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Sabin Vaccine Institute Begins Phase 2 Clinical Trial for Sudan Ebolavirus Vaccine

Laboratory at Makerere University Walter Reed Project, where Sabin’s Phase 2 Sudan ebolavirus vaccine clinical trial begins this month.

WASHINGTON, July 15, 2024 (GLOBE NEWSWIRE) — Sabin Vaccine Institute launched a Phase 2 clinical trial for its vaccine against Sudan ebolavirus, with healthy volunteers receiving the single–dose vaccine at Makerere University Walter Reed Project (MUWRP) in Uganda. There are currently no approved vaccines for this strain of ebolavirus, which saw an outbreak end just last year. Ebolavirus disease kills on average half the people infected, according to the World Health Organization.

Sudan ebolavirus is a filovirus, in the same family as Marburg virus disease and Zaire ebolavirus, which killed 11,325 in one outbreak in West Africa from 2014–16. Ebolavirus disease spreads between people via direct contact with the blood or other bodily fluids of infected people and is highly virulent, causing hemorrhagic fever.

Based on the same cAd3 platform as its Marburg vaccine candidate, Sabin’s single–dose investigational Sudan ebolavirus vaccine was found to be promising in Phase 1 clinical and non–clinical studies, with results showing it to be safe, while eliciting rapid and robust immune responses that lasted up to 12 months.

This is Sabin’s second Phase 2 clinical trial partnership with MUWRP, based in Uganda’s capital, Kampala. A Phase 2 trial for a Marburg vaccine is already underway, having recently completed enrollment. Initial results from the Marburg trial are expected later this year.

Dr. Betty Mwesigwa, deputy executive director of MUWRP, is once again the principal investigator (PI) for the Sabin–sponsored trial for the Sudan ebolavirus vaccine. In the coming weeks, participants will also be enrolled at the Kenya Medical Research Institute in Siaya, Kenya, with Dr. Videlis Nduba serving as PI for that site. In all, 125 volunteers will participate in the trial across the two countries.

“We are delighted to advance a vaccine candidate that can thwart a deadly and devastating disease, especially one that caused a fairly recent outbreak and for which no approved treatments exist,” says Amy Finan, Sabin’s Chief Executive Officer. “Sabin’s vaccine candidate is backed by strong safety and immunogenicity data, and we hope this trial will yield further evidence to move the vaccine closer to licensure.”

The most recent outbreak of Sudan ebolavirus occurred in the fall of 2022 in Uganda, after six suspicious deaths in the Mubende district. That outbreak ultimately resulted in 55 deaths. Sabin’s vaccine was the first to arrive in Uganda during that outbreak after the World Health Organization included it as one of three vaccines for possible use in an outbreak trial. The outbreak ended on January 11, prior to vaccine being deployed for use.

“Makerere University Walter Reed Project is pleased to partner with the Sabin Vaccine Institute once again,” says Dr. Mwesigwa. “Uganda has the most experience with Sudan ebolavirus outbreaks so we understand the importance of testing and researching an effective Sudan ebolavirus vaccine that could be used in the event of an outbreak.”

The Phase 2 clinical trial will evaluate safety and immunogenicity for the vaccine among a larger group of individuals than in previous trials. This is a randomized, placebo–controlled, double–blind study, meaning that neither the participants nor the researchers will know whether trial participants receive a vaccine dose or a placebo dose until after the trial is over, an approach used to help reduce experimental bias.

Participants in the clinical trial will be monitored for a full year and will include both younger (18–50 years) and older age groups (51–70 years). Interim results are expected next year. In addition to the current trial in Uganda and Kenya, Sabin plans to conduct a similar Phase 2 clinical trial for Sudan ebolavirus vaccine in the U.S.

The Sudan ebolavirus vaccine trials are supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under multi–year contracts between the organizations.

To date, Sabin has received around $216 million in contract awards from BARDA for furthering vaccine research and development against Sudan ebolavirus and Marburg virus diseases. BARDA and Sabin began working together in September 2019 to develop the two monovalent vaccine candidates.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010.

About the Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.

About Sabin’s Vaccine R&D Using the cAd3 Platform

In August 2019, Sabin announced exclusive agreements with GSK for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Zaire ebolavirus, Sudan ebolavirus and Marburg virus. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary cAd3 platform, were further developed by GSK, including the Phase 2 development for the Zaire ebolavirus vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines.

