An Analysis Of 2017 FDA Warning Letters On Data Integrity by Barbara Unger

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Interesting article about the focus on "Data Integrity" by the FDA by Barbar Unger, Unger Consulting, in BioProcess Online.  Read the full article HERE.

 

Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions.

The FDA initiated enforcement actions in this area as early as 1999 and continued to the point where the last three years have seen data integrity cited in 68 to 80 percent of warning letters. We have seen ever-increasing participation by global health authorities.

Executive Management Ownership

  • Executive management must understand that health authority focus on this area is not going to diminish. Data governance applies to both paper and electronic data throughout its life cycle.
  • Executive management must establish and maintain a corporate culture of openness where employees may report problems and failures without fear of retribution. In fact, reporting of problems should be encouraged and rewarded.
  • Executive management must own the gap assessment process and remediation efforts. Remediation may be costly and time-consuming. Firms often uncover additional problems along the way. Don’t expect to complete remediation quickly; it’s often a multiyear process.

 

Savsu and Doctors Without Borders in the Ebola fight

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While Savsu's main business focus is providing thermo informatic systems for the regenerative medicine marketplace, our roots are in creating products for the public health market and we still are actively engaged with non-profits and NGO's working on the front line against terrible diseases like ebola and monkey pox.   Savsu's complete line of  "quiet" evo devices are designed to be rugged, simple-to-use, effective protectors of vital medicines and vaccines that work in difficult conditions.   The CryoQ in particular has played a vital role in combating recent ebola outbreaks and is being used by the World Health Organization and Doctors Without Borders.

While we are very happy to contribute to this global battle, the real heroes are the volunteers who are working on the front line in difficult and confusing situations.   In this post we want to highlight the effort of Doctors Without Borders (Medecines Sans Frontieres) who are seemingly everywhere there is a need for critical medical help.

The first link is to a post on their website updating readers on the latest reemergence of the ebola virus in the Democratic Republic of Congo.  

"Unlike in previous Ebola outbreaks in DRC, where cases have been concentrated in remote villages, patients have now been diagnosed in Mbandaka, a Congo river port city of more than one million inhabitants. While easy access to transportation routes increases the risk of the virus spreading, surveillance is being reinforced."

The second link is an NPR interview with Leah Feldman, a nurse form Maryland and a volunteer with Doctors Without Borders, giving a glimpse of what it is actually like to be in theses remote areas fighting an outbreak.

"Well, you try to breathe because it's very hot. And make sure you don't have fog on your glasses. The taking of the sample is exactly the same as for any nurse who does a blood sample anywhere — but be very, very careful with the needle. Make sure you have all your materials with you before start, then just take a normal blood sample."     Leah Feldman via NPR

Savsu's Public health page opens with the statement "We believe global health starts with local health."  Our quiet evo products are designed to deliver and protect life saving medicines in challenging environments to protect "local health" wherever that maybe.   However, organizations like Doctors without Borders, WHO and volunteers like Leah Feldman are the ones who put themselves at risk to make it work on behalf of all of us.   

You can donate to support Doctors Without Borders HERE .

Xconomy: With Roche Data, Cancer Combos Post First Win Vs. Small Cell Lung Cancer

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"Cancer immunotherapy combinations continue to chalk up wins against lung cancer. For the first time, an immunotherapy-chemotherapy combination has succeeded in a late-stage study of patients with small cell lung cancer (SCLC), a particularly aggressive form of the disease often linked to smoking."

--Xconomy, June 25, 2018

Interesting article about combinations therapies successfully fighting small cell lung cancer for the first time.   Therapies combining immunotherapies and chemotherapies are already being used to treat non-small cell lung cancers.  Read the full post HERE

FDA to issue guidance on cell and gene therapy in July

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Gottlieb pointed to the hundreds of Investigational New Drug applications currently in place for cell and gene therapies, citing one study that suggests as many as 40 of these drugs could be approved over the next few years.....

”A lot of the complexity with gene therapy is in product-related issues, not the clinical issues. Whereas with normal drug review, I’d say 80% is the clinical portion and 20% is the CMC and product portion of the review,” he said, referring to the Chemistry, Manufacturing and Controls section of an application.

