Celerion

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  • Celerion Appoints Dr. Marc Hoffman as Chief Medical Officer

    Celerion Appoints Dr. Marc Hoffman as Chief Medical Officer

    Celerion Appoints Dr. Marc Hoffman as Chief Medical Officer

    Lincoln, NE (February 22, 2017) – Celerion, continues to grow in response to the evolving needs of early clinical research. With the increasing focus on evaluating drug effects in relevant patient populations earlier in development, Celerion is pleased to announce that Dr. Marc Hoffman has joined the company as Chief Medical Officer. Dr. Hoffman will have responsibility for leading the global medical staff and providing medical oversight and expertise to support early clinical research studies.

    Dr. Hoffman joins Celerion from Patient iP where he served as Chief Medical Officer, providing clinical leadership around Patient iP’s innovative platform, customer programs and related medical affairs activities. Prior to joining Patient iP, he held the roles of Chief Medical Officer and Senior Vice President and General Manager over the Biopharmaceutical Business at Theorem Clinical Research, leading the development of drugs and biologics. Previously in his career, Dr. Hoffman held positions of increasing responsibility in Medical and Scientific Affairs at Baxter, Hospira and Covance, providing senior-level strategic direction for Phase II-IV programs.

    Dr. Hoffman brings over 28 years of knowledge and experience as a physician in the pharmaceutical, device, and CRO industries to this role. He is experienced in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams.

    “We are pleased to have Marc join our executive leadership team during this exciting period of growth in our company,” said Susan Thornton PhD, President and CEO. “His depth of experience in managing all aspects of global drug development in multiple therapeutic areas will not only make him a valuable asset for our organization but also for our clients.”

    About Celerion
    Translating science into medicine, Celerion is a premier provider of early clinical research and translational clinical pharmacology sciences from their global locations in North America, Europe and Asia.

    Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and clinical pharmacology research supporting product labeling. With purpose-built clinic and laboratory facilities and highly automated technology, Celerion provides full study services including clinical study conduct, data management and biometrics, PK/PD analysis, bioanalytical services, medical writing, and regulatory and drug development program management. For more information please visit www.celerion.com.

    Media Contact:
    Michelle Maklas-Baker
    Manager, Global Marketing
    +1 732-306-7804
    media.inquiries@celerion.com

  • Newsletter: Q1 2017

  • Celerion Announces Celexus as a Premier Safety Reporting Tool for Phase I Clinical Trials

    Celerion Announces Celexus as a Premier Safety Reporting Tool for Phase I Clinical Trials

    Celerion Announces Celexus as a Premier Safety Reporting Tool for Phase I Clinical Trials

    Lincoln, NE (November 17, 2016) – Celerion is pleased to announce a key technology addition to its early clinical development capabilities, Celexus®.

    Celexus® offers clients a first look at their early clinical research data in real-time, as it is collected in the clinics and laboratories, from a first in class web-based portal. Celexus® is a sophisticated approach to viewing, analyzing and trending clinical data during acquisition. The viewable data includes screening, recruiting, adverse events, clinical laboratory, pharmacodynamics, pharmacokinetic and bioanalytical data.

    Celexus is directly populated with data from Clinquick®, Celerion’s proprietary electronic data acqui­sition platform that captures source data directly from the clinic, eliminating the need for manual recording and transcription into a secondary electronic capture system.  Designed specifically for clients’ evolving needs, Celexus provides visual displays and the ability to define parameters to enable faster assessment of trends and identification of potential safety signals.

    Safety data visualizations include, among many others, vital signs, dosing, adverse events, ECGs and inclusion/exclusion criteria. These visualizations and source data are easily exported into multiple formats for analysis and creation of ad hoc reports.  Another highlight of Celexus is the Key Performance Indicator Dashboard which displays the progression of the study with information such as recruitment, deviations, study milestones/timelines, dosing and retention.

