Author: Celerion

Celerion scientist proud recipient of Scientific and Technological Achievement Award (STAA) from EPA.

(Lincoln, NE; Jan 11, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce Don Graff, PharmD, has received the prestigious Scientific and Technological Achievement Award (STAA) from the United States Environmental Protection Agency (EPA). The award is based on the research Dr. Graff undertook while at the EPA, prior to joining the Clinical Pharmacology Sciences business at Celerion.

The body of work submitted for the award examined the findings of epidemiological studies conducted in the US and around the world. These data show that various subsets of the population are at risk to suffer cardiopulmonary events, including death, following episodes of elevated particulate matter (PM) pollution in the air. This work addresses biological plausibility and demonstrates that various size fractions of PM may be responsible for the diverse health effects noted in previous studies.

Dr. Graff earned a Doctor of Pharmacy degree and completed a residency in Pharmacy Practice at the University of Nebraska Medical Center. He continued his post-graduate training at the University of North Carolina-Chapel Hill where his research focused on treatment and pathophysiology of heart failure. Upon joining the EPA, his work continued in the cardiopulmonary arena through bench-top and clinical studies assessing the effects of air pollution particulate matter on human health. In his role at Celerion, Dr. Graff has applied his cardiopulmonary expertise to the design and analysis of unique clinical research studies.

“We are extremely proud of Dr. Graff, and the work submitted to the EPA. This research is especially relevant as it aligns with Celerion’s key strategic focus in the respiratory therapeutic area and early cardiac services,” said Michelle Combs PhD, Vice President of Clinical Pharmacology Sciences at Celerion. “This award is representative of the depth and breadth of scientific expertise that Celerion’s scientists have and is reflected in the high quality work delivered to our clients.”

Celerion has one of the most experienced Clinical Pharmacology Sciences team operating in six global locations in North America and Europe for over 40 years. The team produces more than 200 clinical study reports annually and has developed over 4000 protocols.

The mission of the EPA is to protect human health and the environment, and air pollution is a significant area of focus for the National Health and Environmental Effects Research Laboratory (NHEERL) within the EPA’s Office of Research and Development. For over two decades scientists at NHEERL have been conducting clinical studies evaluating the effects of air pollutants in support of the Clean Air Act, leading to the implementation of ozone and PM health advisory systems commonly used throughout the US. In addition, these studies have brought about considerable improvements in air quality and air pollution-related health outcomes.

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA – enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.

Celerion receives license enabling Investigational Medicinal Products (IMPs) to be imported directly to their GMP-licensed facility

The addition of the Import license saves time, costs and initiates direct communication earlier with clients to expedite early stage clinical studies.

(Lincoln, NE; Sep 07, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that its clinical research operations in Belfast, Northern Ireland UK, have received authorization from their competent authority, the Medicines and Healthcare product Regulatory Agency (MHRA) to have importation of IMPs added to their manufacturing (MIA(IMP)) license. The addition to the license enables the elimination of a third party vendor to import IMPs on behalf of Celerion thereby saving time, cost and initiating direct communication with clients to expedite early stage clinical studies.

The import license gives Celerion’s facility in Belfast the ability to import investigational products from outside the European Economic Area when manufacturing standards from the exporting country have been confirmed as equivalent to the standards required by European legislation.

“The addition of the import license was based on client demand and continues to demonstrate the high quality work and experience at Celerion,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “This import license underpins Celerion’s commitment to a global clinical strategy and reduces the lead time from study concept to first dosing. Clients also benefit from reduced costs by eliminating third party storage and transport prior to certification of the product.”

This latest announcement continues to demonstrate Celerion’s commitment to delivering upon the evolving needs of our clients and exemplifies the Belfast team’s commitment to meeting and exceeding our clients’ expectations.

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA – enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.

Celerion appoints Dr. Raymond Farmen as Vice President of Global Bioanalytical Services

(Lincoln, NE; Jun 29, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce the appointment of Dr. Raymond Farmen as Vice President of Global Bioanalytical Services. Dr. Farmen will have responsibility for the company’s bioanalytical operations in Zurich, Switzerland and Lincoln, Nebraska USA.

