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Robin Robinson

Awards Creating PREP Act - Avian & Swine Flu Vaccines

Led the development of the first avian influenza H5N1 vaccine—cited as the #3 medical breakthrough of 2007 by TIME magazine.

When news of the recent swine flu outbreak hit, a lot of people raised questions about our government’s preparedness to deal with such a threat and whether or not the presidential transition, which has created several vacancies in key leadership posts, left the American people particularly vulnerable.

The reality is that our government is in a much better position to deal with this type of risk than it was a few short years ago, and one big reason is the Biomedical Advanced Research Development Authority (BARDA). The man who runs and practically singlehandedly built this office is Dr. Robin Robinson.

“Our way of thinking and doing business has completely changed. In the past, government and industry were timid. After Katrina, we saw what can happen if you don’t prepare properly for a disaster. We now leave no stone unturned. That approach permeates every aspect of our work, from the stockpiling of vaccines to the R&D,” said Dr. Robinson.

Tucked away within the U.S. Department of Health and Human Services (HHS), BARDA provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies.

Barely five years old, BARDA has already made significant achievements under Dr. Robinson’s leadership. In particular, this unit led the development of a vaccine for the strain of bird flu that has killed more than 200 people since 2003.

TIME magazine recognized this discovery as the third most significant medical breakthrough of 2007. Dr. Robinson’s team also established a pandemic influenza vaccine stockpile for at least 20 million people two years ahead of schedule, and it has plans to expand this stockpile to include 150 million doses.

Looking forward, the establishment of this office now means our government can hit the ground running when it comes to developing treatments for outbreaks like the swine flu.

Congress created this new office as part of the Pandemic Flu and All Hazards Preparedness Act of 2004. Dr. Robinson was recruited from private industry to help start the office. “I was asked to head the pandemic influenza work after I had already worked to develop a number of vaccines in the private sector. I felt that I could make more of a difference in the public sector with the resources provided,” said Dr. Robinson.

“When he started, he was an army of one,” said Dr. Noreen Hynes of Johns Hopkins Medical Center, who was Dr. Robinson’s supervisor at HHS from April 2005 to December 2006. “All of the initial accomplishments were just Robin: sending out the request for proposals, setting up the review panels, putting out the requests for information.”

Congress would eventually appropriate billions to support Dr. Robinson’s work on the avian flu vaccine. He quickly used these new resources to build out his internal team. He also succeeded in convincing private research firms to join in this effort.

Dr. Gerald Parker, a deputy assistant secretary at HHS who recommended Dr. Robinson for his current job, cites a variety of factors for Dr. Robinson’s success. “Obstacles always present themselves, especially in the medical vaccine and all hazards medicine industry. Dr. Robinson displays agility and flexibility to listen to other views and incorporates them into a path forward,” said Parker. “His commitment to the team effort is also critical to the success they have achieved.”

Nobody sings Robin Robinson’s praises more loudly than his current supervisor, William Vanderwagen, who is the Assistant Secretary for Preparedness and Response at HHS. “Robin Robinson sacrificed personal gain in the pharmaceutical industry to pursue public service. His dedication to the public health medical emergency preparedness mission has inspired both older and younger colleagues from industry, academia and government to join him at BARDA.”

With Robin Robinson on the job and others following his lead, the American public can feel better knowing that our government is more prepared than ever to deal with public health emergencies.1)

Congressional Witness Bio Pandemic Influenza Expert

Biosketch - ROBIN ROBINSON, Ph.D.

Dr. Robin Robinson currently serves as Vice President of Scientific Affairs for RenovaCare, Inc. directing development of cellular therapies for wound healing. Concurrently he is a Fellow for Regenerative Medicine and Biomedical Research at the Thought Leadership and Innovation (TLI) Foundation on regenerative medicines and independent consultant on vaccines and biodefense matters.

He reentered the biopharmaceutical business sector after retiring in 2016 from federal public service at the U.S. Department of Health and Human Services, where he served from 2008 - 2016 as the first director of the Biomedical Advanced Research and Development Authority (BARDA) and Deputy Assistant Secretary for Preparedness and Response and as BARDA’s Influenza and Emerging Disease program director (2004- 2008).

Dr. Robinson brought BARDA into prominence as one of the top 10 fully integrated R&D organizations worldwide supporting advanced development and acquisition of drugs, vaccines, diagnostics, and medical devices to address the deleterious outcomes of man-made biodefense threats, pandemic influenza, and emerging infectious diseases including Ebola and Zika viruses. 32 of its 250+ medical countermeasure products that BARDA supported since 2008 were fully approved and licensed by the FDA during his tenure; today that total is 52.

