Coldchain

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Coldchain Technology Services, located in Spring Branch, Texas, was founded in 2006 and is a Service Disabled Veteran Owned Small Business focused on providing cold chain management solutions for the storage and distribution of time temperature sensitive products. CTS qualifies as a small business under the NAICS code 322212, size standard 750. CTS operations meet or exceed current Good Manufacturing Practices (cGMP) regulatory compliance standards as outlined by the FDA and are VAAWD accredited for drug distribution and supply chain design.

Global Medical Material Supply Chain Solutions Provider

CTS has extensive experience in developing shipping systems, supplying thermal shippers, creating shipping protocols, and managing drugs, supplies, and emergency asset materials. The founder and owner of CTS served as the Associate Director of Logistics for the Centers for Disease Control and Prevention’s Strategic National Stockpile (SNS) from its inception, through its rapid post-9/11 expansion, and continues to provide Subject Matter Expertise to the program. CTS upholds a strong tradition of innovation and leadership, introducing industry-defining systems, technologies, quality programs, compliance processes, and enterprise-wide inventory optimization initiatives.

One example of CTS’s innovation is the development and use of the reusable high-performance insulated thermal shipper within a closed-loop system of supply and reclamation. This system includes full disassembly and sanitization (per the Validated SHIP2Q Process) of the shipper prior to reuse. This innovative approach reduces landfill waste by 100%, enhances performance, and allows the shipper to be used up to 50 times before being fully recycled and repurposed, delivering significant cost savings to clients.

CTS and its founder have developed sophisticated logistics management services and readiness-related software applications for multiple government and commercial clients, including the US Army, the Centers for Disease Control and Prevention, Reserve Component forces, Johnson & Johnson brands, and the Chicago Department of Public Health. Our services cover the full spectrum of logistics, including selection, sourcing, qualification testing, receipt, storage, distribution, utilization, kitting, recovery, and redistribution. CTS has established and operated specialty warehouses supporting the H1N1 campaign and other pandemic response events. At these warehouses, CTS has supplied and maintained insulated thermal shippers and refrigeration packs needed to kit and deploy drugs for up to six million patients to dispensing clinics

 

Exec Team With 80+ Years Vaccine and Medical Material Management Expertise

CTS is dedicated to serving the needs of various commercial and government agencies, with medical readiness as its core business. With over 30 years of combined experience in cold chain management, CTS excels in Research and Development, First Article Testing (FAT), Validation, SOPs, Storage and Warehousing, Process Management, Distribution, Transportation, cGMP Compliance, Training, Regulatory Consulting, and Monitoring solutions. CTS designs, validates (to GDP/ICH/WHO/GMP standards), manufactures, assembles, distributes, and recovers thermal shippers intended to deliver critical lifesaving medical materials globally. This comprehensive capability positions CTS as a valuable partner to the DLA mission, ensuring the highest safety, efficacy, and potency in the distribution process of medical materials.

As the primary contractor to the Bureau of Health Preparedness and Emergency Response, Chicago Department of Public Health, CTS designs, tests, and deploys all medical countermeasure kits for the Chicago metropolitan area. During the 2009 H1N1 response, CTS managed the receipt, maintenance, kitting, and distribution of 900,000 doses of influenza vaccine and 1.2 million doses of Tamiflu, achieving the highest “take” rate of any project area. CTS ensures compliance with all state and federal regulations in centralized storage, distribution, and delivery of vaccines and countermeasures. Additionally, CTS trained 34 hospitals and 7 clinics on proper storage, handling, reverse logistics, and medical waste retrieval. Chicago set the “gold” standard for pandemic response, meeting or exceeding Federal goals before any other project area in the country.

CTS is a unique organization, we provide the world’s leading technology in temperature controlled shippers and perform pinpoint distribution of drugs all over the world.

CTS employs some of the leading subject matter experts in medical material management and logistics for time and temperature-sensitive products. Our owner, Mr. Wayne Williams, contributed to developing the first evaluations, specifications, and qualifications for the current CID and packout protocols used by depots when loading shippers with products for delivery while at USAMAA.

If awarded this contract, CTS will provide not only the appropriate insulated shippers but also the expertise in their utilization, drawing on our practical experience in similar work with the DLA. CTS has the capability to supply insulated thermal shippers and assist the DLA in continuously improving its program. Unlike past awardees such as Thermosafe and CCT, which are primarily manufacturers and suppliers, CTS has direct experience in packing and distributing vaccines and drugs, enabling us to address deficiencies and proactively enhance distribution processes.

CTS is required to meet strict regulatory compliance guidelines across our operations. We are a VAWD Accredited Wholesale Distributor by the National Association of Boards of Pharmacy, licensed for the wholesale distribution of drugs in 28 states, and compliant with USP 1079/1083, FDA 21 CFR Part 11/210/211 & 820, ICHQ8/Q10, and ISO 17025, the accreditation standard for testing and calibration laboratories. The CDC vaccine for children program does not recognize testing performed by non-ISO17025 accredited organizations.