Dr. Farmen comes to Celerion with over 30 years of experience in the contract research organization (CRO) and pharmaceutical industries. Prior to joining Celerion, he held executive positions at PharmOptima, a CRO that specializes in ocular research services; Eurofins AvTech Laboratories, a CRO that specializes in small and large molecule bioanalytical chemistry as well as QC testing and analysis of finished drug products and pharmaceutical ingredients; and Camargo Pharmaceutical Services, a CRO that provides scientific and regulatory oversight during the drug development process. Dr. Farmen also held leadership positions in the bioanalytical sciences at MDS Pharma Services, Phoenix International Life Sciences, and Bristol-Myers Squibb.

Dr. Farmen has in-depth knowledge of both large and small molecule bioanalysis, DMPK, regulatory strategies, and GLP/GMP regulations. He played a pivotal role at the Crystal City meetings which helped to shape the early regulatory landscape and guidelines for bioanalysis of pharmaceutical products.

“We are very pleased to have Ray on the management team at Celerion,” said Susan Thornton, President and CEO of Celerion. “His in-depth knowledge of drug development, bioanalysis and regulatory strategy from both the client and CRO perspective will be a great asset to our organization.”

Dr. Farmen earned his doctorate in pharmacology from Indiana University and did post-doctoral research in Biochemistry at the Upstate Medical Center in Syracuse, New York.

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.

Celerion achieves major milestone of successfully analyzing over 25,000 platelet aggregation samples.

Celerion’s unmatched experience in platelet aggregation benefits clients by producing higher quality data, reduced timelines and lower costs.

(Lincoln, NE; Jun 21, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces it has achieved a major milestone of generating over 25,000 platelet aggregation sample results. These samples were collected from over 1000 participants dosed in more than 20 studies. Platelet function assays are inherently variable, so this level of experience is critical to produce reliable and accurate platelet aggregation results.

The FDA public health advisory, released in 2009, described the potential for reduced anti-blood clotting activity due to drug-drug interactions. This has led to an increased need for platelet aggregation studies to better evaluate the impact of drug-drug interactions on platelet function.

To meet this industry need and client demand, Celerion made significant investments to implement intensive staff training and added cutting edge technology. The fully trained staff, in combination with state-of-the-art analyzers has produced unparalleled precision. Equally important, by deploying this technology, Celerion has been able to increase cohort size on studies requiring platelet aggregation, from eight to 40 participants, creating efficiency in the conduct of these studies.

“Reaching this milestone is a testament to Celerion’s ability to respond to the evolving needs of early clinical research,” said Phil Bach, Vice President, Global Clinical Research. “Our experience has already benefited many clients in producing high quality data efficiently, to help them achieve their goal of getting products to market sooner.”

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds, Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.

Celerion announces highly automated ECG Analysis enabling data delivery within 37 days from first patient dosed

Clients benefit from faster access to higher quality data and cost savings in their drug development programs.

(Lincoln, NE; Jun 20, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the successful completion of a 133 participant parallel design Thorough QT (TQT) study using the innovative Celerion Hybrid Phase I/ ECG Core Lab. The efficiencies developed in both clinical conduct and ECG analysis enabled Celerion to quickly collect and analyze over 9,000 ECG recordings, delivering the final dataset containing all data for the study to the sponsor company within 37 days from first patient dosed.

“This study continues to demonstrate Celerion’s commitment to implement innovative technologies that enable fast access to high quality data and ultimately save costs for clients,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “The Hybrid Phase I/ ECG Core Lab, when used for the execution of TQT studies and ECG assessment in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, enables our clients to deliver on their goal of getting products to market faster.”

The Hybrid Phase I/ ECG Core lab provides highly automated ECG analysis for Celerion’s global Phase I clinical network that minimizes cardiologist review time and expense. This novel approach was built upon the knowledge gained from conducting more than 100 studies with intensive ECG monitoring including 36 TQT studies and fully integrates both the core lab and clinic functions. Extensive experience in early cardiac safety services allowed Celerion to carefully define where efficiencies could be realized when developing the Hybrid Phase I/ ECG Core Lab. Integration of the core lab and clinic minimizes the inefficiencies associated with separate management of the two functions.