    “Technology is a key differentiator in the rapid transfer of information when translating science to medicine. Celerion is at the forefront of providers in the early clinical research space with respect to investing in the development of new technologies which provide speed and ease of data analysis to our pharma and biotech clients,” said Charles Rapier, Executive Director, Technical Business Solutions. “Celexus brings together key data from disparate systems into one single platform, providing real-time actionable insights to help our clients manage their drug development program.”

    “Our clients require visibility and transparency to effectively run their clinical study,” said Susan Thornton, President and CEO. “Real-time access to data has many empirical benefits such as reduced timelines, improved data quality and lower study costs.  It also provides a window into the clinical and operational data of ongoing studies which enables clients to make informed decisions and ultimately helps get their products to the market faster.”

    About Celerion 

    Translating science into medicine, Celerion is a premier provider of translational clinical pharmacology sciences from their global locations including North America, Europe and Asia.

    Celerion conducts first-in-human, clinical proof of concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. For more information please visit www.celerion.com.

    Media Contact:

    Michelle Maklas-Baker
    Marketing Manager
    +1 732 306 7804
    media.inquiries@celerion.com

     

     

  • Celerion Named Best Translational Clinical Pharmacology Company 2016

    Celerion Named Best Translational Clinical Pharmacology Company 2016

    Celerion Named Best Translational Clinical Pharmacology Company 2016

    Lincoln, NE (October 5, 2016) — Celerion is pleased to announce that it is the recipient of the 2016 International Life Sciences Award in the Best Translational Clinical Pharmacology Company category. The awards panels evaluated global nominees over a wide range of parameters including leadership in innovation, excellence in products and services, success stories and client testimonials. The results have been published in GHP’s 2016 International Life Science Awards Winners’ Supplement.

    Celerion Translates Science into Medicine, using state of the art technologies and new, innovative approaches in early clinical research. Serving clients of all sizes in the pharmaceutical and biotechnology industries, Celerion focuses on clinical pharmacology Phase I and IIa trials.

    Translational medicine, where evaluation of drug safety, tolerability and efficacy is assessed for the first time in humans, represents the cutting edge of pharmaceutical science. Celerion invests in and applies targeted technologies to support our clients’ need for greater clarity earlier in the drug development process.

    “This award highlights the innovation and commitment of Celerion to support clients’ evolving needs,” said Susan Thornton, President and CEO. “Our highly experienced team, consulting expertise, robust technologies and methodologies enable us to enhance efficiency, precision and reduce costs, helping clients get their products to the marker faster.”
     
    About Celerion
    Translating science into medicine, Celerion is a premier provider of translational clinical pharmacology sciences from their global locations including North America, Europe and Asia.

    Celerion conducts first-in-human, clinical proof of concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. www.celerion.com

    Media Contact:
    Lorraine M. Rusch, Ph.D
    Vice-President, Commercial Development
    Lorraine.rusch@celerion.com

     

  • Newsletter: Q4 2016

  • Supporting the Next Major Health Epidemic

    Supporting the Next Major Health Epidemic

    Supporting the Next Major Health Epidemic

    Non-alcoholic fatty liver disease (NAFLD)/Non-alcoholic steatohepatitis (NASH) is viewed as the next major health epidemic and with no current anti-NASH medication on the market to treat this chronic disease; it is expected to place a heavy burden on our healthcare systems.

    NAFLD is considered to be a hepatic manifestation of metabolic syndrome, associated with obesity and insulin resistance. The incidence of NAFLD/NASH is rapidly increasing worldwide, currently affecting over 1 billion people, and the prevalence of NAFLD/NASH is not limited to adults as the rise of this disease is also observed in children. Presently, the standard of care for NAFLD/NASH includes invasive liver biopsy procedures for diagnosis and management. Therefore, NASH is expected to become the most common indication for liver transplantation in the United States by 2020, surpassing viral diseases like hepatitis C.

