TrakCel Chief Operating Officer awarded ‘International Director of the Year’

James Rudolf recognised at annual Welsh Institute of Directors Awards.  

The Chief Operating Officer of TrakCel is “extremely proud” to have been named as ‘International Director of the year’ at this year’s Welsh Institute of Directors Awards.  

James Rudolf, who has been with the TrakCel since 2016 was nominated in recognition of the company’s international impact, with an increasing number of personalised therapy companies across North America and Europe adopting TrakCel’s supply chain orchestration software.  

TrakCel has witnessed rapid growth over the last 12 months with business highlights including 300% growth, expansion into additional premises and surpassing 100 staff from its Cardiffbased offices.  

Speaking of the award, James commented: 

“I was delighted to pick up this award and honoured to be around so many inspirational directors..

“The last few years have been phenomenal in terms of business success and subsequent growth at TrakCel, but this success is down to the whole team. 

“We have huge aspirations to grow our business globally but in order to do so, we need to increase our workforce in Wales.   

“We’re proud of the fact that we are helping to bring truly life-changing products to the market through our innovative software, and we hope that others will be attracted to our story and our journey.”

James Rudolf Director of the Year

James Rudolf, TrakCel COO wins ‘International Director’ of the Year

Both Liam Fox, Secretary of State for International Trade & President of the Board of Trade and Secretary of State for Wales Alun Cairns attended the prestigious awards at Cardiff’s Sophia Gardens and recognised the success of inspiring and pioneering business leaders in Wales.  

Dr. Fox encouraged attendees to be optimistic about the future of Welsh businesses because of their underlying strengths and contribution to Wales’ bright trading future.   

The awards, now in their ninth year, have become an established highlight on the Welsh business calendar and celebrate business achievements and inspirational leaders across Wales while bringing all sectors of the business community together, irrespective of size, geography and longevity. 

Robert Lloyd Griffiths, Director IoD Wales said: “I am delighted that The Secretaries of State for International Trade and for Wales were able to support us at our awards celebration. Businesses across Wales are making huge efforts to contribute to the economy and our members continue to make a positive impact in Wales, the UK and on the global stage. The Institute of Directors (IoD) Wales Awards recognise the very best talent and achievements of Directors and we are confident that great Directors mean great businesses which ultimately means a better economy.

“Sincere thanks to all those who entered and sponsored this afternoon’s awards which were a celebration of exemplary leadership, which was showcased here to an incredible extent.”

Press Release – Cutting edge medical software company hits 100 employee mark

Press Release. Cardiff, Wales, UK.

Cardiff medical software company TrakCel will be increasing its headcount beyond 100 as it continues to expand its workforce to meet global demand for its product.

Having more than doubled its employee numbers during the financial year, the innovative software developer is set to recruit over 40 people in 2019.

The company’s recruitment drive comes off the back of 300% revenue growth in 2018.

To accommodate its growing team, the award-winning firm, which develops supply chain management software solutions for cell and gene therapy companies all over the world, has expanded into its third office in Cardiff city center.

Forecasting for further growth this year, the firm is recruiting various roles at its Cardiff headquarters, including Customer Support, Technical Business Analysts and Software Developers.

With offices in the UK and North America, TrakCel has witnessed rapid growth in the US over the last year with over 80% of its business now deriving from there. Consequently, the company is also looking to recruit two Directors of Customer Delivery in the US to further enhance service levels to its growing North American client base.

To facilitate its recruitment drive, TrakCel has brought in Head of People and Talent, Joy Lewis-Middleton. HR specialist Joy brings a wealth of experience having held senior roles at Target Group and Capital Law.

She said: “It’s an exciting time to be at TrakCel. We doubled in size last year and we are still growing. There are a number of roles we’re looking to fill across Software Development, Product Management, Testing, Business Analysis, Process Analysis and Project Management which we are confident of filling through local talent.

We’re extremely passionate about what we do and what we do matters. That’s one of the main reasons people are attracted to working for us. Not only can they pursue their career with us, but they can do so knowing they’re helping bring truly life-changing products to the market through our innovative software.”

TrakCel company growth

TrakCel CEO, Ravi Nalliah and Head of People & Talent, Joy Lewis-Middleton.

The growing field of personalized medicine is producing very promising treatments against a variety of cancers by utilizing a patient’s own cells to target and fight back against cancer. TrakCel was developed in 2012 to trace and streamline the complex supply chains associated with these personalized treatments. It has since gone on to experience a huge demand for its innovative software.

