Leading the way to
eliminate herpes.
Our global team has deep healthcare industry experience and is fueled by a shared desire to eradicate herpes and transform the lives of people around the world who are afflicted with herpes-related infections.
Executive team
Agustin Fernandez
Chief Executive Officer
Agustin Fernandez
Chief Executive Officer
Prior to founding Rational Vaccines, Mr. Fernandez served as the managing director of Mega films, the production arm of Spanish Broadcasting System (SBSA), and CEO of Duende Media, Inc. where he structured over US $100M of film and television financing. Mr. Fernandez is a 9-time EMMY award winning writer/director/producer and the executive producer of the 2014 academy award winning documentary “The Lady In Number Six”.
David Brindley, DPhil, MEng; PG Cert, (IP), RAC (US), FRSA, FRSB
Chief Operating Officer
David Brindley, DPhil, MEng; PG Cert, (IP), RAC (US), FRSA, FRSB
Chief Operating Officer
DPhil MEng PG Cert (IP) RAC (US) FRSA FRSB
Dr. David Brindley is an experienced life science C-level executive and Board Member, specializing in cell/gene/viral therapies and digital health. Under Dr. Brindley’s leadership, multiple therapeutics and medical devices have achieved market approvals in the US, EMEA and ASEAN supporting transactions, including IPOs, trade sales and joint ventures. Dr. Brindley has published more than 100 peer reviewed publications in high impact journals, including Nature, Nature Biotechnology and Cell Stem Cell.
Edward Gershburg, PhD
Chief Technology Officer
Edward Gershburg, PhD
Chief Technology Officer
Prior to joining Rational Vaccines, Dr. Gershburg was an Associate Professor (with tenure) at Southern Illinois University School of Medicine from 2007 to 2017. Dr. Gershburg’s area of expertise is Virology (with focus on DNA viruses) and Antivirals. His research was supported by National Institutes of Health and American Cancer Society. Dr. Gershburg authored over 20 peer-reviewed publications and was a co-author on all the key publications associated with the company’s lead product (RVx-201). Dr. Gershburg continues his professional public service on editorial boards of Antiviral Research and PLoS ONE, as well as an Ad Hoc Reviewer for the Italian Ministry of Health.
Luis Rios-Nogales, MD, PhD, MBA
Chief Development and Medical Officer
Luis Rios-Nogales, MD, PhD, MBA
Chief Development and Medical Officer
Dr. Luis Rios-Nogales Garces currently is the Chief Medical Officer managing Non-Clinical and Clinical Development, Regulatory Affairs, R&D Quality Assurance, Vaccine Safety, and Corporate Procurement. Prior to joining Rational Vaccines, Dr. Rios-Nogales served as Head of Global Development Operations at Takeda Vaccines. He has over 30 years of experience, with increasing senior roles in Clinical, Medical Affairs, Global Marketing, Regional Medical Office, Commercial and General Management at Sanofi, GSK and Astra Zeneca. Dr. Rios-Nogales was also Senior Vice President of Med Surg at Boston Scientific Corporation between 2006–2009. He has made a significant impact on the prevention and treatment of stroke, hypertension, Afib, CHF and VTD, through his active participation in large scale clinical projects. Notably, he was the Global Project Lead for the landmark Heart Outcomes Prevention Evaluation (HOPE) study, under the leadership of Professor Salim Yusuf of McMaster University.
Kelly Smith MD, MHS
Global Safety Officer
Kelly Smith MD, MHS
Global Safety Officer
Dr. Smith received her Medical Degree from the University of Maryland School of Medicine and a Master’s in Health Sciences from Duke University School of Medicine. She trained in Internal Medicine and completed a research fellowship in women’s health. Dr. Smith has been working in the pharmaceutical industry since 1997 in areas of clinical drug development, medical affairs and pharmacovigilance. Over the past 15 years, she has developed expertise in the operational aspects of drug safety, as well as the implementation of benefit-risk profiles for a variety of products, including traditional pharmaceuticals, drug-device combination products, consumer products, vaccines and biological therapeutics.
Gerhard Hager, PhD
Head of Non-Clinical Development
Gerhard Hager, PhD
Head of Non-Clinical Development
Dr. Gerhard Hager is a serial entrepreneur and an expert in non-clinical research and development with a vast experience in the performance of preclinical programs for a wide range of drug candidate classes and therapeutic strategies. He is CEO of The NCD Company. He was Head of Toxicology at Baxter, Baxalta and Shire and has successfully overseen the development of a variety of products in different development stages, from drug discovery right to market approval at EMA, FDA and PMDA. Before that he was founder, scientific director and CEO of Aurigon and the Aurigon Group, an international non-clinical full-service research institute (CRO). He holds a PhD in Zoology from the LMU Munich and the Max-Planck-Institute of Psychiatry.
