Genomics in Precision Oncology Xchange
East Coast, Boston
December 7, 2021

Welcome to hubXchange’s East Coast Hybrid Genomics in Precision Oncology 2021, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in genomics-led oncology precision medicine strategies.
Discussion topics will cover Cancer Genomics, Translational Bioinformatics, Data Quality & Access, Genomics Informed Clinical Decisions and Precision Oncology.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.

Please note all COVID safety protocols will be adhered to at this hybrid meeting.

Cancer Genomics

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote:

Unlocking the value in FFPE tissue for precision oncology using isotachophoresis

The history of FFPE and importance in Precision Oncology
The challenges of FFPE for modern analysis methods
Isotachophoresis-based nucleic acid extraction

Greg Gonye

Principal Field Application Scientist
Purigen Biosystems

Dr. Gregory E. Gonye is a Principal Field Application Scientist at Purigen Biosystems, a transformative nucleic acid extraction company. Dr. Gonye earned BSc degrees in Biochemistry and Microbiology from the University of Massachusetts Amherst and a PhD in Molecular Biology and Biochemistry from the University of Connecticut School of Medicine. He completed a Postdoctoral Fellowship in Neuroscience at the Dupont Merck Pharmaceutical Company. He then joined DuPont CR&D, reverse engineering blood pressure regulation, while applying functional genomics and computational biology across several DuPont businesses. Dr. Gonye went on to co-found the Daniel Baugh Institute for Functional Genomics and Computational Biology at Thomas Jefferson University. After more than a decade at TJU, Dr. Gonye joined NanoString Technologies, applying his gene regulation expertise to expand adoption of the platform. Excited by the transformative potential of isotachophoresis, he joined Purigen Biosystems early in 2020.

9:05 – 10:05am

Connecting Cancer Genomics with Environmental Stress Adaptation: Considerations for Drug Discovery

Tumor targeted therapies in genetically defined patient populations have revolutionized cancer treatment paradigms. However, innate or acquired therapy resistance cannot be completely explained by genetic hypotheses.
It is increasingly recognized that environmental pressures promote tumor dependencies that may or may not be genetically driven.
This discussion will focus on our emerging understanding of tumor genetic lesions and their cross-talk with environmental stressors.
Can these learnings inform on the next generation of cancer drugs or on novel therapeutic combinations?

Charles Sinclair

Senior Principal Scientist, Lab Head, Oncology Drug Discovery
Bristol-Myers Squibb

Charles is a Senior Principal Scientist at Bristol-Myers Squibb, leading drug discovery programs targeting the interface between tumor-intrinsic biology and the tumor microenvironment. Charles originally trained as an immunologist, completing his PhD in immune cell biology at the MRC National Institute for Medical Research (London, UK) and postdoctoral training in inflammation at Emory University. He previously led a small molecule immuno-oncology group at AstraZeneca (Cambridge, UK), where his team discovered a clinical candidate antisense oligonucleotide targeting FOXP3. Charles also has a longstanding interest to understand the immunomodulatory functions of the PI3K/MTOR signaling pathway in cancer and inflammation.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings / Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Data centric AI in clinical research

Multimodal data is a powerful asset in healthcare
Complementary information across different modalities can lead to more accurate disease diagnoses and outcomes predictions
Emerging RWD capabilities are uncovering valuable new insights to support drug discovery efforts, clinical development, and commercialization

Ryan Fukushima

Chief Operating Officer
Tempus

Ryan Fukushima serves as Chief Operating Officer at Tempus. Prior to Tempus, Fukushima was an Entrepreneur-in-Residence and Vice President at Lightbank, focusing investments on enterprise software and launching businesses. Earlier he was at Hyde Park Venture Partners, where he concentrated on enterprise investments in the Midwest. Before landing in Chicago, Fukushima worked predominantly as an engineer, designing and implementing backend systems for Cisco and VMware. Fukushima has received a bachelor’s degree in Engineering from California Polytechnic University and holds an MBA from the Ross School of Business at University of Michigan, where he was a Zell Scholar.

