ONCOLOGY COMPANION DIAGNOSTICS XCHANGE
WEST COAST
San Francisco
February 9, 2023

Welcome to hubXchange’s West Coast Oncology Companion Diagnostics Xchange 2023, 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.

Venue Details: DoubleTree by Hilton San Francisco Airport, 835 Airport Blvd, Burlingame CA 94010-9949

SNAPSHOTS OF DISCUSSION TOPICS

Track 1: Clinical Biomarkers

Biomarkers for cancer immunotherapy: clinical implications
Use of predictive/prognostic markers for co-development of diagnostic tools
Validating biomarker tests to expedite approval and guide use of NDE’s

Track 2: Clinical Development

Designing patient selection strategies that de-risk future CDx approval
Strategies to implement personalized therapies for patients

Track 3: Liquid Biopsies

Use ctDNA to advance oncology clinical trial development
Clinical applications of ctDNA assessment in disease monitoring and detection of early relapse

Track 4: Next Generation CDx

Challenges in adoption of liquid biopsy based multi cancer early detection
Is it possible to harmonize and standardize digital pathology AI algorithms?

Full Xchange Agenda

Click on each track for detailed agenda

Clinical Biomarkers

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation
Spatial Biology to Improve Clinical Trial Outcomes

Increasing accuracy and yield of existing biomarker assays
Investigating spatial and image analysis solutions for patient selection
Expanding the use of spatial imaging applications beyond oncology

Tom Turi

Chief Scientific Officer, Flagship Biosciences

Thomas Turi, Ph.D. currently serves as the Chief Scientific Officer for Flagship Biosciences developing and implementing Spatial Biology and Digital Pathology solutions to accelerate drug development programs. He previously served as the Chief Scientific Officer for Nexelis where he assisted in the development of multiple approved and authorized COVID vaccine programs in addition to overseeing R&D activities in biomarkers and preclinical sciences.

In addition to his current responsibilities, Dr. Turi has served on the Board of Trustees for The Life Sciences Foundation and as a member of the Global Health Research Roundtable of the Indiana Clinical and Translational Sciences Institute. He has previously served on the Board of Directors for Caprion Proteomics (CellCarta) and led several external partnerships including those with Rules Based Medicine, Celera, Incyte, and Affymetrix. He has also served on grant and program project review boards for NASA’s Section for Biotechnology and Tissue Engineering.

Dr. Turi received bachelor’s degrees in Biochemistry and Chemistry from the University of Illinois at Urbana-Champaign and his doctorate in Molecular Genetics from the University of Cincinnati College of Medicine. He completed postdoctoral training at the Yale University School of Medicine applying molecular genetic techniques to investigate the mechanisms of protein transport.

09:05 – 10:05

Biomarkers for cancer immunotherapy: clinical implications

How to use PD-1, PD-L1 and key checkpoint biomarkers for clinical monitoring
How to address patient variability and tumor type when interpreting biomarker data
How to combine tumor biomarker with genomic signatures

Oscar Segurado

Chief Medical Officer, ASC
Therapeutics

Former CMO for Symvivo, Myriad Genetics and CellMax Life, Vice President for Becton Dickinson and Global Medical Head for Abbott/AbbVie (Humira). Executive veteran with extensive global leadership experience in translational science, clinical development and global regulatory and medical affairs.

Author and co-author of over 100 peer-reviewed publications, including Nature and Lancet, books and medical articles and member of several scientific and medical societies. Forbes Council Board Member. Holding a tenured Professorship of Immunology at the University of Leon, Spain. Received PhD from the University of Wuerzburg, Germany and MD from the University of Salamanca, Spain.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshment Break

11:20 – 12:20

Challenges / Barriers to broader adoption of spatial biology analysis techniques

Testing technology options
What are the limits to integrating spatial platforms
Challenges with integrated data analysis

Tom Turi

Chief Scientific Officer, Flagship Biosciences

12:20 – 13:20

Networking Lunch

13:20 – 14:20

Use of predictive/prognostic markers for co-development of diagnostic tools

Assessment of the COU of a biomarker
Qualification of both exploratory and established biomarkers based on the drug’s MOA
Technology platforms for future development of diagnostic tools to select patients

