The Zika Response Working Group is under the Infectious Outbreak Response Group, also known as iOrg (non profit status pending).  The team is comprised of industry leaders, infectious and biothreat specialists, academics and thought leaders.  Please peruse the bios of our team members, and think about how you can help.  Because...right now, the world must work together to solve this crisis.  If you are a person who has something to offer our program, please contact us!  We are also accepting donations, and are looking for investors or philanthropists because the world can't move fast enough to find treatments and diagnostic options for women and children exposed to this virus.

 

Robert W. Malone, M.D., M.S.  CEO and co-founder of RW Malone MD, LLC. Dr. Malone has extensive research and development experience in the areas of clinical trials, vaccines, gene therapy, bio-defense, and immunology.  He has over twenty years of management and leadership experience in the academia, pharmaceutical and biotechnology industries.  His FDA, HHS, and DoD agency knowledge is extensive.  Dr. Malone is an internationally recognized scientist and is known as one of the original inventors of “DNA Vaccination.”  Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines.  He has over fifty peer-reviewed publications, has been an invited speaker at over thirty-five conferences, has chaired numerous conferences and he has sat on numerous study sections.  Dr. Malone is in the Harvard Medical School Global Clinical Scholars Program in 2015-2016.

In August 2014, colleagues at the Department of Defense/Defense Threat Reduction Agency asked Dr. Malone to step in and help NewLink manage the Ebola project and develop the contracts necessary to move the "orphan" PHAC/rVSV ZEBOV vaccine forward quickly.  Dr. Malone got the project on track, recruited our client Focus Clinical Trials to team with USAMRIID/WRAIR to develop the immunoassays, put WHO leadership in touch with Pentagon leadership to expedite the initial WRAIR clinical trials, recruited the government of Norway to help fund the clinical research, used social media (LinkedIn) to recruit Merck Vaccines to join the project, recruited a management team, and lead the development of the BARDA and DTRA contracts - yielding over 200M$ in resources.  Those were frightening times, but now we have a remarkably effective vaccine, developed in record time.

Jane Homan, Ph.D., MRCVS  CEO and co-founder, ioGenetics. Jane is a veterinary epidemiologist and microbiologist who came to the biotechnology sector after 20 years international, research and administrative experience in academia, including field research in arbovirology in Latin America. The EigenBio uTOPE™ analysis is a powerful immunoinformatics system developed at ioGenetics.  uTOPE™ analysis enables integrated mapping of proteins to identify predicted B-cell epitopes, predicted MHC-I  and MHC-II binding affinity and cross presentation across abroad array of HLA types, and protein topology mapping.  The statistical methods underlying uTOPE™ mapping are based on principal component analysis of amino acids.  The analytical output can be portrayed in high data-density graphs of epitope maps, in which patterns of epitope distribution are shown.  uTOPE™ mapping is applicable to proteins of any source including microbial, mammalian, plant or synthetic biopharmaceutical proteins.  A high throughput system, uTOPE™ analysis can be applied to whole microbial proteomes, or to compare epitopes conserved across microbial strains or protein isotypes.  uTOPE™ analysis provides a reasoning environment for design of vaccines, diagnostics and antibodies, as well furthering the understanding of the immune response.  It has applications in infectious diseases, allergy, autoimmunity and cancer biology.

Daniel Janies, PhD The Carol Grotnes Belk Distinguished Professor of Bioinformatics and Genomics, University of North Carolina at Charlotte.  Dr. Janies received a Bachelor of Sciences degree in Biology from the University of Michigan in 1988 and a Ph.D. in Zoology from the University of Florida in 1995.  Dr. Janies worked as a postdoctoral fellow (1996 - 1999) and a principal investigator (2000-2002) at the American Museum of Natural History in New York City where he lead a team that, using off-the-shelf PC components, built one of the worlds largest computing clusters in 2001.  Most recently Dr. Janies was a tenured faculty member in the College of Medicine at the Ohio State University.  Dr. Janies is a national principal investigator in the Tree of Life program of the National Science foundation and is funded by the Defense Applied Research Projects Agency.  His work involves empirical studies of organismal diversity and development of software, such as Supramap. Supramap is used by public health scientists to put pathogen genomic data into context with geography and hosts.  The results are akin to weather maps for disease.

