Oncology Companion Diagnostics Xchange
East Coast
Boston - March 15, 2022

Welcome to hubXchange’s East Coast Hybrid Oncology Companion Diagnostics Xchange 2022, 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 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 a HYBRID meeting. Participants can join in-person and virtually. All COVID safety protocols will be adhered to.

Venue Details: Hilton Boston Woburn Hotel, 2 Forbes Road, Woburn MA 01801

Clinical Biomarkers

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote (STILLA TECHNOLOGIES): Getting de-centralized testing into routine clinical oncology using high-performance genetic multiplexing

Digital PCR is an accessible, easy-to-use technology that deploys seamlessly across labs in the liquid biopsy space
Assay standardization democratizes this tool for the absolute quantification of ctDNA, supporting the practical clinical development of biomarkers
Fast turnaround times, higher multiplexing, and increased sensitivity – all without the need for outsourcing of samples – can bring uncompromised real-time oncology diagnostics and monitoring to patients

Philippe Mourer

President & 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.

9:05 – 10:05am

Predictive biomarkers beyond PD-1/PD-L1 assays

• How to improve the predictive biomarker for immune-oncology therapy
• Liquid biopsy for predictive biomarker development
• How to implement biomarker strategies involving multiple biomarker modalities

Yan Wang

Senior Director, Translational Medicine, Alkermes

Yan Wang is a senior director of Translational Medicine at Alkermes. She has over 20 years of oncology research and development experience and has keen interests in using biomarkers to facilitate optimization of cancer patient care. Yan has led the programs from inception to phase 2 proof-of-concept clinical study. Yan is an inventor/co-inventor of 9 patents and has authored over 20 publications in peer reviewed journals. She graduated with a B.S. in Biochemistry from Peking University and earned a Ph.D. in Molecular Biology from Princeton University. Yan conducted her post-doctoral research on p53 at Columbia 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 Refreshment Break

11:20am – 12:20pm

Getting de-centralized testing into routine clinical oncology

Identifying and measuring personalized mutations in the patient monitoring setting
Centralized vs de-centralized: When to consider profiling versus targeted approaches
Setting proper thresholds of sensitivity for better deployability in clinical settings

Philippe Mourere

President & CEO, Stilla Technologies

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

GUARDANT HEALTH Spotlight Presentation: Comprehensive Liquid Biopsy across the Continuum of Care: Are We There Yet?

Expanding use cases in late-stage cancer with molecular response
Adjuvant and MRD opportunities using blood only
Next stop: Early detection

Chris Dankulich

Senior Director of Business Development, Guardant Health

Chris has spent 16+ years specializing in translational and precision medicine biopharma partnerships. At Guardant, Chris has been responsible for developing Guardant’s biopharma clinical research and companion diagnostics collaborations. Prior to Guardant, he held biopharma specialist and business development roles at Illumina and Asuragen, Inc.

1:55 – 2:55pm

Precision Medicine in Immuno-Oncology

CDx for CAR-T cell therapy
Targetable biomarkers for CAR-T cell therapy
Regulated NGS clinical assays and CDx

Priya Chokalingam

Vice President, Head of Clinical Bioanalytics & Translational Sciences, Beam Therapeutics

Priya has a PhD in Biochemistry with four years of academic and twenty plus years of pharmaceutical drug discovery & development experience in Translational Sciences, Translational Medicine, Clinical BioAnalytics, Biomarker & Diagnostic strategy, discovery, development and Implementation for Immunology, Immuno-Oncology and Rare Genetic diseases at Pfizer (L-Wyeth), Takeda (L-Shire) and Biogen. She is currently Vice President, Head of Clinical Bioanalytics & Translational Sciences at Beam Therapeutics.

