Resource Type: Webinars

Dr. Jude O’Donnell discusses Clinicial Trial Assay & CDx Development in the era of Precision Medicine.

Synopsis

• Regulatory considerations for assay development, validation & commercialization
• Choosing the right diagnostic partner: experience, ability to deliver, transparency & trust
• Biomarker-led clinical trial assay and companion diagnostic development & validation challenges
• Case study showcasing a recent Almac Biomarker Program with a large global pharma partner

Molecular biomarkers offer tremendous potential to classify patients into subgroups of relevance for prognostic & predictive utilities.  However, there are many challenges and considerations in translating a biomarker to a molecular diagnostic test (Clinical Trial Assay). When defining the intended use of novel biomarker, decisions including specimen collection, molecular content and platform selection can have a significant impact on a biomarker program. 

A strategic approach to the development & analytical validation of clinical trial assays at each stage of clinical validation ensures the highest quality molecular data is acquired in the most efficient way whilst minimising the potential risk of product redesign for Biopharma companies.

Almac Diagnostic Services has substantial experience of analytical validation across all stages of diagnostic test development from utilisation in early proof of concept trials through to IVD Companion Diagnostic (CDx) tests, often consulting to help guide Biopharma companies through the process. 

This talk will highlight a series of case studies to explore the strategic considerations at each stage of the development & validation journey to ensure that assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.

Takeaways:

Participants will learn about:

• Key considerations in the development & validation of CTAs for clinical stratification
• The importance of adequate specimen collection & stabilisation
• Major factors influencing platform selection
• The requirement of bridging studies and lessons learned
• Challenges of demonstrating adequate analytical performance of panels
• Considerations for data analysis pipelines

In this talk, Almac Diagnostic Services VP of UK Operations, Dr Leeona Galligan, will explore the realities of running next-generation sequencing (NGS) liquid biopsy panels in biomarker-driven clinical trials from a CLIA laboratory diagnostic provider viewpoint.

We will discuss the opportunities and challenges of NGS liquid biopsy panels and the critical steps involved in ensuring that they are ready for stratification use within clinical trials, as demonstrated by a biotech case study.

Almac Diagnostic Services has experience in both the development & analytical validation of blood-based molecular biomarkers so that the assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.

What You Will Learn

• Key aspects of running NGS liquid biopsy panels in biomarker-driven clinical trials
• Challenges of demonstrating adequate analytical performance of the panel
• The importance of adequate specimen collection and stabilisation
• Data analysis pipeline considerations for liquid biopsy panels

Cancer patients’ need innovative medicines more than ever, and they require personalised therapies specific to their unique biology fast. Together, international partners such as Illumina and Almac can get pharmaceutical pipelines ready quickly for global oncology clinical trials.

Utilising comprehensive genomic panels that can test for multiple biomarkers at the same time, whilst maximising clinical trial data from one patient sample, is key to delivering these solutions at speed.

Illumina discuss how they can gain speed in clinical development by avoiding bridging studies while Almac demonstrate how we deliver diagnostic testing utilising cutting edge genomic panels & providing tailored support at clinical sites through our global footprint of CLIA and CAP certified laboratories.

Webinar presenters:

Matt Nelson

Senior Director, Companion Diagnostic (CDx) Partnering, Illumina

Dr Leeona Galligan

VP of UK Operations, Almac

Shared with kind permission from Illumina

RNA Gene expression signatures (GESs) offer tremendous potential to classify patients into molecular subgroups of relevance for prognostic & predictive utilities. However, variations in gene expression caused by technical imprecision in the analysis process, has led to uncertainty regarding the suitability of GES for clinical trial stratification.

Download this complimentary webinar to explore key considerations in the development & analytical validation of developing RNA biomarkers suitable for clinical stratification.

Topics in this presentation include:

• Lessons learned during the development & validation of an in-house developed Next Generation Sequencing (NGS) gene expression signature
• Supporting evidence for Gene Expression Signature suitability for clinical trials
• Innovative reporting of GES with a software solution

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Webinar Description:

RNA Sequencing (RNA-seq) is an increasingly popular technology for biomarker discovery in cancer research. High-throughput RNA-seq produces large quantities of complex data that require computational bioinformatics pipelines to enable interpretation.

