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5 Reasons to Conduct Early Clinical Development in Canada

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 same time as the Clinical Trial Application. This follows Institutional Review Board Approval. With a 21-day timeline, the CTA process itself is also streamlined. Overlapping activities and shorter timelines present an opportunity for significantly earlier access to FIH trial data. You can then use that data to strategically enhance your IND submission in the U.S. Tax Credits and Favorable Exchange Rates Another major benefit of conducting early clinical development in Canada is cost savings. If your company already has a presence in Canada, attractive tax credits can contribute to your development program’s cost-effectiveness. A lower currency value, thanks to favorable exchange rates, is another cost-saving factor. Canadian research operates at the same level as the United States’ technology, and the country has comparable scientific advancement. As a result, your organization gets to benefit from these similarities. Quality of Clinical Research Canada complies with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and many reputable clinical research teams call Canada home. These teams are experienced in managing complex studies that span international borders. Plus, they have health research networks and strong information-management systems to support their efforts. High-Quality Potential Participants Your clinical trials will have high-quality potential participants, thanks to publicly funded free universal healthcare. The Government of Canada supports the Medicare initiative, which is universally administered while each province is individually managed. There is a “continuum of care” across the country, helping manage patient health and making recruiting for clinical trials more efficient. Pharmaceutical and biotechnology companies can leverage the high quality of potential trial participants during pivotal early phase clinical trials. Easier Access to Clinical Teams Canadian contract research organizations offer U.S.-based clients relative proximity, meaning live interactions with staff and program monitoring are possible. Same-day travel to Phase 1 clinical trial units is also possible, and in many cases, travel documents or visas are not required. This can facilitate smooth program deployment and interactions between your organization and the CRO. About Altasciences As a mid-sized contract research organization, Altasciences understands all the intricacies of the complex drug development process. This CRO with pharmaceutical CDMO capabilities uses their proprietary communication database to quickly share data across teams, helping streamline your drug development program. Biotechnology and pharmaceutical organizations rely on Altasciences’ integrated, innovative approach for preclinical studies, clinical trials, and manufacturing. When partnering with Altasciences, you gain the team’s expertise in various therapeutic indications and study types. These include first-in-human clinical trials and CNS clinical trials. This dynamic CRO/CDMO offers partners access to a wealth of resources, including Phase 1 clinical trial units with more than 580 beds, a recruiting database of more than 400,000 potential participants, and trained and experienced staff. Partner with Altasciences for early clinical development in the US and Canada at https://www.altasciences.com/ Original Source: https://bit.ly/3SNa7an

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Flexibility in Timing for Phase 1 Clinical Studies

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, and clinical pharmacology studies include both conditional and mandatory studies. You will only need conditional studies when specific safety data is required for regulatory approval. These can sometimes be conducted at different stages of your program. Human Abuse Potential studies might be part of CNS clinical trials, for example, and may be done in Phase 1 or later. They are likely needed for the end of Phase 2. In some cases, these studies may be waived, thanks to supporting data. Combining Protocols in Phase 1 Combining protocols requires planning for and conducting multiple analyses. It might include multiple cohorts in a Phase 1 trial. For instance, you may need to assess the food effect for a small molecule, and this step can be incorporated into your first in human clinical trials. You might include a special population cohort at the beginning of the study to help you gain a deeper understanding of PK/PD or early proof of concept within those groups. Flexible protocol language is also necessary when combining protocols and different assessments. Deep knowledge of the molecule, applicable regulatory guidance, and clearly defined assessments are also required. Combining protocols means earlier access to data, helping eliminate certain clinical pharmacology studies, obtaining waivers for specific analyses that usually occur later, and reducing requests for additional information. Special Population Trials Another way to strengthen the data collected in Phase 1 and optimize your submission package is to include a special population cohort. This special population should be made of those likely to be treated by the investigational drug. This additional cohort should be studied after SAD and MAD cohorts. Special populations could include pediatric or elderly patients and individuals with a concomitant chronic disease or medication regimen such as hypertension, diabetes, or depression. Allocating Resources Resource availability frequently influences decisions regarding the acceleration of study timing. If your organization has multiple drugs in development, you may opt to balance those timelines to maximize revenue streams. Funds from approved drugs can be used to fund discoveries. If there is little need for supplemental analysis based on early preclinical and clinical signals, you may choose to wait until later in the development process to perform specific assessments. About Altasciences As a mid-sized contract research organization, Altasciences understands all the intricacies of the complex drug development process. This CRO with pharmaceutical CDMO capabilities uses their proprietary communication database to quickly share data across teams, helping streamline your drug development program. Biotechnology and pharmaceutical organizations rely on Altasciences’ integrated, innovative approach for preclinical studies, clinical trials, and manufacturing. When partnering with Altasciences, you gain the team’s expertise in various therapeutic indications and study types. These include first-in-human clinical trials and CNS clinical trials. This dynamic CRO/CDMO offers partners access to a wealth of resources, including Phase 1 clinical trial units with more than 580 beds, a recruiting database of more than 400,000 potential participants, and trained and experienced staff. Learn how Altasciences can help accelerate your drug development program at https://www.altasciences.com/ Original Source: https://bit.ly/3ULoptR

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The Basics of Choosing a CRO/CDMO for Your Drug Development Program