Jonathan Dry

Vice President Scientific Discovery
Tempus

Trained in Biomedical Sciences and Bioinformatics at the University of Manchester and University of Exeter UK: studied the genetics of type 1 diabetes, and sponsored by GlaxoSmithKline to develop neural networks to predict optimal host cells for recombinant protein production.
Over 17 years at AstraZeneca: Built and managed a 55 person global organization delivering computational biology and data science for Early Oncology. Pioneered target biology transcriptomics for precision medicine, new methods for actionable DNA variant detection, and research advancements for knowledge integration and causality in machine learning. Seeded multiple new drug projects; discovered biomarkers and translated to companion diagnostics; expanded indications for several drugs including selumetinib (MEK-i), olaparib (PARP-i), tagrisso (EGFR-i), and immunotherapies. Led AstraZeneca data and AI transformation strategy for Research.
VP Scientific Discovery at Tempus: pharma and biotech partnerships; research for diagnostic platforms; target selection; disease modeling; new opportunities.
>40 publications in peer reviewed journals including Nature, Cell and Science family. Workstream lead for BloodPac, and scientific advisor to multiple venture, startup and SME’s applying data technology in health.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation

Bridging the gap between complex genomics data and actionable genetic insights using digital PCR

With its ability to quantitate multiple genetic mutations in in a single sample, digital PCR can help to democratize the use of tissue and liquid biopsy testing in clinical settings, providing accurate and actionable data. Stilla’s Crystal Digital PCR technology can be deployed into translational and clinical environments, bringing usability and quick turnaround to high-plex datasets that are typically associated with complex NGS techniques while maintaining a high degree of specificity and absolute quantification.

Philippe Mourere

President and CEO
Stilla Technologies

Philippe is an executive life sciences leader with over 25 years’ experience gained through leadership roles at global organizations serving drug discovery and development organizations and with his strong biomarker landscape knowledge has a proven track record of influencing both translational and clinical programs.

1:55 – 2:55pm

The Current Landscape of Immunogenomics

Are multi-omic technologies helping inform patients responses to immunotherapy?
What are the challenges in collecting, integrating and sharing immuno-(gen)omic data from clinical trials within your organization?
Which indication agnostic biomarkers are currently most promising? Are there indication specific biomarkers that are promising?
How close are antigen presentation machinery and loss of HLA to being companion biomarker diagnostic ready?

Rami Rahal

Senior Director of Cancer Biology
Scorpion Therapeutics

Rami is a Senior Director of Cancer Biology at Scorpion Therapeutics, leading small molecule drug discovery programs targeting cancer drivers. Rami originally trained as a yeast geneticist at MIT and conducted postdoctoral fellowships at Harvard Medical School and the Novartis Institutes of Biomedical Research (NIBR), where he leveraged pharmacological and genomic profiling to identify new treatment strategies for lymphoma and characterized novel synthetic lethal cancer vulnerabilities. Rami has spent the majority of his career in drug discovery prosecuting multiple target classes for both precision oncology and immunotherapy. Most notably, he led the biology for Blueprint Medicine’s RET inhibitor BLU-667/Pralsetinib, now an FDA approved drug (Gavreto) for RET-driven NSCLC and thyroid cancers.

3:00 – 3:30pm

1-2-1 Meetings / Networking Break

3:30 – 4:00pm

1-2-1 Meetings / Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster

The RNAscope RNA In situ hybridization platform in companion diagnostics

RNAscope is a highly sensitive and specific RNA ISH platform for biomarker detection with superior performance to IHC for many targets
RNAscope is available on automated IVD IHC/ISH platforms and has been widely adopted for a variety of diagnostic applications
RNAscope is being used in multiple companion diagnostic programs with partners in place for CDx IVD assay development and broad commercialization

Rob Monroe

CMO
BioTechne

Dr. Rob Monroe leads Bio-Techne’s Advanced Cell Diagnostics (ACD) programs to develop diagnostic and CDx applications with the RNAscope platform. In this role, Dr. Monroe works with pathologists and researchers to identify unmet needs in biomarker testing and subsequently oversees development of RNAscope-based tests for these applications. Dr. Monroe also serves as the clinical lead in ACD’s CDx partnerships with Leica Biosystems and multiple biopharma companies for the development of CDx assays using RNAscope technology. Prior to ACD, Dr. Monroe served as Medical Director and VP of Laboratory Operations for the molecular diagnostics company Veracyte. Prior to Veracyte, Dr. Monroe served as Chief Medical Officer of BioImagene (acquired by Roche in 2010), a leading provider of imaging solutions for anatomic pathology, where he headed development of software applications for pathologists, including multiple FDA-cleared algorithms for immunohistochemistry. Dr. Monroe holds an MD/PhD from Harvard and is board-certified in cytopathology, anatomic pathology, and clinical pathology.

