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Celerion appoints Dr. Bruce Morimoto as Executive Director, Applied Translational Medicine

(Lincoln, NE; May 21, 2013) – Celerion is pleased to announce the appointment of Dr. Bruce Morimoto as Executive Director of Applied Translational Medicine. Dr. Morimoto will have responsibility for developing and implementing strategies for patient populations in early clinical research and clinical pharmacology studies. Dr. Morimoto will also assume leadership for the External Studies Management and Clinical Monitoring Services teams.

The appointment of Dr. Morimoto reinforces Celerion’s focus on delivering Applied Translational Medicine. Celerion is focused on applying 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.

Dr. Morimoto comes to Celerion with over 20 years of experience in the pharmaceutical and biotechnology industries as well as in contract research organizations (CRO). Prior to joining Celerion, he was Vice President of Drug Development at Allon Therapeutics, where his focus was to manage their neurodegeneration and dementia therapeutic programs including preclinical, manufacturing and clinical development. Dr. Morimoto also held positions at MDS Pharma Services, a full service CRO; Neuromed Technologies, a biotech company developing novel pain therapeutics; Phoenix International Life Sciences, a global CRO; and Amur Pharmaceuticals, a biopharmaceutical company focused on diabetes and drug delivery research.

Dr. Morimoto’s hands-on drug development experience that includes program, project and portfolio management, combined with an understanding of the CRO industry, provides him with invaluable insight into how best to tackle the inclusion of patients in both clinical pharmacology as well as Phase IIa Proof-of-Concept studies.

“We are very pleased to have Bruce join the Drug Development Services team at Celerion,” said Susan Thornton Ph.D, President and CEO of Celerion. “His in-depth knowledge of drug development as well as focus on Applied Translational Medicine from both the client and CRO perspective will be a great asset to our organization.”

Dr. Morimoto earned his doctorate in biochemistry from the University of California, Los Angeles (UCLA), completed post doctorate research at University of California, Berkeley, and was also on the faculty in the Chemistry department at Purdue 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 (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 Builds on Respiratory Capabilities With the Addition of an On-site Bronchoscopy Suite

(Lincoln, NE; Jan 9, 2013) – Celerion, the premier provider of innovative early stage drug development solutions, announces the expansion of its capabilities in the respiratory therapeutic area, with the addition of a dedicated Bronchoscopy Suite in the Belfast, Northern Ireland, UK facility. The Bronchoscopy Suite allows bronchoalveolar lavage (BAL) to be performed within the Celerion clinic utilizing study participants from our extensive database.

The addition of the Bronchoscopy Suite complements our ability to reliably explore the expression and quantification of protein biomarkers within the fluid lining of the lower respiratory tract. Using a multiplex approach, BAL samples can be analyzed for a panel of customized biomarkers and thereby provide a more reliable picture of the performance of potential airway drug candidates.

“Celerion has successfully conducted a number of studies that include mild to moderate and severe asthmatics, COPD and Cystic Fibrosis patients. Due to an increasing demand from clients for analysis of BAL samples, the dedicated Bronchoscopy Suite offers on-site access to this procedure,” said Phil Bach, Vice President of Clinical Research at Celerion. “This investment continues to demonstrate Celerion’s response to the market’s increasing demand for conducting Phase I studies in patients with access to more specialized techniques.”

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, men’s sexual health, ophthalmic and gastro-intestinal studies.

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 global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global 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.

Media Contact:

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

Celerion is the First CRO headquartered in the USA to Receive Full Accreditation from AAHRPP.

(Lincoln, NE; Sep 17, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that it has been awarded full accreditation by the Association for the Accreditation Human Research Protection Programs (AAHRPP). Celerion’s clinical facilities in the USA; Lincoln NE; Neptune NJ; and Phoenix AZ, have achieved this significant milestone.

AAHRPP is an independent, non-profit accrediting body that uses a voluntary, peer-driven, educational model to ensure that Human Research Protection Programs (HRPPs) meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence—through policies, procedures, and practices—of their commitment to scientifically and ethically sound research and to continuous improvement.

