Arthur F. Spalding

Art Spalding Mr. Spalding has over 20 years’ experience in pharmaceuticals and medical devices directing various functions including: reimbursement, clinical trial design and facility recruitment, distribution, business development, managed markets, market research, hospital sales, forecasting, and sales operations. Mr. Spalding held management and director level positions at various companies including Parke-Davis, Pfizer, Solvay, Peer-Point Medical Education, and Columbia Laboratories.In 2009, Mr. Spalding started TAMM Net, Inc., a consultancy servicing biomedical manufacturers. TAMM Net has helped manufacturers: conduct clinical trials using federal resources; gain reimbursement; gain marketing approvals/clearances; and sell to federal purchasers. Mr. Spalding holds a B.S. in Chemistry from Union College, Schenectady, NY and an MBA in Health Administration from Temple University in Philadelphia.

F. Blix Winston, MPA, MS

Mr. Winston worked for 27 years in the U.S. Food & Drug Administration, gaining a broad range of contacts and knowledge of how the agency works. With more than 17 years of experience with the Center for Devices and Radiological Health, Mr. Winston has a comprehensive understanding of FDA laws and medical device regulation. He assisted thousands of U.S. and foreign medical device firms at the Division of Small Manufacturers Assistance, and managing the Operations Branch, he developed a unique perspective on the needs of the device industry. With his in-depth knowledge of FDA regulatory requirements he was able to provide direct regulatory assistance that saved companies time and resources and to design and conduct 1-3 day workshops that served the needs of both small and large companies. In addition to planning and conducting workshops for the medical device industry Mr. Winston trained FDA and CDRH staff, such as medical device reviewers, as well as foreign government officials from India, Malaysia, Japan, the People’s Republic of China, Korea, Australia, Taiwan, Canada, Denmark, France, Argentina and Brazil.His military training in clinical laboratory medicine and hospital lab experience served as a springboard into a toxicology and pharmacology research position in FDA. Following a three-year rotation as an FDA management intern, Mr. Winston spent the majority of his career in CDRH. He retired from FDA in 2002 and teaches Medical Device Regulation at a Hood college. Mr. Winston holds a Bachelor of Science from the University of Maryland, a Master of Public Administration from the University of Southern California, Washington Public Affairs Center, and a Master of Science in Pastoral Counseling from Loyola College of Maryland.

Janan VanOsdell, MBA, MHSA

Ms. Van Osdell has over 25 years’ experience in various aspects of health care and the pharmaceutical industry resulting in a unique blend of business and science. Her primary responsibilities are clinical research projects. She is an excellent medical writer of both clinical and regulatory documents. She develops and coordinates professional education and training events to support clinical research staff and training on new technologies and procedures.

Before joining TAMM Net, she managed Continuing Medical Education department at Solvay Pharmaceuticals, Inc. where she was responsible for regulatory compliance, processes, budgeting, and grant review. Her career includes 15 years with Procter & Gamble Pharmaceuticals where she worked in Clinical Research, Professional Relations, Health Economics, and Educational Marketing. Her achievements at Procter & Gamble Pharmaceuticals include clinical research trial manager for bringing naproxyn sodium from RX to OTC as the branded OTC analgesic, Aleve®; and she worked seven years with inflammatory bowel disease physicians and patients with the branded mesalamine, Asacol®. Prior to Procter & Gamble Pharmaceuticals, she was a research dental hygienist and managed the Periodontal Dental Research Clinic at Emory University.  Ms. Van Osdell earned both MBA and MHSA (Health Services Administration) degrees from Xavier University in Cincinnati, Ohio. Her bachelor degree in Dental Hygiene is from the LSU Health Sciences Center in New Orleans, LA.  She also completed accounting and finance studies and is a Certified Public Accountant.

Dr. Darrell R. Galloway

Galloway Dr. Galloway has been a significant contributor to the biodefense R&D establishment for more than 28 years. As a tenured faculty member of The Ohio State University, Dr. Galloway served as mentor for 13 doctoral students, received an NIH National Career Development Award and enjoyed an international reputation in the field of bacterial toxin research. In conjunction with his university career, Dr. Galloway completed a military career as a Naval officer, retiring at the rank of Captain in 2006. CAPT Galloway was Deputy Director of the Naval Medical Research Center’s, Biodefense Research Program and later served at various posts at the Defense Threat Reduction Agency, eventually retiring as Director of the Chemical-Biological Defense Directorate in 2010. From 2006-2010, as a member of the Senior Executive Service, he was responsible for the R&D component of the U.S. Department of Defense CBR program. While at DTRA Dr. Galloway also served as the Executive Chair of the International TTCP CBR working group with representation from the U.K., New Zealand, Canadian and Australian defense departments. In 2010 Dr. Galloway established a biodefense consulting company and currently holds an academic appointment as Professor of pharmaceutical chemistry at the University of Utah. He is the recipient of numerous research and leadership awards.

