Aliri Overview brochure
The increased focus on precision medicine, oncology and other therapies has changed how companies are planning for drug discovery and clinical development. There are many challenges to navigate, including:
- Robust regulatory environment
- Developing a thorough program but also advancing with speed
- Having access to a breadth of technical expertise to assist
- And much more…
This is why choosing a partner like Aliri is critical to the success of your program. We provide a range of bioanalysis, spatial bioanalytical, and spatial biology services to support the lifecycle of your drug. Our labs have proven operational excellence across a range of traditional and innovative technologies, and the experience to support the unique needs of your development program.
Utilize our team of seasoned scientists and technical experts to help advance your molecule from discovery through clinical:
- Access quality data for filing your IND, NDA, or CTA with speed
- Anticipate technical issues or potential roadblocks that may cause delays
- Showcase drug efficacy in the pertinent spatial context up to the cellular level to improve drug candidate evaluation and selection
- Maximize the value of your drug discovery and development investments
Check out our company overview to learn more about our services and how we can work together to provide you with accurate data FAST.
RNAscope assay: Single cell transcriptomics for drug target discovery
When dealing with biomarkers in drug target discovery, profiling the tissue transcriptome in its spatial organization is key to understanding and predicting that tissue’s response to immunotherapy, because the tissue function within the body relies on the precise spatial organization of the cells. This is especially true when dealing with complex and heterogeneous tissues, such as tumors.
With tumors, the relationship between the cells and their environment is what ultimately shapes a patient’s fate. Applying the RNAscopeTM assay allows that evaluation of the presence of transcripts within a spatial context. This technique then ultimately can predict the tumor’s response to immunotherapy.
To further explain the impact of the RNAscope assay, this application note details a case study on a non-small-cell lung cancer (NSCLC) sample to predict its response to immunotherapy. This case study:
- Investigates the presence of the PD-L1 drug target transcript and the Granzyme B (GZMB) biomarker of clinical outcome transcript
- Explains quality control measures taken to validate the hybridization technique
Looks at the heterogenous distribution of transcripts in the NSCLC tissue section & examines the quantification of the PD-L` and GZMB to draw conclusions on the tissue’s reaction
Aliri – Industry-leading Services
Choosing a bioanalytical CRO to assist you with bringing your drug to market is critical to the success of your project. Aliri Bioanalysis provides a wide range of bioanalysis , spatial bioanalysis, and spatial biology solutions to support the lifecycle of your drug.
Work with us to utilize our team of experience scientists and industry experts to advance your molecule from discovery through clinical:
- Achieve quality data for filing your IND, NDA and CTA with speed
- Forecast technical issues or potential roadblocks that may cause delays
- Maximize the growth of your drug discovery and development investments
Check out how our advanced technologies can advance your molecule and bring your drug to market with ease.
Timeline planning tips for importing or exporting biological samples
Missed deadlines in drug development often stem from improper planning and coordination during the import and export of biological samples. Establishing and executing a proper plan for this part of the process can help ensure that your program stays on-track, while avoiding unnecessary stress such as costly delays, lost shipments, etc.
Download this infographic to learn more about this robust process:
- Permits and government agency requirements
- Human vs animal requirements
- Timelines and expectations
- Resources and process planning
QMSI vs. QWBA: evaluating benefits and risks
Knowing when to use Quantitative Mass Spectrometry Imaging (QMSI) instead of Quantitative Whole-Body Autoradiography (QWBA) can make or break a timeline and budget for pharma and biotech companies.
Consider the following key advantages when selecting which technique is right for your drug development program:
QSMI Advantages:
- Label-free quantification of thousands of analytes
- Excellent differentiation among parent drugs, metabolites, and other substances
- Highly specific in quantification by location in tissue
QWBA Advantages:
- Highly precise quantification capabilities, even at low and high limits of detection
- Spatial resolution at the cellular level
- Gold standard technique for the late-stage regulatory distribution studies
Even though QWBA remains the gold standard technique during late stage for regulatory agencies, QMSI is frequently used in support of the autoradiography in certain circumstances.
Further evaluate the benefits and risks associated with each technology.
Buy vs Build: Bioanalytical lab
Buying a bioanalytical lab vs. building one yourself – what do you need to consider?
