Breakout Discussions

Tuesday, March 3, 2020 • 2:00 - 3:00 pm • Exhibit Hall

These interactive discussion groups are open to all attendees, speakers, sponsors, and exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion. The list of topics below span Tri-Con’s three core conferences: Conference 1: Precision Health, Conference 2: Digital Health, and Conference 3: Bio-IT World Conference & Expo WEST. Visit here for finer details on our core conferences.

Precision Health

Table 1 CTCs as Liquid Biopsy

Massimo Saini, PhD, Postdoctoral Researcher, Department of Biomedicine, University of Basel, Switzerland

• The use of CTCs as liquid biopsy for predicting anti-PD-L1 therapies
• The use of CTCs as liquid biopsy for studying WBC-CTC interactions
• Methylation assessment at single-cell level in CTCs and CTC clusters

Table 2 Liquid Biopsy beyond Cancer

Steven A. Soper, PhD, Professor, Micro and Nanofabricated Tools for Biological Discovery and Medical Diagnostics, University of Kansas

• What disease(s) are currently being managed using a liquid biopsy besides cancer?
• Is blood the only source of liquid biopsy markers? If not, what other clinical samples can be used?
• As with any oncology-related liquid biopsy molecular assay, isolation/enrichment of the liquid biopsy marker is critical to secure quality molecular information. Can all of the successful isolation/enrichment technologies used for oncology be utilized for the non-oncology diseases? How does the molecular assay need to change for the non-oncology diseases?
• For oncology, the liquid biopsy markers typically include CTCs (or rare cells), cfDNA, and EVs. For the non-oncology diseases, is there others that should be considered? Should these be added to the list of oncology-related liquid biopsies as well?
• Should the name Liquid Biopsy be changed to make sure it encompasses not just the oncology-related diseases, but the non-oncological diseases as well?

Table 3 Interrogation of Structural Variants Using DNA versus RNA

Helen Fernandes, PhD, Co-Director Genomic Oncology, Laboratory of Personalized Genomic Medicine, Columbia University Medical Center

• Finding gene fusions in DNA and RNA
• Advantages and disadvantages of DNA and RNA for detection of fusions
• Cost effectiveness of methodologies for detection of fusions

Table 4 Diversity and Inclusion in Bio-IT

Chris Dwan, Senior Technologist and Independent Life Sciences Consultant

• Useful practices for people at all levels and roles in an organization
• Today’s major challenges
• Measurable goals and aspirations
• Role models and resources

Table 5 Regulation of LDTs

Lakshman Ramamurthy, PhD, Senior Director, Global Regulatory Affairs, Oncology, GSK

• FDA and Europe’s evolving framework on oversight of Laboratory Developed Tests
• Is VALID a valid legislative remedy to resolving the uncertainty around diagnostic regulation?
• What do differential coverage of LDTs and FDA-approved NGS tests via the recent CMS national coverage mean for patient access?

Table 6 Patient Selection for Cancer Immunotherapy

Moderator to be announced

• Can we propose patient enrichment strategies for early clinical trials for IO?
• What have we learned so far about response prediction biomarkers for IO?
• Blood-based biomarkers for patient selection in IO
• ctDNA as a surrogate endpoint of recurrence

Table 7 Exosomes as Liquid Biopsy Markers

Sam Hanash, MD, PhD, Director, McCombs Institute for Cancer Detection and Treatment

• Exosomes vs. whole plasma for liquid biopsy
• Decoy function of exosomes
• Do exosomes inform us about tumor immunophenotypes?

Table 8 Which Is the Higher Priority? Improving Access to Rapid Home Diagnostic Testing in the Developed World or Bringing Simple POC Testing to the Developing World?

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

• Is the problem the economics of sustainability?
• What is the current role of philanthropy that promotes global health?
• Is big industry interested, or is this going to be managed by small startups?

Table 9 Difficulty of Getting Lab-on-a-Chip Technologies Beyond the Lab

Mehdi Javanmard, PhD, Associate Professor, Electrical and Computer Engineering, Rutgers University New Brunswick

• What are the technological challenges developers are facing?
• Who will get access to these expensive tests? Access to the data?
• What is the next step in Lab-on-a-Chip technology?

Table 10 Grassroots Innovation in POCT

Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, MA

• Why is the innovation process different for POCT and large instrument-based central laboratory testing?
• What is the role of grassroots innovation (bottom of the pyramid) in POCT?
• Funding opportunities for grassroots innovation in POCT. Do we need a new approach?

Table 11 Enabling POCT in the Pharmacy

Michael Klepser, PharmD, FCCP, FIDP, Professor, College of Pharmacy, Ferris State University

• Beyond infectious diseases, what types of POCT could be utilized in a pharmacy?
• What types of specimens could be collected in a pharmacy?
• Do pharmacists really want to offer these services?

