Laboratory Considerations for Clinical Trials

This podcast from Q² Solutions looks at factors sponsors should consider when preparing for 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:

  • 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

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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.

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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

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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.

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:

  • How consent is or has been documented
  • The benefits of electronic consent documentation
  • Specific consent attributes, e.g. genetic testing
  • Handling consent requirements from different countries or institutions
  • Understanding consent for future use, including limitations and expirations

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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:

  • The varying approaches of small vs. large laboratories
  • Risks of insufficient tracking
  • Tracking consent for future use
  • Current practice and opportunities for improved tracking

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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.

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.

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