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Celerion Announces Membership into the Cardiac Safety Research Consortium (CSRC)

(Lincoln, NE; Oct 15, 2014) – Celerion is pleased to announce our membership into the Cardiac Safety Research Consortium (CSRC). As a member of the CSRC, Celerion will engage with other thought leaders on key issues that impact cardiovascular safety. This will include discussions regarding alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

Celerion is a leading provider of cardiovascular safety services in early clinical research. In our 40 years of experience, Celerion has conducted over 150 studies for cardiovascular compounds, and completed more than 50 Thorough QT (TQT) studies. By leveraging this expertise, Celerion developed the innovative Highly Automated ECG Core Lab that enables clients to expedite ECG review, thereby significantly reducing the time and cost for cardiac safety studies over traditional approaches. Membership into CSRC highlights Celerion’s leadership role and contributions in cardiovascular safety evaluation, and allows us to collaborate in critical discussions to ensure we deliver on our clients’ and public health needs.

The CSRC was launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.

CSRC supports research by enlisting stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, Think Tank Incubator programs, and consensus white papers. Additional work is under way to expand the portfolio of research projects beyond the ECG data into other areas of cardiac safety evaluation from the preclinical through the postmarket periods.

“We are delighted to be a member of the CRSC, and help define novel paradigms for cardiovascular safety assessment of new chemical entities in clinical research,” said Robert Lester MD FACC, Chief Cardiologist, and Global Medical Director, Cardiovascular Safety at Celerion. “Being part of this prestigious organization and collaborating with our peers in academia, the pharmaceutical industry, as well as other Contract Research Organizations (CROs) in the area of cardiovascular safety evaluation, will enable Celerion to help shape the future of cardiac safety in drug 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, Cardiovascular 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 Appoints Dr. Robert Lester as Chief Cardiologist, Global Medical Director of Cardiac Safety Services

(Lincoln, NE; Jun 16, 2014) – Celerion is pleased to announce the appointment of Robert Lester MD FACC, as Chief Cardiologist, Global Medical Director of Cardiac Safety Services. Dr. Lester will develop and lead Celerion’s strategic vision in Cardiac Safety Services. He will be based in our state-of-the-art facility in Phoenix, Arizona.

Dr. Lester comes to Celerion with over 25 years’ experience in clinical medicine and academia, as well as over 13 years’ experience as a Director and Senior Cardiologist at several leading Contract Research Organizations (CROs) and ECG Core labs. Dr. Lester will utilize his extensive experience and expertise in the area of cardiac safety, to provide advice and lead client programs. He will also be a driving force for Celerion’s innovative Highly Automated ECG Core Lab that enables clients to expedite ECG review, thereby significantly reducing the time and cost for cardiac safety studies over traditional approaches.

“The appointment of Robert continues to reinforce Celerion’s leadership role in the area of cardiac safety studies,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “His comprehensive expertise and knowledge in the area of cardiac safety will be invaluable for Celerion and for our clients. Robert will also lead the efforts to ensure we meet the needs of our clients, as the regulatory landscape changes.”

Dr. Lester earned his BA with highest honors in Sociology at Princeton University and a doctorate in Medicine at Duke University Medical School. He continued his training at Duke University Medical Center in Internal Medicine and Cardiology. Thereafter he was recruited by the National Institutes of Health as an Expert Consultant in Cardiac Critical Care medicine where he became acting Chairman of that Department. This was followed by professorships at the University of Pennsylvania and University of Minnesota before entering the CRO industry in 2001. Dr. Lester is the author of numerous publications, and has been an invited speaker at leading conferences and key organizations.

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 Selected by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium for The Beta Cell Project

(Lincoln, NE; Jun 11, 2014) – Celerion is pleased to announce it has been selected by the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium to provide clinical support for The Beta Cell Project.  The Beta Cell Project is a program of studies designed to standardize biomarker measures of beta cell function. Celerion will provide clinical recruitment and conduct to support The Beta Cell Project and assist the FNIH in developing pharmacodynamic measures of beta cell function, with the goal to create industry standards.

The Biomarkers Consortium is a public-private biomedical research partnership managed by the FNIH that endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. The consortium is helping create a new era of personalized medicine, with more highly predictive markers that have an impact during a patient’s illness or lifespan. Their goal is to combine the forces of the public and private sectors to accelerate the development of biomarker-based technologies, medicines, and therapies for the prevention, early detection, diagnosis, and treatment of disease.

“Celerion has continued to invest in and expand our capabilities in metabolic disease to support early Proof-of-Concept studies in the development of diabetes, obesity, metabolic and cardio-metabolic interventions. We are therefore delighted to have been selected to support programs by the FNIH in the area of metabolic disorders,” said Philip Bach, Vice President of Global Clinical Research at Celerion. “The award of this program, and knowing that our contribution will help set industry standards, is recognition of our expertise in this area and the quality of data delivered to clients.”

