and parents joined our hybrid My Ocean Challenge kids event on 27 November to learn about sailing
his trusted sailing companion is onboard with him for their 6th circumnavigation
Hybrid My Ocean Challenge event in Großhansdorf
which Boris Herrmann live from the South Atlantic during the Vendée Globe 2024-2025
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It is with great pleasure that I invite you to participate in the ESMO Deep Dive Lung Cancer Webinar on the topic of Advanced NSCLC – Non-oncogene Addicted
and the microbiome represent critical advancements in the treatment of advanced NSCLC emerging in the 2010s
ADCs offer targeted cytotoxic therapy by delivering potent chemotherapeutic agents directly to cancer cells while minimizing systemic toxicity
particularly immune checkpoint inhibitors targeting PD-1/PD-L1
has transformed NSCLC management by enhancing anti-tumor immune responses
and offering durable remissions in select patients
Emerging evidence also suggests that the gut microbiome modulates immunotherapy efficacy
influencing response rates and toxicity profiles
Understanding these evolving therapeutic strategies is essential for optimizing patient outcomes and advancing personalized treatment approaches in NSCLC
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ESMO Deep Dive: Lung Cancer
Clinical Practice Guideline – Non-Oncogene-Addicted Metastatic Non-Small-Cell Lung Cancer
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He received his BA in English from Rutgers University
Gawel has been in medical editing since 2015
He is an editorial director for Healio’s Allergy/Asthma and Pulmonology groups
When he joined Healio in 2021 as an online managing editor
he was instrumental in launching the Allergy/Asthma and Women’s Health news feeds as well as the Climate Change & Health Resource Center
During his more than 20 years in publishing
Gawel also has been a digital content editor with Dentistry Today
a staff editor with North Jersey Media and a managing editor with Penton Media’s Design & Engineering Group
He and his son have reached level 43 in Pokemon Go and have caught Mewtwo
Elevated baseline levels of type 2 biomarkers predicted improved lung function and reduced exacerbation rates with dupilumab among patients with asthma
according to a study in The Journal of Allergy and Clinical Immunology: In Practice
Treatment achieved these results regardless of whether patients met guidelines for allergic asthma
professor of pneumology at Christian-Albrechts-Universität in Kiel
and director of the German Center for Lung Research
and medical director of LungenClinic Grosshansdorf
The Global Initiative for Asthma (GINA) defines type 2 inflammation as blood eosinophil counts of 150 cells/µL or greater
fractional exhaled nitric oxide counts of 20 ppb or greater
The researchers defined allergic asthma as a baseline serum total IgE of 30 IU/mL or higher and one or more perennial aeroallergen-specific IgE levels of 0.35 kU/L or higher
When patients with type 2 inflammation cannot control their asthma with high-dose inhaled corticosteroids (ICS), GINA guidelines suggest that the use of add-on biologics such as dupilumab (Dupixent
Sanofi Genzyme/Regeneron) should be considered
The phase 3 LIBERTY ASTHMA QUEST study involved 1,902 patients aged 12 years and older with moderate to severe asthma who received 200 mg or 300 mg of add-on dupilumab or a matched placebo every 2 weeks for 52 weeks
71.4% had blood eosinophil counts meeting or exceeding 150 cells/µL
60.4% had FeNO of 20 ppb or higher and 56.9% had allergic asthma
83.3% had elevated blood eosinophils or FeNO at baseline
and 91.7% had elevated eosinophils or FeNO or allergic asthma
those treated with dupilumab had fewer severe exacerbations and greater improvements in prebronchodilator FEV1 than those treated with placebo
exacerbation rates increased with increasing baseline levels of blood eosinophils
FeNO or total serum IgE among patients with allergic asthma treated with placebo but not for those treated with dupilumab
Annualized exacerbation rates fell with dupilumab treatment regardless of allergic asthma status for those patients with blood eosinophil counts of 150 cells/µL or greater (allergic asthma
those with FeNO of 20 ppb or higher (allergic asthma
0.368) and those with type 2 inflammatory asthma phenotypes (allergic asthma
the presence of allergic asthma did not impact the efficacy of dupilumab in improving prebronchodilator and postbronchodilator FEV1 in patients with elevated type 2 biomarkers at study baseline
Treatment with dupilumab led to significant increases in postbronchodilator FEV1 at every time point in the study
regardless of whether patients met criteria for allergic asthma compared with placebo
dupilumab significantly reduced rates of severe exacerbations and improved lung function among patients with a type 2 inflammatory asthma phenotype
although allergic status had no impact on outcomes
the researchers concluded that blood eosinophil and FeNO levels may be better predictors of the benefits of dupilumab treatment for moderate to severe asthma than allergy testing
Because it binds the IL-4 receptor that blocks both IL-4 and IL-13
dupilumab is known to work well in type 2 inflammatory patients with severe asthma
dupilumab is expected to work well among patients who have either increased eosinophils or increased exhaled nitric oxide or both
This can occur in conjunction with or independent of allergic status
These findings also are consistent with my prior clinical experience
Dupilumab works well independently of allergic status
Doctors should consider measuring these biomarkers
eosinophils and exhaled nitric oxide in all patients with moderate to severe asthma so they can get a more personalized
researchers should compare these results with other biologics