Dr. Robinson established a pandemic influenza program with scientific and technical experts to implement the national and global strategic plans and policies for the development of new influenza antiviral drugs, vaccines, and diagnostics outlined in the National Strategy for Pandemic Influenza.

For his leadership in this role, Dr. Robinson was the recipient of the Department of Defense’s Clay Dalrymple Award in 2008, the HHS Distinguished Service Award three times, and a finalist for the Service to America Medal in 2009.

In 2013-2015 Dr. Robinson was recognized as one of the top 50 most influential persons worldwide in vaccines by Vaccine Nation. In 2018 Dr. Robinson was recognized by Medicine Maker as one of the top 100 innovators in medicine.

Dr. Robinson received a Bachelor of Sciences degree in Biology from Millsaps College in 1976, a Doctoral degree in 1981 from the University of Mississippi Medical School in medical microbiology under Dr. Dennis O’Callaghan on herpes virus oncogenesis, and completed in 1983 a NIH postdoctoral fellowship at the State University of New York at Stony Brook under Dr. Arnold Levine on molecular mechanisms in oncology.

Dr. Robinson pursued his own research as a faculty member in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical School from 1983-1992 on the molecular pathogenesis of herpesviruses and HIV.

Prior to federal public service, Dr. Robinson served as the Director of Vaccines at Novavax, Inc. (Rockville, MD) from 1995-2004, where he led the development of 20+ vaccines to hepatitis B and E, influenza, HIV, noroviruses, and human papilloma viruses from early development, clinical trials, manufacturing scale-up, and commercialization through FDA licensure.

While at Novavax, he developed patented platform vaccine technologies including virus-like particles and subunit protein vaccines for human pathogens including malaria, human papilloma, hepatitis, and influenza and for prostate, melanoma, and cervical cancers.

Dr. Robinson also served on the Senior Advisory Group for the World Health Organization (WHO) on emerging infectious diseases and pandemic influenza. Additionally, he continues to serve as an editorial board member and reviewer for several professional scientific and technical journals on virology, vaccines, public health, and biotechnology. 2)

C-SPAN Appearances

On the C-SPAN Networks - Robin Robinson is a Vice President for Scientific Affairs in the RenovaCare with five videos in the C-SPAN Video Library; the first appearance was a 2009 Speech as a Director for (BARDA) Biomedical Advanced Research and Development Authority in the Department of Health and Human Services.

The year with the most videos was 2014 with two videos as a Deputy Assistant Secretary for the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services.

The year with the highest average number of views per program was 2019 with an average of 15,267 views per program.

Appearances by Title - c. September 1, 2019 - Present Vice President, Scientific Affairs, RenovaCare Videos: 1

Previously Director, Biomedical Advanced Research and Development Authority, Department of Health and Human Services c. April 1, 2008 - c. January 20, 2009 Videos: 3

Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services c. April 1, 2008 - c. January 20, 2009 Videos: 1 3)

C-SPAN Congressional Testimony

December 11, 2009 - Advances in Influenza Vaccine Technologies

The Department of Health and Human Services held a seminar to familiarize the media with government research on new

People in this video -

Francis Collins M.D. - Director National Institutes of Health

Anthony Fauci M.D. - Director National Institute of Allergy and Infectious Diseases

Bruce Gellin - Program Director Department of Health and Human Services National Vaccine Program

Jesse Goodman M.D. - Deputy Commissioner U.S. Food and Drug Administration

Bill Hall - Director Department of Health and Human Services News Division

Carole A. Heilman Director National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases

Gary Nabel M.D. - Director National Institutes of Health Vaccine Research Center

Robin Robinson Director Department of Health and Human Services - Biomedical Advanced Research and Development Authority

Jerry Weir - Director U.S. Food and Drug Administration - Viral Products Division 4)

September 16, 2014 - West Africa Ebola Outbreak

Federal health officials and health workers testified at a joint hearing of the Senate Health, Education, Labor and Pensions

October 16, 2014 - U.S. Response to Ebola

Centers for Disease Control and Prevention (CDC) Director Tom Frieden and other federal health officials testified

November 19, 2015 - Influenza Season Preparedness

Public health agency officials testified on their organizations' preparations for the upcoming influenza season and other infectious diseases. Representative Degette (D-CO) questioned the continued use of egg-based technology instead of cellular and if the U.S. would be nimble enough to use newer technologies if there was a pandemic.

