PODCAST · science
Laboratory Considerations for Clinical Trials
by Q Squared Solutions
This podcast from Q Squared Solutions looks at factors sponsors should consider when preparing for clinical trials.
Episodes
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What is the Role of Digital Pathology in Clinical Trials
In this episode, Dr. Monika Lamba, a pathologist from Q² Solutions, discusses the transformative role of digital pathology in clinical trials. Despite its origins aiming to streamline trials, it's not yet the default. Dr. Lamba explores its evolution from telepathology and its integration into...
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AI in Pathology: Advancements, Challenges, and the Road Ahead
In this episode Dr. Monika Lamba Saini and Bruno Larvol of “LARVOL & Friends” discuss the role of artificial intelligence (AI) in pathology and its potential impact on healthcare. They delve into the slower adoption of AI in pathology compared to other medical specialties and examine the…
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Flow Cytometry as an IVD technology for Companion Diagnostics
In this episode, Megan McCausland, Scientific Advisor for Flow Cytometry at Q2 Solutions, and Scott Bornheimer, Associate Director of Medical and Scientific Affairs at BD Biosciences talk about the enormous potential of flow cytometry as a clinical diagnostic tool. Currently, pharma companies are...
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Flexible Approaches for Biotech Companies in Clinical Trials
With fewer people covering more roles with less specialization and novel therapeutics with unique testing requirements, the needs of small biotech companies in clinical trials are different from larger sponsors. In this episode, Alex Watt, Global Head for Biotech Integrated Laboratory Solutions…
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Risk Management for Biotech Companies in Clinical Trials
In this episode, Alex Watt, Global Head for Biotech Integrated Laboratory Solutions and Alan Wookey, Global Head of Companion Diagnostics discuss how to manage both scientific and operational risk in clinical trials for biotech companies. Looking at risk as uncertainty reveals not only threats to...
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3 Things to Consider in Preparation for Your Biotech Testing or Trial
Alex Watt is the Global Head for Biotech Integrated Laboratory Solutions at Q2 Solutions. In this episode, the first of a three-part series, he talks about how biotech companies can best prepare for testing with a CRO or clinical trial. First it's important to understand you analytical needs.…
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Hybrid assays: an interview with Barry Jones and Adriane Spytko
Becoming bilingual in bioanalysis In this podcast Barry Jones (Director, LC–MS Biologics and Biomarkers at Q² Solutions) and Adriane Spytko (Manager, LC–MS Biologics at Q² Solutions; both NY, USA) discuss hybrid assays using both LBA and LC−MS techniques. They share their thoughts on bottom-up...
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Managing Sample Data from Vendors
Most clinical trials involve a variety of laboratory vendors and CROs to provide services during the course of the study. Disparity in how each vendor handles, tracks and reports its data can present a challenge. In this episode, Barbara Nagaraj, Senior IT Architect at Biofortis, a Q2 Solutions...
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Automation within an ADME Laboratory
Taking an assay from bench to an automated platform In this podcast, Prakash Bhosale (Director of Discovery ADME at Q2 Solutions; IN, USA) discusses high-throughput in vitro screening and how to understand structure-activity relationships against ADME properties. The advantages of the Tecan...
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Bioanalytical Automation of Samples
In this podcast interview, Jason Evans (Scientist at Q² Solutions) discusses the importance of automation and key advantages of taking an assay from the bench to an automated platform. He also explains the increase in throughput when his lab transitioned to automated assays and the hurdles he…
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Consent Tracking for Clinical Samples
Tracking patient consent for the use of their samples in clinical trials is essential to both minimize risk of non-compliance and maximizing potential for future use. In this episode, Barbara Nagaraj, Sr. IT Architect at BioFortis, a Q2 Solutions company, explains informed consent for patient...
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Tracking Clinical Trial Samples
The clinical trial ecosystem is a complex web of investigator sites, laboratories, couriers, patient samples and more. The ability to track those samples though this ecosystem with full visibility for the sponsor is essential for a successful trial. In this episode, Barbara Nagaraj, Sr. IT...