Dr. Hager supports Rationale Vaccines in the non-clinical development of his promising therapeutic HSV-2 vaccine candidate RVx201.
Uwe Michaelis, PhD
IMPD Submission Operations
Uwe Michaelis, PhD
IMPD Submission Operations
Dr. Michaelis is a serial entrepreneur and an expert in the early development of NBE´s, vaccines and drug delivery systems. He started his carrier at Roche AG, is cofounder of two biotech companies and held leading positions in the pharma industry and several biotech companies. As Chief Scientific Officer and co-founder of Munich Biotech AG he has established a platform for development of vascular disrupting agents for tumor treatment with EndoTAG-1 currently being in clinical phase 3 studies. After the acquisition of the EndoTAG technology by Medigen AG, he held the position of Vice President of Research and Early Stage Development. As cofounder of ImevaX GmbH, he supported the company as Chief Operating Officer in developing IMX101, a therapeutic vaccine against H. pylori infection. Dr. Michaelis holds a PhD in Biology from the LMU Munich. His company Michaelis Bioscience offers consulting services in the life science area.
At present Dr. Michaelis is Chief Operating Officer of Thermosome GmbH, which is developing proprietary thermosensitive nanocarriers for targeted delivery of drugs to heated target tissues.
Dr. Michaelis supports Rational Vaccines in drug quality and release of its RVx201 drug candidate for treatment of HSV-2 infection.
Kerstin Westritschnig, MD
Head of Clinical Development
Kerstin Westritschnig, MD
Head of Clinical Development
Kerstin Westritschnig, MD is specialized in clinical immunology and has 20 years of working experience in R&D, thereof 15 years in vaccine development. Her areas of expertise are vaccines, infectious disease, immuno-oncology and biologics. She has served as the medical lead for design and conduct of approximately 20 clinical vaccine studies from Phase I to Phase IV in more than 7 infectious disease indications. She was involved in two successful marketing/new drug applications at FDA and/or EMA (Japanese encephalitis vaccine, IXIARO ®; GD2-antibody for the treatment of neuroblastoma, Qarziba ®). She previously served as Senior Vice President and member of the Executive Committee of Intercell AG, Valneva SE and as Chief Medical Officer of Apeiron Biologics AG.
Konstantin Kousoulas PhD
VP of Scientific Affairs
Konstantin Kousoulas PhD
VP of Scientific Affairs
Dr. Konstantin “Gus” Kousoulas received his BS in Physics from Fairleigh Dickinson University in Teaneck, NJ, and his MS and PhD degrees from Pennsylvania State University in Biophysics and Molecular Cell Biology, respectively. He received postdoctoral training at the University of Chicago working in Dr. Bernard Roizman’s laboratory and at the University of California at San Francisco with Dr. Lenore Pereira, where later he was promoted to Research Assistant Professor. He joined Louisiana State University in Baton Rouge and became full professor in 1994. He is currently Professor of Virology and Biotechnology at the LSU School of Veterinary Medicine and Director of the Division of Biotechnology & Molecular Medicine with adjunct appointments at the Department of Biological Sciences, College of Basic Sciences at LSU Baton Rouge, the Department of Microbiology and Immunology at the LSU Health Sciences Center in New Orleans, and the LSU Health Sciences Center’s Stanley S. Scott Cancer Center in New Orleans. Dr. Kousoulas has substantial expertise in animal models of viral and bacterial infections including non-human primates. Currently, he serves as the NIH National Scientific Advisory Board (NSAB) of the Southwest National Primate Research Center and has previously served as Chair of the NSAB of the Tulane National Primate Research Center. His primary research interests are focused on the molecular biology and immunopathogenesis of human herpes viruses. He has extensively utilized herpes simplex viral vectors for vaccine development and cancer treatment. He has constructed and patented herpes simplex viruses that have been shown to be highly efficacious as preventative and therapeutic vaccines for herpes genital and ocular infections and as potent adjuvants for cancer immunotherapy approaches in animal models. Other research interests include computational approaches to protein structure and function, the use of virus-like particles for drug delivery, and the utilization and development of bioinformatics and advanced diagnostic solutions for infectious diseases and cancer.