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 development and manufacturing. Drug development and manufacturing are inherently complex, meaning you want a partner organization that can simplify the logistics and ensure a speedy and successful path to market. Likewise, you want a partner that operates with a fully integrated model from lead candidate selection to clinical proof of concept (and beyond) and full-service solutions, including preclinical safety testing, bioanalysis, pharmacology, proof of concept, and clinical monitoring. Most importantly, you’ll want a CRO/CDMO that can help you make streamlined, more educated decisions at every stage of your drug’s development cycle. A Proactive and Flexible Approach Given the complexities of drug development and manufacturing,it’s also important to partner with a CRO/CDMO that offers a proactive and flexible approach. You need an organization that can anticipate your project’s needs from the very beginning. This helps mitigate potential risks, condense timelines, and provide cost savings across your entire drug development program. For instance, imagine the benefits of being able to plan the details of your clinical program while your preclinical safety assessment is still ongoing. Similarly, what if you could start first-in-human trials sooner by timing small-scale drug formulations with clinical conduct? While these are just a few examples, they showcase how a well-designed roadmap designed by the right CRO/CDMO can help you get to clinical proof of concept that much faster. An Expansive Network of Modern and Efficient Clinical Facilities The right CRO partner that offers CDMO pharma services should also have an expansive and strategically placed network of modern and efficient clinical facilities. This means you’ll want to find a CRO whose preclinical trial facilities are purpose-built and capable of conducting regulatory safety testing and research support services for both small and large molecules. Likewise, their clinical trial facilities should include Phase 1 and Phase 2 clinical pharmacology units for healthy volunteers and patient population studies. From there, you’ll want to gauge their specialized assessment capabilities for driving simulation studies or studies related to human abuse potential. A Reputation for Precise Bioanalytical Services To echo the above, you’ll also want to ensure that you’re partnering with an organization that has a reputation for precise bioanalytical services across a wide range of study types. Again, experience is essential here. Whether it’s a stand-alone analysis of your samples or part of a package, the right CRO/CDMO should have facilities that include designated containment Level 2 areas for work with Risk Group 2 pathogens. As an added level of security, look for expertise in LC-MS/MS, ligand binding, microsampling, and gene therapy analysis. These various considerations ensure that you’re able to choose a CRO/CDMO partner that can accommodate all your bioanalytical or preclinical needs. About Altasciences As a mid-sized contract research organization, Altasciences understands all the intricacies of the complex drug development process. This CRO with pharmaceutical CDMO capabilities uses their proprietary communication database to quickly share data across teams, helping streamline your drug development program. Biotechnology and pharmaceutical organizations rely on Altasciences’ integrated, innovative approach for preclinical studies, clinical trials, and manufacturing. When partnering with Altasciences, you gain the team’s expertise in various therapeutic indications and study types. These include first-in-human clinical trials and CNS clinical trials. This dynamic CRO/CDMO offers partners access to a wealth of resources, including Phase 1 clinical trial units with more than 580 beds, a recruiting database of more than 400,000 potential participants, and trained and experienced staff. Partner with Altasciences for your next drug development program at https://www.altasciences.com/ Original Source: https://bit.ly/3CgzJXB

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How Asian Ethnobridging Trials Can Shorten Drug Development Timelines

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 repeated for Phases 2 and 3, making it possible to use the same Phase 1 clinical trial units without finding other units globally. This can help reduce drug development timelines, often by years. Why Should You Perform Ethnobridging? More than half of the world’s population is genetically Asian. Within the many Asian subgroups are known differences in pharmacogenetics and previously identified variants. These are significantly more or less prevalent in Asian populations compared to other populations. In the past, this meant timelines for drugs developed in Asia differed from Western regions. Time lag could last for years. While some of these problems have been addressed in the past few decades, it is still easier to perform ethnobridging locally as opposed to multiple studies worldwide. Bridging Data with ICH E5 Guidance Another strategy for addressing this lag was with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issuing the ICH E5 guidelines. Drug development sponsors must have a complete clinical data package. This includes adequate characterization of PK/PD, safety and efficacy, and a clear definition of dose response. Authorities will also review region-specific medical and diagnostic approaches. Once it passes this step, your organization can consider a bridging strategy for implementation. ICH E17 Guidance ICH E17 provides further guidance, giving context for multi-regional clinical trials (MRCTs) that support global drug development. These guidelines include genomic sampling, the use of good clinical practice, and statistical principles for control groups and sample sizes. MRCTs that follow E17 allow for investigation of treatment effects, such as safety evaluations in the overall population. It can also facilitate submitting marketing authorization applications to multiple regulatory authorities in different regions simultaneously. This can provide earlier access to new drugs worldwide. Accelerating Asian Drug Development Through Ethnobridging Depending on the region of Asia you’ve decided to target, your drug development may only need to perform Phase 2 studies and beyond in the target regions. Phase 1 studies could be done in the U.S. with an ethnobridging strategy. FIH, SAD/MAD, and ethnobridging trials can be conducted in the U.S. if your drug is developed for all Asian markets simultaneously. Target development regions and ethnobridging strategies can be identified, with further decisions following consultations with regulatory authorities across the regions. About Altasciences Altasciences, a mid-sized contract research organization, understands drug development is a complex process. Their fully integrated team helps keep their sponsors’ drug development projects smooth and streamlined, from discovery to preclinical to clinical, and beyond. Altasciences is a fully integrated CRO with pharmaceutical CDMO capabilities, and all their teams share access to a proprietary database. Pharmaceutical and biotechnology companies of all sizes count on Altasciences’ innovative, integrated approach for preclinical studies and clinical trials. Partnering with the Altasciences team means you gain expertise in a wide variety of therapeutic indications and study types, including first-in-human clinical trials and CNS clinical trials. This CRO/CDMO offers sponsors access to many resources, including more than 580 beds, highly trained and experienced staff, and a recruiting database with more than 400,000 potential participants. Partner with Altasciences for an ethnobridging study at https://www.altasciences.com/ Original Source: https://bit.ly/3D8erw7

