Semi-Annual IVD Clinical & Regulatory Affairs Conference

December 12-13, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY ONE | TUESDAY, OCTOBER 22

8:00 REGISTRATION & WELCOME COFFEE

8:50 OPENING REMARKS

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

INTERVIEWEE:
Brad Spring, BD

 

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

 

11:30 CASE STUDY: DEVELOPMENT OF A SOFTWARE CONNECTED MULTI-GENE IVD TEST & PATH TO REGULATORY APPROVAL

  • Collaboration with the FDA throughout test development
  • Proving analytical & clinical validity of multi-gene test
  • Process to develop software as a medical device
  • Regulatory approval of machine learning algorithms

Oliver Liesenfeld, MD, Chief Medical Officer, Head of Clinical Affairs, INFLAMMATIX, INC

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 JUMP-STARTING REVIEW OF IVDs IN FDA’S 510(k) THIRD PARTY REVIEW PROGRAM
FDA believes that increased utilization of the Third Party Review Program for review of IVDs is possible and would add real value for the IVD community. Many IVDs are eligible for review through this program. Additionally, review decision summaries are publicly posted and readily accessible to third party reviewers. With these and other opportunities in mind, FDA is exploring the launch of an IVD pilot for the Third Party Review Program.

  • Brief history of the Third Party Review Program
  • Successes of the program
  • Opportunities for IVDs in the program

Doug Rheinheimer, Third Party 510(k) Team, FDA

 

2:00 INSIGHT ON DIGITAL HEALTH PROGRAMS & FUTURE REGULATION OF IVD TESTS

  • FDA Digital Health Software Pre-Cert Pilot Program: Journey thus far
  • Artificial Intelligence/Machine Learning (AI/ML): FDA’s proposed regulatory framework
  • Anticipated future regulatory oversight of digital health
  • Considerations for an effective Software QMS (Quality Management System)

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

 

2:30 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.

Michael Ryan, Partner, MCDERMOTT WILL & EMERY

 

3:00 COFFEE AND NETWORKING BREAK

 

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.

 

3:15 PART ONE: PRE-MARKET PREPARATION & CLINICAL TRIAL DESIGN

  • Potential risk re-classification for IVD products
  • Defining substantial & validated clinical evidence
    • Clinical evaluations under MEDDEV 2.7/1
    • Acceptance of international clinical data
    • Modifications in conformity assessments
  • Designing IVDR compliant clinical trials for tests

Renee Howell, PhD, Senior Director, Clinical Affairs, SIEMENS HEALTHINEERS

 

4:00 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

 

4:45 PART THREE: 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: Molly Millet, GLOBAL MEDICAL WRITING & TRANSLATION

INTERVIEWEE: Julien Senac, PhD, TUV SUD

 

5:30 END OF DAY ONE CONFERENCE

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