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 and Korean Drug Development Fund Form Collaboration to Strengthen Early Phase Clinical Research in South Korea

(Lincoln, NE; Seoul, ROK, May 28, 2014) – Celerion and the Korean Drug Development Fund (KDDF) are pleased to announce their formal collaboration to provide drug development expertise and support for the emerging drug discovery and development industry in South Korea.

The agreement in the form of a Memorandum of Understanding (MOU) provides the framework for collaborations of mutual benefit to both organizations. Companies funded by KDDF will have access to Celerion’s extensive experience and expertise in early clinical research and bioanalysis, as well as the global footprint of external partner sites. The collaboration will support a sharing of knowledge between KDDF and Celerion, and will focus on developing innovative and efficient ways to bring Korean drug discoveries to the global market. The MOU further enhances both organizations’ ability to effectively apply principles of translational medicine to the development of innovative new drugs.

“We are delighted to collaborate with KDDF, and provide early clinical research expertise to support and strengthen the emerging pharmaceutical industry in South Korea,” said Susan Thornton PhD, President and CEO of Celerion. “Our agreement with KDDF is further evidence of Celerion’s enthusiasm and commitment to contributing to the growth of South Korea’s biomedical research industry.”

“The KDDF is very happy to have established a partnership with Celerion. This collaboration is aligned to our vision to build effective partnerships between government, industry and academia,” said Dongho Lee MD MBA, CEO of KDDF. “Together with Celerion, KDDF will be able to provide professional consulting services to the Korean research communities to advance the research activities and promote important innovation.”

Celerion will support all programs with KDDF, from the recently announced business expansion within the Biomedical Research Institute at Seoul National University Hospital (SNUH), in South Korea.

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.

About Korean Drug Development Fund
Signaling a new change in government-funded strategy, the KDDF was established in 2011 and operates through close management of development projects, linking grant support to the achievement of milestone-based research objectives. With a budget of US$1 billion, including private matching funds, the KDDF is an unparalleled response to the clinical demands of the 21st century. This investment in the country’s future is aimed at nurturing success that is initially driven by government and then transformed into a sustainable growth engine through valued researchers and industry partners.

Media Contact:

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

Celerion Opens Operations in South Korea at Seoul National University Hospital Clinical Trial Center

(Lincoln, NE; Mar 4, 2014) – Celerion is pleased to announce the expansion of clinical operations to South Korea. Through partnership with Seoul National University Hospital (SNUH), the new Asian office is located within the SNUH Clinical Trials Center. This enables Celerion and our clients access to the 80-bed clinical research unit, particularly geared toward clinical pharmacology, oncology, and pediatrics, as well as the highly trained staff at this center. The new Asian office will be overseen by John Horkulak, Executive Director, Eurasian Site Operations. Mr. Horkulak brings over 20 years of experience in managing clinical pharmacology studies in patient populations to this role.

The focus of the SNUH Clinical Trials Center is translational medicine and aligns with Celerion’s strategic vision to provide effective global services that support growing interest in complex early clinical studies, often involving patients. In addition, Celerion has built relationships and audited three other clinical trial centers in South Korea to support the need for multi-site early clinical studies in patients often requiring confinement.

South Korea has become a leader in the Asia Pacific region for conducting clinical studies. Over the past 10 years, the South Korean government has provided funding and resources to create a network of well-equipped hospital-based clinical trial centers as a focus for training and growth in clinical pharmacology. By partnering with Celerion, SNUH and other clinical trial centers will gain exposure to our best practices and processes as well as broader involvement in global drug development. Through Celerion, clients will have access to patient populations suitable for participation in early clinical research in oncology, HCV, cardiovascular (atherosclerosis and hypertension), diabetes, arthritis, osteoporosis, pain, psychiatric conditions, Alzheimer’s disease, Parkinson’s disease, asthma and COPD. In addition, Celerion’s partners will provide expertise in pharmacogenetics and ethnic bridging studies in Asian populations.

“We are very pleased to have a presence in South Korea through our partnership with Seoul National University Hospital,” said Susan Thornton PhD., President and CEO at Celerion. “They are a highly respected institution and among the global leaders in the conduct of quality medical research. Collectively, we are in a solid position to successfully conduct and analyze complex clinical pharmacology studies involving patients with access to specialized equipment and facilities.”

“It is an honor for us to partner with Celerion, a global leader in early clinical research,” said Prof. Yung-Jue Bang MD PhD., President of the Biomedical Research Institute at SNUH, who also serves as the Director to the Clinical Trials Center. “The partnership enables us to participate more actively in global drug development programs as well as supporting the early clinical research needs for the emerging Korean drug discovery industry.”

