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Wednesday, 22 June 2011 04:52
DaVita Clinical Research Expands Capabilities With Investments In Central Laboratory
DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, today announced the company’s recent investment in its Central Laboratory, servicing pharmaceutical, biotechnology and medical device industries.
The investment was applied to analytical methodology, information technology (IT) and instrumentation in support of DCR’s continued drive to serve its clients. Over the past three years, DCR has had a strategic focus on Central Laboratory services, investing in state-of-the-art capital equipment, infrastructure and laboratory expansion/remodeling. The investment was placed in DCR’s Central Laboratory to ensure continuous delivery of customized care and satisfaction to its patients.
The Central Laboratory uses the latest in laboratory instrumentation to provide rapid, accurate results. Some examples of the lab’s instrumentation and ever-increasing test menu include:
At DCR’s Central Laboratory, individual trial samples are tracked using LabScope Online®, a leading-edge order-entry and reporting system designed to streamline lab processes while maintaining strict quality assurance. Additional services include the new, innovative green packaging capabilities featuring a unique IATA-compliant, storage-friendly design, and the lab’s highly dedicated customer support team, which ensures most specimen turnaround time of 24 hours or less.
“DCR’s Florida-based Central Laboratory facility is one of the industry’s best kept secrets,” said DCR Vice President, Commercial Development Kevin J. Goudreau. “We are confident that, over time, our continued investments in both physical assets and an expanded assay list will position us to be a prominent player in the clinical trials support business.”
The DCR Central Laboratory team is led by experienced medical technologists, medical technicians and clinical pathologists, and receives formal guidance from top nephrologists in the industry.
DaVita, DaVita Clinical Research, DCR and Falcon Lab are trademarks or registered trademarks of DaVita, Inc. All other trademarks are the property of their respective owners.
About DaVita Clinical Research (DCR)
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, facilitating the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
About DaVita
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of March 31, 2011, DaVita operated or provided administrative services at 1,642 dialysis facilities, serving approximately 128,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com.
The investment was applied to analytical methodology, information technology (IT) and instrumentation in support of DCR’s continued drive to serve its clients. Over the past three years, DCR has had a strategic focus on Central Laboratory services, investing in state-of-the-art capital equipment, infrastructure and laboratory expansion/remodeling. The investment was placed in DCR’s Central Laboratory to ensure continuous delivery of customized care and satisfaction to its patients.
The Central Laboratory uses the latest in laboratory instrumentation to provide rapid, accurate results. Some examples of the lab’s instrumentation and ever-increasing test menu include:
- 7 Olympus 5400
- 17 Siemens Centaur
- 9 Tosoh G-8
- 2 Liaison Diasorin
- 8 Perkin-Elmer ICP-MS
- 2 Nova
- 2 Dianex
- 23 Siemens Advia 2120
- 2 TOPS Coagulation
- 19 BACTEC 9240
- 14 Lonza BioTek
- 4 Vitek-2
At DCR’s Central Laboratory, individual trial samples are tracked using LabScope Online®, a leading-edge order-entry and reporting system designed to streamline lab processes while maintaining strict quality assurance. Additional services include the new, innovative green packaging capabilities featuring a unique IATA-compliant, storage-friendly design, and the lab’s highly dedicated customer support team, which ensures most specimen turnaround time of 24 hours or less.
“DCR’s Florida-based Central Laboratory facility is one of the industry’s best kept secrets,” said DCR Vice President, Commercial Development Kevin J. Goudreau. “We are confident that, over time, our continued investments in both physical assets and an expanded assay list will position us to be a prominent player in the clinical trials support business.”
The DCR Central Laboratory team is led by experienced medical technologists, medical technicians and clinical pathologists, and receives formal guidance from top nephrologists in the industry.
DaVita, DaVita Clinical Research, DCR and Falcon Lab are trademarks or registered trademarks of DaVita, Inc. All other trademarks are the property of their respective owners.
