“ 28,424 cases of Ebola and still counting—what have we learned?” AAMC Briefing Dr. Jim LeDuc Director Galveston National Laboratory University of Texas.

“28,424 cases of Ebola and still counting—what have we learned?” AAMC Briefing

Dr. Jim LeDucDirector

Galveston National Laboratory

University of Texas Medical Branch

13 October 2015

GNL Mission

The mission of the GNL is to assist the NIAID and the nation by conducting basic and applied research designed to improve the prevention, diagnosis and treatment of naturally emerging and purposefully disseminated infectious diseases.

Basic Research Product Development

Proof of Concept

Concept Validation

Pre-clinical/ GLP Studies

Human Clinical Trials

Animal Rule

Phase I: Safety

Phase II: Expanded Safety

Phase III:Efficacy

FDA Licensure

NIH R01 and other Funded

Research

FDA Restricted Use

Approval

UTMB

GNL

From bench to bedside…

Impact of Research on Ebola

ReEBOV Rapid Diagnostic Test for Ebola – commercialized and in use in West Africa.

siRNA post-exposure treatment for Ebola went to Phase 1 and Phase 2 clinical trials.

Zmapp (human monoclonal antibodies therapy) clinical trials and applications.

rVSV (recombinant vesicular stomatitis virus) vaccine trials in Africa and Europe.

Adenovirus vectored vaccine trials.

Important research moved through preclinical phases, into clinical trials, and to patients.

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Current status of rVSV vaccine

Efficacy and effectiveness of an rVSV-vectored vaccineexpressing Ebola surface glycoprotein: interim results fromthe Guinea ring vaccination cluster-randomised trial,

August 2015

April 2015

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Rapid Test for Ebola

• 15 min rapid screening assay using whole blood from finger prick

• Produced by Corgenix (Broomfield, Colorado)• Uses antibodies to identify specific Ebola virus protein• Anticipated cost about $15/test• 92% of infected people identified; 85% of uninfected—

confirmation by PCR• Approved by FDA and WHO

Department Name Goes Here

Cepheid EBOV Diagnostics

10 minutes

~90minutes

Collaboration with Cepheid initiated October 2014 in response to West Africa EBOV outbreak; Cepheid has footprint in Africa for Tb work.

Worked with Cepheid to build EBOV specific diagnostic test

Tested limit of detection (LoD) for EBOV RNA and live EBOV virus

Participated in mock clinical study which led to Cepheid receiving emergency use authorization (EUA) to use diagnostic in the West Africa outbreak

EUA received by March 2015 through working with UTMB at the GNL.

Progress: From no product in October 2014 to diagnostic test used in Africa under EUA by March 2015.

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Unique Strengths of Academic Medical Centers

• Highly trained experts in their field.

• Cutting edge knowledge of current advances, including unpublished work in progress.

• Immediate access to reference pathogens and reagents.

• Through the NIH network, access to appropriate biocontainment laboratories.

• Skilled workforce approved to handle select agents.

• State-of-the-art equipment and instrumentation.

• Appropriate biosafety and biosecurity training—skills being passed on to clinicians.

Conclusions

• The health of the nation is intimately intertwined; an outbreak anywhere is a threat everywhere—pathogens don’t carry passports!

• Some of today’s health threats—like Ebola—are extremely dangerous and require highly specialized facilities and skilled personnel to develop the drugs and vaccines needed to protect the nation.

• The investments by NIH have created a network of biocontainment laboratories on academic medical centers that fosters innovation and discoveries to address the most dangerous global threats to health.

• Challenges going forward include sustained funding to support basic and translational research in these specialized facilities, and a regulatory environment that fosters collaboration and innovation.

Thank You!

For more information:www.utmb.edu/gnl

Jim [email protected]