Semi-Annual IVD Clinical & Regulatory Affairs Conference

December 12-13, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY ONE | THURSDAY, DECEMBER 12

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Lorry Weaver Huffman, Principal Consultant, QSERVE GROUP US

9:00 OPENING ICE BREAKER: STATE OF THE INDUSTRY, PAST, PRESENT, & FUTURE
As IVD regulatory and clinical professionals face major changes both domestically and internationally, conference participants are encouraged to reflect on the previous year to consider industry updates and technological innovations affecting the current state of the IVD market. In addition, as the industry anticipates future developments such as the proposed VALID Act and the EU IVDR, this opening ice breaker provides an opportunity to share key concerns as well as areas of progress for diagnostic companies. In this interactive session, all participants will have the chance to meet new attendees and connect through engaging conversations and immediately build contacts with peers to kick off the event networking platform.

 

9:15 FIRESIDE CHAT: EXAMINING THE VALID ACT & PRIMARY IMPLICATIONS FOR THE DIAGNOSTIC INDUSTRY
The proposed Verifying Accurate, Leading-edge IVCT Development Act, or VALID Act, is a drafted bill in congress, establishing an entirely reconstructed regulatory framework for a new category of diagnostic tests called IVCTs or In Vitro Clinical Tests, including both test kits and LDTs. The framework outlines a unified risk based approach for all IVCTs and introduces various concepts such as a precertification program, premarket review of high risk tests, and pathways for early patient access to breakthrough therapies. In addition, the VALID Act also encompasses post market requirements to track patient health and incorporates laboratory inspection audits.

  • Regulatory importance of guidance for oversight of IVCTs
  • Proposed timeline for legislative priority & implementation
  • Commercial impact on the development & approval of tests

INTERVIEWER: Yarmela Pavlovic, HOGAN LOVELLS

INTERVIEWEES: Kristin Godfredson, BIOTHERANOSTICS

David Jackson, PhD, NEURAPTIVE THERAPEUTICS

 

10:00 CASE STUDY: ALIGNING A ROBUST REGULATORY SUBMISSION FOR THE DE NOVO CLASSIFICATION PROCESS

  • Determination of test suitability for de novo submission
  • Assembly of materials for successful de novo requests
  • Review of pre-submission meeting process with the FDA

Tammy Moncur, VP, Quality & Regulatory Affairs, AMBRY GENETICS

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 LEGAL PERSPECTIVE: GAP ANALYSIS OF CURRENT DE NOVO PROCESS & 2018 FDA PROPOSED RULE

  • Gap analysis between current procedure & proposed rule
  • Requirements for format & content of the de novo request
  • Legislative reasoning for updates to regulatory pathway
  • FDA proposed review process for de novo classifications

Yarmela Pavlovic, Partner, HOGAN LOVELLS

 

MULTI-PART MODULE: REGULATION OF DIGITAL HEALTH, WEARABLE DEVICES, & MACHINE LEARNING TECHNOLOGY
More diagnostic companies are developing connected products such as wearable devices and utilizing digital health as well as artificial intelligence within IVD tests. The FDA is fostering new technological progress through the MyStudies Application and the Software Pre-Certification Pilot Program, both of which encourage industry thought leaders to allocate resources to the development of innovative devices. As companies focus efforts on forward thinking approaches to diagnosis and healthcare delivery, regulatory and clinical professionals are tasked with designing studies and ensuring data quality to accommodate the needs of new technology.

 

11:30 PART ONE: ARTIFICIAL INTELLIGENCE & MACHINE LEARNING CHALLENGES FOR FDA IN REGULATION INNOVATION
Beverly Lorell, MD, Senior Medical & Policy Advisor, KING & SPALDING

 

11:45 PART TWO: INSIGHT ON DIGITAL HEALTH PROGRAMS & FUTURE REGULATION OF IVD TESTS

  • Proceedings of the Software Pre-Cert Pilot Program
    • Assessing safety & effectiveness of software
    • Approval of machine learning technology
    • Review process for different risk categories
  • Anticipated future regulatory oversight of digital health

Taranjit Samra, Head of Quality (Software-IVDs), GUARDANT HEALTH

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 LEGAL PERSPECTIVE: FDA ENFORCEMENT TRENDS WITHIN THE DIAGNOSTIC INDUSTRY
With the FDA issuing the first warning letter for an LDT in more than five years, the diagnostic industry is facing concerns about future enforcement trends and requirements for tests that previously lacked a formal authorization requirement. The recent enforcement development emphasizes the continuous debate between the FDA and the industry on authoritative reach of the agency to regulate LDTs, with many stakeholders lacking a clear comprehension of FDA expectations. Diagnostic companies await further notice on additional enforcement action from the FDA and the potential implementation of a regulatory pathway for LDTs.

Marian Lee, Partner, GIBSON, DUNN & CRUTCHER

 

EU IVDR LEARNING MODULES: DEPLOYING PRACTICES COMPLIANT WITH THE IN VITRO DIAGNOSTICS REGULATION
As the May 26, 2022 implementation date for the European Union In-Vitro Diagnostics Regulation continues to draw closer, diagnostic companies must strategize an execution plan to meet certification requirements. Diagnostic tests that were previously compliant under IVDD are subject to major changes including risk re-classification, aligning substantial and validated clinical evidence, as well as conforming to post market reporting requirements. Diagnostic companies seek clarification on unclear regulatory specifications, interaction with notified bodies, and the overall impact on business models used in the EU.

 

1:45 PART ONE: PRE-MARKET PREPARATION & CLINICAL TRIAL DESIGN

  • Re-classification of IVD products & modifications in conformity assessments
  • Defining substantial & validated clinical evidence
  • Designing IVDR compliant clinical trials

Gail Gasior, Senior Manager, Clinical Compliance, HOLOGIC

 

2:30 COFFEE AND NETWORKING BREAK

 

3:00 PART TWO: POST-MARKET REQUIREMENTS & QUALITY MANAGEMENT SYSTEMS

  • Analysis of post-market surveillance (PMS) requirements
  • Post-market reporting requirements for different classes:
    • Post-market surveillance report for classes A & B
    • Periodic safety update report for classes C & D
  • Incident reporting through Field Safety Corrective Actions
  • Coordinating requirements for quality management systems

Julien Senac, PhD, Global Director – IVD Focus Team, TÜV SÜD

 

3:45 PART THREE: IMPACT ON BUSINESS MODELS & COMMERCIAL VIABILITY IN THE EU

  • Shifting regulatory strategies from self-certification to IVDR
  • Compliance ramifications on test claims & product labelling
  • Employing updated business models to accommodate IVDR
  • Preparing commercial launches for IVDR compliant products

Karin Hughes, PhD, Vice President Clinical & Regulatory Strategy, ASTUTE MEDICAL

 

4:30 PART FOUR: NOTIFIED BODY FIRESIDE CHAT: PERSPECTIVE ON CERTIFICATION & PROGRESS ON DESIGNATION

  • Notified body capabilities & responsibilities under IVDR
  • Timing of NB certifications affecting market availability
  • Status update on progress for NBs to IVDR designation
  • Working relationship between manufacturers & NB

INTERVIEWER:
Karen Richards, PRECISION FOR MEDICINE

INTERVIEWEE:
Julien Senac, PhD, TÜV SÜD

 

5:15 END OF DAY ONE CONFERENCE

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