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$300M Fund to Back European Life Science Companies

Currency Dice

(MD4 Group, Flickr)

15 June 2017. A new investment fund plans to invest $300 million in European life science and biotechnology companies in the later stages of their product development. The fund, created and managed by life science venture capital company Medicxi, based in London and Geneva, includes contributions from drug maker Novartis, the European Investment Fund, and Verily Life Sciences, a division of Alphabet, parent company of Google.

The Medicxi Growth 1 fund aims to fill a financing gap faced by life science and biotech companies in Europe as they move from start-up into sustained growth. Medicxi says American companies in health care and biotechnology are able to find local financing for their growth stages. and the company anticipates filling that role for European enterprises.

The Medicxi Growth 1 fund expects to finance companies, either privately owned or public, with at least one asset in intermediate-stage clinical trials or later, and with a good chance of becoming an approved pharmaceutical product. Giuseppe Zocco, co-founder and partner at Medicxi, will lead the fund.

“This late-stage growth fund,” says Zocco in a company statement, “will support ambitious European entrepreneurs who are willing and able to build innovative companies through advanced clinical development and market entry, rather than pursuing a premature and generally sub-optimal early exit through partnering or M&A.”

Medicxi is an offshoot of the venture capital company Index Ventures in London and San Francisco that began sector-specific funds, including one for the life sciences in 2012, which received support from pharma companies Johnson & Johnson and GlaxoSmithKline. In February 2016, Medicxi started up its own life science fund, Medicxi 1, providing €210 million ($US 234 million) to health care and biotech start-ups in Europe.

As reported recently in Science & Enterprise, Alphabet is making more investments in life science enterprises, both through its Verily subsidiary and venture capital division, which in the past year made deals in biotechnology companies developing therapeutics, including stem cell transplants, treatments for infectious diseases, and cancer immunotherapies.

The European Investment Fund provides financing for small and medium-size enterprises in European Union countries, with capital raised on its own or provided by European Investment Bank, the EU, or member countries. The fund provides equity, loans, and micro-finance through intermediaries, like venture funds and banks, not to companies themselves.

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Disclosure: The author owns shares in Johnson & Johnson

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First Agricultural Crispr Products Expected by 2020

Cas9 protein editing a gene

Artist depiction of Cas9 protein editing a gene (Jennifer Doudna, University of California – Berkeley)

14 June 2017. While the genome editing technique known as Crispr is generating discussion in the health field, its first commercial applications are likely to be in agriculture. The 12 June issue of Chemical & Engineering News published by American Chemical Society describes the work of the company DuPont Pioneer and others with advancing applications of Crispr in agriculture.

Crispr, short for clustered regularly interspaced short palindromic repeats is a technique for editing genomes, based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The actual editing of genomes with Crispr in most cases uses an enzyme known as Crispr-associated protein 9 or Cas9. RNA molecules guide the editing enzymes to specific genes needing repair, making it possible to address root causes of many diseases, but also adjust traits in plant crops by removing or changing specific genes.

In agriculture, genome editing with Crispr makes genetic modification more systematic and precise than traditional plant breeding and even earlier genetic modification technologies. Melody Bomgardner, a senior editor at Chemical & Engineering News and the article’s author, notes that before Crispr, “the process of finding useful traits and getting them into reliable, productive plants took many years. It involved a lot of steps and was plagued by randomness.”

Crispr, says Bomgardner, not only makes genetic modification faster, simpler, and in some cases less expensive, it can also make it easier to take advantage of a plant’s natural diversity and variations, thus potentially reducing the need to import genes from other species. The result, adds Bomgarner are more efficient tools for improving yields of crops as well as, resisting disease, tolerating drought, and boosting nutrition and taste.

An early Crispr-based agricultural product, however, may be one that’s never served for dinner. A lead product in DuPont Pioneer’s pipeline is a variety of waxy corn with a high content of the compound amylopectin in its kernels. Amylopectin is one of the 2 components of starch, along with amylose, but amylopectin is more soluble in water than amylose. Thus increasing the content of amylopectin increase’s the starch’s solubility, thus making it a better candidate for food thickeners and paper adhesives.

