Name:
Biomarkers in drug development: guidance, development and validation
Description:
Biomarkers in drug development: guidance, development and validation
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Duration:
T00H06M54S
Embed URL:
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Content URL:
https://asa1cadmoremedia.blob.core.windows.net/asset-8c4645a8-d911-4a5b-a035-153240a8180c/Robert Nelson - Interview 16.mp4
Upload Date:
2020-02-07T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
[MUSIC PLAYING]
ROB NELSON: My name is Rob Nelson. I currently work with Covance in the science innovation group based in Geneva, Switzerland. My career in bioanalysis started with Covance at the Harrogate site in the ligand-binding assay group where I worked in method development, method transfer, work with sponsors to get the methods in and working within Covance. The last five years, I worked in Geneva in a small biotech company where I head up the biological science group with responsibility for PK biomarker, immunogenicity endpoints in support of the therapeutic antibody programs.
Segment:1 What is your primary focus at Covance?.
ROB NELSON: I work in the science innovation group. And the aim of that group is really to gather ideas from across the company, particularly people in the lab, of how we can make the processes that we have better, more efficient, how we can assess new platforms, new technologies that our clients may wish. And one of the most important areas is what also our clients or the sponsors asking for that we either don't have the experience or the capabilities at the moment on how do we bring that into our groups.
Segment:2 Why are biomarkers so important and so widely developed?.
ROB NELSON: Drug development is long and very expensive. And really, as drug developers, we want to make the right decisions as soon as we can to move our product forward or to discontinue it to make sure that we have the right safety profile, to make sure the drug is effective. And biomarkers are really tools that can help us make those decisions of, is the drug engaging with its target?
ROB NELSON: Are we having the downstream effects that we want to have? So they're really important tools to make the drug development process more efficient, quicker, cost-effective, and bring medicines through quicker.
Segment:3 How do you develop biomarker assays?.
ROB NELSON: So for me, we need to understand-- the first question is how is the data going to be used? To speak with the end users to understand what question they're trying to answer so we can understand what confidence they need to have in the data we're going to provide.
ROB NELSON: As a developer, we need to understand the biology of that biomarker. Is it going to be upregulated, downregulated? How are things going to change when we give the drug? Are we looking for big changes, small changes. Is there a large normal variation? And then, we can pull all that information together to basically say, what are our assay requirements, what level of confidence, what level of assay performance do we need to be able to answer those questions.
ROB NELSON: And then, we can move forward into the assay development. Test those assumptions. Make sure what we thought we knew is correct. Go back and reassess if not. And move forward into developing and validating an assay that can answer the right questions.
Segment:4 Since the publication of the US FDA BMV guidance – how has biomarker validation changed?.
ROB NELSON: I think, with the issue of that guidance, people are starting with the assay and not asking the questions and how the data is going to be used.
ROB NELSON: So I see that has pushed people to not ask the right questions to understand the context of use of their data to investigate what is the biology of that biomarker. that starting from a template of assay validation, which is the wrong place to start. I think, if you look through the guidance carefully, you read it with a brave face. How I read it is that the FDA recognize the importance of biomarkers in drug development.
ROB NELSON: They recognize that biomarker assays will be different to PK assays. But if you're going to use your biomarkers for decisions on safety or effectiveness or for how you're going to deliver the dosage or the labeling, then they expect to see something that show that that assay is appropriate for making those decisions.
Segment:5 What are the challenges of developing and validating biomarker assays?.
ROB NELSON: In developing biomarker assays, it's often to have critical reagents, have antibody, have assay reagents that are specific for your target, to have a recombinant protein that is really representative of what you want to measure in your real samples.
ROB NELSON: I think to really characterize your assay to show that how you've set up your assay is appropriate for measuring real samples with real endogenous biomarker. It can often be challenging to obtain real samples to test them in your assay or a sample with sufficient concentration to look in and say, are your assumptions that you've made in assay development, are they true.
Segment:6 Where do you hope the field will be in 5–10 years' time?.
ROB NELSON: I hope that particularly in biomarker assay development and validation, we'll be having better conversations. The people developing the assays will be talking to the people using the data and understanding what questions they're trying to answer and how they can set up the assay to give the right data for stakeholders. So I hope that we will move forward and can have better conversations about the subjects of our assays, answer the right questions, and we put resource where it's needed and we have scientifically valid data.
Segment:7 What impact will new regulations have?.
ROB NELSON: I think, there's some fear in industry that when the ICH M10 guidance is published and that becomes the global PK assay guidance that the FDA guidance, which is the only global guidance at the moment, which contained sections on biomarkers or bioanalytical method validation guidance that becomes a biomarker guidance because that will-- if we follow the PK guidance, we'll be doing bad science for many of the situations.
ROB NELSON: So I think that's fair. I think, the health authorities are in learning mode as well. And there will be further developments in the biomarker area. And hopefully, we can really, as an industry – pharma, CROs, health authorities – come together, have the right discussions and put a framework that works for drug development that we can make the right decisions,
ROB NELSON: we can move the drugs forward with the right confidence. [MUSIC PLAYING]
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