. Matrix Interference in Immunogenicity Assays One of the most challenging parameters to solve is matrix interference in immunogenicity assays. This is especially true when handling disease-type populations. Multiple factors can contribute to interference, including the disease population and demographic, the rh...