Table 12 Challenges Related to Operator Adherence to POCT Policies and Procedures

Julie Shaw, Head, Division of Biochemistry and Director of Point-of-Care Testing, Pathology and Laboratory Medicine, The Ottawa Hospital and Eastern Ontario Regional Laboratories Association

• Positive patient ID
• Repeat policies
• Specimen labelling

Table 13 The Future of Gene Therapy and Genome Editing

Adrian Woolfson, BM, BCh, PhD, Executive Vice President, R&D, Sangamo Therapeutics

• Will in vivo genome editing make gene therapy obsolete?
• Will in vivo genome editing make gene therapy obsolete?
• Will somatic in utero editing become mainstream?
• Will LNPs become standard of care delivery vehicles for in vivo gene editing?
• What editing platform will dominate the future?
• How will we address polygenic diseases?

Table 15 CAR T Cell Therapy in Solid Tumors

Peggy Sotiropoulou, PhD, Director, R&D, Celyad

• Is there an ideal CAR T cell target for solid tumors?
• Is the immunosuppressive TEM the major challenge for CAR T cells in solid tumors?
• Armed CAR T cells or combination treatment?
• Are allogeneic CAR T cells the future?

Table 16 Improving Data Management (Integrity) – LIMS for NGS, LIMS for Cell Therapies

Vasu Rangadass, PhD, President & CEO, L7 Informatics

• How to handle sample tracking from order to results
• What workflow works best for you? How do you give visibility across wet lab and bioinformatics?
• What do you need to scale?
• How to alleviate pain points and increase efficiency for the lab

Table 17 Artificial Intelligence in Healthcare

Maryam Gholami, Vice President, Chief Product Officer, Digital Innovations, Providence Health & Services

• What ethical and moral standards should we be aware of when it comes to development and applications of artificial intelligence in healthcare?
• How do we transform our workforce through the 4th industrial revolution with AI being one of the key drivers?
• How do we evaluate if an AI-enabled solution is ready for real-world applications?

Table 18 Digital Therapeutics

Adam Kaufman, PhD, President & CEO, Canary Health

• Breadth of digital therapeutic types and commercial models
• Digital therapeutic and pharma/medtech partnerships
• Opportunities and challenges with digital therapeutic commercialization

Table 19 Sensors for Patient Monitoring

Chris van Hoof, PhD, Vice President, Connected Health Solutions, imec; Managing Director, OnePlanet Research Center

• How to improve the sensor user experience to increase quality of real-world data and patient engagement
• Next-generation sensors may be ingestibles/insertibles. Are the users ready? Are the specialists ready?
  

Table 20 Why Digital Biomarkers?

Dan Karlin, MD, CEO, HealthMode

• What measurements are improved with digital tools?
• Better, faster, more robust? Sorting hype from reality in digital tools
• Regulatory aspects and challenges

Bio-IT World WEST

Table 21 ML and AI Applications to Drug Discovery

Eric Martin, PhD, Director, Computer Aided Drug Design, Novartis Institutes for BioMedical Research, Inc.

• Which new AI or ML methods have qualitatively changed what we can do for drug discovery (like it did for chess, language translation, and image recognition), which are close?
• What specific drug discovery problems are being most impacted by #1 now and which going forward?
• Where will you be concentrating your ML/AI efforts in the next year?

Table 22 Challenges of Real-World Data

Michael Liebman, PhD, Managing Director, IPQ Analytics, LLC

• How to asses data quality in RWD…the difference between precision and accuracy
• Are all numbers created equal?
• How does this impact clinical decision making? Clinical research (especially Big Data studies)

Table 23 What Technologies Will Bring You from A to Z in R&D

Alan S. Louie, PhD, Research Director, Life Sciences, IDC Health Insights

• What platforms are interesting for patient identification?
• What new technology is there for patient recruitment for clinical trials?
• What would be your ideal platform?

Table 4 Diversity and Inclusion in Bio-IT

Chris Dwan, Senior Technologist and Independent Life Sciences Consultant

• Useful practices for people at all levels and roles in an organization
• Today’s major challenges
• Measurable goals and aspirations
• Role models and resources

Table 16 Improving Data Management (Integrity) – LIMS for NGS, LIMS for Cell Therapies

Vasu Rangadass, PhD, President & CEO, L7 Informatics

• How to handle sample tracking from order to results
• What workflow works best for you? How do you give visibility across wet lab and bioinformatics?
• What do you need to scale?
• How to alleviate pain points and increase efficiency for the lab