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.

Celerion receives ANVISA certification

Brazilian Regulatory Agency Approves Celerion Facilities in both North America and Europe to Conduct Clinical Research and Bioanalytical Services.

(Lincoln, NE; Jun 9, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that its clinical research operations in Belfast, Northern Ireland UK, and its clinical research and bioanalytical services operations in Lincoln, Nebraska USA, have been certified by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).

ANVISA provides regulatory approval for drugs and other products seeking to enter the large and growing Brazilian market. ANVISA-certified service providers are uniquely qualified to help clients clear a key hurdle to access one of the fastest-growing major pharmaceutical markets in the world.

“The approval of ANVISA continues to demonstrate the high quality work done at Celerion.” said Susan Thornton, President and CEO. “By earning ANVISA certification to conduct early clinical studies and bioanalytical research for compounds destined for Brazil, Celerion is now able to better serve our clients’ growing needs in this high–growth, emerging market.”

In addition to ANVISA certification, Celerion’s Belfast, facility has also been certified by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The facility has received both Standard and Supplementary Accreditation from the MHRA, which certifies that the general standards for study participant safety and access to emergency medical response have been met. The MHRA accreditation attests to Celerion’s commitment to participant safety.

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

Celerion Awarded Prestigious LEED® Green Building Certification

Celerion is the first research clinic in the U.S. to be awarded LEED® Silver certification.

(Lincoln, NE; May 26, 2011) – Celerion, a premier provider of innovative early stage drug development solutions, announced today that it has been awarded LEED® Silver established by the U.S. Green Building Council and verified by the Green Building Certification Institute (GBCI). LEED is the nation’s preeminent program for the design, construction and operation of high performance green buildings.

Celerion is the leading provider of comprehensive early stage clinical research and bioanalytical services to the drug development community. The facility in Phoenix, Arizona is a state-of-the-art 300 bed, 104,947sf, early clinical research facility and is the Center of Excellence for early cardiac studies. Celerion was the first CRO to launch the Hybrid Phase I/ECG Core lab, which was developed in Phoenix, and launched to our global network of clinics.

Celerion achieved certification under the LEED for Existing Buildings: Operation & Maintenance rating system for energy use, lighting, water and material use, as well as incorporating a variety of other sustainable strategies to make it the first research clinic of its type in the country to attain such an honor. By using less energy and water, LEED certified buildings save money for families, businesses and taxpayers; reduce greenhouse gas emissions; and contribute to a healthier environment for residents, workers and the larger community.

“We are very pleased to receive this certification,” said Susan Thornton, President and CEO of Celerion. “The upgrades made to our state-of-the-art facility in the Phoenix metropolitan area serve as an example of Celerion’s commitment to creating a healthy work environment, reducing our environment footprint and delivering more efficiency for clients. We applaud the leadership and hard work of our project team and the willingness of third party vendors to volunteer their time to achieving these important goals.” A primary focus for the team was to aggressively pursue no/low cost alternatives to successfully meet the certification requirements.

“Celerion’s LEED certification demonstrates tremendous green building leadership,” said Rick Fedrizzi, President, CEO & Founding Chair, U.S. Green Building Council. “The urgency of USGBC’s mission has challenged the industry to move faster and reach further than ever before, and Celerion serves as a prime example with just how much we can accomplish.” LEED certification of Celerion was based on a number of green sustainable practices, and design & construction features that positively impact the project itself and the broader community. Some of these practices and features include:

• Metering faucets, and ultra-low flow shower heads and aerators that contributed to a 25% reduction in water use
• Collection of 73% of the precipitation falling on the entire site and grounds to reuse for irrigation or evapotranspirates
• Water efficient landscaping by using a micro-irrigation system and native, adaptive plants
• 39% participation in the Alternative Transportation/Trip Reduction Program to offset conventional automobile commuting
• 80% reuse and recycling of consumable waste and 100% reuse, recycling of durable goods
• Building systems perform 20% better than the national average for optimizing energy efficiency

Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma Services, Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

The U.S. Green Building Council

The Washington, D.C. based U.S. Green Building Council is committed to a prosperous and sustainable future for our nation through cost-efficient and energy-saving green buildings.

