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

Titles and Bullets
8:00 – 8:30am
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

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.

James Yen web
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.

Senior Scientist,

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

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

Chief Medical Officer, ASC

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.

Photo_Oscar Segurado_N1c
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 SessionPredictive 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)

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

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.

Marika Sherman web
5:45 – 6:45pm
Closing Address/ Canape/ Drinks Reception

Lead Partner


Oncology Companion Diagnostics Xchange | West Coast 2022