SOUTH SAN FRANCISCO, CA, Apr 23, 2024 – Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today unveiled Cell Q, the first automated quality control (QC) workcell for cell therapy manufacturing. Cell Q addresses a critical challenge: the manual, labor-intensive, low-throughput, and expensive nature of cell therapy QC. Exclusive to Cellares’ industry-first IDMO Smart Factories, Cell Q will offer a substantial improvement in throughput, cost, and reproducibility compared to existing manual QC methods.

First cGMP Cell Q system for automated in-process and release QC of up to 6,000 cell therapy batches per year.

As Cellares Cell Shuttles have addressed upstream bottlenecks in cell therapy manufacturing, Cell Q resolves the downstream QC capacity challenges. Cell Q is engineered to automate the vast majority of cell therapy QC assays for up to 6,000 batches per year. To accelerate analytical method transfer and shorten the time to clinical readout for new IDMO clients, Cell Q includes a pre-qualified set of the most common assays. Additionally, each Cell Q utilizes a modular platform that can be expanded with new instruments providing the flexibility needed to meet varying IDMO client needs.

Setting a new standard in the industry, Cellares is the only IDMO to offer the same unprecedented capacity for upstream cell therapy manufacturing as well as downstream QC via its South San Francisco Center of Excellence and Smart Factory in Bridgewater, NJ. Additional Smart Factories will be coming soon to the EU and Japan.

“Cell Q was designed to match the throughput of our Cell Shuttle platform. This enables the Cellares IDMO to offer a real end-to-end solution for our customers, providing 10 times higher capacity and up to 50% lower batch price,” said Fabian Gerlinghaus, CEO of Cellares. “Our proprietary platform technologies support our mission of becoming the de facto standard for cell therapy manufacturing, accelerating access for patients, and meeting the total patient demand for cell therapies globally.”

To learn more about how Cell Q enriches Cellares’ IDMO ecosystem and how it alleviates the QC bottleneck for cell therapies, please visit cellares.com/technology.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttles integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, CA with its commercial-scale IDMO Smart Factory in Bridgewater, NJ. The company is backed by world-class investors and has raised over $355 million in financing.

For more information about Cellares, please visit cellares.com.

^{for Healthcare, Life Science Organizations}

ORLANDO, FL, Mar 13, 2024 – At HIMSS24, Google Cloud announced several new solutions to help healthcare and life sciences organizations enable interoperability, build a better data foundation for their businesses, and deploy generative AI (gen AI) tools to improve patient outcomes.

Vertex AI Search: smarter search for healthcare data

Healthcare administrative costs were up by 30% in 2022, to reach $60 billion annually (CAQH), physician burnout increased to 53% in 2022 (Medscape), and there is a shortage of more than 13 million nurses in the world (World Health Organization, 2020). This presents a clear opportunity for healthcare providers, payers, electronic health records companies, and life science companies to build gen AI solutions that empower healthcare workers and other employees to work more efficiently and effectively.

Launched today, Google Cloud’s Vertex AI Search for Healthcare helps developers build better assistive technology for clinicians and other health system workers to alleviate administrative burden. Specifically, it enables medically-tuned, gen AI search on a broad spectrum of data, including FHIR data and clinical notes. These search and question-answering capabilities now integrate with MedLM, Healthcare Data Engine (HDE) and Cloud Healthcare FHIR APIs, making it easier for healthcare and life science organizations to build the data analytics and AI solutions needed for next era health systems.

Key Vertex AI Search for Healthcare features include:

• Medically-tuned search: By enabling medically-tuned search on electronic health record (EHR) data, scanned documents, and other clinical data, healthcare applications can now surface the most relevant information to clinicians, and others engaged in the decision making and processing, without the need to click through hundreds of pages of notes or toggle between different screens and applications.
• Configurable cloud APIs: Healthcare application developers can integrate the medically-tuned search directly into the clinician workflow tools using configurable cloud APIs.
• Question-answering: Clinicians can now use the service to answer questions such as “Does the patient have a history of cancer?” which typically involves not only an understanding of medical terminology related to cancers but also understanding the nuances of language in medical notes and scanned documents.
• Factuality: Because the results are grounded in the healthcare organizations’ real data, Vertex AI Search for Healthcare can also cite and link to the specific data points that generated the answers, providing transparency to users, increasing confidence in the responses, and helping reduce the risks of hallucinations or inaccurate responses.
• Data platform integration: Gen AI and search applications require  high-quality data to ensure that the outputs of gen AI are useful. HDE provides automated tooling and components to build a unified high quality patient data platform quickly and easily. The out-of-the-box integration of Vertex AI Search with HDE enables search and summarization use cases without the need for custom integrations.
• Deeper medical understanding: While MedLM tools are expert in complex medical topics, Vertex AI Search for Healthcare delivers medically-tuned search capabilities grounded in the patient record. When combined, healthcare organizations can find the most relevant answers to complex medical questions both from MedLM, as well as within the patient’s medical record. Select customers will have early access to Vertex AI Search for healthcare and life science integration with MedLM.