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6 Things to Know About Repeat-Dose Toxicity Testing

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, administration route, in-life observations, and terminal endpoints based on the properties of your intended clinical use. What Is the Goal of the Tests? When performing toxicity testing, the goal is to identify possible adverse effects of exposure to a test article. This develops dose-response relationships which, in turn, provide relevant information about the severity of effects occurring with exposure. This can be used to predict the effects on human populations. If you are teaming up with a CRO, find one that follows Good Laboratory Practices (GLP). These standard regulatory programs help ensure quality, consistency of format, and the integrity of nonclinical safety test data when submitted for new drug approval to worldwide regulatory agencies. What Do Tests Look for? Repeated-dose toxicity tests look for potential adverse effects with repeated doses of your test article over a period of time. The tests can help determine the maximum dose that can be given over a specified period without compromising the survival of the test models. This information is critical for determining dose ranges when it comes time to perform first-in-human trials. What Are Some of the Common Tests Performed? The two most common tests are the Ames and hERG tests. The Ames tests looks for mutations in DNA. The hERG test checks for cardiac abnormalities. Both can provide valuable data that helps you make decisions in subsequent stages of your project. What Other Toxicity Testing Is Part of Drug Submission? Sub-chronic and chronic toxicity tests may be needed as part of a new drug submission. They are used to test drugs that may be used on human participants on a long-term basis. Much like repeat-dose toxicity study designs, longer chronic and sub-chronic studies are used to further test any hypotheses of mode of action. They are useful for predicting the health effects of your test article in human exposure, further characterizing the dose-response relationship, identifying target organs, and identifying a dose level that does not demonstrate adverse effects. Finding a Partner for Repeated-Dose Toxicity Tests If you are looking for a partner to run toxicity tests, your organization will want a CRO that adheres to GLP practices. Having toxicologists and clinicians can help your organization leverage both preclinical and clinical perspectives while designing GLP repeated-dose toxicity tests that enable first-in-human tests. Ideally, reports should be prepared SEND-ready to help facilitate your submission to any regulatory agencies. About Altasciences Altasciences, a mid-sized contract research organization, understands drug development is a complex process. Their fully integrated team helps keep their sponsors’ clinical research projects smooth and streamlined. Altasciences is a fully integrated CRO with pharmaceutical CDMO capabilities, and all their teams share access to a proprietary database. Pharmaceutical and biotechnology companies of all sizes count on Altasciences’ innovative, integrated approach for preclinical studies and clinical trials. Partnering with the Altasciences team means you gain expertise in a wide variety of therapeutic indications and study types, including first-in-human clinical trials and CNS clinical trials. Partner with Altasciences for repeated-dose toxicity testing at https://www.altasciences.com/ Original Source: https://bit.ly/3q49rkh

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7 Benefits of a CRO That Also Offers Over-Encapsulation and Blinded Study Materials

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. This creates a biased trial and a loss on your organization’s investment. Finding a CRO partner with CDMO pharma capabilities means you have a partner that thoroughly understands the intricacies of blinded study materials and over-encapsulation. Visual Appearance The importance of your drug’s visual appearance, both real and placebo, shouldn’t be understated. Several factors are involved in the proper over-encapsulation of a solid oral dosage form in order to maintain product performance and protect the integrity of the clinical trial. As such, the exterior appearance of the real drug and the over-encapsulate placebo need to be exactly the same to prevent bias. Capsule Shell Selection Ideally, the capsule shell will be specifically designed for the process. This includes a double-locking body and cap and using an opaque color, so the dosage form isn’t visible through the shell. Other important factors include the design and size of the capsule. This can simplify the delivery of the dosage form, like making it easier to swallow, and helps ensure overall patient compliance. These details can be especially important in pediatric trials. Including Backfill The placebo and real drugs should also have the same weight and sensation as the opposite dosage form when shaken. This makes backfill essential in the over-encapsulated capsule. Minimal use of additional lubricants is also a consideration. Backfill can help prevent participants from squeezing the dosage form to test if they can feel a difference. Eliminating Bias Over-encapsulation of the drug you are testing can help effectively blind your clinical trial. It helps eliminate any bias from either the study participant and the investigator, removing elements that could help reveal the drug’s source. This is especially important because any indicators that contribute to bias could potentially impact the placebo’s effect. Tamper-Resistant Capsules The CRO/CDMO should also use advanced technology to enable tamper-resistant capsules. This helps prevent study participants from breaking open the capsule to see whether they are being dosed with a placebo or the real drug. Over-Encapsulation Method There are multiple ways to achieve over-encapsulation. Based on the characteristics of your organization’s drug product, you may need manual, semi-automatic, or fully automatic options. Finding a CDMO with the right methods for your specific drug is essential. There are also less common blinding methods that your CDMO partner might use, such as removing a commercial logo or identifier from the capsule or tablet or over-printing on the dosage form with confusion print. About Altasciences Altasciences, a mid-sized contract research organization, understands drug development is a complex process. Their fully integrated team helps keep their sponsors’ drug development projects smooth and streamlined. Altasciences is a fully integrated CRO with pharmaceutical CDMO capabilities, bioanalytical services, and all their teams share access to a proprietary database. Pharmaceutical and biotechnology companies of all sizes count on Altasciences’ innovative, integrated approach for preclinical studies and clinical trials. Partnering with the Altasciences team means you gain expertise in a wide variety of therapeutic indications and study types, including first-in-human clinical trials and CNS clinical trials. Partner with Altasciences for over-encapsulation capabilities at https://www.altasciences.com/ Original Source: https://bit.ly/3R24dBM

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4 Ways a CRO Can Help During the Preclinical Drug Development Process