They also should evaluate data in nonallergic asthma and consider evaluating dupilumab’s efficacy regarding airway hyper-responsiveness
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the relevant commissions and mediation bodies in Germany reported stable figures: around 25% of 8,000 alleged medical errors investigated were indeed classified as such
the number of alleged medical errors has risen significantly every year during the last decade
with a current estimation of more than 40,000 per year
According to the most recent figures 1,380 patients suffered irreversible health damage
in 2013 the health objectives working group (Gesundheitsziele) declared patient safety to be the new national health objective
safe patient care was included in the Patient Rights Act in 2013
the highest decision-making body in German healthcare self-governance
has mandated that hospitals implement more and significant measures regarding patient safety
Modern error management is mostly based on a system-oriented approach
the entire process landscape is taken into account when prevention and continuous improvement measures are designed
An anonymous error register has been demanded for a long time
to support an error culture that promotes insights rather than punishment
risks must be clearly identified so as to influence the system towards damage prevention
The German Society for Thoracic Surgery (DGT) established a Working Group Patient Safety and Risk Management
While data analysis reported by more than 100 pneumology departments
indicated that in thoracic surgery the number of medical errors is rather low
the data did show that adverse events can be classified with regard to their risk management requirements
Most medical errors were not caused by surgeon’s poor skills but by shortcomings in documentation or communication
DGT certifies so-called ‘Thoracic centres – Competence centres for Thoracic surgery’
Hospitals that wish to obtain this voluntary certification must meet defined quality standards
Based on findings by the Working Group Risk Management
C and I were integrated into the certification specs as of 1 January 2015
This very methodical professional prevention may well serve as a blueprint for the insurer-initiated evaluation of hospital-related risks
At the surgeons’ congress DGT last year a model project for risk mitigation in lung surgery was presented
the Working Group Patient Safety and Risk Management – in collaboration with an insurance broker – published initial findings
‘The total number of alleged medical errors is 23
an extremely low risk range,’ said Dr Christian Kugler
President of DGT and Medical Director at the Department of Thoracic Surgery
‘In the lung clinics wound infections were the major issue
mostly caused by nerve damage in the thorax
‘These damages can occur when the rib cage is opened – a well-know surgery risk that’s routinely included in the pre-surgery patient information process,’ Kugler explained
The same holds true for vocal cord paralysis
which accounted for 9% of all reported alleged medical errors
Kugler: ‘Another possible adverse event in thoracic surgery is when tissue has to be removed in the vocal cord area.’
Devices that are left within the patient are a completely different problem
gauze pads or small haemostats had remained in the body after wound closure
‘This is an obvious medical error.’ Kugler concedes and recommends loud enumeration of all objects that are being inserted in the patient body
‘Two people in the operating room (OR) call out the number of objects being used loudly and clearly.’ Moreover
it is advisable to keep material taken from the patient body after the intervention in a separate container for control purposes
‘When there is profuse bleeding and a lot of material is needed
it’s very possible that the OR team lose track
or the surgeon overlooks a blood-soaked gauze pad.’ To avoid such incidents
many years ago the German Surgery Society demanded the introduction of the WHO checklists to increase patient safety in the OR
wound management and hygiene standards might go a long way
for example using the same wash and cover procedures in the OR can automatically turn into a standard,’ Kugler advised
Experts estimate between 30-50% of all hospital medical errors could be avoided
The DGT responded to the error analysis: risk management has been integrated into the certificate ‘Thoracic Centre (DGT)’
Two surgeons-in-training suggest some sustainable solutions for their energy-intensive discipline
Alcohol-based hand sanitisers have been a mainstay in hospital hygiene for decades
strains of antibiotic-resistant bacteria show signs of overcoming these handwashing agents as well
Loreen Herwaldt doesn’t believe there is a ‘gold standard’ for infection prevention
but she knows there are common sense steps that hospitals can take to prevent disease outbreaks
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2024 (GLOBE NEWSWIRE) -- Velocity Clinical Research (“Velocity”)
the leading multi-specialty clinical sites business
today announces its further expansion in Europe
adding five sites in Poland after acquiring multi-site network KO-MED Centra Kliniczne and two in Germany
having acquired The Pulmonary Research Institute at the LungenClinic Grosshansdorf and KLB Gesundheitsforschung Lübeck
Velocity’s growth is accelerating across Europe
The company is now one of the largest site organisations in Europe in addition to it being the largest sites business in the United States
“Our European network is now larger than the size of Velocity’s network when it was sold to GHO Capital
Velocity is building an integrated network of sites that can change the paradigm and we have the size and scale where we can recruit enough patients
either for entire studies or contribute significantly to country targets in Europe
This dramatically speeds up site start-up times
saving considerable time for CROs and Sponsors.”
