Biomarker



Companion Diagnostics Virtual Conference
20 – 23 October 2020


• Biomarker Drug Discovery and Assay Development
• Proteomics and Genomics based Biomarkers
• Digital Biomarkers, Predictive Biomarkers, Precision Medicine and Big Data
• Clinical Applications of Biomarkers in Immuno-Oncology, Neurology and Inflammatory Diseases
• Commercialization of CDx
• Multiplex Companion Diagnostics and Regulatory Guidelines
• Design of clinical trials in CDx

KEY HIGHLIGHTS


The emergence of the need for safety and efficacy of a drug subjected to individual patients has made companion diagnostics one of the
most sought after topics in the field of In-Vitro Diagnostics. The surge of investment in companion diagnostics has brought forward issues
regarding regulations and their intricacies and boosted new trends in immuno-oncology, immuno-therapies, data interpretation and
unconventional design of clinical trials.
The Biomarker and Companion Diagnostics Virtual Conference scheduled to be held on 20-23 October 2020 would address the gaps between
early stage biomarker development and the commercialization stage of biomarkers.
This conference would also highlight case studies on leveraging emerging technologies in Digital Biomarkers, Precision Medicine and Big
Data.
Regarding commercialization of biomarkers, leading industry and academic experts would share their case studies focusing on advancements
in companion diagnostics area. The keynote presentations would also help the attendees understand the issues related to clinical translation
of biomarkers.

EVENT OVERVIEW


MarketsandMarkets
Biomarker and Companion
Diagnostics Virtual Conference
Leveraging next gen technologies beyond
conventional biomarker drug discovery
20 – 23 October 2020
WHO SHOULD ATTEND
Researchers, scientists, clinicians, academicians and professionals from
• Pharmaceutical companies
• Bio-pharma companies
• Universities and Research institutes
Working in:
• Biomarker discovery/development
• Translational research
• Clinical Biomarker
• Biomarkers in IO and Neurological disorders
• Imaging Biomarkers
• Pathology
• Companion Diagnostics
• Biomarker Imaging
• Proteomics Biomarkers
• Experimental Medicine
• Data Science
• Biomarkers in Clinical Discovery
• Immuno-oncology/Neuroscience Drug Discovery
• Diagnostic Biomarkers development
• Personalized Medicine
• Immunology Biomarkers