4:45 – 5:45pm

Characterizing patient population via RWE, Genotype, and Clinical Phenotypes

Characterizing patient population via RWE, Genotype, and Clinical Phenotypes
Goal: To characterize the treatable patient population, namely disease prevalence, risk, and natural history
Data: Real world data that contain genotype, biomarker, and clinical outcome information: (a) large population based cohort (eg. UK Biobank), (b) disease specific patient registry
Analysis: Genotype-phenotype association, longitudinal growth modeling, etc
Operation: To drive impact beyond Research, often involves collaboration with Clinical and Commercial teams

Evan Bai

Principal Scientist, Computational Genomics
Vertex

Evan Bai is a Principal Scientist at Vertex Pharmaceuticals. Since joining Vertex in 2016, he has been the computational genomics lead on 2 ongoing disease programs, leading collaborations across Research, Clinical, and Commercial. By designing and analyzing genomic studies across the drug discovery pipeline, ranging from target discovery to defining treatable patient population, he contributed to the advancement of one disease program from compound screening into achieving Phase II proof-of-concept. Evan is also a co-chair of Vertex PRIDE, an employee resource network with over 400 members that supports the career advancement of LGBTQ+ employees and allies. Evan has a PhD degree from Yale University where he studied the genomic landscape of brain tumors.

5:45 – 6:45pm

Evening Drinks Reception

Translational Bioinformatics

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote:

Unlocking the value in FFPE tissue for precision oncology using isotachophoresis

The history of FFPE and importance in Precision Oncology
The challenges of FFPE for modern analysis methods
Isotachophoresis-based nucleic acid extraction

Greg Gonye

Principal Field Application Scientist
Purigen Biosystems

9:05 – 10:05am

How Apply Single cell Sequencing and NGS to Identify Biomarkers from the Periphery

Clinical study design utilizing single-cell technologies
Best resolution for best results- the concept of single-cell RNAseq vs bulk sequencing
Challenges: clinical specimen collection, storage, shipment and lab procedures
Computational ”Ground Truth” for single-cell RNAseq analysis

Asaf Rotem

Senior Director, Translational Medicine
AstraZeneca

Asaf joined AstraZeneca from the Center for Cancer Genomics at Dana-Farber Cancer Institute, Boston MA where he served as Associate Director. Asaf received a BSc from Hebrew University, Rehovot, Israel, an MSc from the Weizmann Institute of Science, Rehovot, Israel, and a PhD from Technion – Israel Institute of Technology, Haifa, Israel. Following his education Asaf worked in roles of increasing responsibility: Research Scientist at Rambam Medical Center, Department of Pathology, Israel; Research Scientist at Artemis Pharmaceuticals, Haifa, Israel; Postdoc (with Prof. Kevin Struhl) and then Instructor in the Department of Biological Chemistry and Molecular Pharmacology, Harvard Medical School; cross-appointment at The Broad Institute of Harvard and MIT, Cancer Program and Klarman Cell Observatory; Head of Innovation Lab (2015-18) and Associate Director (2018-19) for the Center for Cancer Precision Medicine at Dana Farber. Asaf has also served as an advisor to a number of start-up companies such as eGenesis, Cambridge MA; NucleAI, Tel-Aviv, Israel; and Celsius Therapeutics, Cambridge MA and in the past has consulted for and served on the board of several other companies and organizations.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings / Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Sponsored Roundtable – Cancer Genomics topic

The challenges of extracting nucleic acids for precision oncology

Most challenging sample types in Precision Oncology
Who does your extraction [yourself, sequencing core, biobank, extraction core]?
Appropriate Nucleic Acid Quantification and QC thresholds
Impact of extraction method on downstream analyses

Greg Gonye

Principal Field Application Scientist
Purigen Biosystems

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation

Bridging the gap between complex genomics data and actionable genetic insights using digital PCR