    This month, Thomas Jefferson University Hospital in Philadelphia reported its 1,000th liver transplant surgery. This milestone calls out to our industry the importance of our work in support of patients with end-stage liver disease.

    Non-invasive diagnostic and prognostic techniques to identify NASH patients and those who will positively response to a given treatment regimen is overwhelmingly needed. Recent advancements in medical imaging, such as magnetic resonance elastography and FibroScan, are contributing to achieving these goals. In addition, an emerging trend in early clinical research is to examine pharmacodynamic effects in patient populations. In this respect, imaging tools as well as soluble biomarkers found in bodily fluids such as blood, urine, saliva, etc. are extremely useful to evaluate NAFLD/NASH drug efficacy.

    A number of pharmaceutical companies are currently involved in NAFLD/NASH research. This list includes, but is not limited to Intercept, Genfit, Galmed, Gilead, Genentech, Pfizer, Merck, and Novartis.

    An experienced contract research organization (CRO) will have NAFLD/NASH capabilities and experience in hepatic lipid metabolism and fibrosis biomarkers to incorporate into drug development Single Ascending Dose (SAD), Multi-Ascending Dose (MAD), Drug Interaction (DDI), Phase 1b, Proof-of-Concept (POC) studies. The scientific and clinical operational staff will have experience and thorough understanding of the disease as well as bioanalytical and non-invasive measurements of hepatic lipid metabolism, inflammation and fibrosis. In addition, the CRO will have a strong recruitment track-record to support special-population studies like diabetes, obesity, NAFLD programs.

    Celerion’s experienced and knowledgeable scientific and clinical operational team can help navigate NAFLD/NASH drug development programs through this emerging market.

    Science leading to medicine, done well, helps saves patients’ lives and provides for a healthy standard of living.

    Celerion was recognized by Biopharmaceutical Clients in May 2016 as a Leader in Contract Research Quality Benchmarking Survey.

     

     

  • Celerion Recognized by Biopharmaceutical Clients as a Leader in Contract Research Quality Benchmarking Survey

    Celerion Recognized by Biopharmaceutical Clients as a Leader in Contract Research Quality Benchmarking Survey

    Celerion Recognized by Biopharmaceutical Clients as a Leader in Contract Research Quality Benchmarking Survey

    (Lincoln, NE May 26, 2016) –Celerion has been highlighted as an industry leader by highly experienced global biopharmaceutical executives in Life Science Leader’s annual CRO Leadership Awards for 2016.

    Celerion was recognized across multiple categories amongst 65 of their peers including Covance, Quintiles and PPD in the annual Contract Research Quality Benchmarking online survey conducted by Industry Standard Research. The survey queried the direct client experience across 27 different performance metrics spanning technical expertise to client service; results have been published in the May edition of Life Science Leader magazine.

    Celerion was recognized as a CRO Leader in categories including Capabilities, Compatibility, Expertise, Quality and Reliability by both big and small pharma clients.

    Additionally, Individual Attribute Awards were developed in response to the intangible capabilities that were identified as critical to successful collaborations. Celerion was recognized for achievement in Data Quality, Innovative Solutions and Operational Excellence.

    “It is an honor to be recognized by our clients with these awards. Celerion delivers Applied Translational Medicine to help our clients generate key data very early and enable faster go/no-go decisions. These awards reinforce our commitment to responding to our clients’ challenges in drug development,” said Susan Thornton, President and CEO.

    About Celerion
    Translating science into medicine, Celerion is a premier provider of translational clinical pharmacology sciences from their global locations including North America, Europe and Asia.

    Celerion conducts first-in-human, clinical proof of concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. For more information please visit www.celerion.com.