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 that can prepare study designs that make sure the process meets your needs, and the studies are effective. When developing a new drug, you need the journey to be efficient, safe, and thorough. That’s why a top-notch CRO will help you develop strategies at the start from the get-go. Pharmacology Studies It’s impossible to predict the future, but a good CRO can come close by providing pharmacological testing services for the preclinical stage of your drug development project. These specialized studies, including tests like liver biopsies, bone marrow aspirates, and serial CSF samples, offer lenses into the future of your new therapeutic entity. A CRO that connects you with highly qualified scientists and analysts to perform these tests can help predict the biological effects of your new drug. Preclinical services should set you up for success, and pharmacology studies can help you better understand the road ahead. Safety First As you begin first-in-human trials, you want to be sure the transition from the preclinical to clinical step occurs as smoothly as possible. This includes ensuring you understand the impact of your new chemical entity or biotechnology-derived product on vital organ systems. That way, when first-in-human drug testing begins, physicians can safely conduct clinical trials with the appropriate design and execution techniques. The best CROs will offer this safety pharmacology as part of their complete development programs. That means they can help you meet all the regulatory guidelines that are in place to keep safety a priority. Preparing for the Next Step Moving from the preclinical stage into the clinical stage is a big step for your drug development project. With the right CRO partner at your side, your Phase 1 clinical trials hit the ground running. A CRO handles manufacturing, and testing is accelerated because they can start producing the clinical supply of your new drug and get the first-in-human trials started sooner. Ultimately, a CRO you can trust is a great partner to take you through the preclinical stages and beyond, so your organization can benefit from a productive and quality drug development cycle and essential resources like Phase 1 clinical trial units. About Altasciences As a mid-sized contract research organization, Altasciences understands drug development is a complex process. The Altasciences team can help make the process smooth and streamlined for their partners. Altasciences is an integrated CRO with pharmaceutical CDMO services with more than 25 years of research experience. Pharmaceutical and biotechnology companies can count on the innovative, integrated approach Altasciences uses for preclinical studies and clinical trials, including bioanalysis and manufacturing. When your organization partners with Altasciences, it gains the team’s expertise in a variety of therapeutic indications study types, including experience in first-in-human clinical trials and CNS clinical trials. The CRO/CDMO offers access to resources including highly trained and experienced staff, more than 580 beds, and a recruiting database of over 400,000 potential participants. Partner with Altasciences for your preclinical and clinical research at https://www.altasciences.com/ Original Source: https://bit.ly/3Sz6TrF

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A Guide to the Phases of Clinical Trials

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 study is designed to assess the safety of the proposed drug and treatment. The first test is usually small, with researchers testing between 20 and 80 participants. Researchers may even conduct these tests on healthy participants instead of those who are intended for the treatment. This phase can identify potential side effects and puts the bioanalysis of the preclinical phase to the test. More bioanalysis will help refine the formulation, and as the clinical trials continue, it could result in the need for a new version of the drug to be manufactured. Phase 2: Efficacy The second phase answers the question of whether the treatment works effectively or not. Efficacy tests the treatment under ideal conditions, while effectiveness deals more with real-world results. While Phase 1 is fairly short, Phase 2 can last months or even years. There are generally between 100 and 300 participants in this stage. Therefore, this phase further examines the safety of the drug. A CRO with experience can help your organization meet all these requirements, addressing any issues prior to IRB submission and minimizing the risk of amendments—for example, if you know your drug development project will need to include CNS clinical trials, there are specific regulatory complexities to navigate. Phase 3: Comparison Is the new treatment or drug comparable or better than what is already available or standard? That is what the third phase tests. If it is not as good or better than what is currently available, there is little or no value in the new treatment. The outcome, cost, and side effects of the treatment are compared in studies that can last several years. Typically, between 1,000 and 3,000 participants are used in this phase. Successfully completing this phase means the study sponsor can seek FDA approval for marketing the treatment. Phase 4: Post Marketing Surveillance Trials Finally, Phase 4 monitors the effectiveness and safety of the drug or treatment over a long period of time in the general population. This can lead to more information about the drug’s benefits and its optimal uses, thanks to long-term data. For example, some side effects may only appear after this much time. Claims and labeling of the drug may need to be modified as a result. About Altasciences As a mid-sized contract research organization, Altasciences understands drug development is a complex process. The Altasciences team can help make the process smooth and streamlined for their partners. Altasciences is an integrated CRO with pharmaceutical CDMO services and more than 25 years of research experience. Pharmaceutical and biotechnology companies can count on the innovative, integrated approach Altasciences uses for preclinical studies and clinical trials. When your organization partners with Altasciences, it gains the team’s expertise in a variety of therapeutic indications study types, including experience in first-in-human clinical trials and CNS clinical trials. The CRO/CDMO offers access to resources including highly trained and experienced staff, more than 580 beds, and a recruiting database of over 400,000 potential participants. Get help moving through clinical trial phases from Altasciences at https://www.altasciences.com/ Original Source: https://bit.ly/3Qylnq3

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4 Things to Look for When Selecting a CRO/CDMO

