Laboratory Considerations for Clinical Trials

Q Squared Solutions

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This podcast from Q² Solutions looks at factors sponsors should consider when preparing for clinical trials.

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25 episodes

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 trials. The conversation covers challenges in trial organization, patient matching, and the crucial role pathology plays in eligibility, engagement, and consent. Pathology's significance in patient stratification, randomization, and outcome evaluation is highlighted, showing how it guides precision medicine and targeted therapies.   Monika Lamba, MD, Ph.D. is a pathologist-scientist with 15+ years of experience and proficiency in the diagnosis of benign and malignant diseases of different organs, both by cytology and histopathology, incorporating morphology, immunohistochemistry, FISH, cytogenetics and molecular studies. She has extensive experience with clinical trials and is passionate about the digitization of pathology, and algorithm development for image analysis. She has published in well-known medical journals, is a peer reviewer of national and international scientific publications, and is an invited speaker on various international platforms. Professional interests include translational research, transduction pathways, cancer biology, immunopathology, digital pathology, AI, medical writing/ publications, and public speaking.

29m
Nov 17, 2023
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 challenges that lie ahead. The conversation explores the need for regulatory approval, integration with hospital systems, and standardization of AI solutions in pathology. Dr. Saini shares insights on image recognition, the digitization of healthcare, and the transformative potential of AI in diagnostic algorithms. Listen to gain a deeper understanding of the future possibilities of AI in pathology and its implications for precision medicine.

28m
Jun 30, 2023
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 looking for simplified, standardized flow cytometry tests to help with enrolling patients and understanding outcomes in their studies.  In the longer term, Megan McCausland notes what will lead to the use of flow as a CDx: “I think the drug development landscape really continues to evolve towards more personalized medicine. As this happens, biomarkers and their potential translation into companion diagnostics are playing an ever-increasingly important role. The regulatory bodies are pushing, perhaps even expecting, this co-development of biomarkers and treatments with CDx really becoming vital to regulatory approval and clinical use.” - Megan McCausland To learn more visit q2labsolutions.com/flow-cytometry https://q2labsolutions.com/flow-cytometry

20m
Nov 30, 2022
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 and Mona Henderson, Director of Laboratory Network Solutions (both at Q2 Solutions) discuss how our dedicated biotech teams focus specifically on the unique needs of those customers. Alex and Mona cover: __ __ You can learn more at https://q2labsolutions.com/biotech. https://q2labsolutions.com/biotech  

23m
Jun 22, 2022
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 project timelines but also opportunities to take a new approach.  Alex and Alan talk about: __ __ You can learn more at https://q2labsolutions.com/biotech. https://q2labsolutions.com/biotech

21m
May 16, 2022
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. __ __ Alex goes in depth on each of these and also highlights a number of items that can be overlooked and cause delays as well as what is an appropriate lead time to begin conversations with your vendor to meet your company's timeline. You can learn more at https://q2labsolutions.com/biotech. https://q2labsolutions.com/biotech

25m
Apr 07, 2022
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 LC−MS methods and the concern about detecting analyte that is not intact as well as future projects that bridge LC−MS and LBA.

11m
Mar 17, 2022
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 company, describes those challenges and how to mitigate them by asking the right questions in advance. She talks about: __ __ To learn more, visit www.q2labsolutions.com/labmatrix http://www.q2labsolutions  

17m
Sep 15, 2021
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 technology are also addressed as well as top tips for driving SAR analysis. Questions discussed include: __ __

8m
Aug 26, 2021
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 faced when automating assays.

11m
Jul 30, 2021
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 samples and the importance of easily tracking consent as samples move through the clinical trial ecosystem.    She describes: __ __ Learn more at https://www.q2labsolutions.com/labmatrix

18m
Jul 28, 2021
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 Architect at BioFortis, a Q2 Solutions company, describes that ecosystem and the lifecycle of patient samples.    She describes: __ __ Learn more at https://www.q2labsolutions.com/labmatrix    

14m
Jul 28, 2021
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 a panel of multiple tests is ordered and a sample doesn't have a sufficient volume of blood to run all the tests in the panel, the test is canceled, resulting in no data for the sponsor and unnecessary stress for young patients and their families. Q Squared Solutions has developed a protocol prioritizing a subset of tests for short samples. The decision to run the alternate panel is made by licensed medical technologists. Combined with specific sample collection kits for pediatric patients, this protocol minimizes the number of canceled tests.