To meet the full requirements for AAHRPP accreditation, Celerion reviewed all internal procedures and processes to ensure extensive safeguards were in place at every level of clinical research. Throughout the organization our teams evaluated their respective areas of responsibility, and reviewed policies, processes, and Standard Operating Procedures (SOPs). This ensured the highest levels of standards were adhered to, well documented and even more critical, translated into practice.

“The approval of AAHRPP certification continues to demonstrate the leadership role Celerion has taken to reach the highest standards and protections for human participants. By voluntarily undergoing the accreditation process, Celerion has committed to participants in our clinical studies that rigorous standards will be applied to ensure their safety and rights are strictly adhered to,” said Susan Thornton, Ph.D., President and CEO at Celerion.  “This accreditation also highlights our commitment to increased quality and transparency in conducting ethically sound research for our clients.”

“I am pleased that Celerion is setting an example and raising the bar for research protections among CROs. With AAHRPP accreditation, Celerion now offers a level of quality assurance that distinguishes it among CROs and boosts its appeal to research clients,” said Marjorie A. Speers, Ph.D., AAHRPP President and CEO. “Our hope is that Celerion’s decision has a ripple effect across the research enterprise and that other CROs follow its lead.”

This accreditation places Celerion alongside a leading pharmaceutical company as well as Institutional Review Boards (IRBs), universities and hospitals to ensure we all collaborate in working with the highest standards in clinical research.

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.

Media Contact:

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

Celerion announces expanded state-of-the-art ADME Suite in its Lincoln, Nebraska USA Facility

The state-of-the-art ADME Suite benefits from on-site bioanalytical services and Phase I clinical facilities to offer clients a one stop solution.

(Lincoln, NE; May 17, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that it has expanded its ADME (Absorption, Distribution, Metabolism and Excretion) Suite in Lincoln, Nebraska USA. Celerion has invested in new state-of-the-art equipment and laboratory space to perform on-site scintillation counting allowing for radioactivity recovery results to be delivered in real-time. This service ensures high total recovery of radioactive dose while providing for efficient clinical study conduct.

The newly expanded ADME Suite adds to Celerion’s capabilities to manage all aspects of human radiolabeled ADME studies from synthesis and formulation of an appropriate radiolabeled drug through dosimetry assessment and clinical conduct to final isolation, identification and quantification of metabolites in the samples collected. Radiolabel dosage forms suitable for administration to humans can be readily prepared at Celerion’s purpose-built pharmacy clean room at the Lincoln facility. Considering that the Lincoln clinic can also conduct micro-radiotracer studies, Celerion is one of a few organizations globally capable of conducting specialized human ADME studies to regulatory standards.

“The enhancement in our facility was driven by client needs, including a growing interest in conducting these critical studies earlier in a drug’s development. This is a response to regulatory guidances concerning knowledge of human metabolism and metabolites during safety assessment,” said Raymond Farmen, Vice President, Global Bioanalytical Services. “The on-site bioanalytical and Phase I clinical facilities in Lincoln offer seamless integration of services and data. For bioanalytical analyses, the ADME suite interfaces with Celerion’s global electronic laboratory notebook system thereby increasing data compliance.”

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.

Media Contact:

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

Celerion and Ricerca Biosciences announces “The Biosimilars Alliance” to offer clients a more effective development path for biosimilars

(Lincoln, NE; Feb 29, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, and Ricerca Biosciences, a drug safety assessment expert in harnessing external preclinical innovation, announce the formation of “The Biosimilars Alliance”. The Biosimilars Alliance is focused on preclinical and early clinical assessment of biologics manufactured by a new supplier.

The formation of The Biosimilars Alliance was driven by client demand for an integrated service solution for the development of biosimilar products. The market for biosimilars is forecast to grow from $2.4B in 2012 to $44B by 2020. While there has been an established pathway for the approval of biosimilar products in Europe for several years, the US FDA has only recently issued its guidances. The foundation now exists for development of newly sourced versions of some of the most effective treatments that have emerged from medical research in the last 20 years.