About the Makerere University Walter Reed Project

MUWRP is a non–profit biomedical research organization with a mission to mitigate disease threats through quality research, health care and disease surveillance. The project’s scope includes, among others; clinical research in infectious and non–infectious diseases such as HIV, Ebola, Marburg, COVID–19, Influenza and Influenza–like illnesses, and neglected tropical diseases such as Schistosomiasis, among others. A major part of the clinical research are clinical trials, where the MUWRP has conducted more than 12 phase 1 and 2 vaccine clinical trials including the first Ebola vaccine trial in Africa.

Media Contact:
Monika Guttman
Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 662–1841
press@sabin.org

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7ea30f47–768e–4cd0–b0a3–19adff04b2ab


GLOBENEWSWIRE (Distribution ID 9177893)

Zenas BioPharma Appoints Orlando Oliveira as Chief Commercial Officer

WALTHAM, Mass., July 01, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immunology–based therapies, today announced the appointment of Orlando Oliveira as its Chief Commercial Officer. With a career spanning nearly 25 years, Mr. Oliveira brings a wealth of experience building high–performing global commercial teams, driving revenue growth, and fostering strategic partnerships in the biotechnology and pharmaceutical industry.

“As we continue to advance multiple mid– to late–stage clinical development programs, we are thrilled to welcome Orlando to the Zenas leadership team,” said Joe Farmer, President and Chief Operating Officer. “His expertise and track record of building and leading high performing commercial teams will be instrumental in the establishment of the obexelimab franchise and achievement of our goal to bring obexelimab to patients worldwide. We will benefit immensely from Orlando’s broad commercial knowledge and leadership as Zenas evolves to become an integrated development and commercial biopharmaceutical company.”

“I am eager to join the seasoned executive team Zenas has built, guided by their mission to deliver transformative immunology–based therapies to patients in need,” said Mr. Oliveira. “I look forward to working with this team to further develop and execute the strategies and plans for the eventual commercialization of obexelimab and to establish Zenas as a leading global immunology–based development and commercial company.”

Prior to joining Zenas, Mr. Oliveira served as Senior Vice President & Head of International at Mirati Therapeutics (acquired by Bristol Meyers Squibb), where he helped lead and set up the international foundations of the company and prepared multiple oncology launches, including leading the European Medicines Agency approval of KRAZATI®. Previously, he served as Senior Vice President & General Manager International at Agios Pharmaceuticals (oncology business acquired by Servier), and in the same capacity at TESARO (acquired by GlaxoSmithKline). Previously, he served as Vice President Europe & Intercontinental Operations at Cubist Pharmaceuticals (acquired by Merck). Mr. Oliveira also held, during more than a decade, numerous roles of increasing responsibility at Amgen. Mr. Oliveira currently serves as a Board member at OncoInvent AS, a privately held clinical–stage radiopharmaceutical company. He obtained a degree in Pharmacy and a post–graduate degree in Drug and Pharmacy Law from the University of Coimbra, Portugal.

About Zenas BioPharma

Zenas BioPharma is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of immunology–based therapies for patients in need. With clinical development capabilities and operations globally, Zenas is advancing a portfolio of potentially differentiated autoimmune therapeutics in areas of high unmet medical need. Zenas’ experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on X at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Argot Partners
Zenas@argotpartners.com


GLOBENEWSWIRE (Distribution ID 9171428)

Fortrea lance un studio d’innovation en IA pour galvaniser les solutions technologiques et humaines afin d’améliorer la réalisation des essais cliniques

DURHAM, État de Caroline du Nord, 28 juin 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE), un organisme de recherche sous contrat (« ORC ») de premier plan au niveau mondial, a annoncé aujourd’hui le lancement de son studio d’innovation en intelligence artificielle (« IA »), marquant ainsi un investissement stratégique visant à remodeler l’exécution des essais cliniques aujourd’hui et à l’avenir.

Le studio développera et déploiera des technologies d’IA et d’apprentissage automatique visant à favoriser la rapidité, l’agilité, la qualité et le renforcement de la sécurité des patients dans le processus de recherche clinique en équipant et en habilitant les personnes à se concentrer sur l’élément humain critique des essais cliniques.

« Partout dans le monde, des patients attendent des traitements novateurs qui changeront leur vie. Grâce à l’IA, nous avons désormais le pouvoir — et l’obligation — de les aider à trouver des solutions plus rapidement », a déclaré Alejandro Martinez Galindo, directeur des systèmes d’information de Fortrea, avant d’ajouter :

« Le studio d’innovation en IA de Fortrea offrira des capacités technologiques améliorées qui permettront aux systèmes dotés d’IA d’exécuter des processus de pointe, tels que des simulations d’essai, des analyses prédictives et la reconnaissance de motifs, ainsi que des tâches administratives répétitives, « adaptées aux machines ». Cela permet de libérer la disponibilité des personnes pour qu’elles puissent apporter leur créativité humaine et leur connexion à l’essai clinique de demain et se concentrer sur ce qui compte : le patient. »

Le studio d’innovation en IA de Fortrea vise à :

  • établir des partenariats au sein de Fortrea et avec nos clients afin de fournir des solutions technologiques pour des stratégies d’innovation sur mesure pour les centres et les promoteurs ;
  • développer de nouvelles innovations technologiques nettes qui améliorent de manière globale la réalisation des essais cliniques pour les promoteurs, les centres, les patients et nos équipes ; et
  • soutenir l’infrastructure et les opérations existantes avec une technologie améliorée afin de permettre de nouvelles et meilleures méthodes de travail et créer les meilleures expériences pour les utilisateurs.