”I think with gene therapy and cell-based regenerative medicine it’s completely inverted. We’re having to think very differently about the regulatory issues with these.”
— Scott Gottlieb, Head of the FDA as quoted in post at BioPharma Dive

FDA guidelines should be very interesting.  They recognize the growth and potential in this area.   Read the whole post at BioPharmaDive, here.

Busting Entrepreneurial Myths in New Mexico

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Three entrepreneurs in the high desert of New Mexico are shattering an important myth – that there is not enough talent in the interior of the USA to create world-class companies...

...The implications for the rest of the country are significant.  For managers, the moral is that you can thrive outside the traditional centers of business, by adjusting your approach to talent.  For venture capital investors, the lesson is that you can make excellent returns by backing the right entrepreneur – the likes of Andy Lim, Chris Ziomek, and Terry Dunlay – who will find talent, even in the desert.

--from the article    "Lim, Ziomeck, Dunlay – Busting Entrepreneurial Myths in New Mexico"  June 1, 2018 by Kevin R. McDonald

Great article by Kevin McDonald (an investment banker in Albuquerque, NM) about entrepreneurs here in the state, attacking a myth about New Mexico: that you can't find talent for start-ups.   You absolutely can...you just may need a different approach.

Savsu is delighted to be located in Albuquerque, NM.  We love our town and our state.  We are hiring and finding really smart, talented young people who love life in ABQ.   Here is a little secret:  Albuquerque and Santa Fe are attracting an increasing number of tech businesses like ours.  Why? Great technology (UNM, Sandia Labs, Los Alamos Labs), great weather (for golfing, hiking, mountain biking, skiing, rafting), great beer (really great beer...see article here), great food, great art and a great airport (yeah you usually have to connect but, you can park right next to the terminal and walk in for Pete's sake!).  Oh and it is affordable.   Come visit.

Read Kevin's article HERE

Immune cells from the woman’s own body used to wipe out tumours

  Judy Perkins says her condition had deteriorated a lot and she was planning her death. But since the treatment she has been on a 40 mile hike. Photograph: Courtesy of Judy Perkins  from article in the Guardian "Doctors hail world first as woman’s advanced breast cancer is eradicated".   Link below

 Judy Perkins says her condition had deteriorated a lot and she was planning her death. But since the treatment she has been on a 40 mile hike. Photograph: Courtesy of Judy Perkins  from article in the Guardian "Doctors hail world first as woman’s advanced breast cancer is eradicated".   Link below

I had resigned my job and was planning on dying. I had a bucket-list of things I needed to do before the end, like going to the Grand Canyon,” she added. “Now, I have gone back to normal everyday life.
— Judy Perkins

Every so often a story comes along that really highlights the promise (and increasing reality) of the new cell therapies.  This story that ran in several sources yesterday is one of them.  Judy Perkins was at death's door, having exhausted all other treatment options.   An experimental cell therapy cured her advanced breast cancer.  

“We are now at the cusp of a major revolution in finally realising the elusive goal of being able to target the plethora of mutations in cancer through immunotherapy,”  
— -Laszlo Radvanyi, scientific director of the Ontario Institute for Cancer Research.

Someday this will be routine but, for all of us it still feels like a miracle.  Everyone at Savsu is proud to be working in this incredible industry right now.

Read the full article at The Guardian web site HERE

Overstuffed! We Are Moving

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New people, new equipment, new services:  We need a bigger facility...so, we are getting one!  

Very excited to announce that we will be moving Savsu's Design and Technology Center to a wonderful, new facility in Albuquerque, NM.   Still finalizing things so we can't disclose the location yet but, here is what we can tell you:  it's not too far away from our current facility, it is big enough to support our near term growth, and we expect to complete the move in July, 2018.  

Team Savsu is already in full design, plan and move mode.   We will be working nights and weekends until completion but, we don't expect any noticable disruptions in the flow of new products to you.

More info soon!

 

 

New Stuff @ Savsu!

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extreme surf warning!

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Fun and crazy week here at Savsu! We are in Montreal (coffee and food are great) and announcing a bunch of new stuff:   

1) We are at ISCT 2018 in Booth 718.   Come see us at (Palais des Congrès de Montréal ) and we can demo our evo.is® v1.0 software and talk to you about our new evo extreme™ models (see below)!

