Session Abstract – PMWC 2024 Silicon Valley
Speaker Profile
Biography
Shawnnah Monterrey founded BeanStock Ventures following a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for startups and mature organizations including Covidien and Illumina with an emphasis on the development of medical devices for life science, diagnostics, and clinical applications. Shawnnah often volunteers her time and expertise to the medical device community by serving as a mentor for various MedTech accelerators and startups, angel investor and as a recurring NIH SBIR grant reviewer.
Talk
Fast Track Your LDT to IVD FDA Clearance
With the recent FDA issued proposed rule that would allow the FDA to regulate LDTs as medical devices, BeanStock Ventures has developed customized services and products that will enable LDT manufactures to rapidly comply with FDA regulations such as: Regulatory Strategy Services, FDA Third-party review, FDA compliance training, technical templates, IVD analysis software platform
Digital Health Showcase:
BeanStock Ventures
BeanStock Consulting is an FDA-accredited third-party 510(k) review organization, which provides Regulatory Strategy Services, FDA Third-party review, FDA compliance training, technical templates, and IVD analysis software platform.
Speaker Profile
Biography
As part of the UCSF Innovation Ventures Office of Strategic Alliances, Amy designs, implements, and maintains tailored action plans and partnering strategies for multidisciplinary research collaborations and agreements with industry partners. Previously, Amy served as a Lead within the Strategic Science Engagements Office for the Physical and Life Sciences Directorate at Lawrence Livermore National Laboratory where she coordinated efforts across various Department of Energy (DOE) labs and the National Cancer Institute and was recognized in 2017 by the United States Department of Energy for the Secretary's Appreciation Award for responding to the Vice President's Cancer Moonshot.
Talk
UCSF Innovation Ventures: Personalized Medicine Technologies Applications
We will provide an overview of UCSF Innovation Ventures as well as showcasing the lifecycle of one or more of our university technologies from disclosure to development, to the evolution of industry partnership.
Digital Health Showcase:
UCSF Innovation Vent
The University of California, San Francisco (UCSF) Innovation Ventures is dedicated to helping our research and clinical community navigate the complexities of translational technology development and commercialization. Our goal is to support the transition of UCSF innovation into the marketplace and advance health worldwide.
Speaker Profile
Biography
Mike Papac has spent the last 20-yrs in Industry developing medical products for companies such as Alcon, Novartis, and Optovue, and is now focused on creating start-up companies that bring new innovative products to market. Mike is part of the UCSF Innovation Ventures team which aims to commercialize UCSF technologies.
Talk
UCSF Innovation Ventures: Personalized Medicine Technologies Applications
We will provide an overview of UCSF Innovation Ventures as well as showcasing the lifecycle of one or more of our university technologies from disclosure to development, to the evolution of industry partnership.
Digital Health Showcase:
UCSF Innov. Ventures
The University of California, San Francisco (UCSF) Innovation Ventures is dedicated to helping our research and clinical community navigate the complexities of translational technology development and commercialization. Our goal is to support the transition of UCSF innovation into the marketplace and advance health worldwide.
Speaker Profile
Biography
Dr. Behar is interested in the development of robust, low-priced genetic testing that fosters a personalized genetic medicine approach for the general public. Dr. Behar previously served as Chief Medical Officer of Gene by Gene Ltd. where he developed genetic testing using a direct internet-based customer approach. During the course of his work he gained expertise in various aspects of mass genotyping, database creation and mining, genetic analysis and more.
Talk
Ensuring Precise Result Delivery in Precision Medicine
The development of precision lab tests has made huge leaps in recent years. However, as the scope of testing becomes increasingly larger, lack of domain expertise leaves providers feeling uncomfortable when explaining results to patients. Lets explore the underlying challenges and discuss how Igentifys Digital Genetic Assistant is alleviating this significant pain in clinical management.
Digital Health Showcase:
Igentify
Igentify alleviates bottlenecks in the genetic testing process via its Digital Genetic Assistant. The Digital Genetic Assistant provides software tools to increase clinician efficiency, empower patients with relevant and accessible information about their genetics and perform advanced analysis of genomic data.