Almac Diagnostic Services has developed a unique reporting solution called clara^T* – A unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive, easy-to-interpret report.

The clara^Treport outputs include the entire study cohort and individual sample reports from Almac internally developed bioinformatics pipelines. clara^T reports on relevant public and proprietary gene expression signatures as well as single gene targets within all 10 Hallmarks of Cancer using Almac’s optimised RNA exome panel.

What you will learn: 

• How the clara^T report was created
• The structure and layout of the clara^T report
• A detailed walk through of both the cohort and sample summaries
• How the clara^T report can support biomarker discovery and aid novel cancer research findings
• Case study: Utilising clara^T in a real world gene expression dataset for malignant melanoma

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Presented by:

Dr. Gemma Logan, Senior Product Manager, Almac Diagnostic Services. 

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In this Webinar you will learn about Almac’s:

• Novel strategy for patient stratification in basket & umbrella trials
• A solution to enable multiple biomarkers to be evaluated from one sample
• DNA & RNA panel solutions for translational research & clinical trial use
• Customised patient reporting enabling simple interpretation of molecular data

A changing clinical trial landscape

The clinical trial landscape for precision medicine has shifted significantly in recent years towards multiple biomarkers being used to select patients for multiple therapies (umbrella studies) or include patients from multiple cancer types (basket studies).
When multiple biomarkers are required in these types of studies, this usually involves complex logistics with multiple vendors and excessive sample requirements which can increase time to manage and cost to run.

Diagnostic solutions for multi-arm clinical trial design

Almac Diagnostic Services has created novel panel solutions for complex clinical trials – enabling clients to evaluate multiple biomarkers from one sample, whilst saving precious tissue, time and cost. Almac offer a full portfolio of DNA and RNA assays which can be run using dual extraction from one FFPE sample. When combined, the assays provide a comprehensive review of tumour biology, the results of which are presented in an easily interpreted patient molecular data report which can be tailored to client requirements.

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In this webinar, Dr Leeona Galligan, VP UK Operations at Almac Diagnostic Services will discuss:

• An overview on Almac Diagnostic Services
• TruSight® Tumor 170 overview
• TruSight® Tumor 170 Analytical Validation at Almac
• Clinical Trial Framework for TruSight® Tumor 170 at Almac

For more information visit our Current Assay section.

As the pharmaceutical industry embraces the concept of personalised medicine, there is an increased interest in the application of biomarkers earlier in the drug development pipeline. This can pose significant challenges for both Pharma and diagnostics companies.

Almac has significant experience in the discovery of single target and multivariable signature based biomarker assays in a pre-clinical setting from both cell line and xenograft models and translating them into analytically validated clinical tests that can be used to enrich clinical trials from as early as phase I.

This webinar presents an overview of some of the key components involved in developing such products including:

• Platform selection
• Optimising tests for FFPE tissue
• Assay migration (tissue type and/or platform)
• Determination of assay analytical parameters to CLIA standards
• Biomarker clinical trial design and management
• Clinical assay delivery

Speakers for this Event:

• Tim Davison , B. Math, Ph.D., VP, Bioinformatics and Biostatistics, Almac
• Susan Farragher, Operations Manager, Almac

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NGS panels are a powerful tool for parallel assessment of genomic integrity and expression across multiple targets. This facilitates biomarker discovery in early phase clinical trials and also subsequent development of CDx assays with potential utility across multiple drug targets.

In this webinar, Dr Cheryl McFarlane, Operations Manager at Almac Diagnostic Services will summarise the main considerations of development and analytical validation of such panels and describe our experience identifying important technical and regulatory challenges.

Topics covered include:

• Use of NGS panels for patient selection
• Biomarker Discovery pathway in early phase trials
• A customised CDx Development approach
• Regulatory challenges and solutions

The webinar is now available on demand should you wish to view or share with a colleague. To instantly access the webinar please submit the form below.

