Improving Biomarker Development Work Flow in Phase I Clinical Development

Helen Winsor

Reto Ossola, Group Leader for Biomarker Research at Biognosys, joins Pharma IQ to discuss the main challenges in biomarker development and some key ways to address these. Ossola offers some best practice tips for assessing and working with a CRO, when entering into discovery outsourcing and collaborations. Ossola also outlines some of the different types of partnerships that Biognosys has been involved in and what he thinks is the best approach. To listen to the podcast now go to Streamlining the Development and Validation Process in Discovery to Phase I Clinical Development.

Pharma IQ: Welcome to the show, Reto, how are you today?

R Ossola: Hello Helen.

Pharma IQ: Pleased you could join us. Now, to start with I’d like to ask you, where do you think the main challenges are in biomarker development at the moment?

R Ossola: There is actually a clear technology gap between the states of biomarker discovery and the clinical trials of a drug, because usually in the discovery phase, they use traditional genomic tools, where at the end they have 10 to 100 candidates. As they generally, want to move to the clinical trials, an area that can process less than 10 candidates, and so there’s a clear need to validate just over 100 candidates.

Pharma IQ: Ok, at the moment, phase I is an area where there are a lot of cost-efficiency pressures. Successful biomarker development, improving trial design and micro-dosing, are all among the solutions to improve ‘go’ or ‘no-go’ decisions. Has Biognosys, been involved in these sorts of initiatives, and can you give some examples?

R Ossola: We try to overcome this technology gap by workflows, based on aspect geometry, where we build assays, geometry assays for specifically all possible proteins, and we use assays to screen our complete list of candidates, which come from the discovery phase, in human plasma, and then use the experimental data to make go/no decisions and move equipment to the next phase of clinical trials. So, we really try to use experimental data in the highest group of matter and to decide what is and what is not a good candidate, without compromising them to missing data or experimental data points.

Pharma IQ: Do you see any other areas where cost-efficiencies could be made?

R Ossola: Well, with careful controls, and a well-balanced system of clinical example is a very important subject, so you cannot suggest a technology platform and benefits if you don’t have the right samples. We’re running these in the late stage, obviously.

Pharma IQ: Ok. What advice would you give about assisting and working with a CRO, based on your own experience?

R Ossola: Usually, what we recommend is to start with a smaller project, where it’s always open to the customer to evaluate our technology platform, and the closer we get, to get a smooth start into the project. I would say that these have the least highest candidate numbers because we really try to cut them down during the project work flow, because you know the projects the most and also how to handle samples. You are particularly expert in it.

Pharma IQ: Absolutely, and what is the main challenge in selecting partners and ensuring a good working relationship, when entering into discovery outsourcing and collaborations?

R Ossola: It is very important that they are up-to-date with clinical data, so something like follow-up data of patients, what was the drug treatment before the people picked up, the medical history of the sample picked, that’s one important point. There is also the point, when it comes to validation, to ensure your own interest in the working relationship, and the consequences on specification, I would say.

Pharma IQ: Sure, and please could you explain some of the different types of partnerships that you’ve been involved in, and what you think essentially is the best approach?

R Ossola: We usually try to reach a win-win situation in partnerships. One type of collaboration we have is where we will try to connect to the partners, and together we improve our work flows, also on the software side, and also our R&D work together. Another partnership is from industry, where we’ve had some of these early stage projects, in order to evaluate the technology platform, and some of them, they’ve moved now into later stage projects.

Pharma IQ: To move onto another area within your domain, obviously there’s a lot of hype in the market at the moment about the identification and validation of biomarkers. Is this something you think will provide benefit in phase I trials?

R Ossola: Absolutely. For drug development, having a biomarker for drugs, a very specific result for testing it, it will result in possible trials which can take some time, for the pharma side and also for the patient. This moves into customised treatment. Biomarkers will help you with classification into groups and therefore, giving the right drugs to the right patients and minimising over-treatment. Biomarkers also have a very high market in early diagnosis, so the earlier you can earlier detect a cancer affects the overall survival of the patient.

Pharma IQ: Thank you. I understand that you will be speaking at the upcoming Innovation in Phase 1 Clinical Development conference, which will take place in Munich from 20th - 22nd September 2010. Now, for anybody interested in attending, what would you say will be the key learning points to be gained from your presentation?

R Ossola: I would like to show people that next-generation tools, talking of the assay geometry, will improve the biomarker development work flow, in terms of project time and cost, and in terms of the number of candidates and patients you can screen in a short time.

Pharma IQ: Final question, which presentations or aspects of the event are you personally looking forward to the most?

R Ossola: I personally look forward to what’s coming from organisations that are already in this field and have some experience in early clinical trials, to really understand what their needs are, and also to understand what their requirements are.

Pharma IQ: Well, thanks so much for your time today, Reto. It’s been great to talk to you ahead of the conference and we do look forward to hearing more in your presentation.

R Ossola: You’re welcome.

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