Oncology Companion Diagnostics Xchange
Europe 2022
Munich, June 29
Welcome to hubXchange’s European Oncology Companion Diagnostics Xchange 2022, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in developing oncology companion diagnostics.
Discussion topics will cover Clinical Biomarkers, Clinical Development, Liquid Biopsies and Next-Generation CDx.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.
Please note this is an In-Person meeting with a hybrid option to join virtually.
Venue Details: Hilton Munich City, Rosenheimer Strasse 15, Munich
Clinical Biomarkers
Opening Keynote: Challenges in developing NGS based CDx; Sensitivity, Cost, serial testing for MRD and the increased use of liquid biopsies
- There is a clear shift to utilizing NGS based methods in favour of single analyte tests
- None the less, many countries have yet to adequately reimburse NGS based testing
- As minimally invasive tests utilizing liquid biopsy are developed, that enable multiple tests per patient throughout the treatment life-cycle, these costs will only increase
- To demonstrate adequate clinical utility, assays development must demonstrate robust sensitivity and specificity, as well as clinical utility
CEO, Predicine Europe
Dennis Merkle, PhD, MBA, is the Global Head of Biopharma Business and CEO of Predicine Europe. Dennis has over 20 years’ experience in Precision Oncology, having held numerous positions across both commercial and R&D functions in the pharmaceutical and diagnostics industries. Most recently he served as senior vice president of corporate development, oncology development strategy and alliance management at Invitae (formerly ArcherDx). Prior to that, Dennis was the global head of market enabling technologies and companion diagnostics at Merck KGaA, where he over-saw the development of numerous companion diagnostics across the entire Merck KGaA drug pipeline. Dennis was awarded an Alexander von Humboldt fellowship for his post-doctoral work at the Technical University of Dresden, Germany and obtained his BSc and PhD in Chemistry from the University of Calgary, Canada, focusing on DNA double-strand break repair mechanisms. Dennis also holds an MBA from Durham University Business School, UK.
Predictive biomarkers beyond PD-1/PD-L1 assays
- What have we learned from PD-L1?
- What’s next in the biomarker pipeline?
- New technologies – how do they help us already today?
- Is tissue the issue, then why don’t we go to blood?
Director, Clinical Biomarkers & Companion Diagnostics, Merck Group
Marcus Otte is Head of Biomarker Test Strategy & Profiling group in the Translational Medicine Department at Merck Healthcare KGaA. Before joining Merck Healthcare KGaA he worked at Definiens (Astra Zeneca), ORIDIS Biomarkers GmbH and Switch Biotech AG in several management and scientific positions in the drug and biomarker R&D field.
In his current role the focus is on translation and clinical implementation of new biomarker and assay technologies for patient selection and Mode-of-Action analysis in early and late clinical development.
Marcus received his PhD at the Technical University of Darmstadt (Germany) and did his Post-doc in Munich (Institute of Immunology) and Hamburg (University Hospital Eppendorf).
Validation of digital pathology workflows in a clinical setting
The current probability of success of a drug reaching the market from initial research is staggeringly low, only ~3%, how can workflows in digital pathology improve on these statistics? Will a multi-omics approach in clinical trials help?
Discussion of the practicalities and obstacles in implementing digital pathology workflows into a clinical setting, given the latest issues with the PDL1 assay, how can we improve discrepancies in available PD-L1 immunohistochemistry assays (https://dailynews.ascopubs.org/do/10.1200/ADN.22.200944/full/)
Discuss appropriate training and validation datasets
Associate Director, Scientific Affairs, Ultivue
Angela Vasaturo is Associate Director, Scientific Affairs at Ultivue. Prior to Ultivue, Angela was a Senior Researcher in Dr. Jerome Galon’s Laboratory of Integrative Cancer Immunology at the Cordeliers Research Center. From 2010-2015 Angela was a postdoctoral researcher in the field of Tumor Immunology at the NCMLS in Nijmegen, NL, and was the recipient of an EMBO short-term fellowship, amongst others. In 2012, Angela was among the first postdocs in Europe to be involved in the development of multiplex IHC and multispectral imaging and analysis of up to six
immunofluorescence markers, and today is considered a leading European expert in multiplex IHC
techniques, multispectral digital pathology, and tissue imaging.
1:25 – 2:25pm
Implementing evolving actionable biomarkers in clinical practice: opportunities and challenges
- Lack of evidence of prevalence of new biomarkers in the ”to be launched” country?
- How to ensure fast and effective implementations of new biomarker testing in clinical practice?
- Lack of reimbursement for biomarker-testings (how to deal with it)?
- Challenges pathologists facing as more and more biomarker testing are emerging?
- Comprehensive genomic profiling, way to go?
Oncology Diagnostics Liaison, AstraZeneca
Naresh Chandra, Ph.D., is trained as life-science researcher and now contributing to medical affairs with focus on Biomarkers in cancer care. Naresh has done his Ph.D. within virology and oncology from Umeå University, MIMS-EMBL, Sweden. After his Ph.D., Naresh has joined BioReperia, Linköping, Sweden, as International Representative Sales and Scientific Affairs. BioReperia has developed a novel in-vivo model for oncology drug discovery and is being evaluated as in vitro-diagnostics tool. Currently, he is working as Oncology Diagnostic Liaison, Sweden, at AstraZeneca. His main areas of interests and expertise are precision medicine /biomarker testing in cancer, liquid biopsy and digital pathology. His long term goal is to contribute in development and implementation of novel and reliable technologies for early cancer detection and screening.
3:45 – 4:45pm
The impact of the new EU IVD regulation on the pharmaceutical industry
- How will these new regulations impact patient access to precision medicines?
- How will the new EU regulatory changes for IVDs and CDx impact precision medicine development?
- How will these changes be implemented and who is going to pay for them?
- How will the UK will be aligned with Global and EU IVD and CDx Regulations?
Director, Precision Medicine Policy, AstraZeneca
Patrick is currently the Director of Precision Medicine Policy at AstraZeneca and is also a precision medicine representative at 2 industry trade bodies (EFPIA and ABPI) in their regulatory impact work streams. Patrick has worked in the pharmaceutical industry for the last 29 years, with 17 of these focused upon oncology precision medicines. In the last 4 years, his focus has been upon the changing European regulatory environment for companion diagnostics and IVDs and the impact upon precision medicine development. He holds a degree in Molecular Biology and a MBA, in addition to a post graduate certificate in health economics.
