Clinical Trial of Pleuromutilin Antibiotic

August 21, 2009

Nabriva_BlogNabriva Therapeutics announced the initiation of a clinical Phase I trial for BC-3781, a pleuromutilin antibiotic being developed to treat serious infections including complicated skin and skin structure infections and community-acquired pneumonia. The clinical study is designed to evaluate the safety and tolerability of BC-3781 in humans via intravenous administration.

The antibiotic is highly active against key gram-positive pathogens, including MRSA, and gram-negative pathogens associated with community-acquired pneumonia. Its novel mode of action ensures that it overcomes resistance mechanisms affecting all approved classes of antibiotics. In addition it belongs to the first generation of pleuromutilins to combine availability of both oral and i.v. dosage forms.

Dr. David Chiswell, CEO of Nabriva Therapeutics said: “In 2009 we intend to generate key human data for our two lead pleuromutilin-based antibiotics, BC-3205 and BC-3781. The BC-3205 oral administration clinical trial is already underway and we are delighted now to be also commencing the trial for intravenously administered BC-3781. Of particular note is that this is the first time a pleuromutilin antibiotic has been administered via the intravenous route opening the possibility for pleuromutilin based step-down therapy.”

www.nabriva.com


Building Skills in Individuals and Teams

July 13, 2009
Prof. Dr. Doris Østergaard, immediate past president of SESAM, and Prof. Dr. Wolfgang Heinrichs, AQAI simulation centre Mayence (Photograph: MR)

Prof. Dr. Doris Østergaard, immediate past president of SESAM, and Prof. Dr. Wolfgang Heinrichs, AQAI simulation centre Mayence (Photograph: MR)

SESAM Medical Simulation Conference in Germany

Increased awareness around patient safety, a shortage in resources, and pressure for continuing education are key drivers which put simulation on the agenda of caregivers. Today, the call for this approach reaches well beyond the education of specialists at university level. – Last June, a conference brought together experts, users, and the industry.

The Society in Europe for Simulation Applied to Medicine (SESAM) – founded 15 years ago by a small group of anaesthetists – held its 15th annual meeting in Mayence, Germany. “Physicians are trained to work as individuals, not as team members”, explained immediate past president of the society, Prof. Dr. Doris Østergaard. Issues in organizing workflows and in communication between healthcare workers involved in a patient case contribute significantly to problems. “Things do go wrong inside and outside hospitals, and education and training are required to achieve improvements. Simulation helps in optimizing the distribution of tasks, in communicating, and interacting within teams”, Prof. Østergaard went on to say. Procedures in cardiac arrest are a case in point: first, staff from various medical disciplines and nursing needs to acquire know-how; second, training has to take place – e.g. on a skill simulator; third, these skills have to brought together in a simulation scenario, where team skills are trained.

“Focus Is On Processes”

Prof. Østergaard is the Director of the Danish Institute for Medical Simulation and Associate Professor at Copenhagen University. In addition to the university, her institute today serves caregivers in the capital region in Denmark, with simulation campaigns such as this: “A 55-year old goes jogging at five in the morning, falls, and the ambulance is calle. and takes the patient to the hospital. The team arrives in the emergency unit and proceeds to handle the case. Actions are video recorded, and in a post mortem, are discussed in detail to identify necessary improvements.” The manikin used for resuscitation training, and the ancillary IT which evaluates the effect staff action would have on a real human being, are only part of the “big picture” – the focus is on processes and interaction. The teacher, or facilitator, in these scenarios is challenged in several ways: interdisciplinary know-how is required from him/her, and there is a difficult borderline between letting project members act “as if in real life” and stepping in to curb serious errors. Participants value these scenarios because they receive immediate feedback.

Prof. Dr. Wolfgang Heinrichs is the co-founder of the AQAI simulation centre in Mayence which is one of a few organizations serving healthcare providers in Germany: “We help hospitals of all sizes in improving medical/nursing and social skills for their staff. The private group Helios, for example, uses our organization to train incident management in anaesthetics”.

Optimizing Safety and Cost

Patient safety statistics show clearly that there is significant room for improvement in care. Cost reductions are another benefit to be reaped from optimized education and training. How, according to the expert from Denmark, should specialist and team training be organized? “I think you have to have regional centres plus local simulation activities; and you should collaborate to produce overall comprehensive learning.” The benefit of the use of manikins from Meti, Laerdal, Gaumard, and further vendors is obvious: they allow for a lifelike training of novices which is more suitable than the use of animals. Healthcare workers receive a higher level of qualification before they start working on humans, which helps avoid harm being afflicted to patients.