The Biosimilars Alliance offers convenient access to all of the specialized services required to perform early assessment of the viability of a potential biosimilar product before beginning costly multi-center comparator studies in the target patient populations. These services include in vitro and in vivo pharmacological assessments of activity and toxicological and immunotoxicological studies to support CTAs and INDs. Importantly, The Biosimilars Alliance also provides access to bioanalytical assay development to enable pharmacokinetic (PK) and pharmacodynamic (PD) assessments in animal and human studies, PK/PD modeling, immunogenicity screening during clinical studies and the regulatory and integrated project management support to ensure timely results for strategic decision-making.

“The announcement of The Biosimilars Alliance demonstrates Celerion’s ability to respond to client needs and offer effective solutions that leverage the knowledge base built up over the past 20 years of supporting biologic drug development,” said Susan Thornton PhD, President and CEO at Celerion. “The formation of The Biosimilars Alliance is consistent with Celerion’s goal of providing fully integrated services to get to go/no go decisions quickly.”

“Ricerca Biosciences is well positioned in Europe, Asia and North America to enhance the success of The Biosimilars Alliance. Biosimilars are a rapidly growing segment of the market and we see increasing demand from our clients for safety and efficacy testing to assess viability,” said Ian Lennox, CEO of Ricerca. “The Biosimilars Alliance is an important step for Ricerca in supporting the future needs of our clients.”

The Biosimilars Alliance will also work with other solution providers to offer the full scope of services required to bring biosimilar products to market.

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 global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global 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.

About Ricerca Biosciences
Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon and Concord facilities hold AAALAC certification. For more information, visit www.ricerca.com.

Media Contact:

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

Celerion First Early Stage Contract Research Organization to Adopt a Participant Verification System to Improve Participant Safety and Data Quality

(Lincoln, NE; Feb 02, 2012) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce it has implemented VCT Verify™ from Verified Clinical Trials, to instantaneously ensure accurate participant identification and qualification for clinical research. Celerion is the first Early Stage Contract Research Organization (CRO) to partner with Verified Clinical Trials to set the standard for the industry to adopt.

Celerion will more effectively screen and select higher quality study participants by using this tool to instantly identify ineligible candidates for enrollment.  The system searches a global clinical database registry to identify participants that are currently enrolled in other clinical studies. Clients benefit from improved participant selection and higher data integrity.

Celerion chose to implement the VCT Verify™ product across all our global clinical facilities to solve the long recognized problem of inaccurate applications that compromise study success.  The system has been reviewed and applauded by numerous Institutional Review Boards (IRBs) and Verified Clinical Trials is safe harbor certified.

“Celerion continues to apply rigorous standards to protect the safety of participants and enhance data integrity while supporting our commitment to our clients. This implementation sets a standard in the industry to continue to improve clinical research and more effectively bring new drugs to the market,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “We are excited to partner with Verified Clinical Trials, the leader in this specialized field, to take a firm stance on ensuring the highest quality data and participants for our clients.”

“Verified Clinical Trials offers a comprehensive and unique clinical research database registry to enhance the quality of both early and late stage studies globally. The system has been designed to streamline the clinical trial process and offers protection from various other potential liabilities,” said Mitchell Efros, MD FACS, CEO at Verified Clinical Trials. “We are pleased to be working with Celerion, the first CRO to implement this product, as they continue to demonstrate their leadership position in the industry.”

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 global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global 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.

About Verified Clinical Trials
Verified Clinical Trials is a forward thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials.  Verified Clinical Trials defines itself as the world’s leader in the field of database registries in clinical trial research.  Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials and has the scalability to reach all sites nationally as well as on a global level.  Verified Clinical Trials offers numerous other value added services to the clinical research site, CRO, and Pharmaceutical Sponsor, that prove invaluable with regards to financial and legal issues and liabilities. For more information, visit www.verifiedclinicaltrials.com.

Media Contact:

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

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.