"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 trail update

evoCryo2.jpg

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