A new Antimicrobial Resistance (AMR) Accelerator Programme as part of new Calls for proposals was launched in July by the Innovative Medicines Initiative (IMI). Of the other topics launched in the Calls, many address brain disorders (e.g. Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, major depression) and immune-mediated diseases (e.g. rheumatoid arthritis and lupus as well as inflammatory bowel diseases such as Crohn’s and colitis, and skin diseases like dermatitis and psoriasis). Among other things, the topics aim to make clinical trials more patient-centric, contribute to medicines safety, and apply blockchain technologies to the drug development and health sectors.
The Calls for proposals launched in July (IMI2 – Calls 15 and 16) have a total budget of EUR 434 million. Around half of this comes from Horizon 2020, the EU’s framework programme for research and innovation. The other half comes from EFPIA companies and IMI Associated Partners; these do not receive any funding from IMI but contribute to projects, mainly through ‘in-kind’ contributions (e.g. researchers’ time).
The aim of the new IMI AMR Accelerator is to progress the development of new medicines to treat or even prevent resistant bacterial infections in Europe and worldwide. The programme comprises three pillars. A Capability Building Network will coordinate the programme and carry out research to strengthen the scientific basis in the AMR field, while the Tuberculosis Drug Development Network will work to accelerate the discovery of new combinations of drugs to treat TB. Finally, Portfolio Building Networks will support collaborative efforts to discover, develop and advance new and innovative agents to prevent or treat AMR. The scope of the AMR Accelerator is broad; under one structure, it will address many of the scientific challenges of AMR, and it will support the development of new ways to prevent AMR (including vaccines) and treatments (including new antibiotics). More broadly, the IMI AMR Accelerator also contributes to the European action plan on AMR, which includes a chapter on boosting research, development and innovation for AMR.

A new study has found that genes cause about 1 in 10 cases of chronic kidney disease in adults, and that identifying the responsible genes has a direct impact on treatment for most of these patients.
“Our study shows that genetic testing can be used to personalize the diagnosis and management of kidney disease, and that nephrologists should consider incorporating it into the diagnostic workup for these patients,” says Ali Gharavi, MD, chief of nephrology at Columbia University Vagelos College of Physicians and Surgeons and a co-senior author of the study.
It’s estimated that 1 in 10 adults in the United States have chronic kidney disease. Yet, for 15 percent of patients with chronic kidney disease, the underlying cause of kidney failure is unknown.
“There are multiple genetic causes of chronic kidney disease, and treatment can vary depending on the cause,” says Gharavi. “And because kidney disease is often silent in the early stages, some patients aren’t diagnosed until their kidneys are close to failing, making it more difficult to find the underlying cause.”
DNA sequencing has the potential to pinpoint the genetic culprits, but has not been tested in a wide range of patients with chronic kidney disease.
“Our study identifies chronic kidney disease as the most common adult disease, outside of cancer, for which genomic testing has been demonstrated as clinically essential,” says David Goldstein, PhD, director of Columbia University’s Institute for Genomic Medicine and a co-senior author of the study.
Nearly 1 in 10 patients have a genetic kidney disorder
In this study, researchers used DNA sequencing to look for genetic kidney disorders in 3,315 individuals with various types of chronic or end-stage kidney disease. For 8.5 percent of these individuals, clinicians had not been able to identify the cause of disease.
The researchers found that a genetic disorder was responsible for about 9 percent of the participants’ kidney problems, and DNA testing reclassified the cause of kidney disease in 1 out of 5 individuals with a genetic diagnosis. In addition, DNA testing was able to pinpoint a cause for 17 percent of participants for whom a diagnosis was not possible based on the usual clinical workup.
DNA results had a direct impact on clinical care for about 85 percent of the 168 individuals who received a genetic diagnosis and had medical records available for review. “For several patients, the information we received from DNA testing changed our clinical strategy, as each one of these genetic diagnoses comes with its own set of potential complications that must be carefully considered when selecting treatments,” Gharavi says.
About half of the patients were diagnosed with a kidney disorder that also affects other organs and requires care from other specialists. A few (1.5 percent) individuals learned they had medical conditions unrelated to their kidney disease, In all of these cases, the incidental findings had an impact on kidney care. “For example, having a predisposition to cancer would modify the approach to immunosuppression for patients with a kidney transplant,” adds Gharavi.
“These results suggest that genomic sequencing can optimize the development of new medicines for kidney disease through the selection of patient subgroups most likely to benefit from new therapies,” says Adam Platt, PhD, Head of Global Genomics Portfolio at AstraZeneca and a co-senior author of the study.
Irving Medical Centerhttps://tinyurl.com/y2xct8uo