Yu Liang

Director, Clinical Biomarkers
Compugen

Yu Liang is currently Director of Clinical Biomarkers at Compugen heading implementation of biomarkers in clinical trials to develop drugs targeting immune checkpoints. He brings in 20 years of expertise and leadership in precision medicine, including assay development in research and IVD, and application of genomic and genetic profiling for patient stratification. Before Compugen, he was Director of Translational Sciences in Oncology at Ipsen, leading translation of pre-clinical biomarkers into early phase clinical trials. Prior to Ipsen, he led development of clinical biomarker for drugs targeting amino acid metabolism at Calithera and managed the clinical biomarker portfolios of Ibrutinib for non-Hodgkin’s lymphomas at Pharmacyclics.

14:25 – 14:55

1-2-1 Meetings / Networking Break

14:55 – 15:25

1-2-1 Meetings / Networking Break

15:25 –15:35

Afternoon Refreshment Break

15:35 – 16:35

Validating biomarker tests to expedite approval and guide use of NDE’s

Selection of the relevant biomarker(s) or combination of biomarkers
What are the best tools for the determination of relevant biomarkers and the response to therapy?
How many biopsies are necessary pre and post therapy, relapse, intermittent?

Feng Hong

Senior Director, Clinical Biomarker Operations, Turning Point Therapeutics

Dr. Feng Hong received a B.S. in Microbiology from Fudan University in Shanghai, an MS-equivalent in Cell Biology and a Ph.D. in Environmental Science, the latter two from University of Cincinnati. He has worked in biopharma and medical diagnostic industry for over twenty years, taking on a variety of roles in R&D. For the last 16 years he has established himself as an expert in management of clinical trial samples and operational support of translational research. Currently he is Senior Director of Clinical Biomarker Operations at Turning Point Therapeutics, a fully-owned subsidiary of Bristol Myers Squibb Company.

16:35 – 17:35

Canape / Drinks Reception

Clinical Development

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation
Spatial Biology to Improve Clinical Trial Outcomes

Increasing accuracy and yield of existing biomarker assays
Investigating spatial and image analysis solutions for patient selection
Expanding the use of spatial imaging applications beyond oncology

Tom Turi

Chief Scientific Officer, Flagship Biosciences

09:05 – 10:05

Designing patient selection strategies that de-risk future CDx approval

To patient select or not, factors to consider
How to de-risk when choosing a Partner, methodology and Analyte for CDx development
Reagent and sample considerations for CDx development

Monique Dail

Senior Principal Scientist, Oncology Biomarker Development, Genentech

Monique Dail works in Oncology Biomarker Development at Genentech. Her experience spans both small and large molecules in several Hematology indications, with significant experience in Myeloid Malignancies including AML and MDS. She supported the successful development and launch of Venetoclax in AML and is currently supporting similar efforts with Venetoclax in t(11:14) positive MM. Additionally, she has a longstanding interest in advancing MRD assays and uses in AML drug development. Before Genentech, she was an assistant professor and post-doc at UCSF, where her research focused on preclinical testing of RAS-targeting regimens and predictive biomarker evaluation in mouse models in T-ALL.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshment Break

12:20 – 13:20

Networking Lunch Break

13:20 – 14:20

Strategies to implement personalized therapies for patients

An exponential growth in information
Integration of clinical data to tailor treatment (interoperability, data handling, analysis, and interrogation)
Involvement of other diagnostic techniques
Reforming the disease classification system

Xiao Wang

Principal Scientist, Zai Lab

Xiao Wang is currently a Principal Scientist within the Translational Medicine team at Zai Laboratory, supporting the development of DNA Damage Response targeted therapy for the treatment of cancers. Xiao was trained as an orthopaedic surgeon in China and received his PhD at Oxford. Prior to Zai, Xiao worked in the Department ofOrtho paedic Surgery at Johns Hopkins University, where he led a translational team, focusing on understanding the relationships between DNA damage responses anda utoimmune skeleton diseases.

