Concept to Commercialization 2.0

September 11, 2019 • 8:00 AM

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Our Events » Concept to Commercialization 2.0


Event Description

The 2nd Annual OCRA – SBDC @ UCI Beall Applied Innovation conference is tailored to life science pioneers, entrepreneurs, and developers. Attendees will receive targeted information from industry experts about how to interpret and define their inventions as emerging technologies collide across traditional product boundaries and regulatory requirements. Listen to real-world experiences and cutting edge insights in interactive panels, including discussion of inevitable detours and setbacks, how to benefit from novel FDA programs, and successfully navigate an ever-evolving global regulatory landscape.

Concept to Commercialization

Speakers

Kwame Ulmer – Principal, Ulmer Ventures

Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. This experience allows him to help companies at all stages efficiently navigate global regulatory agencies. Kwame has particular expertise in all aspects of the USFDA, from premarket applications to postmarket compliance. Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation (Fortune 150) operating company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has in-depth knowledge of the cross-functional activities needed to take a medical device from concept to product launch in markets including North America, EU, EMEA, China, and LATAM. Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) and personally evaluated over 1,000 medical technologies. He has successfully overseen products through all FDA application types (IDE, 510(k), PMA, 513(g)) and advised over 100 early-stage MedTech companies on a regulatory path. Mr. Ulmer is a member of the Executive Committee of Tech Coast Angels (LA), the world’s largest angel investing network and a Venture Partner at Wavemaker Three-Sixty Health – the leading Southern-California based, early-stage venture capital firm (Seed and Series A) focused on the healthcare industry. Kwame earned his B.S. in Physics from Lincoln University (Pennsylvania) and both an M.S. in Materials Engineering and M.B.A. from the University of Virginia.

Grant Bennet – CEO, BrandWoodCKC

Grant Bennett has a deep and practical experience of regulatory affairs gained through medical devices industry roles across the Asia Pacific. His prior experience includes roles as Regional Regulatory Affairs Manager Asia Pacific and Australia/New Zealand Quality Assurance Manager with a US-headquartered, multinational supplier of professional Medical Devices. An internationally respected industry leader, Grant chairs both the Regulatory Affairs Expert Panel and National Advisory Council for Australian industry peak body AusMedtech. He is an adviser to the Asian Harmonization Working Party (AHWP), supporting regulatory guidance development in pre-market assessments, labeling and UDI implementation. Grant has specialist expertise in distribution and logistics and requirements for Universal Device Identifiers (UDI) and national implementations including the Australian National Product Catalogue (NPC) controlled by the Australian National E-Health Transition Authority and the corresponding DHB National Catalogue for Healthcare in New Zealand. Before joining the Medtech industry, Grant had extensive prior experience in accountancy, commercial software and project management. Earlier roles included support of existing clients with the implementation of their MRP systems, as well as developing process flows, detailed financial analysis, and reporting, allowing clients to better understand their business.

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Morning Session: Regulatory Pathway Basics of Drugs, Devices and Other Regulated Products

Keynote Lunch Speaker: “What Am I?” How To Determine and Get FDA Agreement On Your Product Classification

Afternoon Session: Emerging Technologies (Breakthrough Devices, SaMD, Stem Cell theraputics)

Afternoon “Disaster Panel”: What Happens If a Company Decides to Take a Shortcut or Deviate From Regulations?

Event Sponsors

SBDC @ UCI Beall Applied Innovation
SBDC @ UCI Beall Applied Innovation
Orange County Regulatory Affairs
Orange County Regulatory Affairs