2nd SoCalBio Digital Health Conference

2018 Who Should Attend?

Medical device developers

Component manufacturers

Information technology providers

Information security professionals

Digital health investors

Providers & payers

Pharmaceutical/OTC manufacturers

Research organizations, universities, institutes

Public sector

Clinical/contract research organizations (CROs)

Associations & advocacy group

Thanks to Sponsors

www.SoCalBioDH.com

2nd SoCalBio Digital Health Conference

Medical Grade Wearables:

Innovation, Market Opportunities, and Regulatory Challenges

Hotel Maya (700 Queensway Dr, Long Beach, CA 90802)

November 9, 2018 -- 8:00 am – 6:30 pm

#SoCalBioDH

The SoCalBio Digital Health Conference is an annual event organized by the Southern California Biomedical Council (SoCalBio), the trade association of the bioscience and health industries in the Greater Los Angeles region. The conference showcases Southern California innovators and provides a forum for key providers, payers, entrepreneurs, and investors to share how digital innovations can improve the delivery of care at lower costs. In its second year, this SoCalBio conference will focus on smart wearables, particularly medical-grade devices and related solutions. The event will highlight how wearables — including devices based on Southern California innovations — are on track to become a new modality in the interaction between patients and healthcare providers. Topics to be covered: What makes the wearables market tick: consumer vs. medical

grade wearables. Wearables hot-spots: growth drivers and investment trends. Wearable innovations: current & future applications. Who are the innovators in Los Angeles and Southern California. Innovation adoption, chronic disease care and population aging. Regulatory, cybersecurity and privacy challenges.

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Conference Agenda 8:00 Welcoming Remarks

8:05 Opening Presentations by:

• Robert Greenberg, MD, PhD, Executive Chairman, Alfred Mann Foundation &

Chairman, SoCalBio

• Ahmed Enany, President & CEO, SoCalBio

8:45 Break

8:55 Panel Discussion: Trends in the Wearables’ Markets and Technologies

Do wearables matter? Wearables have a checkered history. There were a lot of promises that they would be able to detect and mitigate health problems rather than just simply relay health data. That hasn’t really happened in a big way. The use cases are sparse. Now, there is some renewed interest in wearables that the Apple Watch has been approved by the FDA. We are seeing more and more startups trying to use sensors as a gateway into health data collection and clinical care. Wearables can be used in clinical trials to collect real work data, and health systems understand that monitoring devices can create efficiency. But, what is required to bring wearables into the mainstream of healthcare. Do we see trends indicating that we are moving in this direction?

Introductory Presentation:

• Stuart Karten, President & CEO, Karten Design

Panelists:

• Samir Chatterjee, PhD, Professor of Design, TClaremont Graduate University

• Ron Goldberg, President & CEO, IsoWalk

• Stacey Schepens Niemiec, PhD , Assistant Professor, USC Occupational

Science and Occupational Therapy

• Jens Paetau, Practice Lead at NextFlex, California Manufacturing Technology Consulting (CMTC)

• Chris Thierfelder, Former Executive from Halyard / Digital Health Consultant

9:55 Break

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10:00 Southern California Wearable Device Showcase I:

Moderators:

• Steven Goldman, President & CEO, Geshtalti and Member, Keiretsu Forum

• William Dolphin, PhD, CEO, CueSquare

Presenting Companies:

• Adela Health (Smart Shirt for Good Posture and Healthy Spine Naturally)

• Eyedaptic (Simulated Natural Vision Eyewear for Age-Related Macular

Degeneration)

• Life Beat (A Music-Based Treatment Platform, Helping People Reach Emotional

Balance and Reduce Stress Levels)

• Atlazo (Health-System-on-Chip for Intelligent Body-Worn Devices and IoMT)

10:55 Break

11:00 Southern California Wearable Device Showcase II:

Moderators:

• Richard Koffler, CEO, Greenwings Biomedical

• David Hood, President, DH3 & Associates

Presenting Companies:

• GTX (miniaturized Global Positioning System Tracking Technology for Monitoring

the Elderly and People with Dementia)

• Visus Technology (Motion Analytics and Home Health for Improved Clinical

Outcomes)

• Wytcote Technologies (IoT Platform for Elderly Care)

• Senseer (Smart Microsensing Platform Technology for Remote Monitoring to

Guide Evidence-based Treatment)

• Tagnos (Clinical Logistics Automation Platform that Combines Real-Time Patient,

Staff and Asset Data with AI to Optimize Operational Workflows)

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12:05 Networking luncheon

12:45 Luncheon Panel Discussion:

Partnering to Build the Future of Wearables in Clinical Research and Healthcare

Delivery

As the commercial and scientific potential of wearable devices in medicine becomes clearer, both tech titans and scores of digital health start-ups are vying for some of the action. This presents bioscience companies with new potential opportunities for partnering to integrate wearables into their offerings and make sense out of the data generated. This may help in boosting their value propositions and strengthening their competitiveness. But challenges also abound. This luncheon discussion will explore how partnering can increase the potential of mobile and wearable technologies in transforming drug and device development as well as improving healthcare delivery.

