Clinical Trials - AI-Tech Park https://ai-techpark.com AI, ML, IoT, Cybersecurity News & Trend Analysis, Interviews Wed, 03 Jul 2024 12:17:49 +0000 en-US hourly 1 https://wordpress.org/?v=5.4.16 https://ai-techpark.com/wp-content/uploads/2017/11/cropped-ai_fav-32x32.png Clinical Trials - AI-Tech Park https://ai-techpark.com 32 32 QuantHealth Taps OMNY Health to Improve AI Platform Dataset Structures https://ai-techpark.com/quanthealth-taps-omny-health-to-improve-ai-platform-dataset-structures/ Wed, 03 Jul 2024 08:00:00 +0000 https://ai-techpark.com/?p=171740 Data Collaboration Advances QuantHealth’s Trial Simulation Capabilities QuantHealth, the leading AI-driven clinical trial design company, today announced a partnership with OMNY Health, the premier healthcare ecosystem for facilitating compliant cross-industry health data sharing. This collaboration aims to unlock novel insights from OMNY Health’s vast network of de-identified data, fostering new opportunities...

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Data Collaboration Advances QuantHealth’s Trial Simulation Capabilities

QuantHealth, the leading AI-driven clinical trial design company, today announced a partnership with OMNY Health, the premier healthcare ecosystem for facilitating compliant cross-industry health data sharing. This collaboration aims to unlock novel insights from OMNY Health’s vast network of de-identified data, fostering new opportunities for clinical trials, evidence-based practice, and medical research for QuantHealth’s customers, which include four out of the five largest pharmaceutical companies globally.

By integrating diverse EHRs into organized, de-identified research data products, OMNY equips researchers and providers with comprehensive information to address disparities in clinical trials and close significant demographic information gaps in drug discovery and development. OMNY’s extensive data portfolio supports downstream analytic needs for life sciences innovation. The partnership with QuantHealth will unlock insights to accelerate life-changing innovation, further underscoring data as the power source for AI companies.

QuantHealth’s AI technology, trained on a dataset of 350 million patients, enhances clinical trial timelines, mitigates trial risks, and identifies sub-populations likely to respond to treatments. This collaboration will help QuantHealth’s pharmaceutical partners expedite drug development through simulated clinical trials informed by real-world evidence and predicted clinical trial outcomes, drug efficacy, and patient responses.

“Biotech is entering a vibrant part of life sciences history,” said Omri Matalon, VP Clinical Data Science and Head of R&D Operations. “This partnership with OMNY Health furthers QuantHealth’s commitment to quality data and access for our partners. “This diverse and highly organized, de-identified research and data will optimize our simulated clinical trials, enabling us to provide the highest quality insights to our life sciences partners and continue to revolutionize the research and development arena.”

This partnership represents OMNY Health’s focus on life sciences data and accelerating diverse participation in clinical trials, significantly enhancing its real-world data ecosystem, which supports compliant research AI company partnerships at scale. By facilitating secure and mutually beneficial data sharing, OMNY helps companies like QuantHealth simulate trials at scale and expedite, de-risk, and optimize drug development, to provide the world with effective medication expeditiously.

“Life sciences organizations and healthcare providers often face time and budget constraints that limit their ability to utilize their data effectively. By partnering with QuantHealth, we can break down these barriers and provide organized, on-demand, and data-driven answers to pressing clinical questions. This collaboration will accelerate drug development and optimize clinical trials, leading to improved therapeutic outcomes and enhanced patient care,” said Mitesh Rao, CEO, of OMNY Health. “Our mission is to free data from silos, enabling it to be shared, analyzed, and transformed into life-saving treatments and improved patient care.”

This collaboration follows QuantHealth’s recent strategic investment from Accenture Ventures and a leading CRO firm, bringing its Series A funding total to $17M. Founded in 2020, QuantHealth aims to help pharmaceutical companies advance and de-risk their programs by using AI to simulate clinical trials. The company’s technology predicts clinical trial outcomes, drug efficacy, and patient responses, delivering real-world evidence and enhancing clinical trial success.

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N-Power Medicine Emerges with Series B Funding https://ai-techpark.com/n-power-medicine-emerges-with-series-b-funding/ Mon, 01 Jul 2024 14:15:00 +0000 https://ai-techpark.com/?p=171553 • Series B led by Merck Global Health Innovation Fund• First-of-its-kind integrated data platform provides infrastructure support for both clinical trials and routine patient management• 7,000 patients enrolled in Kaleido Registry N-Power Medicine, a company reinventing the clinical trial process, announced the initial close of a Series B funding round, raising its total...