2)  Today we launched evo.is v1.0, a major upgrade to our cloud based software.  evo.is v1.0 has a ton of changes to the underlying code, setting us up for new features arriving later this year.   However, the most visible changes are to the User Interface!   We spent the past year training, talking, and watching how you worked with our earlier version of the software and built a brand new UI to make it easier and more "error free" to set-up shipments and to manage evo inventory.    We also overhauled our powerful communications section.    You can read all about it in the evo.is blog HERE.  Please note that both V 0.9beta and V1.0 are still accessible and compatible so, you can play with v1.0 and move when you are ready (we think you will want to adopt it quickly...it's that good).

3) On the hardware side, we continue our fast and furious product development and today are announcing two new products that begin what we are calling our evo extreme line.   You asked and we responded: both models use new technology to push performance in the 2-8C and -80C temp ranges to extreme levels.   Like other evo models, the extreme series offers a flexible trade-off between payload size and autonomy based on your particular needs.   Both models can comfortably offer 10+ days of autonomy in a small, reusable shipper.   This is allowing our early customers to do some really cool, creative stuff with their supply chain management, from clinical trials through commercialization.    Like all evo's, the new extreme models are smart and use our evo.is cloud based information and communication system.   

Click HERE to read the announcement that we sent out this morning.   And...if you can't visit with us in Montreal, you can contact us to talk about the new stuff (or the old stuff), HERE

Stay tuned, more announcements coming in the next few weeks!

Cheers!

(Oh and following up our extreme surfing theme...check out the video below of surfer riding an 80-foot wave.  Yikes!)

Beating Leukemia

  Emma Whitehead, with her mother, Kari. Last spring, Emma was near death from acute lymphoblastic leukemia but is now in remission after an experimental treatment at the Children’s Hospital of Philadelphia.    CreditJeff Swensen for The New York Times    

Emma Whitehead, with her mother, Kari. Last spring, Emma was near death from acute lymphoblastic leukemia but is now in remission after an experimental treatment at the Children’s Hospital of Philadelphia.   CreditJeff Swensen for The New York Times 

 

“These T-cells are living drugs. With a pill, you take it, it’s eliminated from your body and you have to take it again.” But T-cells, he said, “could potentially be given only once, maybe only once or twice or three times.”

Beautiful story.   Emily Whitehead received an experimental CAR T treatment back in 2011 that saved her life and then, in 2018, wrote a tribute to Dr. June in Time magazine's 2018 Time 100 list (here).   More extensive article in NYTimes from 2012 (here).   Dr. June's page at University of Pennsylvania - Perelman School of Medicine (here)

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See you in Montreal!

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Savsu will be exhibiting at ISCT Annual Meeting at Palais des Congrès de Montréal, May 2-5.   Come visit us in booth 718!   We will have a -80C evo and DV4 and DV10 in the booth to show you.

(Workshop) Logistics: Connecting Patients to Advanced Therapies at Clinical & Commercial Scale

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Date:  25th & 26th April 2018

Location:  World Courier Heathrow (Feltham, United Kingdom)

Savsu's Bruce McCormick will be presenting at this workshop which is part of World Courier's Knowledge Series.   Other workshop participants are from World Courier, Trakcel, and Catapault (see below for more detail on presenters).   You can register here

"2017 was a tipping point for the advanced therapy industry. Reaching commercialization more rapidly, the industry is now presented with new challenges to its logistics infrastructure. Creating commercially viable supply chains is essential but requires the definition of a logistics platform that enables therapies to efficiently move through it as required, in the early stages of the process.
This workshop intends to provide an environment for industry professionals to meet and exchange with other subject matter experts, facing similar challenges in their own supply chain. The interactive format will consider aspects related to current and future business models for each industry as well as the challenges moving from clinical to commercial stage. This session will include workshops with industry leaders providing additional input and insights into how to integrate operations and build a logistics platform."

Presentors:

Jacqueline Barry is Chief Clinical Officer at Cell and Gene Therapy Catapult. Prior to this she worked at the Scottish National Blood Transfusion Service in a number of senior regulatory and quality positions, the responsibility for which included designing the regulatory strategy for the Cellular Therapies developed by the Blood Transfusion Service, acting as Responsible Person for Blood and Qualified Person for medicinal product release. Before that she held a number of post-Doctoral academic posts at the University of Edinburgh studying neuromuscular regeneration. She has considerable experience in the development, translation, clinical trial and approval of cell based medicinal products and therapies.