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Thank you for submitting your details to view our webinar on ‘Optimizing Assays from FFPE for Biomarker Strategies’.

If you need further assistance or have any questions related to this topic, please do not hesitate to contact our team of experts.

The field of personalised medicine is developing rapidly and companion diagnostic approvals are becoming more and more common. To date, however, the vast majority of tests are relatively low complexity DNA or protein based assays. In our experience, more complex gene signature based tests are beginning to enter the pipeline with many of our clients currently using these tests for trial enrichment strategies as early as Phase I.

When it comes to clinical delivery of such assays, the ability to work with FFPE tissue is critically important. This is an area of significant experience and expertise for Almac and in this webinar we will present some of our experience.

Some of the key components will be:

• Platforms, platform selection and migration
• Optimizing tests for FFPE tissue
• Clinical delivery for trial enrichment
• Development routes for companion diagnostics

Speaker for this Event:

• Dr. Austin Tanney, Scientific Liaison Manager, Almac

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Thank you for submitting your details to view our webinar on ‘Developing and Applying Biomarkers in Early Phase Clinical Trials’.

If you need further assistance or have any questions related to this topic, please do not hesitate to contact our team of experts.

As the pharmaceutical industry embraces the concept of personalised medicine, there is an increased interest in the application of biomarkers earlier in the drug development pipeline. This can pose significant challenges for both Pharma and diagnostics companies.

Almac has significant experience in the discovery of single target and multivariable signature based biomarker assays in a pre-clinical setting from both cell line and xenograft models and translating them into analytically validated clinical tests that can be used to enrich clinical trials from as early as phase I.

This webinar presents an overview of some of the key components involved in developing such products including:

• Platform selection
• Optimising tests for FFPE tissue
• Assay migration (tissue type and/or platform)
• Determination of assay analytical parameters to CLIA standards
• Biomarker clinical trial design and management
• Clinical assay delivery

Speakers for this Event:

• Tim Davison , B. Math, Ph.D., VP, Bioinformatics and Biostatistics, Almac
• Susan Farragher, Operations Manager, Almac

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Thank you for submitting your details to view our webinar on ‘An Integrated Approach to Biomarker Discovery’.

If you need further assistance or have any questions related to this topic, please do not hesitate to contact our team of experts.  

One of the main challenges of biomarker discovery is the unbiased evaluation and rational selection of most promising biomarkers suitable for independent validation. The absence of a robust evaluation procedure can result in selecting too many biomarkers (thus creating multiplicity problems) with biased and often too optimistic estimates of performance and with limited clinical utility.

Almac’s Approach:

Almac has developed an integrated approach to biomarker model development, evaluation and selection and applied it to real life projects. This approach is implemented in classification workflow software. This allows for parallel development of multiple biomarkers models and simultaneous generation of the data used in the model evaluation procedure we are going to describe in this webinar. An important feature of this procedure is the use of both statistical and functional characteristics of the models evaluated. While traditional approaches to biomarker model generation commonly focus on purely statistical properties, in this webinar we demonstrate how functional analysis can be used as both an essential component of biomarker discovery as well as integral part of the biomarker selection process.

View this webinar and learn:

• How some of the major challenges of biomarker discovery can be addressed in an integrated manner.
• How to discover and select the biomarker models most suitable for independent validation.
• The importance of functional analysis as an essential component of biomarker discovery.

Presenting this wbebinar:

• Max Bylesjo, Ph.D., Bioinformatics Team Leader, Almac
• Nicolas Goffard, Ph.D, Bioinformatics Scientist, Almac

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Biomarkers and companion diagnostics are becoming a key component of drug development. Identifying sub-populations of patients that will respond to a drug is often based on complex biology. The current model for companion diagnostic development using single protein or simple mutation assays often fails to capture this biology. Multiplex signatures that can identify the complex biology underlying a disease or drug response and increase the chance of developing a successful CDx. This webinar will present Almac’s experience and expertise in the discovery, development and commercialisation of multiplex signatures. Examples will be shown of tests for DNA damage (DDRD), colorectal cancer recurrence (ColDx) and Angiogenesis drug response (AADx).Learning Objectives:

