Certara’s Simcyp Consortium Celebrates 25th Anniversary
Certara (Nasdaq: CERT) celebrates the 25th anniversary of its Simcyp Consortium, a pre-competitive scientific research group comprising 35 leading biopharmaceutical companies. The consortium has become a global authority on physiologically-based pharmacokinetic (PBPK) modeling and simulation.
The Simcyp Simulator, used by pharmaceutical companies, academia, and regulatory agencies, has informed dosing decisions for over 375 label claims across 115+ drugs. It accurately predicts drug behavior in the human body, aiding various stages of drug development.
The consortium has awarded grants totaling $1.4 million to support 13 PhD and postdoctoral researchers. Simcyp provides academic licenses to more than 110 universities worldwide, and its publications have been cited over 8,000 times in scientific literature.
Certara (Nasdaq: CERT) celebra il 25° anniversario del suo Simcyp Consortium, un gruppo di ricerca scientifica pre-competitiva composto da 35 importanti aziende biopharmaceutiche. Il consorzio è diventato un'autorità globale nel modellamento e simulazione farmacocinetica basata sulla fisiologia (PBPK).
Il Simcyp Simulator, utilizzato da aziende farmaceutiche, università e agenzie regolatorie, ha influenzato le decisioni di dosaggio per oltre 375 richieste di etichetta su più di 115 farmaci. Prevede accuratamente il comportamento dei farmaci nel corpo umano, assistendo nelle varie fasi dello sviluppo dei farmaci.
Il consorzio ha assegnato sovvenzioni per un totale di 1,4 milioni di dollari per supportare 13 ricercatori di dottorato e post-dottorato. Simcyp fornisce licenze accademiche a più di 110 università in tutto il mondo e le sue pubblicazioni sono state citate oltre 8.000 volte nella letteratura scientifica.
Certara (Nasdaq: CERT) celebra el 25º aniversario de su Simcyp Consortium, un grupo de investigación científica precompetitiva compuesto por 35 importantes empresas biofarmacéuticas. El consorcio se ha convertido en una autoridad global en modelado y simulación farmacocinética basada en fisiología (PBPK).
El Simcyp Simulator, utilizado por empresas farmacéuticas, academia y agencias reguladoras, ha informado decisiones de dosificación para más de 375 solicitudes de etiqueta en más de 115 fármacos. Predice con precisión el comportamiento del fármaco en el cuerpo humano, ayudando en diversas etapas del desarrollo de medicamentos.
El consorcio ha otorgado subvenciones por un total de 1,4 millones de dólares para apoyar a 13 investigadores de doctorado y postdoctorado. Simcyp proporciona licencias académicas a más de 110 universidades en todo el mundo, y sus publicaciones han sido citadas más de 8.000 veces en la literatura científica.
Certara (Nasdaq: CERT)는 35개의 주요 생명공학 제약 회사로 구성된 경쟁 전 사전 과학 연구 그룹인 Simcyp Consortium의 25주년을 기념합니다. 이 컨소시엄은 생리학 기반 약물동태학(PBPK) 모델링 및 시뮬레이션의 글로벌 권위로 자리잡았습니다.
제약 회사, 학계 및 규제 기관에서 사용되는 Simcyp Simulator는 115개 이상의 약물에 대한 375개 이상의 라벨 요구 사항에 대한 용량 결정을 안내했습니다. 이 시뮬레이터는 인체에서 약물의 행동을 정확하게 예측하여 약물 개발의 여러 단계에서 도움을 줍니다.
컨소시엄은 박사 및 박사후 연구원을 지원하기 위해 총 140만 달러의 보조금을 지급했습니다. Simcyp는 전 세계 110개 이상의 대학에 학술 라이선스를 제공하며, 그 출판물은 과학 문헌에서 8,000회 이상 인용되었습니다.
Certara (Nasdaq: CERT) célèbre le 25e anniversaire de son Simcyp Consortium, un groupe de recherche scientifique précompétitif composé de 35 grandes entreprises biopharmaceutiques. Le consortium est devenu une autorité mondiale en matière de modélisation et simulation pharmacocinétique basée sur la physiologie (PBPK).
Le Simcyp Simulator, utilisé par les entreprises pharmaceutiques, le milieu académique et les agences réglementaires, a façonné les décisions posologiques pour plus de 375 demandes d'étiquettes sur plus de 115 médicaments. Il prédit avec précision le comportement des médicaments dans le corps humain, aidant aux différentes étapes du développement des médicaments.
Le consortium a attribué des subventions totalisant 1,4 million de dollars pour soutenir 13 chercheurs doctorants et postdoctorants. Simcyp fournit des licences académiques à plus de 110 universités dans le monde, et ses publications ont été citées plus de 8 000 fois dans la littérature scientifique.