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 send over results, as they are already in the database. Bioanalytical services can start much sooner due to reduced wait times. Fully integrated CRO/CDMO services result in a smoother, streamlined drug development cycle overall. What Manufacturing Services Are Offered? If you are choosing a CRO with pharmaceutical CDMO capabilities, you are likely choosing it because the organization can take your drug development cycle from formulation to manufacturing, packaging to commercialization. This means you must ensure the CRO/CDMO has all the necessary capabilities. Can it manufacture your drug quickly for your clinical trial and to accommodate potential changes during the clinical trial? Can it perform nanomilling to increase the solubility of your drug? Can it fill vials, liquid-filled capsules, and/or powder-filled capsules? Find a CRO/CDMO that offers the areas of expertise you need to complete your drug development cycle, without needing an outside vendor. Does the CRO/CDMO Have Specialized Facilities and Equipment? Do they have custom-built Phase 1 clinical trial units? Do they have beds if you are planning to perform clinical trials with overnight components? Do they have specialized equipment, such as driving simulators for CNS clinical trials? It’s best to go with a CRO/CDMO that already has access to the resources you need because this effectively saves you time during clinical trials since you won’t have to use outside vendors. Can the CRO Recruit? What are the CRO’s recruiting capabilities? You will want to partner with a CRO that has an in-house team well-versed in marketing through multiple channels to reach the target population required for your trials. The ideal CRO will have a substantial database of healthy normal, patient, and special populations. This can greatly simplify recruiting as many are pre-screened and have shown interest in being part of clinical studies. About Altasciences As a mid-sized contract research organization and CDMO, Altasciences understands drug development is a complex process. The Altasciences team can help make the process smooth and streamlined for their partners. Altasciences is an integrated CRO with pharmaceutical CDMO services and more than 25 years of research experience. Pharmaceutical and biotechnology companies can count on the innovative, integrated approach Altasciences uses for preclinical studies and clinical trials, as well as bioanalysis, manufacturing, and analytical services. When your organization partners with Altasciences for clinical trials specifically, it gains the team’s expertise in a variety of therapeutic indications study types, including experience in first-in-human clinical trials and CNS clinical trials. The CRO/CDMO offers access to resources including highly trained and experienced staff, more than 580 beds, and a recruiting database of over 400,000 potential participants. Get the CRO/CDMO services you need with Altasciences at https://www.altasciences.com/ Original Source: https://bit.ly/3ByTEB8

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4 Things to Look for in an All-in-One Contract Research Organization

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 recruiting a much faster, streamlined experience.

Do They Have Experience?

Any CRO can claim they are all-in-one. When choosing a CRO, you will need to evaluate them based on experience. If they have successfully navigated regulatory submissions, recruited for clinical trials with healthy normal, patient, and special populations, successfully completed a variety of clinical trials, and helped bring therapeutic drugs to market, they are a good candidate for your organization to partner with. If the CRO you are considering as a partner does not have enough experience in a specific area, you might still need to bring on another CRO to cover the gap. This creates extra complications in your drug development cycle, so a full-service CRO partner is best.

Can They Manufacture the Drug?

Many CROs claim to be all-in-one but lack an important aspect of the process: manufacturing. You want a CRO with pharmaceutical CDMO capabilities. This means everything is done in-house. While one team is finalizing lead candidate formulation, another team is already determining the best way to manufacture it. There is far less downtime when you start a clinical trial, as you won’t have to depend on a secondary CRO to manufacture the drug for the trial. When it’s time to go to market, your CRO’s in-house manufacturing team already has key experience creating the drug for the trial and can start manufacturing for the market faster.

Do the Teams Communicate?

Finally, it’s vital for a fully integrated, all-in-one CRO’s teams to freely communicate with each other. This means information flows freely and is easily accessible by other teams. A proprietary database with all key client and study information, for instance, means the bioanalysis team already has the data from the clinical trial team and can start much sooner. There is very little wait time, especially compared to having one CRO’s team waiting on another CRO’s team to send information to them.

About Altasciences

Altasciences, a mid-sized contract research organization, knows drug development can be a complex process. The Altasciences team will make your organization’s next drug development project smooth and streamlined. As an integrated CRO with pharmaceutical CDMO capabilities, Altasciences offers partners over 25 years of research experience. Many pharmaceutical and biotechnology companies have come to rely on Altasciences’ innovative, integrated approach for preclinical studies, clinical trials, bioanalysis, and formulation and manufacturing. Partnering with Altasciences means gaining their team’s expertise in various therapeutic indications and study types. This includes valuable experience in first-in-human clinical trials and CNS clinical trials. The CRO offers clinical trial partners access to a wide variety of resources, including more than 580 beds, a highly trained and experienced staff, and a recruiting database of over 400,000 potential participants.

Partner with Altasciences for an all-in-one, fully integrated CRO experience at https://www.altasciences.com/

Original Source: https://bit.ly/3IjVlDK

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6 Facts About Clinical Research of Psychedelics

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, post-traumatic stress disorder, addiction, and even fear of death. For example, in November 2019, the US FDA designated psilocybin therapy as a “breakthrough therapy” for major depressive disorder. In general, psychedelics, along with dissociative drugs and entactogens, have shown promise for mood, substance use, and anxiety disorders. Risks of Using Psychedelics as Mental Health Treatment Psychedelics are generally considered safe but can also contribute to serious side effects, including paranoia, psychosis, and cardiovascular issues. They can also affect the central nervous system, which compromises sound judgment and can lead to accidents. Should your organization move forward with drug development, know that CNS clinical trials will likely be required. Many of the risks associated with psychedelics can be attenuated by having participants take the drugs in a controlled setting with expert supervision provided by trained medical experts. Regulatory Challenges There are a special set of regulatory challenges for Schedule I drugs. There was a long pause in research on their potential benefits, and psychedelic drugs are often characterized as lacking any acknowledged therapeutic use. There is also the potential for abuse. Due to these and other factors, these drugs are highly controlled and often placed in the most restrictive categories. This can make conducting research and moving to commercialization difficult. Licensing Requirements for Research Drug licensing requirements are an important aspect of controlling the use of psychedelics while conducting clinical research. Each country has a different set of licensing conditions. These can strictly limit research for legitimate activities at a qualified testing site. For example, in the US, organizations must have a Schedule I site license for the facilities where the studies will be conducted, such as in Phase 1 clinical trial units. Partnering with a CRO with existing expertise or an existing license can save time and streamline the otherwise challenging process. Getting a Psychedelic Drug to Commercialization An additional challenge is getting your psychedelic drug to commercialization. As noted, CNS clinical studies, such as driving tests and human abuse potential, will be required. There may be potential for unexpected after-effects, with additional provisions for longer-term assessment and monitoring. About Altasciences Altasciences, a mid-sized contract research organization, knows drug development can be a complex process. The Altasciences team will make your organization’s next drug development project smooth and streamlined. As an integrated CRO with pharmaceutical CDMO capabilities, Altasciences offers partners over 25 years of research experience. Many pharmaceutical and biotechnology companies have come to rely on Altasciences’ innovative, integrated approach for preclinical studies, clinical trials, bioanalysis, and formulation and manufacturing. Partnering with Altasciences means gaining their team’s expertise in various therapeutic indications and study types. This includes valuable experience in first-in-human clinical trials and CNS clinical trials. The CRO offers clinical trial partners access to a wide variety of resources, including more than 580 beds, a highly trained and experienced staff, and a recruiting database of over 400,000 potential participants. Partner with Altasciences for expertise in psychedelic drug development at https://www.altasciences.com/ Original Source: https://bit.ly/3P98B0p