Hongjun Yin, PhD

Hongjun Yin Dr. Yin earned his doctorate degree from the University of Illinois at Chicago. Trained in pharmacoeconomics and outcome evaluation, Dr. Yin has carried out research in outcome measurement, economic modeling, health care policy, pharmacoepidemiology, and health care utilization. He has conducted research for Merck, Pfizer, Novartis, Aventis (now Synofi), Johnson and Johnson and guided academic projects in Long Island University and Philadelphia College of Osteopathic Medicine.

His research have covered cardiovascular diseases, diabetes, mental health, infectious diseases, oncology, quality of life and health policy. Findings from his research have been presented in the Society for Medical Decision Making (SMDM), International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and conferences focused on specific diseases. He published in many journals such as: Journal of Managed Care Pharmacy, Journal of Medical Economics, Value in Health, Medical Care, and American Journal of Orthopedics.

Cham Dallas, Ph.D.

Patrick Phelan Dr. Dallas is a Professor at the University of Georgia and Director of the Institute for Health Management and Mass Destruction Defense in the College of Public Health; and a member of the Department of Health Policy and Management, College of Public Health as well as being a Clinical Professor in the Department of Emergency Medicine in the Georgia Health Sciences University. Dr. Dallas has held many positions in his over 25 years at UGA including Director of the Interdisciplinary Toxicology Program and Director of the Center for Mass Destruction Defense, a CDC Center in Public Health Preparedness. He served as president of the Southeastern chapter of the Society of Toxicology. Dr. Dallas has been recognized by faculty and students alike with numerous teaching awards.Among his many appointments, Dr. Dallas consults with the US department of Defense, the U.S. Senate, the National Academy of Sciences, and other federal agencies concerning toxicology issues. He is recognized internationally as a leader in radiological and toxicological threats. He has made numerous national television appearances, including over 30 this year. He is one of the founders of National Disaster Life Support (NDLS), which has trained over 100,000 medical and first responders in handling mass casualties nationwide and in 9 countries. Dr. Dallas has published extensively and been an invited speaker dozens of times internationally.

Dr. Dallas has received millions of dollars for research from numerous US government agencies. Dr. Dallas earned his BA in Biology and his MS and Ph.D. in Toxicology at the University of Texas.

Jennifer Short

Jennifer Short Ms. Short has 14 years’ experience in medical device distribution in the Orthopedic and OBGYN marketplace, as well as in the dental Cad/Cam industry. Ms. Short has worked her way up the sales ladder, from associate to national sales manager. Ms. Short has built her own businesses and helped small companies pioneer new devices and procedures. Ms. Short is a lead by example sales manager, who has proved to be successful at any level. Ms. Short has a Master’s Certificate from UCI for Medical Product Development, and obtained a B.S. in Exercise & Sport Science-Sports Medicine Concentration from Colorado State Universit

Charles Smeltzer

unknown Mr. Smeltzer has over 10 years experience in big data processing and analytics. He supports innovative software development in a number ways: efficient query design [MySQL, PostGRE], interactive software design [GTK], web design [Javascript, HTML5], microsensors and XML phrasing. He is an experienced research associate from the Georgia Institute of Technology and holds a masters in atmospheric science with focus on improving satellite retrieval algorithms and numerical model simulations of the atmosphere. He taught a course statistical analysis [MATLAB, R]. Mr. Smeltzer sits on the NASA GES DISC board, the largest distributor of Earth science data in the world. Before coming to TAMM Net, Mr. Smeltzer developed software for Airborne Research Consultants, Institute for Airborne Research, Xerxzed Inc., and Blend Logic LLC.

POC: NOAA is the largest distributor of operational weather forecasting data.

David R. Dills

Mr. Dills brings more than 24 years of international experience in the areas of Regulatory Affairs, Compliance and Quality Systems with proficiency in medical devices, In Vitro Diagnostics, and pharmaceuticals. His experience extends beyond FDA to include: EMA, MHRH, ANVISA, PMDA, TGA, and Health Canada. Mr. Dills prepares regulatory submissions including: 510(k), PMA, IDE   applications, NDA, supplements, and amendments. Mr. Dills works closely with agency/center reviewers regarding submission meetings and negotiations.Mr. Dills has a robust understanding of global quality systems interpretation and application.  He has installed and shepherded projects requiring: 21 CFR 210/211, 21 CFR 820, GMP, and ISO 13485 and CE Mark.  He has helped dozens of companies successfully navigate consent decrees, warning letters, 483 observations, and customer generated compliance events. Mr. Dills conducts: GxP inspections, mock FDA audits, due diligence and assessing state of readiness for pre-approval inspection (PAI/PMA), proof of management oversight, and records and document controls.

Mr. Dills has serves on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News.  He previously served on the Faculty Advisory Board for the Pharmaceutical Training Institute. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.  Mr. Dills authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.