Moderator:

• Joseph Boystak, Managing Partner, Health2047 Capital Partners

Panelists:

• Steven Bowers, Assistant Director, Product Assurance and Security Legal, Intel Corporation

• John Donello, PhD, VP, Research Pharmacology, Allergan • Bethany Grant, PhD, Director R&D, Digital Product Engineering, Johnson &

Johnson 1:45 Break

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2:00 Southern California Wearable Device Showcase III:

Moderators:

• Steven Corr, Partner, Jones Day

• George Colindres, Sr. Counsel, Perkins Coie

Presenting Companies:

• QT Medical (Compact, Digital, and Wireless ECG That Works with Mobile

Devices)

• Pressao Medical (Smart Wearables for Treating Pre-Hypertension)

• StimAire (Wireless Neuro-stimulation Wearable to Treat Sleep Apnea)

• Expy Health (Platform for Orthopedic Surgery Recovery)

• Allevion Therapeutics (Smart Wearables for Treating Essential Tremors)

• Flint Rehabilitation Devices (Wearables for Clinic and at-Home Therapy After

Stroke, Spinal Cord Injury, or Traumatic Brain Injury)

3:00 Break

3:05 Panel Discussion:

Regulatory Challenges and Strategies for Wearable Medical Technology

Despite their promise, most wearables have been developed to serve the young, well-to-do, fitness-oriented users, and self-quantification enthusiasts. The transition of wearables from direct-to-consumer novelties to health devices requires passing the rigorous FDA regulatory processes for product approval or clearance. The purpose of these processes is to ensure that the type and quality of data generated are both relevant and applicable in a clinical setting. This panel will discuss current FDA approaches in regulating mHealth and wearables, and how and when your technology might encounter regulatory scrutiny.

Moderator:

• Peter Blaisdell, PhD, Chair, SoCalBio Innovation Catalyst Program

Panelists: • Shep Bentley, President, Bentley Biomedical Regulatory Consultants • Sugato De, M.S., Principal Consultant, PAREXEL International • Phil Johnson, Senior Principal, Quality & Compliance Services, IQVIA • Raju Joshi, Managing Partner, Clinical Partners Group, LLC

4:05 Break

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4:10 Panel Discussion:

Consumer Adoption & Reimbursement

Even if wearables pass strict FDA scrutiny, the ability to drive adoption in the healthcare system depends on who is paying for them. This panel will explore when the patients themselves can pay for wearables. The role of government – through the Centers for Medicare & Medicaid Services (CMS) – will be discussed. CMS has recently released new payment rules that may give mHealth technology a better shot at reimbursement. This is an important step in driving medical wearable implementation in healthcare settings where patients are either reluctant or cannot afford wearable technologies. This panel will also discuss when health insurers cover the cost of health wearables as part of an emerging market of employers looking for healthy workers.

Moderator:

• Scott Witt, President, Witt Venture Development

Panelists:

• Patrick Bertagna, President & CEO, GTX

• Katherine Lewinter, MD, Pediatric Pulmonology, Children’s Hospital Los Angeles Division of Occupational Science and Occupational Therapy

• Soeren Mattke, PhD, Director, USC Center for Improving Chronic Illness Care

• Ayman Salem, MD, President & CEO, iKioo

• Philip van Allen, Graduate Media Design, Art Center

5:10 Final Remarks by Panel Moderators:

Where to Go from Here?

Building a Sustainable Digital Health Economy in Greater Los Angeles

5:30 Concluding Reception:

Meet the Speakers

6:30 Conference Adjourns

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The Alfred E. Mann Institute for Biomedical Engineering

(AMI-USC) was established at the University of Southern

California in 1998. Its mission is to help bridge the gap between

biomedical innovation and the creation of commercially

successful medical products to improve and save lives.