CEO and co-founder Ravi Nalliah, who recently retained his place in the distinguished Medicine Maker Power List 2019, said: “The last few years have been phenomenal in terms of business success and subsequent growth and we’re delighted to hit the 100-employee mark. We have huge aspirations to continue to grow our business globally and we need to increase our Wales-based workforce to facilitate this. It’s a pivotal time in our journey and we’re looking forward to welcoming more new people to the team over the course of the year.”

Established in 2012, TrakCel is an international technology company providing supply chain management software solutions to companies discovering, developing and commercializing cell and gene therapies and personalized medicine.

For more information on joining TrakCel, visit www.trakcel.com/careers

TrakCel CEO named in Medicine Maker Top 100 Power List 2019

Ravi Nalliah retains place in the distinguished Medicine Maker Power List.

Now in its 4th year, the annual Medicine Maker Power List awards celebrate the achievements of some of the most influential figures within the pharma industry. The awards recognize individuals across four categories: Masters of the Bench, Industry Influencers, Business Captains and Champions of Change, reflecting the great talent within the industry, from pioneering scientists to entrepreneurs and regulators.

This year’s List mirrors the ongoing evolution of the pharma industry, with the emergence of advanced therapies being reflected in a record number of places awarded to scientists and business people from the cell and gene space. The awards also feature a record number of nominees from Asia, including the first employee of a Chinese company – reflecting the increasing importance of China to the global industry.

After entering the Power List for the first time in 2018, Ravi Nalliah (TrakCel CEO) has successfully retained his position within the “Business Captains” category of the list in recognition of the growth and innovation demonstrated by TrakCel within the pharma industry.

Ravi Nalliah - TrakCel CEO

TrakCel CEO, Ravi Nalliah

Speaking of the award, Ravi Nalliah commented:

“I am honored to be featured on the ‘Medicine Maker Power List’ alongside some of the most pioneering scientists, regulators and thought leaders. Retaining my position in the 2019 Power List is testament to the commitment and innovation of my colleagues at TrakCel and our shared vision to support the delivery of life-changing advanced therapies”.

TrakCel is the market leading developer of clinical orchestration software designed to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining compliance and traceability.

More information about the Medicine Maker awards can be found here.

Government boost for expanding the use of cell and gene therapies in the UK

The SAMPLE programme (Standard Approach to atMP tissue colLEction), a vital programme to help build capacity for the NHS to expand the use of a new generation of cell and gene therapies for cancer and non-cancer illnesses has been given the green light by Innovate UK, the UK’s innovation agency.

An award made by Innovate UK, through the Industrial Strategy Challenge Fund is supporting the SAMPLE programme, a project to standardise the way cell and gene samples are collected to then be modified to become Advanced Therapy Medicinal Products (ATMPs).

The project will be led by a team of researchers from The Christie, part of the Manchester Cancer Research Centre. This team will be working with a nationwide consortium of NHS Trusts (Manchester University NHS Foundation Trust, Guy’s and St. Thomas’ NHS Foundation Trust, Newcastle upon Tyne), NHS Blood and Transplant and the Scottish National Blood Transfusion Service and industrial partners Asymptote, TrakCel, Immetacyte and Autolus. The Cell and Gene Therapy Catapult, a centre of excellence in innovation, with the core purpose of building a world-leading cell and gene therapy sector in the UK, will support the project in its role of coordinator of the Advanced Therapy Treatment Centre Network.

The number of patients to be treated with ATMPs is predicted to rise to 10,000 per annum over the next decade, from approximately 200 patients in 2018, which will require a doubling or tripling in sample processing capacity to support this level of activity. The SAMPLE programme will focus on developing a standardised approach to the collection of tissue and cell based starting materials essential to the manufacture of ATMPs by building on existing resources and capabilities.

The consortium will be investigating standardising cell and tissue procurement, processing and storage processes within the NHS.

Unlike conventional medicines, cell and gene therapies offer revolutionary treatments which repair, replace, regenerate and re-engineer genes, cells and tissues to restore normal function, sometimes offering potential cures where acute unmet medical need exists. Such treatments often manipulate the patient’s own cells to fight these diseases. However, new systems are needed to deliver these transformative therapies into the NHS.