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• Series B led by Merck Global Health Innovation Fund
• First-of-its-kind integrated data platform provides infrastructure support for both clinical trials and routine patient management
• 7,000 patients enrolled in Kaleido Registry

N-Power Medicine, a company reinventing the clinical trial process, announced the initial close of a Series B funding round, raising its total funding to date to $72 Million. The Series B round is led by Merck Global Health Innovation Fund, with participation by a US-based healthcare focused investor. The funds will support the expansion of the company’s network of oncology clinics and biopharmaceutical company collaborations leveraging N-Power’s unique platform for integrating clinical research into everyday patient care.

“The average oncology drug takes 10 years to go from development to market, and eight of those years are typically spent in clinical trials. Today’s clinical trial paradigm is very inefficient at the centers that run trials and out of reach for the majority of oncologists and their patients in the community,” said Mark Lee, M.D., Ph.D, N-Power Co-Founder and Chief Executive Officer. “Our vision is to radically accelerate drug development timelines through a new model where every oncologist and cancer patient can readily participate in advancing drug development. In the end we believe this is what patients will benefit from most.”

N-Power Medicine was founded in 2021 to accelerate the drug development process and expedite patients’ access to innovative therapies. The company has developed a first-of-its-kind integrated platform providing a single workflow for both clinical trial and routine patient management. N-Power’s “human in the loop” model, consisting of virtual and on-site staff assisted by AI-enabled workflow automation, supports oncologists in generating research-ready data for all patients in the practice and in preparing standardized clinical documentation for the medical record.

“At the Merck Global Health Innovation Fund we are focused on partnering with innovative companies such as N-Power that facilitate and optimize biopharmaceutical operations with the goal of improving patient care,” said David M. Rubin, Ph.D., Managing Director, Merck Global Health Innovation Fund. “N-Power’s unique approach offers the important opportunity to expand clinical research to more oncologists and their patients through standardized data collection, actionable insights, and the time and resources to participate in a model of accelerated drug development.”

N-Power’s platform consists of three fundamental components:

  • The Kaleido™ Registry collects prospective, real-time, standardized patient data expressly designed to support clinical trials and drug development. To date, over 7,000 patients have consented and enrolled in the registry.
  • The point of care technology enables seamless workflow management and provides secure, timely access to patient data and insights while ensuring compliance with regulatory requirements and quality standards for prospective clinical research.
  • On-site and virtual experts support oncologists and research staff to operationalize the Registry and support clinical documentation, while reducing their overall workload, allowing them to focus on patient care and research.

With all patients participating in the Registry, standardized data collection readily enables actionable insights for clinical research, such as real-time, proactive identification of trial-eligible patients as well as patient characteristics and outcomes which inform trial design.

By partnering with oncologists, research staff, and patients to unlock the full potential of every patient’s data, N-Power Medicine is expanding access to clinical trials and enabling unprecedented insights for biopharmaceutical drug development.

“N-Power is working to solve major challenges for oncologists: managing electronic medical records, finding patients for clinical trials, and reporting requirements for CMS,” said Barbara L. McAneny, MD, FASCO, MACP, founder and Chief Executive Officer of the New Mexico Cancer Center in Albuquerque and Gallup and Past President of the American Medical Association. “Using N-Power’s ‘superscribes’ enables cancer doctors to focus more on patients, as the N-Power Staff manages the chart and consents the patient to join the registry. The registry allows us to find the trial candidates and send the required reports. The collaboration has been valuable.”

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Klick Health Wins Innovation Grand Prix, Triples Cannes Lions Awards https://ai-techpark.com/klick-health-wins-innovation-grand-prix-triples-cannes-lions-awards/ Mon, 24 Jun 2024 09:00:00 +0000 https://ai-techpark.com/?p=170550 World’s largest independent health agency welcomes new Gold, Silvers, and Bronze to its growing pride of Lions for ‘Voice 2 Diabetes,’ ‘American Cancer Story,’ and ‘47’ Klick Health more than tripled the number of Lions it’s picked up over the past couple days at the Cannes Lions Festival of Creativity, earning...

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World’s largest independent health agency welcomes new Gold, Silvers, and Bronze to its growing pride of Lions for ‘Voice 2 Diabetes,’ ‘American Cancer Story,’ and ‘47’

Klick Health more than tripled the number of Lions it’s picked up over the past couple days at the Cannes Lions Festival of Creativity, earning an Innovation Grand Prix, three Entertainment Lions (a Gold, a Silver, and a Bronze), and a Silver Lion for Digital Craft. After earning a Gold in Pharma and a Bronze in Health & Wellness earlier this week, Klick’s latest honors bring its Cannes tally to seven thus far.