Philippe Mourere

President and CEO
Stilla Technologies

1:55 – 2:55pm

Liquid biopsies- future and current clinical application opportunities

How can we impact clinical decisions using ctDNA, ctRNA , and circulating tumor cells from liquid biopsies?
Early Detection, MRD , cost efficient screening solution
Examine the current detection methodology available, e.g. low pass WGS, WES etc
The value and roles of using the RWD LBx genomic data in drug development
How can AI /ML be applied to robustly distil information and impact clinical decisions

Zheng Feng

Head of Molecular Biomarker & Genomics at Global Clinical Biomarkers & Companion Diagnostics
EMD Serono

Since 2007, He has been working in the Biotech and Pharmaceutical companies including Pfizer, EMD Serono, EMD Millipore etc… Dr. Feng published more than forty papers & abstracts in both peer journals and conferences in the areas including: cancer biology, regenerative medicine, neurological diseases, biomarker, clinical next generation sequencing, liquid biopsy, tissue diagnostic, fit for purpose clinical biomarker assay development etc… He is also the invited peer reviewer for over twenty scientific international journals.

Dr. Feng has Medical Degree and received PhD of Pharmacology in Institute of Materia Medica, Chinese Academy of Medical Sciences (CAMs) & Peking Union Medical College (PUMC), Beijing, China. He did the postdoctoral training in Yale University, School of Medicine.

3:00 – 3:30pm

1-2-1 Meetings / Networking Break

3:30 – 4:00pm

1-2-1 Meetings / Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster session

Unleashing the power of single-cell multi-modal analysis to advance precision medicine

Measuring clonality and understanding therapy resistance
Clonal profiling by SNV, CNV and Immunophenotype
Detection and characterization of MRD in blood cancers

George Kopitas

Vice President, Sales & Support
Mission Bio

George began his career as a research scientist in the molecular biology group at Pfizer and later moved to the tools’ side of the life sciences industry. Over the past 20 years, George has had commercial leadership roles in sales and technical support at companies in the genomics space and in stem cells and regenerative medicine. George completed his BS and MS in Microbiology from the University of Illinois.

4:45 – 5:45pm

Discover Tumor Evolution, Understand Resistance, Inform Therapy

Assess the currently available genomic technologies and databases for tumor evolution deconvolution
Discuss the current industry’s adherence to standardised medical genomic guidelines for mutation interpretation
How do use the discovered tumor biology to inform patient therapeutic options

Zhongwu Lai

Director of Bioinformatics
AstraZeneca

Zhongwu Lai is currently a Sr. Director of Oncology Bioinformatics at Astrazeneca. He managed a team with focus on clinical genomic biomarkers and their application in guiding clinical development for patient selection and identification, including late stage prospective clinical trials that span from DNA repairs to immunotherapies. He is a well-recognized genomic expert in oncology. The variant caller he developed, VarDict, has been widely adopted in the field for both research and clinical applications. He also developed rules and guidelines in interpreting mutations detected in clinical samples, and how they should be used in clinical studies. He also has extensive knowledge of the current clinical assays using both tumor tissues and ctDNA. He was also part of the team that sequenced the human genome, published in the landmark Science paper in 2001. He got his Ph.D in Chemistry from New York University and a B.S. from Peking University.

5:45 – 6:45pm

Evening Drinks Reception

Data Quality & Access

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote:

Unlocking the value in FFPE tissue for precision oncology using isotachophoresis

The history of FFPE and importance in Precision Oncology
The challenges of FFPE for modern analysis methods
Isotachophoresis-based nucleic acid extraction

Greg Gonye

Principal Field Application Scientist
Purigen Biosystems

9:05 – 10:05am

Effective approaches in multi-omics data integration to enable oncology biomarkers discovery

Share experiences in data curation
What are the best methods in facilitating data integration for ML application?
Discuss the benefits of data curation and the application of data re-use for Reverse Translation
Explore the most efficient application integrated data for target and biomarker discovery

Erik Koenig

Director, Data and Analytics,
Takeda

Erik has been rooted in the intersection of technology, innovation and science throughout his 20+ year career leading genomics, computational and translational teams in oncology. In his tenure with Takeda he has contributed to biomarker research and development for advancing protein homeostasis, targeted and immune-oncology programs. Over the past few years he established a vision for an oncology biomarker data strategy and, with DSI, led the development of STORK, a comprehensive data platform and suite of tools that enable better use of data for translational decision-making. Erik’s recent leadership experiences include Translational Innovation Management team focused on increasing capabilities including, translational model systems, patient data sets, knowledge management, AI/ML, and reverse translation. In the Data Science Institute Erik is currently partnering with our cell therapy colleagues on end to end data strategy, data integration and execution.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings / Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Real-world data access for oncology: opportunities and challenges

