Certara

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

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火曜日, 9月 19, 2023
Medical Affairs Bureau, Central nervous system, Drug development, NDS, Therapy, Marketing, Type 2, Pediatrics, New Drug Application, European Medicines Agency, Health care, CMC, Clinical trial, NDA, Therapeutic Goods Administration, Cancer, CTA, Regulatory science, CNS, Common Technical Document, EMA, Chemistry, Shanda, Investigational New Drug, Patient, Pinnacle, Certara, Medicines and Healthcare products Regulatory Agency, MAA, Rare, TGA, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, BLA, Food, MHRA, Pharmaceutical industry, Risk management, Medical device, EU, Swiss Medical Students' Association

Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.

Key Points: 
  • Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.
  • “As the global regulatory drug development environment changes at an ever-increasing pace, Certara has combined regulatory writing expertise with technology platforms that streamline a complex process,” said Demetrius Carter, Sr. Vice President, Regulatory Sciences & Medical Affairs at Certara.
  • In addition to regulatory submission services, Certara offers a software portfolio that saves time and resources in submission development.
  • The software portfolio includes:
    Pinnacle 21™ software used to facilitate all aspects of preparing clinical trial data for regulatory submissions.

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

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金曜日, 8月 4, 2023
Science, Software, Biotechnology, Research, Pharmaceutical, Health, Technology, Clinical Trials, Clinical Data Interchange Standards Consortium, Medicines and Healthcare products Regulatory Agency, Adam, Korea Institute of Science and Technology, SDTM, Toxicity, KIT, Data analysis, PMDA, Drug discovery, Toxicology, CORA dataset, SEND, R, CDISC, FDA, NMPA, Exploration, Medical device, Online shopping, Certara

Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .

Key Points: 
  • Certara, Inc. (Nasdaq: CERT), a global leader in Biosimulation, today announced that a Korea Institute of Toxicology (KIT) have decided to implement Certara’s Pinnacle 21 Enterprise data conformance and submission software and SEND Explorer pre-clinical data visualization software .
  • The combination of Pinnacle 21 Enterprise and SEND Explorer enables synergy for meeting global regulatory guidelines and delivering efficiency.
  • SEND Explorer is a validated, web-based application that provides advanced viewing, data summarization and visualization capabilities for nonclinical study data.
  • Using SEND Explorer, scientists generate visualizations of single and multiple toxicology studies to inform decisions and quickly address questions from health authorities.

Certara Reports First Quarter 2023 Financial Results

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月曜日, 5月 8, 2023
Insurance, Growth, Travel, EBITDA, Acquisition, Software, Sarbanes, Certara, Vyasa, Video game, Management, Cryptocurrency

PRINCETON, N.J., May 08, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2023.

Key Points: 
  • PRINCETON, N.J., May 08, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2023.
  • “We are pleased with our first quarter financial results and performance in software and biosimulation services” said William F. Feehery, chief executive officer.
  • Total revenue for the first quarter of 2023 was $90.3 million, representing growth of 11% over the first quarter of 2022.
  • Adjusted diluted earnings per share for the first quarter 2023 was $0.12 compared to $0.11 for the first quarter of 2022.

Xentria Announces Peer Reviewed Publication of Biosimulation Model in Frontiers in Pharmacology Journal

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火曜日, 3月 21, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ohio State University, Sarcoidosis, Heart, Medical Affairs Bureau, Human, Central nervous system, Serum, Clinical trial, Granuloma, HIV disease progression rates, Patient, Ohio State University Wexner Medical Center, Clinical research, Certara, Internal medicine, FDA, Skin, Disease, Pharmaceutical industry, Vaccine, Pharmacology

Xentria, Inc., a biotech company focused on developing treatments to address unmet clinical needs, today announced the peer reviewed publication in Frontiers in Pharmacology of a biosimulation model for XTMAB-16, its sarcoidosis treatment candidate.

Key Points: 
  • Xentria, Inc., a biotech company focused on developing treatments to address unmet clinical needs, today announced the peer reviewed publication in Frontiers in Pharmacology of a biosimulation model for XTMAB-16, its sarcoidosis treatment candidate.
  • The publication, entitled “Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment” can be found here .
  • The multi-system condition has widely variable disease manifestations and outcomes which require targeted therapies that help prevent disease progression.
  • A population pharmacokinetic modeling and simulation framework was applied to characterize XTMAB-16 concentration-time profiles in serum following administration to healthy volunteers.

A.I. Coming to Certara’s D360 Scientific Informatics Software

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木曜日, 3月 9, 2023
Software, A.I, Research, Deep learning, Lab, Mobile phone, Risk management, Certara, Vyasa

PRINCETON, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, is adding deep learning capabilities to D360 , a leading scientific informatics software platform.

Key Points: 
  • PRINCETON, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, is adding deep learning capabilities to D360 , a leading scientific informatics software platform.
  • Novel Structure Generation – Deep learning models within D360 will create and optimize chemical structure ideas for assessment by discovery scientists.
  • Access to Unstructured Data – Traditionally, D360 has delivered insights from structured sources such as databases and web services.
  • By applying these models to D360, our users are armed with the tools needed to expand these capabilities and accelerate their decision-making confidently.

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

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火曜日, 3月 7, 2023
Growth, FDA, MBI, Simulation, SVP, Pharmacokinetics, Trial of the century, QSP, LAI, PBPK, Lactation, Doctor of Philosophy, Drug development, Pregnancy, Excipient, Metabolism, Patient, Quantitative systems pharmacology, PD, Generic drug, Pharmaceutical industry, Simcyp, Pharmacodynamics, Certara

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.