• The value of companion diagnostics
• The potential of multiplex signatures as companion diagnostics
• Almac’s experience and expertise in the discovery, development and commercialisation of multiplex signatures

Presenting this webinar:

• Prof. Richard Kennedy, Medical Director and Vice President, Almac and Professor of Experimental Cancer Medicine, Queens University Belfast
• Michael Sloan, VP Business Development, Almac

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Sample Access and Profiling for Biomarker Discovery to Help Rescue or Reposition your Drug

With personalised medicine becoming more commonly accepted, an increasing number of drugs in development have a biomarker strategy. In situations where a drug has not performed as well as hoped, a biomarker strategy could potentially rescue the drug or increase market uptake through the use of a companion diagnostic.

Almac have developed a service to enable biomarker studies to be carried out retrospectively in trials where there was not one in place from the start.

This service includes obtaining ethical approval and corresponding consent, identification of clinical information for patients in partnership with investigators, contractual arrangements, sample sourcing and providing full logistical and regulatory oversight of sample preparation, shipping, receipt and biobanking.

Almac have a team of highly experienced experts that work exclusively in the delivery of this service, that have:

• Established workflows for projects of this type
• Expertise and experience of ethical submission and regulatory requirements in a range of countries and institutions
• A prepared bank of template documentation for this type of study
• Experience of working with large number of recruiting sites worldwide
• Relationships with many different investigators and background staff in recruiting centres
• Extensive experience in contractual arrangements for sample access and shipping worldwide
• Global capabilities to expedite the process of clinical site participation and sample access
• Experts in sample preparation, packaging and shipping
• Experience in study design and delivery of large research studies which involve a wide range of downstream genomic and proteomic assays that impact upstream sample selection and preparation
• Specialist knowledge and vast experience of working in a range of oncology indications

In this webinar, Almacs head of project management Dr Peter Kerr, along with Michael Sloan, VP of Business Development, and Kinga Wojciechowska, lead project manager for Ethics and Tissue Collection, give an overview of the service. The talk highlights the reasons for the development of the service and give some details on the potential benefits to biopharma. The details of the service are explained and a case study is used to elucidate the process.

Speakers:

• Dr. Peter Kerr, Head of Project Management & Product Development, Almac Diagnostic Services
• Michael Sloan, Vice President, Business Development, Almac Diagnostic Services
• Kinga Wojciechowska, Project Manager – Ethics/Tissue Collection, Almac Diagnostic Services

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Thank you for submitting your details to view our webinar on ‘Retrospective Sample Collection – Biomarker Discovery to Help Rescue your Drug’.

If you require further assistance or have any questions related to this topic, please do not hesitate to contact our team of experts. 

Thank you for requesting to view our webinar, Next Generation Sequencing in Companion Diagnostic Development.

Learning Objectives: 

• The process of developing, validating and implementing a clinical NGS assay
• The issues and considerations in the development of such an assay
• How NGS clinical testing works in a central lab
• The long term potential of NGS as a companion diagnostic

Speakers 

• Dr. Leeona Galligan, Head of Laboratory Operations, Almac Diagnostic Services
• Michael Sloan, VP of Business Development, Almac Diagnostic Services

The use of next generation sequencing for clinical applications is growing rapidly and the use of Next Generation Sequencing (NGS) panels is, in some areas, becoming standard of care. While panels can be highly informative from a broad perspective, it is not guaranteed that the particular SNP or insertion/ deletion of interest will be present. When a specific targeted therapy is under evaluation and a single gene is of primary interest, there is a strong rationale for developing a NGS assay specifically for that gene.

In this webinar, Almac’s Head of Laboratory Operations Dr. Leeona Galligan presents details on the development and implementation of a clinical NGS assay for TP53 which is being used routinely for clinical trial stratification.

The webinar is now available on demand should you wish to view or share with a colleague. To instantly access the webinar please submit the form below.