About DaVita Clinical Research (DCR)
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, facilitating the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
About DaVita
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of March 31, 2011, DaVita operated or provided administrative services at 1,642 dialysis facilities, serving approximately 128,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com.
Published in
CRO Industry News
Wednesday, 22 June 2011 04:49
Celerion Receives ANVISA Certification
Brazilian Regulatory Agency Approves Celerion Facilities in both North America and Europe to Conduct Clinical Research and Bioanalytical Services.
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, 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.
Published in
CRO Industry News
Tuesday, 21 June 2011 04:52
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.
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, 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.
Published in
CRO Industry News
Tuesday, 21 June 2011 04:49
Celerion Announces Highly Automated ECG Analysis
Clients benefit from faster access to higher quality data and cost savings in their drug development programs.
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, 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.
Published in
CRO Industry News
Friday, 03 June 2011 09:29
Worldwide Clinical Trials Appoints Gerald Messerschmidt as Vice President, Oncology Medical Affairs
Worldwide Clinical Trials Inc., a global provider of clinical research services, is pleased to announce the appointment of Gerald Messerschmidt M.D., as Vice President, Oncology Medical Affairs.
“We are delighted to have Dr. Messerschmidt join us at Worldwide Clinical Trials where his extensive experience of oncology product development and the challenges inherent to patient care in this area, are of enormous value,” stated Michael F. Murphy, M.D., Ph.D., Chief Medical and Scientific Officer, Worldwide Clinical Trials. “His appointment supports our ongoing commitment to furthering oncology clinical development and, market access to those drugs that positively affect patient’s lives.”
Dr. Messerschmidt is a healthcare industry executive and clinician with over 20 years’ clinical, and operational leadership in the development of critical therapies for a multitude of oncology indications. His portfolio of experience includes; small molecules, biologic products, medical devices, genetic modification of living organisms and immune modulation therapy.
Prior to joining Worldwide Clinical Trials, Dr. Messerschmidt held the position of VP, Clinical Development at Talon Therapeutics, Inc. (formerly Hana Biosciences) where he co-led the successful development of Marqibo®, a novel liposome plus vincristine product. Between 2008 and 2010, Dr. Messerschmidt held senior positions within oncology at Onyx Pharmaceuticals and ICON Clinical Research, preceded by leading Wild-Type Enterprises consulting as Chairman and CEO between 2000 and 2008.
Dr. Messerschmidt is Board Certified by the American Board of Medical Specialties; Certified in Internal Medicine, Medical Oncology and Hematology and trained and networked at the National Cancer Institute (Bethesda, MD). Dr. Messerschmidt is also past head of the NCI, Medicine Branch, Experimental Hematology Section.
About Worldwide Clinical Trials
As one of the most innovative and scientifically-driven contract research organizations, Worldwide Clinical Trials offers clients exceptionally strong clinical trial methodology integrated with an effective global operations network. Worldwide Clinical Trials specializes in providing drug development services to the pharmaceutical and biotechnology industries across multiple therapeutic areas, with an emphasis on CNS, cardiovascular, chronic inflammatory, and oncology indications.
“We are delighted to have Dr. Messerschmidt join us at Worldwide Clinical Trials where his extensive experience of oncology product development and the challenges inherent to patient care in this area, are of enormous value,” stated Michael F. Murphy, M.D., Ph.D., Chief Medical and Scientific Officer, Worldwide Clinical Trials. “His appointment supports our ongoing commitment to furthering oncology clinical development and, market access to those drugs that positively affect patient’s lives.”
Dr. Messerschmidt is a healthcare industry executive and clinician with over 20 years’ clinical, and operational leadership in the development of critical therapies for a multitude of oncology indications. His portfolio of experience includes; small molecules, biologic products, medical devices, genetic modification of living organisms and immune modulation therapy.
