Carl N. Kraus, M.D., FACP (Chairman and CEO)
Dr. Kraus is a graduate of the Washington University School of Medicine, and trained in internal medicine at the University of Chicago. He completed fellowship training in infectious diseases, including work on M. tuberculosis new drug development at the National Institutes of Health, and then served as a Medical Officer for the Infectious Diseases Section at the Food and Drug Administration. He was appointed a member of the Infectious Disease Society of America’s Antibiotic Resistance Committee, working with both the FDA and the NIH on policy recommendations for drug sponsors.
For the past decade, Dr. Kraus has held scientific and management roles in the pharmaceutical industry, including i3Research (a subsidiary of United Health Group) where he served as Sr. Director, Infectious Diseases; PRA International, where he was the Global Scientific Head for Infectious Diseases. He has most recently served for three years as the Chief Medical Officer for Nanotherapeutics, a biodefense-oriented biotechnology company, where he was responsible for oversight and management of the Scientific and Regulatory Affairs, Pharmacovigilance, and Clinical Operations groups; in addition, he directed development programs involving several vaccines and an anti-infective agents.
Joe McMahon (Director)
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 lead the sale of KBI Biopharma to JSR Corporation, a Tokyo-based multinational company. In 2016, Joe also lead 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 lead the engineering and technical services groups for a large medical device company.
Barry D. Garfinkle, Ph.D. (Director)
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.
He has served as a Director of kSep Systems, LLC. and as a Director of KBI Biopharma Inc. He is also a member of the Scientific Advisory Board for PBS Biotech.
Dr. Garfinkle has also volunteered as a member of the USP Council of Experts, serving first on the microbiology committee, general chapters’ committee, and finally being elected as Chair of the Vaccine and Virology Committee. He worked jointly with the USP and EP to achieve harmonization of several monographs and chapters. He has also worked on the ISO WG9 committee which established the first ISO aseptic guidelines. Barry has also provided training to the U.S. FDA in the areas of validation and microbiology, and was a member of the Parenteral Drug Association, Pharmaceutical Manufacturers Association, and was elected to American Men of Science. Dr. Garfinkle has also published several chapters on Validation and Sterilization (Remington) and authored or co-authored over two dozen technical papers.
Joe St. Geme III, M.D. (Director)
Joseph W. St. Geme III, MD, received his bachelor’s degree from Stanford University, Stanford, CA, and his medical degree from Harvard Medical School, Boston, MA. He completed a pediatric residency and chief residency at The Children’s Hospital of Philadelphia and pursued postdoctoral training in microbiology and infectious diseases at Stanford University. 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 was recruited to Duke University, Durham, NC, where he was 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. In addition, 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 involving pathogenic bacteria. Dr. St. Geme has been elected to the Society for Pediatric Research, the American Pediatric Society, the American Society for Clinical Investigation, the Association of American Physicians, the American Academy of Microbiology, the American Association for the Advancement of Science, and the Institute of Medicine.
Laszlo Otvos, Jr., Ph.D., D.Sc., CBA
Dr. Laszlo Otvos received his PhD degree from the Hungarian Academy of Sciences, Budapest in 1991 for developing novel chemical technologies in order to identify and characterize immunologically active peptides and processes in Alzheimer’s disease and anti-viral vaccine development. Later his research repertoire was extended to antimicrobial peptides and peptidic modulators of adipokine receptor responses focusing on cancer and cardiovascular/metabolic disease research. 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 Councilor for the American Peptide Society and Associate Editor for Frontiers of Chemical Biology. Laszlo Otvos is Regional Editor for Protein and Peptide Letters and Associate Editor for Current Protein and Peptide Science. An author of more than 220 peer-reviewed papers with over 15,000 references to his publications, Laszlo Otvos is among the top 1% most cited researchers in the life science arena.
Scott R. Evans, Ph.D.
