Team Management Carl N. Kraus, MD President/CEO,Chairman of the Board X Carl N. Kraus, MD President/CEO,Chairman of the Board Dr. Kraus is the President & CEO of Arrevus. He has more than 15 years’ experience in drug development, ranging from discovery and first-in-man studies through late-phase/risk-management program implementation. He is a former FDA Medical Officer and has held scientific and management roles with Ingenix (Senior Director, Infectious Disease and Vice President, Clinical Informatics), PRA International (Global Scientific Head, Infectious Diseases), and Chief Medical Officer of Nanotherapeutics/medical lead for DoD Advanced Development & Manufacturing (now Ology Bioservices), support for which included a >$400M contract. Dr. Kraus is the principal investigator of numerous NIH-sponsored research grants. Daina Zeng, PhD Sr. Director, Research & Development X Daina Zeng, PhD Sr. Director, Research & Development Dr. Daina Zeng is Senior Director of Research and Development for Arrevus. Her expertise is in identifying, characterizing, and developing novel mechanism of action therapeutics to treat human diseases. She received her PhD in Biochemistry from Duke University School of Medicine where she did her doctoral work in the laboratories of Dr. Christian RH Raetz and Pei Zhou on designing and evaluating novel inhibitors of outer membrane biosynthesis (LpxC inhibitors) to be used as antibiotics against multidrug-resistant gram-negative pathogens and studied mechanisms of resistance. Prior to Arrevus, she was Director of Research and Development for Agile Sciences, where she managed $9M of small business grants and contracts from the federal government. She also serves as primary investigator on numerous NIH grants. Denise Watts Director, Facilities and Administration X Denise Watts Director, Facilities and Administration Ms. Watts is Director of Facilities and Administration. She has been working in drug development for > 15 years across CROs and biotechnology companies. Ms. Watts has broad experience in supporting clinical trial programs as well as coordinating activities of Medical & Scientific Affairs teams. In these roles she provided administrative support and assured compliance with requisite federal guidelines including Good Clinical Practices. Board of Directors Carl N. Kraus, MD President/CEO,Chairman of the Board X Carl N. Kraus, MD President/CEO,Chairman of the Board Dr. Kraus is the President & CEO of Arrevus. He has more than 15 years’ experience in drug development, ranging from discovery and first-in-man studies through late-phase/risk-management program implementation. He is a former FDA Medical Officer and has held scientific and management roles with Ingenix (Senior Director, Infectious Disease and Vice President, Clinical Informatics), PRA International (Global Scientific Head, Infectious Diseases), and Chief Medical Officer of Nanotherapeutics/medical lead for DoD Advanced Development & Manufacturing (now Ology Bioservices), support for which included a >$400M contract. Dr. Kraus is the principal investigator of numerous NIH-sponsored research grants. Barry Garfinkle, PhD Board Member X Barry Garfinkle, PhD Board Member Barry D. Garfinkle, Ph.D. serves as Principal of Barry Garfinkle & Associates Consulting, LLC. Dr. Garfinkle has extensive experience in the biologics, vaccines and pharmaceutical industry in which he has worked for over 40 years. During his career at Merck Sharp & Dohme Corp. he held several positions at the VP level including: VP Biological Quality Control and Responsible Head, VP Vaccine Technical Operations, and finally VP Biological Sciences and Strategy. He has worked in the areas of biologics, vaccines, sterile and non-sterile pharmaceutical dosage forms. His previous experience has included late stage process development, process improvements, process troubleshooting, and facility design for manufacture of biologics, vaccines, sterile operations and testing. His expertise includes pharmaceutical microbiology, cGMP’s, biotechnology manufacturing, vaccine manufacturing, aseptic processing, analytics and Quality Systems. During his career at Merck Sharp & Dohme Corp. he has worked on over a dozen vaccines and peptides which achieved commercial licensure. Joe St. Geme, MD Board Member X Joe St. Geme, MD Board Member From 1992 to 2005, Dr. St. Geme was a member of the faculty in the Department of Pediatrics and the Department of Molecular Microbiology at Washington University in St. Louis, MO. There he served as director of pediatric infectious diseases and co-leader of the Pediatric Infection, Immunity and Inflammation Research Unit. In 2005, Dr. St. Geme joined Duke University as the James B. Duke professor and chairman of pediatrics, the chief medical officer of Duke Children’s Hospital, and a professor of molecular genetics and microbiology. In 2013, Dr. St. Geme relocated to Philadelphia to assume new responsibilities as the chairman of the Department of Pediatrics and physician-in-chief at The Children’s Hospital of Philadelphia. He is also chairman of Pediatrics and professor of pediatrics and microbiology at the Perelman School of Medicine at the University of Pennsylvania. Dr. St. Geme has an active laboratory research program that focuses on the molecular basis of host-pathogen interactions. Robert House, PhD Board Member X Robert House, PhD Board Member Dr. House is Senior VP of Government Contracts at Ology Bioservices and was the former President of DynPort Vaccine Company. Dr. House has nearly 30 years’ experience in basic and applied biomedical research and development, specializing in the assessment of inadvertent and therapeutic immunomodulation. Dr. House earned a BA in zoology and an MSPH and PhD from the University of North Carolina at Chapel Hill. He is the author/ co-author of more than 100 journal articles and 28 book chapters and editor of two books in the fields of immunomodulation, immunotoxicology, host defense, cytokine biology and biodefense.Dr. House is an adjunct professor at George Mason University where he teaches graduate courses in medical countermeasure development. He is a fellow of the Academy of Toxicological Sciences. Joe McMahon Board Member X Joe