20 – 23 October 2020
SPEAKING PARTNER
MEETING PARTNER
SPONSOR/EXHIBITOR
GOLD SPONSORS
SILVER SPONSOR
For more information please contact Konark at konark.varshney@marketsandmarkets.com | +91 20 4859 8271
MarketsandMarkets Biomarker and
Companion Diagnostics Virtual Conference
20 – 23 October 2020
SPEAKERS PANEL
• Roy Baynes, Senior Vice President, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, USA
• John Rossi, Senior Director, Head, Cell Therapy, Kite Pharma, USA
• Fen Huang, Biomarker Lead, Denali Therapeutics, USA
• Mike Baratta, Scientific Director, Chief of Staff, Clinical Biomarker Development and Innovation, Takeda Pharmaceuticals, USA
• Pallavi Sachdev, Senior Director, Eisai, USA
• Shashi Ramaiah, Head, Safety Biomarkers, Translational Sciences, Pfizer, USA
• Nadia Hassounah, Principal Scientist, Novartis, USA
• Adil Daud, Director, Melanoma Clinical Research, UCSF, USA
• Ben Chih, Translational Scientist, Genentech, USA
• Saumya Pant, Director, Clinical Genomics and Genetics, Bristol-Myers Squibb, USA
• Majid Ghoddusi, Senior Director, Clinical Biomarkers, Poseida Therapeutics, USA
• Xinyin Lai, Senior Research Scientist, Eli Lilly, USA
• Ian Pyrah, Senior Vice President, Translational Sciences, Seattle Genetics, USA
• Shamim Mollah, Assistant Professor, Department of Genetics, Washington University School of Medicine, USA
• Yuk Yee Leung, Assistant Professor, Pathology and Laboratory Medicine, University of Pennsylvania, USA
• Parag Mallick, Associate Professor, Radiology, Stanford University, USA
• Tanja Zabka, Principal Scientist, Pathologist, Genentech, USA
• Nancy Casanova, Professor, University of Arizona, USA
• Michelle Graham, Principal Scientist, Translational Medicine and Biomarkers, AbbVie, USA
• David Mozley, Professor, Nuclear Medicine, Cornell University Weill College of Medicine, USA
• Kevin Wang, Director, Program for Neurotrauma, Neuroproteomics and Biomarkers Research, University of Florida, USA
• Paul Wood, Director, Metabolomics Unit, Lincoln Memorial University, USA
• Scott Reid, Executive Director, Strategic Alliances and CDx, Neogenomics, USA
• Senior Representative, Burning Rock Dx, USA
• Bryan Downie, Senior Scientist, Gilead Sciences, USA
• Dhiman Ghosh, Scientist, DMPK, Takeda, USA
• Ian Pike, Chief Executive Officer, Proteome Sciences, UK
• Senior Representative, Larvol, USA
• George Pell, Principal & Chief Strategy Officer, Thirty-Six, USA
• Senior Representative, Owlstone Medical Ltd., UK
For more information please contact Konark at konark.varshney@marketsandmarkets.com | +91 20 4859 8271
MarketsandMarkets Biomarker and
Companion Diagnostics Virtual Conference
20 – 23 October 2020
Day 1, 20th October 2020
(PST TIME ZONE)
10:00 Online Registration
10:25 Welcome note from MarketsandMarkets
10:30 Opening Remarks from the Chairman
10:35 Keynote Presentation: Discussing clinical biomarker qualification strategies (regulatory aspects)
BIOMARKERS IN CLINICAL & TRANSLATIONAL DEVELOPMENT: DRUG DISCOVERY AND ASSAY DEVELOPMENT
11:00 Enhanced Biomarker Discovery and Validation Using TMT® Proteomics
• Applying advanced proteomic based Mass Spectrometry techniques in oncology based research through to clinical trials.
• Visualise >8,000 proteins from human serum/plasma and apply extensive bioinformatics to identify those proteins that predict
disease, help stratify patients or monitor drug trials.
• Targeted Mass Spectrometry applications to solve protein quantification where ELISA fails or antibodies do not exist.
• Quantify 100’s of site specific phospho protein epitopes in one multiplex experiment.
• New! Quantifying protein degradation (PROTAC) experiments, measuring class 1 and 2 MHC peptides and Tryptophan and its
downstream metabolites.
Ian Pike, Chief Executive Officer, Proteome Sciences, UK
11:25 Solution Provider Presentation
11:50 Predictive biomarkers of response to PD-L1 inhibition
12:15 Functional biomarker assay development for cancer treatment
12:40 Solution Provider Presentation
13:05 Clinical biomarker development for an intratumoral TLR7 agonist
• LHC165 is an intratumoral TLR7 agonist that is absorbed to aluminum hydroxide and is hypothesized to induce a type 1
interferon response driven by Th1 promoting chemokines/cytokines resulting in local and abscopal antitumor activity
• LHC165 single agent and in combination with PDR001 is currently underway in a Phase I/Ib FIH clinical trial in patients with
advanced solid tumors
• Preclinical data and the anticipated mechanistic role of LHC165 in driving antitumor activity guided clinical biomarker assay
development
Nadia Hassounah, Principal Scientist, Novartis, USA
13:30 Panel Discussion: Use of biomarkers in clinics-success and challenges of getting a good biomarker
• How do we identify patients for the biomarker combination trials?
13:55 Closing Remarks from the Chairman
14:00 Networking and One-on-One Meetings
End of Day 1
For more information please contact Konark at konark.varshney@marketsandmarkets.com | +91 20 4859 8271
MarketsandMarkets Biomarker and
Companion Diagnostics Virtual Conference
20 – 23 October 2020
Day 2, 21st October 2020
(PST TIME ZONE)
10:00 Online Registration
10:25 Welcome note from MarketsandMarkets
10:30 Opening Remarks from the Chairman
10:35 Keynote Presentation: Precision Medicine Tools and Immuno-Oncology
• Initial phase 2 screening was enabled by precision medicine
• Precision medicine tools enabled and accelerated monotherapy clinical development
• Precision medicine tools have led to histology agnostic approvals
• Precision medicine tools have provided insights to mechanisms of resistance and combination therapy selection
Roy Baynes, Senior Vice President, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, USA
INNOVATIONS IN BIOMARKER RESEARCH: DIGITAL BIOMARKERS, PRECISION MEDICINE AND BIG DATA
11:00 Applying Big-Data and Mathematical Modeling to Biomarker Discovery
• Low cost diagnostic strategies for cancer early detection and treatment strategy personalization are expected to radically
improve patient outcomes and decrease healthcare costs