The acquisition of KO-MED is Velocity’s first foray into Oncology research
which accounts for roughly 40-50% of clinical trials globally
KO-MED has been the leading multi-site network in Poland since 2020
having enrolled over 9,000 patients into clinical research
“I have been involved in clinical research for over 25 years and there are always new challenges which stimulate me to find new approaches
the participant of a clinical trial benefits from taking part
I’ve seen first hand when under my supervision
patients who previously had very little chance of surviving now live longer
“Being a part of Velocity is a wonderful opportunity to merge capacities with the best clinical trials network in the world
Integration rather than affiliations allows us to unite with common values
In my new role as Vice President Corporate Development (CEE) and Medical Director (CEE) together with my expertise of building out a site network
I intend to support the development of Velocity in Poland and in Europe more widely.”
The Pulmonary Research Institute has carried out over 300 studies since opening 25 years ago
MD PhD both join Velocity as principal investigators (PIs)
being leaders in Pulmonary research in Europe
“Since the beginning of our career as internal medicine doctors and pneumologists
we realised that only clinical research holds the potential for innovation
The therapeutic progress over the last 15 years in COPD
pulmonary fibrosis and asthma is a major achievement towards an improved quality of life of our patients
“With the backbone of Velocity we clearly see the unique opportunity for faster recruitment
use of common resources and infrastructure and the collaboration within a family of experienced and highly professional set of researchers
we will be able to focus more on our patients and their needs because administrative tasks will be handled by the common infrastructure backbone Velocity provides.”
KLB Gesundheitsforschung Lübeck is located in the heart of the city of Lübeck
conducting clinical studies for respiratory diseases since 2008
“We are undergoing a structural change in our working world
changing demands on employees and their redefined needs are important issues that can be better addressed through integration into a large network
Velocity brings together very experienced and highly professional study sites with comparable standards of quality and scientific work
creating many synergies from which all participants can benefit
This is what makes integration into this network so attractive
We are pleased to be part of an international company.”
The new sites join Velocity’s existing four sites in Germany
of which three are newly-opened greenfield sites
Velocity has almost 100 locations globally and access to more than 220 principal investigators and one million patients
Velocity’s sites are fully integrated via a centralised infrastructure and common technology backbone
allowing for superior patient enrolment and consistent
CROs and biopharma companies can benefit from Faster and simplified access to patients in North America and Europe
Velocity is the leading integrated site organisation for clinical trials
With nearly 100 sites and more than 220 investigators
Velocity partners with pharmaceutical and biotechnology companies to research new drugs
and combination products that could improve human health and wellbeing
Velocity offers unified research site solutions to efficiently provide the right patients
and research staff for clinical trials across the U.S
MDPhDDr Konieczny is a specialist in cardiology and internal medicine
He is the founder of the first and largest network of clinical study sites in Poland - KO-MED CK
encompassing both private research facilities within research and teaching hospitals
he drew inspiration from best practices in the United States
He established collaboration with the Medical College of Wisconsin and has been involved as a principal investigator and co-investigator in over 200 clinical study projects
Recognized for achieving the best recruitment results not only in Poland and Europe but also globally
he has been entrusted with prestigious roles as a national coordinator
earning trust backed by numerous audits and inspections
highlighting the highest quality present in KO-MED CK
Anne-Marie holds a medical degree from the University of Hamburg with a doctoral thesis focusing on nitric oxide production in human airways
After graduating she worked at the University of Mainz
of Internal Medicine and became the Head of Pulmonary Research Institute office at Krankenhaus Grosshansdorf
Since 2008 she has been the managing director of PRI
Henrik Watz studied medicine at Justus-Liebig-University
He gained additional medical qualifications from Kompetenzzentrum für klinische Studien
He was a physician at Pulmonary Research Institute at Krankenhaus Grosshansdorf before becoming managing director at PRI in 2008
he has clinical experience in Bronchial carcinoma