Certara (Nasdaq: CERT) feiert das 25-jährige Bestehen seines Simcyp Consortium, einer vorkompetitiven wissenschaftlichen Forschungsgruppe, die aus 35 führenden biopharmazeutischen Unternehmen besteht. Das Konsortium hat sich zu einer globalen Autorität im Bereich physiologisch basierter pharmakokinetischer (PBPK) Modellierung und Simulation entwickelt.
Der Simcyp Simulator, der von Pharmaunternehmen, der Akademie und Regulierungsbehörden genutzt wird, hat die Dosisentscheidungen für über 375 Zulassungsanträge bei mehr als 115 Arzneimitteln beeinflusst. Er sagt das Verhalten von Arzneimitteln im menschlichen Körper genau voraus und unterstützt verschiedene Phasen der Arzneimittelentwicklung.
Das Konsortium hat Zuschüsse in Höhe von insgesamt 1,4 Millionen Dollar vergeben, um 13 Doktoranden und Postdoktoranden zu unterstützen. Simcyp bietet akademische Lizenzen für mehr als 110 Universitäten weltweit an, und seine Publikationen wurden über 8.000 Mal in der wissenschaftlichen Literatur zitiert.
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The pre-competitive scientific research consortium of top pharmaceutical companies remains a critical force in advancing qualified PBPK modeling and simulation to further drug development and regulatory decisions
RADNOR, Pa., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announces the celebration of the 25th anniversary of the Simcyp® Consortium.
The Simcyp Consortium has become a global authority on mechanistic physiologically-based pharmacokinetic (PBPK) modeling and simulation. With members from 35 leading biopharmaceutical companies, the Simcyp® Consortium was created to guide the development of best practices, identify the most critical use areas, and fill the scientific gaps that were needed for studying drug handling by the body in computer-generated, virtual patients and beyond the limited framework of clinical trials.
The Simcyp Simulator is used by pharmaceutical and biotech companies, academia and has been adopted by all the leading regulatory agencies, including the US FDA, Europe’s EMA, and Japan’s PMDA. Modeling and simulation results from the Simcyp Simulator have informed dosing decisions for more than 375 label claims for more than 115 drugs in lieu of clinical studies. Of all novel drugs approved by the FDA between 2019 and 2023 that leveraged PBPK, more than
“The Simcyp Consortium has accelerated the pace of progress, innovation, and adoption of biosimulation across drug discovery and development over the last 25 years,” said William F. Feehery, CEO of Certara. “Hitting this remarkable anniversary is a reminder of the successful collaboration we’ve had as we continue to serve and advance the scientific community.”
The Simcyp Simulator accurately predicts drug behavior within the human body, aiding in various stages of drug development. It supports decision-making from dosing and optimizing clinical study designs to evaluating new drug formulations, predicting drug-drug interactions, and conducting virtual bioequivalence analyses.
“Very few scientific consortiums have shown as dynamic an impact as the Simcyp Consortium over the years, especially on the PBPK applications in model-informed drug discovery and development,” said Kunal Tasker, Director, Global Head PBPK Modeling at GSK and chair of the Simcyp Consortium Members Discussion Group (SMDG). “The inputs from various industry consortium members have led to relevant advances in the Simulator. We all, along with the Certara Simcyp scientists, should be very proud of our collective impact on the wellbeing of patients around the globe.”
“It is an honor to witness the Simcyp Consortium achieve this 25th anniversary milestone and to be one of the longest-running consortia focused on a specific area," said Amin Rostami, PharmD, PhD, Chief Scientific Officer at Certara. "We are proud that our work is helping not only better understand therapeutics and optimize their chance of success in the clinic, but also to support simulations of therapies in understudied and difficult-to-reach populations including pediatric, pregnancy, lactation, renal-impaired, and other important populations. The ultimate goal of technology is to extend our ability beyond what is currently possible. Our collaboration in the consortium has helped us achieve that goal, and we will continue to drive innovation and new scientific understanding in coming years together.”
Simcyp Consortium Awards & Grants
To recognize research excellence and give back to the scientific community, the Simcyp Consortium presents awards as well as funding for either a PhD or a post-doctoral research program annually. The Simcyp Consortium’s 2024 Most Informative Scientific Report Award is awarded to the National Taiwan University for the paper titled: ‘Physiologically based mechanistic insight into differential risk of valproate hepatotoxicity between children and adults: A focus on ontogeny impact.’
The Simcyp Grant and Partnership Scheme has awarded over
In addition to its annual awards and funding, Simcyp provides academic teaching and research licenses to more than 110 universities and research institutions around the world. Further, Simcyp publications (including articles, meeting abstracts, reviews, letters, and book chapters) have been cited more than 8,000 times in scientific literature.
For more information about Certara’s Simcyp Simulator, please visit: https://www.certara.com/software/simcyp-pbpk/
About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions and regulatory agencies across 66 countries. Visit us at www.certara.com.
Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
certara@pancomm.com
FAQ
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