People in this video

Carole A. Heilman - Director National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases

Karen Midthun M.D. - Director U.S. Food and Drug Administration Center for Biologics Evaluation and Research

Frank Pallone Jr. - U.S. Representative [D] New Jersey

Robin Robinson - Director Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA)

Anne Schuchat M.D. - Principal Deputy Director Centers for Disease Control and Prevention Agency for Toxic Substances and Disease Registry

Susan W. Brooks - U.S. Representative [R] Indiana

Chris Collins - U.S. Representative [R] New York

Diana DeGette - U.S. Representative [D] Colorado

Gene Green - U.S. Representative [D] Texas

Morgan Griffith - U.S. Representative [R] Virginia

Markwayne Mullin - U.S. Representative [R] Oklahoma

Tim Murphy - U.S. Representative [R] Pennsylvania 5)

Flu Vaccine Science and Innovation

The House Science, Space and Technology Committee held a hearing with public health officials on efforts to improve flu vaccines and develop a universal flu vaccine.

The witnesses in the first panel were Dr. Anthony Fauci, National Institute of Allergy and Infectious Diseases director, and Dr. Daniel Jernigan, director of the Center for Disease Control and Prevention (CDC) Influenza Division.

The second panel comprised former Health and Human Services Director for Influenza Robin Robinson and Pennsylvania Health Department Bureau of Epidemiology Director Sharon Watkins.

People in this video

Brian Babin - U.S. Representative [R] Texas

Jim Baird - U.S. Representative [R] Indiana

Ami Bera M.D. - U.S. Representative [D] California

Suzanne Bonamici - U.S. Representative [D] Oregon

Sean Casten - U.S. Representative [D] Illinois

Steve Cohen - U.S. Representative [D] Tennessee

Anthony S. Fauci M.D. - Director National Institute of Allergy and Infectious Diseases

Bill Foster - U.S. Representative [D] Illinois

Anthony Gonzalez - U.S. Representative [R] Ohio

Daniel Jernigan M.D. - Director Centers for Disease Control and Prevention Influenza Division

Eddie Bernice Johnson - U.S. Representative [D] Texas

Frank D. Lucas - U.S. Representative [R] Oklahoma

Jerry McNerney - U.S. Representative [D] California

Bill Posey - U.S. Representative [R] Florida

Robin Robinson - Vice President RenovaCare Scientific Affairs

Haley Stevens - U.S. Representative [D] Michigan

Sharon Watkins - Director Pennsylvania Department of Health Bureau of Epidemiology

Jennifer Wexton - U.S. Representative [D] Virginia 6)

Full hearing Housatonic Rumble 7)

Dr. Robin Robinson, Founding Director of BARDA Joins RenovaCare

SCOTTSDALE, Ariz., Aug. 20, 2019 (GLOBE NEWSWIRE) – RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of tissues and organs, is pleased to announce the appointment of its Vice President of Scientific Affairs, Dr. Robin A. Robinson, a respected authority on the development of breakthrough biomedical technologies, for which he was cited in 2018 as one of the top 100 innovators in medicine by The Medicine Maker.

Notably, Dr. Robinson was appointed as Director of the Biomedical Advanced Research and Development Authority (BARDA), with an annual budget of $1.35 billion and a staff of 250 scientists and medical experts. He brought BARDA into prominence as one of the top 10 fully integrated R&D organizations worldwide supporting advanced development and acquisition of more than 240 drugs, vaccines, diagnostics, and medical devices for man-made biodefense threats, pandemic influenza, and emerging infectious diseases including Ebola and Zika viruses. 32 of these medical countermeasure products that BARDA supported were approved and licensed by the FDA during his 12-year tenure.

During his tenure at BARDA, Dr. Robinson oversaw the funding of over $535 million in contracts for skin regeneration, burns, stem cell therapies, and related technologies for thermal and radiation burn wounds.

At RenovaCare, Dr. Robinson will oversee and direct the Company’s strategy, execution and engagement with government agencies, commercial research groups, academic institutions and select opinion leaders.

“The patented RenovaCare SkinGun™ technology and its ability to ultra-gently spray stem cells could present a special opportunity for investigations and applications in a wide range of regenerative therapies,” stated Dr. Robin Robinson, newly appointed Vice President of Scientific Affairs at RenovaCare, Inc.

“I look forward to working with the RenovaCare team as we capitalize on this very exciting cell deposition innovation.”