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 Refreshment Break

5:45 – 6:45pm

Canape/Drinks Reception

Clinical Development

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote (STILLA TECHNOLOGIES): Getting de-centralized testing into routine clinical oncology using high-performance genetic multiplexing

Digital PCR is an accessible, easy-to-use technology that deploys seamlessly across labs in the liquid biopsy space
Assay standardization democratizes this tool for the absolute quantification of ctDNA, supporting the practical clinical development of biomarkers
Fast turnaround times, higher multiplexing, and increased sensitivity – all without the need for outsourcing of samples – can bring uncompromised real-time oncology diagnostics and monitoring to patients

Philippe Mourere

President & CEO, Stilla Technologies

9:05 – 10:05am

Overcome cross functional barrier in CDx approval and launch

Pros and cons of implementing the CDx assay in a pivotal study
Key stakeholders of a PMA submission
Economics of CDx development and launch

Ying Su

Executive Medical Director, Clinical Development, Codiak Biosciences

Trained as a physician scientist, Ying is currently overseeing oncology clinical development as a medical lead and has led clinical biomarker and companion diagnostic development from the Translational Medicine perspective in the past. Focus has been on targeted agents including small molecule TKIs and antibody drug conjugate in both solid tumors and hematology malignancy

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 Refreshment Break

11:20am – 12:20pm

Overcoming scientific and operational challenges inherent in running complex clinical trials

What challenges do you face when transitioning custom assays from pre-clinical into the clinic and how do you manage them?
What issues are you facing with sample processing of PBMCs for your study?
How are you currently tracking high-value samples? How is that working? What logistical challenges do you face?
How do you integrate data from disparate sources, in non-standard (SDTM) format?

Theresa Heath

Vice President, Business Development, LabConnect

Theresa is a conceptual leader with more than 30 years of experience commercializing molecular diagnostics and clinical development consulting. She has proven expertise in developing new technologies and global market development. Theresa joined LabConnect in September 2019.

12:20 – 1:20pm

Networking Lunch Break

1:20 – 1:50pm

GUARDANT HEALTH Spotlight Presentation: Comprehensive Liquid Biopsy across the Continuum of Care: Are We There Yet?

Expanding use cases in late-stage cancer with molecular response
Adjuvant and MRD opportunities using blood only
Next stop: Early detection

Chris Dankulich

Senior Director of Business Development, Guardant Health

1:55 – 2:55pm

Innovative approaches towards implementing predictive and pharmacodynamic biomarkers into early phase clinical studies

How to optimize the right therapy for the right patient through a proactive biomarker strategy
Implementation of a stepwise approach to a rational biomarker strategy in early stage clinical development
How cancer biology can guide clinical development through developing appropriate biomarker strategies for FIM studies

Johan Baeck

Senior Vice-President, Clinical Development and Medical Affairs, Jounce Therapeutics

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 tumours, 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.

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 Refreshment Break

4:45 – 5:45pm

Commercial Considerations for CDx strategies and beyond

• Key considerations for patient selection
• Criteria for partner selection
• Market development activities
• Patient identification strategies

Chowdary Dondapati

Executive Director/ Commercial Head, US Companion Dx, Bayer

Chowdary Dondapati PhD, MBA is an Executive Director and Head of Diagnostics Marketing, Precision Medicine at US Bayer Oncology and leads patient identification, diagnostics strategy, and commercialization. A cancer biologist with training on anti-tumor drug mechanism on DNA replication and role of p53 in ubiquitin pathway and apoptosis. He has led groups in biomarker development in oncology as well as helped develop IVD products. He has led global CDx strategy, partnerships, business development and product commercialization at several pharmaceutical companies to help drive Precision Medicine. Prior to joining pharmaceuticals, he co-led establish a CLIA accredited molecular diagnostics laboratory and served as strategy, market development and operational head.

5:45 – 6:45pm

Canape/Drinks Reception

Liquid Biopsies

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote (STILLA TECHNOLOGIES): Getting de-centralized testing into routine clinical oncology using high-performance genetic multiplexing

Digital PCR is an accessible, easy-to-use technology that deploys seamlessly across labs in the liquid biopsy space
Assay standardization democratizes this tool for the absolute quantification of ctDNA, supporting the practical clinical development of biomarkers
Fast turnaround times, higher multiplexing, and increased sensitivity – all without the need for outsourcing of samples – can bring uncompromised real-time oncology diagnostics

Philippe Mourere

President & CEO, Stilla Technologies

9:05 – 10:05am

Overcoming challenges of detecting low concentrations of ctDNA when identifying early-stage cancers