This project is proactively addressing the organisational changes needed to address this increasing requirement for treatment with ATMPs. ATMPs have significant health economic and organisational implications which need to be proactively addressed to enable more life changing treatments to be provided to children and adults with cancer and non-cancer diseases.

Fiona Thistlethwaite, Medical Oncology consultant at The Christie and a SAMPLE project lead said “SAMPLE represents a fantastic opportunity to link UK partners from across the NHS and industry to establish standard practices in the complex but very exciting field of Advanced Therapies.”

Marc Turner, Medical Director at the Scottish National Blood Transfusion Service said: “Advanced Therapies have the potential to change the way we treat many common serious diseases including degenerative conditions and cancers.  SNBTS is delighted to be working with our commercial, academic and healthcare partners across the UK working to help realise this next generation of personal medicines.”

Dr Ian Campbell, Interim Executive Chair, Innovate UK for UKRI, said: “The project announced today will bring real benefits to patients and boost the knowledge economy as part of the government’s modern Industrial Strategy. This is vital for the UK as a global leader in the development of advanced therapies and medicine manufacturing.” Innovate UK has funded not only the SAMPLE study but the development of the Advanced Therapy Treatment Centres themselves.

This programme links together a national network of IUK funded Advanced Therapy Treatment Centres including iMATCH (Innovate Manchester Advanced Therapy Centre Hub), the Northern Alliance Advanced Therapies Treatment Centre (encompassing Newcastle, Leeds and Scotland) and the Midlands and Wales Advanced Therapies Treatment Centre (comprising Birmingham, Nottingham and Wales). Innovate UK has already committed to supporting Advanced Therapy Treatment Centres until 2021, to specialise in the delivery of cell and gene therapy products, for further information see https://www.theattcnetwork.co.uk/.

Notes for editors

The Christie

The Christie is the largest single-site cancer centre in Europe. As well as housing the largest early-phase clinical trials unit in the UK and one of the largest in Europe, it is also the first UK centre to be officially accredited as a comprehensive cancer centre.

Innovate UK:

Innovate UK is the UK’s innovation agency. We work with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. Since 2007 we have invested over £1.5 billion in innovation, matched by a further £1.5 billion in partner and business funding. We have helped more than 5,000 innovative companies in projects estimated to add £7.5 billion to the UK economy and create 35,000 extra new jobs. https://www.gov.uk/government/organisations/innovate-uk

The Industrial Strategy Challenge Fund

The Industrial Strategy Challenge Fund is part of government’s Industrial Strategy, the long-term plan to raise productivity and earning power in the UK.

The fund is a core pillar in the government’s commitment to increase funding in research and development by £4.7 billion over 4 years to strengthen UK science and business.

It will invest in the world-leading research base and highly-innovative businesses to address the biggest industrial and societal challenges today.

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With over 180 experts focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.

TrakCel and WindMIL Therapeutics partner on cell therapy supply chain management and orchestration platform

Cardiff, UK, and Baltimore, U.S., January 29, 2018 –

TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and WindMIL Therapeutics, a clinical stage oncology cell therapy company leveraging a proprietary platform to develop a novel class of cell therapies called MILs™ (Marrow Infiltrating Lymphocytes), today announce they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform to support clinical development of proprietary autologous cell therapies by WindMIL.

The supply chain platform will be used to manage WindMIL’s entire supply chain as WindMIL expands its program of cell therapy clinical trials later this year. This expansion of clinical trials follows WindMIL’s completion of a $32.5 million Series B fundraising in June 2018. WindMIL’s unique expertise in bone marrow immunology includes the only replicable and scalable process to create a cell therapy product from bone marrow-derived T cells, which are naturally tumor specific and of a memory phenotype.

The TrakCel platform will be live in over 100 sites globally by Q1 2019. This will enable WindMIL to leverage clinical site familiarity with the platform, while ensuring connectivity across all organizations and professionals involved. The system will harmonize with all partner internal systems, including those of clinical sites, couriers, CROs and CMOs. This will support an efficient and well controlled supply chain that makes the precision of collection, transportation and manufacturing visible to all involved. It also will encompass a specifically designed
interface for physicians and medical teams.

