Oncology Companion Diagnostics Xchange
West Coast
March 31, 2022

Welcome to hubXchange’s West 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 developing oncology companion diagnostics.
Discussion topics will cover Clinical Biomarkers, Clinical Development and Liquid Biopsies.
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 protocols will be adhered to.

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

Clinical Biomarkers

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Easing the Complexity of CDx Development

Review strategies for early through late stage CDx development
Overview of post-commercialization programs at NeoGenomics and their benefits
Case study of NeoGenomics’ journey supporting a single site HDE submission

James Yen

Associate Director, CDx Strategy, NeoGenomics

James Yen is a Senior Scientific Manager within NeoGenomics’ Pharma Services division. He completed his doctorate studies at UC Irvine studying the mechanism of protein degradation. Afterwards, he began working at Zymo Research (Irvine, CA) to lead the development of research reagents and kits for the study of epigenetics. He subsequently joined MDxHealth (Irvine, CA) in 2011 to setup their CLIA/CAP lab operations within the US and worked in both the clinical operations and product development teams as a senior scientist. In 2014, James joined Clarient (GE Healthcare) to manage the Pharma Services molecular and FISH operation teams. NeoGenomics acquired Clarient from GE Healthcare in 2015, and his current role is as a scientific liaison with a focus on NeoGenomics’ molecular, FISH and companion diagnostic service offerings.

9:05 – 10:05am

Validating biomarker tests to
expedite approval and guide use of NDEs

How many digital biomarkers have been validated and approved by the FDA?
Guidelines for FDA digital biomarker approval.
Challenges in digital biomarker discovery & analytical validation.
Current resources in digital biomarker field and scope for improvisation.

Shilpi Mahajan

Senior Scientist,
AstraZeneca

Shilpi Mahajan is a Senior Scientist at AstraZeneca in the Bioanalysis group. She is a Molecular Biologist and her current focus is on new drug modality areas including mRNA-LNP, Antisense Oligonucleotides (ASO) and Cell therapy (CAR-T). She has been the lead scientist for the strategy design and development of a number of assays in new drug modality. She has developed droplet digital PCR (ddPCR) and qPCR based assays for CAR-T programs. Prior to joining AstraZeneca she worked at Genentech in the oncology biomarker development group and contributed to the strategy design and development of assays for both small and large molecules. She has also worked on liquid biopsy and extracellular vesicles.

Shilpi received her PhD from the International Center for Genetic Engineering & Biotechnology (ICGEB), New Delhi and did her postdoctoral studies at UCSF. Her career interests include molecular biology, immuno-oncology and biomarker development.

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

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

Keith Chun

Vice President of Business Development, New Products, Guardant Health

Keith’s background includes education as a Chemical Engineer and Physician. He trained in Internal Medicine before returning to biopharma strategy. His experience includes McKinsey & Co, Johnson & Johnson, Nektar Therapeutics, Novartis Vaccines and Diagnostics, Jazz Pharmaceuticals, Johnson & Johnson Innovation, and now Guardant Health.

1:55 – 2:55pm

Biomarkers for cancer immunotherapy: PD-1/PD-L1 and beyond

Guidelines for prediction and monitoring of response to checkpoint inhibitors
Inter- and intra-individual variability of biomarker expression
Tumor mutational burden and 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.

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: Predictive biomarkers for immune checkpoint inhibition

Blood based metabolite concentrations correlation with progression-free survival (PFS) and the ability to predict the response to ICI treatments could lead to enhance performance CDx and the opening of a potential avenue to bypass resistance.
Companion diagnostics (CDx) are used to detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. How can we improve this task?
– Response prediction, (bypassing) primary / secondary Resistance/ immune-related adverse events (irAEs)

Matthias Scheffler

Chief Business Officer, Biocrates

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.

4:45 -5:45pm

Precision medicine in immuno-oncology

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

Marika Sherman

Associate Director, Translational Medicine, Instil Bio

Marika Sherman is currently an Associate Director within the Translational Medicine team at Instil Bio, supporting the development of tumor infiltrating lymphocytes (TIL) therapy for the treatment of cancer. Prior to Instil Bio, Marika spent 6 years within the Clinical Pharmacology, Translational Medicine team at Kite (a Gilead company) where she led the Pharmacodynamics team, which focused on understanding the relationships between soluble analytes found in peripheral blood and clinical outcomes to CAR-T therapy.