Prior to joining Worldwide Clinical Trials, Dr. Messerschmidt held the position of VP, Clinical Development at Talon Therapeutics, Inc. (formerly Hana Biosciences) where he co-led the successful development of Marqibo®, a novel liposome plus vincristine product. Between 2008 and 2010, Dr. Messerschmidt held senior positions within oncology at Onyx Pharmaceuticals and ICON Clinical Research, preceded by leading Wild-Type Enterprises consulting as Chairman and CEO between 2000 and 2008.
Dr. Messerschmidt is Board Certified by the American Board of Medical Specialties; Certified in Internal Medicine, Medical Oncology and Hematology and trained and networked at the National Cancer Institute (Bethesda, MD). Dr. Messerschmidt is also past head of the NCI, Medicine Branch, Experimental Hematology Section.
About Worldwide Clinical Trials
As one of the most innovative and scientifically-driven contract research organizations, Worldwide Clinical Trials offers clients exceptionally strong clinical trial methodology integrated with an effective global operations network. Worldwide Clinical Trials specializes in providing drug development services to the pharmaceutical and biotechnology industries across multiple therapeutic areas, with an emphasis on CNS, cardiovascular, chronic inflammatory, and oncology indications.
Published in
CRO Industry News
Wednesday, 01 June 2011 07:26
DaVita Clinical Research - Setting New Standards For Its Health Economics And Outcomes Research Svcs
DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney care as well as a multitude of specialty therapeutic populations, is setting new standards for its Health Economics and Outcomes Research services. These services, a key focus for DCR, will be on display at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual International Meeting in Baltimore, May 21-25, 2011.
The DCR Health Economics and Outcomes Research team designs and executes studies and economic models and translates the results into tools and products for its customers. By understanding client needs and current trends in the marketplace, DCR has successfully supported access and utilization of multibillion-dollar drug franchises.
DCR’s Health Economics and Outcomes Research services include:
DCR brings unsurpassed knowledge, skill and expertise to pharmaceutical research, facilitating the success of clinical trials. During ISPOR, at DCR’s booth #70, donations will be made on behalf of tradeshow attendees to the National Kidney Foundation to help prevent kidney disease. Additionally, DCR representatives will give an oral presentation on the “Impact of a Pharmacy Refill Management System on Outcomes in ESRD Patients,” as well as have two scientific poster presentations at ISPOR.
Podium Session 1: Effects of Drug Management Programs on Patients (DM1)
Title: Impact of a Pharmacy Refill Management System on Outcomes in ESRD Patients
Date: Monday, May 23, 2011
Time: 1:45 p.m. – 2:45 p.m.
Poster 1 Title: (PUK1) Incidence and 30-day Mortality of Community Acquired Pneumonia (CAP) in the Medicare Fee-for-Service (FFS) Population – Poster in collaboration with Pfizer
Date: Monday, May 23, 2011
Poster 2 Title: (PUK 24) Use of Biomarkers in Propensity Score Matching to Mitigate Channeling Bias in a Retrospective Cohort of ESRD Patients
Date: Monday, May 23, 2011
DaVita Clinical Research and DCR are registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners.
About DaVita Clinical Research
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, facilitating the success of their clients’ clinical trials. Its clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites is focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
About DaVita
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of March 31, 2011, DaVita operated or provided administrative services at 1,642 dialysis facilities, serving approximately 128,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com.
The DCR Health Economics and Outcomes Research team designs and executes studies and economic models and translates the results into tools and products for its customers. By understanding client needs and current trends in the marketplace, DCR has successfully supported access and utilization of multibillion-dollar drug franchises.