“We are excited to soon treat more patients with MILs through this expansion of our clinical trial program. MILs harness the power of the body’s own immune system, specifically cells residing in the bone marrow. We are the only company focused on manufacturing and developing this natural source of tumor-targeting, central-memory T cells,” said Brian Halak, President and CEO, WindMIL
Therapeutics. “However, developing novel cellular therapies is also about logistics. It is important for us to ensure the supply chain works for each of the individuals involved in the patient’s care and for the oncology patients themselves. We wanted to appoint a company that we saw as a partner, capable of delivering a supply chain solution that is essential for clinical success. TrakCel had the expertise and experience to achieve this.”

“The entire cell therapy sector now realizes the importance of managing and tracking the supply chain from an early stage. As a result, TrakCel is now working with a range of companies at the initiation of the clinical stage as well as at the late stage of clinical development,” said Ravi Nalliah, CEO of TrakCel. “The opportunity cost of the resources used for managing supply chains is even more important for companies at the earlier clinical stage. This means it is essential for TrakCel to continue to develop our cell therapy supply chain solutions as the cell therapy market continues to evolve.”

About TrakCel https://trakcel.com

TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability. TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by end of 2019, following a number of senior appointments in 2016 and 2017.

About WindMIL Therapeutics Inc. https://windmiltherapeutics.com

WindMIL Therapeutics is a clinical-stage company developing a novel class of cell therapies based on marrow infiltrating lymphocytes (MILs™) for cancer immunotherapy. As the leader in cellular therapeutics emanating from bone marrow, WindMIL translates novel insights in bone marrow immunology into life-saving cellular therapeutics for cancer patients. The company’s proprietary process to extract, activate and expand these cells offers unique immunotherapeutic advantages, including inherent tumor-specificity, high cytotoxic potential, and long persistence. WindMIL Therapeutics has offices in Baltimore, MD and Philadelphia, PA.

TrakCel and Quick partner to provide industry-leading digital supply chain IT solution for cell and gene therapies

Platform enhances visibility and performance of the entire personalized medicine process – from the initial sample collection to final patient treatment

Cardiff, UK, and New York, US, January 17, 2019 –

TrakCel, the leading cell and gene therapy supply chain tracking and orchestration system software developer, and The Quick Life Science Group (Quick Healthcare and QuickSTAT) today announce a partnership to offer an integrated IT logistics orchestration platform.
The platform enables the global cell and gene therapy industry to track products and manage the logistical processes of each needle-to-needle supply chain through a single interface. As TrakCel is the leading developer of cell and gene therapy supply chain IT solutions, and Quick, the premier global priority logistics company, and selected preferred transportation partner for the first FDA approved cancer immunotherapy, this partnership will have a considerable impact across the entire supply chain industry.

The integrated platform streamlines the supply chain and enhances the user experience by combining the core strengths of both organizations into a single intuitive interface. The platform enables automatic scheduling of activities across multiple supply chain partners, product-specific workflows to ensure consistent handling and execution of tasks, and validated chain-of-identity tracking to guarantee correct drug product delivery and infusion. Clinics and manufacturing sites across North America and Europe will greatly benefit from the improved efficiency and security offered by this initiative.

The volume and growth of clinical and commercial products is increasing the workload for all stakeholders across the supply chain including clinical sites, apheresis collection centers, manufacturing facilities, and couriers. In addition, individual cell and gene therapy supply chains face unique complexities such as precise scheduling requirements and the need to transport temperature and time sensitive materials globally. A combination of these factors increases the necessity for control and visibility of the timing of sample collection through to product
infusion.

“The collaboration between TrakCel and Quick was a critical factor in our vendor selection process,” said Knut Niss, Ph.D., Chief Technology Officer, Mustang Bio. “For autologous supply chains to function seamlessly, logistics vendors need to work together with the aim of creating a single intuitive interface that automates the supply chain – this is exactly what TrakCel and Quick have achieved. Without such integration, supply chain stakeholders are burdened by manually creating and managing orders in disparate systems, increasing the likelihood of error. The fact that this important integration is already in place allows Mustang to rapidly deploy a powerful customized solution.”
“As one of the world’s largest providers of medical logistics services, Quick Specialized Healthcare Logistics transports every year over 80,000 human organs and tissue samples. It is now essential not only to track the transport of these products that patient’s lives depend on but to offer every person involved in the supply of these products real-time information of the status and location of these
products,” said David Murphy, Executive Vice President, Quick Specialized Healthcare Logistics. “Based on the continuously growing number of therapeutic companies currently working with TrakCel and Quick, we see this partnership and the work completed as a critical step forward for the industry. It will enable companies to concentrate on developing therapies, rather than worrying about logistics.”
“We continue to see the number of sensitive, high-value materials moving through the supply chain increasing at an unprecedented rate. If not managed, the risk to patients and organizations involved in the development, manufacture, and
delivery of these potentially life-changing therapies will continue to increase,”said Ravi Nalliah, CEO of TrakCel. “The partnership between TrakCel and Quick will enable a significant reduction of these risks. TrakCel will continue to make sure that its partnership with Quick, offers the highest possible protection to patients awaiting much-needed therapies.”