19m
Feb 02, 2021
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 antigens at the same time. Looking primarily at the spike protein, it is dissected into different parts: S1, S2, S1 plus S2, and  the receptor binding domain. The nucleocapsid protein is being evaluated as well. We are taking a 2 pronged approach to the viral neutralization assays, working in collaborations with academic institutions to deliver a cutting edge approach. The first, in collaboration with the laboratory Dr. Pei-Yong Shi at the University of Texas Medical Branch in Galveston, involves viral-like particles (VLPs) where the structural genes of wild type SARS-CoV-2 virus are removed and replaced with a reporter gene. In this particular case, it's a GFP or green fluorescent protein gene along with a neomycin resistance gene. The second approach is a SARS Co-V 2 surrogate neutralization assay used under a license agreement with the Albert Einstein College of Medicine. This is the vesicular stomatitis pseudovirion process, commonly used for viral neutralization assays. It’s a different way of expressing an artificial virus. It involves taking the vesicular stomatitis virus genome, replacing some of the genes for VSV by inserting the SARS-CoV-2 spike genes, plus a reporter gene. Expressing that produces a virus-like particle or a pseudovirion that can be utilized. This approach has been used over the years in a wide variety of different applications at Q2 Solutions for example in Ebola. The vaccine operation at Q2 Solutions has the infrastructure, the capabilities and support to have a three shift operation. We anticipate doing this 24/7, which is exactly what’s needed in the context of a pandemic. Further, our center for vaccine excellence located in Beijing, China will evaluate clinical trial samples coming to us there with the same repertoire of assays that are available in San Juan Capistrano, California. The Q2 Solutions model is that we provide answers globally and with high throughput. Learn more at Q2labsolutions.com /../episode/update/id/Q2labsolutions.com.

18m
Sep 15, 2020
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: __ __ ...I think that fundamental point about more sensitivity, and associated with that is more selectivity, is going to be part of the future adoption of these hybrid assays. We have needs already, we can see needs for looking at quantifying proteins in very small samples, say tissue biopsies. - Steven Lowes Learn more at Q2labsolutions.com /ioq2labsolutions/episode/update/id/Q2labsolutions.com. Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography–Tandem Mass Spectrometry: Current State and Future Vision https://academic.oup.com/clinchem/article/66/2/282/5717988 (Article in Clinical Chemistry)

24m
Jul 29, 2020
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 speed is so important, outsourcing testing overseas may not make as much economic sense as it might have in the past, given shipping costs and the possibilities for delays (at customs for example.)   Dr. Hutzler explains the factors that contribute to the success of high-throughput ADME testing and what advances and innovations we might expect in the future.

20m
Jul 29, 2020
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 from circulating free DNA (cfDNA). The main approaches comprise for evaluating cfDNA are: __ __ She describes the typical panels for each of the approaches, the sample collection requirements and how these analyses are implemented on a global scale.

22m
Jul 29, 2020
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: __ __ You can learn more about this topic at www.q2labsolutions.com https://www.q2labsolutions.com/search#q=ngs%20flu

24m
Oct 25, 2019
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 biomarkers such as PDL1 in that: "...we're leveraging next generation sequencing to generate a composite score from tens of thousands or in some cases millions of bases of sequence. So really you're summarizing this collection of mutations in a singular value versus a more qualitative range of expression levels done by looking at proteins in a microscope. - Victor Weigman One challenge is that as treatments are being developed, the thresholds for the diagnostics are out of sync. Friends of Cancer Research understands the difficulty of harmonizing assays to a standard after FDA approval. For that reason, there is strong interest in harmonizing the results of different assays to a standard reference set.    