Les technologies en cours de développement dans le studio comprennent la collecte de données à l’aide de smartphones, des modèles linguistiques spécialisés à grande échelle pour la compréhension et la génération de textes, l’IA symbolique avec une logique à valeurs réelles (c.–à–d. la construction d’une logique de décision à l’aide de scénarios et de données en situation réelle), la réalité mixte et l’intelligence augmentée, l’exploration de données avancées et l’analyse prédictive, ainsi que le jumelage numérique.

L’application stratégique de ces technologies devrait permettre des avancées significatives en matière de recrutement et de fidélisation des patients, de création et d’optimisation des protocoles, de contrôle de la qualité en fonction des risques, ainsi que de rapidité et de qualité globales des prestations. Ces technologies peuvent également améliorer l’expérience des patients et la productivité des clients, des centres et des employés de Fortrea.

Les développements du studio d’innovation en IA seront essentiels pour la plateforme technologique clinique de Fortrea, qui est conçue pour intégrer la technologie des essais cliniques dans une expérience utilisateur, indépendante de la localisation, omnicanale et basée sur les personas, accessible à partir d’un seul écran.

« Fortrea se concentre sur une vision future du secteur des ORC, ce qui nous permet de construire POUR l’avenir plutôt que POUR le passé », a déclaré Brian Dolan, vice–président du Département d’intelligence artificielle et d’apprentissage automatique, avant d’ajouter : « Nous accordons une grande attention au développement et au déploiement responsables et éthiques de l’IA, en privilégiant les bonnes actions pour les bonnes raisons et en protégeant la sécurité et la vie privée des patients, ainsi que la propriété intellectuelle de nos clients. »

À propos de Fortrea
Fortrea (Nasdaq : FTRE) est l’un des principaux fournisseurs mondiaux de solutions de développement clinique dans le secteur des sciences de la vie. Nous nous associons à des entreprises émergentes et établies du secteur biopharmaceutique, de la biotechnologie, des dispositifs médicaux et du diagnostic pour stimuler l’innovation dans le domaine de la santé et accélérer la mise à disposition de traitements révolutionnaires pour les patients. Fortrea propose des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique et de consulting. Nos solutions s’appuient sur 30 ans d’expérience dans 20 domaines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée répartie dans plus de 90 pays est dimensionnée pour fournir des solutions ciblées et agiles à nos clients, partout dans le monde. Pour en savoir plus sur la manière dont Fortrea est un moteur d’influence du pipeline au patient, rendez–vous sur Fortrea.com et suivez–nous sur LinkedIn et X (anciennement Twitter).

Coordonnées de Fortrea :
Hima Inguva (Investisseurs) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Médias) – 919–410–4195, media@fortrea.com
Kate Dillon (Médias) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea startet KI-Innovationsstudio, um Technologie und menschliche Lösungen zur Verbesserung der Durchführung klinischer Studien zu bündeln

DURHAM, N.C., June 28, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE), ein führendes globales Auftragsforschungsinstitut (CRO), gab heute die Einführung seines Innovationsstudios für künstliche Intelligenz (KI) bekannt und signalisiert damit eine strategische Investition in die Neugestaltung der Durchführung von klinischen Studien heute und in Zukunft.

Das Studio wird KI–Technologien und Technologien für maschinelles Lernen (ML) entwickeln und einsetzen, um den klinischen Forschungsprozess zu beschleunigen, flexibler zu gestalten, die Qualität zu verbessern und die Patientensicherheit zu erhöhen, indem es die Mitarbeitenden in die Lage versetzt, sich auf das kritische menschliche Element der klinischen Studien zu konzentrieren.

„Weltweit warten Patienten auf neue, lebensverändernde Behandlungen. Mit KI haben wir jetzt die Möglichkeit – und die Verpflichtung – ihnen schneller Lösungen zu liefern“, sagte Alejandro Martinez Galindo, Chief Information Officer von Fortrea.