RWD use cases for Oncology
Limitations to RWD access
Tumor samples and advancing precision medicine

Umesh Katpally

Head of Advisory and Commercial Product Manager
BC Platforms

Umesh Katpally is currently Director – Data Advisory for Data Sciences at BC Platforms. In his current role at BC platforms he supports potential and current Data Science customers with advising on the strategy needed to answer their research questions, inclusive of data sources and data points. This is to help with integrating and mining clinical phenotypic data combined with genotypic profiling data sets from various data sources to augment customers’ drug development pipeline. Previously, he worked at Novartis focusing on research informatics and before that he worked at various bio-pharma companies and academic institutions focusing on viral vaccines research. He received his Ph.D. from Purdue University in Structural Virology with a focus on vaccine development.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation

Bridging the gap between complex genomics data and actionable genetic insights using digital PCR

Philippe Mourere

President and CEO
Stilla Technologies

1:55 – 2:55pm

Integrating oncology clinical trial multi-omics data and electronic health medical records (EHR) for patient stratification and biomarkers discovery

Share experiences on the use of oncology EHR data providers with genomic / multiomics datasets
Discuss best use cases for EHR cohorts with multiomics datasets in the context of biomarker assessment and patient stratification.
When and which multi-omics dataset/ approach should be deployed to confirm biomarkers hypothesis for a specific patient subgroup?
Considerations regarding multiomics integration / normalization across EHR and clinical trial data?
Exploring the use of longitudinal data in biomarkers discovery

Alejandro Balbin

Head of Data Science
Glympse Bio

Alejandro, PhD, is a translational data scientist with more than 7 years of pharmaceutical industry experience working at the cutting edge of non-invasive disease profiling and monitoring, precision medicine and drug development to unveil and treat the causes of cancer and chronic diseases.

In cancer personalized medicine, he developed computational methods and analysis for integrating large and diverse patient’s molecular profiles in order to understand mechanisms of response and resistance to cancer therapies, particularly lung and breast cancers. In Novartis, he led the biomarker analysis for Trabeca clinical trials in NSCLC patients with MET exon 14 skipping mutations and biomarker analysis to understand mechanisms of resistance for Kisqali in ER+ breast cancer patients. He also directed a team aiming at understanding the impact of Clonal Hematopoiesis in cancer patients’ response across multiple disease areas. In non-invasive cancer diagnostics and monitoring, I developed computational methods and infrastructure for the analysis of cell-free DNA deep sequencing data, co-lead development of new assays that can be applied on liquid biopsies and have a deep interest on advancing these technologies in the patient monitoring and earlier detection setting. Most recently, he led a cross-functional team aiming at advancing the concept of patient journeys and longitudinal monitoring for Novartis oncology therapies by integrating electronic health medical records (EHR) and control clinical trial data.

3:00 – 3:30pm

1-2-1 Meetings / Networking Break

3:30 – 4:00pm

1-2-1 Meetings / Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster

Cancer Genomics Topic-

Rare CRISPR BCL-2 KO cells discovered using levitation technology

Hypodiploid B cell acute lymphoblastic leukemia cell line is sensitive to BCL-2 inhibition
Inhibition of BCL-2 is not complete and residual activity remains
LeviCell enriched for these rare genetically modified clones that are impossible to recover with standard techniques

Joseph Breier

Technical Sales Manager
LevitasBio

4:45 – 5:45pm

Enabling Precision Oncology by Addressing Data Challenges

What infrastructure and investment is necessary to fully realize the potential of “big” data?

How flexible are data management systems to enable orthogonal data types to be ingested and integrated? Is the field moving at the speed at which novel data types are being generated?

How can we democratize and disseminate complex data to avoid knowledge conglomeration?

Are platforms and visualization tools available that truly enable non-SMEs to leverage insights in real-time to inform their decision-making and translational plans?

How do we increase engagement across the biotech, pharma, academic and healthcare system to enable scalable hypothesis testing that informs patient decisions?
Can “big” data help the community to identify and phenotype highest risk patient with most urgent need for therapeutic intervention? Reverse translation in action…

Michaela Bowden

Senior Vice President, Biology & Translation
Flare Therapeutics

Previous Experience:

Bristol Myers Squibb
Dana Farber Cancer Institute
Life Technologies, Inc.
Novartis Institutes of Biomedical Research Inc.

