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Today

Webinar - Regulatory Horizons: What to Expect 2019 and Beyond

When:

Wednesday, January 30, 2019, 8:15 AM until 10:00 AM

Where:

Category:

Webinar

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Capacity:

Active Member (Regular, Student, Government)

No Fee

Non-Member

$60.00

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The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
NO webinar recording will be available after the meeting.

TOPIC: Regulatory Horizons: What to Expect 2019 and Beyond

TOPIC DESCRIPTION: Cancer panels, digital health and use of augmented intelligence (AI) are driving rapid changes in regulatory pathways. This presentation will examine the key issues impacting the changing regulatory framework for diagnostics and will provide tips on what is required to obtain successful regulatory approval for these niche products.

Requirements for regulatory submissions, quality management systems and reimbursement are in flux. Key issues impacting near term and future regulatory strategies will be discussed.

The following topics will be covered:
• Current U.S. regulatory activities and requirements for molecular diagnostics
• Biomarker qualification, breakthrough designations, and use of NGS gene panels
• Regulatory and reimbursement convergence – the NGS NCD

SPEAKER: B. Melina Cimler, PhD

SPEAKER BIOGRAPHY: Melina Cimler is the CEO and Founder of PandiaDx LLC. She has over 28 years of experience in the life science and FDA-regulated diagnostic industry leading regulatory, quality systems, clinical affairs, research, and product development organizations with a focus on precision medicine.

Dr. Cimler served as SVP of Regulatory & Quality at Adaptive Biotechnologies until April 2018. In her role, she developed the regulatory strategy for NGS-based immunosequencing products and led regulatory interactions with pharma partners to allow use of NGS-based minimal residual disease tests in oncology drug trials andsubmissions. She was previously Head of Global Quality and VP of Quality, Regulatory, Clinical and Government Affairs at Illumina Inc.

She defined and executed on the regulatory strategy resulting in the first next generation sequencing platform (Illumina’s MiSeqDx) receiving FDA marketing authorization.

She serves on the Board of Directors of Nanostics, Inc., and as a member of the Scientific Advisory Board of M3 Biotechnology. She is an Expert Consultant for NDA Partners.

Previously, she held leadership positions in quality, regulatory and government affairs as SVP at Beckman Coulter Inc. She also served in senior quality, clinical and regulatory roles at Abbott Molecular, Gen-Probe Inc., and C.R. Bard, and as head of Product Development at Epitope, Inc. (now OraSure Technologies). Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.

WHO: Clinical, regulatory, quality, manufacturing and legal

Attendance at this meeting may be applied as 1.5 points towards RAC re-certification