Semi-Annual IVD Clinical & Regulatory Affairs Conference

December 12-13, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY TWO | FRIDAY, DECEMBER 13

8:00 REGISTRATION & WELCOME COFFEE

8:20 CHAIRPERSON’S OPENING REMARKS
GLOBAL MEDICAL WRITING & TRANSLATION

 

8:30 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
Ashanti Brown, BD

GROUP THREE: South Korea
Ronald Dunn, LUMINEX CORPORATION

GROUP FOUR: Canada
Jeff Hergesheimer, HOLOGIC

 

9:15 TOP 4 CONSIDERATIONS FOR DEVELOPMENT & IMPLEMENTATION OF A COMPANION DIAGNOSTIC

  • Early determination of biomarker target, including:
    • Targeted mutation(s)
    • Sample type
  • Deciding final CDx & appropriate partnerships
  • Move from research phase to testing process
  • Risk determination & communicating with FDA

Karen Richards, Senior Vice President, In Vitro Diagnostics and Quality, PRECISION FOR MEDICINE

 

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.

LEARNING OBJECTIVES:

  • Clinical trial design & validation for test development
  • Aspects of dual-review regulatory pathway for CDx tests
  • Appropriate partnerships to support commercialization

 

10:00 CDx CASE STUDY
Aastha Kohli, Director, Global Regulatory Affairs, NOVARTIS

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 MYRIAD GENETICS CASE STUDY
Russell Henderson, Director of Regulatory Affairs International, MYRIAD GENETICS

 

11:30 EISAI CASE STUDY
Elizabeth Somers, Director, Diagnostics, EISAI, INC.

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 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

 

2:00 CASE STUDY: BIOMARKER DEVELOPMENT, VALIDATION, & CLEARANCE FOR PRECISION MEDICINE

  • Assessing & designing acceptable test validation
  • Biomarker cutoffs & test performance in studies
  • Identifying clinical utility of various biomarkers
  • Regulatory pathways & clearance for biomarkers

Karla Grasso, Clinical Research Manager, ABBOTT

 

2:45 COFFEE AND NETWORKING BREAK

 

3:15 CASE STUDY: EXPANSION OF DIRECT TO CONSUMER IVD TESTS & PATHWAY TO REGULATORY APPROVAL
The diagnostic industry is continuously evolving as new biomark¬ers 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. This case study will provide an inside look into trial design to prove analytical and clinical validity of novel IVDs to ultimately prepare comprehensive regulatory sub¬missions.

LEARNING OBJECTIVES:

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

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

PANELISTS:
Rob Guigley, AMBRY GENETICS

Beverly Lorell, MD, KING & SPALDING

Ronald Dunn, LUMINEX CORPORATION

 

4:30 END OF CONFERENCE

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