• We hypothesize that the tumor-blood relationship is driven by combinations of non-linear processes, which lead some proteins
to not shed from the tumor into the blood or, once shed drive to not persist (possibly due to slow intratumoral diffusion
kinetics or fast degradation kinetics)
• By integrating data from large-scale studies with a novel mathematical model, we have recently developed a new software tool
that is able to prioritize markers based upon their likely circulating kinetics
Parag Mallick, Associate Professor, Radiology, Stanford University, USA
11:25 Solution Provider Presentation
11:50 Mechanism of Immune Checkpoint Therapy: new data
• How does Immunotherapy work?
• Converting cold to hot with immunotherapy
• Systemic response to cancer-exploiting it
Adil Daud, Director, Melanoma Clinical Research, UCSF, USA
12:15 Solution Provider Presentation
12:40 Multi-purpose approach to biomarker development: Diagnostic, Prognostic, Safety and Response biomarkers
• Define types of biomarkers based on the FDA BEST document to establish common understanding
• Review approach and strategy to enable multiple uses for biomarkers as diagnostic, prognostic, safety and response
biomarkers
• Provide case studies to exemplify considerations for using this approach that is being leveraged at Genentech as well as
through Consortia Qualification work
Tanja Zabka, Principal Scientist, Pathologist, Genentech, USA
For more information please contact Konark at konark.varshney@marketsandmarkets.com | +91 20 4859 8271
MarketsandMarkets Biomarker and
Companion Diagnostics Virtual Conference
20 – 23 October 2020
Day 2, 21st October 2020
13:05 Next Generation Intelligence | precision and personalized medicine for the brain, mind, and nervous system
• Psychiatric and Neurocognitive | tracing the molecular, cellular, and metabolic basis of every presentation, for every individual
• Microbes and Pathogens | modeling individual host response to microbes, the products they make, and their true collective
impact
• Injury and Trauma | a more precise, meaningful, and actionable picture of the biological and neurophysiological cascades of
neurotrauma
• Autoimmunity and Neurodegeneration | mapping the details and dynamics of each individual’s perfect storm, and how to
unwind it
George Pell, Principal & Chief Strategy Officer, Thirty-Six, USA
13:30 Closing remarks from the Chairman
13:35 Networking and One-on-One Meetings
End of Day 2
For more information please contact Konark at konark.varshney@marketsandmarkets.com | +91 20 4859 8271
MarketsandMarkets Biomarker and
Companion Diagnostics Virtual Conference
20 – 23 October 2020
Day 3, 22nd October 2020
(PST TIME ZONE)
10:00 Online Registration
10:25 Welcome note from MarketsandMarkets
10:30 Opening Remarks from the Chairman
10:35 Keynote Presentation: How Digital Biomarkers are redefining personalized medicine?
EMERGING TRENDS IN CDX: IDENTIFICATION OF RIGHT BIOMARKERS & DESIGN OF CLINICAL TRIALS IN CDX
11:00 Overcoming technical hurdles of sensitivity to perform copy no. variations and gene expression profiling in liquid biopsy
11:25 Solution Provider Presentation
11:50 Targeting chromatin remodeling for cancer therapy
• Epigenetic modifications that control chromatin remodeling are flexible and dynamic, thereby making them promising
therapeutic targets
• The regulation of chromatin remodeling is carried out by the precise coordination of covalent histone modifications and
remodeler proteins through catalytic activities
• Integrative frameworks can reveal the mechanisms of action of specific drugs on chromatin remodeling machinery in cancer
cells potentiate for improved development of chromatin-based cancer therapy
Shamim Mollah, Assistant Professor, Department of Genetics, Washington University School of Medicine, USA
12:15 Unravel the molecular mechanisms of non-coding genetic variants in Alzheimer’s Disease using a scalable high-throughput
pipeline
• Present a scalable platform for harmonizing functional genomics data
• Describe a robust and powerful pipeline for dissecting noncoding regulatory mechanisms for human diseases
• Summarize mechanistic findings from non-coding genetic variants from the world’s largest Alzheimer’s disease GWAS data
Yuk Yee Leung, Assistant Professor, Pathology and Laboratory Medicine, University of Pennsylvania, USA
12:40 Solution Provider Presentation
13:05 Biomarker Identification, Selection, and Development
• 8 ways to identify biomarker candidates
• 24 biomarker properties to enable biomarker selection
• 1 solution for biomarker development
Xinyin Lai, Senior Research Scientist, Eli Lilly, USA
13:30 International harmonization of biomarkers used in CDx
13:55 Closing Remarks from the Chairman
14:00 Networking and One-on-One Meetings
End of Day 3
For more information please contact Konark at konark.varshney@marketsandmarkets.com | +91 20 4859 8271
MarketsandMarkets Biomarker and
Companion Diagnostics Virtual Conference
20 – 23 October 2020
Day 4, 23rd October 2020
(PST TIME ZONE)
10:00 Online Registration
10:25 Welcome note from MarketsandMarkets
10:30 Opening Remarks from the Chairman

10:35 Keynote Presentation:Merging cross-functional groups to commercialize a successful CDx test


CDX COMMERCIALIZATION, REGULATORY UPDATES, STATISTICS & DATA IN CDX

11:00 Transition to commercially viable platforms to detect multiple targets for CDx
11:25 Launching a Companion Diagnostic (CDx): Research and Development Through Commercialization
• Case Studies (ssPMA, IVD PMA)
• Regulatory pathways & considerations
• Commercial Launch: Day-One Launch of a CDx (e.g. PIK3CA CDx)
Scott Reid, Executive Director, Strategic Alliances and CDx, Neogenomics, USA
11:50 A well founded partnership with the right partners to develop a successful CDx
12:15 Solution Provider Presentation
12:40 Assessing lab developed tests to achieve standardization in CDx
13:05 NGS based CDx: potential value and challenges
13:30 Closing remarks from the Chairman
13:35 Networking and One-on-One Meetings
End of Conference

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