Our robust quality control and assurance processes exceed typical insulated shipper suppliers, adding significant value to the DLA beyond the shippers themselves.

Medical Logistics, Medical Material Fulfillment, Controlled Environment Pharmaceutical Storage & Distribution, Emergency Services Planning and QA/QC, Temperature Monitoring Systems, Monitoring System Oversight and Alert Center, Inventory Management of Medical & Surgical Supplies, and Coldchain System Evaluation/Design

  • VAWD Accredited Wholesale Distributor by the National Association of Boards of Pharmacy
  • Licensed for the Wholesale Distribution of Prescription Drugs in 26+ States
  • USP 1079/1083, FDA 21 CFR Part 11/210/211 & 820, ICHQ8/Q10, ISO 17025 Compliant
  • FDA Part 11 Compliant Electronic Inventory Management System
  • All Facilities and Materials Continuously Monitored and Electronically Controlled
  • Oversee and Manage >100,000 Square Feet of cGMP/GDP Facility Space
  • Independently Audited and Qualified for Processing, Packing, Holding, and Distribution Finished Pharmaceuticals
  • Exec Team with 80+ Years of Vaccine & Drug Logistics Subject Matter Expertise
  • Maintain Electronic Inventory Management Platform for 55+ Hospitals and Chicago Department of Public Health

"Anything less than total product protection for critical life-saving medicines is not an option.
Coldchain Technology Services is committed to protecting the patient by safeguarding the integrity of time and temperature-sensitive medical materials throughout the entire life cycle, from manufacturing to distribution, issue, and disposal."

- Wayne Williams, CEO

Our Team

Wayne Williams

Wayne Williams is the Executive Director of Warehouse Asset Management (WAM) and Coldchain Technology Services (CTS). Previously, Mr. Williams was the Director of Logistics for Logistics Health Inc. (LHI) and was responsible for management and oversight of LHI’s Supply Support Technology Group, General Logistics Council for all logistical operations for LHI and the primary inventor for LHI’s Environmental Witness System. Prior to LHI, Mr. Williams was the Associate Director of Logistics for the Strategic National Stockpile Program, a federal program managed by the Department of Health and Human Services, Department of Homeland Security, and the Centers for Disease Control and Prevention. As the lead logistician for the Strategic National Stockpile Program (SNS), Mr. Williams was responsible for coordinating the movement of SNS assets during the terrorist attacks at the World Trade Center and the anthrax attacks of 2001. He has also coordinated asset response for many additional incidents including the cyanide truck hijacking in Mexico, the Houston floods, and the Winter Olympic Games in Salt Lake City. Mr. Williams has participated in numerous exercises at the federal, state, and local levels regarding asset deployment in a terrorism or mass casualty event, including TopOff 1 in Denver. Mr. Williams is one of the nation’s leading experts on Cold Chain Management and has lectured and written several key documents describing this process. These processes are currently used within the Supply Support Technology Group at LHI, Strategic National Stockpile Program and the Department of Defense Distribution Operations Center at US Army Medical Materiel Agency, where he developed these procedures.

When dealing with temperature sensitive, high value, critical products, experience counts. Mr. Williams and his companies’ staff have over 30 years of combined experience in every aspect of the cold chain management process to include: Research and Development, Validation, SOPs, Storage and warehousing, Process management, Distribution, Transportation, current Good Manufacturing Practices (cGMP) compliance, Training, Regulatory consulting, and Monitoring. Mr. Williams and CTS will perform the warehouse functions associated with the contract, including shipping and receiving, kit assembly, stock control, and cold chain management. CTS maintains the operation of these functions at its warehouse center in Spring Branch, TX (San Antonio).

David J. Croyle M.D.

M.D. Imaging/Neuroradiology
Dr. Croyle received his B.S. from Gannon University in Erie, PA and completed his M.D. at the Uniformed Services University of the Health Sciences in Bethesda, MD. Dr. Croyle completed his internship and diagnostic radiology residency at Brooke Army Medical Center in Fort Sam Houston, TX. In addition, Dr. Croyle completed a body imaging fellowship at the Naval Medical Center in San Diego, CA and a neuroradiology fellowship at Georgetown University Hospital in Washington D.C. He was also an instructor of radiology at Tripler Army Medical Center, Hawaii.