Cecilia Huaman, MPH, Ph.D
Director Immunology and Diagnostics
Cecilia Huaman, MPH, Ph.D
Director Immunology and Diagnostics
Cecilia Huaman holds a Ph.D. in Medical Sciences from Nagasaki University, Japan. Dr. Huaman also holds a Master’s in Public Health from the University of California, Berkeley, and a Certificate in Drug and Medical Device Development from MIT Emeritus. Dr. Huaman has over 25 years in biomedical research, both in academia and industry. She has worked in proof-of-concept and pre-clinical studies, and clinical trials in the development of vaccines and therapeutics. Dr. Huaman pursued post-doctoral training at the National Institutes of Health, National Institute of Allergy and Infectious Diseases, her research was focused on the development of malarial vaccines and natural immunity against malarial antigens. In 2009, she moved to Industry, she has worked in the development of vaccines against tuberculosis, HIV and other pathogens. Dr. Huaman has served as Cellular and Molecular Immunologist and Subject Matter Expert in the design, execution, and analysis of Immunogenicity Vaccine Studies. During her tenure in Clinical Research Organizations, she has implemented laboratories with GLP, ICH-GCP, and GCLP regulations, in compliance with the FDA. More recently, Dr. Huaman expertise in the rationale for biomedical research, laboratory science, and quality systems has helped to advance the drug development of several small and medium pharmaceutical companies in the field of vaccines against infectious diseases and therapeutics for cancer and autoimmune diseases.
Christian Wallasch, PhD
Head, Global Operations
Christian Wallasch, PhD
Head, Global Operations
Christian Wallasch has 20 years of experience along the value chain from early research through phase 1 clinical development dealing with small molecule inhibitors, antibodies and vaccines. He served in various executive positions from operations to project management at Axxima, GPC-Biotech, Intercell, PDC-Biotech and Catalym. At present, he serves as COO at ATRIVA Therapeutics, being responsible for the transition from early research projects into the clinic. Christian’s main focus is project management with an emphasis to connect people in virtual environments for successful project work. He has diploma in molecular biology from the Ludwig-Maximilians-University Munich and holds a PhD from Max-Planck-Institute of Biochemistry in Martinsried.
Quinn Steele
Head of GxP and Regulatory E-Systems
Quinn Steele
Head of GxP and Regulatory E-Systems
Quinn began her career in the Life Sciences industry in 2002 in an administrative role in Clinical Operations with a global Clinical Research Organization. In 2004, after having gained experience in the end to end clinical trial process, she moved into a system-focused role as a Global Trainer for the implementation of the Clinical Trial Management System. In 2012, Quinn obtained her Certified Business Analysis Professional (CBAP) certification, and her BSA in Information Systems in 2014 from Kaplan University. Over the course of her 18-year career in a regulated environment, she has led projects ranging from custom system development, data integration, mobile application development, data migration, off-the-shelf implementation, dashboard development and predictive analytics. Quinn’s expertise lies where people, process and technology come together in new and innovative ways.
Diane Abbitt, Esq
Patient Advocate
Diane Abbitt, Esq
Patient Advocate
Diane Abbitt has expertise in the areas of strategic planning, administrative law, government and public sector law, real estate law, and business law. Abbitt has assisted such companies as Mobil Exxon, Fujisawa Pharmaceuticals, USA, Lynch/Frost Productions, Inc. and the Bio Tech Trade Union Association through the maze of governmental regulation and the legislative process. Other corporate clients have included Porton Medical Laboratories, ICN Pharmaceuticals, and Paragon Group. Over the last almost forty years, Ms. Abbitt has been a community activist serving on the boards of the National Organization for Women, Co-chairing MECLA, the first Political Action Committee in the country dedicated to achieving equality and secure legal protections for LGBT people and was the founding Co-President of AIDS Project Los Angeles.
David B. Mixner
Diversity Outreach Advisor
David B. Mixner
Diversity Outreach Advisor
Mr. Mixner has been a well-known and respected international human rights activist for six decades. He has advised Presidents and Prime Ministers on civil rights, human rights and diversity issues.
Over the years, in addition to his advocacy and activism, he has advised companies such as DuPont, ATT, Intermedia, Chevron and many others on diversity and human rights.
He has appeared on the Today Show, Good Morning America, Face the Nation, CNN, MSNBC and many other media outlets.
He is currently an active member of Barilla (International) Diversity and Inclusion Board.
Mr. Mixner has had three best-selling books, starred in four sold out one man shows off Broadway and on the road in Milan, Paris, Los Angeles, Chicago and Atlanta. He has received numerous honors and awards.
Mr. Mixner came out as a gay man in 1976.
Scientific Advisory Board
Paul Predki, PhD
SAB Chair, Biotech executive, co-founder and CTO of Iridia Inc.
Paul Predki, PhD
SAB Chair, Biotech executive, co-founder and CTO of Iridia Inc.