„Das KI–Innovationstudio von Fortrea wird erweiterte technologische Fähigkeiten ermöglichen, die KI–fähigen Systemen erlauben, innovative Prozesse wie Versuchssimulationen, prädiktive Analysen und Mustererkennung sowie sich wiederholende, administrative, 'maschinenfreundliche Aufgaben' durchzuführen. Das gibt Menschen die Freiheit, ihre menschliche Kreativität und Verbundenheit in die klinische Studie von morgen einzubringen und sich auf das zu konzentrieren, was zählt: den Patienten.“

Das KI–Innovationsstudio von Fortrea zielt auf Folgendes ab:

  • Partnerschaft mit Fortrea und unseren Kunden, um Technologielösungen für maßgeschneiderte Innovationsstrategien für Standorte und Sponsoren zu entwickeln;
  • Entwicklung neuer technologischer Innovationen, die die Durchführung von klinischen Studien für Sponsoren, Standorte, Patienten und unsere Teams ganzheitlich verbessern; und
  • Unterstützung bestehender Infrastruktur und Abläufe durch verbesserte Technologie, um neue, verbesserte Arbeitsweisen zu ermöglichen und erstklassige Benutzererfahrungen zu schaffen.

Zu den Technologien, die im Studio entwickelt werden, gehören Smartphone–gestützte Datenerfassung, spezialisierte große Sprachmodelle für Textverständnis und –generierung, symbolische KI mit realwertiger Logik (d.h. Aufbau von Entscheidungslogik unter Verwendung von Szenarien und Daten aus der realen Welt), gemischte Realität und erweiterte Intelligenz, fortgeschrittenes Data Mining und prädiktive Analysen sowie digitale Zwillinge.

Es wird erwartet, dass die strategische Anwendung dieser Technologien zu bedeutenden Fortschritten bei der Rekrutierung und Bindung von Patienten, der Erstellung/Optimierung von Protokollen, der risikobasierten Qualitätsüberwachung sowie der allgemeinen Bereitstellungsgeschwindigkeit und –qualität führen wird. Diese Technologien können auch zu einem verbesserten Patientenerlebnis und einer höheren Produktivität für Kunden, Standorte und Mitarbeitende von Fortrea führen.

Die Entwicklungen des KI–Innovationsstudios werden für die klinische Technologieplattform von Fortrea von entscheidender Bedeutung sein. Sie soll die Technologie für klinische Studien in eine verbrauchergerechte, ortsunabhängige, kanalübergreifende und personenbezogene Erfahrung integrieren, die über einen einzigen Bildschirm zugänglich ist.

„Fortrea konzentriert sich auf eine Zukunftsvision der CRO–Branche, die uns ermöglicht, FÜR die Zukunft zu bauen und nicht VON der Vergangenheit aus“, sagte Brian Dolan, Vice President of Artificial Intelligence & Machine Learning. „Wir legen großen Wert auf die verantwortungsvolle und ethische Entwicklung und den Einsatz von KI. Dabei ist es uns wichtig, das Richtige aus den richtigen Gründen zu tun und die Sicherheit der Patienten und den Schutz ihrer Daten sowie das geistige Eigentum unserer Kunden zu schützen.“

Über Fortrea
Fortrea (Nasdaq: FTRE) ist ein weltweit führender Anbieter von Lösungen für die klinische Entwicklung in der Biowissenschaftsbranche. Wir arbeiten mit aufstrebenden und großen biopharmazeutischen, biotechnologischen, medizintechnischen und diagnostischen Unternehmen zusammen, um Innovationen im Gesundheitswesen voranzutreiben, die das Angebot lebensverändernder Therapien für Patienten beschleunigen. Fortrea bietet Management von klinischen Studien der Phasen I–IV, klinische Pharmakologie und Beratungsdienste an. Die Lösungen von Fortrea basieren auf drei Jahrzehnten Erfahrung in mehr als 20 Therapiegebieten, einer Leidenschaft für wissenschaftliche Strenge, außergewöhnlichen Erkenntnissen und einem starken Netzwerk von Prüfzentren. Unser talentiertes und vielseitiges Team in über 90 Ländern ist so skaliert, dass wir unseren Kunden weltweit gezielte und flexible Lösungen anbieten können. Mehr darüber, wie Fortrea zu einer transformativen Kraft von der Pipeline bis zum Patienten wird, erfahren Sie auf Fortrea.com und wenn Sie uns auf LinkedIn und X (früherTwitter) folgen.

