Hello From ISCT - London!

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Having a terrific time at ISCT 2017 - London.   We are here through Saturday, May 6 and are sharing booth space with our partner, BioLife Solutions.   Come visit us at Booth 410!

Response to the announcement of our new dry vapor shippers, and the evo® 2-8 XL has been overwhelming.  Thanks to all who have stopped by the booth so far to discuss working with us.  This conference has such intelligent, imaginative people doing such interesting things...fun to talk to!

DV-4 is a smart dry vapor shipper designed for domestic shipments of 4-5 days duration (example: within US and Europe).   DV-4 is about half the size of full sized dry vapor shippers, still has a wide neck to accommodate full size cassettes, charges in 20 mins, uses the same evo Vision cloud based platform as all other evo products, and cleans easily.  

DV-10 is our long range dry vapor shipper, offering 10-15 days autonomy, and, like the DV-4,  features our new Fusion technology which speeds charging, dramatically improves dynamic performance, and improves protection of precious  payloads.

evo 2-8C XL is designed primarily for larger volume, fresh cell, inbound shipments.   Simple pack out , very long autonomy, and the evo Vision platform combine to give leading biotech companies and specialty couriers unprecedented information and control over their process.  The evo Cold Chain 2.0 system significantly lowers risk in one of the riskiest sections of the suppy chain. 

See you at the booth,

Dana

SAVSU Technologies Announces New evo® DV™ line of Dry Vapor Smart Shippers with New Fusion™ Technology

SAVSU Technologies Announces New evo® DV™ line of Dry Vapor Smart Shippers with New Fusion™ Technology for Rapid Charging and Superior Dynamic Performance

 

-196°C Liquid Nitrogen Shippers Expand Existing Cold Chain 2.0™ System

 

ALBUQUERQUE, NM — May 4, 2017 -- SAVSU Technologies, the leading developer of smart, precision shipping containers and cloud-based cold chain management SaaS solutions, today announced that it is extending its product line with the addition of two new evo dry vapor liquid nitrogen shippers for frozen transport of biologic materials at -196°C. The products are making their debut at The International Society for Cellular Therapy Annual Meeting, May 3-6 in London. Both new models share the brand-new evo Fusion System™ which combines the Fusion Smart Cap™ and Fusion Quick Core™ for extended dynamic performance and dramatically faster charge times. The two new models are the evo DV-4 with four-day autonomy for domestic shipments and the DV-10 with 10-day autonomy for international shipments. The DV-4 is approximately half the weight of standard, full size, large neck, dry vapor shippers.

 

In addition to rapid charging, the new evo Fusion system is safer and easier to load and unload, provides a safer method of storing the biologic materials such as a manufactured cellular therapy, and, in the case of the DV-4, offers improved ergonomics for cell therapy manufacturers and clinicians.

 

Both evo DV models are smart and communicate with evo Vision™, SAVSU’s IoT award-winning,  cloud-based data and communications SaaS. With the addition of the -196°C product line, SAVSU is now the only company offering products to support the entire temperature range (CRT, 2° - 8°C, -80°C and -196°C) for source materials and manufactured cell therapies; all sharing a common data system, specifically designed for live cell therapy companies.

 

evo Cold Chain 2.0 is a disruptive live cell visibility platform consisting of the evo Smart Shipper family and evo Vision cloud-based, live cell visibility platform for temperature sensitive biologic materials and drug products.

 

“Despite numerous requests from our customers to develop an evo shipper in the -196°C range, we said we wouldn’t do it unless we could dramatically advance the existing dry vapor shipper technology. We don’t do ‘me too’ products,” said Bruce McCormick, President of SAVSU. “Well, now we have done it!  With the development of the new evo Fusion technology powering our new evo DV line, we have significantly advanced dry vapor shipper technology, which hasn’t changed much in 40 years. We believe these are important new products to support the commercialization of new personalized cell therapies.”

 

Both new evo DV models will be available for order on May 3, 2017.   Visit SAVSU at the BioLife/SAVSUbooth at ISCT in London.   For more information, please visit www.savsu.com.

