Program • • •

All lectures are explicitly interactive, and intended to generate discussion. For this reason a moderator is suggested with the lecture-sessions. Breakout sessions entail discussions in subgroups of up to 15 persons, on selected topics that relate to the theme of the day. Posters will be on display throughout the workshop week. All participants are encouraged to present a poster.

Monday 7 February 2011 09:00 – 10.00

Registration, Office Assignment and Coffee Put up your poster!

10:00 – 10:15

Introduction to the Lorentz Center Mieke Schutte (manager LC)

10:15 – 10:30

Introduction to the Workshop Jaap den Toonder/Anja van de Stolpe

10:30 – 12:00

Interactive morning session: State-of-the-art and clinical needs Moderator: Anja van de Stolpe 10:30 – 11:00 11:00 – 11:15 11:15 – 11:45 11:45 – 12:00

Opening Lecture: Leon Terstappen (University of Twente): What makes a CTC a circulating tumor cell Discussion Stefan Sleijfer (Erasmus University Medical Center): Circulating tumor cell detection: on its way to routine diagnostic implementation? Discussion

12:00 – 14:00

Lunch

14:00 – 14:30

Interactive afternoon session: Clinical Needs Johann De Bono (The Institute of Cancer Research): Defining when a circulating cell is a CTC

14:30 – 15:30

Breakout Session: Clinical Needs, Diagnostic Needs and Workflow Moderators: Clinical experts: Johann De Bono, Stefan Sleijfer, Stefanie Jeffrey, Minetta Liu, Anja van de Stolpe Topics:  Vision on oncology diagnostics and treatment in 2015: will cancer turn into a chronic disease?  Vision on CTC-based diagnostics in 2015; CTC counts versus molecular diagnostics  Use of CTC diagnostics within Pharma for drug discovery, drug development and companion diagnostics  What is the definition of a CTC?  CTC subpopulations: what is the evidence, and do we need them?  Differences between different cancers or cancer subtypes?  CTC (sub)population- versus single cell-based diagnostics  Viability and CTC culture  Regulatory issues: differences between CTC isolation device (“liquid biopsy”) and CTC diagnostic platform with integrated diagnostic assays? Would establishing a multidisciplinary team to support the FDA on this topic make sense?  Workflow: • sample collection and conservation • time to result

• centralized lab (for example academic center) versus local hospital  Reimbursement  Clinical trials? Result: 1 summary slide / group for follow up discussion on Tuesday evening 15:30 – 16:00

Coffee Break

16:00 – 17:00

Poster Flash Presentations

17:00

Wine and Cheese party and Poster Presentations

Tuesday 8 February 2011 09:00-10:15

Interactive morning session 1: CTC enrichment and isolation: Clinical Relevance Moderator: Arie van Doorn 09:00 – 09:30

09:30 – 10:00

10:00 – 10:15

John Martens (Erasmus University Medical Center): Characterization of Cellsearch-enriched Circulating Tumor Cells: opportunities, challenges and limitation Matthew Krebs (Paterson Institute for Cancer Research, Manchester): The Clinical Utility of CTC Enumeration and Characterization in Patients with Lung Cancer Discussion

10:15 – 10:45

Coffee break

10:45 – 12:00

Interactive morning session 2: CTC enrichment and isolation approaches Moderator: Stefani Jeffrey 10:45 – 11:15

11:15 – 11:45 11:45 – 12:00

Peter Gascoyne (M. D. Anderson Cancer Center): Antibody‐independent isolation of circulating cancer cells by continuous flow dielectrophoretic field-flow fractionation Hywel Morgan (University of Southampton): Single Cell Electrical Impedance Analysis - Label Free Identification of CTCs Discussion

12:00 – 14:00

Lunch

14:00 – 15:15

Interactive afternoon session: CTC enrichment and isolation approaches Moderator: Peter Gascoyne 14:00 – 14:30 14:30 – 15:00

15:00 – 15:15

Brian Kirby (Cornell University): Capture and Analysis of Circulating Tumor Cells in GEDI microdevices Ram Datar and Richard Cote (University of Miami): Novel Approaches to Circulating Tumor Cell Capture and Molecular Characterization Discussion

15:15 – 15:45

Coffee Break

15:45 – 17:15

Breakout session: Technological issues: CTC enrichment and isolation Moderators: Peter Gascoyne, Hywel Morgan, Brian Kirby, Menno Prins, Jaap den Toonder Topics:  Challenge of large volumes and high throughput  Viability and CTC culture  CTC isolation – diagnostics: to what extent and how to automate/integrate?

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Which combination of technologies would be preferred for isolation of viable (subsets of) CTCs, suited for pathology and molecular diagnostics (how to come from isolation to diagnostics without losing CTCs) • What are the CTC characteristics that can be used to identify and select?  What are the major technological challenges? How to reduce volume? Negative versus positive selection.  What about System Architecture? Result: 1 summary slide per group for follow up discussion on Thursday

17:15 – 18:00

Departure for drinks and dinner in the Van der Valk hotel

18:00

Drinks and dinner; theme: “Clinical utility of CTCs” (signing up is necessary!). The discussion outcome from the Monday breakout session will form the basis for the informal discussions in small groups (not pre-defined).