Kontakt zu Fortrea:
Hima Inguva (Investoren) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Medien) – 919–410–4195, media@fortrea.com
Kate Dillon (Medien) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea Lança AI Innovation Studio para Galvanizar Tecnologia e Soluções Humanas para Aprimoramento da Entrega de Ensaios Clínicos

DURHAM, N.C., June 28, 2024 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje o lançamento do seu AI Innovation Studio, sinalizando um investimento estratégico na reformulação da execução de ensaios clínicos hoje e no futuro.

O Studio desenvolverá e implantará tecnologias de IA e aprendizado de máquina (ML) para impulsionar a velocidade, agilidade, qualidade e segurança aprimorada do paciente no processo de pesquisa clínica, equipando e capacitando as pessoas a se concentrarem no elemento humano tão essencial nos ensaios clínicos.

“Pacientes de todo o mundo estão esperando por novos tratamentos que irão mudar suas vidas. Com a IA, agora temos o poder – e a obrigação – de ajudar a fornecer soluções para esses pacientes mais rapidamente”, disse o diretor de informações da Fortrea, Alejandro Martinez Galindo.

“O AI Innovation Studio da Fortrea viabilizará os recursos tecnológicos aprimorados que permitirão que os sistemas habilitados para IA executem processos de ponta – como simulações de testes, análises preditivas e reconhecimento de padrões – além de tarefas repetitivas, administrativas e fáceis de operar. Isso permite que as pessoas possam contribuir com a criatividade humana e a conexão com o ensaio clínico futuro e se concentrar no que é o mais importante: o paciente.”

O AI Innovation Studio da Fortrea visa:

  • Estabelecer parcerias em toda a Fortrea e com nossos clientes para fornecimento de soluções tecnológicas para estratégias de inovação sob medida para locais e patrocinadores;
  • Desenvolver inovações tecnológicas novas e inovadoras que aprimorem holisticamente a entrega de ensaios clínicos para patrocinadores, locais, pacientes e nossas equipes; e
  • Apoiar a infraestrutura e as operações existentes com tecnologia aprimorada para viabilizar novas e aprimoradas maneiras de trabalho e criação das melhores experiências de usuário da categoria.

As tecnologias em desenvolvimento no Studio incluem coleta de dados habilitada para smartphones; grandes modelos de linguagens especializados para compreensão e geração de texto; IA simbólica com lógica de valor real (ou seja, criação de lógica de decisão com cenários e dados do mundo real); realidade mista e inteligência aumentada; mineração avançada de dados e análise preditiva; e geminação digital.

A aplicação estratégica dessas tecnologias deve resultar em avanços significativos no recrutamento e retenção de pacientes, criação/otimização de protocolos, monitoramento de qualidade baseado em risco e velocidade e qualidade gerais da entrega. Essas tecnologias também podem proporcionar uma melhor experiência para o paciente e maior produtividade para os clientes, locais e funcionários da Fortrea.

Os desenvolvimentos do AI Innovation Studio serão fundamentais para a plataforma de tecnologia clínica da Fortrea que está sendo projetada para integrar a tecnologia de ensaios clínicos em uma experiência de nível de consumidor, independente de localização, omnicanal e baseada em persona, acessível por meio de uma única tela.

“A Fortrea está focada em uma visão de futuro da indústria de CRO que nos permite criar Voltados para o futuro e Não para o passado”, disse Brian Dolan, Vice–Presidente de Inteligência Artificial e Aprendizado de Máquina. “Estamos sendo bem cautelosos e levando em consideração o desenvolvimento e a implantação responsáveis e éticos da IA, priorizando fazer a coisa certa pelas razões certas e protegendo a segurança e a privacidade do paciente e a propriedade intelectual dos nossos clientes.”

Sobre a Fortrea
A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I–IV, farmacologia clínica e serviços de consultoria. As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada que trabalha em mais de 90 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo. Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para pacientes na Fortrea.com e siga–nos no LinkedIn e X (antigo Twitter).

Contatos da Fortrea:
Hima Inguva (Investidores) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Mídia) – 919–410–4195, media@fortrea.com
Kate Dillon (Mídia) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea Launches AI Innovation Studio to Galvanize Technology and Human Solutions to Improve Clinical Trial Delivery

DURHAM, N.C., June 27, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), today announced the launch of its artificial intelligence (AI) Innovation Studio, signaling a strategic investment in reshaping the execution of clinical trials today and into the future.

The studio will develop and deploy AI and machine learning (ML) technologies to drive speed, agility, quality and enhanced patient safety in the clinical research process by equipping and empowering people to focus on the critical human element of clinical trials.

“Patients around the world are waiting for novel, life–changing treatments. With AI, we now have the power—and the obligation—to help deliver solutions to them faster,” said Fortrea’s Chief Information Officer Alejandro Martinez Galindo.