Co-founder & Chief Technology Officer of Iridia Inc. Dr. Predki is a seasoned biotech executive and entrepreneur with 25 years of technology and product development experience, and a co-founder of 3 successful start-ups.
Rahul Singhvi, ScD, MBA
Operating Partner, Flagship Pioneering
Rahul Singhvi, ScD, MBA
Operating Partner, Flagship Pioneering
Dr. Singhvi is an Operating Partner at Flagship Pioneering, a unique Boston-based life sciences innovation firm. At Flagship Pioneering, Dr. Singhvi is responsible for operating young start-up companies launched from Flagship’s innovation foundry, Flagship Labs.
Prior to Flagship, Dr. Singhvi was the Chief Operating Officer of Takeda’s Vaccine Business Unit where he was responsible for global vaccine operations at the Takeda Pharmaceutical Company. During his 6-year tenure at Takeda, the vaccine business grew to over 500 employees and created an impressive late-stage pipeline of vaccine candidates against dengue, norovirus and Zika. Before joining Takeda, Dr. Singhvi was President and CEO of Novavax, Inc. a clinical stage vaccine company listed on the Nasdaq (NVAX). Under his leadership, Novavax transformed from a failed specialty pharmaceutical business to a vaccine development company with vaccine candidates against influenza (funded by BARDA) and respiratory syncytial virus (RSV). Dr. Singhvi’s professional career began at Merck & Co in 1994, where he held several positions in R&D and manufacturing.
Dr. Singhvi serves on the Executive Advisory Board of the Leonard Davis Institute (LDI) of Health Economics at the University of Pennsylvania and as an advisor to the Office of Technology Transfer at the University of Maryland, Baltimore. He is a mentor instructor in the Undergraduate Projects Opportunity Program (UPOP) at MIT. He serves as a visiting lecturer at the University College London (UCL) and is also on the faculty of the University of Sienna’s Master’s course on Vaccinology.
Dr. Singhvi graduated as the top-ranked chemical engineer from IIT, Kanpur, India and obtained both his MS and ScD chemical engineering degrees from MIT. He received an MBA from the Wharton School of the University of Pennsylvania, where he graduated as a Palmer Scholar.
Lional Raj, MD
Medical Director, Department of Cornea and Refractive Surgery, Dr. Agarwal’s Eye Hospital, India
Lional Raj, MD
Medical Director, Department of Cornea and Refractive Surgery, Dr. Agarwal’s Eye Hospital, India
Professor Lionel Raj is a Regional Medical Director of Dr. Agarwal’s Eye Hospital, Tirunelveli, India. He is one of the leading corneal transplantation surgeons in the world. He served as the Chief of Department of Cornea and Ocular Surface Diseases from 2006 to 2010 at Aravind Eye Care System, Tirunelveli. He has completed over a 100,000 surgeries in his career and has won 12 international and several national awards in the field of ophthalmological research.
Daniel J.J. Carr, PhD
Dean of Research, McGee Eye Institute and Optometry, University of Oklahoma, USA
Daniel J.J. Carr, PhD
Dean of Research, McGee Eye Institute and Optometry, University of Oklahoma, USA
Daniel J.J. Carr, PhD received his Bachelor of Science degree in Biology from Southern Methodist University in Dallas, TX in 1983 and his Doctor of Philosophy degree in Microbiology in 1987 from University of Texas Medical Branch in Galveston, TX. Following a postdoctoral fellowship at University of Alabama at Birmingham, Dr. Carr joined the faculty as an Assistant Professor in Microbiology, Immunology, and Parasitology at LSU Medical Center in New Orleans, LA in 1991. Following tenure and promotion to Associate Professor in 1997, Dr. Carr moved his lab to Oklahoma City, OK in the Department of Ophthalmology at the University of Oklahoma Health Sciences Center in 1999 and was promoted to Professor in 2008. His main area of focus is ocular- and neuro-immunology and the host immune response to herpes simplex virus infection. He has published over 200 peer-reviewed papers and book chapters and reviews, mentored several graduate medical students and postdoctoral fellows, and received numerous awards and grants from the National Institutes of Health and private foundations, including Research to Prevent Blindness. He currently holds the Stanton L Young Chair in Ophthalmology and the George Lynn Cross Research and PHF Presidential Professor awarded by the University of Oklahoma Health Sciences Center.