“In the field of medicine, simulation-based cross-disciplinary training will be required which orients itself to clinical pathways”, predicted Prof. Heinrichs at the conference; “simulation needs to be a requirement in curricula, and an integral part of existing training programmes”, stated Prof. Østergaard; “in future, patients will demand this type of training from their caregivers.”

Genetics and biomarkers are at the top of the agenda; simulation may appear to be a less attractive topic, but it is key to necessary improvements in care. “Many European countries see the need to establish a national society to be linked to SESAM; this is the right path”, “underlined the Danish expert, towards advancing the simulation approach in Europe”.

Pioneering Example – Investment in Simulation

According to a statement from Dr. Ian Curran, Associate Dean and Lead for the Simulation and Technology-enhanced Learning Initiative at London Deanery last April, “The London Deanery’s pioneering advances in simulation and medical education are providing our doctors and clinical teams with unique opportunities to develop their individual and team-based skills in a patient safe way. Over the last 18 months, with the support of NHS London, we have invested over £11 mn. equipping every one of the 32 acute trusts in London with state of the art educational equipment. Therefore, we are confident that as simulation training is adopted more widely, it will support the provision of higher quality and safer patient care for London both today and in the future.”

SESAM’s Mission

… is to “…encourage and support the use of simulation in medicine for the purpose of education and research.” Members are physicians, nurses and other health care professionals, also technicians, engineers, psychologists, physicists, and biologists: www.sesam-web.org.


Multi-Modality Breast Imaging Workstation – Optimized Workflow and Productivity

July 1, 2009
The Kodak Carestream Mammography Workstation enables diagnostic review of all breast imaging as well as all general radiology exams.

The Kodak Carestream Mammography Workstation enables diagnostic review of all breast imaging as well as all general radiology exams.

European healthcare facilities are turning to vendor-neutral, multi-modality breast imaging workstations to streamline reading of digital breast exams. “Productivity at many European facilities is hampered by the need to read full-field digital mammography (FFDM) exams on each vendor’s proprietary workstation, and then switch to additional workstations to review other types of breast exams. The need for an efficient workflow is driving strong sales for our flexible multi-modality workstation,” said Stephen W. Archer, Director of Worldwide Marketing, Mammography Solutions, Carestream Health.

The Kodak Carestream Mammography Workstation enables diagnostic review of all breast imaging exams (FFDM, ultrasound, MR, CR, and others) as well as all general radiology exams. “Features such as CAD integration, multi-modality functionality, and rapid retrieval were very important to us when selecting our breast imaging workstation platform,” said Radiologist Dr. Hubert Kubin at the Institute of Radiology in Salzburg, Austria. “Carestream Health’s mammography workstation is easy to use and offers many specific functionality features which improve diagnostic reading workflow.”

The vendor’s workstation offers a variety of time-saving features including user-customizable hanging protocols and an eight-key programmable mouse. “I appreciate the high flexibility offered by the display protocols, which are tailored to my specific needs for productive reading,” said Radiologist Dr. Regine Rathmann, Head of Regional Assessment Centre for Screening Programmes, Hanover, Germany. “During the past three years I have read more than 100,000 mammography cases on [this vendor’s] multi-modality workstations, and have found the system to be stable and highly reliable. We have four workstations dedicated to mammography, and I can easily review all exams from both screening and general radiology at each.”

According to the company, more than 100 healthcare providers worldwide have ordered the Kodak Carestream Mammography Workstation – including a number of orders from northern Europe, namely Uppsala County, Sweden; Ringsted Sygehus in the Sjaelland Region of Denmark; the Icelandic Cancer Society; Mammography Screening Centre in Bielefeld, Germany; the Institute for Radiology in Hollerbrunn, Austria and Clinic Dr. Hancken in Stade, Germany.


Change In Key Position

July 1, 2009
Michael Reitermann, CEO of Siemens Healthcare’s US organization

Michael Reitermann, CEO of Siemens Healthcare’s US organization

Michael Reitermann has been appointed the new CEO of Siemens Healthcare’s US organization. In his new position, Reitermann will lead the marketing, sales, and service functions for Siemens Healthcare in the US, including the medical imaging, therapy, and healthcare information technology businesses. He will be based at the vendor’s US headquarters in Malvern, Pennsylvania. Reitermann succeeds Dr. Heinrich Kolem, who will assume the role of global head of Siemens Healthcare’s Angiography, Fluoroscopy and X-ray business unit, based in Forchheim, Germany.