About TrakCel https://trakcel.com

TrakCel is the market leading designer, developer, and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene, and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity while maintaining needle-to-needle compliance and traceability. TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by the end of 2019, following a number of senior appointments in 2016 and 2017.

About The Quick Group www.quick.aero

Since 1981, The Quick Group has been serving the life science and healthcare community worldwide, providing 24/7 priority logistics and transportation solutions for time and temperature-sensitive, mission-critical and lifesaving needs.

Quick Specialized Healthcare Logistics

Quick is the trusted logistics leader for the healthcare industry, safely transporting human organs and tissue for transplant or research, personalized medicine, as well as blood, blood products, cord blood, bone marrow, and medical devices/equipment.

QuickSTAT Global Life Science Logistics

QuickSTAT specializes in managing global clinical trial logistics for all phases of research and drug development, safely transporting clinical research specimens, investigational drugs, clinical trial supplies, and personalized medicine worldwide.

Marken And TrakCel Collaborate To Serve Cell and Gene Trials

RESEARCH TRIANGLE PARK, N.C.Dec. 18, 2018 /PRNewswire/ — Marken announced a new collaboration with TrakCel, the leading provider of fully integrated software for the comprehensive management and tracking of the many stages of the cell and gene therapy supply chain.

Cell and gene therapies represent a new area of groundbreaking innovation in the biopharmaceutical industry.  This new technology targets difficult to treat diseases by using a patient’s own genes, tissues or cells (or those of a donor) as key ingredients in the manufacture of a new medicinal therapeutic agent.  After manufacturing, many of these agents are either personalized or donor-recipient matched, temperature sensitive, and in most cases are irreplaceable.  In addition, the personalized nature of these treatments requires a Chain of Identity for each  batch to ensure the treatments are used only by the intended patient.  The clinical supply chains required to handle these treatments are arguably the most complex in the industry and Marken has made investments to supply these services.

Technology plays a key part in the supply chain and Marken has chosen TrakCel to deepen capabilities in this category of services.  TrakCel has developed leading integrated technology to effectively and easily orchestrate the cell therapy supply chain for autologous and allogeneic therapies.  The software tracks patient and donor registration, material collection, manufacture, shipment data and final patient infusion details. The interface between TrakCel’s and Marken’s operating systems allows users to automatically schedule or amend material collections in line with manufacturing capacity and each healthcare provider’s treatment schedules. Clinicians are then able to view the progress of therapies through each stage of the supply chain with a single, integrated system.

Wes Wheeler, Chief Executive Officer for Marken commented, “The collaboration between Marken and TrakCel is a natural next step in our strategy to expand Marken’s service offerings into the cell and gene clinical supply chain market. Our network of 49 global sites now include eight cryogenic (LN2) service stations and a very large and well-distributed fleet of specialty shipping containers to serve these trials.  We also ensure 100% of all cell and gene shipments travel with our GPS tracking technology and are monitored by our 24/7 Global Control Center.  We look forward to our new collaboration with TrakCel and what we can achieve together.”

“Success in cell and gene therapy development and commercialization relies on close collaboration between industry partners,” says Ravi Nalliah, TrakCel’s Chief Executive Officer. “Our collaboration with Marken further enhances the level of needle-to-needle visibility and control that clients can achieve through TrakCel’s software. Importantly, this integration is not dependent on any specific client’s infrastructure. The benefits of our collaboration are available to all clients without the time and cost associated with custom integrations, saving the client valuable resources, and is scalable on a global basis.”

About Marken 
Marken is a wholly owned subsidiary of UPS. Marken is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 49 locations worldwide for clinical trial material storage and distribution. Marken’s more than 900 staff members manage 55,000 drug and biological shipments every month at all temperature ranges in more than 150 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.

www.marken.com

About TrakCel 
TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability.  TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey.