Dr. med. Andrea Ludwig-Sengpiel is managing partner of KLB Health Research Lübeck
she has conducted more than 180 phase I-IV clinical trials in the indications of bronchial asthma
allergic bronchopulmonary aspergillosis (ABPA) and bronchiectasis
She graduated from the University of Hamburg with a medical degree and was a research physician at Pneumologisches Forschungsinstitut am Krankenhaus Großhansdorf before becoming the managing director of KLB
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MassDevice
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
May 21, 2021 By Sean Whooley
Germany-based Neoscan’s lightweight scanner deviates from the current MRI scanners
which weigh around eight tons and need to be located on floors that can bear such weight
while also requiring more space and support equipment along with liquid helium supercooling
Neoscan’s smaller design uses digitizers and AWGs (arbitrary waveform generators) from Spectrum Instrumentation that offer sub-nano-second coherence precision to generate the scanner signals and capture results
The team at Neoscan developed a dry magnet to create a standard 1.5 Tesla field inside the scanner that doesn’t require liquid helium
cylindrical magnet generating 2.5 Tesla and an outer cylindrical magnet that counteracts the inner field
Current MRI scanners require three large racks of specifically developed electronics that the manufacturer custom designed and built
but Neoscan uses a PC with software created by the company
plus high-end measurement PC cards from Spectrum Instrumentation
Neoscan said it will be installing its first devices in German hospitals so prospective customers can observe the system as it scans babies
while the process for obtaining CE mark approval is ongoing and expected to conclude by the end of 2021
“Having worked with MRI scanners for many years, I recognized the problem,” Neoscan founder Stefan Roell said in the release
“Scanning a sick child usually means a long journey out of the ward to the scanner and babies may need support equipment that is not easily transportable
We have designed an MRI scanner specifically for newborns and infants which means that the hole in the middle is only 30cm in diameter
the scanner is much smaller (170cm x 150cm x 110cm) and can go through standard doorways
it can be installed in a spare room directly on the children’s ward
Carrying a sleeping baby only a few meters to the MRI is a big advantage
saving a long journey through the building and the need for sedatives to keep the baby motionless for the scan.”
Filed Under: Business/Financial News, Imaging, Pediatrics Tagged With: Neoscan Solutions
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In Lung Cancer, News
Progression-free survival (PFS) was improved in patients with advanced non-squamous non-small cell lung cancer (NSCLC) using a combination of Avastin (bevacizumab)
and chemotherapy in a Phase 3 clinical trial
The chemotherapy treatment used was carboplatin plus paclitaxel
Only groups B and C were compared in this presentation
Avastin is designed to inhibit the formation of new blood vessels (a process called angiogenesis) in tumors that allow them to thrive
It is hoped that combining Avastin with Tecentriq
a checkpoint inhibitor (which inhibits the molecule programmed death-ligand 1
will reinforce Tecentriq’s anti-tumor effects
Results showed that PFS in group B rose to values ranging from 7.7 to 9.8 months versus 6.0 to 7.1 months in group C
In the patients in group B who lacked gene mutations in their tumors
Serious adverse events (severe but not life-threatening) occurred in 25% of the patients in group B versus 19% in group C
“This is the first phase III trial to report on the combination of chemotherapy, antiangiogenic treatment and immunotherapy as first line treatment for advanced non-squamous NSCLC,” Martin Reck, chief oncology physician, Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany, said in a press release
“There were no new safety signals or toxicity issues with this combination so it appears to be a feasible approach for this group of patients” Reck added
The results suggest that it is possible to improve the effectiveness of chemotherapy-based treatment in patients with advanced non-squamous NSCLC through immunotherapy
“These exciting results pave the way for a new standard of care in advanced non-squamous NSCLC,” said Solange Peters, head of medical oncology, Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV)
you double the number of patients who have not progressed from 18% without immunotherapy to 37% when you add the immunotherapy,” Peters sais
the team emphasized that although the initial overall survival data looks encouraging
other trials will report results in frontline treatment-naïve NSCLC patients using the combination of chemotherapy and immunotherapy or the combination of two immunotherapy drugs
The challenge will then be to judge which strategy is the best,” Peters said
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