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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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Regulatory Intelligence and Strategy Planning using Magellan and SaaS Technology

Title: Regulatory Intelligence and Strategy Planning using Magellan and SaaS Technology

Speaker: Mark Thomson, President and CEO, RegIQ Solutions, Inc.

Date: 09/25/2018

Brief Description:
Interested in improving your regulatory process for medical device? This presentation is on Magellan, the first SAAS regulatory compliance platform for medical devices with onboard market specific intelligence, project planning, and license management capabilities. Magellan is unique, game-changing technology and a great improvement to current regulatory practice for presubmission planning and post-market management.

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Preparing for the Ups and Downs of a Startup Company

Title:  Preparing for the Ups and Downs of a Startup Company

Speaker:  John Hendrick, CEO Mynosis

Date:  07/31/2018

Brief Description:
Mr. Hendrick speaks about the trail from concept through a market release for a medical device company. He spoke what it takes from funding through various evolutions of the company as well as the regulatory process of CE Mark and FDA approval. Additionally, he details the trials and tribulations of the attempts for reimbursement with the final outcome which was presented on July 31.

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Why dental & orthodontic product markets are more exciting than other medical device spaces

Title:  Why dental & orthodontic product markets are more exciting than other medical device spaces

Speaker:  Thomas Ross

Date: 07/24/2018

Brief Description:
Total sales and the potential markets for dental and orthodontic products are huge – and growing rapidly! Most of your medical device experiences and learned lessons are directly transferable to this exciting field. We’ll discuss regulatory, operations, sales & marketing as well as financial aspects of these markets. I’ve found the opportunities for innovation, growth and financial rewards to be significant.

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