Last night, after receiving the coveted Innovation Grand Prix for ‘Voice 2 Diabetes’, Klick Co-Founder and Chairman Leerom Segal said, “We our incredibly proud of the lifesaving innovations arising from Klick Labs and all our Klicksters who’ve been on this remarkable machine-learning journey. It began over a decade ago, before AI was sexy, and was entirely incubated in our lab against a legitimate market gap. We invested years of effort in this area with clinical trials made even more challenging through the pandemic. By remaining hyper-focused, embracing our hacker roots, and prioritizing outcomes over optics, our team didn’t just make diabetes screening ambient and accessible through a simple app, they invented a practical way to help the millions of people across the globe who have diabetes, but don’t know it.”

‘Voice 2 Diabetes’ is a smartphone app that turns voice samples into an equitable life-saving tool using AI to detect Type 2 diabetes through subtle vocal changes imperceptible to the human ear. Currently in submission with Health Canada as Software as a Medical Device (SaMD), ‘Voice 2 Diabetes’ also took home a Gold Pharma Lion on Monday.

At a press conference yesterday, Innovation Lions Jury President Diego Machado said, “The Innovation category consistently offers a glimpse into the future, transforming ideas into tangible realities…This year, the jury faced an exceptionally competitive range of contenders…In such a competitive year, one particular entry stood out to the Jury. This groundbreaking piece combines years of technological and medical research into a seamless user experience. Its excellence not only earns today’s top award but also paves the way for a new frontier in medical, mobile, and democratic access to healthcare.”

Inspired by culture of experimentation

Agency Chief Creative Officer Rich Levy said, “I joined Klick five years ago because I was looking for new and innovative ways to solve impossible problems in health and help propel creative to new heights. Receiving an Innovation Grand Prix plus Lions in Entertainment and Digital Craft is huge recognition of what makes Klick different. It also pays tribute to the incomparable, world-class team of Klicksters who bring it everyday and never stop believing in the power of creativity.”

On Tuesday, Klick won two Entertainment Lions – a Gold and Silver – for ‘American Cancer Story,’ the film it created for Change the Ref, an organization founded by the parents of Joaquin Oliver, who was tragically killed in the Parkland school shooting. The shocking coming-of-age short spotlights horrifying CDC statistics attributing cancer and gun violence as the number three and number one killers of children and teens in the U.S. It was co-written and directed by José Padilha, and produced by Taking Over Films, with original score by Maroon 5’s James Valentine and VFX by Pierre Buffin.

According to Strategy magazine, Entertainment Jury President Geoffrey Edwards said ‘American Cancer Story’ “was probably the best demonstration of brand collaboration that we saw out of just about every piece of work. The twist at the very end was one that we all loved, and we didn’t see it coming.”

Klick also received a Silver Digital Craft Lion and a Bronze Entertainment Lion for the animated film ’47.’ Produced for Café Joyeux, a global family of cafe-restaurants that hires and trains people with intellectual and developmental disabilities, the film was inspired by the journey of a boy with Down syndrome. Klick co-created the film with Zombie Studio, Canja Audio Culture, and the Down syndrome community. It also won a Bronze Health & Wellness Lion on Monday.

Klick’s Latest Cannes Results

INNOVATION

  • GRAND PRIX: Voice 2 Diabetes – KVI Brave Fund Inc: Early-Stage Technology

PHARMA

  • GOLD LION: Voice 2 Diabetes – KVI Brave Fund Inc: Non-Regulated – Innovative Use of Technology: Patient or Healthcare Professional – Creative Data
  • SHORTLIST: Voice 2 Diabetes – KVI Brave Fund Inc: Non-Regulated – Innovative Use of Technology: Patient or Healthcare Professional – Healthcare Product Innovation

HEALTH & WELLNESS

  • BRONZE LION: 47 – Café Joyeux: Health Awareness & Advocacy – Brand-Led Education & Awareness – Film Craft: Production Design/Art Direction

ENTERTAINMENT

  • GOLD LION: American Cancer Story – Change The Ref: Partnerships – Brand Partnerships, Sponsorships & Collaborations
  • SILVER LION: American Cancer Story – Change The Ref: Branded Content – Fiction Films: Up to 5 Minutes
  • BRONZE LION: 47 – Café Joyeux: Challenges & Breakthroughs – Social Behavior & Cultural Insight
  • SHORTLIST: American Cancer Story – Change The Ref: Challenges & Breakthroughs – Social Behavior & Cultural Insight