 

 

About SAVSU Technologies

 

SAVSU is a leading designer and manufacturer of innovative high performance cloud-connected passive storage and transport containers for temperature sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials. For more information please visit www.savsu.com.

 

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SAVSU and TrakCel announce collaboration to integrate Cell Therapy Manufacturing and Cold- Chain data management platforms

Integrating Cell Orchestration and Live Cell Visibility Platforms Will Provide Enhanced, Auditable Vein-to-Vein Documentation Supporting Clinical Trials, Commercial Distribution and Reimbursement of Cell-Based Therapies  

  

ALBUQUERQUE, NM and CARDIFF, UK — April 25, 2017 -- SAVSU Technologies, the leading developer of smart precision shipping containers and cloud-based cold chain management SaaS solutions, today announced that that it will collaborate with Cardiff-based TrakCel Ltd to integrate  its evo® Cold Chain 2.0™system with TrakCel’s Cellular Orchestration Platform™.

evo Cold Chain 2.0 is a disruptive live cell visibility platform for management of time and temperature sensitive biologic materials powered by the evo cloud-connected Smart Shipper and evo Cold Chain Management SaaS. This cloud-based, cold chain management platform integrates shipping container pack-out, freight carrier selection and purchase, and real-time GPS location and payload temperature monitoring, with critical alerts provided to stakeholders in the clinical delivery chain, including shipment, approaching destination, delivered, opened and remaining shelf life.

TrakCel’s Cellular Orchestration platform facilitates efficiency and compliance to quality standards in cell therapy manufacturing by enabling program-critical information to be collated, tracked and and documented. Detailed processes and managed workflows for every participant in the value chain enable safe and efficient scaling outward and upward as production increases. Conditional logic workflows for all participants including clinicians, logistics and manufacturing partners ensure standardization and compliance with validated procedures.

Bruce McCormick, President of SAVSU Technologies, remarked, “Our optimized technologies represent the next generation of integrated, cloud-connected cold chain technologies. We are very pleased to collaborate with TrakCel and look forward to integrating our respective data platforms to provide even more value to our mutual customers. We are committed to driving a paradigm shift away from traditional, risk-laden cold chain practices based on the use of poor performing shipping containers and disconnected data systems.” 

Ravi Nalliah, CEO at TrakCel, commented, “We scoped the packaging and cold chain technologies space to identify best of breed ecosystem partners. SAVSU is so far ahead of traditional container and data logger suppliers, and we are very keen to integrate their innovations into our Cell Orchestration Platform. The timing of this collaboration is perfect as the cell therapy market continues to mature and awareness is peaked on the need to use better tools to enable clinical trial success, commercial scale-out, and reimbursement supported by evidence of compliance throughout manufacturing, distribution and patient administration.”

 Chain Link Research and Pharmaceutical Commerce market research estimate that there are 80 million to 130 million annual temperature sensitive pharmaceutical shipments requiring cold chain management, resulting in $12 billion spent annually on cold chain logistics, with $9 billion for transportation and $3 billion for specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase change materials, temperature sensors and dataloggers. The use of currently available cold technologies results in $15 billion to $35 billion spent annually replacing products lost due to temperature excursions.

 

About SAVSU Technologies

SAVSU is a leading designer and manufacturer of innovative, high performance, cloud-connected passive storage and transport containers for temperature-sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials. 

For more information please visit www.savsu.com.

 

About TrakCel

TrakCel's cell, gene and immunotherapy management solution improves clinical study efficacy and accelerates global scale-up and scale-out by implementing communications technology to integrate the delivery path from needle-to-needle. The technology provides interactive instructions to

professionals across the supply chain and gives stakeholders on-demand visibility of procedural results and chain-of-custody data for immediate traceability, validation and compliance audits. 

TrakCel technology is increasingly being adopted by leaders in the cell, gene and immunotherapy industry. TrakCel is headquartered in Cardiff, Wales with a U.S. offices in Newport Beach, Californiaand Bridgewater, NJ. 