Michaela is an accomplished research scientist and translational leader with more than 15 years of interdisciplinary expertise spanning academia, biotech and biopharma.

Throughout her career, she has been a pioneer in developing multidisciplinary research models to meet future precision medicine-driven drug discovery. Michaela has built fruitful research partnerships across a diverse oncology network with a proven strategic collaborative mindset at the intersection of clinical and pre-clinical studies, real-world molecular data, novel drug platforms and next-gen disruptive technology. Additionally, she has had 60+ peer-reviewed publications across 10+ tumor segments spanning novel biological insights, biomarkers of drug response/resistance, clinical outcomes, and technology development.

5:45 – 6:45pm

Evening Drinks Reception

Genomics Informed Clinical Decisions

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote:

Unlocking the value in FFPE tissue for precision oncology using isotachophoresis

The history of FFPE and importance in Precision Oncology
The challenges of FFPE for modern analysis methods
Isotachophoresis-based nucleic acid extraction

Greg Gonye

Principal Field Application Scientist
Purigen Biosystems

9:05 – 10:05am

Selecting the Right Clinical Genomic Assays for the Right Questions
• How can we structure and formulate the right questions and select the right genomic assays?
• How can the generated genomic data be best utilized to inform clinical development decisions?
• What are the gaps to implementing emerging technologies such as single cell sequencing as clinical genomic assays?

Koji Yasuda

Associate Director, Translational Oncology Lead
Pfizer

At Takeda, Koji lead a team of clinical biomarker scientists in executing and implementing biomarker readouts for dose and disease-indication selection, and patient stratification. In addition, Koji led a cross-functional team at Takeda in assessing emerging clinical technologies, specifically for single-cell sequencing.

Prior to Takeda, Koji was an Associate Director at Kintai Therapeutics (now Senda Biosciences) focusing on the discovery of microbiome-derived bioactive molecules in the area of GI, Oncology, and Neuroscience. Koji received his PhD from Harvard University studying the biogeographical distribution of the gut microbiome and has a DVM from Cornell University.

10:10 – 10:40am

1-2-1 Meetings / Networking Break

10:40 – 11:10am

1-2-1 Meetings / Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Utilizing next-generation sequencing (NGS) technologies in immuno-oncology precision medicine

Rapid advances in NGS technologies have revolutionized progress in personalized cancer vaccines, precision medicine and biomarker discovery. Despite improvements in many aspects, there are still many existing challenges that must be addressed. This roundtable discussion will review various prevailing issues and strategies facing the field.

Comprehensive bioinformatics reporting requirements
Technical characteristics of assays and analytical validation
Robust stratification of patient response
Sample input and format
Leveraging transcriptomics

Erin Newburn

Director, Field Applications Scientist
Personalis

Dr. Newburn joined Personalis as a Field Applications Scientist in 2013 with over 12 years of research experience in the areas of molecular biology, genetics, and biotechnology. As the Director, Field Applications Scientist, Erin’s team has the responsibility of providing both pre- and post-sale technical support for the Personalis ImmunoID NeXT Cancer Portfolio.
Erin completed her postdoctoral training at the National Institute of Mental Health (NIMH) investigating candidate susceptibility genes for major psychiatric illnesses. Erin received her Ph.D. from the Ohio State University in Integrated Biomedical Science as a Presidential Fellow.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

Spotlight Presentation

Bridging the gap between complex genomics data and actionable genetic insights using digital PCR

Philippe Mourere

President and CEO
Stilla Technologies

1:55 – 2:55pm

Successful Biomarker Strategies, What to Consider when a Companion Diagnostic May be Needed
• When should planning begin for a Companion Diagnostic?
• What are the advantages and disadvantages of different approaches (e.g. single site PMA, multi-site distributable kits?
• What are some of the key complexities that should be considered if a global launch is planned?
• What are some key considerations regarding biomarker trial designs?