Head Nominated for “healthymagination” Campaign

July 1, 2009
Michael Barber is head of GE's healthymagination campaign

Michael Barber is head of GE's healthymagination campaign

GE Chairman and CEO Jeff Immelt has named Michael Barber VP of healthymagination, the vendor’s global commitment to reduce costs, improve quality, and expand access of healthcare for millions of people. Barber, 48, is a 27-year veteran of GE and since 2005 has served as chief technology officer for GE Healthcare.

“Over the last four years, Mike has led all aspects of product development for advanced healthcare technologies”, stated Immelt. “Mike knows how our technology can help patients, he knows what physicians, clinics, and hospitals need to improve care and cut costs – and he knows how to lead teams. With his deep experience in engineering and technology, and his strong operations and process-driven expertise, he is the right leader to lead healthymagination and to grow our healthcare partnerships globally.”


Improved Access, Optimized Quality, Reduced Cost

June 18, 2009
Dr. Rolf Lucas, President & CEO, GE Healthcare Germany

Dr. Rolf Lucas, President & CEO, GE Healthcare Germany

GE Launches “healthymagination” Initiative

More than US-$ 3 bn: this is the huge figure General Electric has pledged to invest in our sector in the next six years. The aim, explained Georg Knoth, CEO and Regional Executive for Germany, Austria, and Switzerland, at a recent presentation in the GE Research Centre near Munich, is to provide better access to care for more people at reduced cost. Furthermore, the vendor will make available US-$ 2 bn for financing and US-$ 1 bn to drive health IT and care in rural and underserved regions. These activities – which build on the experiences gained from the ecomagination initiative – are designed to foster the growth of the company.

These investments by GE – a 100% increase, according to company speakers – are the pillars of the “healthymagination” initiative. It comprises a series of projects to be realized by 2015. The investment of US-$ 3 bn in research and development, e.g., is set to launch at least 100 innovative products on to the market, to lower the cost, to increase the availability of health-related services, and to boost quality of care by 15%. The company will also apply its expertise in services and its suite of performance improvement tools.

“We will work with partners”, said Dr. Rolf Lucas who heads GE Healthcare Germany, “to focus innovations on four critical needs: accelerating healthcare IT; target high-tech products to more affordable price points; broaden access to the underserved; and support consumer-driven health”. GE will engage experts and leaders on policy and programs and create a GE Health Advisory Board, which will include former US senators Bill Frist and Tom Daschle as well as further leaders from the sector.

Targets And Examples

healthymagination will draw on capabilities from GE divisions such as Healthcare, Capital, Water, NBC Universal, the Global Research Centres as well as the GE Foundation, the vendor’s philanthropic arm. “Healthcare is an important industry that is challenged by rising costs, inequality of access, and persistent quality issues,” underlined GE Chairman and CEO Jeff Immelt. “[The sector] needs new solutions. We must innovate with smarter processes and technologies that help physicians and hospitals deliver better healthcare to more people at a lower cost. The new products are supposed to “measurably improve cost, access and quality. That means lower-cost technology for more customers, products matched to specific local needs, and process expertise – such as low-cost digital X-ray machines, portable ultrasounds, and more affordable cardiac equipment.

Local Partners Playing A Major Role

The initiative integrates local partners; this was illustrated by the event in Munich where outstanding physicians from Germany presented state-of-the-art approaches in diagnostics and therapy. Prof. Dr. Thomas Helmberger, Head of the Institute for Diagnostic and Interventional Radiology and Nuclear Medicine, Hospital Munich-Bogenhausen, outlined the benefits of the digital information flow in radiology: By using networked communication within and outside the hospital, and through tele-radiology, the former “slow lane” of information was transformed into a communication chain which helps reduce staff capacity use and patient stay while improving quality at the same time. Tumor boards are a case in point. – Presymptomatic detection of neurodegenerative conditions by functional imaging integrating radiopharmaceuticals helps avoid damaging neurons, according to Dr. Niklas Manthey. The Head of the Nuclear Medicine Department, Radiology Munich South West, outlined how non-appropriate medication therapies can be prevented using SPECT – an annual savings potential of roughly 75 mn €. – Thermoablation of uterus myomas using focused ultrasound is an approach used by Dr. Matthias Matzko. The Head, Clinical and Interventional Radiology, Dachau Hospital, says the non-invasive method sustains fertility. The procedure, which lasts up to two hours and causes no complications, permits 100% necroses. Until now, financing of „MRgFUS“ interventions is to be handled by patients, fully or in part.