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Avoiding Canceled Tests in Pediatric Samples
In this episode, Charlie Fix, Global Director of Scientific Harmonization for Q Squared Solutions describes the challenges of safety testing for drugs in pediatric patients where sample volumes may be limited. Clinical analyzers are set up to maximize throughput and minimize turnaround time. When…
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Covid Vaccine Testing
In this episode, Dr. Robert Bailer, Senior Director for Vaccines at Q2 Solutions, describes the processes for testing vaccines against the novel coronavirus, SARS-CoV-2. He covers both ELISA and virus neutralization assays. Q2 Solutions has developed an ELISA assay to evaluate multiple different...
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Hybrid Assays for Protein Bioanalysis
In this episode, Drs. Steven Lowes and Barry Jones discuss hybrid assays, combining immuno-affinity with liquid chromatography-mass spectrometry (LC-MS). This is a growing area of opportunity for protein bioanalysis. Topics covered include: What is meant by hybrid assay Reasons to choose a hybrid...
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High Throughput ADME Testing
ADME testing (Absorption, Distribution, Metabolism and Excretion) is an essential part of early stage drug development. In this episode, Dr. Matt Hutzler, Director of ADME Services at Q2 Solutions, describes the common paradigm of ADME testing and why short turnaround times are important. Because...
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Liquid Biopsy Collection in Clinical Development Programs
A liquid biopsy is a minimally invasive alternative to a more traditional surgical solid tumor biopsy. In this episode, Dr. Stephanie Hastings, genomics product lead at Q Squared Solutions, lays out the considerations for liquid biopsy collection and the type of information that can be gathered...
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An Next Generation Sequencing Approach to Influenza Vaccine Development
In this episode, Dr. Wayne Hogrefe and Dr. Pat Hurban discuss the use of NGS in the development and assessment of new vaccines against the influenza virus. Topics covered include: What health organizations are looking for that drives the selection of the next season's vaccine strains How sequence...
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Standardization of Tumor Mutational Burden by Alignment to Reference Standards
In this episode, Victor Weigman, Director of Translational Genomics at Q Squared Solutions and Mark Stewart, Vice President of Science Policy at Friends of Cancer Research (FOCR) joined to talk about standardization of TMB measurements by alignment to reference standards. TMB differs from other...
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Monitoring the Tumor Micro-environment with Flow Cytometry - Mark Edinger
Mark Edinger is the Scientific Advisor for Flow Cytometry at Q2 Solutions. In this episode, he describes recent advances in flow cytometry and what that means for immuno-oncology trials. New instruments, reagents and software are enabling researchers to monitor 30-some markers simultaneously to…
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Companion Diagnostic Strategies for Commercial Success
In this episode, he describes strategies for mitigating risk in the development of companion diagnostics (CDx) for immuno-oncology. Depending on the bio-marker, there might be difficulties in developing an assay that correctly characterizes that bio-marker. There are also, there could be reduced...
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The Role of Genomics in Clinical Trials for Immuno-oncology - Dr. Patrick Hurban
Genomics has come a long way from the days of being primarily a discovery tool. It used be that essentially all of the genomic data that was being produced as part of clinical trials was purely exploratory in nature. We're doing a great deal of that now, there's no doubt about that. However, now...
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Bioanalysis for Immuno-oncology - Dr. Mike Brown
Mike Brown is the Senior Director of Immuno-analytical and the Bioanalytical Site Lead at Q2 Solutions. In this episode, he describes the considerations for pharmacokinetic and immunogenicity assays in the development of biologics. He lays out the types of analysis that are needed along with the...
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Anatomic Pathology
In this episode, Dr. Radha Krishnan describes three key challenges in immuno-oncology development related to anatomic pathology. Some of the key challenges organizations that support clinical trials I-O drug development see, particularly with the context of companion diagnostics, involves…
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Selection of Biomarkers for Immuno-Oncology - Patrice Hugo
Dr. Patrice Hugo, Chief Scientific Advisor at Q2 Solutions discusses the selection and use of biomarkers in Immuno-oncology trials and the importance of early engagement between sponsors and clinical trial partners. We are seeing that too often, in early phase clinical trials, drug developers for...
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