Sarah Hersey

Vice President Translational Sciences & Diagnostics
Bristol Myers Squibb

Sarah is currently the Vice President, of Translational Sciences & Diagnostics for Bristol Myers Squibb. She has more than 20 years of industry experience in leading R&D organizations, CLIA and GLP laboratories, device manufacturing, consortiums, assessment and implementation of technology strategies, and development of in vitro diagnostics. Prior to joining BMS, Sarah was the Vice President, Precision Medicine & Companion Diagnostics for Celgene, where she founded their Precision Medicine Organization in 2016. She joined Celgene after having held the position as the Global Head of Future Precision Medicine for Novartis.

Sarah has also held multiple roles with increasing responsibility within Johnson and Johnson (JNJ) including Global Head of Operations, Assay Program Leader for Companion Diagnostics Center of Excellence, Director of Materials Process Development and Enabling Technologies. Sarah has BS and MS degrees in Chemistry and Biology from Northern Illinois University, Regulatory Affairs Certification (RAC) and an MBA from California State University.

3:00 – 3:30pm

1-2-1 Meetings / Networking Break

3:30 – 4:00pm

1-2-1 Meetings / Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

Poster

Comprehensive predictive and pharmacodynamic biomarker evaluations optimized to preserve precious clinical trial samples

Comprehensive biomarker profiling is crucial for executing successful precision oncology programs. Common obstacles to completing biomarker profiling studies, especially in retrospective exploratory biomarker research, are the lack of sufficient sample volume and low quality of clinical trial samples. In this presentation, Discovery Life Sciences (Discovery) will describe optimized approaches to performing genomic, proteomic, and cell-based biomarker analyses from low quantity, and in some cases low quality, clinical trial samples with a single chain of sample custody to make the most efficient use of these precious samples. Discovery’s optimized protocols and processes facilitate more exhaustive biomarker analyses from each patient than was possible in the past, with the goal of enabling faster and more accurate targeting of therapies to the right populations.

Donald Skifter

SVP, Genomics
Discovery Life Sciences

Don received his PhD in pharmacology and neuroscience focusing on the molecular and genetic mechanisms of learning and memory at the University of Nebraska Medical Center in 2002. He received his MBA from the University of Nebraska Omaha in 2001. On the heels of the completion of the human genome project in 2003, following a post-doctoral fellowship in Cambridge, MA, he pursued a career in the commercialization of genomic technologies and next generation sequencing services with particular expertise in facilitating oncology genomic biomarker programs. Don’s work history includes Commercial and Technical Application Support leadership roles at several genomic technology and services companies including Invitrogen (now Thermo Fisher Scientific), Sequenom (now Agena Bioscience), Complete Genomics (IPO in 2010), the Broad Institute, and OneOme (a start-up pharmacogenomics spinout of the Mayo Clinic). He currently serves as the Senior Vice President, Genomics within the HudsonAlpha Discovery Genomics division of Discovery Life Sciences.

4:45 – 5:45pm

Proactive Biomarker Planning Strategies for Smart Clinical Development
• When and how should build your biomarker plan from identified biomarkers?
• How can we accurately predict biomarkers and PK/PD at an early stage of development?
• How can we see effectiveness beyond safety using a proactive biomarker plan?

Johan Baeck

Senior Vice President, Clinical Development and Medical Affairs
Jounce Therapeutic

Johan is a physician with more than twenty-five years of experience in the pharmaceutical industry as well as over fifteen years in Oncology clinical development and medical affairs. Focus has been on both targeted agents, small molecules as well as antibody therapies; in this in both solid and liquid tumors, as well as immune-oncology. Johan worked for several years at Novartis in Oncology Translational Medicine with particular focus on biomarker driven clinical studies in order to identify the optimal patient population as well as optimize clinical benefit. In addition, Johan has worked closely with other functions while in medical affairs to optimize pre as well as post-launch programs to further optimize business opportunities.

5:45 – 6:45pm

Evening Drinks Reception

Precision Oncology

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote:

Unlocking the value in FFPE tissue for precision oncology using isotachophoresis

The history of FFPE and importance in Precision Oncology
The challenges of FFPE for modern analysis methods
Isotachophoresis-based nucleic acid extraction

Greg Gonye

Principal Field Application Scientist
Purigen Biosystems

9:05 – 10:05am

Effective Patient Stratification Based on Molecular and Clinical Data

• What are the barriers to acquiring sufficient and comprehensive data to build patient stratification model?
• Discuss the common challenges in patient stratification and how can they be mitigated
• Discuss the best approaches in dividing patients into subgroups based on molecular data
• How can we best draw understanding from models to exact benefit for patients?

