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.
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.
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.
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.