To learn more, see: http://ami.usc.edu/

Perkins Coie is a leading international law firm that is known

for providing high value, strategic solutions and extraordinary

client service on matters vital to our clients’ success. With more

than 1,000 lawyers in offices across the United States and in

Beijing, Shanghai and Taipei, we provide a full array of

corporate, commercial litigation, intellectual property and

regulatory legal advice to a broad range of clients, including

many of the world’s most innovative companies and industry

leaders as well as public and not-for-profit organizations.

To learn more, see www.perkinscoie.com

VWR recently merged with Avantor to create a vertically integrated global supplier of lab supplies and scientific instruments. From discovery to delivery, VWR is the trusted global partner to customers and suppliers in the life sciences and advanced technology industries. By providing superior product and service solutions, VWR catalyzes innovation and empower the success of its customers. The company helps SoCalBio members conserve cash by offering deep discounts on lab supplies and equipment procurement through the SoCalBio Group Purchasing Program.

To learn more, see: www.vwr.com

Office Depot, Inc. is an office supply retailing company. It is part of the SoCalBio Group Purchasing Program offering SoCal-Bio member companies significant discounts on the purchases of office supplies.

To learn more, see: www.officedepot.com

Thanks to Event Sponsors and Supporters

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The Consulate General of Canada in Los Angeles is

responsible for enhancing Canada’s economic relationships

with Southern California, Arizona, Nevada and New Mexico

through promoting, trade, investment and science and

technology. The Consulate General has helped to build strong

ties between world class academics, research institutions and

the biomedical industries in Canada and California.

Canada’s highly diversified medical device manufacturing and

development industry encompasses more than 1,000 firms that

are well positioned to leverage innovative research being

conducted in Canadian universities, research institutions and

hospitals to offer cost effective and patient centric healthcare

solutions.

To learn more, see: international.gc.ca/world-monde/united_states

-etats_unis/los_angeles.aspx

Jones Day is a global law firm with 43 offices in major centers

of business and finance throughout the world. Covering 18

countries on five continents, Jones Day’s unique governance

system fosters an unparalleled level of integration and contrib-

utes to its ranking as one of the best in the world in client ser-

vice.

Many of the nation's leading health systems rely on Jones

Day's health care practice for their legal needs and count on its

multi-disciplinary team to deliver practical, business-oriented

solutions to their most challenging problems.

To learn more, see www.jonesdeay.com

Knobbe Martens is an agent of innovation, providing clients worldwide with forward-focused Intellectual Property and Tech-nology law service and representation. We are one of the larg-est IP law firms in the United States, with more than 300 attor-neys and scientists representing the complete spectrum of tech-nologies and IP practice areas.

We combine unmatched technical and litigation expertise to de-liver superior results in both transactional and contested mat-ters, for both cutting edge start-ups and established Fortune 500 companies. Our work spans fields ranging from physics to pharmaceuticals and entertainment to engineering.

To learn more, see https://www.knobbe.com

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Since its founding 20 years ago as (part of the Rebuild LA initiative), the Southern California Biomedical Council (SoCalBio) has supported growth of bioscience-related industries across the Greater Los Angeles region.

An organization built by and for Los Angeles-area entrepreneurs, SoCalBio pursues ongoing programs that help local firms gain access to capital, potential partners and business support services. The organization’s marquee event – the annual SoCalBio Conference -- has grown to become the region’s premier showcase for emerging life-science companies and technologies. SoCalBio is also tasked with promoting technology transfer and workforce training, while informing policy makers and the public at-large about the benefits of the region’s bioscience-related industries.

In addition, SoCalBio delivers value to its members through exclusive benefits essential to running a bioscience or digital health company. Such benefits include a comprehensive group purchasing program that enables members to conserve cash and enjoy significant discounts on everything from lab/office supplies and waste management to insurance, PR news distribution and shipping.

SoCalBio helped develop the watershed Battelle Master Plan for growing Los Angeles County’s biotech cluster and its members are more committed than ever to helping build support for the plan among local stakeholders and policymakers. SoCalBio is proud to serve as the focal point for industry-driven partnerships to support the plan based on local entrepreneurial resources embedded within the community.

SoCalBio looks forward to beginning its third decade as the voice of the bioscience and digital health communities across Greater Los Angeles. In partnership with local, state and national organizations (such as California Technology Council, Biotechnology Innovation Organization and Medical Device Manufacturing Association), SoCalBio embraces its role as the region’s primary advocate and watchdog for the issues that impact local biotech, medtech, diagnostic and digital

health communities.

About SoCalBio

617 S. Olive St., Ste . # 700, Los Angeles, California 90014

800-418-7079 ext 1 | 213-403-7688 (fax) | scbc@socalbio.org