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Our Process Ensures Predictable Outcomes

A multi-step process ensures we learn all we can about your needs and provide consistent, high-quality product.

Discovery and Requirements

8-12 step process.

It is vital to take the time and effort required to completely capture the knowledge you have about your product and therapeutic area. Asking the right questions at this stage is critical for helping to prevent needless expenditures and inefficiencies.

When we perform claims analysis there are many different databases from which to collect claims data. By asking our clients detailed questions about the purpose of the analysis and their knowledge of where the procedures are performed and by whom, we can propose the most appropriate resources.

Planning (GAP Analysis)

11-18 step process

For a recent cellular therapy client, performing a gap analysis was critical in their initial fundraising. By identifying exactly what additional information was needed to obtain an IND, they presented successfully to investors.


Reimbursement is its own strategic morass. By creating an overall portfolio clinical development plan, we can anticipate any resistance that may be brought by medical societies or payers. For a client in a very competitive space with huge existing competition, this enabled us to plan a sequential new coding strategy to minimize resistance.

Implementation & Execution (Clinical Development Plan)

9 step process

A carefully laid plan leads to a systematic execution and the ability to adapt when regulatory bodies change their minds. Our internal processes ensure that execution is both accurate and timely.

Delivery

9-18 step process

Delivery is another dialogue. We typically deliver a draft to ensure that we are capturing everything in the statement of work. Once all parties agree on the draft final versions are produced.

“TAMM Net has been a valuable partner helping us navigate reimbursement and regulatory. They coordinated our activities with CMS including a successful C-code application and connected us with policy representatives in medical societies. TAMM Net’s regulatory team efficiently wrote and submitted our successful 510(k) application for CivaSheet. They have helped our company meet key milestones. We continue to work with TAMM Net because of the professionalism and effectiveness they bring to each task.”
Susan Babcock

Close & Continuation

6-8 step process

We engage with our clients early in the development process and stay connected after any project is done. For most of our clients, our engagement is an ongoing partnership. We want to make sure that if there are any questions about our work, we are there to answer them as they arise. Of course, this also leads to many referrals, for which we are grateful.

 

Just ask our clients

We customize solutions that fit the needs of needs of all our clients, and strive to ensure the success of each and every one of them

  • Vincent L. Olmo, COO
    TAMM Net played a critical role in the creation of our Quality Management System. They did so in a precise and efficient manner, allowing us to meet an objective at a reasonable price. We considered a number of different firms to help us, both big and small, but we found that TAMM Net simply provided the greatest value. We are a better company because of our relationship with TAMM Net.
    Vincent L. Olmo, COO
    Revolutions Medical Corporation
  •  Jonathan Mountjoy
    Art is one of the most creative people I have ever met or worked with. The integrity and intelligence he has displayed during our professional and personal relationship is remarkable. His ability to provide solid and complete analysis of the medical field is invaluable. I would recommend TAMM Net for any business consultation due to their honest and detailed commitment to excellence! Top qualities: Expert, High Integrity, Creative.
    Jonathan Mountjoy
  • Phil Mansour, Principal
    TAMM Net team brought exceptional insight and clarity to an extremely diverse and complicated landscape, adding tremendous value. December 1, 2010 Top qualities: Expert, Good Value, High Integrity
    Phil Mansour, Principal
    PMC Consulting
  • Paul J. Fitzpatrick, CEO
    TAMM Net provided expertise in the grant development and budgeting processes enabling Atlanta Catheter Therapies, Inc. (ACT) to receive a $244,479 grant on our first application. TAMM Nets knowledge of the agency and procedures provided ACT with clear directions to facilitate completing the request. Not only do I highly recommend TAMM Net for obtaining non-dilutive research funding, but we plan to engage TAMM Net again for larger funding opportunities.
    Paul J. Fitzpatrick, CEO
    Atlanta Catheter Therapies, Inc., ("ACT")
  • Richard Wunderlich
    Clinical Trials
    TAMM Net has been an integral and vital partner in our efforts to conduct clinical trials, obtain FDA clearances, and understand reimbursement for interventional pain management. They interacted with FDA to gain direction for clinical trial, gain approval for an IDE in 30 days. Additionally, they authored and submitted a successful 510 (K). TAMM recruited key opinion leaders to serve as principal investigators on pivotal trials, for which they wrote the protocols, in the military and private settings. They successfully negotiated very reasonable fees with the Henry Jackson Foundation and Brentwood Biomedical Institute. They help us refine our training agenda and identified quality cadaver labs. Then, they helped staff and manage those training sessions. I am pleased to recommend TAMM Net without reservations for any of these services. They bring top-notch capabilities and integrity to each project, which is why they continue to be a valuable partner after five years.
    Richard Wunderlich
    President, Myelotec
  • Suzanne Babcock
    Reimbursement & Regulatory
    TAMM Net has been a valuable partner helping us navigate reimbursement and regulatory. They coordinated our activities with CMS including a successful C-code application and connected us with policy representatives in medical societies. TAMM Net’s regulatory team efficiently wrote and submitted our successful 510(k) application for CivaSheet. They have helped our company meet key milestones. We continue to work with TAMM Net because of the professionalism and effectiveness they bring to each task.
    Suzanne Babcock
    CEO, CivaTech

 

Leadership Team

TAMM Net is led by a world-class team of experienced biomedical professionals

Arthur F. Spalding

President

(678) 429-2978


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

Director, Regulatory Affairs

(xxx) xxx-xxxx


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

Director, Clinical Research

(xxx) xxx-xxxx


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

((To come))

(xxx) xxx-xxxx


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.

Jennifer Short, RN

Regional Director, Clinical Research

(xxx) xxx-xxxx


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

Director of IT

(xxx) xxx-xxxx


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.