Key Points: 
  • The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.
  • The Simcyp Simulator has proven use cases across drug development, including first-in-human dosing, extrapolation to special populations, bioequivalence testing, optimizing clinical study design and predicting drug-drug interactions (DDIs).
  • “We are excited to expand and improve upon the Simcyp Simulator capabilities to advance modern drug development with the launch of our latest version,” said Masoud Jamei, Ph.
  • For more information about the Simcyp PBPK Simulator and Simcyp Designer, please visit: https://www.certara.com/software/simcyp-pbpk/

Certara Announces Transition Plan for Chief Financial Officer

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水曜日, 3月 1, 2023
FP, BD, Integration, Ford, CFO, Certified Treasury Professional, Partnership, Feehery, Growth, BD (company), General Electric, Health, Management, Certara

PRINCETON, N.J., March 01, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), announced today that John Gallagher will succeed Andrew Schemick as Chief Financial Officer, effective April 1, 2023.

Key Points: 
  • PRINCETON, N.J., March 01, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), announced today that John Gallagher will succeed Andrew Schemick as Chief Financial Officer, effective April 1, 2023.
  • Mr. Schemick will transition into a newly created position as Senior Vice President, Corporate Operations and Integration, and he will be focused on supporting John’s transition, and then building operational excellence as Certara continues to grow.
  • John brings almost 25 years of experience to Certara, most recently serving as the Chief Financial Officer of Cue Health, a publicly traded healthcare technology company.
  • William Feehery, President and Chief Executive Officer, stated, “I am excited to welcome John to the Certara team as we continue executing our business strategy and creating strong value for all stakeholders.

ClariMed, Inc Launches Integrated Medical Device Services Partner

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月曜日, 1月 30, 2023
Safety, Ecosystem, Medtech, Fortune 500, Health, Partnership, MDR, Chairperson, FDA, European Medical Students' Association, O Clarim, Patient, Acquisition, IRB, Engineering, Pharmaceutical industry, Industrial design, Risk management, Management, Certara

WILMINGTON, Del., Jan. 30, 2023 /PRNewswire/ -- ClariMed, Inc., today announced the launch of the first MedTech services partner to take an integrated, human-centric approach to medical product development.  The Company also announced today the acquisition of San Jose-based UserWise, LLC, and the appointment of Kelley Kendle as Chief Executive Officer and Chair of the Board of Directors. The Company was formed in partnership with NaviMed Capital, a private investment firm focused exclusively on the healthcare industry.

Key Points: 
  • WILMINGTON, Del., Jan. 30, 2023 /PRNewswire/ -- ClariMed, Inc., today announced the launch of the first MedTech services partner to take an integrated, human-centric approach to medical product development.
  • We bring together firms with differentiated services to provide a comprehensive offering and a multi-regional footprint.
  • ClariMed was formed to meet the MedTech industry's growing need for an integrated partner focused on development and regulatory services.
  • "Evolving FDA regulations and the EU Medical Device Regulation (MDR) are motivating medical product sponsors to continue their focus on risk mitigation.

ClariMed, Inc Launches Integrated Medical Device Services Partner

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月曜日, 1月 30, 2023
Safety, Ecosystem, Medtech, Fortune 500, Health, Partnership, MDR, Chairperson, FDA, European Medical Students' Association, O Clarim, Patient, Acquisition, IRB, Engineering, Pharmaceutical industry, Industrial design, Risk management, Management, Certara

WILMINGTON, Del., Jan. 30, 2023 /PRNewswire/ -- ClariMed, Inc., today announced the launch of the first MedTech services partner to take an integrated, human-centric approach to medical product development.  The Company also announced today the acquisition of San Jose-based UserWise, LLC, and the appointment of Kelley Kendle as Chief Executive Officer and Chair of the Board of Directors. The Company was formed in partnership with NaviMed Capital, a private investment firm focused exclusively on the healthcare industry.

Key Points: 
  • WILMINGTON, Del., Jan. 30, 2023 /PRNewswire/ -- ClariMed, Inc., today announced the launch of the first MedTech services partner to take an integrated, human-centric approach to medical product development.
  • ClariMed was formed to meet the MedTech industry's growing need for an integrated partner focused on development and regulatory services.
  • "Evolving FDA regulations and the EU Medical Device Regulation (MDR) are motivating medical product sponsors to continue their focus on risk mitigation.
  • These sponsors need a strategic partner with a differentiated platform of services to guide them through development milestones while maintaining a constant awareness of evolving agency expectations.

Certara Acquires Vyasa, an Artificial Intelligence Company that Delivers Predictions to Accelerate Scientific Innovation

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水曜日, 1月 4, 2023
Drug development, Organization, Acquisition, Intelligence, Medical device, Vyasa, Certara

PRINCETON, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), today announced it has acquired Vyasa Analytics, LLC.

Key Points: 
  • PRINCETON, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), today announced it has acquired Vyasa Analytics, LLC.
  • Vyasa provides scalable deep-learning software which allows life sciences organizations to perform predictions and answer complex questions across structured and unstructured bio-medical information.
  • The acquisition will elevate Certara’s software by bringing state-of-the-art artificial intelligence (AI) capabilities to its end-to-end platform.
  • “We are pleased to announce the acquisition of Vyasa, a cutting-edge company that will enhance existing Certara software platforms and further expand our capabilities across our product portfolios,” said William F. Feehery, Chief Executive Officer of Certara.