Post-Event Report

Biomarkers Week 2021: Market Trends and Industry Insights

By Tia Byer |
01 November 2021
What are the key market trends and challenges facing the Biomarker industry today? We sat down with an advisory group of leading pharmaceutical and biotechnology experts to discuss our latest Biomarkers Week Conference and the exciting insights it disclosed.

On the 17th – 21st May 2021, Oxford Global held Biomarkers Week: Online. Running over 5 days, the digital event showcased a range of industry-leading keynotes, 60+ presentations and case studies, as well as 15+ roundtables, panel discussions, and workshops. The conference had 500 + delegates from the foremost pharmaceutical and biotech companies, as well as the top research institutions, and provided an in-depth look at biomarker research, from precision medicine and companion diagnostics through to digital biomarkers and drug development.

Key speakers included Thomas Condamine (Senior Director of Translational Sciences at Carisma Therapeutics), Caoimhe Vallely-Gilroy (Global Head of Digital Health & Therapeutics at Merck KGaA), Elizabeth Somers (Diagnostic Pathway Lead at Eisai), Ed Schuuring (Full Professor in Molecular Oncological Pathology and Senior Clinical Scientist in Molecular Pathology at University Medical Center Groningen), and Vilma Decman (Director and Head of the Cellular Biomarkers Group, Bioanalysis, Immunogenicity & Biomarkers at GlaxoSmithKline). In the post-event report, we have gathered some highlights from the event, including a summary of the key topic areas discussed in our post-event advisory board meeting and the major trends and challenges facing the biomarker industry today.

The Event – Key Topic Areas

Biomarkers Week featured 5 in-depth conference days, each with a different thematic focus crucial to the biomarkers industry. On Day 1, the spotlight was on Biomarkers in Drug Discovery & Preclinical Development and featured two thematic sessions focussing on Immunology & Oncology and Neuroscience & Emerging Modalities. The day’s most popular presentation with 105 views and led by the Vice President and Head of Business Development was Oncimmune’s ‘The Utility Of Autoantibodies In Oncology, Autoimmune And Infectious Diseases’. The second most viewed presentation was NeoGenomics’ ‘Perivascular Accumulation Of Immunosuppressive Cells In The Stroma Of  Human Tumours: Implications For Immunotherapy’. With 103 views, NeoGenomics’ Principal Scientists spoke of the advantages of using multiplexed immunofluorescence to improve the efficacy of IO therapy.

Day 2 covered the topic of Biomarkers In Clinical Development, delving into discussions about patient sample management as well as biomarker-driven clinical trial design. ‘Introduction To Roche Dx’ Neurology Pipeline’ received 91 views and was showcased Roche’s cutting-edge ADC CSF Biomarkers design. The second most popular presentation of the day, with 86 views, was the panel discussion looking at ‘Transforming Clinical Development Through Biomarker Driven Clinical Trial Design’. The discussion was moderated by the Assistant Professor of Neurology at Ohio State University and featured panellists from the leading pharma companies Genentech, Viracta Therapeutics, GSK, Roche, and Galapagos and addressed strategies for overcoming the challenges of biomarker-based stratified trials.

Day 3 provided an in-depth analysis into Novel Diagnostic Tools & Biomarker Technologies, with a focus on diagnostic device development within neuroscience and oncology. Reaching 90 views, Akoya Biosciences’ ‘A Spatial Biology Approach For Biomarker Discovery And Validation In Immuno-Oncology’ was the most popular presentation. In this, the Business Development and Strategy Manager addressed the current market need for spatial phenotyping platforms during discovery, translational, and clinical research. The day’s second most popular event was the World Health Organisation’s keynote address that looked at the challenges of ‘Developing Diagnostics Through High-Quality Biomarker Panels’. Presented by the Head of Laboratory Services and Biobanking, the address received over 70 views and provided a detailed analysis of strategies to enable the availability of high-quality biomarker panels for both LMIC research and capacity development.

