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 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.

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.

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

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: Operational strategy, from supply chain to data management The role of LNS in contracting and managing specialty, third-party labs Collaboration with our parent company, IQVIA and Adapting to evolving customer strategies  You can learn more at https://q2labsolutions.com/biotech.  

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 different risks are evaluated and prioritized and the processes put in place to mitigate and/or respond to those risks if they occur.  What sponsors can do to reduce the risks for their study How Q2 Solutions' in-house scientific and regulatory expertise ensure that your data are compliant to global regulations You can learn more at https://q2labsolutions.com/biotech.

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 be used? Third is logistics and supply chain. How does sample get to the analytical location and then to its final destination? 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.

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.

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: The need to harmonize data moving between systems How to approach vendors of different sizes and capabilities The best time to engage a vendor about data management Questions to be answered in negotiations A success story that save a lot of time and effort To learn more, visit www.q2labsolutions.com/labmatrix  

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 is compound management and storage important? Do you suggest that a lab goes full in on automation or transitions to automation over time? When do you take an assay from the bench to an automated platform? How much experience do you need with programming to implement automated tools? What are the advantages of the Tecan technology? What are your top tips for driving SAR analysis?

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.