Wednesday 9 February 2011 09:00-10:15

Interactive morning session 1: CTC enrichment and isolation approaches Moderator: Menno Prins 09:00 – 09:30 09:30 – 10:00 10:00 – 10:15

Jean-Louis Viovy (Institut Curie): Combining microfluidic and magnetic separation for CTC: the best of two worlds? Liesbeth Lagae (IMEC): A smart miniaturized system for isolation and characterization of single circulating tumor cells Discussion

10:15 – 10:45

Coffee Break

10:45 – 12:00

Interactive morning session 2: CTC Diagnostics Moderator: Jaap den Toonder 10:45 – 11:15 11:15 – 11.45 11:45 – 12:00

Peter Kuhn (Scripps Research institute): HD-CTCs, the fluid biopsy of solid tumors David Basiji (Amnis Corporation): Circulating Tumor Cell Detection and Characterization using the Amnis Imagestream-X System Discussion

12:00 – 13:45

Lunch

13:45 – 15:00

Interactive afternoon session: CTC Diagnostics Moderator: John Foekens 13:45 – 14:15 14:15 – 14:45 14:45 – 15:00

15:00 – 16:30

Ruth Katz: Genetically Abnormal Circulating Tumor Cells in Patients with Non-Small Cell Lung Cancer Using Genomic Specific Probes Bob van Gemen (Philips Healthcare): Digital Pathology empowering pathologists Discussion

Breakout Session: Technical Issues: CTC Diagnostics, Moderators: Jim Hicks, Marielena Mata, Ola Soderberg, Humphrey Gardner, Anja van de Stolpe Topics:  CTC subpopulations: what is the evidence, and do we need them?  CTC population or single cell diagnostics?  Challenges of single cell diagnostics? • Pathology (IHC, FISH); Sequencing; PCR

• Quality control and statistics • Viability • Clinical interpretation  CTC culture  What are the major technological challenges? Result: 1 summary slide per group for follow up discussion on Thursday 16:30

Departure for boat trip and workshop dinner

Thursday 10 February 2011 09:00-10:30

Interactive morning session 1: Clinical Trials Moderator: Stefan Sleijfer 09:00 – 09:20

09:20 – 09:40 09:40 – 10:00

10:00 – 10:30

Stefanie Jeffrey (Stanford University): CTCs as a window on cancer biology - specific opportunities to guide cancer therapy Minetta Liu (Georgetown University): Clinical Trial Designs to Evaluate the Clinical Utility of CTC Assays in Breast Cancer Howard Scher (Memorial Sloan-Kettering Cancer Center): Toward Qualification of Circulating Tumor Cell Biomarkers in the Context of Unmet Medical Needs in Prostate Cancer Discussion

10:30 – 11:00

Coffee Break

11:00 – 12:00

Interactive morning session 2: Clinical trials / Commercialization perspectives Moderator: Johann de Bono 11:00 – 11:20

11:20 – 11:40 11.40 – 12:00

Jeffrey Chalmers (Ohio-State University): Expanding the definition of tradition CTCs: Detection and characterization of cells associated with cancer in the blood of patients with solid malignancies Iris Lin (Veridex China): Veridex and Business Potential of CTC in the China Emerging Market Wolfgang Mann (Beckman Coulter): Analysis of single CTCs after their isolation by multi-color flow cytometry: applications and technical considerations

12:00 – 13:00

Lunch and discussion

13:00 – 14:00

Interactive afternoon session: Regulatory Challenges Moderator: Anja van de Stolpe 13:00 – 13:30 13:30 – 14:00

Introduction Debra Rasmussen (J&J): Overview to regulations in EU and US that apply to CTC assays past and in the future. Discussion

14:00 – 14.30

Coffee Break

14.30-16:10

Interactive discussion session: Pharma and CTC-based companion diagnostics Moderator: Leon Terstappen 14:30 – 14:50 Humphrey Gardner (Novartis): Circulating tumor cell evaluation in pharma: challenges of tumor heterogeneity and pharmacodynamic assessments 14:50 – 15:10 David Shalinsky (Pfizer): Pharmaceutical Considerations for Employing CTCs in a Meaningful Way in Industry 15:10 – 15:30 Glen Clack (Astra Zeneca): CTCs: An Industry View Point 15:30 – 15:50 Evelyn McKeegan (Abbott): Circulating Tumor Cells in Drug Discovery

15:50 – 16:10

Discussion

16:10 – 16:30

Coffee Break

16:30 – 18:00

Slide Presentations on Breakout Sessions and Plenary Discussion

Friday 11 February 2011 09:00 – 10:30

Interactive morning session 1: A vision to the future Moderator: TBA 09:00 – 09:30 09:30 – 10:00 10:00 – 10:30

Klaus Pantel (University Medical Center Hamburg-Eppendorf): Historical Perspective on CTCs and state-of-the-art Jim Hicks (Cold Spring Harbor Laboratory): Genomic profiling of single cells: applications for CTC and cancer diagnostics Phil Lefebvre (Abbott): title TBA

10:30 – 11:00

Coffee Break and discussion

11:00 – 12:00

Interactive morning session 2: A vision to the future, Moderator: Klaus Pantel/Jaap den Toonder 11:00 – 11:30 11:30 – 12:00

Marielena Mata (Johnson & Johnson): CTC analyses: From enumeration to comprehensive characterization Ola Söderberg (Uppsala University): Single-cell expression profiling and mutation detection

12:00 – 14:00

Lunch

14:00 – 15:30

A vision to the Future of CTCs, what’s next? Moderators: organizers • Consensus on how to bring CTC diagnostics to the clinic – Which technological approach(es) – Which diagnostics? – Which clinical setting and questions? • Collaborations • Next steps • Committee for next steps / continuation / FDA alignment

15:30 – 16:00

Coffee Break

16:00 – 17:00

Closing Lecture Larry Norton (Memorial Sloan-Kettering Cancer Center): Biological and Clinical Implications of Circulating Tumor Cells as Self-Seeds