Challenges and Opportunities in the Next Generation of Bioassays for Biologics
Kaitlyn Barago:
Hello everyone, and welcome to this podcast from Cambridge Healthtech Institute for the Protein Engineering Summit, which runs April 30th to May 4th 2018 in Boston, MA. I'm Kaitlyn Barago, Associate Conference producer. We have with us today one of our speakers form the Optimizing Bioassays for Biologics Conference, Steven Walfish, who is the Principal Scientific Liaison at the United States Pharmacopeia. Steven, thank you for joining us today.
Steven Walfish:
Well thank you for having me Kaitlyn.
Kaitlyn Barago:
One of your current roles is leading the 2015 to 2020 General Chapters Statistics Expert Committee work plan at the USP. Can you explain a little bit more about the goals of the group?
Steven Walfish:
Yes, so the General Chapters Statistical Expert Committee were responsible for providing statistical and meteorological support for other expert committees within USP and work with them to develop and approve monographs, general chapters and any reference materials. Our focus is on the general chapters concerned with statistical treatment of data, as well as anything that is related to statistics, or biostatistics. We also have a couple of expert panels that we are sponsoring, one of them is on the validation and verification, the second is analytic chapters and then Bayesian methods.
Kaitlyn Barago:
What do you see as some of the biggest challenges that bioassay scientists are facing, and how do you think we will be able to overcome them?
Steven Walfish:
So one of the biggest challenges that I see is the need for bioanalyst or bioassay scientists to look for improvements in assay performance, including things like accuracy or precision or linearity, but there is a lot of difficulty to that right now, due to the fact that we really don't have a lot of very good metrics, and a lot of very good methods for us to be able to get to that process improvement or that assay improvement. Hopefully, I think one of the ways that we could overcome it here at USP, is through developing chapters that will help with some more concrete methodology around statistics, and around analytical development that can help the bioassay scientist to be able to define what is acceptable accuracy, acceptable precision.
One of the concepts that you will hear, and hopefully will be heard around this conference is the idea of total measurement, uncertainty and analytical target profiles, and the idea that prior to development of methods that we set these acceptance criteria, that will hopefully allow for the bioassay scientist to be able to develop good methods.
Kaitlyn Barago:
In recent years novel technologies have been introduced for bioassays, such as automation and data analysis software. Which emerging technologies are you most excited about?
Steven Walfish:
That's a good question, so as a statistician one of the things that I am most excited about is some of the data analysis software that's coming out, and some of the automation methods that are being developed. It's the teaming of those two things that I think will really move us forward, because we'll be able to now automate the experimentation and the analysis of bioassay, but then we can take the software that is available to us and that can handle this randomization, bio automation and really start to get us to be able to develop some more novel and more cutting edge analytical designs and statistical designs to really move the process forward. Right now we are pretty much limited by a serial dilution concept and we're pretty much limited by plate layouts, and I think as the automatization software picks up and the analysis piece picks up, we'll able to design better, more robust analytical methods.
Kaitlyn Barago:
How do you think that these technologies will affect regulations and standards for bioassays?
Steven Walfish:
As automation becomes more common, statistical designs, plate layouts will become more sophisticated. I think the regulatory landscape will have to change, because the expectation will be for sponsors to start looking at these more cutting edge, more sophisticated methods. One of the things at USP, we're trying to understand is how do we write a chapter to help companies stay at the head of that regulatory landscape, because as most people know, as the regulatory landscape changes, we at USP have to change our chapters to reflect that, that we are being as current as possible.
Kaitlyn Barago:
And finally, what are you looking forward to most at the Protein Engineering Summit this year?
Steven Walfish:
As a panelist I'm kind of looking forward to really hearing what industry's challenges are around applying statistics to bioassay design, as I opened up this discussion about the USP general chapters on statistics is responsible for bioanalytical methods, and bioanalytical analysis. So I'm really interested in how the stakeholders, these people who are out there using and doing bioassay every day, are using our chapters and how they're using our statistical methods, and how we can improve upon them, and make them more current thinking to meet our stakeholder's needs.
Kaitlyn Barago:
Steven thank you so much for your time and your insights today.
Steven Walfish:
No problem, thank you.
Kaitlyn Barago:
That was Steven Walfish, the Principal Scientific Liaison, at the United States Pharmacopeia. He will be speaking at the Optimizing Bioassays for Biologics Conference, a part of the Protein Engineering Summit, running April 30th to May 4th 2018 in Boston, MA. If you'd like to hear him in person, go to www.pegsummit.com for registration information and enter the key code: podcast. I'm Kaitlyn Barago, thank you for listening.