    Media Contact:

    Lorraine M. Rusch PhD
    Vice President, Commercial Development
    + 1 (845) 570 3250
    media.inquiries@celerion.com

     

  • Assign Clinical Research Joins Celerion

    Assign Clinical Research Joins Celerion

    Assign Clinical Research Joins Celerion

    (Lincoln, NE Jan 11, 2016) – Celerion is pleased to announce that effective January 1 2016, Assign Clinical Research, headquartered in Vienna, Austria, has joined Celerion, further expanding our global presence and capabilities in the conduct of complex early clinical studies. Assign conducts early stage clinical studies, as well as specialized later stage studies, across a broad range of therapeutic areas with a particular focus in oncology, vaccines, cancer immunotherapy, personalized medicine and autoimmune disorders. They specialize in difficult to recruit clinical studies through relationships with study centers located across 30 countries.

    The addition of these capabilities demonstrates Celerion’s strategic focus in responding to our clients’ challenges in drug development. With the increasing importance of incorporating patients earlier into clinical research programs, Celerion’s strengthened service offerings in early phase patient studies provide clients with better information, faster to reach go/no-go development decisions on new drug candidates.

    “Assign perfectly complements Celerion’s services in early clinical development,” said Susan Thornton PhD., President and CEO at Celerion. “I am excited to bring two industry leaders together to provide our clients with a highly specialized suite of services which strengthens our competencies in Applied Translational Medicine. The talent and scientific expertise at Assign combined with that of Celerion deepens our position as the global leader in early clinical research.”

    “There is a strong cultural fit with Assign and Celerion,” said Klaus Fischer PhD, CEO at Assign. “Both companies are committed to delivering on our clients’ ever-evolving needs in the conduct of complex clinical studies. I look forward to joining the Celerion team to integrate our services and offer clients access to the largest and the most comprehensive global early stage clinical research organization.”

    About Celerion
    Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

    With over 40 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical Proof-of-Concept, cardiac safety (TQT, robust QT), ADME and NDA- enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. For more information please visit www.celerion.com.

    About Assign
    Assign specializes in the conduct of complex patient studies across a broad range of therapeutic areas with a particular focus in oncology, immunotherapy, vaccines , personalized medicine, and autoimmune diseases. Assign has been providing clinical development support to pharmaceutical, biotechnology, and medical device companies globally since 2002. The Company offers a comprehensive suite of services across all phases of development. Through relationships with study centers in 30 countries, Assign has a strong track record of success in difficult to recruit patient studies. Assign provides expertise in adaptive trial design, clinical data services, biostatistics, clinical conduct, and IMP handling and QP releases for the European Union.

     

    Media Contact:

    Michelle Maklas-Baker
    Celerion
    Manager, Global Marketing
    media.inquiries@celerion.com

  • Celerion Expands its Cell-Based Assays Capabilities in Global Bioanalytical Services

    Celerion Expands its Cell-Based Assays Capabilities in Global Bioanalytical Services

    Celerion Expands its Cell-Based Assays Capabilities in Global Bioanalytical Services

    (Lincoln, NE; Nov 3, 2014) – Celerion announces the expansion of laboratory capabilities to meet growing demand for cell-based assays. Assays involving whole cells provide a variety of measures of drug activity or effect that can be important endpoints in clinical research. Celerion has expanded this capability in response to client demand for immunogenicity assessment for large molecule analysis and for immune monitoring assays in drug development. It also supports the recently issued FDA Guidance on “Immunogenicity Assessment for Therapeutic Protein Products”.

    For more than 30 years, Celerion’s laboratory in Zurich, Switzerland has supported immunogenicity testing to detect anti-drug antibodies in serum samples of animals or patients treated with new drug therapies under development. Through investments in state-of-the-art technology and resources, Celerion is able to support clients’ evolving needs in immunogenicity assessment, by leveraging appropriate biological models for the assessment of antidrug neutralizing antibodies. This methodology can be used to examine cell morphology, cell differentiation, cell cycle effects including apoptosis, protein regulation including modification and expression levels, and transcription activity. These assays are important biomarkers in clinical research programs of large molecule and biologically manufactured drugs including biosimilars.