Oxford Analytica, an independent international research and consultancy firm, is reviewing GE commitments in new products and services to determine if they meet healthymagination standards. To date, the organization has qualified seven GE products that yield a 15% improvement in cost, access, and quality. The vendor’s goal is to qualify 100 healthymagination innovations by 2015.

Presenting the healthymagination initiative in Munich (from left): Georg Knoth, CEO & Regional Executive, GE Germany, Austria, and Switzerland; Prof. Dr. Thomas Helmberger, Head of the Institute for Diagnostic and Interventional Radiology and Nuclear Medicine, Hospital Munich-Bogenhausen; Dr. Matthias Matzko, Head, Clinical and Interventional Radiology, Dachau Hospital; Dr. Niklas Manthey, Head of the Nuclear Medicine Department, Radiology Munich South West

Presenting the healthymagination initiative in Munich (from left): Georg Knoth, CEO & Regional Executive, GE Germany, Austria, and Switzerland; Dr. Carlos Härtel, Managing Director GE Global Research Centre Europe; Prof. Dr. Thomas Helmberger, Head of the Institute for Diagnostic and Interventional Radiology and Nuclear Medicine, Hospital Munich-Bogenhausen; Dr. Matthias Matzko, Head, Clinical and Interventional Radiology, Dachau Hospital; Dr. Niklas Manthey, Head of the Nuclear Medicine Department, Radiology Munich South West


Unified Healthcare Information System for United Family Hospitals in China

June 9, 2009

United Family Hospitals (UFH) has signed a contract with InterSystems which provides the caregiver with TrakCare, an advanced Web-based healthcare information system. It will link the UFH network of hospitals and clinics in China to create a unified healthcare information platform to support the organization’s rapid growth.

UFH – a “pioneering, world-class healthcare organization in China”, according to speakers – along with InterSystems China took less than four months to complete the first implementation of the solution at the new Guangzhou United clinic.

Deployments at other UFH outpatient clinics and hospitals in Beijing and Shanghai are expected to be completed over the next eighteen months. UFH will also deploy TrakCare in the expansion of its Beijing facilities and at its anticipated new full service hospital in Guangzhou.

The solution supports UFH’s rapid growth by providing advanced clinical and administrative functionality – including multi-language and multi-currency support – and a shared Electronic Patient Record within a single unified healthcare information platform that also provides easy interoperability with other information systems.

Roberta Lipson, CEO of Chindex International, which owns and operates UFH, stated, “We have aggressive plans for expansion of the UFH network in China and, while our previous information platform was excellent, it could not meet our increasing requirements. TrakCare gives us a solid platform across our network to support us in our growth plan.” Daniel Fulton, Vice President of Information Technology Services for UFH, said, “We needed a world-class healthcare information solution from a vendor with the experience of international best practices and a strong local implementation and support team in China.”

Rapid deployment was possible because of a good fit with UFH’s requirements and the flexibility of the TrakCare. The Web-based solution’s ease of configuration was key, allowing InterSystems to supply a solution without extensive customization. “[This product] came closest to meeting our needs,” said Fulton. “The fit was in the 70-80% range, the rest comes down to configuration.” – UFH is already gaining benefits at the Guangzhou United clinic. “On the billing side, TrakCare is doing everything we wanted to do. We are very happy with the support for the insurance plans and with the multi-currency and multi-language support,” Fulton continued.

“Leading healthcare providers across the region like UFH are delivering the best possible quality of patient care and improving operational efficiency using our technology,” stated InterSystems Managing Director for Asia Pacific, Joerg Klingler. “With TrakCare’s Electronic Patient Record, for example, clinicians can access a patient’s complete medical history which helps prevent prescribing errors and adverse drug reactions.” The solution’s integration capability, enabled by the vendor’s Ensemble rapid integration and SOA platform, also proved to be very valuable. At the Guangzhou clinic, TrakCare has already been integrated with software from an InterSystems application partner, Disclinc’s Alphalinc supply chain system, and CMPMedica’s MIMS online drug database. “CMPMedica provides a good local pharmaceutical dataset which is key to preventing adverse drug reactions and takes us to a new level in providing support systems for our clinicians,” underlined Fulton.

Alphalinc ensures efficient handling of medicines and other materials, which can account for up to 40 percent of a provider’s total expenses, from suppliers to pharmacists, nursing stations, emergency rooms, patient wards, and operating theatres with full visibility over item availability, location, lot and expiry data, costs and pricing. – UFH is also integrating TrakCare with its Oracle Financials accounting system. Interoperability with specialist dental systems and ENT systems is also planned.


