Archives: Speakers

Hal has 30 years of Clinical Research experience ranging in perspective from the study site, small and large CRO’s, big pharma, and large diagnostics companies.  During his 15 years with GlaxoSmithKline, Hal spent six years designing and conducting Clinical Trials before focusing on outsourcing and supplier management.  In 2013, Hal joined Roche Molecular Systems in Pleasanton, CA where he oversees Clinical Contracting, Outsourcing, Clinical Quality, eSolutions and Logistics for Clinical Operations and Biometrics.

Everett Crosland is a commercial leader in digital health, focused on scaling complex therapeutic solutions across a diversity of channels. At AppliedVR, Everett leads the company’s commercial, sales, and health economic efforts overseeing the health system sales, DoD and VA sales and partnerships, and launch readiness for AppliedVR’s leading virtual reality medical device pipeline.

Srihari has worked mainly in Women’s Health and Dermatology/Quality Of Life improvement; Cardiology, Oncology and Orthopedics. He has performed Front End Research, Conceptual Design, IP Generation, Multi-generational prototyping, Design Improvements, Verification and Validation (V&V), Assembly Process Design, Design Transfer, New Product Introduction, Manufacturing Process Development/Improvement and Service Process Development.

Srihari is a Certified SolidWorks Expert, and carry several other CAD certifications and several thousands of hours, with experience ranging from Design, to Solution Implementation, Troubleshooting, Product Data and Lifecycle Management. He also has experience in Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD), ranging all the way from simple linear analysis to non-linear analyses. He has worked with several customers, across various industries, helping them solve complex modeling, analysis, and product data management issues.

Robert J. Greenberg, M.D., Ph.D., is the Executive Chairman of the Alfred Mann Foundation. He was a co-founder and former CEO and Chairman of the Board of Second Sight Medical Products, Inc. (NASDAQ: EYES) in Los Angeles, California.  Dr. Greenberg is a leader in the field of neural prosthetics – having developed and brought to market the world’s most advanced implantable neural stimulator, the Argus II visual prostheses, to treat retinitis pigmentosa, a form of blindness.  Dr. Greenberg was also a medical reviewer at the FDA’s Office of Device Evaluation.  Dr. Greenberg is the recipient of numerous honors and awards, has over 260 issued US patents and over 100 international patents, and has published over 60 articles.  He received MD and PhD degrees from The Johns Hopkins School of Medicine in Baltimore, Maryland.  Dr. Greenberg joined AMF in 2004 as Chairman of the Board of Directors.

Prior to joining Fitbit Health Solutions, Carolyn Walsh served as senior director of global marketing for Qualcomm Life, Inc. Ms. Walsh joined the Qualcomm Life leadership team from HealthyCircles, an enterprise healthcare software-as-a-service platform company, where she led Business Development and Client Services. HealthyCircles was acquired by Qualcomm Life in April 2013.

Prior to HealthyCircles, Walsh was the global director of New Ventures, Franchise Development for Johnson & Johnson Diabetes Care. Walsh was responsible for the digital health strategy, software innovations and formulating growth strategies for the emerging markets of India and China. While at Johnson & Johnson, Walsh served in global commercial leadership roles spanning acute, health care professional and consumer engagement channels.

Before transitioning into the health care industry, Walsh was a versatile executive with Coca-Cola with a proven track record of success in sales management, strategic marketing, brand building and channel development in a major U.S. market along with international assignments in Poland and New Zealand.

Dave brings 20 years of experience in product execution and innovation. As the founding CEO of Striiv Corp, he spearheaded all aspects of building and executing seven generations of biometric wearables, shipping millions of devices to customers including United Healthcare, Pfizer, Walgreens, Acer, Best Buy and Qualcomm Life. Dave’s expertise is in building teams while simultaneously building products that combine multiple technology disciplines. Dave graduated from Stanford University with a dual M.S. degree in Electrical Engineering and Management Science and Engineering, and he received a B.S. in Electrical Engineering and Computer Science from UC Berkeley. He also holds over 15 patents in the fields of sensors, algorithms, edge processing and validation.

