Leadership

Carl Genberg, B.Sc., JD

Chief Executive Officer
  • Sr. VP, R&D, Ceragenix Pharmaceuticals; Co-Founder, Board Member and Regulatory counsel to Neuromedical Systems, Inc., where he designed clinical trial leading to PMA approval of lead product in 14 months and key advisor to CEO, leading to $100 million IPO led by Goldman Sachs
  • Successful track record leading commercialization of medical device products, including 510(k) and PMA, managing clinical studies, establishing research networks and obtaining non-dilutive financing; co-inventor on multiple patents
  • Prior experience as an attorney with experience in intellectual property licensing transactions and issues and FDA regulatory matters

Ronald Bracken

President and COO
  • Medical device executive and former V.P. of R&D for C.R. Bard with 28 years of product development and commercialization experience
  • Responsible for development, clinical testing and launch of many medical devices, including the Agento® I.C. anti-infective ETT
  • 17 issued patents plus several pending applications

Glenn Brunner, MS

VP, Product Development
  • President, Opticon Medical; prior Director, Global Technology, Medex
  • Substantial medical device R&D, regulatory and commercialization experience and expertise

Timothy Hammond, PhD

Consulting Toxicologist
  • Dec 1999 – March 2012 Vice President Safety Assessment UK, AstraZeneca
  • Safety Pharmacology Society – Distinguished Scientist Award
  • Significant experience in respiratory toxicology
  • Involved in the development of numerous drugs
  • Experience with FDA and other regulatory agencies

Harris Kaplan

Commercialization Consultant
  • Managing Partner, Red Team Associates; CEO, Healogix
  • Founded and exited multiple healthcare industry research companies
  • Involved in the development and launch of over 100 new life science products across drug, device, and diagnostic markets; 30-year industry veteran; role in commercializing blockbusters such as Crestor, Rituxan, Nexium, Lipitor, Incivek, Kalydeco, Eteplirsen (Sarepta), Austedo (Teva)

Shawn Langer, MD

Director
  • Former Senior Partner, McKinsey & Company; leader healthcare private equity practice
  • BHMS Investments, Operating Partner

Paul B. Savage, PhD

Inventor, Consultant and Sponsored Research
  • Reed M. Izatt Professor of Chemistry and Biochemistry at Brigham Young University and inventor of the ceragenin compounds
  • Research emphases include development of non-peptide mimics of antimicrobial peptides and optimization of glycolipid adjuvants, including a glycolipid vaccine adjuvant that entered human clinical trials
  • Author on over 190 papers, and inventor on over than 35 issued US patents
  • Technologies developed in Prof. Savage’s laboratory have been licensed to multiple companies and are in various stages of clinical development

Michael S. Niederman, PhD

Scientific Advisor and Consultant
  • Clinical Director and Associate Chief in the division of Pulmonary and Critical Care Medicine, at Weill Cornell Medical Center, and Professor of Clinical Medicine at Weill Cornell Medical College
  • Previously Professor of Medicine and Vice-Chairman of the Department of Medicine at the State University of New York at Stony Brook, Chairman of the Department of Medicine at Winthrop-University Hospital in Mineola, for 16 years
  • Boston University School of Medicine, training in internal medicine at Northwestern University School of Medicine, pulmonary and critical care medicine fellowship at Yale University School of Medicine
  • Expertise in respiratory tract infections, mechanisms of airway colonization, the management of community and hospital-acquired pneumonia, the role of guidelines for pneumonia, and the impact of antibiotic resistance on the management and outcomes of respiratory tract infections
  • Published over 400 peer-reviewed or review articles, and has lectured widely, both nationally and internationally
  • Served as co-chairman of the committees that created the American Thoracic Society 1993 and 2001 guidelines for the treatment of community-acquired pneumonia and the 1996 and 2005 committees that wrote guidelines for the treatment of nosocomial pneumonia
  • Served for 6 years as a member of the Board of Regents of the American College of Chest Physicians and in 2013 was elected as a Master of the American College of Physicians
  • Editor-in-Chief of Clinical Pulmonary Medicine, and serves on the editorial boards of Critical Care Medicine, Intensive Care Medicine, Critical Care and Chest

Dr. John Thomas, MD

Consultant
  • Principal Scientist, Allegheny Health Network
  • Prior Professor and Professor Emeritus, West Virginia University, Morgantown, WV, USA for 23 years
  • Recognized as an “International Educator and Global Microbiologist” having lectured in more than 43 countries while a clinical microbiologist in pathology, dentistry and medicine for 51 years
  • Over 50 publications, multiple book chapters, significant grant support, pending patents and over 100 posters and abstracts at national and international meetings
  • Member of the ADA Scientific Advisory Committee for the last 8 years
  • Faculty at 6 Universities during his career, and has received Alumni and University awards for research and International Student Mentoring
  • Through Global Microbiology Consulting utilizes the advanced resources of the Allegheny Health Network in Pittsburgh, PA, Carnegie-Mellon University and Massachusetts General Hospital, Boston, MA
  • Research emphasizes biofilms and medical devices including endotracheal tubes and the connection between oral diseases, VAP and wound infections (Intellectual Design), and the recent integration of micro 3-D bio-printing using bio-plastics and unique Probiotics (Therapeutic Bacteria) for intervention

Don Boyer

Regulatory Consultant
  • President, CRE, specializes in providing strategic and regulatory advice to the medical device and pharmaceutical industry on various aspects of Canadian regulatory requirements
  • Interim Strategy Lead, Regulatory Affairs Professionals Society (RAPS), February 2016 to November 2016, provided management and leadership oversight to RAPS staff while the organizations undertook its search for a new Executive Director
  • World Health Organization (WHO) Working Group, Model Regulatory Framework for Medical Devices, February 2016 to present, involves providing regulatory expertise to the development of guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices  
  • Health Canada, December 1982 to September 2014
    • Held several senior management and director positions requiring the establishment and nurturing of working relationships with industry, industry associations, international regulatory partners and other stakeholders; played a significant and key role in shaping the contents of the medical devices regulatory framework of 1998
    • In the international arena, represented Health Canada in various fora. Active at the management and working level within Global Harmonization Task Force (GHTF) and its successor organization, the International Medical Devices Regulators Forum (IMDRF)); Negotiated Mutual Recognition Agreements (MRA) and other arrangements in the form of memoranda of cooperation with Health Canada’s international regulatory partners