Semi-Annual IVD Clinical & Regulatory Affairs Conference

December 12-13, 2019 | San Diego, CA

Andaz San Diego Hotel

Download AgendaRegister Now

DAY TWO | WEDNESDAY, OCTOBER 23

8:00 REGISTRATION & WELCOME COFFEE

8:35 OPENING REMARKS

8:45 DEEP DIVE REVIEW OF INTERNATIONAL REGULATIONS FROM EMERGING MARKETS
Teresa Raich, PhD, Senior Director, Regulatory Affairs, ABBOTT

 

9:15 BREAKOUT GROUPS: NAVIGATING CHALLENGES WITHIN INTERNATIONAL DIAGNOSTIC REGULATIONS
Global diagnostic companies face many challenges while seeking approval of tests as each market has a unique and constantly evolving regulatory pathway, in addition to specific requirements surrounding the acceptance of clinical data, which often remain unclear to US-based professionals. This peer-to-peer learning session allows participants to exchange concerns and best practices for complex regions, ensuring knowledge share of resource efficient methods to enter international markets. To enable discussion, the audience will break into smaller groups, focusing on specified regions that prove challenging for regulatory approval as listed below, with the possibility of adding further groups and categories deemed necessary by the audience:

GROUP ONE: CHINA
Julia Yeh, AMGEN

GROUP TWO: JAPAN
Grace Lee, AGILENT TECHNOLOGIES

GROUP THREE: CANADA
Sid Mathur, MERCK

 

9:45 IMPLEMENTING THE MEDICAL DEVICE SINGLE AUDIT PROGRAM FOR IVD ORGANIZATIONS

  • Considerations to determine involvement within MDSAP
  • Requirements within MDSAP specific to diagnostic tests
  • Preparing for time and format requirements of MDSAP audits

Hilary Baldwin, Regulatory Affairs Manager, CARIS LIFE SCIENCES

 

10:15 COFFEE AND NETWORKING BREAK

 

MULTI-PART CASE STUDY: COLLABORATIVE CLINICAL TRIALS & REGULATORY SUBMISSIONS BETWEEN PHARMACETICAL & DIAGNOSTIC ORGANIZATIONS
Throughout the development of companion diagnostics, pharmaceutical and diagnostic companies encounter different challenges while pursuing approval and navigating separate regulatory requirements from both CDRH and CDER. With companion diagnostics emerging for a variety of patient populations, organizations must revise traditional clinical trial design to accommodate for unique biomarkers as well as inclusion and exclusion criteria. In addition, to successfully bring companion diagnostics to market, pharmaceutical and diagnostic companies must communicate respective regulatory expectations to comply with both CDRH and CDER requirements and align submissions for a streamlined approval process.

 

10:45 IVD PERSPECTIVE
Kenneth Bloom, MD, Chief Medical Officer of Konica Minolta Precision Medicine
INVICRO AND AMBRY GENETICS

 

11:15 PHARMACEUTICAL PERSPECTIVE
Sid Mathur, Regulatory Affairs Director, Companion Diagnostics, MERCK

 

11:45 IVD PERSPECTIVE
Bertrand Plouffe, M.Sc., Director – Clinical Study Design, SIEMENS HEALTHINEERS

 

12:15 COMPANION DIAGNOSTIC PERSPECTIVE
Laura Tracy, Senior Regulatory Affairs and Clinical Quality Assurance Professional
LEICA BIOSYSTEMS

 

12:45 LUNCHEON FOR ALL PARTICIPANTS

 

1:45 CASE STUDY: BIOMARKER DEVELOPMENT, VALIDATION, & CLEARANCE FOR PRECISION MEDICINE

  • Clinical, technical, regulatory hurdles toward CDx approval
  • Biomarker cutoffs & test performance in studies
  • Identifying clinical validity of various biomarkers
  • Regulatory pathways & clearance for biomarkers

Matt Marton, PhD, Executive Director, Companion Diagnostics & Genomics, MERCK

 

CASE STUDIES: EXPANSION OF DIRECT TO CONSUMER IVD TESTS & PATHWAY TO REGULATORY APPROVAL
The diagnostic industry is continuously evolving as new biomarkers and assays are developed for IVD tests, allowing organizations the capability to establish personalized medicine for unique patient needs. Although industry innovation progresses quickly, revised regulatory pathways to accommodate advanced technologies are often delayed and diagnostic companies examine peer approaches to approval as well as schedule preliminary meetings with the FDA to determine regulatory expectations. Brief case studies deliver an inside look into trial design to prove analytical and clinical validity of novel IVDs to ultimately prepare comprehensive regulatory submissions.

LEARNING OBJECTIVES:

  • Planning initial meetings with the FDA
  • Analytical & clinical validity of the assay
  • Design controls specific to IVD assays
  • Constructing the regulatory submission

 

2:30 CASE STUDY ONE: ORASURE
Tiffany Miller, Senior Director, Regulatory Affairs, ORASURE

 

3:00 COFFEE AND NETWORKING BREAK

 

3:15 CASE STUDY TWO: 23ANDME
Lisa Charter, Director, Regulatory Affairs, 23ANDME

 

3:45 PANEL: ALIGNMENT OF CLINICAL & REGULATORY EFFORTS TO SUPPORT IVD REIMBURSEMENT & MARKET ACCESS

  • Review of traditional pathways to secure IVD reimbursement
  • Analyzing the need for reimbursement dependent on test type
  • Update on FDA & CMS parallel review process for IVD tests
  • Evidence generation during studies to support reimbursement

MODERATOR: Molly Millet, GLOBAL MEDICAL WRITING & TRANSLATION

PANELISTS:
Rob Guigley, AMBRY GENETICS

Paul Radensky, MD, MCDERMOTT WILLL & EMERY

Stephanie Ibbotson, LUMINEX CORPORATION

 

4:30 END OF CONFERENCE

Share This