“Fortrea’s AI Innovation Studio will enable enhanced technological capabilities that will allow AI–enabled systems to perform cutting–edge processes—such as trial simulations, predictive analytics and pattern recognition—as well as repetitive, administrative, ‘machine–friendly tasks’. This frees up people to contribute human creativity and connection to the clinical trial of tomorrow and focus on what counts: the patient.”

Fortrea’s AI Innovation Studio aims to:

  • Partner across Fortrea and with our customers to provide technology solutions for bespoke site and sponsor innovation strategies;
  • Develop net new, greenfield technology innovations that holistically improve the delivery of clinical trials for sponsors, sites, patients and our teams; and
  • Support existing infrastructure and operations with enhanced technology to enable new, improved ways of working and create best–in–class user experiences.

Technologies under development in the studio include smartphone–enabled data collection; specialized large language models for text comprehension and generation; symbolic AI with real–valued logic (i.e., building decision logic using real–world scenarios and data); mixed reality and augmented intelligence; advanced data mining and predictive analytics; and digital twinning.

Strategic application of these technologies is expected to result in meaningful advancements in patient recruitment and retention, protocol creation/optimization, risk–based quality monitoring and overall delivery speed and quality. These technologies can also deliver an improved patient experience and greater productivity for Fortrea customers, sites and employees.

Developments from the AI Innovation Studio will be critical to Fortrea’s clinical technology platform, which is being designed to integrate clinical trial technology into a consumer–grade, location–agnostic, omni–channel, persona–based experience accessible thorough a single screen.

“Fortrea is focused on a future vision of the CRO industry, allowing us to build TO the future rather than FROM the past,” said Brian Dolan, Vice President of Artificial Intelligence & Machine Learning. “We are exercising great care and consideration to the responsible and ethical development and deployment of AI, prioritizing doing the right thing for the right reasons and protecting patient safety and privacy, and the intellectual property of our customers.”

About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life–changing therapies to patients. Fortrea provides phase I–IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).

Fortrea Contacts:
Hima Inguva (Investors) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Media) – 919–410–4195, media@fortrea.com
Kate Dillon (Media) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170022)

Adalvo erhält erste Generika-Zulassung in der EU für Liraglutid-Fertigpen

SAN ĠWANN, Malta, June 17, 2024 (GLOBE NEWSWIRE) — Adalvo gibt die erfolgreiche DCP–Zulassung für Liraglutid–Fertigpens und damit die erste Generika–Zulassung in der EU bekannt.

Als Bioäquivalent zu Victoza®, einem Fertigpen für die Behandlung von Typ–2–Diabetes, erzielte das Peptid–Präparat laut IQVIA im Jahr 2023 einen weltweiten Umsatz von mehr als 4,8 Mrd. US–Dollar.

Die erfolgreiche Entwicklung von Liraglutid verdeutlicht die Kompetenz von Adalvo als Anbieter eines vielfältigen und umfassenden Diabetes–Portfolios, das sowohl komplexe Peptid–Präparate zur Injektion als auch niedermolekulare Medikamente zur oralen Einnahme umfasst.

Die Verpflichtung von Adalvo zur Bereitstellung qualitativ hochwertiger, differenzierter Produkte bei gleichzeitiger Bewältigung komplexer Produktionsabläufe stärkt die Position des Unternehmens als zuverlässiger Marktführer in der Pharmabranche.

Klicken Sie hier, um das Diabetes–Portfolio von Adalvo anzusehen

Für Adalvo gibt es keine halben Sachen – der Erfolg steht immer im Fokus. Das Unternehmen hat sich zum Ziel gesetzt, schneller und stärker als seine Wettbewerber zu sein und seine Vision mit einem erfolgreichen Team umzusetzen.

Adalvo verpflichtet sich im Rahmen seiner Geschäftstätigkeit zur Einhaltung höchster Qualitätsstandards und freut sich darauf, auch weiterhin innovative Lösungen für das Gesundheitswesen zur weltweiten Verbesserung der Lebensqualität von Patienten bereitzustellen.

Über Adalvo

Adalvo ist ein weltweit tätiges Pharmaunternehmen und eines der führenden B2B–Pharmaunternehmen in Europa mit Handelspartnerschaften in mehr als 130 Ländern und für über 140 Handelspartner weltweit. Das erklärte Ziel des Unternehmens ist die weltweite Verbesserung der Lebensqualität von Patienten. Grundlage dafür sind unser intelligentes Kooperationsnetzwerk und die Verpflichtung, unseren Partnern differenzierte Produkte und Dienstleistungen von höchster Qualität bereitzustellen.