Day 4 looked at Novel Technologies and showcased a range of industry insights on the latest technologies impacting the biomarker field, from flow cytometry and proteomic methods to digital pathology and imaging tools. With 64 views was the sponsor presentation ‘Enhanced Biomarker Discovery And Validation Using TMT® Proteomics’. Conducted by Proteome Sciences’ Chief Scientific Officer, the talk covered the recent developments in proteomics, making it an essential tool for supporting drug development. Merck’s ‘Being Critical Breeds Confidence: Critical Reagent Evaluation And Building Commercial ELISAs’ was the second most popular presentation, receiving 55 views. In this, Merck’s Portfolio Lead of ELISAs & Specialty Assay showcased the Enhanced RUO ELISA Assay Validation, which is critical to reagent evaluation and independent confirmation.

Finally, Day 5 brought back our popular focus on Genomic Markers for Precision Medicine. With critical advancements ensuring continuous developments and new data in this field, pioneers in genomic technologies and markers shared their experiences across the development pipeline to facilitate precision medicine. The University Medical Center Groningen’s keynote address ‘Developing Assays For Liquid Biopsies – ctDNA As A Marker’ was the most viewed presentation. It received 59 views and discussed the current industry challenges of identifying optimal diagnostic ctDNA tests and reducing cost. The second most popular presentation was Angle’s ‘Circulating Tumor Cells As Liquid Biopsy: From Discovery To Clinical Implementation’, which received 47 views and was led by the Head of Research & Development. This presentation discussed how CTC analysis enables minimally invasive insight into a patient’s cancer – providing protein and gene expression data.

Market Trends:

As they are vital in all phases of drug development, the global market for biomarkers is vast – it is set to grow from $43.3 billion in 2020 to $92.1 billion by 2025, at a CAGR of 16.3%. Growth in this market is mainly driven by increasing diagnostic applications of biomarkers, increasing R&D funding for pharma and biotech companies, an increasing number of CROs, high prevalence of cancer (still the dominant therapeutic area), and new initiatives for biomarker research.

1.) Regulatory Challenges: Due to the political implications of Brexit, the regulatory landscape for biomarkers in the UK is set to change radically. Next year the certification of the acceptability of a biomarker for specific use in pharmaceutical research and development will alter. As such, this overhaul could have significant implications on diagnostics, leaving the field guessing as to the exact form regulatory considerations will take. Once the Brexit transition period ends, stakeholders, including manufacturers and notified bodies, will have to adapt to the imminent changes. Moving forward, the industry will have to adopt a flexible approach to the biomarker clinical trials and development in both the UK and European markets.

2.) Growing Importance of Companion Diagnostics: Companion diagnostics have become a major driver in the recent market growth of biomarkers. The medical device provides information that is essential for the safe and effective use of a corresponding drug or biological product. Companion diagnostics can help identify those patient populations who are most likely to respond to a particular drug and significantly improve diagnosis, treatment, and patient monitoring. Biomarkers are crucial to developing companion diagnostics as they help identify drug target molecules and thus increase the demand for safer and more specialised therapies.

3.) Opportunity for Personalised Medicine: Developing biomarkers for the use of personalised medicine is a rapidly growing interest of the industry. Biomarkers play a key role in certain aspects of personalised medicine as they have the potential to improve the efficacy of diagnosis, prognosis, and selection of targeted therapies for a wide array of disease areas. In particular, biomarker diagnostic products are also frequently used as companion diagnostics for numerous investigational therapies. Recent advances in the optimisation of genomics have led to promising identification of biomarkers for HER2 positive gene mutations in breast cancer. With many other ongoing clinical trials for biomarkers in personalised medicine, the market can expect to grow exponentially over the next few years.

Challenges:

With all the momentum surrounding the latest market expansion, there are still several challenges to overcome before the biomarkers industry reaches its full potential.

1.) Data Regulation: An ongoing challenge in the biomarkers industry is the issue of data sharing and regulation. Despite a recent drive to increase patient communication and return data during the monitoring stage, regulations currently are region-specific. This is especially the case with genomic data, where data regulations differ from country to county, and certain data information is prohibited from being shared. The industry is not yet aligned on how much data should be collected and how much should be fed back to the patient or any other agency that requests access. As an industry, there needs to be a more harmonised approach to patient experience and data regulation.