Celerion’s expansion of business operations to South Korea builds on our long-standing expertise in clinical pharmacology and reflects the latest step in our strategic commitment to Applied Translation Medicine.

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 (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 Seoul National University Hospital
Seoul National University Hospital has been looking after public health over the past 100 years, leading the development of medicine in Korea. It was established in 1885 as Korea’s first national hospital under the name of Kwang Hye Won. Later it became the affiliate hospital for Seoul National University’s College of Medicine and College of Dentistry before being recognized as a special corporate body under the name of Seoul National University Hospital.

Today the hospital is comprised of the Main Hospital, the Children’s Hospital, the Cancer Hospital, the Dental Hospital, and the Clinical Research Institute. Over 1,700 hospital beds, approximately 2,000 inpatients and 8,000 outpatients are treated each day by 533 medical professors and 5,800 staff.

With the arrival of the 21st century, Seoul National University Hospital is striving to develop into a world-class hospital, safeguarding the health of mankind. The hospital’s vision for the 21st century is based on patient-oriented care, respect for mankind, the creation of knowledge and public service. For more information, please visit www.snuh.org.

Media Contact:

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

Celerion Celebrates 80 Years of Conducting Business at Global Headquarters in Lincoln, Nebraska

(Lincoln, NE; Dec 17, 2013) – Celerion is proud to announce the 80th anniversary of operations at our first facility in Lincoln, Nebraska. Celerion is at the forefront of early clinical research with corporate headquarters in Lincoln, plus seven other facilities globally involving 950 employees and over 750 beds of capacity. Celerion has proudly supported the development of many experimental and currently marketed drugs by conducting over 6000 clinical studies globally, including support for agents that treat diabetes, hypertension, blood lipid disorders, obesity, gastrointestinal conditions, respiratory diseases, inflammation, pain neurologic disease, infections, and reproductive health.

The operations in Lincoln started in 1933, with legacy company Harris Laboratories, and were focused on the science of food testing, analysis of water and animal feeds and later, agricultural testing. In 1969 the focus of the company expanded to healthcare by offering comprehensive clinical research services. At that time the company was one of the first to offer an independent clinical research testing environment and in doing so, helped to create the contract clinical research industry. Celerion was formed in 2010 through the acquisition of the early stage development operations of MDS Pharma Services. Prior to that, the facility in Lincoln conducted business under the name MDS Harris, following the acquisition by MDS Inc. an international healthcare organization.

Celerion’s facility in Lincoln is one of the few sites in the industry offering clinical study conduct, clinical pharmacology data analysis and reporting, plus a large supporting bioanalytical laboratory in one location. The facility also has an on-site ADME suite capable of handling radiotracers, a USP <797> Clean Room, microdosing capabilities and has conducted over 300 First-In-Human studies. Our alliance with Bryan Health Hospital which includes 24 on-site beds, has enabled access to conduct complex studies by leveraging their personnel and state-of-the-art techniques and equipment, including MRI, PET scans, CT, EMG, EGD and CNS/cognitive testing.

“We are extremely proud of our 80 year heritage and the impact of our services globally,” said Susan Thornton PhD, President and CEO of Celerion. “Harris Laboratories was visionary in developing innovative clinical research services for the pharmaceutical industry. Celerion continues this legacy in Applied Translational Medicine by leveraging our experience, expertise, innovative technologies and access to patients earlier in clinical research.”

Celerion continues to focus on ways to deliver high-quality clinical pharmacology that enables better decision making for new products in development for our clients, and makes a positive impact on disease management and the public health.

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 (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 Appoints John Horkulak as Executive Director, Eurasian Site Operations

(Lincoln, NE; Dec 5, 2013) – Celerion is pleased to announce the appointment of John Horkulak as Executive Director, Eurasian Site Operations. Mr. Horkulak will lead the efforts to further expand the company’s early phase patient capabilities in Europe and Asia.

The appointment of Mr. Horkulak continues to reinforce Celerion’s commitment to accelerating drug development through Applied Translational Medicine. Incorporating patients earlier into clinical research programs continues to be an important step in providing better information, faster, during the drug development process. Celerion recognizes this critical client need and the importance of patient studies.

Mr. Horkulak will focus on identifying and building partnerships with specialist early phase organizations with proven access to target patient populations in Europe and Asia. By leveraging his knowledge of sites in Central and Eastern Europe that perform pharmacokinetic and pharmacodynamic studies in patients with hepatic and renal insufficiency, diabetes, rheumatoid arthritis as well as asthma and COPD, he will complement services offered at Celerion’s clinic in Belfast, Northern Ireland UK. In addition, Mr. Horkulak will explore new relationships to build patient access in Europe and Asia for supporting early clinical studies in neurodegenerative diseases, cardiovascular disease and oncology. Moreover, he will be guiding future investment in infrastructure and personnel in these regions that fit Celerion’s global systems and growth strategy.

