insiderlogo1-1

 

The BARDA Industry Day Breakdown

 

Presenter:


 
Georgia_SlobodaGary Disbrow, PhD
Director,
Biomedical Advanced Research and Development Authority

Dr. Gary Disbrow is the Director of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services.

Dr. Disbrow joined BARDA in January of 2007 and has held a variety of positions related to the advanced development and procurement of medical countermeasures against an array of threats to national security and public health. Prior to becoming the BARDA Director, Dr. Disbrow served as Acting BARDA Director, Deputy Assistant Secretary of ASPR and Medical Countermeasures Program Director.

In October 2013, Dr. Disbrow was named Acting Director of the Chemical, Biological, Radiological and Nuclear (CBRN) Division and was subsequently named the Director of the Division in December of 2014. During that time, the CBRN Division built a robust pipeline of candidate products under advanced research and development. In 2014 and 2015, Dr. Disbrow was identified as the Ebola Incident Coordinator for BARDA and worked closely with the BARDA Director on funding needs, development of candidate products, and was the primary liaison for BARDA across the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). These efforts led to the first licensed Ebola vaccine, ERBEVO, licensed in December 2019.

 

Panelists:


 
James Taylor PNG Image-1Kristen Herring, PhD
Vice President,
The Conafay Group

Dr. Kristen Herring is a former government program manager with over a dozen years of experience in scientific research within a variety of federal agencies. Throughout her career, Dr. Herring’s work has included developing countermeasures for weapons of mass destruction (WMD), protecting the White House from hazardous threats, and managing federal research initiatives for innovative medical therapies.

Dr. Herring began her career in the federal government at the Defense Threat Reduction Agency (DTRA) as part of the prestigious Presidential Management Fellows (PMF) program. During her five plus years at the agency, Dr. Herring oversaw programs that developed early-stage medical countermeasures and diagnostics to protect the warfighter from chemical and radiological weapons.

Following her time at DTRA, Dr. Herring joined the Secret Service as a chemist in 2014 at the White House Mail Screening Facility.

After a year and a half with the Secret Service, Dr. Herring became a program manager at the Biomedical Advanced Research and Development Authority (BARDA). Though Kristen’s primary role was in developing treatments against chemical threats such as chlorine and opioids, over the last two years she has assisted in the federal COVID therapeutics response, negotiating and managing monoclonal antibody and oral antiviral development and procurement contracts.

While at BARDA, she also launched the ReDIRECT Program, a new initiative to repurpose FDA approved and late-stage development drugs to treat chemical injuries.


 
Ivan Silva, PhD
Principal Consultant,
Latham BioPharm Group

Dr. Ivan Silva has more than 17 years of experience in medical devices and in vitro diagnostics. As a principal consultant at Latham BioPharm Group, he supports and grows the Medical Devices and Diagnostics sector with a focus on IVDs and serves as a primary Subject Matter Expert (SME) on projects involving IVD.

Before joining LBG, Dr. Silva was an interdisciplinary scientist and reviewer in the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services for 12 years. During this time, he provided scientific and program management expertise in identifying, addressing, and coordinating biodefense research initiatives relevant to the development of assigned diagnostic tools or other medical countermeasures for public health medical emergencies, including chemical, biological, radiological, nuclear agents, pandemic influenza, and emerging infectious diseases.

In addition, Dr. Silva managed complex projects and programs and provided technical oversight of manufacturing, testing, clinical and non-clinical, regulatory, and quality aspects of advanced development and acquisition programs for diagnostics. He was also the program lead responsible for program management, administration, and evaluation of advanced development of nanotechnology and other technologies for use in medical countermeasures.

Most recently, Dr. Silva actively participated in the development of medical countermeasures to the COVID-19 pandemic on behalf of the US Government.  


 
James Taylor PNG Image-1Joshua Speidel, PhD
Managing Partner,
Latham BioPharm Group

Dr. Joshua Speidel currently leads the development and execution of our Government Services service offering, as well as operations for the Latham Biopharm Group. Formerly, he led the significant expansion of LBG’s Product Development Management and Strategic Consulting service offerings into areas of vaccine, cell and gene therapy, medical devices and diagnostics by developing subject matter expertise and advisory services on pharmaceutical product development, mergers and acquisition, strategic business development, and due diligence to clients.

Dr. Speidel is a biotechnology product development professional with experience from pre-discovery through lifecycle management of mature products. He has direct experience with management of the Health and Human Services (HHS) Pandemic Influenza Vaccine Stockpile. Dr. Speidel provides technical expertise, program management, and federal contract compliance support to clients. He has led teams in the submission of proposals resulting in $400M of awards. As a health scientist for the US Department of HHS, Biomedical Research and Development Authority (BARDA), he led efforts to establish the core capabilities to support the licensure of medical countermeasures in the areas of manufacturing capacity, product development, clinical studies, and long-term stockpiling.

At BARDA, Dr. Speidel was responsible for the post-licensure management of three pandemic influenza vaccine stockpile programs, one advanced development program for a licensed recombinant influenza vaccine, and the establishment of the Clinical Studies Network program.


 
Georgia_SlobodaBrian Tse, PhD
Vice President,
The Conafay Group

Dr. Brian Tse has over a decade of experience in the development of medical products, with an emphasis on advancing technologies to strengthen national health security. His experiences span a variety of product types (drugs, biologics, devices, diagnostics), biomedical threat areas, and partnership models between the federal government and private sector.

For 11 years, Dr. Tse served as Project Officer in the Biomedical Advanced Research & Development Authority (BARDA) within the Division of Chemical, Biological, Radiological, and Nuclear (CBRN) Countermeasures,

Dr. Tse led a variety of projects across antibacterial, chemical, radiological/nuclear, and thermal burn programs. His initiatives spanned the preclinical and clinical stages of development, with several achieving FDA approval, licensure or clearance. He also supported several of BARDA’s acquisitions through Project BioShield. Dr. Tse also served as an interim Chief-of-Staff for the BARDA Director in 2017-2018, and has played key roles in several of BARDA’s emergency responses, including supporting the launch of a vaccine clinical trial during the West African Ebola crisis and serving on the Operation Warp Speed Plasma Team during the COVID-19 pandemic.