Besonders stolz ist Adalvo auf seine Möglichkeiten, Partner bei der Erreichung ihrer Ziele, beispielsweise der Steigerung von Umsätzen oder Erschließung neuer Märkte, zu unterstützen. Das Unternehmen setzt sich unermüdlich für herausragende Leistungen ein, getragen von einer tief verwurzelten Leidenschaft dafür, neue Maßstäbe für ihre Partner zu setzen.

Die zielgerichtete Unternehmenskultur verpflichtet sich der weltweiten Verbesserung der Lebensqualität von Patienten. Das dynamische Führungsteam von Adalvo verfügt über umfangreiche Erfahrungen und Branchenkenntnisse, die zum Erfolg des Unternehmens als zuverlässiger globaler Partner in der Branche beigetragen haben.

Kontakt: Gabrielle Cassar, gabrielle.cassar@adalvo.com

Ein Foto zu dieser Mitteilung finden Sie unter https://www.globenewswire.com/NewsRoom/AttachmentNg/e1e895aa–f689–4215–a1f8–25285851af9d


GLOBENEWSWIRE (Distribution ID 1000966644)

Adalvo obtient la première approbation générique de l’UE pour son stylo prérempli de liraglutide

SAN ĠWANN, Malte, 17 juin 2024 (GLOBE NEWSWIRE) — Adalvo annonce l’approbation par procédure décentralisée de son stylo prérempli de liraglutide, soit la toute première approbation générique dans l’UE.

En tant que version bio–équivalente du stylo prérempli Victoza®, indiqué pour le traitement du diabète de type 2, ce médicament peptidique a affiché des ventes mondiales supérieures à 4,8 milliards de dollars en 2023, comme le signale IQVIA.

Le développement réussi du liraglutide met en évidence la capacité d’Adalvo à proposer une gamme diversifiée et complète de traitements pour le diabète, intégrant à la fois des peptides complexes injectables et des traitements oraux à petites molécules.

L’engagement d’Adalvo à fournir un accès à des produits différenciés de haute qualité tout en en maîtrisant les enjeux de fabrication renforce sa position de leader reconnu au sein de l’industrie pharmaceutique.

Cliquez ici pour consulter la gamme de traitements pour le diabète conçue par Adalvo

Chez Adalvo, la notion de demi–mesure n’existe pas. À ce titre, les résultats sont toujours au rendez–vous. La mission de la Société est d’être plus rapide et plus performante que ses concurrents, à l’appui d’une équipe motivée au service de sa vision.

Adalvo s’engage à maintenir les normes d’excellence les plus strictes dans toutes ses activités et entend continuer à proposer des solutions de soins de santé novatrices qui apportent des changements positifs dans la vie des patients du monde entier.

À propos d’Adalvo

Adalvo est une entreprise pharmaceutique d’envergure mondiale et figure parmi les principales entreprises pharmaceutiques B2B d’Europe. Ses partenariats commerciaux sont actifs dans plus de 130 pays, à l’appui de plus de 140 partenaires commerciaux à l’échelle planétaire. L’objectif déclaré de l’entreprise vise l’amélioration de la vie des patients du monde entier au moyen d’un réseau de collaboration intelligent et d’un engagement à fournir des produits et services différenciés de la plus haute qualité à ses partenaires.

Adalvo est fière de sa capacité à accompagner ses partenaires dans la réalisation de leurs objectifs, qu’il s’agisse de relever leur chiffre d’affaires ou de conquérir de nouveaux marchés. Animée par un puissant désir d’apporter des résultats concrets à ses partenaires, Adalvo s’efforce sans relâche d’atteindre l’excellence dans toutes ses activités.

Grâce à sa culture axée sur les objectifs, l’entreprise s’engage à améliorer la vie des patients du monde entier. Son équipe de direction dynamique apporte une expérience et un savoir–faire industriels considérables ayant contribué à faire de l’entreprise un partenaire mondial fiable dans le secteur.

Contacts : Gabrielle Cassar, gabrielle.cassar@adalvo.com

Une photo annexée à ce communiqué est disponible sur https://www.globenewswire.com/NewsRoom/AttachmentNg/e1e895aa–f689–4215–a1f8–25285851af9d


GLOBENEWSWIRE (Distribution ID 1000966644)

Adalvo obtém primeira aprovação genérica da UE para caneta pré-cheia com liraglutida

SAN ĠWANN, Malta, June 17, 2024 (GLOBE NEWSWIRE) — Adalvo anuncia a aprovação bem–sucedida do DCP para a caneta pré–cheia com liraglutida, marcando–a como a primeira aprovação genérica na UE.

Como uma versão bioequivalente da caneta pré–cheia Victoza®, indicada para o tratamento do diabetes tipo 2, este medicamento peptídico alcançou vendas globais superiores a US$ 4,8 bilhões em 2023, conforme divulgado pela IQVIA.