DIGITAL CRAFT

  • SILVER LION: 47 – Café Joyeux: Form – Motion Graphics Design & Animation

FILM

  • SHORTLIST: 47 – Café Joyeux: Online Film Sectors – Travel, Leisure, Retail, Restaurants & Fast Food Chains
  • SHORTLIST: 47 – Café Joyeux: Culture & Context – Challenger Brand
  • SHORTLIST: American Cancer Story – Change The Ref: Viral Film
  • SHORTLIST: American Cancer Story – Change The Ref: Screens & Events
  • SHORTLIST: American Cancer Story – Change The Ref: Culture & Context – Single-Market Campaign

FILM CRAFT

  • SHORTLIST: 47 – Café Joyeux: Production – Production Design/Art Direction
  • SHORTLIST: 47 – Café Joyeux: Post-Production – Animation

On Monday, Klick was also ranked the world’s overall number-two Healthcare Agency and number-two Healthcare Network of the Year for the second consecutive year.

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SAS expands data, AI solutions portfolio for life sciences & health care https://ai-techpark.com/sas-expands-data-ai-solutions-portfolio-for-life-sciences-health-care/ Wed, 19 Jun 2024 10:45:00 +0000 https://ai-techpark.com/?p=169990 New clinical data repository built on SAS® Viya® offers an open, cloud-native, and scalable analytics platform to boost productivity and accelerate innovation Data offers limitless opportunities to life sciences and health care organizations. It empowers clinical researchers to analyze and uncover trends that can lead to groundbreaking treatments, and it is the...

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New clinical data repository built on SAS® Viya® offers an open, cloud-native, and scalable analytics platform to boost productivity and accelerate innovation

Data offers limitless opportunities to life sciences and health care organizations. It empowers clinical researchers to analyze and uncover trends that can lead to groundbreaking treatments, and it is the foundation to unlocking health care insights more quickly. 

SAS Clinical Acceleration Repository, a secure, cloud-native data repository with robust audit and administration capabilities, is now available to help drive innovation for life sciences and health organizations. The analytics platform manages clinical research data, integrates with various data sources, improves clinical trial development and accelerates the path to regulatory submission.

Streamlining and securing clinical data for innovation
Establishing a secure, advanced data repository to manage clinical data and support clinical trial development from various sources, transforming and preparing it for statistical analytics, and packaging it for regulatory submission is a common challenge for many global companies. Additionally, data management and governance challenges can delay clinical research. SAS Clinical Acceleration Repository provides a modular, open, cloud-native content repository for managing, reporting, sharing and reviewing data. 

The unique benefits of SAS Clinical Acceleration Repository include:

  • Access to curated research information and health data through a single system of record via an easy-to-use, modern user interface with intuitive dashboards.
  • A production-ready data repository that enables easier and faster data validation. The solution supports groups and permissions, roles and privileges, electronic signatures, version control, search, and an audit trail, while also enabling continuous monitoring and data preservation to support security, and regulatory and data standards compliance.
  • A multi-lingual, open environment to support use of third-party programming languages and tools and data integration from many locations and sources, such as electronic data capture systems, in-house clinical data management systems, labs and contract research organizations.
  • Access to SAS Viya enabled solutions and technology – proven to be 30 times faster than commercial and open-source alternatives – to improve efficiency and speed the path to submission.

“SAS Clinical Acceleration Repository enables researchers and data scientists to better manage their clinical data and empowers organizations to make informed business decisions,” said Gail Stephens, Vice President of Health Care and Life Sciences at SAS. “Accelerating and improving the clinical development process helps bring therapies to market sooner and strengthens the bottom line for life sciences and health organizations.”

SAS will unveil the new solution at the Drug Information Association 2024 Global Annual Meeting (DIA 2024) this week in San Diego, CA.

Generating synthetic data to bridge gaps in real-world data
Synthetic data is increasingly being used in the health care and life sciences industries to train and test AI systems in place of or in addition to real-world data. To further support the data and AI needs for health and clinical research, SAS has introduced SAS Data Maker (currently in private preview).

The powerful synthetic data generation capabilities of SAS Data Maker address data privacy and scarcity challenges by generating synthetic tabular data that statistically represents original training data without compromising sensitive patient health information. This enables health care and life sciences companies to innovate faster by combining trusted data augmentation and generation algorithms in one seamless tool. 