Amir Vajdi

Senior Scientist, Computational Biology
Merck

Amir works on utilizing multi omics data to be support computational analyses for diagnostic development and biomarker identification. Previous to that, he was working as Bioinformatician at Dana-Farber Cancer Institute working on addressing computational questions related to lung cancer data. Amir received his PhD in computer science from University of Massachusetts Boston.

10:10 – 10:40am

1-2-1 Meetings/Networking Break

10:40 – 11:10am

1-2-1 Meetings / Networking Break

11:10 – 11:20am

Morning Refreshments

11:20am – 12:20pm

Metabolomics – new insights in biology leading to higher success rates in drug development

The role of Metabolomics in oncology & drug development
The application of Metabolomics in identifying pharmacodynamic markers
The benefits of extending the oncology related CDx concept (checking the presence of the drug target) to performance CDx approach

Matthias Scheffler

Chief Business Officer
Biocrates

Dr. Matthias Scheffler is biocrates life sciences chief business officer and chief liaison for large cohorts and clinical research in pharma. Matthias holds a Ph.D. in Chemistry from the University of Bochum in Germany and has been active in the field of liquid biopsy biomarker research since 2008. He is a founder and a contributor in biotechnology since 1999, as well as a co-author and patent contributor to multiple biomarker and chemistry applications. Matthias leads biocrates’ science focused brand and corporate content-driven sales and marketing teams along with global partnerships and distribution networks.

12:20 – 1:20pm

Network Lunch

1:20 – 1:50pm

Spotlight Presentation

Bridging the gap between complex genomics data and actionable genetic insights using digital PCR

Philippe Mourere

President and CEO
Stilla Technologies

1:55 – 2:55pm

Precision Oncology- How Precise Can and Should We Go?

• Should biomarkers be used to identify patients with better treatment response or to identify those who don’t respond to standard of care?
• Can we, using biomarkers, differentiate if standard of care or alternative treatment routes will be the best option for patients?
• When should precision medicine be applied to make the most impact for patients?

Justin Lucas

Principal Scientist, Oncology Translational Research Lead
Janssen

Justin Lucas is a translational research scientist with a strong focus on oncology biology. Justin spent 12 years at Pfizer in discovery working on target ID and validation for antibody drug conjugates (ADCs) and immune regulatory pathways. After this Justin spent 3 years at BMS in translational research with a focus on multiplex IHC assays to visualize the spatial relationship of immune cells and the impact on outcome with immune modulatory therapies. At BMS Justin was also a biomarker lead for early phase clinical trails covering various disease areas, including Kidney cancer, GBM, and NSCLC. Justin currently works for Janssen as a principal scientist in translational research leading the development of the FDA approved Androgen Receptor inhibitor (ARi) Apalutamide in Prostate cancer. The focus of his current work is the optimization of biomarkers to identify patients that would receive the greatest benefit from ARi therapy.

3:00 – 3:30pm

1-2-1 Meetings / Networking Break

3:30 – 4:00pm

1-2-1 Meetings / Networking Break

4:00 – 4:10pm

Afternoon Refreshments

4:10 – 4:40pm

One Size Does Not Fit All: Tailor Made Precision Diagnostics from Sample to Insight.

QIAcuity – Non-invasive Urine-Based Patient profiling for Urological tumors using Digital PCR
QIAStat-Dx – Simple, 60 minute Point of Caremultiplex PCR Testing in the clinic.
No Molecule Left Behind – Ultra Sensitive, minimally invasive NGS profiling in plasma

QIAGEN

5:45 – 6:45pm

Evening Drinks Reception

Genomics in Precision Oncology Xchange
East Coast, Boston
December 7, 2021

Cancer Genomics

Translational Bioinformatics

Data Quality & Access

Genomics Informed Clinical Decisions

Precision Oncology

Lead Partner

Partners

© Copyright 2023 by Weblify & Webtec

Genomics in Precision Oncology Xchange East Coast, BostonDecember 7, 2021

Cancer Genomics

Translational Bioinformatics

Data Quality & Access

Genomics Informed Clinical Decisions

Precision Oncology

Lead Partner

Partners

Genomics in Precision Oncology Xchange
East Coast, Boston
December 7, 2021