• Enhance sample prep and target enrichment
• Ultra-deep sequencing and bioinformatics tool
• Multiomics approach
• Emerging trends

Chi Chen

Senior Director, Companion Diagnostic Head, Bayer

Che Chen is responsible for companion
diagnostics development and partnership for oncology programs. Dr. Chen received her Ph.D. in Interdisciplinary Biological Sciences from Northwestern University (IL, USA). She has over 15 years experience in the molecular diagnostics and pharmaceutical industry. Prior to Bayer, she worked at Novartis Precision Medicine and BD Diagnostics. Dr. Chen has been involved in development of multiple approved CDx, including both tissue -and ctDNA-based assays, for oncology targeted therapies

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 Refreshment Break

11:20am – 12:20pm

Addressing the challenges/opportunities of liquid biopsy tests

What key challenges with the current state-of-the art of liquid biopsy practice?
What are key emerging technical opportunities for progress in the field?
What are key regulatory aspects/questions?
What are key reimbursement issues?
What are key unmet medical needs that with opportunity for liquid biomarkers?

Klaus Lindpaintner

Distinguished Scientist, InterVenn

Klaus serves as InterVenn’s Distinguished Scientist and focuses as the scientific alliance ambassador to the global glycobiology constituency. His efforts will aim at raising awareness of glycobiology across life science and biomedical communities, at fostering cross-disciplinary collaborations across basic and clinical research, at supporting working groups for the harmonization of standards, terminologies, and processes in this still evolving field, and at attracting young scientist to the domain.

After serving on the faculty at Harvard University, he joined industry, working in executive positions at Roche, Pfizer, and Thermo Fisher Scientific, with a focus on the field of personalized health care.

Klaus holds degrees in medicine and public health, is a board-certified internist, cardiologist, and medical geneticist, and an elected Fellow of the American Colleges of Physicians, Cardiology, and Medical Genetics. He has co-authored some 250 publications, with basic research interests in population and epidemiological genetics. Klaus is fascinated by the potential of InterVenn’s platform to contribute to a broad spectrum of health care needs, with a current focus on cancer.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

GUARDANT HEALTH Spotlight Presentation: Comprehensive Liquid Biopsy across the Continuum of Care: Are We There Yet?

Expanding use cases in late-stage cancer with molecular response
Adjuvant and MRD opportunities using blood only
Next stop: Early detection

Chris Dankulich

Senior Director of Business Development, Guardant Health

1:55 – 2:55pm

Towards application of liquid biopsy to detect minimal residual disease (MRD) and early relapse in solid tumors

Considerations for use of ctDNA vs. CTC-based assessments in liquid biopsy
Evolution of ctDNA applications: From cancer diagnosis/prognosis, to defining targeted therapy strategies, to monitoring for emergence of resistant clones
Clinical applications of ctDNA assessment in disease monitoring and detection of early relapse

Robin Edwards

Vice President, Translational Science & Biomarkers, Daiichi-Sankyo

Robin Edwards, M.D. is a board-certified pathologist with subspecialty certification in hematopathology and molecular genetic pathology. For the past 14 years in the pharmaceutical industry setting, Robin has held positions of increasing responsibility across the clinical-translational continuum that include design and implementation of clinical oncology and biomarker strategies within early and late development programs and building a world-class translational pathology organization. She has extensive experience in the development and application of pharmacodynamic and patient selection strategies that bridge tumor genetic background, drug mechanism of action, and sensitivity/resistance mechanisms across solid tumor oncology and immunotherapy

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 Refreshment Break

4:10 – 4:40pm

Poster Session: Glycoproteomics as a powerful liquid biopsy tool for disease detection, prediction of therapeutic response and disease monitoring/MRD

What are glycoproteins and what is our current understanding of the biology behind glycoproteomic markers?
What are the computational tools required for interrogating the glycoproteome?
What are the potential liquid biopsy applications of glycoproteomic markers?