DCR’s Health Economics and Outcomes Research services include:
- Strategic consulting
- Economic modeling
- Epidemiology and biostatistics
- Prospective study design, execution, and analysis
- Disease management design, execution, and evaluation
- Psychometric development and validation
- Commercial reimbursement and formulary placement
- Policy analytics and legislative briefings
DCR brings unsurpassed knowledge, skill and expertise to pharmaceutical research, facilitating the success of clinical trials. During ISPOR, at DCR’s booth #70, donations will be made on behalf of tradeshow attendees to the National Kidney Foundation to help prevent kidney disease. Additionally, DCR representatives will give an oral presentation on the “Impact of a Pharmacy Refill Management System on Outcomes in ESRD Patients,” as well as have two scientific poster presentations at ISPOR.
Podium Session 1: Effects of Drug Management Programs on Patients (DM1)
Title: Impact of a Pharmacy Refill Management System on Outcomes in ESRD Patients
Date: Monday, May 23, 2011
Time: 1:45 p.m. – 2:45 p.m.
Poster 1 Title: (PUK1) Incidence and 30-day Mortality of Community Acquired Pneumonia (CAP) in the Medicare Fee-for-Service (FFS) Population – Poster in collaboration with Pfizer
Date: Monday, May 23, 2011
Poster 2 Title: (PUK 24) Use of Biomarkers in Propensity Score Matching to Mitigate Channeling Bias in a Retrospective Cohort of ESRD Patients
Date: Monday, May 23, 2011
DaVita Clinical Research and DCR are registered trademarks of DaVita Inc. All other trademarks are the property of their respective owners.
About DaVita Clinical Research
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, facilitating the success of their clients’ clinical trials. Its clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites is focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
About DaVita
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of March 31, 2011, DaVita operated or provided administrative services at 1,642 dialysis facilities, serving approximately 128,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com.
Published in
CRO Industry News
Wednesday, 01 June 2011 07:15
LabCorp Enters Into Definitive Agreement To Acquire Clearstone Central Laboratories
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced that it has entered into a definitive agreement to acquire Clearstone Central Laboratories, a leading global provider of central laboratory services for late-stage clinical trials.. The transaction, which is subject to customary closing conditions, is expected to close in the second quarter of 2011. Terms of the
agreement were not disclosed.
"This acquisition fully combines the complementary strengths of Clearstone and LabCorp’s clinical trials business to support drug development," said David P. King, Chairman and Chief Executive Officer of LabCorp. "This transaction is an important milestone as it extends our global footprint and service capabilities in key geographies such as Asia Pacific, and advances the Company's companion diagnostics and personalized medicine strategy.”
The agreement provides LabCorp with Clearstone's global network of central laboratories and clinical trials management system APOLLO CLPM™, which provides clients with real-time access to global data, strengthened chain of custody, automated sample stability monitoring and guaranteed consistency across all lab sites. The combined entity will have the largest available biomarker assay portfolio with globally harmonized and state-of-the-art testing platforms in areas such as pharmacogenomics, microbiology, immunohistochemistry, allergy testing, cytogenetics and flow cytometry.
“We are pleased to announce this agreement because of the growth opportunity and long-term strategic value it creates for our clients,” said Clearstone CEO Lewis Cameron. “Clearstone has already been working closely with LabCorp’s Esoterix division under a strategic collaboration agreement, which has resulted in a number of client success stories. We will now be a single team that is completely focused on exceeding our customer’s drug development objectives.”
About LabCorp®
Laboratory Corporation of America® Holdings, an S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $5.0 billion in 2010, over 31,000 employees worldwide, and more than 220,000 clients, LabCorp offers a broad test menu ranging from routine blood analyses to reproductive genetics to DNA sequencing. LabCorp furthers its scientific expertise and innovative clinical testing technology with its Centers of Excellence: The Center for Molecular Biology and Pathology, National Genetics Institute, ViroMed Laboratories, Inc., The Center for Esoteric Testing, Litholink Corporation, Genzyme GeneticsSM*, DIANON Systems, Inc., US LABS, Monogram Biosciences, Inc., and Esoterix and its Colorado Coagulation, Endocrine Sciences, and Cytometry Associates laboratories. LabCorp conducts clinical trials testing through its Esoterix Clinical Trials Services division. LabCorp clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies. To learn more about our organization, visit our Web site at: www.labcorp.com.
