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APPLIED CLINICAL TRIALS: INTEGRIUM LAUNCHES DERMATOLOGY PRACTICE
July 14, 2010 – Early last month, Integrium launched its expansion into the dermatology therapeutic area.
Dr. Mary Spellman, dermatology drug development expert, will lead Integrium’s Dermatology Clinical Research Group.
The company’s new Dermatology Clinical Research Group will help its clients design studies,
leverage its relationships with investigators to help identify and recruit study patients, and effectively manage their studies.
“Selecting the right CRO partner is critical to our success,”
said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals,
a firm focused on developing branded prescription products for the dermatology and women’s health therapeutic areas.
“We selected Integrium not only for their scientific and clinical trial expertise, but for their experience in studies of topical therapies.
They have helped us complete enrollment and lock the study database ahead of schedule for a multi-center Phase 2 trial.”
Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development.
Dr. Spellman has helped to achieve US FDA and ex-US approvals for multiple topical, systemic, and biological drugs,
as well as dermatological devices and vaccines, and has served as a medical and safety officer,
and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies.
In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.
Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance Therapeutics,
where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications.
Before that she held senior roles at Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company)
and Novartis Pharmaceuticals. Before entering the biopharmaceutical industry,
Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California,
San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego.
After earning her medical degree from the Medical College of Wisconsin, she completed an internship in Internal Medicine Residency
at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals.
She is a member of the Board of Directors of the Women’s Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.
INTEGRIUM LAUNCHES DERMATOLOGY PRACTICE,
APPOINTS INDUSTRY EXPERT DR. MARY SPELLMAN TO HEAD GROUP
Leading Specialized CRO Expands Focus to Help Pharmaceutical Companies Navigate the Challenges
Inherent in Dermatology Clinical Trials and Speed Drug Development
Tustin, Calif. – June 8, 2010 – Integrium LLC, a contract research organization (CRO)
specializing in cardiovascular and metabolic disease clinical research, today announced
its expansion into the dermatology therapeutic area. Dr. Mary Spellman, dermatology
drug development expert, will lead Integrium’s dedicated Dermatology Clinical Research
Group.
Patient demand for medical and aesthetic dermatologic health care is on the rise, thanks
in large part to aging baby boomers and an increasing number of available, cost-effective
solutions. According to IMS Health, global therapeutic dermatology is an $18 billion
market and growing – and identifying key trends and addressing needs unique to
dermatologic drug therapy development is critical for pharmaceutical companies to keep
up with demand.
Integrium has differentiated itself by demonstrating a deep understanding of the
complexities and nuances of clinical research in the dermatology area, and by delivering
successful clinical study solutions to biopharmaceutical companies. The company’s new
Dermatology Clinical Research Group will help its clients design scientifically rigorous,
yet feasible studies, leverage its relationships with reliable, high-quality investigators to
help identify and recruit study patients, and effectively manage their studies from start to
finish.
“We founded Integrium believing that a world-class team with experience levels far
above industry norms would set us apart,” said David Smith, M.D., Founding Partner and
Chief Medical Officer, Integrium. “Dr. Spellman’s appointment is very much in keeping
with this approach. Our clients will benefit tremendously from her dermatology expertise
and many years of drug development experience.”
“Selecting the right CRO partner is critical to our success,” said Dr. Sharon Levy, Senior
Vice President of Product Development for Graceway Pharmaceuticals, a firm focused on
developing branded prescription products for the dermatology and women’s health
therapeutic areas. “We selected Integrium not only for their scientific and clinical trial
expertise, but for their experience in studies of topical therapies. They have helped us
complete enrollment and lock the study database ahead of schedule for a multi-center
Phase 2 trial.”
“I’m pleased to be leading Integrium’s new dermatology clinical research group,” said
Dr. Spellman. “Integrium has earned a strong reputation for its expertise in
cardiovascular and metabolic disease clinical trials – and we look forward to carrying that
same level of excellence to ensure our clients focused on dermatology studies are getting
the support they need to bring better, safer therapies to market.”
Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical
research and drug and medical device development. Dr. Spellman has been instrumental
in achieving US FDA and ex-US approvals for multiple topical, systemic, and biological
drugs, as well as dermatological devices and vaccines, and has served as a medical and
safety officer, and nonclinical and clinical development and regulatory strategist to
biopharmaceutical and device companies. In addition to working with Integrium, Dr.
Spellman maintains a pharmaceutical and medical device consulting practice.
Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance
Therapeutics, where she was responsible for the development of novel topical therapies
for aesthetic and medical dermatology indications. Before that she held senior roles at
Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a
GlaxoSmithKline company) and Novartis Pharmaceuticals. Before entering the
biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine
(Dermatology) and Director of Dermatology Clinical Research at the University of
California, San Diego School of Medicine and Medical Center, and an attending
physician at the Veterans Affairs Medical Center in San Diego. After earning her medical
degree from the Medical College of Wisconsin, she completed an internship in Internal
Medicine Residency at Northwestern University McGaw Medical Center and a
Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. She is
a member of the Board of Directors of the Women’s Dermatologic Society and the
Editorial Board of the Journal of the American Academy of Dermatology.
Integrium will be exhibiting at DIA booth #228. Members of the media interested in
speaking with Integrium should contact Juli Greenwood at 781-672-3137 or
jgreenwood@chenpr.com.
About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that
specializes in dermatology, cardiovascular and metabolic clinical research. It has a strong
reputation for delivering high-quality management of global clinical development
programs and service to its clients. Combining the Integrium Clinical Excellence (ICE)
study start-up and management methodology, and therapeutic expertise leads sponsors to
more confident, better-informed drug and device development decisions. For more
information please visit www.integrium.com.