“Not all generative AI is created equal, and in healthcare, the stakes are particularly high,” said Aashima Gupta, global director for Healthcare Strategy & Solutions, Google Cloud. “Healthcare organizations require enterprise-grade gen AI solutions, grounded in real data. Vertex AI Search for Healthcare is already making a difference for healthcare organizations by helping ensure clinicians have the right information and insights at the right time to inform decisions and improve the overall quality of patient care.”

“At Highmark Health, we are constantly seeking ways to harness the power of data and technology to transform the healthcare ecosystem,” said Richard Clarke, chief data and analytics officer, Highmark Health. “Google Cloud’s Vertex AI Search integration with Healthcare Data Engine will enable us to provide even more personalized and proactive care to our members.”

“MEDITECH is dedicated to providing healthcare organizations with innovative tools to improve patient outcomes and streamline clinician experiences,” said MEDITECH Executive Vice President and Chief Operating Officer Helen Waters. “The ability to quickly locate information within EHRs is a well-documented problem today. MEDITECH’s vision to embed search within the Expanse workflows allows us to leverage Google Clould’s AI capabilities to ease this burden. We will continue to empower clinicians with cutting edge decision making tools and enable clinician efficiency.”

Healthcare Data Engine: healthcare data platform for the AI era

To help healthcare organizations around the world build an interoperable high quality data platform, the foundation to take advantage of gen AI, Google Cloud today announced a new consumption-priced managed service of Healthcare Data Engine (HDE), and expanded availability internationally with new features. Key updates include:

• Simplified management, and streamlined pricing: Customers can now deploy HDE as a consumption priced, pay-as-you-go, managed service, which opens up the product to more healthcare organizations, helping them to deploy, build, and manage a near real-time healthcare data platform in the cloud.
• Global Availability: HDE will expand beyond North America, and roll out globally to most cloud regions in Europe and in the Asia Pacific.
• Low-code graphical data mapping IDE: By introducing HDE Data Mapper, a new low-code graphical integrated development environment (IDE), purpose-built by Google Research for healthcare, customers can easily transform their data to build high quality longitudinal patient records in FHIR format to power gen AI applications.
• Foundation for AI and analytics solutions: By integrating HDE with Vertex AI Search for Healthcare, clinicians can look across multiple systems and formats in one search, saving valuable time that can instead be focused on patient engagement and improving the overall patient experience. Integration with MedLM will allow customers to answer complex questions grounded in the patient’s data.

“At HCA Healthcare, we’re focused on integrating technology into solutions that will empower our clinicians to perform at the top of their license and deliver exceptional patient care,” said Michael J. Schlosser, MD, MBA, FAANS, SVP, Care Transformation and Innovation, HCA Healthcare. “Google Cloud understands our commitment. Through our partnership and by deploying its Healthcare Data Engine, HCA Healthcare has the ability to harmonize data from disparate sources into a comprehensive longitudinal patient record, which is fundamental to our advanced analytics and Responsible AI initiatives.”

“Oscar is focused on reorienting the healthcare system around the consumer,” said Mario Schlosser, co-founder and chief technology officer of Oscar Health. “Our end-to-end tech stack enables us to capture the emerging opportunities of new technologies – from machine learning to generative AI – to deliver seamless experiences for members. We continue to partner with forward-looking companies like Google Cloud to accelerate our efforts and drive the change we want to see in healthcare.”

“Becoming the world’s most trusted wellbeing company is a complex journey, and one of the most critical foundational elements is a strong data strategy,” said Steve Fast, CIO, TELUS Health. “Google Cloud’s Healthcare Data Engine, search and gen AI capabilities combined with our unmatched range of services and tools to support the total health and wellbeing of our global population, will help us streamline workflows at scale, unlock deeper insights from healthcare data, and ultimately drive better health outcomes for the nearly 70 million lives we serve worldwide.”

MedLM and more: Google Research innovations coming to Google Cloud customers

Finally, MedLM, a family of foundation models fine-tuned for healthcare industry use cases, will add two new capabilities for Google Cloud customers to explore and test. First, MedLM for Chest X-ray can help with classification of chest x-rays for operational, screening, and diagnostics use cases. It is a domain-specialized model, launched as an application programming interface (API) that converts chest x-ray images into embeddings. App developers and data scientists can use those embeddings along with ground truth labels to train a simple classification model in Vertex AI.

The second new capability is a task-specific API called Condition Summary that aims to provide a chronological list of patient conditions, along with AI-generated briefs about each condition, with citations from original text.

In the coming months, Google Cloud is planning to bring additional functionality to the MedLM suite to offer even more capabilities.

