As liquid biopsies become more commonplace, gaining wider US Food and Drug Administration (FDA) acceptance and even becoming standard of care in some instances, the technology is giving rise to important new questions. In this webinar, the featured speakers will explore the technique’s growing importance in early cancer detection and address common questions about its use.
The webinar will provide insights into developing an in vitro diagnostics test for early cancer detection with clinical, analytical and performance validation considerations. Attendees will learn how to approach single indication vs. multi-cancer screen indications, the advantages and disadvantages of lab-developed tests vs. premarket approval and the regulatory landscape for in vitro diagnostics. In addition, discover strategies for operationalizing large-scale clinical validation studies.
Join this webinar on in vitro diagnostics for early cancer detection for a discussion on the evolution and promise of liquid biopsy technology.
Speakers
Michael Edwards, Senior Director, Regulatory Affairs (MedTech), Premier Consulting (a business unit of Premier Research)
Michael Edwards is a Senior Director, Regulatory Affairs (MedTech) at Premier Consulting. Premier Consulting is a strategic product development and global regulatory consulting business unit of Premier Research, dedicated to supporting the specialized needs of emerging biotech, specialty pharma, and MedTech companies. Premier Research is a leading clinical research company that’s Built for Biotech℠ and Made for MedTech™.
Michael Edwards has more than 25 years of experience in regulatory affairs and quality assurance acquired within the medical device and clinical research industry across a diverse range of medical device technologies and therapeutic disciplines, and organizations from start-ups to multinationals.
Michael Edwards expertise spans the complete product lifecycle including clinical research, design, development, technical support, project management, operations and business development in the medical devices sector. His knowledge of the device development process combined with the regulatory requirements, enables him to provide a balanced interpretation of the pre-market and post-market needs and expectations of regulatory authorities.
In his current role, Michael provides regulatory, quality and technical expertise to clients and sponsors to help bring their products to market safely, effectively and efficiently. His key strengths include developing, formulating and implementing regulatory strategies for device development and pathways to market to meet both existing and new regulations, standards and guidance documents.
Prior to joining Premier Consulting, Michael has held various senior management positions in regulatory affairs, quality assurance and technical with high-profile, international medical device and clinical research organizations.
Message Presenter
Charlie Chrisawn, Executive Director, Program Strategy, In Vitro Diagnostics, Premier Research
Charlie Chrisawn has extensive experience designing and executing studies of sample collection as well as leading validation and utility studies for diagnostics. Specific to oncology, Mr. Chrisawn has managed several diagnostic studies that in total have enrolled approximately 75,000 subjects worldwide and led to a successful PMA and multiple LDTs. His experience in this area includes protocol and study design, both domestic and international study startup, overall site management, sample accountability, staff training and study closure. Mr. Chrisawn has drug/device combination experience in the 505(b)(2) pathway and stand-alone device experience in metastatic lung cancer ablation, in addition to successful 510(k) and CLIA-waived study management.
Mr. Chrisawn earned a Bachelor of Science (BS) degree in Biology from Davidson College.
Message PresenterWho Should Attend?
Senior professionals from Pharma, Biotech and Medtech companies involved in:
- Clinical Trials
- Clinical Operations
- Drug Development
- Preclinical Trials
- Project Management
- Regulatory Affairs
What You Will Learn
Attendees will get an in-depth look at:
- Developing an in vitro diagnostics test: clinical, analytical and performance validation considerations
- Approaching single indication vs. multi-cancer screen indications
- Lab-developed tests vs. premarket approval: advantages and disadvantages
- The regulatory landscape for in vitro diagnostics
- Strategies for operationalizing large-scale clinical validation studies
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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