MDICx: Somatic Reference Samples RFI – Q&A Session

April 4, 2019, 4 p.m. ET/3 p.m. CT/ 1 p.m. PT

This interactive session is for questions about the Somatic Reference Samples Request for Information released on March 30.

Panelists:

  • Zivana Tezak, PhD | Associate Director for Science and Technology, Personalized Medicine | OIR, CDRH, FDA
  • Julie Schnieder, PhD | Acting Associate Director for Research Strategy and Partnerships for Oncology Center of Excellence | OHOP, CDER, FDA. Co-chair SRS RFI/RFP
  • Barb Zehnbauer, PhD | Steering Committee Chair, SPOT/Dx Quality Assurance Pilot project. Co-chair SRS RFI/RFP
  • Alex Lovejoy, PhD | Principal Scientist II, Roche Sequencing Solutions. SRS Hotspot Variant Lead
  • Li Tai Fang, PhD | Staff Scientist – Bioinformatics, Roche Sequencing Solutions. SRS Data Integration Lead

Register Today!

  • Dawn Bardot, Senior Program Manager, Modeling and Simulation, MDIC
  • Tina Morrison, Advisor of Computational Modeling, Office of Device Evaluation, FDA
  • Kyle Myers, Director of the Division of Imaging and Applied Mathematics, Office of Science and Engineering Laboratories, FDA
  • Randy Schiestl, Vice President, Global Technology, Boston Scientific Corporation

Click here for Registration, Directions, and a list of nearby Hotels. The summit is open to the public, but space is limited. Registration is $50. Please bring a photo ID and check in at the security desk.

Summit Location: The Pew Charitable Trusts | 901 E Street NW | Washington, D.C.

Please email CMS@mdic.org with questions about the summit.

Download final agenda

Thursday, June 26

8:30 a.m. — 9:00 a.m. | Coffee reception

9:00 a.m. — 9:10 a.m. | Opening remarks

9:10 a.m. — 9:30 a.m. | Success story: In silico clinical trials

9:30 a.m. — 11:30 a.m. | Simulation of the heart, vasculature, and related medical devices. Track chair: Wei Gan, Medtronic

11:30 a.m. — 12:45 p.m. | 3 slides, 5 minutes: Snapshots of innovation in modeling and simulation. Track chair: James Coburn, FDA

12:45 p.m. — 1:55 p.m. | Simulation of blood damage and hemolysis. Track chair: Marc Horner, ANSYS

1:55 p.m. — 3:25 p.m.  | Magnetic resonance induced heating. Track chair: Victor Krauthamer, FDA

3:25 p.m. — 5:00 p.m. | Knowledge base repositories, validation data, and best practices. Track chair: David Flynn, Boston Scientific

Friday, June 27

8:30 a.m. — 9:00 a.m. | Coffee reception

9:00 a.m. — 9:20 a.m. | Ways to create exemplars: Mock submissions, FDA

9:20 a.m. — 10:55 a.m. | Powering clinical trials with simulation and bench testing. Track chair: Adam Hines, Medtronic

10:55 a.m. — 12:15 p.m. | Views from medical doctors on the future of modeling and simulation in health care. Track Chair: Tina Morrison, FDA

12:15 p.m. — 1:45 p.m. | 3 slides, 5 minutes: Snapshots of innovation in modeling and simulation. Track Chair: Zane Wyatt, FDA

1:45 p.m. — 3:25 p.m. | Modeling and Simulation in Orthopedics. Track Chair: Payman Afshari, Johnson & Johnson

3:25 p.m. — 4:00 p.m. | Interactive session & closing remarks. Track Chair: Dawn Bardot, MDIC