Laboratory Considerations for 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 trials. The conversation covers challenges in trial organization, patient matching, and the crucial role...

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 challenges that lie ahead. The conversation explores the need for regulatory approval, integration with hospita...

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 looking for simplified, standardized flow cytometry tests to help with enrolling patients and underst...

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 and Mona Henderson, Director of Laboratory Network Solutions (both at Q2 Solutions) discuss how our dedi...

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 project timelines but also opportunities to take a new approach.  Alex and Alan talk about: How differ...

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. What services are needed to operationalize the study design? Second is data, How will the data generated b...

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 LC−MS methods and the concern about detecting analyte that is not intact as well as future projects that...

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 company, describes those challenges and how to mitigate them by asking the right questions in advance. S...

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 technology are also addressed as well as top tips for driving SAR analysis. Questions discussed include: Why...

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 faced when automating assays.

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 samples and the importance of easily tracking consent as samples move through the clinical trial ecosys...

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 Architect at BioFortis, a Q2 Solutions company, describes that ecosystem and the lifecycle of patient sample...

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 a panel of multiple tests is ordered and a sample doesn't have a sufficient volume of blood to run all...

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 antigens at the same time. Looking primarily at the spike protein, it is dissected into different parts...

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 assay Top down vs bottom up Specific challenges Assay design considerations Future potential for this...

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 speed is so important, outsourcing testing overseas may not make as much economic sense as it might...

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 from circulating free DNA (cfDNA). The main approaches comprise for evaluating cfDNA are: specific mutat...

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 data is used to evaluate the effectiveness of a vaccine while providing insight into the evolution of...

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 biomarkers such as PDL1 in that: "...we're leveraging next generation sequencing to generate a composite...

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 get a better picture of the tumor micro-environment and the interactions taking place. For example, ther...

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 ability to enter into markets due to the accessibility of that particular technology used to identify t...

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 we're actually translating those into real uses. So for example, we might have specific markers that we...

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 associated challenges, such as detecting the concentration of a specific antibody therapeutic present a...

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 ensuring the sample availability is adequate and appropriate for the different clinical trials, that the assay...

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 immuno-oncology investigation of products are considering bio-markers as true CDx or companion diagnos...