Jim Wilson, MD FAAP CEO, Founder M2, Nevada State Infectious Disease Forecast Station @ UNR, University of Nevada Reno.  Dr. Wilson founded the analytic discipline of indication and warning signature processing for infectious disease events.  He is a world authority on operational infectious disease forecasting and event signature processing.  Dr. Wilson led the creation of the Haiti Epidemic Advisory System (HEAS), the first infectious disease forecasting station in the world.  The HEAS provided first public warning of the cholera disaster in Haiti as well as the first public announcement of the disaster's origins as the UN Mirebalais base.  Since then, he has created several additional forecast stations, including the first operational station inside the US. Dr. Wilson led the team that provided warning of the 2009 H1N1 pandemic to CDC and WHO.  He was the Principal Investigator of Project Argus, Chief of the Argus Research Operations Center, and Division Head of Integrated Biodefense at the Imaging Science and Information Systems Center, Georgetown University.  He conceptualized and created the Biosurveillance Indication and Warning Analysis Community (BIWAC) for the US government. He was a member of the Department of Homeland Security National Biosurveillance Integration System (NBIS) Concept Design Review team and the first Chief of Analytic Operations at the National Biosurveillance Integration Center (NBIC). 
Dr. Wilson has served as a Special Assistant to the Director for Weapons of Mass Destruction at the US Army Medical Research and Materiel Command Telemedicine and Advanced Technology Research Center (USAMRMC-TATRC), Ft. Detrick, Maryland; Visiting Scientist at NASA-Goddard Space Flight Center; consultant to NOAA’s National Environmental Satellite, Data, and Information Service (NESDIS); and research team member of the World Health Organization Tai Forest Project on Ebola Hemorrhagic Fever.

Jill Glasspool Malone, Ph.D.  President and co-founder, RW Malone MD, LLC.  Dr. Glasspool has experience in preclinical, regulatory, and clinical project management, with special expertise in public policy and Federal regulatory issues.  Dr. Glasspool has held supervisory and management positions in the biotechnology industry and academia. She also was a co-founder of Inovio, USA, and Intradigm.  She has an extensive publication record in vaccination and gene therapy, as well as behavioral research and is currently enlisted in the Harvard Medical School Global Clinical Scholars Program 2015-2016.

Stefanie M. Hone, M.S. has over sixteen years of experience in immunology of infectious disease, with a focus on pre-clinical and clinical assay development and validation.  In this capacity, she has worked on immune assay development for diseases such as Tuberculosis, HIV, Toxoplasmosis, Tularemia, Plague, Botulinum, Influenza and Travellers Diarrhea.  As a result of her broad experience in advanced vaccine development, she has gained proficiency in GLP/GCLP/GMP quality systems, the FDA “Animal Rule”, and is adept in writing validation protocols, study protocols, study reports, analytical testing plans, SOPs and equipment IOQs to meet regulatory requirements.  She also has successfully contributed to CMC sections, managed the preparation of regulatory documents in support of IND submissions and as a participant in FDA Type C meetings in support of phase 3 clinical trials.  Mrs Hone received her M.S. in Biophysical Chemistry and Biochemistry from the University of Frankfurt, Germany.

Mr. Jeffry J. DiFrancesco Jeffrey is the Founder and Executive Director for Avancer Group, Inc. and its predecessor company BioPharm CA, Inc. His professional conviction is "Closing the gap between vision and reality!" Professionally, Jeffrey has over twenty-five years of corporate and life science related experience. He has held numerous senior positions – including chief executive, chief financial, chief operating and chief strategic planning officer – and has served as a member of the board of directors of public and private organizations. As an executive, he has planned and commercialized new businesses and product lines, and managed day-to-day profit-loss, operations and global strategic investments. Jeffrey has also orchestrated major transactions including $1.3 billion in public securities, $100 million in divestures, $1 billion in acquisitions, and $30 million in private securities. As a management consultant, he has advised many emerging and Fortune 500 organizations. As a thought-leader, Jeffrey has published original research in peer-reviewed journals, chaired and spoken at over 40 industry international conferences, and has been quoted and interviewed by numerous industry trade journals. In addition, he is a recipient of industry recognitions and corporate awards. Academically, Jeffrey is an adjunct Assistant Professor of Pharmaceutical Business, Mayes College of Healthcare Business and Policy, University of the Sciences in Philadelphia. He teaches graduate courses in capital investment and finance and performs primary research on the operational performance of clinical trials. He has also been an Adjunct Professor at St. Joseph's University Graduate Program and an adjunct faculty member at Drexel University's Bennett S. Lebow College of Business. Educationally, Jeffrey holds a Master of Science in Finance from Johns Hopkins University, a Master of Engineering in Engineering Science from Penn State University, and a Bachelor of Science in Mathematics from Illinois Institute of Technology. He also has certificates in mergers and acquisitions from the Wharton School of the University of Pennsylvania, Level 1 Change Agent from Conner Partners, and Black Belt Six Sigma from Goodwin College of Drexel University.