“SAS Data Maker uses SAS’ cutting-edge, reliable AI models to create statistically accurate data points that truly augment existing data and can capture countless different scenarios, helping organizations better forecast outcomes so they can anticipate their businesses’ changing needs,” said Shadi Shahin, Vice President of Product Strategy at SAS. “This is particularly valuable in instances where specific real-world data is hard to come by or when there’s a need to detect rare case scenarios in highly regulated areas like health care and life sciences.”

AstraZeneca, a global biopharmaceutical company, intends to use SAS Data Maker on the Snowflake Marketplace to empower its data scientists through the use of synthetic data to further improve decision making.

“Synthetic data can enhance our ability to make informed decisions from critical data, and thus has the real potential to help accelerate drug discovery and development, ultimately benefiting patients around the world,” noted Brian Dummann, Chief Data Officer at AstraZeneca. “We look forward to leveraging SAS Data Maker and streamlining how data scientists can access synthetic data for their initiatives.”

Employing AI to boost industry solutions
The new health care and life sciences products are outcomes of SAS’ commitment of $1 billion to AI-powered industry solutions over three years. As outlined in the May 2023 announcement, the investment in AI builds on SAS’ decades-long focus on providing tailored solutions to industry challenges in banking, government, insurance, health care, and more.

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Medidata Launches Clinical Data Studio https://ai-techpark.com/medidata-launches-clinical-data-studio/ Tue, 18 Jun 2024 16:00:00 +0000 https://ai-techpark.com/?p=169870 Delivers data review and reconciliation activities with embedded AI up to 80 percent faster, simplifying the data lifecycle by connecting numerous data sources Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, today announced the launch of Medidata Clinical Data Studio, a unified...

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Delivers data review and reconciliation activities with embedded AI up to 80 percent faster, simplifying the data lifecycle by connecting numerous data sources

Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, today announced the launch of Medidata Clinical Data Studio, a unified experience that unlocks the true power of clinical research data. This groundbreaking technology gives stakeholders greater control over the quality of data and the ability to deliver safer trials to patients faster.

Built on the Medidata Platform, Clinical Data Studio integrates data from both Medidata and non-Medidata sources, accelerating decision-making across the full clinical trial process and delivering holistic data and risk strategies that connect patients, sites, and sponsors. Through AI, study teams can more effectively identify potential data issues and safety signals, resulting in a more accurate understanding of the patient. This reduces the challenges posed by siloed data systems and enables action data review and reconciliation up to 80 percent faster.

“Clinical Data Studio unlocks the broad ecosystem of clinical data. Powered by embedded AI, we are democratizing access to data and revealing the signals, risks, and insights that matter most. Together this accelerates trial execution and creates rich data for new discoveries,” said Tom Doyle, chief technology officer, Medidata.

Clinical Data Studio offers a comprehensive workspace for data integration, transformation, and management. It includes AI-assisted data reconciliation and anomaly detection, self-serve data listings, robust risk-based quality management, and tools to implement a holistic data and risk strategy supported by workflows and visualizations.

“As data volume and sources grow exponentially, managing this data and garnering real-time insights is becoming increasingly complex. Not only is this impacting time-to-market, but it is also delaying the timely delivery of therapies to patients, thus impacting patients’ lives,” said Dr. Nimita Limaye, research vice president, Life Sciences R&D Strategy and Technology, IDC. “By enabling users to manage all their data, both Medidata and non-Medidata data, in one place, Medidata Clinical Data Studio has the potential to disrupt the industry by accelerating clinical trials and getting therapies to patients faster.”

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EDETEK Launches Continuous Study Monitoring Module for CONFORM™ Informatics https://ai-techpark.com/edetek-launches-continuous-study-monitoring-module-for-conform-informatics/ Fri, 24 May 2024 08:45:00 +0000 https://ai-techpark.com/?p=167435 EDETEK, a leading provider of innovative clinical trial solutions, is excited to announce the launching of the Continuous Study Monitoring module within the CONFORM™ Informatics platform. This new module supports both rule-based and unsupervised monitoring to ensure study quality, compliance, and operational excellence across the entire clinical trial portfolio. The Continuous Study Monitoring...

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EDETEK, a leading provider of innovative clinical trial solutions, is excited to announce the launching of the Continuous Study Monitoring module within the CONFORM™ Informatics platform. This new module supports both rule-based and unsupervised monitoring to ensure study quality, compliance, and operational excellence across the entire clinical trial portfolio.

