September Event: Regulation Meets Innovation: A Case Study in Current IVD Regulations Globally


Wednesday, September 27, 2017

Regulation Meets Innovation: A Case Study in Current IVD Regulations Globally


Program Speaker:

David Kern, MBA, RAC

Head of Regulatory Affairs

Illumina, Inc.

Event Agenda: Date:

Wednesday, September 27, 2017

Time: 5:15 – 6:00 PM Registration & Snacks

5:30 – 5:55 PM Speed Networking

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:00 PM Program Presentation


BD (directions on last page of this flyer)

3770 Torrey View Court

San Diego, CA 92130

Program Topic: The regulation of In Vitro Diagnostic (IVD) tests is changing globally. Some countries (US, S. Korea) are adopting more innovative approaches to the regulation of emerging technologies like Next Gen Sequencing (NGS), while other parts of the world (EU, China) are becoming far more stringent. Add to this the regional complexities that have always existed, and the picture of a complicated regulatory environment emerges.

Program Summary:

In the past, most companies pursuing IVD approval designed their product to the FDA standards, knowing that these were the most challenging in the world. However, with the introduction of the IVD regulations in the EU this May, coupled with the challenges of markets like China, it is no longer enough for device manufacturers to focus on a US strategy. Add to this the inherent complexity of technologies like NGS, and IVD development has never been more difficult.

David will talk us through two of Illumina’s recent regulatory approvals – a companion diagnostic in the US and a noninvasive prenatal testing (NIPT) assay in the EU – and discuss some of the issues they faced and what the future holds for the regulation of innovative technologies. Specifically:

  • How are companies and regulators addressing the design, manufacture and regulation of highly disruptive technologies like NGS, where clinical validation and utility may be impossible to demonstrate for devices like microbiology and oncology panels based on whole genome sequencing?

  • What is the impact of the recent FDA clearance of the 23andMe assay have on regulating direct-to-consumer testing, and how will agencies in other countries respond?

  • With the meltdown of Theranos, is there going to be more scrutiny put on companies that develop disruptive technologies, by regulators, investors and payors?

Speaker Biography:

David currently works at Illumina as the Head of Regulatory Affairs. Prior to that, he was a consultant at Myraqa, where he worked on numerous projects that incorporated innovative technologies into IVD applications in areas such as infectious disease, oncology and companion diagnostics. Prior to that, David has worked at various life sciences and diagnostics companies, including UCSF, Chiron, Affymetrix and XDx.

During his career David has worked in product development, program management, alliance management, and regulatory affairs. He was part of the team at Chiron that developed one of the first HIV viral load tests. He was also part of the team at Affymetrix that got the GeneChip scanner cleared as an open platform and was part of the team at XDx that got clearance for a Laboratory Developed Test. He has worked as a regulatory consultant to more than 50% of the devices that have obtained FDA approval in the past 5 years.

David has a bachelor’s degree in Biochemistry from San Francisco State University and a MBA from San Jose State University.

Please make your reservation early. The online registration due date is Monday September 25, 2017. Credit Cards are accepted online only. Cash and Check are accepted at the door.

Online Pre-registration (through Monday September 25, 2017): $15 SDRAN Member, $25 Non-Member

Onsite Registration: $25 SDRAN Member, $35 Non-Member



From the North 5:

I-5 South toward San Diego

Exit toward Carmel Mountain Rd

Left onto Carmel Mountain Rd

Left onto Torrey View Court

Facility is on the right

From the South 5:

I-5 North toward Del Mar

Merge onto I-5 local Bypass

Take Carmel Mountain Rd exit (32)

Turn right onto Carmel Mountain Rd

Turn left onto Torrey View Court

Facility is on the right