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article imageQ&A: Making the patient a key part of the treatment Special

By Tim Sandle     Dec 21, 2018 in Science
In contrast to traditional therapeutics, personalized cell therapies often make the patient a key part of the treatment. Vineti, Inc. and Tessa Therapeutics are partnering to change the way personalized therapies are developed, in Asia.
The company Tessa has chosen Vineti’s digital platform to accelerate the development of its virus-specific T cell therapies. This is reflective of personalized therapies becoming more complex compared to the way we’ve traditionally fought disease. When the patient is also a key part of their own treatment, patient safety becomes increasingly more difficult to safeguard.
To understand more about cell therapy treatments and to find out about the developments in Asia, Digital Journal spoke with Vineti CEO and co-founder Amy DuRoss.
Digital Journal: What are some common applications for cell therapies?
Amy DuRoss: The number of common applications is quickly growing all the time — it’s just one of the things that makes the field of cell therapy so fascinating. Cell therapies are centered around the premise of transplanting human cells (either from the patients themselves or from a donor) to replace or repair damaged cells, tissue or organs.
Currently, approved applications for cellular therapy include treatments for certain blood cancers, damaged cartilage and severe burns. There are, however, a larger number of applications still in the clinical phase, such as for the treatment of an expanded number of blood cancers, solid tumors, autoimmune conditions, cardiac disorders, and a wide range of inherited genetic disorders.
The Alliance for Regenerative Medicine — an industry association that includes cell therapy developers — states that as of Q3 2018, there were 1,003 advanced therapy clinical trials underway worldwide, with more than 57 percent of those in oncology and 17 different indication categories being pursued in total.
DJ: What specific applications are occurring in Asia?
DuRoss: Asia is experiencing rapid growth in cell therapy R&D, and the indications being pursued closely mirror those being pursued worldwide. Although a variety of applications are being studied in a wide range of indications, oncology tends to dominate. Tessa Therapeutics, in Singapore; Nanjing Legend Biotech, in China; and Fosun Kite Biotechnology, also in China, are some of the leaders in oncology-focused cell therapy in Asia.
DJ: Why did you develop the Vineti platform?
DuRoss: It’s a very exciting, dynamic time in personalized therapeutics. I’ve spent more than a decade in personalized medicine, from my work leading California’s Proposition 71 (the Stem Cell Research and Cures Initiative) onward. I’ve dedicated my career to improving patient outcomes and to helping this new field of personalized therapeutics reach as many people as possible.
These advanced cell therapies bring the most complex supply chain in the history of medicine, with huge safety and scalability implications. Each product is a unique, personalized “batch of one,” and it’s become clear that for cell therapy, a technology solution, such as Vineti, really is required for safety and growth.
I co-founded Vineti in response to direct, inbound pharmaceutical customer requests to bridge the technology gap between individualized cell therapies and the various components of production that make them possible. Pharmaceutical developers realized this, and came to my former firm, GE, to look for a way to bridge this gap.
Together with GE and the Mayo Clinic, our team of co-founders wanted to create a robust connection between this innovative field and the broader healthcare system. Today, Vineti is a fully independent company, and we’re working worldwide to help get these transformative cell therapies to more patients.
DJ: What benefits does the platform provide?
DuRoss: In cell therapies, you can’t separate the patient from the process or the therapeutic product. Regardless of the specific therapy, a human being is both part of the supply chain and the end recipient. All stakeholders — from the hospital to the courier to the production lab — have to collaborate continuously on behalf of the patient in new ways. These therapies really require new technology strategies and integrations. Vineti provides that new technology solution.
In addition, we’re the only independent software platform to have been part of a successful, expedited cell therapy filing. We’ve learned a lot about what it takes to offer cell and gene therapies safely at scale, so our focus is on creating a solution that covers the essential elements. To that end, we help biopharmaceutical manufacturers ensure patient safety and compliance by providing digital Chain of Custody and Chain of Identity, with automated audit trails. And we aid in driving clinical adoption of cell and gene therapies, making them as easy as possible for healthcare providers to deliver to their patients, by providing industry-leading simplicity and usability.
Moreover, we’re making it possible for biopharmaceutical developers to have better control over a distributed, highly complex value chain by orchestrating essential cell therapy workflows, from collection to manufacturing to delivery. Finally, we’re optimizing patient care and manufacturing through “Smart Scheduling” that matches patient and clinician schedules to manufacturing capacity. And finally, we’re reducing manufacturing and other costs through automation.
DJ: What benefits are there for researchers?
DuRoss: We’re helping researchers move their trials — and their trial data — along more quickly, easily and safely at lower cost. Cell therapy researchers are amazing scientists. They’re finding that these new therapies require people on their teams to be amazing digital technologists as well. So they have to decide whether they want to develop that capability on their own, or partner with someone who has been there before. They’re also under incredible pressure to move quickly. All of the accelerated designations in cell therapy, such as the FDA’s RMAT or the EMA’s PRIME, are great news for patients. But, at the same time, these designations mean that researchers have greater timeline pressures.
In this regard, we can help researchers (1) move quickly by making their clinical trial operations more automated and more scalable; (2) focus on science and their therapies, rather than having to create novel IT approaches; (3) control their operations costs; and (4) manage their clinical trial data more effectively.
DJ: How have you ensured that data is secure and integral?
DuRoss: Vineti has a great hybrid team of industry experts, and we’ve poured a lot of effort into data security, quality and compliance overall. We’re based in Silicon Valley, and our technology leadership really understands enterprise software and pharmaceutical IT. We’ve got an industry-leading approach to confidentiality and integrity of customer data. Specifically, we use an advanced cloud infrastructure and a comprehensive security program to guard sensitive patient data and proprietary IP.
Vineti is fully committed to key standards, including the Health Insurance Portability and Accountability Act and the European Union’s General Data Protection Regulation, as well as the implementation of relevant National Institute of Standards and Technology cybersecurity guidelines. We also maintain a comprehensive security program based on ISO 27001 to ensure the confidentiality, integrity and availability of customer data.
Finally, we operate around the reality that digital Chain of Identity and Chain of Custody matter more than ever. We’re hyper-focused on supporting the design and manufacturing of safe and effective personalized therapies through the design and development of compliant software (GAMP 5, 21 CFR Part 11), while fostering an environment of continual improvement. To this end, we’ve undergone multiple, successful biopharmaceutical audits. I’m really proud of our team’s work and success in these areas.
DJ: What types of analytics can be drawn from the platform?
DuRoss: Because we support the entire cell therapy supply and value chains, Vineti is offering analytics across the entire cell therapy process. Our data can be used to help provide a comprehensive understanding of the therapeutic process and to improve everything from cell collection and other operations at points of care to shipping, logistics and manufacturing. And we can help improve clinical and commercial outcomes.
We’re always being asked to provide new types of data, and collaborate with our partners to optimize them. As cell therapies work their way into mainstream medicine, there will be a growing need for data to support even more parts of the value chain, such as hub services and commercial operations.
DJ: Which companies do you work with?
DuRoss: We work with a wide range of biopharmaceutical developers and ecosystem partners, only a few of which are publicly announced at this time. On the biopharmaceutical side, we have publicly announced partnerships with Kite Pharma and Tessa Therapeutics. On the ecosystem side, we have publicly announced alliances with Deloitte, Quick Specialized Healthcare Logistics and World Courier. We’re expanding very rapidly, and we should have a great deal of news to share along these lines in 2019.
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