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How CROs Ensure Reliable Study Results with Robust Sample Management

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 will need a variety of storage containers set at proper temperatures to ensure the integrity of the samples. Stabilizers, anticoagulants, and other preservatives may be necessary. The CRO should have a comprehensive sample collection manual detailing the requirements, ensuring that study personnel are well informed. The CRO should also be flexible to accommodate study variables. Standardizing Workflows Improves Risk Management and Chain of Custody To minimize potential risks to sample integrity or breaks in the chain of custody, the CRO should have consistent, standardized workflows. An electronic data capture system at the clinical site can help ensure complete data entry. This decreases erroneous identification of clinical samples or mislabeling. An EDC system can also track all relevant information for specimens, accounting for them as they move from collection to transport and lab analysis before going into storage. A laboratory informatics management system should be used in a bioanalytical laboratory to ensure chain of custody and traceability. Understanding Environmental Conditions with Stability Testing Stability testing is needed to understand which samples will remain viable when tested against certain environmental conditions, such as time, humidity, temperature, agitation, evaporation, and light. Shelf-life stability in those conditions should be determined and maintained. Short-term and long-term stability are both important. Laboratory Management for Keeping Data Organized Clinical samples are entered into the LIMS at the bioanalytical site according to labeling and documentation provided by the clinical site. Each sample tube will be assigned a barcode if the clinical site uses an EDC. The LIMS will use that barcode. This makes it much easier to manage than manually prepared documentation. It helps immediately identify any discrepancies. Managing Bioanalytics You will need a comprehensive sample management program that can handle a wide variety of matrices for bioanalysis. It will require robust method development and validation expertise. The laboratory must have exhaustive procurement procedures, as well as an in-house inventory of matrices available for validation, stability testing, sample analysis, and method development. This can be important for later phases, such as when it comes to CDMO pharma services, especially when determining the best method for delivery. About Altasciences Altasciences, a mid-sized contract research organization, knows drug development can be a complex process. The Altasciences team can make your organization’s next drug development project smooth and streamlined. As an integrated CRO with pharmaceutical CDMO capabilities, Altasciences offers partners over 25 years of research experience. Many pharmaceutical and biotechnology companies have come to rely on Altasciences’ innovative, integrated approach for preclinical studies, clinical trials, bioanalysis, and formulation and manufacturing. Partnering with Altasciences means gaining their team’s expertise in various therapeutic indications and study types. This includes valuable experience in first-in-human clinical trials and CNS clinical trials. Best of all, the CRO/CDMO offers clinical trial partners access to a wide variety of resources, including more than 580 beds, a highly trained and experienced staff, and a recruiting database of over 400,000 potential participants. Partner with Altasciences for reliable data at https://www.altasciences.com/ Original Source: https://bit.ly/3ydoUCo

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4 Reasons to Partner with a CRO for Driving Simulation Studies During Drug Development

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 database is also essential when your organization is doing specialized testing, such as CNS clinical trials. These trials have more specific requirements for potential participants than a typical clinical trial. CROs Have Resources Partnering with a CRO also means gaining access to its resources. This can include driving simulators and experienced teams. The CRO will have the equipment needed to conduct the driving tests. Suppose you are choosing an integrated CRO and performing other tests besides driving simulations, such as first-in-human clinical trials. In that case, this also means resources such as Phase 1 clinical trial units. The CRO should be able to provide everything you need to help your drug to progress through the early phases of drug development. CROs Have the Experience You Need There’s another type of resource you will have access to when you partner with a CRO: trained employees. These employees have the experience necessary to carry out the driving simulation. They know how to work the equipment and how to guide participants through the test. Other employees know how to collect and present data. When you use a CRO for more than just the tests, the employees can also interpret the results and help with your drug development cycle. It’s Easier and Safer Than Typical Driving Tests A typical driving test might be done on a closed course in a real car. Among other considerations, you will need space to perform the test, the car itself, gas, safety cones, and more. Plus, you will need someone in the passenger seat to observe the participant driving. Partnering with a CRO that has access to driving simulators means you won’t need any other resources. It’s also safer for the participant as there is no crash risk. Instead, it uses a simulated car with computer monitors to mimic driving on the road. A CRO that specializes in driving studies will also be able to offer oversight by fully-certified, in-house driving simulation study specialists to help ensure you are recording proper results. About Altasciences Drug development can be a complex process. Altasciences, a mid-sized contract research organization, can help make it more streamlined. This integrated CRO with pharmaceutical CDMO capabilities offers partners more than 25 years of research experience performing preclinical studies and clinical trials. Pharmaceutical and biotechnology companies have come to rely on the innovative, integrated approach that Altasciences uses. Partners gain the team’s expertise in studies for a wide variety of therapeutic indications. Altasciences also gives partners access to the CRO’s various resources, including over 580 beds, experienced and highly trained staff, and a recruiting database with more than 400,000 potential participants. When you need a partner for all your early clinical development needs, trust Altasciences. Partner with Altasciences for driving simulations and a whole lot more at https://www.altasciences.com/ Original Source: https://bit.ly/3aAlp0I

