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ClinPhone, the world’s largest Clinical Technology Organization (CTO), has received the GCP Inspection Statement to complete the latest Inspection by the GCP Inspectorate of the Medicines and Healthcare Products Regulatory Agency (MHRA).

The MHRA is an executive agency of the Department of Health and was established in April 2003 from a merger between the Medicines Control Agency and the Medical Devices Agency. The agency is responsible for ensuring that medicines and medical devices work and are acceptably safe.

As with any organization involved in the clinical trials process, ClinPhone has implemented rigorous procedures to ensure compliance with Good Clinical Practice (GCP). These are assessed by clients, who conduct in excess of 40 audits per year at ClinPhone, as well as by Regulatory Authorities.

In the UK, ClinPhone is subject to inspection by the MHRA, in accordance with ‘The Medicines for Human Use (Clinical Trials) Regulations’ (Statutory Instruments 2004/1031 as amended). ClinPhone underwent their second routine GCP Inspection in mid-November 2007. Following submission of responses to the Inspection Report, a revised GCP Inspection Statement, signifying the completion of the latest inspection cycle, was received on 23rd April 2008.

Steve Kent, CEO, ClinPhone comments, “This reinforces to our clients that ClinPhone are fully committed to Good Clinical Practice. We have the appropriate policies and procedures in place, as well as robust technology with sufficient back-up systems, to successfully manage our clients’ studies to the very highest standards.”

To find out more about the Medicines and Healthcare Products Regulatory Agency (MHRA), please visit: http://www.mhra.gov.uk/aboutus/index.htm.

For further information on ClinPhone’s clinical trial technology solutions, please visit http://www.clinphone.com, or alternatively email info@clinphone.com.

About ClinPhone

ClinPhone plc is the world’s largest Clinical Technology Organization (CTO) with an unrivaled track record of innovation in the development of clinical trial technology. Headquartered in Nottingham UK with offices around the world, ClinPhone works with leading global biotechnology organizations, pharmaceutical companies and Contract Research Organizations (CROs).

ClinPhone is the largest and most accomplished CTO with experience in over 2,000 clinical trials spanning 88 countries and 71 languages. The Company’s experience includes Phase I to Phase IV studies, ranging from single center studies with 20 patients to “mega trials” with over 40,000 patients.

ClinPhone’s product portfolio, consisting of software and services, is backed by continuous research and investment in the latest technologies, coupled with extensive in-depth clinical industry experience. Its industry-leading software solutions include electronic data capture (EDC) and clinical trial management systems (CTMS), which can be licensed or implemented as hosted solutions. Delivered via its renowned Interactive Voice Response (IVR) and Interactive Web Response (IWR) platform, ClinPhone offers randomization, trial supply management, trial supply simulation, electronic patient reported outcomes (ePRO), and patient recruitment solutions.

ClinPhone’s products can integrate, taking the pain out of juggling and managing multiple sources of disparate information. This approach provides more control over data, improves data integrity and streamlines the data validation process.

http://www.clinphone.com

The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific papers outlining the progress made on ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative. Written by subject matter experts representing the global pharmaceutical manufacturing industry, these papers present preliminary practical scientific and technological approaches to implementing ICH documents that address Pharmaceutical Development (Q8 and Q8(R)), Quality Risk Management (Q9), and Pharmaceutical Quality Systems (Q10). The June issue will be published in print and with Open Access on SpringerLink (available at www.springer.com/journal/12247) with the possibility to comment.

The Product Quality Lifecycle Implementation (PQLI) initiative was launched by ISPE in June 2007 to help industry find practical technical solutions to the challenges of implementing guidelines put forth by the ICH. The first three Task Teams formed focused on Criticality, Design Space and Control Strategy, and how these areas are linked; a Legacy Products Task team has also been formed as the fourth topical area.

Through PQLI, ISPE is providing technical frameworks to facilitate the implementation of Q8, Q9, and the imminent Q10 for new products and processes, as well as for existing approved products which could benefit. PQLI will provide better understanding of Quality by Design (QbD) applied to new products and processes, and is developing cross-functional tools valued by both the Industry and Regulatory Authorities worldwide. While the output is critical for industry application, the conclusions have been reached with input from global regulators. With the publication of these articles, the ISPE PQLI Task Teams are seeking additional feedback prior to developing their respective positions into technical documents.

