About Synedgen

Team

High performance drug development team

Our industry-leading team combines polymer chemistry, microbiology and molecular biology expertise with advanced product development know-how. By targeting polysaccharide therapeutics to mucosal surface biology in pulmonary and GI diseases, we work to create breakthrough drugs for superior therapeutic impact.

Dr. Wiesmann is an accomplished physician, medical scientist, and program manager with experience in cell biology, systems biology, medical device development and extensive experience leading and conducting basic scientific and medical research. He served as the Director for Combat Casualty Care at the U.S. Army Medical Research and Materiel Command Post, at Ft. Detrick, where he led the design and development teams that produced novel technologies for improved battlefield survival until he retired from the Army as a colonel in 1997. His innovations, which include the LSTAT Transportable Life Support System, the Advanced Surgical Suite for Trauma Casualties (ASSTC), the SAVe ventilators, and the HemCon hemostatic bandages, have transformed medicine both on the battlefield and in civilian trauma centers. In 2004, the military named the 4-by-4-inch HemCon bandage one of the year’s “Top 10 Greatest Inventions” for its ability to stop seriously wounded soldiers from bleeding to death. He holds 59 awarded or pending patents from his work in biosensors, automated diagnostic devices, advanced tissue engineering, wound care, and infection control. Dr. Wiesmann has been published in more than 75 peer-reviewed medical journals.

Dr. Wiesmann has received many honors for his development work in government, including the US Army Meritorious Service Medal, the US Army R & D Achievement Award, and the Army Commendation Medal. He was awarded an honorary Doctor of Science degree from the University of Cincinnati.

He is a co-founder of Hawaii Chitopure, BioSTAR West, Tissue Genesis, AutoMedx Inc., and Synedgen, Inc.

Dr. Shenda Baker has more than 20 years of experience conducting, generating funds for, and directing chemistry, materials science, and biochemistry research. She provides scientific leadership, manages the intellectual property as well as the scientific and regulatory collaborations, and provides financial and organizational oversight at Synedgen. Previously, Dr. Baker was a professor of Chemistry at Harvey Mudd College from 1991-2014 with a research focus on polymer nanostructures and self-assembly. She served on the Board of Directors of the Materials Research Society and has served on advisory boards with the National Institutes of Health, National Science Foundation and the Department of Energy. Dr. Baker is a member of the American Chemical Society and the Materials Research Society and currently serves on the Advisory Council of the National Institute of Dental and Craniofacial Research of the NIH. She is co-inventor on all of the Synedgen technology.

Dr. Stacy Townsend has expertise in microbiological research with a special interest in host-pathogen interactions. Her graduate work at Texas A&M University and postgraduate studies at Childrens Hospital Los Angeles and abroad developed her extensive knowledge of host-pathogen interactions. Specifically, her work with method development,  in vitro and in vivo models, antibacterial assessment techniques, and biofilm analysis has resulted in a tract record of successfully completed research studies. Dr. Townsend has been an integral part of Synedgen research since 2007.

Dr. Christopher Ryan has extensive expertise in polysaccharide structural analysis and interactions of pathogens with human tissue. He has overseen the scale up of synthesis and directed quality specifications of Synedgen FDA approved products. Dr. Ryan completed a postdoctoral fellowship at the University of California, Los Angeles, where he performed structural analysis of polysaccharide compounds and natural products from T. vaginalis and human pathogens as potential drug targets. He has also conducted research at the University of Dundee in Scotland, and at SUNY in Buffalo, New York.

Michelle has more than 20 years of experience in drugs and devices, including inhalation drugs and devices (aerosol & powder), vascular grafts, catheter based vascular therapies, suspensions, solutions/injections, creams, ointments, shampoos, nasal sprays, tablets, syrups, diagnostic drugs, wound healing, topical and aesthetic products, and orphan drugs and devices.  Michelle’s forte is in early negotiations with FDA, particularly pre-IND and pre-IDE meetings to secure agreement early on in development programs to ensure smooth submissions and subsequent approvals.

Dr. Jeffrey A. Staffa has had extensive experience in all aspects of the pharmaceutical industry spanning a career of over 30 years. He has worked for the U.S. FDA, a small privately held company, a small publicly held company, a large publicly held company, and the largest chemical company in the world. He has worked and participated in regulatory affairs, x-ray crystallography, medicinal and agricultural chemical synthesis, pilot plant manufacturing, quality control, safety surveillance, preclinical toxicological evaluation, pharmacokinetics, clinical pharmacology, and clinical development. He has served as the scientific advisor to attorneys working for the federal government and for numerous companies. He has advised Commissioners of the FDA and prepared FDA General Counsel for hearings and trials. He is fluent in the business aspects of the pharmaceutical industry. He has worked with biologics, drugs, devices, foods, and veterinary products.

Dr. Osheroff has over 35 years of regulatory expertise in toxicology and drug development, with extensive experience in IND/NDA writing/submissions, program monitoring and management including competitive bidding and negotiations as well as on-site CRO qualifications visits (domestic and overseas), toxicology study monitoring and report review, operational improvements, mentoring and coaching of study directors and other scientific staff, specific topics research and development of white papers, and due diligence activities. Dr. Osheroff has authored multiple Expert Reports/White Papers that have been submitted to the US FDA to support registrations, and is an active member and Treasurer of the Roundtable of Toxicology Consultants.

Mr. Burns has more than 25 years experience in the senior Pharmaceutical Operations environment including site organizational design, management, and product introductions, and Quality Compliance /Technical Production experience including cGMP compliance, Quality Assurance and Compliance, and Regulatory Affairs. He has overseen retooling and reformulation of products produced on the billion-pill scale to building manufacturing facilities for liquids, emulsions and powder/cpasules.

Mr. Gill is a skilled Regulatory, QA, QC compliance specialist with an extensive knowledge of quality assurance and quality control systems, document controls and regulatory requirements. He has 27 years of experience in the pharmaceutical industry with extensive knowledge of managing US FDA, EU and German regulatory authority inspections for US manufacturing facilities, and provides a full service of regulatory and compliance consultation for the pharmaceutical industry, including regulatory, cGMP, cGLP, and cGCP compliance.