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Bioanalysis in Drug Development

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 bioanalysis can be performed, your assay must be validated. This demonstrates it is suitable for its intended purpose. There are a wide variety of assays that can be used for bioanalysis, but not all will be right for your drug. Some, for example, will only work with small-molecule compounds. A Good Laboratory Practices validated bioanalytical method is required to support your drug developmental cycle, during both toxicology and first in human clinical trials. When Is Bioanalysis Performed? Bioanalysis is performed in both drug discovery and drug development. During discovery, the aim of bioanalysis is to provide reasonable values for either concentrations or exposures. This is used for lead series identification or discrimination amongst lead candidates. Bioanalysis is required before any clinical trials to determine the drug’s safety profile. Validation is formalized and mandated. Testing may be done on animals for pharmacodynamics, PK, ADME (absorption, distribution, metabolism, and elimination), and toxicity. At the clinical stage, assays for human samples need to be more rugged and robust. They should withstand future testing, as this is the longest phase of development. Keep in mind, assays might require minor modifications as the drug changes slightly. Finding the Right CRO for Bioanalytical Services Bioanalysis results must be quantitative and valid, per FDA and worldwide regulatory guidances. These results form the foundation of drug approval. It’s essential that your results are accurate. This is why you should partner with a contract research organization that boasts experienced bioanalytical services. Regulatory authorities often audit these results for accuracy before approving the drug. Outsourcing to a CRO with experience and proven results means you have a much higher chance of getting accurate results that will be approved and validated. The CRO needs to have flexible bioanalytical services in order to adapt to any changes you need to make to the drug. You might consider choosing a CRO that offers bioanalytical services as part of a full drug development package to allow for reliable communication and synergy between teams. About Altasciences Drug development can be a complex process. Altasciences, a mid-sized contract research organization, can help make it more streamlined. This integrated CRO with pharmaceutical CDMO capabilities offers partners more than 25 years of research experience performing preclinical studies and clinical trials. Pharmaceutical and biotechnology companies have come to rely on the innovative, integrated approach that Altasciences uses. Partners gain the team’s expertise in studies on a wide variety of therapeutic indications. This includes significant experience in first-in-human clinical trials and CNS clinical trials. Altasciences also gives partners access to the CRO’s various resources, including over 580 beds, experienced and highly trained staff, and a recruiting database with more than 400,000 potential participants. When you need a partner for all your early clinical development needs, trust Altasciences. Partner with Altasciences for flexible bioanalytical services at https://www.altasciences.com/ Original Source: https://bit.ly/3xzfceJ

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5 Ways a CRO with CDMO Services Can Help with Phase 1 Clinical Trials

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 through billboards, online ads, or other methods. This can help make recruiting for your first-in-human clinical trials much faster, helping you get to the trials and results and staying on or ahead of schedule. Gain Access to Resources You will also gain access to the CRO’s other resources. Trained staff that can carry out your Phase 1 clinical trials and supporting CRO services, within their Phase 1 clinical trial units are resources your CRO partner might be able to offer your organization. This makes it far easier to start a study. If the CRO doesn’t have access to the necessary resources for your specific clinical trial, it may have a list of approved vendors. With the right CRO, you won’t need to find staff who know how to use the equipment either since they will already have staff with the proper training. In-House Manufacturing Another resource you gain by choosing a CRO combined with a pharmaceutical CDMO is in-house formulation and manufacturing. This means you won’t have to go to another CDMO to produce the drug for your clinical trials. This can drastically reduce the startup time for your clinical trial. Because the CRO has already helped with earlier stages of the drug development process, information flows to all the in-house manufacturing teams and vice versa. Streamline the Process Overall, partnering with a CRO can help streamline your organization’s next drug development cycle. Because they have the experience, the resources, and, if it offers CDMO services, the manufacturing capabilities, you won’t have to find multiple partners to handle different aspects of the process. It’s also much easier than your organization trying to do the work when you don’t have multiple successful trials to your name. Streamlining the process means taking less time than was scheduled, which can help manage your budget. Choosing an Integrated CRO/CDMO When you use an integrated CRO/CDMO, you have a partner from the earliest stages of clinical development until you take your drug to market. The right partner should be able to handle every aspect from lead candidate selection to manufacturing, recruiting to performing clinical trials. The information doesn’t need to be exchanged between different CROs, but instead, teams within the same CRO. It’s the easiest way to enjoy a successful drug development process. About Altasciences Drug development can be a complex process. Altasciences, a mid-sized contract research organization, can help make it more streamlined. This integrated CRO with CDMO pharma capabilities and bioanalytical services offers partners more than 25 years of research experience performing preclinical studies and clinical trials. Pharmaceutical and biotechnology companies have come to rely on the innovative, integrated approach that Altasciences uses. Partners gain the team’s expertise in studies on a wide variety of therapeutic indications. Altasciences also gives partners access to the CRO’s various resources, including over 580 beds, experienced and highly trained staff, and a recruiting database with more than 400,000 potential participants. When you need a partner for all your early clinical development needs, trust Altasciences. Partner with Altasciences for streamlined Phase 1 clinical trials at https://www.altasciences.com/ Original Source: https://bit.ly/3xawGh5