*Genzyme Genetics and its logo are trademarks of Genzyme Corporation and used by Esoterix Genetic Laboratories, LLC, a wholly-owned subsidiary of LabCorp, under license. Esoterix Genetic Laboratories and LabCorp are operated independently from Genzyme Corporation.
This press release contains forward-looking statements. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace and adverse actions of governmental and other third-party payors. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp’s financial results is included in the Company’s Form 10-K for the year ended December 31, 2010, and subsequent SEC filings.
About Clearstone
Clearstone Central Laboratories is the largest and most experienced private company exclusively focused on providing central lab services to support late-stage drug development with accurate and timely test data. With over 20 years of experience in mature and emerging markets, we offer world-class laboratory testing, project and data management, and logistical support to leading pharmaceutical and biotech companies around the world. Clearstone also owns and operates APOLLO CLPM™ – a leading proprietary central laboratory protocol management system. For more information, visit our website at www.clearstonelabs.com.
agreement were not disclosed.
"This acquisition fully combines the complementary strengths of Clearstone and LabCorp’s clinical trials business to support drug development," said David P. King, Chairman and Chief Executive Officer of LabCorp. "This transaction is an important milestone as it extends our global footprint and service capabilities in key geographies such as Asia Pacific, and advances the Company's companion diagnostics and personalized medicine strategy.”
The agreement provides LabCorp with Clearstone's global network of central laboratories and clinical trials management system APOLLO CLPM™, which provides clients with real-time access to global data, strengthened chain of custody, automated sample stability monitoring and guaranteed consistency across all lab sites. The combined entity will have the largest available biomarker assay portfolio with globally harmonized and state-of-the-art testing platforms in areas such as pharmacogenomics, microbiology, immunohistochemistry, allergy testing, cytogenetics and flow cytometry.
“We are pleased to announce this agreement because of the growth opportunity and long-term strategic value it creates for our clients,” said Clearstone CEO Lewis Cameron. “Clearstone has already been working closely with LabCorp’s Esoterix division under a strategic collaboration agreement, which has resulted in a number of client success stories. We will now be a single team that is completely focused on exceeding our customer’s drug development objectives.”
About LabCorp®
Laboratory Corporation of America® Holdings, an S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $5.0 billion in 2010, over 31,000 employees worldwide, and more than 220,000 clients, LabCorp offers a broad test menu ranging from routine blood analyses to reproductive genetics to DNA sequencing. LabCorp furthers its scientific expertise and innovative clinical testing technology with its Centers of Excellence: The Center for Molecular Biology and Pathology, National Genetics Institute, ViroMed Laboratories, Inc., The Center for Esoteric Testing, Litholink Corporation, Genzyme GeneticsSM*, DIANON Systems, Inc., US LABS, Monogram Biosciences, Inc., and Esoterix and its Colorado Coagulation, Endocrine Sciences, and Cytometry Associates laboratories. LabCorp conducts clinical trials testing through its Esoterix Clinical Trials Services division. LabCorp clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies. To learn more about our organization, visit our Web site at: www.labcorp.com.
*Genzyme Genetics and its logo are trademarks of Genzyme Corporation and used by Esoterix Genetic Laboratories, LLC, a wholly-owned subsidiary of LabCorp, under license. Esoterix Genetic Laboratories and LabCorp are operated independently from Genzyme Corporation.
This press release contains forward-looking statements. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace and adverse actions of governmental and other third-party payors. Actual results could differ materially from those suggested by these forward-looking statements. Further information on potential factors that could affect LabCorp’s financial results is included in the Company’s Form 10-K for the year ended December 31, 2010, and subsequent SEC filings.