Georg Holländer, MA, MD, FMedSci, FRCPCH, FHM Pediatrics
Chair, Department of Pediatrics, University of Oxford, Oxford, UK
Georg Holländer, MA, MD, FMedSci, FRCPCH, FHM Pediatrics
Chair, Department of Pediatrics, University of Oxford, Oxford, UK
Georg Holländer trained in both Pediatrics and Experimental Immunology in Switzerland and the U.S. He held academic positions at Harvard Medical School, Boston, U.S. and the University of Basel, Switzerland before he joined the University of Oxford, UK in 2010. Since 2019, he is also the Director of the Botnar Research Centre for Child Health. His research is focused on the development and function of the immune system, with a particular interest in how our immune system can effectively distinguish between the body’s own cells and potentially harmful antigens of other origins.
Todd Margolis, MD, PhD
Chair, Department of Ophthalmology, Washington University, St. Louis, MO, USA
Todd Margolis, MD, PhD
Chair, Department of Ophthalmology, Washington University, St. Louis, MO, USA
Todd Margolis MD, PhD is the Albert and Edith Wolff Distinguished Professor and Chair of the John F. Hardesty MD Department of Ophthalmology and Visual Sciences at Washington University in St. Louis.
Dr. Margolis has a long-standing interest in regulation of infection with HSV. Prompted by his neuroscience background, his lab research has focused on how HSV and sensory neurons interact to regulate productive and latent viral infection.
In his clinical practice, Dr. Margolis cares for patients with complicated infectious and inflammatory eye disease. He is particularly well known for his clinical expertise in the areas of HSV and VZV eye disease. He is currently working as the protocol chair for an AIDS Malignancy Collaborative study (AMC -104), a feasibility study of OSSN surgical excision in HIV infected patients in 4 countries in west Africa.
During his career, Dr. Margolis has supervised 17 pre-doctoral students and 16 postdoctoral fellows in his lab, as well as over 100 clinical fellows (including 31 international fellows), many of whom conducted clinical research. Four of his fellowship trainees are currently chairs of departments of ophthalmology. He has over 160 peer reviewed publications in the scientific literature (H factor=46) and has received a number of awards, including the Jules Stein Vision Research Award, RPB Career Development Award, RPB Lew Wasserman Merit Award, RPB Senior Scientific Investigator Award, Faculty AOA Award and 2012 Heed Award. He has served on a number of NIH study sections, NEI council, as an executive editor of the American Journal of Ophthalmology, and as president of ARVO.
Jim Robinson, BS, MS
Industry Consultant
Jim Robinson, BS, MS
Industry Consultant
James Robinson has 35 years of experience in biological manufacturing, late-stage development and quality. He has held executive level positions with Sanofi Pasteur, Merck and Novavax. His most recent role was Vice President of Technical and Product Operations for Merck Vaccines, Biologics, and Sterile Manufacturing network from 2010–2015. Collectively, Jim has managed the production of nearly 2 billion doses of nearly every vaccine, including influenza, tetanus, meningitis, chicken pox and shingles, rotavirus, MMR, human papilloma virus, hepatitis A and B, and developmental recombinant protein vaccines, spending much of that time “industrializing” vaccine and therapeutic protein manufacturing technologies, expanding capacity, improving reliability and reducing costs. In December 2012, he was featured in Life Science Leader Magazine for transforming Merck’s approach to vaccine manufacture. Jim has a BS and MS in Chemical Engineering from Lehigh University and is a licensed Professional Engineer.
David I. Bernstein, MD, MA
Professor of Pediatric Infectious Diseases at Cincinnati Children’s Hospital Medical Center
David I. Bernstein, MD, MA
Professor of Pediatric Infectious Diseases at Cincinnati Children’s Hospital Medical Center
Dr. Bernstein attended medical school at the State University of Buffalo and then did a pediatric residency at the University Southern California in Los Angeles and the New England Medical Center in Boston. During his infectious diseases fellowship at UCLA he became interested in vaccines and antivirals. He moved to Cincinnati in 1983 and began his work studying rotavirus infections and vaccines as well as herpes virus infections. During this time, teaming with Dr. Richard Ward, he developed a rotavirus vaccine that eventually became Rotarix, a vaccine used around the world. Dr. Bernstein has been the principal investigator for the NIH contract to study vaccines and antivirals for the treatment of herpes virus infections in animal models since 1990. During this time, he refined the guinea pig model of genital HSV. Uniquely, he has also been the principal investigator for the NIH funded contract to evaluate vaccines and treatments (VTEU) in clinical trials. As a clinical investigator he has performed several trials of both prophylactic and therapeutic HSV vaccines. Dr. Bernstein ascended the ranks and became a Professor and the Director of the Division of Infectious Diseases at Cincinnati Children’s Hospital Medical Center (CCHMC). He has published over 300 manuscripts and numerous chapters focused on vaccines and antivirals.