Dr. Evans is the Director of Harvard’s Statistical and Data Management Center (SDMC) for the Antibacterial Resistance Leadership Group (ARLG). His interests include the design, monitoring, analyses, and reporting of and education in clinical trials. He is the author of more than 100 peer-reviewed publications and three textbooks on clinical trials including Fundamentals for New Clinical Trialists. Dr. Evans is a member of an FDA Advisory Committee, the Board of Directors for the Society for Clinical Trials and Mu Sigma Rho (the National Honorary Society for Statistics), and the Steering Committee of the Clinical Trials Transformation Initiative (CTTI). He is the Editor-in-Chief of CHANCE and Statistical Communications in Infectious Diseases (SCID). Dr. Evans is a Visiting Professor at the Department of Medical Statistics at Osaka University in Japan. He is the Past-President of the Boston Chapter of the American Statistical Association (ASA), the Past-Chair of the Development Committee of ASA, the Past-Chair of the Teaching Statistics in the Health Sciences section of ASA, and the Past-Chair of the Statistics in Sports section of ASA.
John H. Powers, MD FACP FIDSA
Dr. Powers is a Professor of Medicine at the George Washington University School of Medicine. Prior to his current position, Dr. Powers was the Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives in the Office of Antimicrobial Products, Center for Drug Evaluation and Research, at the US Food and Drug Administration where he was responsible for issues related to clinical trials and policy in antimicrobial research. Dr. Powers was a co-chair for the Inter-Agency Task on Antimicrobial Resistance of 11 federal agencies responsible for implementing the Public Health Action Plan to Combat Antimicrobial Resistance. Prior to joining the FDA, Dr. Powers was assistant professor in the Division of Infectious Diseases at the University of Maryland School of Medicine and he still is on the faculty there as an Assistant Clinical Professor of Medicine. Dr. Powers has been an investigator on over 50 clinical trials. He is a fellow in the American College of Physicians and the Infectious Diseases Society of America, was a member of IDSA’s Research in Resistance Working Group, currently a member of the VA Clinical Studies Scientific Evaluation Committee (CSSEC) and had served on the World Health Organization’s AGISAR (Advisory Group on Integrated Surveillance of Antibiotic Resistance).
John Wade, Ph.D.
John Wade obtained his PhD in 1979 in protein chemistry at Monash University (Australia) and then undertook postdoctoral studies at the MRC Laboratory of Molecular Biology, Cambridge, UK, with one of the pioneers of chemical peptide synthesis, Dr RC Sheppard. He returned to Australia in 1983 to the University of Melbourne where he presently holds appointments as Professor at the School of Chemistry and Professor of Neuroscience at the Florey Institute of Neuroscience and Mental Health. He has made numerous contributions to the field of the development of the chemistry of solid phase peptide synthesis and its application to the chemical biology of large, complex peptides with a particular emphasis on the maternal hormone, relaxin, related insulin-like peptides, and antimicrobial peptides. John has published more than 250 peer reviewed articles, book chapters and patents, and has been peer elected to fellowship of both the Royal Australian Chemical Institute and Royal Society of Chemistry. He is also editor-in-chief of International Journal of Peptide Research & Therapeutics, Frontiers in Chemistry, and Australian Journal of Chemistry.
Ralf Hoffmann, Ph.D.
Dr. Ralf Hoffmann is a full professor at the Institute of Bioanalytical Chemistry at the University of Leipzig, Germany, and affilitated to the Center of Biotechnology and Biomedicine (University of Leipzig). Dr. Hoffmann received his Ph.D. from the Biochemistry department of Saarland University, Germany. His research interests focus on enzymatic and non-enzymatic protein modifications, including the development of proteomics techniques and immunoassays for diagnostics as well as the design and optimization of peptide lead structures. Dr. Hoffmann’s work is documented in more than 200 peer-reviewed publications and nine patents. Dr. Hoffmann is the European Editor of “Protein and Peptide Letters”, the Associate Editor of “Current Protein and Peptide Science”. Dr. Hoffmann established the annual International Meeting on Antimicrobial Peptides (IMAP) conference series.