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.