Klaus Lindpaintner

Distinguished Scientist, InterVenn

4:45 – 5:45pm

Exploring liquid biopsies for advanced clinical trials

Liquid biopsies can be used at different points in a clinical trial (i.e., selection vs endpoint). What are the strength and weaknesses of the different liquid biopsy sample types; does one type lend itself to a better use than others?
Extracellular vesicles can contain lipids which are stripped out of FFPE tissues during the fixation process. Do these sample types provide the ability to discover new biomarkers for cancer?
With late-stage clinical trials, the issue of centralized vs decentralized sample analysis and the impact on reproducibility and sensitivity of liquid biopsies becomes an issue. How to develop the assay to meet the trial requirements? Are certain liquid biopsy types better suited for a decentralized approach than others?
What are some therapeutic areas that provide an opportunity for use of liquid biopsies and at what stage (i.e., biomarker vs surrogate endpoint)?

Melinda Day

Associate Director, Translational Clinical Development, Kronos Bio

Melinda is an Associate Director at Kronos Bio, managing late stage preclinical and clinical programs targeting transcriptional regulatory networks in oncology. Prior to joining Kronos, her PhD training was completed at the University of Michigan studying the cytoplasmic and epigenetic regulation of autophagy. She then trained as a post-doctoral scientist at the University of Illinois elucidating how chaperone proteins promote a dynamic nuclear environment. In 2015 she joined Roche’s Tissue Diagnostic Division, where she worked on an early research and development program addressing how to better capture tumor heterogeneity within a diagnostic sample. From there she joined Cyteir Therapeutics where she led the discovery team in moving a program targeting DNA repair from hit to lead efforts through to IND enabling studies and Phase I clinical trials.

5:45 – 6:45pm

Canape/Drinks Reception

Next-Generation CDx

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote (STILLA TECHNOLOGIES): Getting de-centralized testing into routine clinical oncology using high-performance genetic multiplexing

Philippe Mourere

President & CEO, Stilla Technologies

9:05 – 10:05am

Integration of computational quantitative pathology in precision CDx

• What are the challenges to implementing computational pathology in the clinical setting and CDx development to improve diagnostic accuracy and predictive power in personalized treatment regimen and drug development?

• Among the current available predictive biomarkers for immunotherapy, have we maximized the utility of the approved CDx/PD-L1 IHC assay and the existing, unmined information /pathological features in digital images?

• With rapid technology advances, will liquid biopsy replace the need for tumor biopsy or reduce the tissue analysis values which would potentially deprioritize the development of CDx/digital image derived biomarkers?

• The value of digital pathology platform in the clinical trial, from patient enrollment, biomarker implementation strategies to CDx. Is multiplexing IHC/IF ready for prime time in I-O drug development? Key stakeholders, the path and the challenges?

Qing Li

Head of Clinical biomarker and CDx Strategy, H3 Biomedicine

Qing Li is a physician scientist with over 20 years of clinical, academic and industrial experiences in diagnostic, translational and clinical research with primary focus in oncology. She has special interests in integration of real world clinical evidence and clinical biomarker(s) in precision drug development, and directed R&D projects, executed biomarker and CDx development for clinical stage programs at BMS, Taiho oncology. Dr. Li is a co-inventor of the first IF multiplexing technology and led image analysis algorithm development at GE. Dr. Li received her MD from the school of Medicine, Shandong University where she completed her residency and was an anatomic/surgical pathologist before she earned PhD in Japan. She conducted her postdoctoral research in anti-angiogenesis therapeutic agents at Harvard Medical School and was a junior faculty at HSDM.

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 Refreshment Break

11:20am – 12:20pm

Liquid Biopsy Topic: Beyond MRD: Developing patient-centered diagnostics through tumor-informed comprehensive insights

Earlier detection of disease recurrence
Utility in more disease indications, and at earlier stages of disease
Clinical trial needs for patient enrichment
Screening/enrollment
Surrogate endpoint analysis
Necessity for additional biomarker readouts

Natalie Lafranzo

Director, Business & Market Development, Personalis

Natalie LaFranzo is the Director of Marketing Communication at Personalis, a next generation genomics company dedicated to delivering tumor-informed comprehensive insights to enable patient-centered diagnostics. Since receiving her PhD in Chemistry at Washington University in St. Louis in 2013, she has held numerous commercial roles in biotech. Previously, she helped launch Predictive Immune Modeling, a multidimensional approach to RNA biomarkers, which enabled the development of Cofactor Genomics’ OncoPrism RNA diagnostic. As a part of Horizon Discovery’s Diagnostics Division, she also launched and supported diagnostic reference standards.

