Biomoda, Inc.

Advisors and Partners

Biomoda is privileged to work with an outstanding team of advisors and partners who are highly respected for their work in medicine, lung cancer research, medical devices and regulatory policy and practice.

ADVISORS

• Thomas Bauer, MD, is Chief of Thoracic Surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Newark, Delaware, and national Principal Investigator of the Biomoda pilot study.  He is also clinical assistant professor of surgery at Jefferson Medical College and adjunct assistant professor of biological sciences at the University of Delaware.  He has lead several lung and esophageal cancer studies, including Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP).  Dr. Bauer has authored dozens of peer- and non-peer-reviewed publications and abstracts and serves on many committees and programs.

• Steve Groshong, MD, PhD, is a pathologist at the National Jewish Hospital in Denver and assistant professor at the University of Colorado, Denver.  Board-certified in anatomic pathology and clinical pathology, Dr. Groshong is nationally known for his subspecialty in lung disease.  He had conducted research on interstitial lung disease (ILD) and pulmonary fibrosis.

• David G. Hill, MD, is the local Principal Investigator for the CyPath® pilot clinical trial at Waterbury Pulmonary Associates Research, the clinical research arm of a large pulmonary and critical care group.  Dr. Hill practices critical care medicine, pulmonology and internal medicine and leads all of Waterbury’s pulmonary and critical care research.  He earned his MD from the Medical College of Pennsylvania.

• Richard G. Holcomb, PhD, is an Associate Senior Consultant with Quintiles.  Dr. Holcomb works with clients in the medical device, pharmaceutical, biologic and biotechnology industries to develop and implement preclinical and clinical development plans, with special emphasis in medical devices regulated by the Food and Drug Administration (FDA).  Dr. Holcomb has a PhD in Biometry from the University of Minnesota.

• Marty Jacobson, PhD, is Research Director at the St. Mary’s Hospital and Regional Medical Center, Saccomanno Research Institute, in Grand Junction, Colorado, where he leads basic and translational cancer research.  The Institute builds on research by the late Gene Saccomanno, PhD, MD, in diagnostic applications of sputum cytology.  Dr. Jacobson received his PhD in microbiology and molecular biology at North Carolina State University.

• Timothy Kennedy, MD, is associated with the University of Colorado and specializes in internal medicine, pulmonology and cytopathology.  He is an expert in sputum cytology.  Dr. Kennedy has authored many peer-reviewed publications, belongs to dozens of professional societies and serves on many committees.  He has held faculty positions at the University of Arizona and University of Colorado Health Sciences Center.

• Daniel Merrick, MD, is associated with the Denver VA Medical Center and the University of Colorado School of Medicine.  He is known for his work in anatomic and clinical pathology and molecular genetic pathology with a subspecialty in the pathology of neoplastic lung disease.  He has published several papers on lung cancer and is an expert on sputum cytology.  Dr. Merrick graduated from the University of Washington Medical School.

• Lara Patriquin, MD, is the local Principal Investigator in Albuquerque, New Mexico, for Biomoda’s pilot study on the CyPath® diagnostic assay.  Dr. Patriquin practices diagnostic radiology at Radiology Associates and Presbyterian Hospital in Albuquerque.  She received her MD from McGill University Faculty of Medicine.

• Richard Phillips, MSPH, PhD, is a Principal Consultant in medical device development at Quintiles Consulting.  Previously, he worked in the FDA’s Office of Device Evaluation, where he acquired broad knowledge of medical device law and regulations and premarket evaluation policies and practices.  Prior to joining the FDA, Dr. Phillips worked for three in vitro diagnostic device companies as Director of Clinical Research/Clinical Affairs.  Dr. Phillips is a Diplomate of the American Board of Forensic Toxicology, and the author of numerous papers in clinical chemistry, analytical and forensic toxicology, and in vitro diagnostic devices.  He earned his PhD from Indiana University.

• Dino U. Vallera, MD, practices cytopathology, clinical pathology and anatomic pathology in Illinois where he is affiliated with five hospitals.  He is an expert in digital fluorescent cytology and provides his services to Biomoda through Quintiles Global Digital Pathology Services. He earned his medical degree from the University of Chicago, Pritzker School of Medicine.

PARTNERS

• Gordon Bennett provides fluorescent microscopy services to Biomoda. Mr. Bennett has a B.S. in Physics and a J.D. from the University of New Mexico.  His background is in photonics and electronics. He has been adjunct faculty at the College of Santa Fe and has held the Chair in Photonics and Biophotonics at Central New Mexico Community College.

• Christiana Care Health Services of Newark, Delaware, provided sample procurement and assay research and development for the pilot clinical study of the CyPath® assay.  Christiana Care recruited a cohort of patients diagnosed with lung cancer to participate in the study and assisted Thomas L. Bauer, MD, thoracic surgeon and cancer researcher, in his role as national Principal Investigator overseeing the Biomoda clinical studies for early lung cancer detection.

• Quintiles Consulting in Rockville, Maryland, provides regulatory consulting and clinical study design to Biomoda.  Quintiles Consulting is the regulatory consulting unit of Quintiles Transnational Corp., a global corporation that provides a broad range of professional services in product development, financial partnering and commercialization for the pharmaceutical, biotechnology and medical device industries.

• Quintiles Global Digital Pathology Services of Westmont, Illinois, provides the digital fluorescent pathology services of Dino Vallera, MD.

• Radiology Associates of Albuquerque in Albuquerque, New Mexico, was the collection site for the high-risk cohort of the pilot clinical trial.  As part of the study, Radiology Associates performed computed tomography (CT) scans of patients participating in the clinical studies and provided results to their primary care providers and Biomoda.

• Regulatory & Clinical Research Institute (RCRI), Inc. in Minneapolis, Minnesota, serves as the Contract Research Organization (CRO) for the ongoing clinical studies of the CyPath® assay.  RCRI provides medical device, in-vitro diagnostic and biologics companies with expertise in regulatory affairs, clinical trial design and management, database development, reimbursement strategy, health economics, quality systems and compliance, biostatistics and venture capital due diligence.

• Saccomanno Research Institute at St. Mary’s Hospital and Medical Center in Grand Junction, Colorado, collaborates on research to advance Biomoda’s patented system for measuring the photon emission rate of CyPath®-stained cells for the early detection of lung cancer.

• University of Texas Health Science Center of San Antonio is one of the country’s leading health sciences universities.  Biomoda has signed a Memorandum of Understanding with the University of Texas Health Science Center at San Antonio to assist in optimizing the CyPath® assay and advance the application of the Company’s technology to additional cancers.  UTHSCSA ranks in the top 3% of all institutions worldwide receiving federal funding.  The Office of the Vice President for Research performs biomedical research focused on accelerating, facilitating, and increasing the discovery, development, and dissemination of biomedical solutions that improve the quality of life.

• Waterbury Pulmonary Associates Research, the active clinical research arm of a large single-specialty private practice pulmonary and critical care group in Waterbury, Connecticut, provided sample procurement for the positive control cohort of the pilot clinical study of the CyPath® diagnostic for lung cancer under the direction of David G. Hill, MD, local Principal Investigator for Waterbury’s participation in the Biomoda studies.