2.) Validation Difficulties: A major challenge within the industry is the ability to identify an efficient biomarker that has the potential for universal application. Since 2006, the FDA has named the development of more accurate biomarkers and evaluation tools as a top priority. Validated biomarkers are integral to guiding safe clinical trials and determining important market decisions. However, this is no easy feat as biomarker validation tests are not always reliable and efficient. Many biomarkers do not even make it to the companion diagnostic stage. To address the increasing need for quality and effective technologies, characteristics such as detection limit and robustness will become paramount. Moving forward, evolving biomarker validation will require collaborations between manufacturers and agencies.

3.) Reducing Cost and Time: A willingness for collaborations in the validation biomarker field will inevitably reduce manufacturing time and costs. Open communication between the biomarker manufacturers and regulatory agencies will lead to clear guidelines, that will reduce waste levels and streamline the labour intense development process. Improved biomarkers significantly reduce the discovery costs of drug candidates, and therefore, the probability of failure during later-stage development. By accelerating the therapeutic approval process, better-developed biomarkers can also ensure a more sustainable discovery process.

Future Outlooks:

As Biomarkers are integral to all stages of drug development, it remains an area of intensive research and sustained investigation. 2020 alone saw huge growth in biomarker research within infectious diseases due to the outbreak of the COVID-19 pandemic and the heightened need for rapid diagnostic testing. While these developments accounted for the largest application segment in the market this past year, here at Oxford Global, we firmly believe the biomarkers industry will only continue to go from strength to strength.  

The market trends and the important insights provided by the advisory board will inform the structure and content of our 2021 Biomarkers UK In-Person event on 8th and 9th November. Stay tuned for further information, but in the meantime, why not sign up for our highly anticipated Digital Biomarkers & Pathology Symposium on 7th December? In this, we take an in-depth look at how the latest digital technologies can transform the future of healthcare and the clinical trials process.


Speaker Biographies

Ike Fisher, Vice President and Head of Business Development at Oncimmune At Oncimmune, Fisher is working to help revolutionise both the detection of cancer and its treatment by harnessing the sophisticated disease detection capabilities of the immune system to find cancer in its early stages. He is also a regular feature on TechNation & BiotechNation, a weekly radio broadcast focusing on the impact of technology and science on modern life. Previously, Fisher worked as Director of Strategic Alliances at Abcodia Ltd.

Anna Juncker-Jensen, Principal Scientist at NeoGenomics – Juncker-Jensen has worked for NeoGenomics for the past four years and has had roles such as Associate Director of Academic Collaborations and Scientific Liaison. Previously she worked as a Senior Scientist for NantBio, developing and utilizing cell-based high-throughput bioassays in support of oncology drug development programs. Perform target identification and validation.

Ivonne Suridjan, Global Clinical Leader Neurology at Roche Diagnostics – Prior to starting at Roche Diagnostics, Suridjan worked as a Principal Research Scientist of Neuroscience at AbbVie, designing and conducting clinical trial in biomarkers. Other expertise includes developing imaging biomarker and translational strategic plans, as well as managing implementation of strategies. She has also worked as a Senior Scientist and Clinical Imaging Lead for Sunnybrook, a clinical research program in neuroscience and psychiatry.

Rawan Tarawneh, Assistant Professor of Neurology at Ohio State University – Tarawneh is a cognitive neurologist and translational neuroscientist with special interest in Alzheimer disease and frontotemporal dementia. Her research focuses on the use of bioinformatics to identify novel genetic and molecular markers and drug targets for AD and FTD. Tarawneh’s previous research has led to the identification of 2 novel markers for neuronal and synaptic injury in AD.

Alekhya Pochiraju, Biomarker Operations Manager and Clinical Product Development at Genentech – Alekhya provides Genentech with clinical oncology biomarker operations expertise and believes that biomarkers are the future of personalised medicine and a critical element of cancer drug development and cancer therapeutics. Her recent talk at Healthcare Businesswomen’s Association and conference at Precision In Clinical Trials Summit and Salesforce Women’s Summit, focus on health equity disparity among minorities and people of colour.

Ivor Royston, Chief Executive Officer at Viracta Therapeutics – With over 40 years in the biotech industry, Viracta has been a Managing Partner (1990-2017) of Forward Ventures, a San Diego life science venture capital firm, and the founding President and CEO of the Sidney Kimmel Cancer Center (1990-2000). Prior to the above, he was Director of Clinical Immunology of the University of California, Cancer Center and co-founded Hybritech, Inc., San Diego’s first biotechnology company.  Viracta also co-founded IDEC Corporation, which developed the first monoclonal antibody for cancer therapy, and which subsequently merged with Biogen.