PQLI is projected to be at least a five-year initiative that has started with highly interactive fact-gathering sessions held in the USA and Europe. Working groups will continue to collect and process information for distribution as white papers, articles to be published in ISPE’s Journal of Pharmaceutical Innovation and Pharmaceutical Engineering Magazine, leading to detailed technical documents, and training programs that will be produced by ISPE for the industry worldwide.

“The ISPE PQLI Task Teams are to be congratulated for their technical publications in JPI on criticality, design space, and control strategy, which embrace inputs from open, interactive global workshops that included participation from both industry and regulators,” said Moheb M. Nasr, Ph.D., Director, Office of New Drug Quality Assessment (ONDQA, CDER, FDA). “These papers, and the PQLI initiative, are important ‘next steps’ to facilitate the implementation of QbD and to answer the tangible challenges.”

Referring to the importance of understanding the future role of the EU Qualified Person within the frameworks of ICH Q8, 9 and 10, Jacques Morenas (AFSSAPS) and current chairman of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) said “EU regulators are ready to work with ISPE on this topic taking into account it is a critical point. Work is already on progress as we can see with work made into PAT team at the EMEA level and we will be happy to continue.”

The Criticality article describes a mechanism for categorizing and delineating criticality for quality attributes, variables, material attributes and process parameters in accordance with a risk based approach reflective of QbD principles articulated in ICH Q8R. The article introduces the adoption of a Criticality Analysis Decision Tree to categorize criticality relative to a variable’s impact to quality and delineate levels of criticality with respect to relative risk.

Design Space discussions considered the linkage of the patient experience with product quality. It also focused on how risk assessment methodologies integrate with process design principles, provided perspective on selection of mechanistic versus empirical approaches, and clarified how they may be applied to legacy products, and biotech products. The team also discussed a number of useful methods for depicting design space. The team recognizes that organizations may choose different, scientifically defensible means to arrive at design space.

The Control Strategy team has proposed a Model process to enable a clear logic to be used on how a Control Strategy differentiates between patient and business requirements, as well as showing the linkage from Critical Quality Attributes, e.g. via Critical Process Parameters, to individual controls such as analytical, PAT, engineering, procedural or other controls. The Model illustrates how the Control Strategy embraces ICH requirements (product and systems). It will also provide a discussion bridge between disciplines such as development scientists and controls engineers.

The Legacy Products team has started work and will produce a paper later in 2008 in JPI. The team is considering how to derive business benefits by reviewing knowledge about a product and/or process and proposing opportunities for flexibility in a post approval regulatory application for an approved product. A suggested workflow process will be produced and supported by case studies.

“The publication of these papers is a milestone event as it will bring together an industry view of a risk and science based design approach for pharmaceuticals,” said James C. Spavins, Vice President, Global CMC, Pfizer. “The use of risk based analyses to determine design constraints and then determine appropriate controls is a foundational process for the advancement of science and technology - it is time for pharmaceutical professionals to have an aligned view.”

The Journal of Pharmaceutical Innovation (JPI) is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI’s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation. The journal brings together in a single source the most exciting work from a variety of fields - from R&D to market. JPI publishes Perspectives, Case Studies, Research Letters, Research Articles, and Reviews in the following categories: materials science; process design, optimization, automation, and control; product design; facilities; information management; regulatory policy and strategy; supply chain developments; and education and professional development. JPI is published by ISPE in collaboration with Springer.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders.

Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, with a European office in Brussels, Belgium, and an Asia Pacific office in Singapore.

www.ISPE.org

The newest version of GE’s featured MUSE data management system incorporates upgrades in information technology, ECG management processes and clinical report editing in an all-digital environment for truly paperless workflow. “The MUSE version 7. 1 offers new benefits including additional options that enhance clinical workflows and improved IT connectivity,” said Dr. Matthias Weber, cardiologist and vice president of GE Healthcare’s Diagnostic Cardiology business. “The system is intended to better meet the needs for accessing comprehensive ECG data across the enterprise.”