INTEGRIUM'S ENROLLMENT SKILL DRIVES NEED FOR REAL-TIME TRACKING
April 13 2010 - As reported last week, full-service CRO Integrium, a specialist in running trials for dermatology, cardiovascular and metabolic disease treatments,
has signed with Phase Forward for the latter's Interactive Response Technology (IRT) trial planning and management solution.
Integrium became a Phase Forward customer about a year ago, when it implemented the InForm EDC solution.
The Tustin, CA-based CRO is known for quicker-than-predicted trial enrollment, says COO Eileen McAuley via email.
"We have had great success in the enrollment aspect of our trials and in fact this success has created the need for better tools to let us monitor enrollment in real-time."
Phase Forward's IRT solution, she says, will contribute to automating the enrollment-tracking aspect of Integrium's clinical research services.
Some trials in the past, she says, involved no interactive voice response or Internet-based tools and required manual management of enrollment status.
The CRO will roll out IRT in its newly launched dermatology service as well as its traditional cardiovascular and metabolic services.
The goal is efficiency at the site level for both enrollment tracking and supply management, she says.
INTEGRIUM SELECTS PHASE FORWARD IRT FOR ENHANCED CLINICAL TRIAL
SUPPLY MANAGEMENT
Specialized CRO Selects Phase Forward’s Interactive Response Technology Solution
to Help Ensure Optimal Supply Availability
WALTHAM, Mass. – April 6, 2010 – Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety,
today announced that Integrium LLC, a contract research organization (CRO) specializing in dermatology, cardiovascular and metabolic disease clinical research,
recently signed an agreement for the use of Phase Forward™ IRT.
Integrium works with specialty, development-stage, mid-size, and large biopharmaceutical and medical device companies, providing a complete range of clinical
trial management services for Phase I through Phase IV dermatology, cardiovascular and metabolic disease studies. Integrium is headquartered in Tustin, Calif.,
with operational offices in Bedminster, N.J. and Johannesburg, South Africa.
The Integrium team implemented Phase Forward IRT because of its cutting-edge technology, rapid deployment and streamlined workflow to support advanced clinical
trial planning and management, according to Integrium. Total cost of ownership was also a key consideration.
“A strong technology strategy is critical to overall success and cost efficiency in clinical drug and device development,” said Eileen McAuley,
Chief Operating Officer, Integrium LLC. “We implemented Phase Forward IRT because we were impressed by the capabilities of the technology, Phase Forward’s
reputation as a market leader, and the potential to adopt additional products within the company’s suite as our needs evolve over time.”
“Integrium has developed a strong reputation for expertise and excellence in dermatology, cardiovascular and metabolic disease clinical trials,” said Scott Dixon,
Vice President, Global CRO Partnerships, Phase Forward. “We look forward to working with the Integrium team to help deliver the consistent, high-quality results
that sponsors count on from the company.”
Phase Forward’s CRO partnership strategy is designed to assist CRO clients in achieving success in both the short and long term.
Its customized structure and flexible pricing options help CROs of all sizes to invest in their own capabilities and capitalize on new growth opportunities.
About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that specializes in dermatology, cardiovascular and metabolic clinical research.
It has a strong reputation for delivering high-quality management of global clinical development programs and service to its clients.
Combining the Integrium Clinical Excellence (ICE) methodology and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions.
For more information please visit www.integrium.com.
About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety.
Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study
participants at over 300 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute,
Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International,
Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, SGS, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency.
Additional information about Phase Forward is available at www.phaseforward.com.
ERT (ERESEARCHTECHNOLOGY, INC.) AND INTEGRIUM, LLC FORM ALLIANCE
TO DELIVER INTEGRATED CARDIAC SAFETY AND AMBULATORY
BLOOD PRESSURE MONITORING SERVICES
PHILADELPHIA, January 30, 2009 -- eResearchTechnology, Inc. (ERT), (NASDAQ: ERES - News), and Integrium, LLC announced today their alliance to provide integrated Cardiac Safety and Ambulatory Blood Pressure Monitoring centralized core laboratory services to clinical trial sponsors and managers worldwide.
eResearchTechnology is a leading provider of centralized electrocardiographic (ECG), eClinical technology, ePRO, and other services to the biopharmaceutical , medical device, and related industries. Integrium is a cardiovascular, metabolic disease
and dermatology focused clinical research organization (CRO) offering a full range of clinical development services, including Ambulatory Blood Pressure Monitoring (ABPM) centralized core laboratory services.
Under the agreement, ERT and Integrium will deliver a combined solution to meet the increased demand for centralized cardiac safety and ABPM services during clinical trials. The partnership will offer integrated services from project planning and set-up through study conduct, management, and data delivery for primary and secondary Cardiac clinical trial endpoints.
Integrium will provide a full range of ABPM supporting services to include robust & reliable equipment, proprietary analysis software, global on-demand 24/7 attended call center and scientific leadership. ERT will perform digital collection, measurement, interpretation, review, and distribution of cardiac safety data through its EXPERT 2.0 workflow-enabled data management system.
"This alliance addresses a growing need in clinical research to offer comprehensive, best in class services in these two closely related areas of clinical study," said Michael McKelvey, President and CEO of ERT. "While many sponsors recognize and source each company for its respective area of expertise, customers increasingly seek consolidation and streamlining in all phases of a clinical trial. ERT and Integrium approach the market in the same way -- focusing on scientific excellence, providing a quality product, and client satisfaction. We are both metrics driven and process oriented to ensure on-time, on-budget, reliable data delivery on a global scale."
Integrium is a trademark of Integrium, LLC.
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