This article is reproduced courtesy of Biotechin.Asia.
Biotech Connection Singapore organized a Panel Discussion- “Roadblocks to Biomarker Discovery” on 19th August 2015 from 6-9:30 pm at Creation Theatrette, Biopolis in partnership with ETPL, A*STAR.
The Panel discussion was moderated by Dr. Sidney Yee, CEO of DxD Hub who is also the Senior Vice President of ETPL’s Investments & Spinoff Management Division. The Panellists consisted of esteemed members of the public such as Prof. Dominique PV de Kleijn, Prof. Patrick Tan, Mr. Joseph Lee.
Prof. Dominique PV de Kleijn is the Research Professor of Surgery, NUS and the Preclinical director of cardiovascular Research Institute at NUHS. His talk was on “Liquid biopsies in cardiovascular disease” and focussed on the clinical needs perspective. He addressed the issue about how do we go from biomarker to actually using it in the clinic to help patients.
He stressed on the fact that Cardiovascular disease is no longer a western problem, it has become omnipresent and there is an urgent necessity to diagnose these conditions using biomarkers. These conditions costs billions worldwide and liquid biopsies can provide information on diagnosis and prognosis of a CVD event. He spoke about how the biomarker you have should be better than the existing ones in the market and needs to be adjusted for risk factors. A lot of research publications come out but they are not better than the existing biomarkers in the market. He said they might look good in the publication, but may not be worth following up in later stage.
Prof. Patrick Tan is a Professor at DUKE-NUS Medical School, Senior Group Leader at GIS and Senior Principal Investigator at CSI and he spoke about how to validate a biomarker to match upto clinical standards. He spoke about precision medicine and mentioned how with the current technological capabilities we can look at all the transcripts, DNA and advise treatment precisely for each individual. It is about matching the right patient to the right drug/treament and could lead to improved clinical outcomes and decrease in treatment toxicities. This branch of medicine is intimately tied to the use of biomarkers.
The College of American Pathologists (CAP) has set various requirements for the validation of a biomarker assay for clinical use which includes Accuracy, sensitivity and specificity; precision, Quality metrics and reportable range, lower limit of detection etc. Even after publishing a paper about a possible biomarker, he said it is not right to expect a company to approach you, as it has to undergo many more levels of testing and validation as mentioned above. The process from discovering a biomarker to licensing it for use, is a big one. He gave an example of how a Gastrointestinal cancer panel is being developed as a part of the POLARIS project which can help detect mutations that are clinically relevant to GI cancers.
The third panelist, Mr. Joseph Lee is the Commercialization Director of AIT Biotech and director of AIT ventures. He spoke about the things that people with commercial interest will look at in a diagnostic product. Each biomarker has a different development pathway based on their intended use. In order to commericalize it, one needs to know the target markets, customer base and the existing competition. One needs to have a clear idea of the value proposition, features, benefits and intended use of the biomarker. While developing the product, it is necessary to maintain close communication with the drug development partner and actively manage the project, while anticipating contingencies. During each stage, the documentation procedures only increase and he stressed that start-ups tend to under-estimate the importance of documentation, the cost and resources required for manufacturing and scale up and the external environment.
The talk was followed by a fruitful panel discussion and a networking session.
6:30 – 7:00 pm: Registration, arrival of speakers
7:00 – 7:10 pm: Introduction to BCS and Partners
7:10 – 8:30 pm: Speaker Introduction and Panel Discussion
8:30 – 9:30 pm: Networking reception