The Continuous Study Monitoring module is designed to assess study risks and evaluate the safety and efficacy outcomes of clinical studies. It serves a diverse user base, including data managers, medical monitors, biostatisticians, and clinical operations personnel. By offering continuous monitoring, sponsors gain complete transparency, independent oversight, and precise information on study progress and readiness for milestone analysis.

Key Features and Benefits

Rule-Based and Unsupervised Monitoring: Provides flexible monitoring options to address various study needs and scenarios, ensuring comprehensive oversight.

Quality and Compliance: Ensures adherence to regulatory standards and study protocols, enhancing data integrity and reliability.

Operational Insights: Offers real-time operational insights, helping to identify and mitigate risks early in the study process.

Transparency and Oversight: Delivers complete transparency and independent oversight, giving sponsors confidence in their study data and processes.

Efficiency and Cost Savings: Eliminates manual, labor-intensive, and inconsistent review processes, saving time and reducing costs associated with expensive programming efforts.

User-Friendly Interface: Designed for ease of use by diverse users, enabling seamless integration into existing workflows.

Empowering Clinical Research

“The launch of the Continuous Study Monitoring module represents a significant advancement in our commitment to providing state-of-the-art solutions for clinical trials,” said Jian Chen, CEO of EDETEK. “By integrating advanced monitoring capabilities into the CONFORM™ Informatics platform, we empower sponsors with the tools needed to ensure the highest standards of study quality and operational efficiency.”

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GCCL Leverages ddPCR for Gene/cell Therapy Clinical Trial Services https://ai-techpark.com/gccl-leverages-ddpcr-for-gene-cell-therapy-clinical-trial-services/ Wed, 22 May 2024 08:30:00 +0000 https://ai-techpark.com/?p=167156 Introduced the first ddPCR device in Korea to provide high-quality clinical trial sample analysis services by increasing test accuracy Differentiate global lab services for cell and gene therapy clinical trials with cutting-edge technology GCCL, a Korean clinical trial sample analysis company, has introduced Droplet Digital PCR devices (ddPCR) for the...

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  • Introduced the first ddPCR device in Korea to provide high-quality clinical trial sample analysis services by increasing test accuracy
  • Differentiate global lab services for cell and gene therapy clinical trials with cutting-edge technology
  • GCCL, a Korean clinical trial sample analysis company, has introduced Droplet Digital PCR devices (ddPCR) for the first time in the domestic clinical trial sample analysis industry, enhancing its capabilities in analyzing samples for cell and gene therapy clinical trials.

    Currently, real-time PCR analysis is widespread in the field of clinical trial sample analysis for cell and gene therapy. However, the existing analysis methods have limitations such as relying on calibration reference standard samples for relative quantification, low analysis efficiency due to manual labor, and the necessity of separate analyses.

    GCCL solves the existing problems by implementing automated ddPCR-based analysis. The newly introduced ddPCR device from Bio-Rad’s QX ONE Droplet Digital PCR, utilizes a different operating principle than conventional real-time PCR, enabling absolute quantitative analysis without the need for calibration standards. Moreover, stable PCR reactions allow detection in low-concentration samples and the automated devices have a very low rate of human error that could occur with manual labor.

    Notably, GCCL is a leader in its field as it has the first clinical trial sample analysis experience for CAR-T therapy in Korea. Based on this, GCCL plans to provide ddPCR-based clinical trial sample analysis services through its newly established R&D unit.

    GCCL’s Director of Operations for the Lab Operations division, Hee Joo Lee, mentioned, “The first implementation of the automated ddPCR device in the clinical trial sample analysis field will enable faster and more accurate results to help advance the success of cell and gene therapy drug development.” Furthermore, she added, “With the introduction of this device, GCCL has secured competitiveness not only in the domestic but also in the global market.” Lee concluded, “GCCL will position itself as a global central lab by providing superior clinical sample analysis for advanced biopharmaceuticals including cell and gene therapies, with ongoing investment and proven expertise in oncology, central nervous system (CNS) disorders, infectious disease, and in other various areas.”

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    Parallel Bio Launches Clinical Trial in a Dish to Speed Drug Discovery https://ai-techpark.com/parallel-bio-launches-clinical-trial-in-a-dish-to-speed-drug-discovery/ Mon, 20 May 2024 09:45:00 +0000 https://ai-techpark.com/?p=166814 Five pharmaceutical partners start testing immunotherapies on human models created from immune organoids at population scale Parallel Bio, a biotech company using the immune system to cure disease, today announced the release of its Clinical Trial in a Dish for studying the efficacy and safety of new immunotherapies using human...