 

For more information please visit www.trakcel.com

 

SAVSU Media & Investor Relations                                      

Dana Barnard                                                                                       

Chief Executive Officer                                                        

SAVSU Technologies, Inc.                                                                   

505.466.1962

info@SAVSU.com

 

 

TrakCel Media & Investor Relations

Hannah James

Marketing manager

TrakCel Ltd.

pr@trackcel.com

Stem cells offer hope for autism

Stem cells offer hope for autism

 

Fascinating article/news piece on CNN.  Very early study using stem cells to treat autism.

"Cautious Optimism.....Kurtzberg has a hypothesis about what may be happening: that certain immune cells within the cord blood are crossing the blood-brain barrier and altering brain connectivity while also suppressing inflammation, which may exist with autism."

Read article here

Interview with Sam Herbert - World Courier

Very good interview with Sam Herbert, President - World Courier, in American Pharmaceutical Review.   Sam describes the unprecedented complexity that cell and gene therapy companies are facing as they begin to commercialize their therapies.

 

 "Because the patient’s own body is part of the product—and therefore part of the manufacturing and supply chain processes—cell and gene therapy manufacturers face complexities that are orders of magnitude greater than many other specialty and orphan products."
Sam Herbert   President - World Courier

Read more here:

 

Fisher BioServices - Packaging Qualification Webinar

Fisher BioServices - Packaging Qualification Webinar

"The experts at Fisher BioServices have an extremely informative presentation on Process Validation and Packaging Qualification. They also cover the critical considerations of dynamic testing, packaging orientation, and payload specifically qualification.

This is essential information for the handling of bio materials used in Cell and Gene Therapies. This presentation highlights many of the dynamic process issues that we take into account when designing our EVO® products."

Bruce McCormick, President - Savsu Technologies

Find video blog of webinar here.

 

"This is the future of medicine. There is no turning back"

Albuquerque: SAVSU's Kevin O'Donnell presenting at Global Clinical Supply Group's 2017 Annual Conference

SAVSU will be co-presenting Supply Chain Requirements for Cell & Gene Therapy workshop at the Global Clinical Supply Group Spring Conference at the Hyatt Regency Tamaya Resort & Spa in Albuquerque, NM, on April 24th and 25th, 2017.  

This marks the 30th year for the Annual Conference. The workshop will be delivered over two days by Kevin O’Donnell, VP Cold Chain Standards, Practices & Compliance at SAVSU Technologies, and Krisztina Poda, Director of Business Operations Cell/Gene Therapy, at Pfizer Inc., Global Clinical Supply.

This will be the first year GCSG has had a workshop specifically targeting Cell & Gene Therapy clinical trials.

Workshop Title:  Supply Chain Requirements for Cell & Gene Therapy

Description:

The distribution and handling of precious gene therapy supplies requires a higher level of controls to ensure quality and sustainability.

Learning Objectives:

Attendees will be able to:

(1) Compare and contrast the logistics requirements of standard cold chain products versus cell and gene therapy products

(2) List at least two (2) concerns in the handling of cell and gene therapy clinical materials

(3) Describe the appropriate classification and labeling of cell and gene therapy products to ensure compliant transportation

"Can CAR-T Be Tamed?"

"Administering CAR-T therapy isn’t like dispensing pills or infusing chemotherapy. Treating patients with CAR-T “requires an immense amount of planning and coordination and meetings,” says Fathi of Massachusetts General Hospital. He ticks off a long list of personnel who have to be in the loop, including cell processing experts, nurses, clinical trial coordinators, lab researchers, pharmacists, and physicians who specialize in infectious disease, pulmonary and critical care, and neurology.  "   

From the article "Possible Cures. Mystery Deaths. Daunting Costs. Can CAR-T Be Tamed?"

http://www.xconomy.com/national/2017/03/13/possible-cures-mystery-deaths-daunting-costs-can-car-t-be-tamed/?single_page=true

 

These advanced live cell therapies demand a new, "many-to-many" communication system because "a long list of personnel have to be in the loop".   As these therapies get closer to commercialization many parties are recognizing the need for a new approach as existing systems cannot offer a solution.  Cold chain 1.0 is a "1-1" communication system (shipping clerk to shipping clerk), where data are received post-transport and generally relying on manual notification to stakeholders after-the-fact.  The evo® Cold Chain 2.0™ communication system is uniquely designed specifically for the challenges of moving live cell therapies - across campus, across country, or across the globe.   It simplifies the task of keeping many parties in the loop by transmitting real-time (or near real-time) data to assignable key personnel, providing timely, relevant, and actionable information.