28m
Oct 25, 2019
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 get a better picture of the tumor micro-environment and the interactions taking place. For example, there's a whole list of new checkpoint inhibitors, like PD-1, CTLA-4, CD-1-52 and a multitude of other CD-47 that have been described, and their ligands on T cells and immune cells, not just T cells, that allows the tumor to actively turn off the host response to the tumor that prevent the tumor from being killed by the immune system. We weren't aware of these, many of these, until we had the tools that allow us to look at many more markers simultaneously. For instance markers of T cell activation have been around for a long time, but that list has expanded remarkably now, and the lists of markers of T cell exhaustion have really expanded as well, and some of those were not discovered until relatively recently, in the last 5 or 6 years. Mark explained how flow cytometry is being used to determine whether a therapeutic is efficacious or not and the benefits that flow to the patient. He stressed, as others in this series have, the importance of early engagement between sponsors and their clinical trials partners. Regular phone calls and direct conversations between scientists help refine the assays to produce the desired result in terms of the information collected from a panel.  

20m
Mar 05, 2019
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 ability to enter into markets due to the accessibility of that particular technology used to identify that bio-marker or test that bio-marker globally. For example, it's common throughout hospitals to have IHC or pathology review of particular of bio-markers but next-gen sequencing is a new and more expensive type of technology, so they might not be able to go after that as a particular companion diagnostic. But, that being said, the trade-off or what they gain from getting a companion diagnostic, they have a greater chance of reaching the correct population of patients that will see the greatest benefit of their therapeutic. The podcast conversation discusses an alternative to the traditional three-way partnership of a drug developer, an IVD manufacturer and a CRO. Single-site, pre-market approval can reduce the front-loaded investment needed for an IVD. It also can align better for the management of the project timeline.   

16m
Feb 26, 2019
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 we're actually translating those into real uses. So for example, we might have specific markers that we're using for patient selection. We might have specific markers that are candidates for eventual development companion diagnostic and so we are taking them into clinical trials, characterizing them further. Dr. Hurban discusses the use of broad genomic features such as microsatellite instability and tumor mutational burden as biomarkers in addition to specific point mutations that have been in use for some time.  He envisions a future where a multidisciplinary approach leads to a companion therapeutic strategy as opposed to a companion diagnostic strategy. In this approach, a single test could direct a patient into any of a number of therapies rather than testing the possibility of one therapy at a time.  

18m
Feb 19, 2019
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 associated challenges, such as detecting the concentration of a specific antibody therapeutic present at 100 picograms/ml in an antibody background of up to 20 billion picograms/ml. He suggests that sponsors think about the reagents that will be essential for the assays that need to be performed. An analyst will ask: "Are you going to help put some tools in our toolbox to be able to see that needle in a haystack?" And what the sponsors need to be able to do is to really have good lines of communication within their company, to make sure during the drug development program, that they actually are beginning to invest in those specific materials. And having disease state matrix during method development, also, in my opinion, it's critical to ensuring that once we get into that patient population, we reduce the risk those are going to be big surprises for working in that biological matrix that's going to interfere with that assay selectivity. The lead times can be significant as can the price, but it really does mitigate risk. Dr Brown also recommends engaging the FDA early to reduce any risk to your timelines. No one wants to get to the point of submission to find out that the approach was unacceptable and lose precious time.  

12m
Feb 12, 2019
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 ensuring the sample availability is adequate and appropriate for the different clinical trials, that the assay outcome is useful and the results are relevant for the clinical trials. It is discussed how having adequacy of tissue samples is one of the most critical components. It's also important that the sites that are sending samples have the ability to process samples in a timely manner, establishing that the fixation and other pre-analytical conditions that influence the outcome of the results are well evaluated. Dr. Krishnan provides a vision that will make the whole process easier for patients and doctors alike.  

15m
Feb 05, 2019
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 immuno-oncology investigation of products are considering bio-markers as true CDx or companion diagnostics; when in fact, they aim at producing information at a later stage, evaluating the potential of these bio-markers to be of CDx. At times the confusion here is adding a lot of pressure to the clinical labs to validate the assays to a level of stringency that is not necessarily required at that early stage. It also adds to the cost and complexity of the study. For bio-markers that are not considered as companion diagnostics, one of the main problems is how the data is generated, and how it's going to be used by the sponsor to support their drug development. Dr. Hugo explains the importance of the results generated from candidate companion diagnostic markers,  the relationship with IVD manufacturers that are developing CDx and the global regulatory environment.  

18m
Feb 05, 2019