Strategic Alliance in Life Sciences

June 9, 2009

A strategic alliance agreement has been signed by Fujifilm and GE Healthcare: Fujifilm will develop, manufacture, and supply advanced biomolecular imaging systems to GE. The products will be sold worldwide under that vendor’s brand in the life science research and drug discovery markets.

Life science research has advanced rapidly in recent years with the advent of tools for genomic and protein research – such as biomolecular labeling, detection, and analysis. These technologies have helped reveal the functions of proteins, thereby contributing to scientists’ understanding of disease processes. The use of life science instrumentation and reagents in bioscience research is growing, and the demand for new and innovative enabling technologies is expanding.

In 1987, Fujifilm was the first company to introduce the digital autoradiography device which utilized the Imaging Plate, a radiation detector with sensitivity 100 times greater than X-ray film. Since then, the company has utilized its chemical and optical technologies cultivated in the field of photo imaging to launch a broad range of instruments, including innovative CCD camera systems, contributing to the advancement of imaging in genomic and protein research.

In 1923, GE Healthcare introduced the first radio isotope reagents, which initiated the field of biomolecular labeling and detection. Since then, the vendor has introduced a series of non-radioactive detection reagents, such as ECL and CyDyes, to enable safe and quantitative biomolecular labeling, detection, and analysis. The company’s system solutions have improved significantly the way scientists can analyze gene and protein expression in tissues and cells.

“This deal represents an important progression for our business,” stated Yuzo Toda, Director, Corporate Vice President, General Manager of Life Science Products Division, Fujifilm. “By forming the alliance, both companies will make the most of our complementary capabilities to continue to contribute to the advancement of genomic and protein research, and to help enhance the quality of life of people worldwide. GE Healthcare’s global presence as a supplier of reagents and instruments, and its competence in biological applications within the life science field combined with Fujifilm’s leading imaging technologies, R&D and manufacturing capabilities will provide our customers with comprehensive system solutions for research, drug discovery and bioanalytical applications.”


“Tradition and Innovation in Simulation”

June 8, 2009

The Society in Europe for Simulation Applied to Medicine SESAM and the Simulation Centre Mainz are organizing the 15th Annual Meeting on medical simulation. Anybody using simulation techniques or with an interest in medical education, and anybody concerned about patient safety is welcome to participate. The event is scheduled for June 11-13 in Mainz/Germany (Mayence – a city of Roman origin, situated on the Rhine in a wine-growing region), at the Kupferberg Congress Centre. The scientific programme and information on accompanying social activities are available on the Web – http://www.sesam2009.ws. The exhibition will include immersion, Laerdal, METI, and further vendors.


New President and CEO, GE Healthcare, Germany

April 7, 2009
Dr. Rolf Lucas, President/CEO GE Healthcare Germany

Dr. Rolf Lucas, President/CEO GE Healthcare Germany

GE Healthcare – the US-$17 bn healthcare business of General Electric Company – has announced the appointment of Dr. Rolf Lucas as its new President and CEO for GE Healthcare, Germany.

Dr. Rolf Lucas, a company speaker said, will play a leading role for GE Healthcare in Germany, developing and executing a dedicated strategy to reinforce the vendor’s position and leverage its full growth potential. Reinaldo Garcia, President and CEO for GE Healthcare, EMEA, stated, “Germany is a key strategic market for GE Healthcare with major growth opportunities in the coming years. Dr. Lucas will continue to strengthen our German footprint, through his broad industry experience and leadership skills”.

Of his appointment, Dr. Rolf Lucas said: “Germany represents a significant growth market for GE Healthcare, and we must continue to drive our long-term strategy here. Our aim is to achieve growth by offering innovative diagnostic imaging and information technologies that help create a more efficient, cost effective, and higher quality healthcare system across Germany. It is through GE Healthcare’s capabilities in providing comprehensive solutions across medical imaging, life sciences, and medical diagnostic that we hope to transform Healthcare delivery by helping our customers and the Healthcare industry detect and treat diseases at an earlier stage.”

Prior to joining GE Healthcare, Dr. Lucas ran his own Medical Devices business and held a number of senior leadership positions with large companies, including Philips and Picker. He was also previously Chief Operating Officer at one of Germany’s largest university hospitals – in Mayence – and most recently he acted as CEO International Business for the German private hospital chain Asklepios.

Rolf studied in Münster and St. Gallen, Switzerland, and holds a PhD in Business Administration and an MBA from the Institute of Technology, Florida, USA.