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3 Challenges You Might Encounter with ADA Assays

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 rheumatoid factor, the drug itself, a co-administered drug, and many other factors. The first step in assessing the matrix effect is characterizing the impact of the demographics and disease state on the assay’s performance. This is where partnering with a CRO with bioanalytical services can be beneficial. The CRO will have the experience necessary to avoid or identify interference factors. To anticipate and understand results obtained from ADA responses, it’s essential to have a good understanding of the drug and its target. Determining Cut-Point Evaluation for Oncology Clinical Studies One problem oncology studies can present is limited access to oncology donors representing the targeted population appropriately. This makes it challenging to determine the correct pre-study cut-point for an immunogenicity oncology study. There may not be enough sample donors for a suitable statistical analysis for cut-point determination. It’s even more difficult when comparing the variability of sub-disease types, such as Hodgkin’s lymphoma and follicular lymphoma. A single cut-point for all the different disease groups is essential if each one does not have an adequate number of donors. In an actual study with a greater number of sample donors, the cut-point can be re-evaluated and adjusted accordingly. When Should a Cell-Based Assay Be Used? It’s important to detect anti-drug neutralizing antibodies (NAbs) that are generated in response to a therapeutic protein to ensure a safety profile and complete efficacy in vivo. While they are complex to develop and use in a regulatory setting, cell-based assays can provide a physiological system for detecting NAbs. The mechanism of action should be reflected in the neutralization assay. The MoA might be reflected by a series of independent events. A cell-based format can assess the entire biological activity instead of just a fraction of the neutralizing interactions. Cell-based assays can also help identify interdependent key receptor-ligand interactions, which can be important if the sequence of events that leads to biological activity isn’t understood. You should also take into account the level of safety concerns, such as high ADA positivity rates, the possible impact on endogenous compounds, or previous indications that there might be autoimmune reactions reported from similar drugs. Ligand binding assays should be used for products that rely on the displacement of the receptor-ligand reaction, giving an alternative approach to NAb detection. About Altasciences Are you looking for a drug development partner? Altasciences, a mid-sized contract research organization, is the partner with the expertise you need to make your next project a success. As an integrated CRO with pharmaceutical CDMO services, Altasciences offers partners more than 25 years of research experience for preclinical studies and clinical trials. This CRO/CDMO uses an innovative, integrated approach that pharmaceutical and biotechnology companies can rely on. Altasciences also offers partners expertise in a wide range of study types and therapeutic indications. This includes a wealth of experience in first-in-human clinical trials and CNS clinical trials. Partners also gain access to essential resources, including experienced and highly trained staff, a recruiting database of over 400,000 potential study participants, and over 580 beds for overnight studies. Choose this trusted CRO/CDMO for all your early clinical development needs. Partner with Altasciences for bioanalysis and other areas of expertise at https://www.altasciences.com/ Original Source: https://bit.ly/38gg8dN

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How to Strengthen Recruiting Methods for Your Clinical Trials

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 must be clearly defined. What should the participant pool look like for your trial? This means considering variables like age, gender, ethnicity, and health status. Are there specifics categories that will be required for your study? The trial may call for an age group between 55 and 72, male and female, but there may be other variables to consider, as well. If you are recruiting for women aged 55 to 72, should they be post-menopausal? What about their osteoarthritic status? The more clearly you can define the essential factors for your potential participants, the more streamlined the recruitment process can be. The Structure of the Clinic Trial Matters The way a trial is structured can directly impact your recruitment process. This is a detail that can be overlooked. For example, a study with a short confinement period with a shorter follow-up period may garner a high level of participant attention. It’s straightforward, the participants get the agreed-upon stipend, and the process ends. A study with a longer period of confinement with a longer follow-up period can be more challenging to recruit for due to the more intensive commitment on the part of the participant. To overcome the challenge, the full time of the trial and the budget may need to be expanded. This expansion allows for an increase in advertising for the trial (thus reaching more potential participants) and compensation for participants. Understand the True Cost of Stipends From early clinical development to Phase 1 trials and beyond, participant stipends can play a important role in the success of your recruitment process. In many cases, potential participants have grown to expect stipends that match their level of involvement. Naturally, shorter or less-involved trials can be paired with a smaller stipend budget. In developing a stipend budget, you should consider several factors, including the length and involvement of participants. However, there are additional factors to keep in mind as well, such as inpatient versus outpatient visits, dosing visits versus non-dosing visits, and more involved visits or stays for participants. More time and effort required by a participant must be met with a stipend that makes sense—for both the participants and the trial sponsor. About Altasciences Are you looking for a drug development partner? Altasciences, a mid-sized contract research organization, is the partner with the expertise you need to make your next project a success. As an integrated CRO with pharmaceutical CDMO services, Altasciences offers partners more than 25 years of research experience for preclinical studies and clinical trials. This CRO/CDMO uses an innovative, integrated approach that pharmaceutical and biotechnology companies can rely on. Altasciences also offers partners expertise in a wide range of study types and therapeutic indications. This includes a wealth of experience in first-in-human clinical trials and CNS clinical trials. Partners also gain access to essential resources, including experienced and highly trained staff, a recruiting database of over 400,000 potential participants, and over 580 beds for overnight studies. Choose this trusted CRO/CDMO for all your early clinical development needs. Learn more about strengthening your clinical trial recruitment at https://www.altasciences.com/ Original Source: https://bit.ly/3srGvod