O desenvolvimento bem–sucedido do liraglutida destaca a capacidade da Adalvo de oferecer um portfólio diversificado e abrangente para diabetes, abrangendo tanto injetáveis de peptídeos complexos quanto tratamentos orais de moléculas pequenas.

O compromisso da Adalvo em fornecer acesso a produtos diferenciados de alta qualidade e, ao mesmo tempo, navegar pelas complexidades de fabricação, reforça a posição da empresa como líder confiável na indústria farmacêutica.

Clique aqui para ver o portfólio de diabetes da Adalvo

Na Adalvo, não há meias medidas – eles sempre atingem o objetivo. A sua missão é ser mais rápida e mais forte que os seus concorrentes, promovendo sua visão com uma equipe vencedora.

A Adalvo tem o compromisso de manter os mais altos padrões de excelência em todos os seus empreendimentos e espera continuar a fornecer soluções de saúde inovadoras que façam a diferença na vida dos pacientes em todo o mundo.

Sobre a Adalvo

A Adalvo é uma empresa farmacêutica global e uma das empresas farmacêuticas B2B líderes na Europa, com parcerias comerciais em mais de 130 países e mais de 140 parceiros comerciais em todo o mundo. O objetivo declarado da empresa é fazer a diferença para os pacientes em todo o mundo, motivado por nossa rede de colaboração inteligente e pelo compromisso de fornecer produtos e serviços diferenciados da mais alta qualidade aos nossos parceiros.

A Adalvo se orgulha de sua capacidade de ajudar os parceiros a atingir suas metas, seja para aumentar a receita ou entrar em novos mercados. Busca incansavelmente a excelência em todos os seus empreendimentos, movida por uma paixão profundamente enraizada por fazer a diferença para os parceiros.

A cultura orientada para o propósito da empresa está comprometida em melhorar a vida dos pacientes em todo o mundo. A equipe de liderança dinâmica da Adalvo traz uma experiência significativa e conhecimento do setor, o que ajudou a estabelecer a empresa como um parceiro global confiável no setor.

Contatos: Gabrielle Cassar, gabrielle.cassar@adalvo.com

Uma foto que acompanha este anúncio está disponível em https://www.globenewswire.com/NewsRoom/AttachmentNg/e1e895aa–f689–4215–a1f8–25285851af9d


GLOBENEWSWIRE (Distribution ID 1000966644)

Adalvo Secures First EU Generic Approval for Liraglutide Pre-Filled Pen

SAN ĠWANN, Malta, June 13, 2024 (GLOBE NEWSWIRE) — Adalvo announces the successful DCP approval for Liraglutide pre–filled pen, marking it as the first generic approval in the EU.

As a bioequivalent version of Victoza® pre–filled pen, indicated for the treatment of type 2 diabetes, this peptide drug achieved global sales exceeding $4.8 billion in 2023, as reported by IQVIA.

The successful development of Liraglutide highlights Adalvo's capability to offer a diverse and comprehensive diabetes portfolio, encompassing both complex peptide injectables and small molecule oral treatments.

Adalvo’s commitment to providing access to high–quality differentiated products while simultaneously navigating manufacturing complexities reinforces Adalvo's position as a trusted leader in the pharmaceutical industry.

Click Here To View Adalvo’s Diabetes Portfolio

At Adalvo, there are no half–measures – they are always on target. Their mission is to be faster and stronger than their competitors, driving their vision forward with a winning team.

Adalvo is committed to maintaining the highest standards of excellence in all their endeavors and looks forward to continuing to deliver innovative healthcare solutions that make a difference in the lives of patients worldwide.

About Adalvo

Adalvo is a global pharmaceutical company, and one of the leading B2B pharmaceutical companies in Europe, with commercial partnerships in more than 130 countries and over 140 commercial partners globally. The company’s declared purpose is to make a difference for patients all over the world, driven by our smart collaboration network and commitment to delivering the highest quality differentiated products and services to our partners.

Adalvo takes pride in their ability to help partners reach their goals – be those increasing revenues or pushing into new markets. Tirelessly strives for excellence in all of its endeavours, driven by a deep–rooted passion for making a difference for partners.

The company’s purpose–driven culture is committed to improving the lives of patients around the world. Adalvo’s dynamic leadership team brings significant experience and industry know–how, which has helped to establish the company as a reliable global partner in the industry.

Contacts: Gabrielle Cassar, gabrielle.cassar@adalvo.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e1e895aa–f689–4215–a1f8–25285851af9d


GLOBENEWSWIRE (Distribution ID 1000966220)