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    Five pharmaceutical partners start testing immunotherapies on human models created from immune organoids at population scale

    Parallel Bio, a biotech company using the immune system to cure disease, today announced the release of its Clinical Trial in a Dish for studying the efficacy and safety of new immunotherapies using human models at the earliest stages of drug discovery. Five pharmaceutical companies, including a Fortune 500 firm, have begun testing 20 drug candidates with the alternative to animal tests.

    Clinical Trial in a Dish creates human models using immune organoids scaled with robotics to represent the biology and diversity of a population. As a result, it more accurately and realistically predicts the safest and most effective drug candidates for human trials compared to animal models. In Parallel Bio’s tests of more than 75 drugs, the results from its Clinical Trial in a Dish matched clinical data in both the fidelity of the immune response and the variations in an individual drug’s effectiveness based on the diverse backgrounds of the patient population.

    “By developing drugs in human models from the start, our platform will shave $1 billion and 6.5 years from each drug candidate in development,” said Juliana Hilliard, Parallel Bio co-founder and chief scientific officer. “Our platform aims to flip the 95 percent drug failure rate into a 95 percent success rate, leading to more drugs approved to treat patients.”

    The average drug costs $2.8 billion over a decade to develop with nearly 95% failing in human trials despite showing promise in animals.

    Clinical Trial in a Dish is Parallel Bio’s first commercially available application of its immune system platform, which utilizes lymph-node organoids at scale to replicate the human immune system across diverse populations. Organoids are 3D, self-assembling models of human biology, or so-called “mini organs.” They mimic the structure and function of parts of the human body and their response to disease or treatment as if the organoids were individual patients.

    Right time for animal alternatives

    “The time is right for human models that work at a speed and level of accuracy simply not possible with lab animals and other in vitro methods,” said Robert DiFazio, co-founder and CEO at Parallel Bio. “We’re pioneering a new type of clinical trial where safety and efficacy are proven in humans before a drug candidate ever reaches a real patient.”

    Recent industry trends and regulatory changes are propelling interest in alternatives to animal models. Major pharmaceutical companies and laboratories are seeking human models that work, and a new law allows the FDA to consider results from human-relevant studies rather than animal tests during preclinical trials.

    Key benefits of Clinical Trial in a Dish

    Initial customers are actively using Clinical Trial in a Dish to test drug candidates, including one focused on effectiveness across a diverse spectrum of patient profiles and another seeking the safest version of a drug candidate ahead of planned human trials.

    Clinical Trial in a Dish is able to represent both health and disease in its human models and offers key advantages over other alternatives to animal studies:

    • Reproducible: Parallel Bio’s immune organoids retain the unique biology of the donor patient, as well as the cells, structures and functions of human lymph nodes.
    • Diverse: Demographics and population dynamics are captured as if each organoid were a real patient, providing a level of diversity once only possible in human trials.
    • Scalable: AI and robotics allow for the rapid creation of large numbers of organoids and the analysis of results, enabling population-scale trials and generation of proprietary data.

    Parallel Bio is actively signing on additional pharmaceutical partners for Clinical Trial in a Dish. Contact bd@parallel.bio to learn more.

    Organoid platforms are the future of medicine

    Because they generate human relevant data and insight, organoid platforms like Parallel Bio’s mini immune system promise to reshape the future of drug development and medicine.

    In the burgeoning field of AI drug discovery, organoid platforms help fill the critical gap for the large datasets of human biological responses needed to feed models. Immune organoids provide early detection for anti-drug antibody (ADA) response, one of the most common and costly blockers for promising drug candidates. Other areas of massive potential include precise modeling of immunological diseases to uncover new treatments, and in producing novel monoclonal antibodies in human immune systems for better efficacy and lower side effects than traditional mAb manufacturing.

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    Veeva Introduces Vault Basics for Biotechs https://ai-techpark.com/veeva-introduces-vault-basics-for-biotechs/ Thu, 16 May 2024 16:30:00 +0000 https://ai-techpark.com/?p=166525 Delivers industry-leading Vault applications in a turnkey solution with no implementation costs for simple adoption Veeva Systems (NYSE: VEEV) today announced the availability of Veeva Vault Basics, a new offering that includes technology, training, and support designed for biotechs. Vault Basics equips fast-growing companies to deploy industry-leading Veeva Vault applications with zero implementation and maintenance...