About Clearstone
Clearstone Central Laboratories is the largest and most experienced private company exclusively focused on providing central lab services to support late-stage drug development with accurate and timely test data. With over 20 years of experience in mature and emerging markets, we offer world-class laboratory testing, project and data management, and logistical support to leading pharmaceutical and biotech companies around the world. Clearstone also owns and operates APOLLO CLPM™ – a leading proprietary central laboratory protocol management system. For more information, visit our website at www.clearstonelabs.com.
Published in
CRO Industry News
Thursday, 26 May 2011 05:55
Celerion Awarded Prestigious LEED® Green Building Certification
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:
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.
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 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.
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.
Published in
CRO Industry News
Wednesday, 18 May 2011 07:07
INC Research To Acquire Kendle International for $15.25 per Share in Cash
INC Research, LLC, a therapeutically focused global contract research organization (CRO) privately held by Avista Capital Partners and Ontario Teachers’ Pension Plan, and Kendle International Inc. (Nasdaq: KNDL), today jointly announced a definitive merger agreement under which INC Research will acquire Kendle in an all-cash transaction with a total equity value of approximately $232 million. Kendle is a leading global CRO with extensive expertise in Phase I-IV clinical development and more than 3,000 associates in 31 countries worldwide.
Under the terms of the agreement, INC Research will acquire all of the outstanding shares of Kendle for $15.25 per share in cash, representing a 60.5 percent premium over Kendle’s closing share price on May 4, 2011. This represents a premium of 51.3 percent over the 30-trading day average of Kendle’s closing price. The Board of Directors of Kendle unanimously approved the transaction, which is expected to close in the third quarter subject to approval by Kendle’s shareholders as well as satisfaction of customary closing conditions and regulatory approvals.
“Joining forces with INC Research is the right decision for our customers and shareholders. Combining our highly complementary assets will provide the scale and scope for the combined company to deliver outstanding global teams, therapeutic expertise and operational excellence for clinical trials of all sizes,” said Kendle President and CEO, Stephen Cutler, PhD. “Because both companies are known for conducting high-quality clinical work and share a common culture based on excellent service delivery, we will be able to maintain a customer-centric focus on each individual project.”
"The combination of INC Research and Kendle will enable us to deliver broader capabilities and reach a critical mass for the emerging drug development outsourcing and alliance partnership models,” said James Ogle, CEO of INC Research. “Together, we bring complementary strengths and expand the breadth and depth of services and expertise that are most valuable to our customers.”
The combination of INC Research and Kendle strengthens both businesses by creating a global CRO with significant therapeutic capability and geographic diversity. The combined company will rank among the top-tier CROs based on size and scale, and will be well positioned to handle large-scale global trials.
As a result of the proposed merger transaction, Kendle’s earnings release and conference call/webcast scheduled for Thursday, May 5, at 8 a.m. Eastern Time has been cancelled. In addition, Kendle’s Annual Meeting of Shareholders has been postponed from May 19, 2011, with a new date to be determined by Kendle’s Board of Directors.
In connection with the transaction, J.P. Morgan Securities LLC acted as Kendle’s financial advisor and Keating, Muething & Klekamp PLL acted as its legal advisor. Morgan Stanley & Co. Inc. acted as financial advisor and Weil Gotshal & Manges LLP acted as the legal advisor to INC Research.
About Kendle
Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing products to market for the benefit of patients worldwide. As one of the world’s largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges. For more information, please visit www.kendle.com.
About INC Research, LLC
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit www.incresearch.com or follow us at @inc_research.
About Avista Capital Partners
Avista Capital Partners is a leading private equity firm managing approximately $4 billion of committed capital with offices in New York, Houston, and London. Founded in 2005, Avista's strategy is to make controlling or influential minority investments in growth-oriented energy, healthcare, media, industrial and consumer businesses. Through its team of seasoned investment professionals and industry experts, Avista seeks to partner with exceptional management teams to invest in and add value to well-positioned businesses. For more information visit www.avistacap.com.