14:25 – 14:55

1-2-1 Meetings / Networking Break

14:55 – 15:25

1-2-1 Meetings / Networking Break

15:25 – 15:35

Afternoon Refreshment Break

16:35 – 17:35

Canape / Drinks Reception

Liquid Biopsies

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation
Spatial Biology to Improve Clinical Trial Outcomes

Increasing accuracy and yield of existing biomarker assays
Investigating spatial and image analysis solutions for patient selection
Expanding the use of spatial imaging applications beyond oncology

Tom Turi

Chief Scientific Officer, Flagship Biosciences

09:05 – 10:05

Use ctDNA to advance oncology clinical trial development

Current practices on applying ctDNA for clinical trial development
Challenges for using of ctDNA for clinical trials
Future potentials and new trends of ctDNA

Ning Wang

Bioinformatics Lead, Arcus Biosciences

Ning is a bioinformatics scientist at Arcus Biosciences, where he is responsible for preclinical and clinical studies in multiple immune-oncology drug programs. Notably, Ning supported bioinformatics analysis for the first A2AR/A2BR inhibitor (Etrumadenant, now in phase 2 clinical trial). He is leading couple of precision immune-oncology initiates to support immune-oncology agent clinical development. Ning holds a PhD in Bioinformatics from UCLA.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

11:20 – 12:20

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 higher resolution variant tracking

Dan Norton

Associate Director, Product Management, Personalis

Dan Norton is currently Associate Director, Product Management, Liquid Biopsies at Personalis following a role as Senior Product Manager, Immuno-Oncology. Prior to this, Dan had several product management and business development roles at Bio-Rad Laboratories, Illumina, Althea Technologies and Bayer Healthcare. Dan has an MBA from University California, San Diego and a BA from University California, Los Angeles.

12:20 – 13:20

Networking Lunch

14:25 – 14:55

1-2-1 Meetings / Networking Break

14:55 – 15:25

1-2-1 Meetings / Networking Break

15:25 – 15:35

Afternoon Refreshments

15:35 – 16:35

Clinical applications of ctDNA assessment in disease monitoring and detection of early relapse

What are the analytical considerations for use of ctDNA for disease monitoring and relapse in Metastatic and Non-metastatic disease?
What are the best technologies and desired features for the different use cases of ctDNA ?
Are the technologies ready? If not, what would it take to get them ready?
What are the clinical considerations for the use of ctDNA for decision making?
What are the compromises between sensitivities and specificities and how do we make them?
How do we integrate ctDNA diagnostics in the clinical care?

Mohan Bolisetty

WW Medical Lead – Biomarkers & Diagnostics, Bristol Myers Squibb

Mohan Bolisetty is the World Wide (WW) Medical Lead, Biomarkers in WW Medical Oncology. He is responsible for driving the solid tumor oncology biomarker strategy including ctDNA along with other genomics biomarkers. Prior to WWMO, Mohan was part of the Clinical Genetics and Genomics group within Translational Sciences at BMS and provided clinical genomics strategy and execution to several early and late clinical programs. Mohan has a PhD from Johns Hopkins University and completed his post-doctoral fellowship at the University of Connecticut.

16:35 – 17:35

Canape / Drinks Reception

Next Generation CDx

Time

Titles and Bullets

Facilitator

08:00 – 08:30

Registration

08:30 – 09:00

Opening Address & Keynote Presentation
Spatial Biology to Improve Clinical Trial Outcomes

Increasing accuracy and yield of existing biomarker assays
Investigating spatial and image analysis solutions for patient selection
Expanding the use of spatial imaging applications beyond oncology

Tom Turi

Chief Scientific Officer, Flagship Biosciences

09:05 – 10:05

Challenges in adoption of liquid biopsy based multi cancer early detection

What are the current technical challenges in assay development for liquid biopsy tests. Is it a greater number of markers needed for detection of greater signal over noise generation via better hardware/chemistries for detection or combination of both.
What level of stage shifting do we expect in the coming years for early cancer detection. As of now through routine testing 67% of cancers are detected in stage 2-3. Do we expect the liquid biopsy based test to perform significantly better?
What further technical challenges does liquid biopsy present in terms of noise and performance in chronic conditions? For example, how much data do we still need to gather to still define what is normal where benign nodules and other chronic inflammation can be separated from cancers.
How will access to liquid biopsy tests be addressed in the coming future? Will the general population have access and will it be represented in the data collected so far?