    Celerion’s laboratory in Lincoln, Nebraska is focused on flow cytometry, a powerful technique that allows the detection and measurement of different cell populations within a biological sample. The use of flow cytometry enables Celerion to develop de-novo flow cytometry assays such as cell signaling, target engagement, natural killer cell and immune function assessments. These methods are utilized to measure therapeutic response, stratification of patient populations and the evaluation of predictive diagnostic or prognostic biomarkers in clinical research. Many of these assays require fresh samples, so being co-located within Celerion’s clinical research unit in Lincoln, Nebraska enables clients to leverage this technology as part of early evaluation of a new drug’s safety and pharmacological effects.

    “Utilizing cell-based assay capabilities enables our clients to gain key safety data that allows them to make critical decisions for their drug development programs,” said Ray Farmen, Ph.D., Vice President of Global Bioanalytical Services at Celerion. “Celerion now offers a complete package of immunogenicity testing with the addition of neutralizing antibody assessments at our Zurich facility. Flow cytometry capabilities are most valuable when performed in immediate proximity to where clinical conduct is performed, making Celerion’s clinical facilities in Lincoln, Nebraska an ideal place to perform such research.”

    Investing in cell-based assay technology is aligned to Celerion’s goal of providing robust and integrated ways for clients to evaluate the true potential of new drug candidates early in clinical development.

    About Celerion
    Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

    With over 40 years of experience and 750 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical Proof-of-Concept, Cardiac Safety Services (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. For more information please visit www.celerion.com.

     

    Media Contact:

    Farzana Azam
    Celerion
    Executive Director, Global Marketing
    media.inquiries@celerion.com

  • Celerion Completes Recapitalization Through Investment by MTS Capital Health Partners

    Celerion Completes Recapitalization Through Investment by MTS Capital Health Partners

    Celerion Completes Recapitalization Through Investment by MTS Capital Health Partners

    (Lincoln, NE; Oct 29, 2014) – Celerion announces the successful recapitalization of its business through investment by MTS Health Investors, LLC, the New York-based healthcare private equity firm. MTS has partnered with management and will provide capital to support future growth. With operations throughout North America, Europe and Asia, Celerion provides comprehensive clinical study solutions to pharmaceutical and biotechnology clients conducting early clinical research. The company serves its clients through its global network of owned facilities with a focus on Applied Translational Medicine to support early drug development decisions.

    “We are excited to partner with MTS as we enter the next phase of our growth. With a strong scientific foundation and commitment to excellence, we have worked to create a market-leading reputation and platform with unique and diversified capabilities to meet the needs of the pharmaceutical industry,” said Susan Thornton PhD, President and CEO at Celerion. “With MTS’s investment we will be provided with additional tools and resources to grow our customer base, drive value to our clients, and explore new pathways for growth.”

    “MTS has spent a significant amount of time evaluating the outsourced pharmaceutical services sector and believes that Celerion represents an ideal investment platform as a market-leader in early clinical research through Proof-of-Concept studies,” said Curtis S. Lane, Partner at MTS. “Celerion’s leadership has built a company with a stellar reputation and a track record of providing unmatched service and rapid turnaround times to its pharmaceutical and biotechnology clients.  We look forward to partnering with the company to provide additional financial and operational resources and to pursue new opportunities for growth.”

    About Celerion
    Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labelling of new medicines.

    With over 40 years of experience and 750 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical Proof-of-Concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. For more information please visit www.celerion.com.

    About MTS
    MTS Health Investors, LLC, located in New York, is a healthcare private equity firm that makes investments in operating companies within the healthcare industry. MTS targets companies that provide differentiated and cost-effective solutions in the healthcare and pharmaceutical services industry as well as low-technology manufacturing sectors of the healthcare industry. For further information, please visit www.mtshealthinvestors.com.

     

    Media Contact:

    Farzana Azam
    Celerion
    Executive Director, Global Marketing
    media.inquiries@celerion.com