Go Boldly!

"Dylan Thomas penned "Do not go gentle into that good night" in 1947, but the sentiment is as timely today as it ever was. Millions of Americans are battling serious illnesses, but they’re not alone in the fight. They have the support of thousands of biopharmaceutical researchers whose lives are dedicated to helping patients go boldly into longer, healthier, and more productive lives."      
--America's Biopharmaceutical Companies (https://goboldly.com/research)

These videos are inspiring.  The more we work with the people in the biopharmaceutical industry the more excited we are about where medicine is going, and the part we are playing in that future.   The story of these researchers and the technology that they have created needs to be told.  Boldly!  (https://goboldly.com)

(Note: Dylan Thomas' poem below the video)

Do not go gentle into that good night

 

Do not go gentle into that good night,
Old age should burn and rave at close of day;
Rage, rage against the dying of the light.
 
Though wise men at their end know dark is right,
Because their words had forked no lightning they
Do not go gentle into that good night.
 
Good men, the last wave by, crying how bright
Their frail deeds might have danced in a green bay,
Rage, rage against the dying of the light.
 
Wild men who caught and sang the sun in flight,
And learn, too late, they grieved it on its way,
Do not go gentle into that good night.
 
Grave men, near death, who see with blinding sight
Blind eyes could blaze like meteors and be gay,
Rage, rage against the dying of the light.
 
And you, my father, there on the sad height,
Curse, bless, me now with your fierce tears, I pray.
Do not go gentle into that good night.
Rage, rage against the dying of the light.
 
Dylan Thomas, 1914 - 1953
https://www.poets.org/poetsorg/poem/do-not-go-gentle-good-night
 
From The Poems of Dylan Thomas, published by New Directions. Copyright © 1952, 1953 Dylan Thomas. Copyright © 1937, 1945, 1955, 1962, 1966, 1967 the Trustees for the Copyrights of Dylan Thomas. Copyright © 1938, 1939, 1943, 1946, 1971 New Directions Publishing Corp.. Used with permission

SAVSU will be at ISCT London. May 3-6

We will be attending and exhibiting at ISCT's annual conference in London, England May 3-6 with our partner BioLife Solutions.   New product announcements!  See you there.

 

http://www.celltherapysociety.org/event/id/851712/ISCT-2017-London-Annual-Meeting.htm

Albuquerque Business Journal

Emerging ABQ bioscience company scaling up, looking to hire.

"Currently we're looking for software developers and we'll be filling out operations roles in the next several months,"
Dana Barnard, CEO SAVSU Technologies

phase 3 clinical trial update

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SAVSU Technologies Provides Performance Update on evo® Cold Chain 2.0™ System in ImmunoCellular Therapeutics Phase 3 Glioblastoma Cell Therapy Clinical Trial

"We have been extremely pleased with the performance of the evo® Cold Chain 2.0™ system for use in our phase 3 study. The unique uni-directional packout prevents errors in packaging and makes it very simple for our clinical sites to package the starting apheresis product for shipment to our manufacturing facilities. Validation of tight temperature stability in every shipment is critical, and we have not experienced any temperature or packaging deviations since switching to evo®. It is clear that an enormous amount of thought and testing went in to the design of the evo® system."

New biz Structure

SAVSU and BioLife Solutions Restructure biologistex™ Joint Venture

Consolidation of Cold Chain Technologies Enables External Investment in evo™ Smart Shipper and biologistex SaaS Opportunity

We have a long list of exciting product and business announcements that we look forward to sharing in 2017. As the pace of innovation increases, having evo product design and development, IT development and environmental testing all under one roof is a significant improvement for us.

Bruce McCormick, President SAVSU Technologies