On January 17 global networks and key stakeholders discussed ECRAID and its sustainable solutions to protect Europe from antimicrobial resistance and emerging threats. Kicked off on January 17th 2019 with a high-level meeting in Brussels, PREPARE and COMBACTE have commenced the development of the business plan for ECRAID, the European Clinical Research Alliance on Infectious Diseases. ECRAID envisages a European-wide sustainable clinical research organization for infectious diseases and antimicrobial resistance that stems from both PREPARE and COMBACTE. The Kick-off Meeting opened with prominent speakers such as Marc Bonten, Coordinator of COMBACTE; Herman Goossens, Coordinator of PREPARE; Carlos Moedas, the EU Commissioner for Research, Science and Innovation; Jeremy Farrar, Director of Wellcome Trust; and Magda Chlebus, Executive Director, Science Policy & Regulatory Affairs, EFPIA. In addition, there were panel discussions with the participation of clinical research networks, such as African EDCTP-funded and Latin-America EU-funded organizations, preclinical research networks, SMEs, and pharmaceutical and diagnostic companies. ECRAID’s vision is to establish a coordinated and permanent European clinical research infrastructure for clinical research on infectious diseases. Due to their network, which is built on the foundations laid by COMBACTE (>950 clinical care sites) and PREPARE (primary care sites), ECRAID will be able to conduct clinical research faster and easier. Moreover, ECRAID will have rapid access to and knowledge of well-developed clinical and laboratory sites. Trials will be conducted continuously, allowing them to expand their experience and knowledge. ECRAID aims to protect public health by generating rigorous evidence to improve diagnosis, prevention, and treatment.  The mission is to cultivate world-class research to protect citizens of Europe against antimicrobial resistance and infectious diseases over the long-term.

IDTechEx Research has recently released a new market report ‘Technology for Diabetes Management, 2019-2029: Technology, Players and Forecasts’, including details of glucose test strips, continuous glucose monitoring (CGM), insulin pumps, insulin pens, digital health / digital therapeutics, side effect management and diagnosis.

The report covers the entire landscape for diabetes management devices, including mature, emerging and future options. The report has been researched via primary interviews with companies, physicians and diabetic individuals to characterize and predict the technology landscape for diabetes devices over the coming decade. In total, activities of 75 companies are covered throughout the report, ranging from the largest players to technology developers and startups developing the next generation of device options.

Historically, diabetics have monitored their blood glucose concentration by using disposable biosensors; following a finger prick, a drop of blood is placed onto a glucose test strip, which is inserted into a reader to provide the result. Whilst billions of test strips are produced each year, this sector as seen profitability shrink due to changing medical subsidies and increased competition. Alternative options have been developed to enable continuous glucose monitoring. These involve devices that are typically worn on the skin, using a sensor on a small needle to test glucose in interstitial fluid. There are now approved devices from several key players, with this industry growing each year.

However, challenges still remain with glucose monitoring devices, with the ultimate aim of providing the best experience for diabetics. CGM devices in the past have been reliant on test strips for calibration, as well as still being invasive or implantable, leading to discomfort. This has led to many players investigating glucose monitoring options which are less invasive, whilst maintaining the required accuracy and reliability. In addition, the possibility of pairing CGM devices with insulin pumps for increasingly automated "closed-loop" systems is becoming increasingly closer. These goals have been in place for decades, and the report follows all the latest news, trends and outlook in each of these technology frontiers around diabetes management devices.

However, managing diabetes is about more than just monitoring glucose levels. The report also covers other aspects of diabetes technology landscape, including insulin delivery, the role of digital health in diabetes, technology for managing side effects, technology for diagnosis and reimbursement, funding and investment examples. The report then includes detailed market forecast following two different methodologies. The first involves the collection of revenue data from companies throughout the space, with historic data back to 2010 by company and by sector. This is then projected given a series of assumptions based on IDTechEx’s primary research efforts. The second forecast scenario involves looking at data for the diabetic population, including number of diabetics, split by type, percentage diagnosis, and then adoption rates by device type for each group. The two forecasts are then discussed and compared, providing with the reader with ample content from which to base business decisions and understand the dynamics in the space.

