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Date/Time
Date(s) - 04/22/2020
12:30 pm - 6:00 pm PT

Location
Radisson Hotel Sunnyvale

Categories

Join NAMSA for its complimentary half-day seminar focusing on clinical and regulatory best practices and proven strategies to assist IVD Sponsors to achieve success throughout the IVD product development lifecycle. There will also be an opportunity to network with NAMSA’s IVD experts during a special happy hour following the event at 5:00 PT.

Who should attend:

  • Regulatory Professionals
  • Clinical Affairs Professionals
  • CEOs and CSOs
  • R&D Professionals
  • VPs and Directors of Regulatory, Quality and Clinical Affairs

Highlighted during the event will be the following presentations:

Do’s and Don’ts for Early Stage IVD Product Development and Effective Risk Mitigation
Presented by: Sonia M. Lecce; Senior IVD Regulatory Consultant

A well-planned approach to navigate the early stages of IVD development will yield significant competitive advantages by shortening time-to-market without additional costs. Planning for a variety of scenarios will assist executives to gauge time and cost to market. Robust plans will effectively impact timelines and should include various factors such as market opportunities, regulatory requirements for market approval and demonstrations of product safety and efficacy.

This presentation will cover:

  • How a start-up to mid-size IVD manufacturer can reduce the risk in product development cycle
  • How to effectively shorten the time to market and secure a competitive advantage
  • Strategic areas of importance within the product development lifecycle where careful planning is required
  • Where a company should invest its resources when planning for a new IVD product

Planning your Clinical Trial: How the Risks Translate to Clinical Strategy
Presented by: Wendy Schroeder; Global Manager of IVD Clinical Services

Clinicians assume diagnostic tests are accurate, reliable and clinically valid. IVD marketing requires evidence that tests accurately take measurements (analytical validation), can detect or exclude a disease or condition (clinical validation) and provide results that aid in clinical management and improve patient outcomes (clinical utility). IVD manufacturers should consider the risks associated with their product claims, the current FDA and CLIA oversight of IVDs and LDTs and business strategy when deciding if and how much clinical data is critical to success.

This presentation will cover:

  • How IVD claims (Intended Use and Indications for Use) drive requirements for clinical data/evidence
  • How IVD risks impact business strategies and clinical data requirements
  • How clinical data impacts payor reimbursement and clinical adoption

Key Considerations for IVDD to IVDR Transition
Presented by: Sonia M. Lecce; Senior IVD Regulatory Consultant

IVD manufacturers have been tasked with the new challenge of bringing marketed and pipeline products into compliance with the EU IVDR by May 2022. This presentation will focus on organizing some of the key steps to initiate and interpret the requirements to meet the new guidelines for existing and new products to secure CE certification marks under the new IVDR.

This presentation will cover:

  • Requirements for currently marketed products (registered under IVDD) to comply with the IVDR
  • Requirements for new products that are looking to obtain CE mark under the IVDR
  • Major gaps that need to be addressed for products with FDA clearance that are looking for a commercialization expansion under IVDR

Panel Discussion: Alignment of Clinical and Regulatory Strategies for Successful Market Access
Moderated by: Larry Martin; IVD Sales Specialist
Presented by:
– Sonia M. Lecce; Senior IVD Regulatory Consultant
– Wendy Schroeder; Global Manager of IVD Clinical Services
– Nathifa Bradshaw; Manager of Global Operations Consulting Services

Disruptive IVD technologies require innovative regulatory and clinical strategies to obtain market clearance in a complex global market. Hear NAMSA’s expert panel share some of their experiences on how to align business objectives and market plans through efficient, effective development strategies.

MEET THE SPEAKERS

 

Sonia M. Lecce
Sonia Lecce has over 20 years’ experience in the IVD and medical device industry, with over 15 years spent in the area of IVD regulatory affairs . Her experience includes working for  Abbott Molecular and Baxter with a focus on IVDs. Additionally, Sonia has experience with  molecular products, companion diagnostics, hematology, flow-cytometry, LDTs, ASRs, FISH technology and PCR technology for both oncology and infectious disease. In medical devices, she has worked in medication delivery, pumps and collection devices. She is currently heavily involved in Biologics License Applications for several products for both US (CBER) and Health Canada. Her regulatory affairs experience has spanned both US and global markets.
Wendy Schroeder
Wendy Schroeder has over 20 years of clinical trial experience in multiple therapeutic areas. She has managed clinical trial operations including site recruitment, resource planning and staff training and development. Wendy has a strong background in IVD research and has been a clinical source of truth for IVD/LDT business and regulatory strategy planning with Sponsor companies. She has biospecimen logistics experience in both research and CLIA certified laboratories and a strong reimbursement/billing background from her roles working in various hospitals and clinics prior to moving to the IVD industry. She has recent peer-reviewed journal publications on clinical trial billing, LDTs and NGS/personalized medicine. Wendy is a registered nurse by profession and received her BSN from Arizona State University. She is certified as a research coordinator and project manager by ACRP.
Nathifa Bradshaw
Nathifa Bradshaw has over 15 years’ experience  in the healthcare industry  with ten years focused on IVD and companion diagnostics. She has managed full implementation of Quality Management Systems based upon ISO 13485 and FDA 21 CFR 820 and has worked cross functionally on design teams from product conception to market launch. She has experience with the U.S. FDA, Health Canada, WHO, MDSAP and EU MDR & IVDR, ranging from initial gap analysis to regulatory compliance. Nathifa has an active membership with the Regulatory Affairs Professionals Society (RAPS) as well as the American Society for Quality (ASQ).
 

Sonia M. Lecce
Sonia Lecce has over 20 years’ experience in the IVD and medical device industry, with over 15 years spent in the area of IVD regulatory affairs . Her experience includes working for  Abbott Molecular and Baxter with a focus on IVDs. Additionally, Sonia has experience with  molecular products, companion diagnostics, hematology, flow-cytometry, LDTs, ASRs, FISH technology and PCR technology for both oncology and infectious disease. She is currently heavily involved in Biologics License Applications for several products for both US (CBER) and Health Canada. Her regulatory affairs experience has spanned both US and global markets.
Wendy Schroeder
Wendy has over 20 years of clinical trials experience in multiple therapeutic areas. She has managed clinical trial operations including site recruitment, resource planning and staff training and development. Wendy has a strong background in IVD research and has been a clinical source of truth for IVD/LDT business and regulatory strategy planning with Sponsor companies. She has biospecimen logistics experience in both research and CLIA certified laboratories and a strong reimbursement/billing background from her roles working in various hospitals and clinics prior to moving into industry. She has recent peer-reviewed journal publications on clinical trial billing, LDTs and NGS/personalized medicine. Wendy is a registered nurse by profession and received her BSN from Arizona State University. She is certified as a research coordinator and project manager by ACRP.
Nathifa Bradshaw
Nathifa Bradshaw has been in the healthcare industry for over 15 years with 10 years focused on IVD and companion diagnostics. Nathifa has managed full implementation of Quality Management Systems based upon ISO 13485 & FDA 21 CFR 820 and has worked cross functionally on design teams from product conception to market launch. She has experience with US FDA, Health Canada, WHO, MDSAP, EU MDR & IVDR from the initial gap analysis to regulatory compliance. Nathifa has an active membership with the Regulatory Affairs Professionals Society (RAPS) as well as the American Society for Quality (ASQ).