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Cardiometabolic Disease among South Asians: Findings from the MASALA Study

Title:  Cardiometabolic Disease among South Asians: Findings from the MASALA Study

Speaker: Dr. Alka Kanaya, Professor of Epidemiology and Biostatistics, University of California, San Francisco

Date: 02/12/2019

Brief Description:

South Asians comprise almost one-quarter of the world’s population and are the second fastest growing ethnic group in the United States. We have created a prospective cohort of South Asians called the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study, which is closely tied to the Multi-Ethnic Study of Atherosclerosis (MESA) for valid cross-ethnic comparisons. We have followed this cohort for approximately 6 years and have learned that there are specific sociocultural, behavioral and biologic factors that are associated with higher disease risk as well as protective factors and sources of resilience in this distinct ethnic group.

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Embracing Change: Your Connected Medical Device Is Never Finished

Title: Embracing Change: Your Connected Medical Device Is Never Finished

Speaker: Aaron Joseph, Principal Consultant, Sunstone Pilot, Inc.

Date: February 5, 2019

Traditional approaches to medical device development focus on tightly controlling a final product design. In the modern healthcare environment of software-intensive, connected medical devices, there is no final design and companies must become adept at frequently updating their products. Only by embracing change can companies address the modern challenges of connecting to complex, evolving software and rapidly changing cybersecurity risks. This presentation will describe how to structure medical device development for rapid design iterations to speed up product development and to ensure devices remain safe and secure after product launch. Learn how to configure design control processes to support efficient software patches to address interoperability, cybersecurity, OS upgrades, and bug fixes. We will discuss techniques medical device companies can leverage to minimize the cost of change during product development and throughout the product life cycle.

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Startup to IPO: Roadmap to Building Secure, Compliant and Smooth Running Operations

Title:
MedTech/Biotech Startup to IPO: Roadmap to Building Secure, Compliant and Smooth Running Operations

Author:  Mark Richards, CEO KalioTek

Date:  01/29/2019

Brief Description:
By making the smart choices at every stage of growth, emerging Medtech and Biotech firms can efficiently build toward a future with smooth-running IT, strong security and compliant systems without the fire drill, expense and disruption that is often experienced when an opportunity appears for an acquisition or IPO. We’ll discuss real-world choices our customers faced by stage of growth, the solutions they chose and the results they experienced. We’ll cover practical, inexpensive solutions to the top 10 security concerns.

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New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

Title:  New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

Speaker: Matt Jorgensen, Nelson Labs

Date: 12/04/2018

Brief Description:
This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of the strategic options available for the evaluation of medical device biocompatibility will be provided, including the use of chemistry and biological risk assessments to save time, money, and spare animal life.

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Biology Guiding Radiotherapy – Turning Cancer on Itself. Finally.

Title: Biology Guiding Radiotherapy – Turning Cancer on Itself. Finally.

Speaker:  Cal Huntzinger, Sr Director, Clinical Development- RefleXion Medical

Date: 11/27/2018

Brief Description:
RefleXion Medical, a biotargeting oncology company, was founded to answer a simple question: if a cancer cell emits a signal, can we shoot right back to destroy it? Cal provided insights in the development and clinical applications of RefleXion’s biologyguided radiotherapy, the first to utilize the cancer itself to guide radiation delivery. The machine uses PET, the gold standard in cancer staging and imaging. The RefleXion machine senses PET emissions and rapidly responds by sending a beamlet of therapeutic x-rays toward the originating tumor. BgRT makes it feasible to track and treat multiple tumors throughout the body in the same session.

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Machine Intelligence in Health Care: Why Now?

Title: Machine Intelligence in Health Care: Why Now?

Speaker: Khalid Ashraf, CEO Semion

Date: 11/13/2018

Brief Description:
This talk is targeted towards an uninitiated audience. We will discuss what machine intelligence means. We will show a few toy examples to convey the idea and how such systems are developed. Then we will discuss machine intelligence in the context of healthcare. We will provide a few examples of interesting recent research and industry developments. We will particularly focus on medical image analysis and their diagnosis applications. Finally, we will discuss part of our work at Semion and what keeps us excited
about this field in general.

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Packaging Design Validation Testing- Sterilization Methods and Design Considerations

Title: Packaging Design Validation Testing- Sterilization Methods and Design Considerations

Speaker: Pal Khangaldy, Packaging Consultant, Nelson Labs

Date: 10/23/2018

Brief Description:
During the presentation, we will look at some packaging definitions/terminologies associated with sterile medical device packaging. We will look at regulations surrounding medical device packaging and package validation and will take an in-depth look at the actual package validation methods and test standards.

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Manipulating the Immune System to Treat Disease

Title: Manipulating the Immune System to Treat Disease

Speaker: Prof Edgar Engleman, MD, Professor of Pathology and Medicine, Medical Director, Stanford Blood Center

Date: 10/09/2018

Brief Description:
The immune system is a powerful multicellular system that defends the body against many types of infection, but when misdirected or withheld, it can promote diseases, including cancer and neurodegenerative disorders. Although new therapies are not without risk or toxicity, they can provide dramatic benefits, even for those with advanced cancers. In addition to cancer immunotherapies, new types of immunotherapy are being developed to treat neurodegenerative diseases. In the future, combined treatment with immunotherapy and other agents will likely control and possibly cure many diseases that have heretofore been considered untreatable.

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A Rapid, Portable, Affordable, Platform Technology for The Early Screening of Breast Cancer

Title:  A Rapid, Portable, Affordable, Platform Technology for The Early Screening of Breast Cancer

Speaker: Aparna Venkatesh, Vice President, Global Marketing

Date: 10/02/2018

Brief Description:

POC Medical Systems was founded to make cancer and infectious disease screening accessible and affordable on a worldwide basis. POC collaborated with LLNL to develop this test for breast cancer. This test can be performed with its portable lab-in-a-box technology. The advantage is its low cost, portable platform technology. In contrast to traditional lab-based ELISAS and mammography, the Pandora CDxTM-MammoAlert system only requires a few drops of blood and does not need to be administered by a highly trained technician. This method of ‘distributed but connected POC’ screening and diagnostics will bring a paradigm shift in medical treatment.

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Marketing Automation: These are the droids you’ve been looking for

Title:  Marketing Automation: These are the droids you’ve been looking for

Speaker: Debbie Donovan

Date: 09/18/2018

Brief Description:
Sending Email to customers and prospects is easy, in theory. This presentation will cover: Segmenting customers and prospects into lists and what content to send each segment. How to set expectations for responses from different segments. Discussion of products available.

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