5:45 – 6:45pm

Closing Address/ Canape/ Drinks Reception

Clinical Development

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Easing the Complexity of CDx Development

Review strategies for early through late stage CDx development
Overview of post-commercialization programs at NeoGenomics and their benefits
Case study of NeoGenomics’ journey supporting a single site HDE submission

James Yen

Associate Director, CDx Strategy, NeoGenomics

9:05 – 10:05am

Exploring two CDx routes: Laboratory Developed Test (LDT) vs Distributed Kits

Pros and cons of each path
Strategic choice
LDT assays approved by the FDA as CDx are mainly PCR or NGS based. Is that the preferable route for new technologies?

Carmela Barbosa

Senior Scientist,
Harpoon Therapeutics

Carmela Dantas Barbosa is a knowledgeable cancer biologist with more than 20 years of experience including 5 years in pharmaceutical and biotech industry. Experienced in discovery through pre-clinical and clinical development in oncology with focus on translational medicine. Carmela is responsible for leading CDx development strategies for Tritac molecules (T-Cell engagers) spanning different cancer indications at Harpoon Therapeutics. Previously, she worked at Tizona Therapeutics and Celgene. Carmela has large experience in biomarker and bioanalytical assay development and validation, spanning multiple technology platforms. Experienced in working with CROs in support of non-clinical and clinical programs. Carmela’s interest in translational medicine have been shaped by her experience working in 3 international hospitals. As a postdoc at Gustave Roussy Institute, the largest hospital and cancer research center in Europe and Leon Berard Center both in France and as scientist, developing molecular based diagnostic assays, at Sarah Hospital in Brazil.

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 – 12:20am

The role (if any) of clinical metabolomics in CDx development and in personalized medicine?

Does better understanding of biology lead to higher response rates and success rates of development?
How do you see metabolomics affect ICI including response prediction, resistance, and Immune-Related Adverse Events (irAEs)?

Matthias Scheffler

Chief Business Officer, Biocrates

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

Keith Chun

Vice President of Business Development, New Products, Guardant Health

1:55 – 2:55pm

Challenges and opportunities for biomarker driven development of novel T cell products for the treatment of solid tumours

• What have we learned from the current class of chimeric antigen receptor T cell products in leukemia/ lymphoma? How can these learnings be applied in the solid tumor space?
• What are the most promising next-generation approaches (TCR, CARs, iPSC, NK, NKT etc) for the treatment of various solid cancers?
• How can predictive biomarkers be deployed to enrich for patients more likely to respond to emerging immune therapies and how can predictive biomarkers be incorporated into clinical trial design to accelerate clinical development in this space?

John Rossi

Senior Vice President, Head
of Translational Medicine, CERo
Therapeutics

I lead the Translational Medicine team at CERo. Prior to joining, I served as Senior Director of Translational Medicine and Head of Cell Therapy Clinical Pharmacology at Kite, a Gilead Company. While at Kite, I led translational activities supporting the clinical development and global approvals of YESCARTA® and TECARTUS® CAR T cell therapies. At Kite, my team also supported work focusing on the mechanistic understanding of engineered cell therapy products under strategic collaborations with the NCI and numerous leading academic institutions. Before joining Kite, I spent 13 years in oncology drug development at Amgen working with teams to identify novel biomarkers for hematologic and solid tumour drug development programs.

3:00 – 3:30pm

1-2-1 Meetings / Networking Break

3:30 – 4:00pm

1-2-1 Meetings / Networking Break

4:45 – 5:45pm

Biomarker testing strategies for patient selection

• Biomarker testing to support patient enrollment in early and late phase clinical studies
• Challenges of new and rare biomarkers for patient selection
• Novel approaches seeking regulatory approval for a companion diagnostic

Harris Soifer

Executive Director, Clinical Biomarkers and Companion Diagnostics, Kura Oncology

Harris Soifer, PhD currently serves as Executive Director of Clinical Biomarkers and Companion Diagnostics at Kura Oncology where he focuses on identify patient selection strategies and diagnostics for solid tumor and hematological malignancies. Prior to Kura, Dr. Soifer lead similar efforts at QED Therapeutics and was part of the team that received FDA-approval for targeted therapy in FGFR2 fusion-positive cholangiocarcinoma and co-approval of an NGS-based companion diagnostic to identify patients whose tumors harbor FGFR2 fusions. Dr. Soifer has more than 15 years of experience in diagnostics development and biomarker research in oncology and rare diseases. Dr. Soifer received his PhD from the Keck School of Medicine at the University of Southern California and did his post-graduate work as a Beckman Fellow at the City of Hope before being an Instructor at the Albert Einstein College of Medicine.