“We’re privileged to have won Dr. Robinson’s confidence in our SkinGun™ technology, especially as we advance our regulatory program, push towards eventual commercialization, and expand our product and clinical pipelines,” stated Mr. Jay S. Bhogal, Chief Operating Officer at RenovaCare.

Dr. Robinson’s appointment follows last week’s award of a new patent to RenovaCare, allowing its SkinGun™ to now spray all varieties of tissues and cells, and thus opening the door for its potential application in regenerative applications beyond skin.

Recent breakthroughs in stem cell therapies include the regeneration of human organs, tissues and bone. RenovaCare believes that the ultra-gentle spray-on application of such cells could be investigated and developed by way of commercial and academic collaborations, an area of Dr. Robinson’s expertise.

Dr. Robin Robinson is a consummate dealmaker, having successfully established over 60 partnerships with federal agencies, including the United States Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health, The Defense Advanced Research Projects Agency (DARPA), The Joint Program Executive Office for Chemical and Biological Defense, and the Defense Threat Reduction Agency.

His non-governmental and more than 80 commercial partnerships included the Bill & Melinda Gates Foundation, Wellcome Trust, Sanofi, GlaxoSmithKline plc, Novartis, Merck, Roche/Genentech, Amgen, Johnson & Johnson (Crucell), SIGA, Regeneron and Emergent BioSolutions.

Dr. Robinson developed collaborations with universities and foreign governments, including the Johns Hopkins University, North Carolina State University, and the United Kingdom, Canada, Australia, France, Germany, and others.

In addition to serving as Director of BARDA, Dr. Robinson was concurrently appointed Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services (Washington, D.C.), by HHS Secretary Michael Leavitt.

Prior to his public service work at BARDA, he served as Director vaccines at Novavax, Inc. resulting in the discovery and development of more than 12 vaccine candidates. Before entering the pharmaceutical industry, he was an assistant professor in the Department of Microbiology and Immunology at the [:University of Texas]] Southwestern Medical School conducting research on the molecular pathogenesis of herpesviruses and HIV-1. There he developed techniques to grow keratinocytes in tissue culture from fresh skin biopsies.

Spraying Skin Stem Cells onto Burns and Wounds

To date, over 70 patients with various types of second-degree burns have been treated on an experimental basis utilizing the technology underlying the Company’s SkinGun™, which RenovaCare has developed as a potential alternative to skin grafting and other treatment options, such as in-vitro cultured epithelial grafts that require a specialized and expensive external laboratory.

Sprayed with a gentle mist of their own skin cells, many of these patients left the hospital within days, avoiding generally painful skin graft surgeries and potentially weeks of hospitalization. Clinical outcomes of early experimental treatments have been peer-reviewed and published in several medical journals, including Burns and Annals of Plastic Surgery.

Patients who undergo skin grafting, today’s default treatment of care, can remain hospitalized for weeks and even months, and often enduring painful and costly surgeries and prolonged physical therapy. Some of these patients may also suffer from the psychological effects of disfigurement caused by permanent scarring and often cope with the ongoing use of pain medications and protracted joint mobility issues.

RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the Company’s planned or filed submissions to the U.S. Food and Drug Administration will be accepted or cleared by the FDA.

About RenovaCare

RenovaCare, Inc. is developing first-of-its-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Its initial product under development targets the body’s largest organ, the skin. The company’s flagship technology, the CellMist™ System, uses its patented SkinGun™ to spray a liquid suspension of a patient’s stem cells – the CellMist™ Solution – onto wounds.

RenovaCare is developing its CellMist™ System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars. In the US alone, this $45 billion market is greater than the spending on high-blood pressure management, cholesterol treatments, and back pain therapeutics.

For additional information, please call Amit Singh at: 888-398-0202 or visit: http://renovacareinc.com 8)

Esperovax Appoints Dr. Robin Robinson as President and CEO

PLYMOUTH, Michigan

May 1, 2023

/PRNewswire/

Esperovax, Inc. a leading oral RNA vaccine and therapeutic technology company specializing in oral mRNA-based medicines, announced today the appointment of Dr. Robin Robinson as President and Chief Executive Officer (CEO). Dr. Robinson will lead the company from technology discovery and early development into the next stages of pre-clinical/ clinical product development and the company's financial growth.

“Esperovax oral RNA technologies are ripe for further development of selected product candidates in animal and early-stage clinical studies,” said Robinson. “These technologies and supportive data are well-suited to meet vaccine needs for better long-lasting mucosal immunity and to metabolic disease and oncology therapeutic needs for oral RNA drug delivery and gene specific tissue-targeting.”