Google Cloud’s customers retain control over their data. In healthcare settings, access and use of patient data is protected through the implementation of Google Cloud’s reliable infrastructure and secure data storage that support HIPAA compliance, along with each customer’s security, privacy controls, and processes.

About Google Cloud

Google Cloud is the new way to the cloud, providing AI, infrastructure, developer, data, security, and collaboration tools built for today and tomorrow. Google Cloud offers a powerful, fully integrated and optimized AI stack with its own planet-scale infrastructure, custom-built chips, generative AI models and development platform, as well as AI-powered applications, to help organizations transform. Customers in more than 200 countries and territories turn to Google Cloud as their trusted technology partner.

For more information, visit Google Cloud website.

^{to Develop 3D Printed Implant, Instruments}

ATLANTA, GA, Mar 12, 2024 – OrthoVentions LLC announced its investment in Motio^OV, an early-stage company created in partnership with the Hospital for Special Surgery (HSS). Motio^OV is developing a novel 3D printed implant and custom instruments to address stiffness and pain associated with arthritis of the first metatarsophalangeal (MTP) joint.

Under the terms of the investment, the company will be funded to complete product development and an initial commercial launch targeting the unmet clinical need of providing a functional MTP joint implant that reduces pain and preserves motion rather than the sub-optimal treatment of joint fusion. The solution under development will consist of various implant sizes and single-use instruments customized to complete total joint arthroplasty. Complaints of arthritic toe pain account for 20-30 percent of all patient visits to foot and ankle surgeon’s practice.

“Motio^OV is based on the fundamental understanding of the anatomy and associated forces of the MTP joint in an arthritic joint to invoke the design of an implant that minimizes insult to the bone and surrounding soft tissues while promoting stability,” said Dr Holly Johnson, co-founder of Motio^OV and an orthopedic foot and ankle surgeon at HSS. Dr. Constantine Demetracopoulos, an orthopedic foot and ankle surgeon at HSS and Co-Founder of Motio^OV added, “We have taken a comprehensive approach combining image-driven design, additive manufacturing to optimize bone in-growth and procedure-specific instruments to deliver an efficient and reproducible surgical plan.”

Jagi Gill, founder and managing director of OrthoVentions, said, “The partnership with Doctors Johnson and Demetracopoulos brings best-in-class surgical experience in fore-foot and total joint arthroplasty to lead the design of our complete solution of implant and instrumentation leveraging the expertise of our product development partners. Arthritis of the MTP joint is a growing clinical burden driven by the aging population with no viable motion preserving option.”

About OrthoVentions

OrthoVentions LLC is a dedicated healthcare fund collaborating with the Hospital for Special Surgery to identify and develop novel technologies developed by their premiere musculoskeletal surgeons. The principals at OrthoVentions bring a strong track record as founders and operators of medical technologies companies with a rich experience in developing and commercializing compelling healthcare solutions.

For more information, visit www.orthoventions.com.

Singapore, Mar 1, 2024 – Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, and Sanofi Vaccines, announced a collaboration to harness Medidata eCOA to deploy in vaccine studies. This builds on Medidata and Sanofi’s longstanding, successful experience using Medidata Rave EDC (electronic data capture).

The collaboration will use an eDiary function within eCOA to create an eDiary library specific to Sanofi’s vaccines. This library will accelerate future study set-up times, improve efficiency, and increase data quality, while ensuring patients have access to eDiaries that are easy to use.

Sanofi has chosen to adopt eCOA’s capabilities in its vaccine studies, optimizing the patient clinical journey by reducing on-site monitoring and allowing patients to input data in real time from any location. Pilots of eCOA were performed in six vaccine studies and demonstrated high levels of patient compliance, providing highly reliable data. As a result, the collaboration has since moved out of the pilot phase, with eCOA being deployed across a pipeline of Sanofi’s vaccine clinical trials.

“Expanding our collaboration with Medidata will enable us to improve our clinical development processes as we seek to deliver breakthrough vaccines to patients,” said the global head of clinical data management at Sanofi Vaccines. “Through a bespoke eDiary library, we can optimize eDiary set-up and improve data quality in current trials, while moving deeper into the digitalization era within the pharma industry.”

Anthony Costello, chief executive officer, Medidata Patient Cloud, said, “At Medidata, we put the patient at the core of all of our work, and collaborating with Sanofi, who share this ethos, helps improve patient experience, the monitoring of patients in current studies, and accelerate study timelines and efficiencies in future studies.”

Medidata eCOA is a full-service offering revolutionizing the way sponsors, contract research organizations (CROs), and sites collect data from patients, physicians, and caregivers. Built as part of the unified Medidata Platform, eCOA reduces study build times by up to 50% and provides a comprehensive view of patient data, while providing patients with flexibility and choice in how they engage in trial activities.