5:45 – 6:45pm

Closing Address/ Canape/ Drinks Reception

Liquid Biopsies

Time

Titles and Bullets

Facilitator

8:00 – 8:30am

Registration

8:30 – 9:00am

Opening Address & Keynote: Easing the Complexity of CDx Development

Review strategies for early through late stage CDx development
Overview of post-commercialization programs at NeoGenomics and their benefits
Case study of NeoGenomics’ journey supporting a single site HDE submission

James Yen

Associate Director, CDx Strategy, NeoGenomics

9:05 – 10:05am

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.

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

Detecting solid tumors via a blood draw: How far have we come? How much further is there?

Progress made with liquid biopsy
The common barriers to liquid biopsy adoption in the era of precision oncology
Incorporating liquid biopsy (ctDNA) into clinical trials

Gina Wallar

President, Pharma Services, NeoGenomics

Gina Wallar started her career with NeoGenomics in 2014 as Director Scientific Affairs and Project Management, having previously served as the Director for LabCorp Clinical Trials for over 12 years. From 2016 to 2018 she was VP, Sales and Project Management for Pharma Services and from 2019 to 2021 served as Senior Vice President, Clinical Division and has transitioned to her current role as President, Pharma Services. Gina received her MPH in Epidemiology and Biostatistics from Boston University and received her PhD at UCLA in cancer epidemiology.

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

Keith Chun

Vice President of Business Development, New Products, Guardant Health

1:55 – 2:55pm

Considerations to overcome low CTC detection levels in early cancer patients

Detection methods: Technical challenges/considerations
Real liquid biopsy: CTCs vs ctDNA: advantages and limitations
Clinical applications (early cancer detection) in solid cancers vs liquid cancers

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.

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: Clinical Biomarkers Topic – Building a path towards commercialization of multiplexed IF

Development including validation
Clinical trials
Commercialization considerations

Qingyan Sandy Au

Director of Multiplexing, NeoGenomics

Qingyan Sandy Au is Director of Multiplexing at NeoGenomics. In this role, she is responsible for overall scientific and operational function of Multiplexing modality including MultiOmyx™, Vectra Polaris™ and RareCyte CTC technology platforms. She has over 15 years of experience in multiplexed immunofluorescence assay development & validation in cell and tissue-based assays in support of exploratory, translational and clinical research studies. Sandy earned her PhD in Biomedical Sciences from the University of California at Riverside, and she also holds Master’s degree in Genetics from Fudan University.

4:45 – 5:45pm

Exploring liquid biopsies for advanced clinical trials

Current status of use of liquid Biopsy in clinical setting
Applications of liquid biopsy
Regulatory considerations and challenges for CDx development

Chetan Deshpande

Director Biomarker Clinical Lead, Pfizer

Chetan Deshpande is a Director, Biomarker Clinical Assay Lead in Global Product Development at Pfizer. He is responsible for leading the biomarker oversight on multiple assets within the Pfizer Oncology portfolio. He is a key member of various initiatives from technical, technological and vendor assessment to adoption of digital technology in clinical trials to improve operational efficiencies. He is a key member leading multiple global collaborations. Prior to joining Pfizer, Chetan spent over 15 years in academic and pharmaceutical industry including Amgen and Stanford Medical Center. Chetan received M.S. in Immunology at University of Tennessee, Memphis, M.Sc. in Microbiology from University of Pune, India, and an MBA in Finance and Global Business from Pepperdine University Business School.

5:45 – 6:45pm

Closing Address/ Canape/ Drinks Reception

Oncology Companion Diagnostics Xchange
West Coast
March 31, 2022

Clinical Biomarkers

Clinical Development

Liquid Biopsies

Lead Partner

Partners

© Copyright 2023 by Weblify & Webtec

Oncology Companion Diagnostics XchangeWest CoastMarch 31, 2022

Clinical Biomarkers

Clinical Development

Liquid Biopsies

Lead Partner

Partners

Oncology Companion Diagnostics Xchange
West Coast
March 31, 2022