Board Certified Date
American Board of Radiology, 1993
National Board of Medical Examiners, 1989
Professional Memberships
American College of Radiology
American Roentgen Ray Society
Cape Girardeau County Area Medical Society
Missouri State Medical Association
Radiological Society of North America

William McBride

William McBride, is the Director of Corporate Compliance for Coldchain Technology Services, BS in Biology from Frostburg State and a Master of Science in Quality Assurance (MSQA) Degree from California State University

  • Implemented GMP quality assurance system at one of the nation’s largest biological specimen repositories. Managed over 12 million samples, over 600 individual pieces of refrigeration equipment, over 800 recording instruments, and 6 separate facilities.
  • Initiated the first sponsor managed inventory facility for the National Pharmaceutical Stockpile (now Strategic National Stockpile)
  • Co-founder of LabPro; a quality assurance consulting and temperature monitoring solutions supplier. Developed initial quality system for the Strategic National Stockpile, Massachusetts Veterans Epidemiology Research and Information Center, Panther II Transportation, and Logistics Health, Inc.
  • Manager of Compliance and Program Evaluation at Logistics Health, Inc. Headed up quality assurance unit for the Environmental Witness System (EWS), a temperature monitoring platform that was designed to be a call-center solution.
  • Facility Operations Manager (Metro-Logics) for 350,000 sq. ft. pharmaceutical logistics warehouse holding over 38,000 room temperature pallets and 5,000 refrigerated pallets. Facility housed materiel in the Strategic National Stockpile.
  • Responded to national and international emergencies: 2009 Spring and Fall H1N1 response, Japan earthquake response, Haiti earthquake response. All 67 project areas were shipped to during H1N1 response.
  • Passed audits for the storage of investigational new vaccines related to the possibility of biological warfare.
  • Maintained over 99% accuracy rate for all years working on project.
  • Managed a surge staff of over 120 employees for emergency response.

Director of Corporate Compliance at Coldchain Technology Services. Obtained verified accredited wholesale distributor status through the National Association of Boards of Pharmacy

Scott Bullard

Scott Bullard works directly with Warehouse Asset Management (WAM) and Coldchain Technology Services (CTS). Teaming with Merck in 1994 for his first major vaccine production validation project, Mr. Bullard has over two decades of experience in operations, business development, validations, manufacturing, movement of large scale time & temperature collections, infectious material management & relocation, regulatory compliance, and quality assurance in cGMP environments, protocol/procedure authoring, cGMP compliance audits, and practical application of cGMP within warehouse and transportation operations.

Mr. Bullard was involved in the Emergency Response efforts for the 2001 anthrax attacks and brings valuable event response experiences to the team. He was the logistics lead for the City of Chicago Public Health Department’s H1N1 Pandemic Response achieving the highest saturation and earliest completion of any major metropolitan area. As the QA/QC (QCU) Co-Lead for the CDC’s DSNS Program overseeing all material management and regulatory compliance for the world’s largest single stockpile of medical assets and ancillary supplies. He has participated in numerous large scale, planned and unplanned, emergency response / security events providing CBRN countermeasure asset management for the health care mission.

Mr. Bullard brings unique and experience in thermodynamics of ambient/frozen /ultra-low temperature environments and cryopreservation. He spent many years selling laboratory equipment including tissue culture incubators, biosafety cabinets, freezers & refrigerators, centrifuges and ultra-lows. In 1995 he co-founded, the first cGMP biorepository specializing in select agent storage and transportation and the preferred offsite storage for the National Institutes of Health’s most valuable research specimens. He has participated in the design and operation of storage and distribution facilities for temperature-sensitive pharmaceutical products, providing project management from site selection through buildout to day-to-day operations. Mr. Bullard is a founder or co-founder of three national companies in the biopharma services; Key Scientific, now part of ThermoFisher, Cryonix now part of ThermoFisher, and Labpro now part of UnitedHealth.

Currently the Director of Business Development for Coldchain Technology Services in Spring Branch Texas providing Medical Material Management & Supply Chain Solutions to Ensure Comprehensive Product Life Cycle Security via Discreet Pinpoint Distribution and Fulfillment.

Juan Rivera

Juan Rivera is the Director of Information and Technology at Coldchain Technology Services. Juan worked as IT Director of Media Services for a small company from July 2006 to 2014 leading strategic accounts, strategic alliances, information technology and solutions such as the City of San Antonio’s Metro Health directive. Before moving to the San Antonio area in June 2006, He worked in the Semi-conductor arena for Agilent Technologies and J&W Scientific for 6+ years developing applications and infrastructure solutions for application developers. He has worked in the technology arena since 1984, working for companies such as Bank of America for 20+ years holding a variety of positions in hardware and software support, consulting, implementing a family of servers, database, and middleware software and solutions.

His background has changed over the years as an IT Director, Systems Architect and earlier and his career Juan also served as Consultant, Web Developer, Applications developer, DBA, System Admin, Systems Consultant in support of Application Developers and generalist, Infrastructure Support designing, implementing Windows 2008/2003/2000/NT and Linux Networks and Applications Solutions. Juan’s passion is to be an innovative solutions provider. He also enjoys a career in video production.

Clint Wallis

Brings facility systems, large equipment and power platform expertise with the drive and focus of Wyoming farm kid. Clint oversees the Coldchain operations with a no nonsense efficiency working closely with the quality to ensure continued maintenance of the cGMP compliance. Clint’s passion is the customers he serves and with whom he shares a very strong bond.