12:20 – 1:20pm

Networking Lunch

1:20 – 1:50pm

GUARDANT HEALTH Spotlight Presentation: Comprehensive Liquid Biopsy across the Continuum of Care: Are We There Yet?

Expanding use cases in late-stage cancer with molecular response
Adjuvant and MRD opportunities using blood only
Next stop: Early detection

Chris Dankulich

Senior Director of Business Development, Guardant Health

1:55 – 2:55pm

Leveraging digital pathology to develop novel clinical biomarkers and diagnostics for drug development

What is the current landscape of digital pathology implementation in the clinic and in drug development?
How do applications of digital pathology in the diagnostic space differ from the needs of drug development?
What datasets are necessary for developing robust digital pathology-derived biomarkers/diagnostics?
What standards will be needed to ensure reproducibility and adoption of digital pathology platforms/biomarkers?

Benjamin Chen

Scientific Director, Translational Pathology, Bristol Myers Squibb

Benjamin Chen is a Scientific Director of Translational Pathology at Bristol Myers Squibb, located in Cambridge, MA, where he leads a team of pathologists and scientists to develop novel, experimental approaches to studying biomarkers of the tumour microenvironment. Particular interest is directed toward analysing spatial biomarker patterns and machine learning to leverage digital pathology capabilities in the setting of our clinical trials. Ben received his MD and PhD from Northwestern University where he worked on the basic biochemistry of influenza viruses. He then completed an Anatomic Pathology residency program at Brigham and Women’s Hospital, followed by a fellowship in Hematopathology. Before joining BMS, Ben was an Assistant Professor of Pathology at UMass Medical School in Worcester, MA, where his clinical practice focused on Heme, GI, and Molecular pathology

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 Refreshment Break

4:45 – 5:45pm

Utilizing homologous repair status (HRD+/-) and genetic signatures (TMB, LOH, MSI) as companion diagnostics in clinical trials and/or clinical use

Discuss the utility of novel biomarkers such as homologous repair deficiency (HRD) genomic instability for personalizing therapy in patients with cancer
Assess the clinical rationale for tumor and HRD genomic instability testing, as well as TMB, LOH, and MSI.

Explore strategies to improve patient engagement in shared decision-making regarding biomarker testing and personalized treatment in cancer along the continuum of care

Timothy Schwartz

Medical Director, Biomarkers and Diagnostics, AstraZeneca

Tim began his research career at the Johns Hopkins School of Public Health, studying population genetics in vector-borne microbes. After earning his Ph.D. in Biological Sciences with a focus on DNA damage response at the University of Delaware, he joined the Applied Biosciences team at the Dupont Company. Later, Tim moved to the start-up, ALSI Clinical Diagnostics, served as COO for Otogenetics Corporation’s NGS laboratory in Atlanta, and returned to manage operations for ALSI’s cytogenetic and histopathology departments in New York and the microbiology department in Philadelphia. Most recently Tim has led the US efforts in Medical Affairs for genomics and oncology at Roche Diagnostics, with an emphasis on next-generation sequencing, circulating tumour DNA, digital PCR, clinical decision support, and sequencing-focused studies. Currently, Tim is the Medical Director for Diagnostics and Biomarkers in DNA Damage Response (DDR) for AstraZeneca.

5:45 – 6:45pm

Canape/Drinks Reception

Oncology Companion Diagnostics Xchange
East Coast
Boston - March 15, 2022

Clinical Biomarkers

Clinical Development

Liquid Biopsies

Next-Generation CDx

Lead Partner

Partners

© Copyright 2023 by Weblify & Webtec

Oncology Companion Diagnostics Xchange East CoastBoston - March 15, 2022

Clinical Biomarkers

Clinical Development

Liquid Biopsies

Next-Generation CDx

Lead Partner

Partners

Oncology Companion Diagnostics Xchange
East Coast
Boston - March 15, 2022