TrakCel to develop and supply Medeor Therapeutics with cellular supply chain management and orchestration system

Cardiff, UK, September 11, 2018 – TrakCel, the cell and gene therapy supply chain tracking and orchestration system software developer, today announces it has been engaged to build a custom-configured system for Medeor Therapeutics, a clinical-stage biotechnology company dedicated to the discovery, development and commercialization of personalized cellular immunotherapies engineered to reprogram the immune system in order to improve outcomes in organ transplant recipients.

The supply chain system will be used in the clinical development and commercialization of Medeor’s MDR-10X product candidates for immune tolerance in living donor kidney transplant recipients. Medeor’s lead product candidate, MDR-101, is in a pivotal Phase 3 trial for genetically-matched living donor kidney transplant recipients.  The company has a pipeline of product candidates to support various other indications.

The TrakCel-built system will seek to ensure that each patient receiving a transplanted organ will also receive therapies manufactured from the blood and bone marrow cells of the specific organ donor. The system will also help to ensure that apheresis material collected from the organ donor will be aligned with the supply chain logistical requirements of multiple US contract manufacturing facilities.

The supply chain system will support a full pipeline of Medeor products, including the ongoing phase 3 clinical trial of MDR-101. It will be specifically designed to:

  • automate and standardize information flow and tasks across supply chain stakeholders
  • manage the complex timing of events for donors, recipients, manufacturers, couriers and clinicians
  • improve efficiencies and minimize supply chain risk and failures, including verifying the chain of identity and chain of custody, ensuring that the transplant recipient receives the right drug every time.

“TrakCel is now supporting a variety of companies and organizations developing a full range of autologous and allogeneic advanced therapies from the cell, gene and personalized cancer vaccine fields. Medeor is now close to a very exclusive peer group of companies with a commercialized cell therapy product.  In addition, the company has a robust development pipeline and has considerable funding to achieve its goals,” said Ravi Nalliah, CEO of TrakCel. “Developing cell therapies in the underserved organ transplant field will be facilitated by our cellular supply chain tracking and orchestration platform, with high levels of flexibility and scalability.” 

About TrakCel

TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability.

TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by end of 2019, following a number of senior appointments in 2016 and 2017.

Contact Information:

Neil Hunter / Michelle Boxall
Image Box Communications
Tel +44 (0)20 8943 4685
neil@imageboxpr.co.uk / michelle@imageboxpr.co.uk

TrakCel and Mustang Bio partner on CAR T supply chain management and orchestration platform

TrakCel, the software developer for cell and gene therapy supply chain tracking and orchestration systems, and Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, today announce that they have partnered to build a custom-configured cellular supply chain tracking and orchestration platform. The platform will be used in the clinical development and commercialization of Mustang’s CAR T therapies. Financial details of the partnership have not been disclosed.

The software platform will enable Mustang’s clinical and logistics teams to have complete visibility across all protocols down to the individual patient level, with a comprehensive electronic record trail and the ability to capture data across all activities, from patient T cell collection to drug infusion.

The platform will be integrated into Mustang’s proprietary CAR T cell therapy manufacturing facility in Worcester, Mass., U.S., and is expected to be operational by the first quarter of 2019. TrakCel will also integrate the platform into the operations of Mustang’s multiple supply chain partners, including collection centers, couriers and other third parties.

“An overview across the entire supply chain is critical to the successful development and delivery of CAR T product candidates,” said Knut Niss, Ph.D., Chief Technology Officer of Mustang. “Mustang selected TrakCel for its ability to configure and build a custom cellular orchestration platform that will specifically meet Mustang’s needs, scale with development, and integrate with our existing systems. This will enable Mustang to decrease the complexities and risks involved in developing autologous CAR T technologies, which have previously used manual and paper-based methods. This may decrease the costs of goods by improving efficiencies throughout the supply chain and ensuring the quality of our CAR T product candidates from needle-to-needle, initiating at collection and ending at infusion. Moreover, the platform will enable us to improve product safety and regulatory compliance, confirming that the correct CAR T therapy is delivered to the right patient every time.”

“TrakCel is custom configuring orchestration platforms for companies leading development across the international cell therapy sector. We have built unrivalled experience and acquired the know-how to provide the critical support needed by cell and gene therapy developers,” said Ravi Nalliah, CEO of TrakCel. “Managing supply chains becomes so complex for some companies that it uses valuable resources that hinder development of much-needed therapies. TrakCel will aid Mustang to use its investment in its in-house manufacturing facilities to develop CAR T immunotherapies for patients with high unmet medical needs.”