Kristin Blouch, Director of Molecular Disease Characterization & Strategy at GlaxoSmithKline – Blouch is leading a novel Molecular Disease Characterization program that provides new opportunities to benefit cancer research and patient empowerment. Prior to this role, as Biomarker Lead, Blouch developed Biomarker strategies for gene-engineered T cell therapy clinical trials ranging from first-in-human Phase I through Pivotal Phase II. She has also worked for the University of Pennsylvania and Johns Hopkins University.

Axel Ducret, Senior Principal Scientist at F. Hoffmann- La Roche Ltd – Ducret is a protein biochemist by training who has been using mass spectrometry for the characterization and quantification of proteins in complex mixtures. Throughout his career first at Merck Frosst in Montreal (Canada), then at F. Hoffmann-La Roche in Basel (Switzerland), he has applied increasingly more complex proteomics strategies for the discovery and validation of biomarkers in tissue, biological fluids, or other complex biological systems.

Virginie Goubert, Business Development and Strategy Manager of Europe at Akoya Biosciences- After 8 years working in research at the Scripps Research Institute (La Jolla, San Diego) and at Caltech (Pasadena, CA), developing diverse techniques in flow cytometry, laser microdissection along with genomics, confocal imaging and multiplex IHC, Virginie returned to France in 2008 to join PerkinElmer. Here she worked as a specialist for cutting-edge ‘High Throughput Screening’ technologies, microplate imaging multimode readers for cell-based assays and quantitative pathology solutions.

Zisis Kozlakidis, Head Laboratory Service and Biobanking at International Agency for Research on Cancer/World Health Organization – Kozlakidis is responsible for one of the largest and most varied international collections of clinical samples in the world, focusing on gene–environment interactions and disease-based collections. This WHO infrastructure supports multinational efforts in making treatments possible and delivering those to resource-restricted settings. Kozlakidis is a Fellow of the Linnean Society, the Royal Academy of Sciences, UK, and a Turnberg Fellow of the UK Academy of Medical Sciences.

Ian Pike, Chief Scientific Officer at Proteome Sciences – Pike has 30 years’ experience working in the diagnostics and biotechnology sectors. Having gained a PhD in Medical Microbiology, he joined Welcome Diagnostics as a research group leader and spent 8 years working on new diagnostic assays, particularly for hepatitis. In December 1999, he joined the Technology Transfer Office of the UK Medical Research Council and has also worked for Cancer Research Ventures. At Proteome Sciences he has held roles in intellectual property and operational management and business development.

Lawrence Rentoul, Portfolio Lead of ELISAs, & Specialty Assays at Merck – Having graduated from the Universities of Aberdeen and Manchester, he undertook a commercial biotechnology career and the continuous education that comes with the role of a field application specialist. Subsequently, he joined the global product management group within Merck’s Life Science business responsible for ELISAs and Specialty Assays, where he has focused on programs that look to decrease the variability in immunoassays.

Ed Schuuring, Full Professor in Molecular Oncological Pathology and Senior Clinical Scientist in Molecular Pathology at University Medical Center Groningen –

For three decades Schuuring’s research has focuses on the identification of prognostic/predictive epigenetic and molecular markers for clinical outcome, response to chemo-radiotherapy, gene-targeted therapy and treatment-resistance in cancer. His interests recently expanded to monitoring plasma ctDNA as a bloodborne-based molecular tool to predict MRD, high risk to develop metastasis and response to targeted and immuno-therapy. He is heading the laboratory of Molecular Pathology offering the latest innovative methods for treatment-decision-making in the region North-Netherlands.

Anne-Sophie Pailhes-Jimenez, Head of R&D at Angle – An expert on cellular biology and immunofluorescence technology, Pailhes-Jimenez has managed multiple projects to develop downstream assays including immunofluorescent staining and characterization of CTCs. Previously, she worked as senior scientist for 6 years at Gustave Roussy in Paris. Before joining ANGLE, Pailhes-Jimenez spent two years at a biopharmaceutical company focused on the development of innovative immunotherapy approaches to treat cancers.

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