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    Delivers industry-leading Vault applications in a turnkey solution with no implementation costs for simple adoption

    Veeva Systems (NYSE: VEEV) today announced the availability of Veeva Vault Basics, a new offering that includes technology, training, and support designed for biotechs. Vault Basics equips fast-growing companies to deploy industry-leading Veeva Vault applications with zero implementation and maintenance costs. Biotechs can quickly adopt applications built on industry best practices, establishing a foundation to scale and manage growth. Ten biotechs are live with Vault Basics to drive efficiency, speed, and compliance.

    “Veeva Vault Basics delivers the complete, pre-validated solution that we need to operate quickly and efficiently as we scale our business,” said Phil Adams, senior director of IT at Longboard Pharmaceuticals. “Adding proven technology that was easy to deploy allows us to remain nimble, reducing our ramp-up time, decreasing risk of non-compliance, and improving data quality to accelerate product time to market.”

    Biotechs using Vault Basics can manage end-to-end processes on Vault applications that are always up to date with the latest features and functionality. Vault Basics is available for North America today and includes:

    • Vault eTMF Basics to ensure quality, timeliness, and completeness of a clinical trial master file.
    • Vault QualityDocs and Training Basics to drive secure GxP document management and centralize employee training and content.
    • Vault Submissions and Submissions Archive Basics to plan, author, review, and approve regulatory submissions with a complete history of regulatory authority interactions.

    “We’re applying our deep expertise in life sciences to offer one of the only solutions purpose-built with the simple path biotechs need to scale for growth,” said Steve Harper, general manager, Veeva Vault Basics. “With 10 biotechs already signed up and starting to see the benefits of Veeva Vault Basics, we’re gaining momentum as more growing companies use Vault with significantly less effort, overhead, and ongoing maintenance.”

    Additional Vault Basics offerings are planned for availability in 2025. For more on Vault Basics, visit veeva.com/VaultBasics.

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    EmVenio Research, Health Wizz partner to reach patients across the US https://ai-techpark.com/emvenio-research-health-wizz-partner-to-reach-patients-across-the-us/ Wed, 15 May 2024 16:15:00 +0000 https://ai-techpark.com/?p=166245 U.S.-based researcher and Health Wizz partner to provide clinical research as a care option Community research provider EmVenio Research and technology company, Health Wizz are pleased to announce a new partnership to address site management and participant engagement in clinical trials. This collaboration unites the strengths of both companies in the areas of...

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    U.S.-based researcher and Health Wizz partner to provide clinical research as a care option

    Community research provider EmVenio Research and technology company, Health Wizz are pleased to announce a new partnership to address site management and participant engagement in clinical trials. This collaboration unites the strengths of both companies in the areas of Localization and Hybrid Clinical Trials, offering a comprehensive, turn-key solution to healthcare providers and systems eager to participate in clinical research and trials.

    Synergizing Strengths for a New Era in Clinical Trials

    At the core of this partnership are two key synergies: First, both EmVenio Research and Health Wizz have been pioneers in enabling Localization and Hybrid Clinical Trials, a methodology that is rapidly gaining traction in the healthcare sector. Second, Health Wizz’s innovative platform, which integrates seamlessly with all leading Electronic Health Records (EHRs) and features a patient engagement mobile app, empowers patients to actively participate in their clinical trial journey. This unique capability allows patients to aggregate and submit their medical records for screening, simplifying the process of patient enrollment in clinical trials.

    Executive Insights

    Reflecting on this partnership, Raj Sharma, CEO of Health Wizz, stated, “We are thrilled to join forces with EmVenio Research, a leader in site and trial management. Our combined expertise will not only streamline the clinical trial process but also help enroll a diverse set of patients. Our technology enables seamless integration with EHRs using Fast Healthcare Interoperability Resources (HL7 FHIR™) to screen patients’ eligibility for clinical trial enrollment. Additionally, it offers a user-friendly platform for patient engagement, marking a new chapter in patient-centric clinical research.”

    Echoing these sentiments, Mark McKenzie, MD of EmVenio Research, remarked, “Our collaboration with Health Wizz represents a significant milestone in our mission to innovate clinical research. By leveraging Health Wizz’s cutting-edge technology and our extensive experience in trial management, we are setting a new standard in the industry. Together, we are positioned to offer healthcare providers a robust, efficient, and patient-friendly solution for conducting clinical trials.”

    A Turn-Key Solution for Healthcare Providers

    This partnership promises to deliver a holistic solution to healthcare providers and systems. By integrating advanced technology with expert trial management, Health Wizz and EmVenio Research are simplifying the path for healthcare providers to engage in clinical research and trials. This turn-key solution not only enhances efficiency but also ensures a higher level of participant engagement and satisfaction.

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