Sean J. Hart, Ph.D – President & Chief Executive Officer of LumaCyte.  Dr. Hart is the President and Chief Executive Officer of LumaCyte, a revolutionary research, instrumentation and diagnostics company headquartered in Charlottesville, VA.  Dr. Hart and his team developed the technology behind LumaCyte’s label-free analysis and sorting platforms while working on systems for biowarfare defense at the Naval Research Laboratory (NRL), with funding from both NRL and the Defense Threat Reduction Agency (DTRA).  LumaCyte’s technologies provide biopharmaceutical companies with a powerful new tool to detect changing cell phenotypes in drug candidates. The technology can also rapidly detect viral infection in mammalian cells, which is useful for infectivity studies for viral vectors and live/attenuated vaccine development and production.

James D. Talton, Ph.D., Co-founder, President and Chief Executive Officer or Nanotherapuetics. Prior to founding Nanotherapeutics, Dr. Talton served as the President and Chief Executive Officer of D&E Management Systems, a leading service organization in Florida.  Dr. Talton is a co-inventor of Nanotherapeutics' technologies and has authored several peer-reviewed publications and book chapters involved in drug delivery systems with a primary focus in drug analysis and controlled release formulations, pharmacokinetics, and pulmonary drug delivery.  Dr. Talton received his B.S. and M.S. in Materials Science and Engineering and his Ph.D. in Pharmaceutical Sciences from the University of Florida.  Dr. Talton is also a Director of BioFlorida, on the Advisory Council at Keck Graduate Institute, and has been a reviewer for the NIH for over ten years.

Ron Cobb, PhD, Chief Scientific Officer Dr. Cobb joined Nanotherapeutics in 2011.  As Chief Scientific Officer, Dr. Cobb is responsible for the development of novel vaccines, biologics, and medical devices.  He also works to help procure outside funding for the company’s strategic programs.  During his tenure at Nanotherapeutics, Dr. Cobb led project teams focused on recombinant protein based drug and vaccine development as well as medical device development.  Prior to joining Nanotherapeutics, he was Director of Research and Development at RTI Biologics.  Under his leadership over 20 new products and line extensions were launched and a stem cell based technology was initiated.  He also spent 7 years as Head of Protein Expression and Purification Group at Berlex Biosciences (subsidiary of Schering, AG).  He has over 20 years of experience in biopharmaceutical and medical device Research and Development and has provided molecular biology expertise to numerous projects ranging from early stage research to supporting protein expression and purification for a Phase II clinical program.  He has over 40 peer-reviewed publications and book chapters and has been a reviewer for several different journals for over 10 years.

Ivan Ruzic, Ph.D., President of Analytical Outcomes. Dr. Ruzic has served in a variety of senior executive leadership roles for multiple technology companies both domestically and internationally. Scientifically trained, he is an analytically-focused executive with the ability to identify and execute the concrete tasks that produce results. An accomplished team builder, Dr. Ruzic has consistently demonstrated his leadership skills by initiating significant change in both startup and established business environments. More recently, Dr. Ruzic has focused on the transformative potential of Big Data and has pioneered the application of sophisticated Big Data analytics to issues of national security, public health, economics and electoral politics at both state and federal levels. Dr. Ruzic received his B.Sc. in Chemistry and Biochemistry as well as a Ph.D. from Monash University, Melbourne, Australia. He also holds a Masters equivalent in Information Technology from Chisholm Institute of Technology (now part of Monash University).

 

Other members of our team include Adriano De Bernardi Schneider (doctoral student),  Adriano's contributions have been invaluable to the group.  Rebecca Zimler (doctoral student),  and Lambodhar Damoaran (intern).  Their contributions have been significant and we appreciate their hard work!