Diagnostic Tests. Brad Spring Director, Regulatory Affairs

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1 Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011

2 Balancing Evidence of Safety & Effectiveness and Time to Market EU (IVD-Non Annex II) Self-Certification Analytical Testing (V&V) Risk Assessment Stability Testing (V&V) Clinical Evaluation (V&V) Labeling/Package Inserts Translations Essential Requirements Checklist Declaration of Conformity FDA (IVD Class I & II) Analytical Testing (V&V) Risk Assessment Stability Testing (V&V) Prospective Clinical Trials (V&V) Labeling/Package Inserts Regulatory Submission S&E Evidence Time to Market S&E Evidence Time to Market

3 Product Development Process 0-Concept 1-Definition 2-Development 3-Qualification 4-Launch Customer Input Customer Requirements Product Requirements Product Specifications Verification Analytical Validation Clinical Evaluations FDA Clearance Business Input Operational Requirements Prospective Clinical Trials FDA Submission Process Requirements Process Specification Process Validation 6 to 18 months

4 Prospective Clinical Trial vs. Clinical Evaluations* Prospective Clinical Trials Multi-center studies in human subjects to assess safety and performance Uses prospectively collected patient specimens Includes studies conducted at hospitals, clinics, and reference labs as well as public, private and government laboratories May require informed consent Clinical Evaluations Assessment and analysis of clinical data to verify safety and performance Data from pre and post market prospective clinical trials Data from scientific literature Published or unpublished reports regarding clinical experience with the device or a comparable device Data from testing of wellcharacterized, archived (retrospective) specimens. Testing may be conducted outside a clinical setting *Global Harmonization Task Force (GHTF) Terminology

5 Prospective Clinical Trials Pros Captures the real-time performance characteristics of the product in its intended setting Broad demographic distribution of patients Good control over specimen collection, handling, transport and storage Feedback from sites on use of the product may provide information for future improvements Cons Long durations especially with low prevalence diseases High costs Informed consent may reduce patient enrollment Logistics of multi-center studies create too many opportunities for things to go wrong, leading to data loss or trial cancelation

6 Clinical Evaluations Pros Many sources of clinical evidence to evaluate safety and effectiveness Shorter prospective trials E.g., if data are evaluated in combination with retrospective trials, literature assessments and other product experiences (e.g., RUO* evaluations) Lower study costs Reduced logistical burden Cons Retrospective studies: Specimen integrity Lack of patient information May still need informed consent Data from existing literature or other clinical experience may not reflect the final product Patients populations may not be broad (e.g., age, race, sex, location, etc.) Must be used collectively; cannot rely on one approach alone *Research Use Only

7 How Can We Further Innovate Clinical Evaluations? Different approaches to choosing a reference method in trials Rely on methods used to characterize archived specimens to determine truth rather than testing on a reference and a test method Adopt composite reference method approach (e.g., culture & PCR) Eliminate the requirement to compare new tests to outdated methods when more accurate, well established methods exist Improve access to specimens with low prevalence organisms Need more specimen banks and clinical lab consortiums with well-characterized human specimens Incentivize partnerships between drug companies and IVD manufacturers to improve specimen access, reduce trial costs, and improve regulatory review times For seasonal diseases or localized outbreaks, rely on prospective data from a limited geographic location Follow up with post-market studies from a broader demographic if possible E.g., for a flu trial, test in Hong Kong first then with post-market studies in Latin America, Canada, U.S. and Europe once the disease migrates to these regions

8 Regulatory Submissions Current and Future Challenges US FDA Office of In Vitro Diagnostics Submission review times continue to increase IVD 510(k) review times in May 2011 ranged from 2 to 34 months with an average of 9.3 months (or 7.3 months if you remove outliers) Lack of a sufficient number of reviewers and proper skill sets may further increase review times and delay accesses to critical diagnostics The 510(k) process is being challenged and will be changing Perceived inadequacies in the review process for other medical devices may have adverse consequences IVD submission review times The regulatory burden for some assays are barriers to market Some assays are not developed by manufacturers due to the costs and time involved Because some tests are critical to public health, labs fill the IVD gap by developing their own, lab developed, in house tests (LDTs); sometimes without adequate analytical and clinical testing EU IVD Directive Recast of IVD Directive will move toward a risk-based classification approach Quality Management System (QMS) audits and Technical File reviews by Notified Bodies will increase due to increases in IVD classifications The requirements for clinical evidence will be increasing Point of Care and Personalized Medicine tests will see increased requirements. In house tests will increase as IVD companies abandon some esoteric tests that lack the return on investment

9 How Can We Innovate Regulatory Pathways? Allow tests on the market based on analytical testing and limited clinical evidence with a requirement for post-market studies With tests for life threatening and/or low prevalence illnesses, limit distribution to public health and some Key Opinion Leader laboratories while post-market studies are conducted Structured pre-submission meetings with government and industry Currently called the pre-ide process with FDA, it is a successful, collaborative approach to improve predictability of regulatory requirements and trial designs. However, some aspects of the pre-ide should be binding Encourage EU to adopt similar il mechanism especially as technologies and regulations rapidly evolve Broaden or change the use of RUO and/or IOU* for urgent issues Tests in the research phase or investigational phase of development may still add value in cases of life-threatening outbreaks of new pathogens or resistant strains More collaborative, solution-oriented, public meetings Brainstorming with academia, IVD industry, government and laboratory stakeholders provides unique opportunities to create innovative solutions *Investigational Use Only

10 Thank you

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