Simon Ellison is the Cell & Gene Therapy Service Director at World Courier. His role is to develop a portfolio of global logistic and supporting service strategies that take the advanced therapy industry forwards. Whilst at the Cell and Gene Therapy Catapult he identified the need for, and built the Seamless Freight portfolio. He also helped develop the commercial operating model for the Catapult Manufacturing Centre that resulted in the first collaborators entering, and the start of a cluster forming around this unique facility. Prior to this Simon was the Head of Commercial at NHS Blood and Transplant (NHSBT).

Bruce McCormick is the Founder and President of SAVSU Technologies. Inventor and researcher, he has been the recipient of a number of US and foreign patents. His commercial products have included an FDA approved medical device for Cardio/Pulmonary indications as well as insulated insoles which were featured in the USPTO museum exhibit on footwear technology. His other work includes sports medicine inventions relating to measuring hidden motion as well as a Garment Fitting System. Bruce has given presentations at many conferences including the IEEE Engineering in Medicine and Biology Society International Conference and the International Conference on Hypertension.

Matthew Lakelin is VP of Scientific Affairs and Business Development at TrakCel. Using his knowledge in handling and distribution of ATMPs he has assisted with the development of TrakCel’s technology platform. Matthew provides a technical bridge between the software development side of the technology platform and the GxP application of the system. He is also a member of the company’s Quality Unit to ensure that development and configuration of TrakCel’s technology platform adheres to a GAMP-5 framework. Prior to TrakCel, Matthew worked as Head of Technical Support for a specialist clinical supplier company.

World Courier - Savsu Global Alliance!

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London, UK and Albuquerque, NM (January 23, 2018) - World Courier, the global leader in specialty logistics and a part of AmerisourceBergen, today announced the availability of SAVSU Technologies’ smart precision shipping containers throughout its network. SAVSU designs and manufactures innovative high-performance cloud-connected passive storage and transport containers optimized for the cell and gene therapy supply chain.

The combination of World Courier’s global logistics network and SAVSU’s patent pending, enhanced temperature-controlled evo DV4 & DV10 liquid nitrogen (LN2) shippers will enable cell and gene therapy developers to more efficiently and effectively move critical biologic shipments at cryogenic temperatures worldwide, with enhanced visibility and shipment monitoring capabilities.

Very excited to announce the beginning of a collaborative program with World Courier.  World is a terrific company with a global footprint.   Our evo product will be distributed globally within their network for use by their cell and gene therapy customers.   Amongst other services, World will be able to rapidly dispatch our DV10 and DV4 units to customers.

If you have an interest in the evo system, you can now contact World's sales and technical team in one of their 140 offices worldwide.

Full announcement here

More Patents For Savsu!

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It is gratifying every time we are granted a patent on our technology.   We have filed a lot of them and more are coming in 2018 (yeah we are working on some really cool new stuff).

Looking at our growing portfolio of patents,  reminds me of how far we have come on this journey of building the evo Cold Chain 2.0 System.   It also reminds me that we do not pursue new technology in this field just for the thrill of accumulating IP.   We pursue new technology because we have a vision and the old cold chain technology has hit a dead end.  With the old tech it was a case of "you can't get there from here...no matter how hard you try".   A radically different approach was required to solve the problem of safely transporting the new cell and gene therapies that are now emerging.   Our vision was for a technically sophisticated system that was easy to use and could scale effortlessly to commercial levels.   Turns out that when we started to build that system, we quickly realized that we were on our own and we would, in the ensuing years,  end up inventing a whole lot of new parts.    That is where the IP comes from...inventing as we go to realize our vision.

Dana 

SAVSU Technologies and BioLife Solutions Increase evo® Intellectual Property Estate with Notice of Allowance of New Patent for Cold Chain Technologies

13 Additional Pending Patent Applications Submitted for evo Smart Shippers, Liquid Nitrogen Dry Vapor Shippers (DVS) and Cold Chain SaaS Application

06:30 ET from  BioLife Solutions, Inc.

BOTHELL, Wash. and ALBUQUERQUE, N.M., Jan. 18, 2018 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and SAVSU Technologies, the leading developer of smart, precision biologic shipping containers and cloud-based cold chain management SaaS solutions, today announced that the USPTO has issued a notice of allowance of a patent application titled "Biologic Stability, Delivery Logistics and Administration of Time and/or Temperature Sensitive Biologic Based Materials". The inventors are Bruce McCormick, President of SAVSU Technologies, and Mike Rice, CEO of BioLife Solutions.