“We are very pleased to have John join the Drug Development Services team at Celerion,” said Fred Pritchard, Vice President, Global Drug Development at Celerion. “His comprehensive knowledge and hands-on operational experience in conducting early phase studies in patients, particularly across emerging geographic regions, will complement Celerion’s efforts in North America and Europe to deliver on our clients’ needs for patient studies.”

Mr. Horkulak comes to Celerion with over 30 years of experience in drug development at both pharmaceutical companies as well as Contract Research Organizations (CROs). His expertise encompasses Phase I and II clinical study operations, primarily in Central and Eastern Europe, as well as general management. Before joining the company, Mr. Horkulak was the founder and CEO of a niche CRO, Pharmacon Research GmbH and, after its successful acquisition, Vice President of Patient Pharmacology at a leading CRO.

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 Appoints Clayton Dehn as Executive Director, Metabolic Diseases

(Lincoln, NE; Nov 5, 2013) – Celerion is pleased to announce the appointment of Clayton Dehn as Executive Director, Metabolic Diseases. Mr. Dehn will lead the expansion of Celerion’s current capabilities that support early Proof-of-Concept in the development of diabetes, obesity, metabolic and cardio-metabolic interventions.

The appointment of Mr. Dehn reinforces Celerion’s commitment to accelerating drug development through Applied Translational Medicine. Clients working in the metabolic area will have access to an arsenal of complex, highly sensitive pharmacodynamic tests capable of detecting early signals of efficacy.  These capabilities combined with Celerion’s expertise in conducting complex early clinical PK/PD studies in healthy participants and patients, provide an effective platform to generate data and information. This improves the quality of decision-making in the drug development process, enabling both time and cost savings.

Within the metabolic disease area, the glucose clamp is the gold-standard measure of insulin sensitivity, beta cell sensitivity, and characterization of the time-action profiles of insulin products. It is an intricate yet powerful, highly sensitive, well established technique that can enhance the value of early clinical research efforts in the development of agents for the treatment of both Type 1 and Type 2 diabetes. Mr. Dehn has experience in conducting thousands of glucose clamps and brings his substantial expertise in a variety of metabolic research tools that include:

• Oral Glucose Tolerance Tests (OGTT)
• Meal Tolerance Tests (MTT)
• Intravenous Glucose Tolerance Tests (IVGTT)
• Maximum Stimulation Tests
• Graded Glucose Infusions
• Stable Isotope Dilution Methods
• Glucose Clamps
• Flow Mediated Dilation (FMD)

“We are very pleased to have Clayton join the Global Clinical Research team at Celerion,” said Phil Bach, Vice President, Global Clinical Research at Celerion. “His comprehensive knowledge of specialized metabolic testing methods and hands-on operational experience will be a great asset to our organization and clients’ drug development programs.”

Mr. Dehn comes to Celerion with 15 years of experience in drug development. He has led highly successful metabolic programs at two leading Contract Research Organizations (CROs), and also served as Director of Clinical Research and Development at a start-up biotech company developing investigational devices, techniques and compounds for use in assisted reproduction. Mr. Dehn earned a Master of Science in Physiology and Bachelors of Science in Animal Science from Texas Tech University.

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 Expands Belfast Facility with Containment Room to Enable Live Biologics and Vaccine Studies.

(Lincoln, NE; June 5, 2013) – Celerion announces the addition of a Containment Room at the Belfast, Northern Ireland UK facility. The new Containment Room will allow Celerion to develop programs that require studies utilizing biologics, as well as vaccines with primary and secondary containment.

The Containment Room is a modular facility comprising a negative pressure processing room which houses a Biosafety Level (BSL-2) cabinet. The addition of the Containment Room further enhances the current GMP licensed site by enabling the processing of live class 2 and class 3 biological products.

“The addition of the Containment Room, coupled with our ability in the Belfast clinic to recruit large numbers of study participants, places Celerion in a strong position to conduct studies requiring biologics and vaccines,“ said Phil Bach, Vice President of Global Clinical Research at Celerion. “Celerion’s facility in Belfast continues to go from strength to strength. This announcement builds on the recent addition of the Bronchoscopy Suite and expansion of our services in the respiratory therapeutic area. The Belfast clinic is widely recognized as the Respiratory Centre of Excellence with experience in asthma, COPD, cystic fibrosis, and bronchiectasis clinical research.”

Celerion’s facility in Belfast, Northern Ireland, UK also has extensive early stage clinical capabilities based on First-In-Human experience with both NCEs and biologics, as well as bioequivalence, biosimilars, obesity, ophthalmic and gastro-intestinal studies.

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 (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