Added Robinson: “I have followed Esperovax for several years as a member of the Scientific Advisory Board, and I am excited to lead the talented Esperovax team to develop new and better medicines to the global community and to build stronger value for our shareholders through long-term strategic collaborations and industry partnerships.”

Dr. Robinson is a renowned international scientific and public health leader in novel and innovative vaccines and biothreat medical countermeasures as the former Vaccine Director at Novavax, Inc. and the founding Director of the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. Government. Dr. Robinson was cited in 2014 – 2016 as one the Top 50 Influential Persons in Vaccines and in 2018 as one of the top 100 innovators in medicine by The Medicine Maker. A pioneer in the creation of Virus-Like Particle (VLP) vaccines, several of his VLP vaccines are licensed vaccines marketed globally. At BARDA using a public-private partnership model, he led hundreds of early-stage product candidates through advanced clinical and manufacturing development resulting in more than 60 FDA-approved and marketed products to date.

Recently Dr. Robinson led the development of a novel stem cell therapy to treat wounds from a pre-clinical stage product into clinical studies while serving as the Chief Scientific Officer at RenovaCare, Inc. This successful effort required his integration of multi-national R&D, manufacturing, and clinical site partners with regulatory agencies. These previous and current experiences and skills will serve Esperovax well during its evolving growth.

Esperovax Board Chairman Roger Newton commented: “The appointment of Dr. Robinson as CEO marks a notable milestone for Esperovax, an organization committed to addressing unmet medical needs and providing hope to patients worldwide, the meaning of “Esperar” in Esperovax. Through the development of cutting-edge mRNA-based therapies, the company aims to revolutionize the field of medicine. With Dr. Robinson at the helm, Esperovax is poised to deliver on its promise of life-saving therapies that will improve the health and wellbeing of individuals across the globe.”

Esperovax's previous CEO, Dr. David O'Hagan, will continue his scientific leadership in the company's R&D and daily operations.

About Esperovax Esperovax is a cutting-edge vaccine company dedicated to developing innovative oral mRNA-based vaccines and therapeutics. The company is committed to advancing the science of medicine to help people live healthier, happier lives. For more information, please visit Esperovax.com. SOURCE Esperovax 9)

See Global Virome Project - Ecohealth Alliance and Dr. Dennis Carroll Director of the U.S. Agency for International Development's (USAID's) Pandemic Influenza and other Emerging Threats Unit. In this position, he led USAID's Emerging Pandemic Threats program, a global effort to combat new disease threats before they can become significant threats to human health. Dennis was responsible for providing strategic and operational leadership for the agency's programs addressing new and emerging disease threats, which has included leading the agency's response to the H5N1 avian influenza and H1N1 pandemic viral threats. 10)

COVID mRNA Contract Awards

PLYMOUTH, Mich., Oct. 3, 2023 /PRNewswire/ – Esperovax, a U.S.-based preclinical biopharmaceutical company and a BLUE KNIGHT™ resident company, is receiving an award for $ 1 M to further develop a yeast-based oral COVID-19 RNA vaccine candidate as part of the BLUE KNIGHT™ QuickFire Challenge: Accelerating Project NextGen.

This award will support critical studies aimed at demonstrating vaccine safety and immunoprotection in orally vaccinated animals challenged with different COVID-19 virus variants. Esperovax is collaborating with Dr. Slobodan Paessler at the University of Texas Medical Branch – Galveston to conduct these studies.

Blue Knight, a joint initiative between Johnson & Johnson Innovation – JLABS (JLABS) and the Biomedical Advanced Research and Development Authority (BARDA), collaborates with companies to accelerate innovation against emerging health security threats.

“This award enables animal challenge studies that may determine whether our unique oral COVID-19 RNA vaccine elicits protective immunity that prevents disease and reduces virus dissemination and affords completion of other requisite studies supportive of an Investigational New Drug application for future clinical evaluation,” stated Dr. Robin Robinson, President and Chief Executive Officer. “Positive results from these studies have the potential to bring inexpensive, safe and long-lasting effective oral vaccines a step closer to address public health threats like COVID-19 and other emerging infectious diseases.”

About Esperovax: Esperovax was founded in 2019 to advance development of its Egress RD™ oral mRNA platform, a transformative technology for delivering mRNA vaccines to the abundant populations of immune cells in the gastrointestinal tract via a small oral capsule.

For more information, please visit our web site at www.esperovax.com11)

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