Since the formation of the BioLife Solutions – SAVSU Technologies biologistex™ joint venture in the fourth quarter of 2014, the companies have submitted 13 other patent applications related to novel innovations incorporated into current, or to be incorporated into future, precision thermal shipping containers under the evo brand. This includes models that precisely maintain biologic payload temperature stability across the entire shipping continuum; including -196°C liquid nitrogen dry vapor shippers, -80°C dry ice shippers, and 2° - 8°C and controlled room temperature (CRT) shippers using conditioned phase change insulating materials. These patent applications also include claims related to the evo.is Cold Chain Software as a Service (SaaS) live cell visibility platform.

Bruce McCormick commented, "We are pleased to receive this notice of allowance of what we believe will be a series of granted patent applications we filed to protect our growing intellectual property estate. We believe our hardware and software innovations, embodied in current and future evo models, will offer significant value to the growing regenerative and personalized medicine markets."

Mike Rice, BioLife CEO, remarked, "This notice of allowance is another validation of the vision SAVSU and BioLife formed several years ago, with a focused and intentional goal to improve cold chain logistics of cell and gene therapies. We believe the advanced and innovative evo hardware and software technologies will have tremendous impact on the preservation, delivery, and quality management of these precious, time and temperature sensitive biologic medicines." 

About SAVSU

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 BioLife Solutions

BioLife Solutions is the leading developer, manufacturer and supplier of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media for cells and tissues. Our proprietary HypoThermosol® and CryoStor® platform of biopreservation media products are highly valued in the regenerative medicine, biobanking and drug discovery markets. These are serum-free, protein-free, fully defined, and formulated to reduce preservation-induced cell damage and death. Our enabling, embeddable technologies provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. 

For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

Cautions Regarding Forward Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, commercial manufacturing of our customers' products, and projected financial results. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

BioLife Solutions, Inc. 

Media & Investor Relations

SAVSU, LLC

Media & Investor Relations

Roderick de Greef

Dana Barnard

Chief Financial Officer

Chief Executive Officer

(425) 686-6003 

(505) 603-5306 

rdegreef@biolifesolutions.com

d.barnard@barson.us

 

 

SOURCE BioLife Solutions, Inc.


 

RELATED LINKS

https://www.biolifesolutions.com

See You At Cell and Gene Therapy: January 22-25 in Miami!

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We are very excited to be exhibiting at Cell and Gene Therapy 2018 in Miami, January 22-25.   Last year's event was terrific.   The venue is the Hyatt Regency - Miami (location here).  This year Savsu will be exhibiting in the unique "Supply Chain & Logistics Hub".  We will be in the hub with seven key cell and gene therapy service suppliers:

Fibrocell

TrakCel

World Courier 

Brooks Life Science Systems

MedCision

Fisher BioServices

You can book a 30 minute tour that exposes you to the full cell and gene therapy supply chain.  From the Cell and Gene Therapy website:   "Take a journey through a cell & gene therapy supply chain of the future! Demystify every component, from cryopreservation to product tracking, and from initial sample collection to clinical site administration. You will leave with a clear vision of what YOUR product’s optimal supply chain management model should look like through scale up to the commercial setting."

Please stop by and learn about our evo® Cold Chain 2.0 System and get a demonstration of our new evo DV4 and DV10, revolutionary dry vapor shippers.   To reserve meeting time with us, please email us here.  If you would like to book a complete tour through the supply chain, you can do that on the Cell and Gene Therapy website,  here

See you in Miami!

 

 

 

Second ‘don’t eat me’ signal found on cancer cells

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Fascinating and important article on finding a second "don't eat me signal" that certain cancers use to protect themselves.   Article about Irving Weissman and his team's work at Stanford can be read here.

"... aggressive cancers express a ‘don’t eat me’ signal in the form of CD47 on their surfaces. Now we’ve identified a second ‘don’t eat me’ signal and its complementary receptor on macrophages. We’ve also shown that we can overcome this signal with specific antibodies and restore the ability of macrophages to kill the cancer cells.”

Irving Weissman, Stanford University School of Medicine

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