About Teachers’ Private Capital
Teachers’ Private Capital is one of the world’s largest private equity investors. It is the private investment department of the Ontario Teachers’ Pension Plan. With $107.5 billion in assets as of December 31, 2010, the Ontario Teachers’ Pension Plan is the largest single-profession pension plan in Canada. It is an independent corporation responsible for investing the fund and administering the pensions of Ontario’s 295,000 active and retired teachers. For more information visit www.otpp.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the proposed transaction between Kendle and INC Research and the expected timing and completion of the transaction. Words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "will," "should," "may," and other similar expressions are intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of Kendle’s management and involve a number of significant risks and uncertainties, many of which are difficult to predict and are generally beyond the control of Kendle and INC Research. Actual results may differ materially from the results anticipated in these forward-looking statements. There can be no assurance as to the timing of the closing of the transaction, or whether the transaction will close at all. The following factors, among others, could cause or contribute to such material differences: the ability to obtain the approval of the transaction by Kendle’s shareholders; the ability to obtain required regulatory approvals of the transaction or to satisfy other conditions to the transaction on the terms and expected timeframe or at all; transaction costs; economic conditions; a material adverse change in the business, assets, financial condition or results of operations of Kendle; and the effects of disruption from the transaction making it more difficult to maintain relationships with employees, customers or other business partners. Additional factors that could cause Kendle’s results to differ materially from those described in the forward-looking statements can be found in the periodic reports filed with the Securities and Exchange Commission and in the proxy statement Kendle intends to file with the Securities and Exchange Commission and mail to its shareholders with respect to the proposed transaction, which are or will be available at the Securities and Exchange Commission's website (http://www.sec.gov) at no charge. Kendle assumes no responsibility to update any forward-looking statements as a result of new information or future developments except as expressly required by law.
Additional Information
This communication is being made in respect of the proposed merger transaction involving Kendle and INC Research. In connection with the proposed transaction, Kendle will file with the Securities and Exchange Commission a proxy statement and will mail the proxy statement to its shareholders. Shareholders are encouraged to read the proxy statement regarding the proposed transaction in its entirety when it becomes available, and before making any voting decision, as it will contain important information about the transaction. Shareholders will be able to obtain a free copy of the proxy statement (when available), as well as other filings made by Kendle regarding the Company, INC Research and the proposed transaction, without charge, at the Securities and Exchange Commission's website (http://www.sec.gov). These materials also can be obtained, when available, without charge, by directing a request to Kendle at This email address is being protected from spambots. You need JavaScript enabled to view it. .
Under the terms of the agreement, INC Research will acquire all of the outstanding shares of Kendle for $15.25 per share in cash, representing a 60.5 percent premium over Kendle’s closing share price on May 4, 2011. This represents a premium of 51.3 percent over the 30-trading day average of Kendle’s closing price. The Board of Directors of Kendle unanimously approved the transaction, which is expected to close in the third quarter subject to approval by Kendle’s shareholders as well as satisfaction of customary closing conditions and regulatory approvals.
“Joining forces with INC Research is the right decision for our customers and shareholders. Combining our highly complementary assets will provide the scale and scope for the combined company to deliver outstanding global teams, therapeutic expertise and operational excellence for clinical trials of all sizes,” said Kendle President and CEO, Stephen Cutler, PhD. “Because both companies are known for conducting high-quality clinical work and share a common culture based on excellent service delivery, we will be able to maintain a customer-centric focus on each individual project.”
"The combination of INC Research and Kendle will enable us to deliver broader capabilities and reach a critical mass for the emerging drug development outsourcing and alliance partnership models,” said James Ogle, CEO of INC Research. “Together, we bring complementary strengths and expand the breadth and depth of services and expertise that are most valuable to our customers.”
The combination of INC Research and Kendle strengthens both businesses by creating a global CRO with significant therapeutic capability and geographic diversity. The combined company will rank among the top-tier CROs based on size and scale, and will be well positioned to handle large-scale global trials.