Sanofi has worked with Medidata for over a decade, leveraging Medidata’s solutions across the organization, including vaccine studies, to securely and efficiently capture and manage data.

About Medidata

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 32,000 trials and 9 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. The company is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization. Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC.

For more information, visit www.medidata.com.

About Dassault Systèmes

Dassault Systèmes, the 3DEXPERIENCE company, is a catalyst for human progress. They provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, their customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all – consumers, patients and citizens. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 150 countries.

For more information, visit www.3ds.com.

ROCK HILL, SC, Feb 22, 2024 – 3D Systems introduced a first-to-market solution for jetted, monolithic (one-piece) dentures that utilizes multiple materials to deliver a durable, long-wear, aesthetically beautiful prosthetic to the patient. This is enabled by the formulation of bespoke materials for both teeth and gums. These unique materials deliver the desired combination of aesthetics, wear- and stain-resistance in the teeth, with exceptional break resistance (toughness and strength) in the gums. This combination results in a denture product that is superior to all other currently available, monolithic, jetted denture solutions. When these materials are used as part of 3D Systems’ complete workflow solution comprising materials, jetted 3D printing technology, software, and services, high-volume dental laboratories can more efficiently deliver dentures with improved performance and aesthetics, resulting in a superior patient experience.

3D Systems’ materials scientists developed NextDent Jet Denture Teeth and NextDent Jet Denture Base — the former uniquely formulated to mimic tooth rigidity and aesthetics, and the latter to absorb impact. When these materials are used as part of the company’s monolithic jetted denture solution, dental labs are able to produce dentures with exceptional performance, including high break resistance, a particularly important customer need. Additionally, the speed of 3D Systems’ jetting technology combined with monolithic denture printing accelerates total production rates in order to significantly reduce time to completion resulting in expedited delivery to the prosthodontist and patient.

In recent months 3D Systems previewed this solution to select customers including Glidewell, the world’s largest producer of restorative dental devices. Stephenie Goddard, CEO, Glidewell shared, “Glidewell prides itself on being on the forefront of technology, and continually bringing innovation to the dental community. Therefore, we need to collaborate with solution providers who share our vision for the power of transformative innovation. As a long-time 3D Systems customer, Glidewell continues to be impressed by the company’s leadership in digital dentistry. The capabilities presented by the new jetted denture solution are unmatched in the industry. The combination of 3D Systems’ high-speed printing technology and its unique materials deliver dentures with superior durability and aesthetics. I’m looking forward to our implementation of this solution later this year, and the benefits it will deliver not only for our business but for our customers and their patients.”

“With each innovation to our digital dentistry portfolio, 3D Systems has been able to help our customers transform the devices they deliver, and how clinicians deliver patient care,” said Chuck Stapleton, vice president & general manager, dental, 3D Systems. “As we announce our jetted denture solution today, I’m proud that we are once again delivering a truly unique offering to the market. We’ve combined innovation in materials and 3D printing, with software, post-processing, and applications expertise into our monolithic jetted denture solution, designed for high-volume production with unparalleled accuracy, repeatability, and lower total cost of operation. I look forward to seeing this solution change the trajectory of denture production, not only over the coming months but in the years to follow.”

The company anticipates 510(k) clearance from the United States Food & Drug Administration (FDA) for its solution in the second half of 2024.

The adoption of 3D printing to produce prosthodontics continues to accelerate, driven by benefits to both manufacturers and patients alike. According to 360 Research Reports, the global 3D Printed Dentures market size was estimated to be more than $1 billion in 2021 and is forecast to reach more than $2 billion by 2028. With 3D Systems’ digital dentistry solutions including its solution for the production of monolithic dentures, dental laboratories and clinics are able to produce dental devices at dramatically increased speed, while reducing material waste and capital equipment expenditures. Patients also experience significant benefits, through reductions in the time it takes to receive their prosthodontics, as well as the number of required office visits.

3D Systems will showcase its new monolithic denture product line along with the breadth of applications addressed by its digital dentistry solution portfolio at LMT Lab Day, to be held February 22-24, 2024 at the Hyatt Regency Chicago (Illinois). Attendees are invited to visit the company’s booth (A-43, B-42, East Exhibit Hall) to learn more about how 3D Systems’ portfolio of entry-level dental 3D printers, mid- and large-platform 3D printers, rapidly scalable workflows and growing range of validated NextDent materials can help expand labs and clinics. Additionally, the company will highlight how it has validated the NextDent materials portfolio to perform across a wide selection of the industry’s most trusted 3D printers. Attendees are also invited to participate in 3D Systems’ seminars to be held in the Comiskey Room, West Tower, Bronze Level. For more information, please visit the company’s website.

About 3D Systems 

More than 35 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. 3D Systems’ solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods.

More information on the company is available at www.3dsystems.com.