As discussed, the report is split into 8 main chapters, discussing each aspect of diabetes management technology (not including pharmaceutical options). Following an executive summary, detailing the main conclusions and discussion of the report, the report introduces the challenges and opportunities in diabetes management, as well as going through the main patent holders and filing trends in the space. Then, topic chapters of the report are as follows:

• Sensors for diabetes management: This chapter includes coverage of glucose sensing, from test strips and glucometers, to continuous glucose monitoring (CGM), and through to a discussion of emerging options in this space. In total, 37 different companies are mentioned in this section, ranging from the largest players in tests strips and CGM (e.g. Abbott, Roche, Medtronic, Dexcom, etc.) through to many emerging players or innovators attempting new approaches to glucose monitoring.
• Insulin delivery: This chapter covers techniques from traditional vial-and-syringe and insulin pens, to insulin pumps and towards closed loop insulin delivery alongside CGM. Key trends discussed in this section include the integration of different connectivity and technology integrated alongside both insulin pump and insulin pens, the links from these devices into wider digital health ecosystems and the adoption of newer devices (particularly insulin pumps) by territory and demographic.
• Digital health: Chronic diseases are a prominent early target for those in the digital health ecosystem, and digital health options for diabetes have been prominent. This chapter discusses activities from both the small and larger players, including major acquisitions and collaborations, in areas including diabetes management systems, device companion software and digital therapeutics.
• Side effect management: The majority of the costs associated with diabetes are around managing side effects. This section focuses on new technology options emerging around areas such as diabetic neuropathy, foot ulcers and ketoacidosis. This includes various wearable, flexible and textile-based technology options.
• Diabetes diagnosis: discussing the use of emerging technologies to aid the early detection of diabetes, thereby preventing long hospital stays and other complications.
• Reimbursement options, funding and investment examples: These final elements to the report fill in details which are important for the broader space. Reimbursement, whether through insurers, national healthcare initiatives or otherwise, is still critical for the majority of diabetes devices. Funding and investment are also present, as with any large, transforming industry.

Over 75 companies are mentioned in the report, including many primary interviews, a patent analysis of the key patent-holders, and revenue data where relevant.

Researchers at Karolinska Institutet in Sweden have identified blood-based biomarkers that may determine which patients will benefit from continued hormonal therapy for advanced prostate cancer. The researchers envision that this discovery may eventually result in a test that contributes to a more personalized treatment of the disease.
Prostate cancer is the most common male cancer in Sweden. Approximately one in four will be diagnosed with or progress to metastatic prostate cancer. Initial systemic hormonal treatment works well for most patients with metastatic prostate cancer. But over time, the tumour develops resistance, resulting in metastatic castration-resistant prostate cancer (mCRPC).
A continued hormonal treatment for the mCRPC condition with drugs such as Zytiga (abiraterone acetate) and Xtandi (enzalutamide) provides additional clinical benefit, however not all patients respond to these treatments. Thus, in order to avoid unnecessary side effects and pharmaceutical expenses, it is necessary to identify those men who will benefit from the medicines before treatment is started.
This problem is now closer to being resolved through new results by researchers at Karolinska Institutet.
“Our method can identify patients who are likely to have a poor outcome to these treatments and therefore should be offered other alternatives, if available,” says lead author Bram De Laere, postdoc at the Department of Medical Epidemiology and Biostatistics.
The researchers’ methodology is based on an analysis of prognostic biomarkers, with known associations with therapy resistance, in the blood of patients with mCRPC.
In prostate cancer, treatment resistance can be caused by changes in genes such as the androgen receptor (AR) and a gene called TP53. Most often, these resistance markers have been studied on a one by one basis, which has led to conflicting results between independent scientific publications.
Instead, the researchers at Karolinska Institutet have developed a method for investigating all known resistance markers in AR and TP53 simultaneously. This was first done in a larger patient cohort, in a study published last year, where the researchers were able to show that individual markers in AR were not independently associated with outcome, when correcting for clinical characteristics, circulating tumour burden estimates and mutations in TP53.
They now show that in the subset of the patients without TP53 mutations, the number of AR resistance markers can indeed provide independent prognostic information.
“We see that the prognosis is poorest for men with three or more resistance markers in AR,” says Johan Lindberg, researcher at the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet, and senior author of the study. “This suggests that patients with a normal TP53 gene, without or with a small number of AR resistance markers would benefit more from continued hormonal treatment with medicines such as Zytiga and Xtandi.”
Consequently, the research group is introducing a new concept, the AR-burden – a measure of the number of treatment-relevant changes in the AR gene.
Karolinska Institutet https://tinyurl.com/y2uxy66o