With a community comprising 80 local affiliates, more than 18,000 member companies and organizations, and more than 155,000 LEED professional Credential holders, USGBC is the driving force of an industry that is projected to contribute $554 billion to the U.S. gross domestic product from 2009-2013. USGBC leads an unlikely diverse constituency of builders and environmentalists, corporations and nonprofit organizations, elected officials and concerned citizens, and teachers and students.

Buildings in the United States are responsible for 39% of CO2 emissions, 40% of energy consumption, 13% water consumption and 15% of GDP per year, making green building a source of significant economic and environmental opportunity. Greater building efficiency can meet 85% of future U.S. demand for energy, and a national commitment to green building has the potential to generate 2.5 million American jobs.

LEED

THE U.S. Green Building Council’s LEED green building certification system is the foremost program for the design, construction and operation of green buildings. Over 32,000 projects are currently participating in the commercial and institutional LEED rating systems, comprising over 9.5 billion square feet of construction space in all 50 states and 114 countries. For more information, visit www.usgbc.org.

Celerion recognized as member of the UK Respiratory Therapeutic Capability Cluster

The membership of Celerion’s Belfast facility within the UK Respiratory Therapeutic Capability Cluster enables faster access to patient populations, specialists and techniques in Phase I & IIa studies. Clients benefit from faster access to data that expedites decision making and speeds up the path to clinical Proof-of-Concept.

(Lincoln, NE; Mar 28, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the membership of the Belfast facility within the UK Respiratory Therapeutic Capability Cluster. Celerion will work with key decision makers and thought leaders in the UK to develop and execute Phase I and IIa studies with targeted patient populations.

The UK Respiratory Therapeutic Capability Cluster is a unique cooperative of internationally leading clinicians and scientists whose aim is to improve the speed of developing innovative therapies for respiratory diseases by working in collaboration with research groups of the pharmaceutical industry.

The collaboration with the UK Respiratory Therapeutic Capability Cluster provides access to patients suffering from asthma, COPD, cystic fibrosis, bronchiectasis and interstitial lung disease. Celerion has access to laboratory capabilities (flow cytometry, flow cytometric cell sorting, microbiology, 16S, deep sequencing, MLST, transcriptomics) as well as lung imaging techniques (CT acquisition of images, dedicated MRI time, advanced CT analysis capabilities and MRI acquisition of images).

“The membership of Celerion into the UK Respiratory Therapeutic Capability Cluster will provide our clients a one stop solution that provides access to targeted patient populations. Celerion provides a full service approach for clinical studies from protocol development through to final report,” said Phil Bach, Vice President of Clinical Research at Celerion. “We have seen an increasing demand for conducting Phase I studies in patients with access to more specialized techniques. This collaboration allows Celerion to address this need and assist clients to gain insight to data earlier in drug development programs.”

All the centres in the UK Respiratory Therapeutic Capability Cluster are recognised for their excellence in basic and translational research in respiratory medicine. Celerion is delighted to be part of this distinguished team of talented individuals, with a proven track-record in helping industry better to understand airways disease and facilitate drug discovery.

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma Services, Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

Celerion adds USP <797>-compliant Clean Room, enabling efficient execution of microtracer and microdosing studies

The addition of the USP <797> Clean Room to Celerion’s Phase I core capabilities, enables sterile extemporaneous compounding in-house for microtracer studies. Clients benefit by accessing quality data earlier in drug development process.

(Lincoln, NE; Mar 2, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the completion of a Clean Room and pharmacist certification to comply with USP <797> guidelines. This enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The sterile preparation and administration allows clients a one-stop option thereby saving time and money.

A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP <797> Clean Room allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. This allows Celerion to take a client’s API, develop customized dosing and compounding that enable very selective dose levels to be administered. This solution combined with our experience in delivering early stage adaptive trial designed studies will allow clients to reach clinical proof-of-concept (PoC) faster.

“The addition of the USP <797> Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier” said Phil Bach, Vice President of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.”

The unique design of this Clean Room includes three separate areas, one ante-room that serves two individual clean rooms. One clean room is a dedicated microtracer area which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding. An additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma Services, Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.