Specialized in development of ophthalmic medical devices with strengths in clinical, regulatory and quality aspects. Has gained extensive experience in clinical research and clinical project management by leading high priority projects to successfully develop and launch best-in-class products in eye care business.

Has experience in building and defending regulatory strategies, as well successfully led and defended multiple internal and external audits, including FDA inspection and recall process.

Oversaw development of Human Factors Evaluations.

Has led high performing global, cross functional teams to respond to short term, immediate needs and developing strategies for long term sustainability by building R&D pipeline.

Proven success with Fortune 500 companies, as well as start-up firms.
Specialties:
Clinical product development, clinical operations, building and executing systems, strategies to streamline processes and improve efficiency.
Develop new strategic alliances and evaluating new technologies.
Organizational development.

Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO).

In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection.

Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018.

Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine.

Mr. Solis is a recognized expert in FDA import operations who has served as the acting assistant
commissioner and director of ORA’s Office of Enforcement and Import Operations (OEIO) since
March 29, 2020. During this time, he has provided leadership and direction to all OEIO field
import divisions as well as the Division of Food Defense Targeting and Division of Import
Operations at FDA HQ. He brought about the leadership and stability needed during the
COVID-19 Pandemic. Mr. Solis was selected as the Assistant Commissioner for Import
Operations on November 22, 2020 and prior to that he was the Division Director for the Division
of West Coast Imports since February 9, 2018.

He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the
Bioresearch field focusing on Medical Device and Drug Application Products after graduating
from the University California of Irvine and the University of La Verne. Mr. Solis has held many
positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist,
HQ position within the Division of Import Operations in Rockville, MD, working as an Import
Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import
Operations Branch.

Mr. Solis is an experienced collaborator who has played an integral role in FDA operational
activities with other federal agencies, partnering with Customs and Border Protection,
Homeland Security Investigations, U.S. Department of Agriculture, U.S. Fish and Wildlife
Service, Drug Enforcement Agency, and state and local law enforcement agencies. Additionally,
he conducts local and national training on imports, is a member of the National Leadership
Development Workgroup at FDA’s Office of Training and Education Development, and has
served as a mentor for the Federal Executive Board in Los Angeles and ORA’s Potential
Supervisors Program.

In his new role, Mr. Solis serves as the principal advisor to Associate Commissioner for
Regulatory Affairs and report to the Deputy Associate Commissioner for Regulatory Affairs
(DACRA) on all import matters. This includes providing direction and oversight to FDA field
import operations, reviewing prior notice and intelligence data on human and animal food, and
leading the development and implementation of new import programs and procedures.
Mr. Solis has had many accomplishments within FDA and these are a few notables:
Implementation of PREDICT at all ports in the US, the implementation of electronic
communications and paperless transactions initiatives with the Trade Associations, formation of
the CBP/FDA Teams including the Opioid Task Force, formation of the West Coast Import
Advisory Council, formation of Federal and State Task Forces, conducting Federal Operations,
streamlining the refusal process in the Ports of LA, San Francisco and Seattle, and development
of strong partnerships with the filers, brokers and importers in the Pacific Region.

Mr. Solis is nationally recognized as a subject matter expert in the program area of Import
Operations and gives local, as well as, national training on Imports Investigations. He is a
member of the National Leadership Development Workgroup at FDA’s Office of Training and
Education Development, has served as a mentor for the Federal Executive Board in Los Angeles
and the Potential Supervisor Program within FDA. He also has had integral roles in FDA
Operations with other Federal Agencies, working with CBP, HSI, USDA, FWS, DEA and State
and local law enforcement agencies. Currently, aside from his duties at the port, Mr. Solis is also
a member of the FSMA – Foreign Supplier Verification Program (FSVP) Implementation Team
as well as the Associate Commissioner’s IT Advisory Workgroup, the Associate Commissioner’s
Import Advisory Panel, member of AFDO, WAFDO, ASQ, OCRA and the Pacific Island Health
Officers Association (PIHOA).

Mr. Solis holds a Masters Degree (MS) in Healthcare Administration from the University of
LaVerne and a Bachelor’s Degree (BS) from University California of Irvine.