Interactive Discussions

Engage in in-depth discussions with industry experts and your peers about the progress, trends and challenges you face in your research!

Interactive discussion groups play an integral role in networking with potential collaborators. They provide an opportunity to share examples from your work, vet ideas with peers, and be part of a group problem-solving endeavor.

These will take place IN-PERSON ONLY.

 

TUESDAY, AUGUST 20

INTERACTIVE DISCUSSIONS: IN-PERSON ONLY

7:30 am Interactive Discussions with Continental Breakfast
Interactive discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges.

TABLE 1: How to Successfully Partner with DDDI and BARDA
Christopher J. Knickerbocker, Contracting Officer Representative, United States Department of Health and Human Services
Kristy Stoudt, PhD, Biologist and Project Officer, Biomedical Advanced Research and Development Authority (BARDA)

  • Preliminary inquiries and interactions
  • Funding mechanisms
  • BAA solicitation process (Stage I – III)
  • Key questions before starting a submission/advice for submitters

TABLE 2: Funding and Commercialization Resources for Cancer Technologies
Linda K. Zane, PhD, Program Director, SBIR Development Center, National Cancer Institute

  • NIH-wide SBIR and STTR
  • Funding opportunities
  • Application tips
  • Assistance and initiatives for awardees and applicants​​

TABLE 3: The Impact of FDA’s Final LDT Rule on Pharmaceutical Clinical Trials
Michelle Neff, JD, Associate Vice President, Global Regulatory Affairs, Diagnostics, Eli Lilly

  • How do the FDA's expectations for LDT compliance with IDE requirements impact pharmaceutical clinical trials?
  • What should the expectations be of both labs and sponsors in the case of routine testing used for clinical trials?
  • What additional clarity are you looking for when it comes to the Final Rule, what would you like to see Agency do?

 

WEDNESDAY, AUGUST 21

INTERACTIVE DISCUSSIONS: IN-PERSON ONLY

7:30 am Interactive Discussions with Continental Breakfast
Interactive discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges.

TABLE 1: How to Successfully Partner with DDDI and BARDA
Christopher J. Knickerbocker, Contracting Officer Representative, United States Department of Health and Human Services
Kristy Stoudt, PhD, Biologist and Project Officer, Biomedical Advanced Research and Development Authority (BARDA)

  • Preliminary inquiries and interactions
  • Funding mechanisms
  • BAA solicitation process (Stage I – III)
  • Key questions before starting a submission/advice for submitters

TABLE 2: Sponsored Testing: Ensuring Patients Have Compliant Access to a Timely Accurate Diagnosis
Nicole Miller, PhD, Vice President, Molecular Diagnostics, Ultragenyx Pharmaceutical, Inc.
Vanessa Rangel Miller, Senior Director, Molecular Diagnostics, Ultragenyx Pharmaceutical, Inc.

  • How and why does sponsored testing aid timely diagnosis for patients?
  • What are key elements of a compliant sponsored testing program?
  • What can we learn from sponsored testing programs to aid timely, accurate patient diagnosis?

TABLE 3: Value Creation to Enhance Market Access Success
Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI

  • Value creation tools/processes
  • Considerations for a compelling value proposition
  • Considerations for maximizing value

TABLE 4: Incorporating Risk into Early Cancer Screening
Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center
How and to what extent should evaluations of cancer risk be a factor in early cancer screening guidelines? What are the pros and cons of enriching clinical trials with patients more likely to develop cancer? How might cancer risk have an impact on algorithm learning?

TABLE 5: Funding and Commercialization Resources for Cancer Technologies
Linda K. Zane, PhD, Program Director, SBIR Development Center, National Cancer Institute

  • NIH-wide SBIR and STTR
  • Funding opportunities
  • Application tips
  • Assistance and initiatives for awardees and applicants​​​
TABLE 6: Blood-Based Colorectal Cancer Screening Tests—Ready for Prime-Time, as a First-Line Screening Test?
Erica Barnell, PhD, CMO, Geneoscopy LLC
Tomasz Beer, MD, CMO, Multi-Cancer Early Detection, Exact Sciences Corp.
Craig Eagle, PhD, CMO, Guardant Health
Jimmy ChengHo Lin, PhD, CSO, Freenome, Inc.
Mark Massaro, Managing Director & Senior Equity Research Analyst, BTIG LLC
Guardant Health and Freenome have recently reported out large clinical trial data readouts of their blood-based colorectal cancer screening tests to the tune of overall sensitivity of 83% and 79%, respectively, at specificity rates of ~90%. While specificity levels are relatively high (limiting false positive rates), the overall sensitivity of these blood tests are a bit lower than standard-of-care tests like colonoscopy and Cologuard from Exact Sciences.  This discussion will cover the advantages (higher patient compliance rates of a simple blood test, ability to screen more people of varying demographics and lifestyles/age groups) and disadvantages (lower sensitivity to Stage 1 cancer and pre-cancers) of these simple blood tests. What are the merits of these tests being positioned by physicians and guideline bodies as a potential first-line screening test, on par with other tests like Cologuard and the FIT test?