With so many outsourcing/insourcing options across the drug development workflow, Pharma companies are faced with finding the right partner to fit all the needs of their unique molecule. Here are some criteria to consider:
- Time to Launch: timelines depend on the approach. A built-for-purpose project translates to long timelines due to all the parties involved. You need time to evaluate location, engineers, & architects. Return on investment and risk impact: both are dependent on the number of programs and the diversity of projects. To fully evaluate, you need to build utilization models to analyze and make predictions
- Staffing appropriately: the job market can be challenging to navigate, and it could prove to be challenging to find the right expertise and employees. Be prepared for this process to take time and be costly.
- Day to Day Logistics: there are a wide variety of permits & licenses needed for day-to-day operations. This regulatory environment can be complicated to navigate as you manage the applications, requirements and maintenance required.
If you are interested in learning more about permits & licenses specifically, check out our fact sheet: Guidelines to Importing & Exporting Biological Samples - And much more…
Explore our comprehensive guide that outlines the benefits & risks associated with buying or building a bioanalytical lab and see what choice is best for you.
Guidelines: Importing & Exporting Biological Samples
The United States government has a heavily regulated process for importing and exporting biological samples, and for good reason. These protocols are designed to prevent the transportation of exotic diseases and to inhibit the supply to illegal markets.
While understanding the reasons for the high regulation, it can still be extremely complicated to navigate the different governing bodies and acquire the correct applications or permits. Failure to follow the process also has dire consequences: samples can get held at customs, there may be fines involved, and your estimated drug development timeline just got much longer.
We know how frustrating delays in your development process are. Our comprehensive guide gives you the information you need to be confident that your samples will not be compromised, and your timeline will not be delayed. Download our comprehensive guide to learn how to properly import and export biological samples to avoid potential issues and stay on track.
Personalized therapy selection: Investigation of multiple immune-checkpoints
PD1 blockade has changed the immunotherapy approach against solid tumors – prescribing patients’ monoclonal antibody-based therapy yielded positive results. However, the number of patients that benefited was small compared to expectations, and lack of attention paid to immunohistochemistry could be responsible. Understanding the tumor microenvironment with a single biomarker is not accurate enough to predict the interaction of the drug with the site of action, or to predict the effectiveness of the drug for the patient.
In this application note, industry expert, Corinne Ramos, PhD, discusses how understanding the tumor microenvironment (TME) at the biomarker level is not enough to predict the interaction of the drug with the site of action. Her study performs a deep spatial profiling of biomarkers on two baseline non-small cell lung cancer (NSCLC) tissue samples. The population of gene expression was characterized with a focus on a specific region of interest on the tissue where she could draw conclusions on the TME.
Her research walks through:
- Immune infiltration
- How phenotype correlates with ICI response
- T-cell-inflamed gene-expression profiles
- Immune suppressive pathways that reduce ICI activity
- Tight immune checkpoint targeting.
Learn why the TME needs to be investigated at the molecular level to accurately prescribe the appropriate therapy.
Top 8 Benefits of Mass Spectrometry Imaging Early in Drug Development
Mass spectrometry imaging (MSI) is a groundbreaking technology that provides visuals of complex biological samples to study a drug’s distribution and understand its potential toxicity. MSI can unlock crucial data and give scientists additional insights into drug discovery, diseases, and personalized medicine.
MSI is beneficial in early development and murine models across many therapeutic areas and is especially suited to oncology due to the availability of tissue. With MSI you can:
- Speed up and optimize the drug discovery process
- Visualize drug distribution in tissues and tissue sub-compartments
- Analyze samples for thousands of compounds at once
- Eliminate sensitivity and chemical alteration concerns
- Know whether efficacy is possible based on distribution
- Locate and identify metabolites to understand potential toxicity
- Improve understanding of pharmacokinetics and pharmacodynamics
- Save money and provide a competitive development edge
Download our infographic to learn more about the benefits of mass spectrometry imaging in oncology.
BIOANALYSIS: Approaches and Techniques for Small vs. Large Molecules
Bioanalysis plays a crucial role in the evaluation of potential drug candidates and in understanding the drug’s pharmacokinetics and pharmacodynamic profile during early clinical trials. By documenting a drug’s behavior within the body, our specialists generate essential data that regulatory authorities rely on to determine whether the drug is safe for market release.
Before choosing a suitable testing technique, it’s important to understand three factors, type of molecule, unique properties of the drug, and its intended application. Regardless of the molecule size, it’s crucial to validate appropriate methods capable of measuring the drug’s concentration and bioactivity over time.
Download our infographic to learn more.