As a result of the proposed merger transaction, Kendle’s earnings release and conference call/webcast scheduled for Thursday, May 5, at 8 a.m. Eastern Time has been cancelled. In addition, Kendle’s Annual Meeting of Shareholders has been postponed from May 19, 2011, with a new date to be determined by Kendle’s Board of Directors.
In connection with the transaction, J.P. Morgan Securities LLC acted as Kendle’s financial advisor and Keating, Muething & Klekamp PLL acted as its legal advisor. Morgan Stanley & Co. Inc. acted as financial advisor and Weil Gotshal & Manges LLP acted as the legal advisor to INC Research.
About Kendle
Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing products to market for the benefit of patients worldwide. As one of the world’s largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges. For more information, please visit www.kendle.com.
About INC Research, LLC
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit www.incresearch.com or follow us at @inc_research.
About Avista Capital Partners
Avista Capital Partners is a leading private equity firm managing approximately $4 billion of committed capital with offices in New York, Houston, and London. Founded in 2005, Avista's strategy is to make controlling or influential minority investments in growth-oriented energy, healthcare, media, industrial and consumer businesses. Through its team of seasoned investment professionals and industry experts, Avista seeks to partner with exceptional management teams to invest in and add value to well-positioned businesses. For more information visit www.avistacap.com.
About Teachers’ Private Capital
Teachers’ Private Capital is one of the world’s largest private equity investors. It is the private investment department of the Ontario Teachers’ Pension Plan. With $107.5 billion in assets as of December 31, 2010, the Ontario Teachers’ Pension Plan is the largest single-profession pension plan in Canada. It is an independent corporation responsible for investing the fund and administering the pensions of Ontario’s 295,000 active and retired teachers. For more information visit www.otpp.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the proposed transaction between Kendle and INC Research and the expected timing and completion of the transaction. Words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "will," "should," "may," and other similar expressions are intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of Kendle’s management and involve a number of significant risks and uncertainties, many of which are difficult to predict and are generally beyond the control of Kendle and INC Research. Actual results may differ materially from the results anticipated in these forward-looking statements. There can be no assurance as to the timing of the closing of the transaction, or whether the transaction will close at all. The following factors, among others, could cause or contribute to such material differences: the ability to obtain the approval of the transaction by Kendle’s shareholders; the ability to obtain required regulatory approvals of the transaction or to satisfy other conditions to the transaction on the terms and expected timeframe or at all; transaction costs; economic conditions; a material adverse change in the business, assets, financial condition or results of operations of Kendle; and the effects of disruption from the transaction making it more difficult to maintain relationships with employees, customers or other business partners. Additional factors that could cause Kendle’s results to differ materially from those described in the forward-looking statements can be found in the periodic reports filed with the Securities and Exchange Commission and in the proxy statement Kendle intends to file with the Securities and Exchange Commission and mail to its shareholders with respect to the proposed transaction, which are or will be available at the Securities and Exchange Commission's website (http://www.sec.gov) at no charge. Kendle assumes no responsibility to update any forward-looking statements as a result of new information or future developments except as expressly required by law.
Additional Information
This communication is being made in respect of the proposed merger transaction involving Kendle and INC Research. In connection with the proposed transaction, Kendle will file with the Securities and Exchange Commission a proxy statement and will mail the proxy statement to its shareholders. Shareholders are encouraged to read the proxy statement regarding the proposed transaction in its entirety when it becomes available, and before making any voting decision, as it will contain important information about the transaction. Shareholders will be able to obtain a free copy of the proxy statement (when available), as well as other filings made by Kendle regarding the Company, INC Research and the proposed transaction, without charge, at the Securities and Exchange Commission's website (http://www.sec.gov). These materials also can be obtained, when available, without charge, by directing a request to Kendle at This email address is being protected from spambots. You need JavaScript enabled to view it. .
Published in
CRO Industry News
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