McMahon Board Member Joe is the President and CEO of Bioventure Partners, a growth advisory and investment firm, serving high-impact, technology-driven organizations. Previously, Joe was with KBI Biopharma, a biopharmaceutical CDMO from 2002 until 2016, having served as its President and CEO. During this period, KBI grew from a startup to a 500+ person organization, serving over 300 biopharmaceutical companies globally. In 2015, Joe led the sale of KBI Biopharma to JSR Corporation, a Tokyo-based multinational company. In 2016, Joe also led the sale of kSep Systems (a KBI Biopharma cell therapy technology spinout), to Sartorius AG. Prior to KBI, Joe was a Vice President with Covance Biotechnology Services (a biopharmaceutical CDMO) from 1996 until 2002, including the sale of Covance Biotechnology Services to Akzo Nobel in 2001. Previously, Joe led the engineering and technical services groups for a large medical device company. Robert Schotzinger, MD, PhD Board Member X Robert Schotzinger, MD, PhD Board Member Dr. Schotzinger is the former CEO of Viamet Pharmaceuticals and has > 20 years’ experience in drug development that has spanned both large pharma and biotechnology companies. He has previously served as Vice President of Pharmaceutical and Clinical Development at Abbott Hospital Products Division, CEO of BioStratum and most recently as Chairman and CEO of Viamet. His expertise includes Pharmacology (PhD), Research, Development, Finance, Licensing and Pharmacovigilance. He successfully built Viamet from a university spin-out into a late-stage clinical development organization, raising >$130M in private equity to support the enterprise. Advisors Brian D. Bollwage, MBA, MSc, JD Regulatory Strategy Advisor X Brian D. Bollwage, MBA, MSc, JD Regulatory Strategy Advisor Brian D. Bollwage, MBA, MSc., JD, is a career regulatory professional. Previously, Brian served as Regulatory Counsel at i3Research. During his tenures with Johnson & Johnson, Pharmacia, and Hoechst-Roussel, Mr. Bollwage has managed the preparation, submission, and associated FDA liaison activities of over 150 INDs and 20 successful NDAs or BLAs. Mr. Bollwage has been the principal FDA contact regarding these submissions and has acted as the U.S. agent for numerous submissions. Mr. Bollwage holds an appointment as Assistant Professor of Food and Drug Law at Temple University and speaks and publishes actively on numerous Food and Drug Law topics. Mr. Bollwage is an active member of RAPS, DIA, and the American Bar Association and is admitted to the NJ Bar. Laszlo Otvos, PhD Scientific Advisor X Laszlo Otvos, PhD Scientific Advisor Dr. Laszlo Otvos has over 40 years of scientific research experience with an h-index of 63. His research has included developing novel chemical technologies to identify and characterize immunologically active peptides in Alzheimer’s disease, anti-viral vaccine development, antimicrobial peptides, and peptidic modulators of adipokine receptor responses. These efforts have spanned infectious diseases, oncology, neurology, cardiology and metabolic diseases. He joined the Wistar Institute in 1995, and after 20 years he moved to Temple University as a Research Professor in Biology. Currently he is president of OLPE, LLC, a consulting firm focusing on peptide- and protein-based drug development and Adjunct Professor at the Institute of Medical Microbiology at Semmelweis University in Budapest. Dr. Laszlo Otvos serves as Associate Editor for Frontiers of Chemical Biology and has served as Regional Editor for Protein and Peptide Letters and Associate Editor for Current Protein and Peptide Science, and Councilor for the American Peptide Society. . Chad Roy, PhD, MSPH Aerosol Development Advisor X Chad Roy, PhD, MSPH Aerosol Development Advisor Dr. Roy is a graduate of the University of Iowa College of Medicine and trained in infectious diseases at the US Army Medical Research Institute of Infectious Diseases (USAMRIID). He completed multiple laboratory residencies in infectious diseases, including performing research on smallpox at the Centers for Disease Control and Prevention, and on models of influenza while at the Commission de l'énergie atomique (CEA) Life Sciences Directorate. In 2010, he was appointed by the National Academy of Sciences as one of four American scientists to represent the US on medical countermeasures development at the Quadrennial Experts Meeting on the Biological Weapons Convention. For the past two decades, Dr. Roy has worked in infectious disease research, initially as a principal investigator within the Center for Aerobiological Sciences at USAMRIID, and for the past 12 years as Professor of Microbiology & Immunology and Director of Infectious Disease Aerobiology at Tulane University School of Medicine. Amanda Sheets, PhD Clinical Development Advisor X Amanda Sheets, PhD Clinical Development Advisor Dr. Sheets is a clinical scientist/microbiologist with 15 years’ experience in infectious disease research, including 7+ years in pharmaceutical industry with focus on antibacterial drug development. She has expertise in molecular biology, bacterial pathogenesis, in vitro and animal models of infection, and clinical development of new antibiotics. She had served as the clinical microbiologist on numerous Phase 2 and Phase 3 clinical development programs. She has also authored multiple eCTD sections for FDA regulatory submissions. Carla Lema Tome, PhD, MBA Therapeutic Strategy Advisor X Carla Lema Tome, PhD, MBA Therapeutic Strategy Advisor Dr. Lema Tome is a Senior Manager in AESARA’s Evidence Institute, focusing on questions related to market access, payer perspectives and product value strategies. Dr. Lema Tome has five years of global medical and commercial strategy consulting experience with emphasis on integrated clinical development, asset and portfolio strategy, launch planning, payer research and payer value communications. Her work includes development of forecast and valuation models, conducting strategic analyses of the competitive and market access environments and developing integrated plans and innovative strategies to maximize asset value. Dr. Lema Tome also maintains an adjunct appointment at Wake Forest School of Medicine.