About TrakCel
TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability.

TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by end of 2019, following a number of senior appointments in 2016 and 2017.

About Mustang
Mustang Bio, Inc. (“Mustang”), a Fortress Biotech Company, is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to leverage the patient’s own immune system to eliminate cancer cells. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with the City of Hope National Medical Center and the Fred Hutchinson Cancer Research Center to develop proprietary chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) therapies across many cancers, and with Harvard Medical School’s Beth Israel Deaconess Medical Center and the Harvard Stem Cell Institute for the development of CRISPR/Cas9-enhanced CAR T therapies in hematologic malignancies and solid tumors. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission.

For more information, visit www.mustangbio.com.

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs.

For more information, visit www.fortressbiotech.com.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contacts:

TrakCel
Neil Hunter / Michelle Boxall
Image Box PR
Tel +44 (0)20 8943 4685
neil@imageboxpr.co.uk / michelle@imageboxpr.co.uk

Mustang Bio
Jaclyn Jaffe
Mustang Bio, Inc.
(781) 652‐4500
ir@mustangbio.com

Mustang Bio Media Relations
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com

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TrakCel to supply UK’s Northern Alliance cell therapy partnership with tracking and orchestration

20-organisation partnership involving NHS tasked by Innovate UK to bring cell therapies to the market to be supported by supply chain platform

Cardiff, UK, April 11, 2018 – TrakCel, the industry-leading software developer for cell and gene therapy supply chain tracking and orchestration, announces today it will be the organization responsible for tracking and documentation of cell and gene therapy products for the Northern Alliance Advanced Therapies Treatment Centre.

The Northern Alliance is a partnership of advanced therapies companies, NHS organisations and academic groups in the North of England and Scotland. The partnership of twenty organisations will be led by Newcastle upon Tyne NHS Hospitals NHS Foundation Trust and the Scottish National Blood Transfusion Service. The alliance has received an Industrial Strategy Challenge Fund three-year grant award from Innovate UK. The grant totals £7 million with an expected additional £2 million contributions from commercial partners.

The Northern Alliance has been tasked with facilitating the development, commercialisation and adoption of cell, gene and tissue engineered therapies in the UK. Specifically, this collaboration will create ‘state-of-art’ infrastructure that includes technology, logistics, storage, manufacturing and supply of clinical sites, evaluation, funding and adoption.

“TrakCel now provides tracking and orchestration to numerous global cell and gene therapy companies across the industry. It is now established across the global industry that all major cell therapy projects require a traceability and management solution for operating their clinical development and furthering their commercialisation strategies,” said Ravi Nalliah, CEO, TrakCel. “As a result, the TrakCel platform will be critical to the success of the development of therapies by the Northern Alliance that could help countless patients across the UK and globally. This is a responsibility that we take
incredibly seriously.”

It is widely anticipated that the first cell therapy CAR-T product will be approved by the European Medicines Agency (EMA) in the next 12 months. The NHS will need a fully integrated network to safely and efficiently deliver these therapies. The solutions developed by the Northern Alliance will increase the capacity of the NHS to deliver these medicines by developing systems and processes within the trusts and hospitals capable of delivering advanced therapies to patients. The resultant systems could potentially be rolled out across the UK and globally.

TrakCel will provide the Northern Alliance with a digital backbone for tracking and documenting the movement of samples throughout the collection, logistics and manufacturing process. This comprehensive log of all activities will be vital for managing traceability and the chain of custody across the multiple organisations and teams involved in the partnership. TrakCel will also create a digital infrastructure across each hospital and the wider partnership to co-ordinate and manage the cell and gene therapy products.

TrakCel is dedicating a development team for the majority of the product timeline, and a project manager and business analyst throughout the project. The TrakCel senior management and the wider organization will be intensely involved throughout the project.

About TrakCel

TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability.

TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by end of 2019, following a number of senior appointments in 2016 and 2017.

For further information please contact:

Image Box PR

Neil Hunter +44 (0) 20 8943 4685
neil@imageboxpr.co.uk

Michelle Boxall +44 (0) 20 8943 4685
michelle@imageboxpr.co.uk

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