Clinical Benefits

MUSE v7.1 provides high-fidelity digital access to resting ECG, Stress and Holter tests, allowing the clinician to review and edit studies on-line, from the comfort of home, anytime night or day. Clinical workflow is enhanced through the use of new display formats, magnification and measurement tools and statement editing capabilities. GE has added further measurement options, meeting the needs of pediatric cardiologists and those in other specialty areas. GE’s innovative Marquette® Serial Comparison program makes algorithmic comparative analysis available, on-demand. In addition, a number of IT capabilities are available to provide clinicians access to important patient data both inside and outside of the workplace.

Information Technology Benefits

Information Technology (IT) highlights include both a SQL 2005 relational database and a Windows Server 2003 operating system and is available as a software-only offering. THE MUSE system offers extensive HL7 interfaces and web integration with most major vendor EMR systems. A dedicated team is available to assist you during your implementation and integration needs. Additionally, the MUSE system provides an end-to-end workflow solution through optional wireless or LAN networking to the MAC5500 and 3500 electrocardiographs. Utilizing the hospital infrastructure for connectivity, along with the MUSE HL7 interface, the user can download patient demographic information and orders directly to the electrocardiograph.

Pharmaceutical Clinical Trials

The MUSE system has long been an important tool in addressing the unique challenges of pharmaceutical clinical trials. The recent MUSE v7 improvements include an Interval Editor option, with capabilities for ICH E-14 “thorough QT study” criteria. It also includes 21CFR Part 11 compliance aids and extensive XML export capabilities to assist in creating a compliant, readily auditable environment for submitting results to the FDA without a cumbersome certification process.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at http://www.gehealthcare.com.

Researchers have developed what they believe is the first new mechanism in nearly 20 years for inhibiting a common target used to treat all HIV patients, which could eventually lead to a new class of AIDS drugs.

Researchers at the University of Michigan used computer models to develop the inhibiting compound, and then confirmed in the lab that the compound does indeed inhibit HIV protease, which is an established target for AIDS treatment. The protease is necessary to replicate the virus, says Heather Carlson, U-M professor of medicinal chemistry in the College of Pharmacy, and principal investigator of the study.

Carlson stresses this is a preliminary step, but still significant.

“It’s very easy to make an inhibitor, (but) it’s very hard to make a drug,” said Carlson, who also has an appointment in chemistry. “This compound is too weak to work in the human body. The key is to find more compounds that will work by the same mechanism.”

What’s so exciting is how differently that mechanism works from the current drugs used to keep the HIV from maturing and replicating, she says. Current drugs called protease inhibitors work by debilitating the HIV-1 protease. This does the same, but in a different way, Carlson says.

A protease is an enzyme that clips apart proteins, and in the case of HIV drugs, when the HIV-1 protease is inhibited it cannot process the proteins required to assemble an active virus. In existing treatments, a larger molecule binds to the center of the protease, freezing it closed.

The new mechanism targets a different area of the HIV-1 protease, called the flap recognition pocket, and actually holds the protease open. Scientists knew the flaps opened and closed, but didn’t know how to target that as a mechanism, Carlson says.

Carlson’s group discovered that this flap, when held open by a very small molecule—half the size of the ones used in current drug treatments—also inhibits the protease.

In addition to a new class of drugs, the compound is key because smaller molecules have better drug-like properties and are absorbed much more easily.

“This new class of smaller molecules could have better drug properties (and) could get around current side effects,” Carlson said. “HIV dosing regimes are really difficult. You have to take medicine several times in the day. Maybe you wouldn’t have to do that with these smaller molecules because they would be absorbed differently.”

Kelly Damm, a former student and now at Johnson & Johnson, initially had the idea to target the flaps in this new way, Carlson says.

“In a way, this works like a door jam. If you looked only at the door when it’s shut, you’d not know you could put a jam in it,” she said. “We saw a spot where we could block the closing event, but because everyone else was working with the closed form, they couldn’t see it.”

For more information on Carlson, click here.

College of Pharmacy: http://www.umich.edu/~pharmacy/

Source: Laura Bailey
University of Michigan