Rajib Schubert

Clinical Development Lead, Roche

Rajib received his PhD from ETH Zurich (Switzerland) Biophysics. He then went on for his postdoctoral studies at Caltech where he focused on developing targeted therapies using cell specific viruses in Brain and solid tumors. He held positions at Novartis Institute of Biomedical research in Research and Early Development in the department of Neuroscience, Basel, Switzerland (2011-2016) before taking up his current positions as a team lead in biomarker technologies at Roche/Genentech, USA, His activities involves techniques to develop new tools and applications in multi cancer early detection.

10:10 – 10:40

1-2-1 Meetings/Networking Break

10:40 – 11:10

1-2-1 Meetings/Networking Break

11:10 – 11:20

Morning Refreshments

12:20 – 13:20

Networking Lunch

13:20 – 14:20

Is it possible to harmonize and standardize digital pathology AI algorithms?

There are about 25 companies specializing in digital pathology AI algorithms; and there are about 10 digital pathology scanner companies.
Digital pathology AI algorithms are all proprietary (black boxes) and images analyzed through one AI algorithms has not been compared to another algorithm.
Not all AI algorithms are scanner agnostic
Are the results obtained through one algorithm for a digital image the same as another algorithm?
Are there any efforts from FDA or EMEA to Harmonize and Standardize Digital Pathology AI Algorithms
Is harmonization and standardization of digital pathology AI algorithms even possible
What is the future? Will all these companies even exist!

George Kumar

Director: World Wide Medical Lead- Diagnostics, Digital Pathology & AI, Bristol-Myers Squibb

George L. Kumar PhD, MBA is a Director and World-Wide Medical Lead for Diagnostics, Digital Pathology, and AI at Bristol-Myers Squibb, Princeton, NJ-USA. Within the BMS medical affairs group, he leads the global PD-L1 training program, collaboration with pathologists, and various artificial and augmented intelligence (AI) initiatives. His recent book “Predictive Biomarkers in Oncology- Applications in Precision Medicine (eds. Badve S and Kumar GL)” was published by Springer Nature in 2019-20. Education: Post-graduate certificate: High-Impact Cancer Research: Harvard Medical School, USA. Ph.D.: Max Planck Institute for Biological Intelligence, Germany.

14:25 – 14:55

1-2-1 Meetings / Networking Break

14:55 – 15:25

1-2-1 Meetings / Networking Break

15:25 – 15:35

Afternoon Refreshments

15:35 – 16:35

Integration of computational quantitative pathology in precision CDx

Current methodologies
Validation stringency
Future methodologies

Veerendra Munugalavadla

Senior Director & Team Lead, Translational Medicine, AstraZeneca

Veerendra Munugalavadla is the Senior Director and Team Lead, Translational Medicine at AstraZeneca. Prior to this, he was at Acerta and Gilead in translational and biomarker roles, following almost 6 years at Genentech in oncology drug discovery. Veerendra spent over 7 years at the University of Indiana where he was Assistant Research Professor at the Herman B Wells Center for Pediatric Research, Research Assistant and Postdoctoral Fellow. Veerendra has a Ph.D in Biochemistry from Osmania University in India, as well as an MSc in Biochemistry and a BSc in Biology & Chemistry from other notable Indian universities.

16:35 – 17:35

Canape / Drinks Reception

ONCOLOGY COMPANION DIAGNOSTICS XCHANGEWEST COASTSan Francisco February 9, 2023

SNAPSHOTS OF DISCUSSION TOPICS

Full Xchange Agenda

Clinical Biomarkers

Lead Partner

Partner

ONCOLOGY COMPANION DIAGNOSTICS XCHANGE
WEST COAST
San Francisco
February 9, 2023