With Crispr, DuPont Pioneer deleted the waxy gene from the corn genome, yielding a variety with 97 percent amylopectin, instead of 75 percent found in ordinary corn. The company says it usually takes several years to achieve these results with traditional breeding, but it started its Crispr program in only in 2015, in a licensing deal with Caribou Biosciences, a company founded by early Crispr researcher Jennifer Doudna at University of California, Berkeley.

The article gives other examples of R&D programs using Crispr to improve oil yield in canola and fiber strength in cotton. But food lovers will appreciate research with Crispr at Cold Spring Harbor Lab to develop a better tasting tomato.

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3-D Printed Patch Helps Grow New Blood Vessels

Heart in rib cage illustration

(CIRM.gov)

14 June 2017. A biomedical engineering team developed a printed patch infused with cells that in lab animals grows new blood vessels to counteract blocked or hardened arteries. Researchers led by Boston University engineering professor Christopher Chen published their findings in yesterday’s issue of the journal Nature Biomedical Engineering (paid subscription required).

Chen and clinical colleagues at University of Pennsylvania, Stanford University, and Brigham and Women’s Hospital in Boston, are seeking better options for patients with ischemia, where blood flow is restricted due to narrowing or hardening of arteries. When the blood flow and oxygen are impaired to heart muscles it’s known as coronary artery disease or coronary heart disease. Ischemia can also occur in blood vessels affecting the brain, leading to stroke. Gangrene can result as well when blood flow is blocked to body tissue, particularly in the limbs.

Surgery is one of the few options available to ischemia patients, but it’s not suitable for individuals that cannot tolerate the procedure, or in some cases involving smaller blood vessels. For these circumstances, Chen’s team developed a patch infused with endothelial cells, the cells lining the inside of blood vessels, to encourage  angiogenesis, the growth of new blood vessels that bypass the veins or arteries restricted by ischemia.

The researchers needed to address another issue with angiogenesis, the haphazard way new blood vessels can grow, when a more structured and organized growth pattern is needed. Chen notes in a university statement that “the new branches that sprout form a disorganized and tortuous network that looks like sort of a hairball and doesn’t allow blood to flow efficiently through it. We wanted to see if we could solve this problem by organizing them.”

The patches in the study were produced by Innolign Biomedical, a company in Philadelphia co-founded by Chen developing implanted engineered tissue to encourage blood vessel growth in people with ischemic heart disease. The company produced 2 types of patches, one with an organized structure of endothelial cells, and a second patch that simply transfers the cells into tissue. Both patches produce very small blood vessels, of about 100 microns.

The team tested the patch implants on lab rodents induced with ischemia in their hind legs or myocardial infarction, commonly known as heart attack, from blocked arteries. The results show patches with a structured cell architecture produce more new blood vessels, as well as prevent more capillary loss and muscle atrophy in the animals than the patches only transferring cells.

“One of the questions we were trying to answer is whether or not architecture of the implant mattered, and this showed us that yes, it does, which is why our unique approach using a 3D printer was important,” says Chen. “The pre-organized architecture of the patch helped to guide the formation of new blood vessels that seemed to deliver sufficient blood to the downstream tissue. While it wasn’t a full recovery, we observed functional recovery of function in the ischemic tissue.”

The researchers next plan to improve the scalability of the patch, and try different architectures to improve growth of new blood vessels.

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Brain-Computer Device Tested with Consciousness Patients

MindBeagle headgear

MindBeagle headgear (Florian Voggeneder, Guger Technologies)

13 June 2017. Tests of a device designed for people with consciousness disorders to provide basic feedback to questions show the system can elicit and capture responses from these individuals. A report of the findings of tests of the MindBeagle system conducted by its developer, Guger Technologies in Graz, Austria appear in the 5 May issue of the journal Frontiers in Neuroscience.

The MindBeagle system uses electroencephalogram or EEG signals in the brain and tactile stimulation on the skin to achieve limited communications with people having less than full consciousness, such as individuals recovering from a coma or in diseases like amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease. In these disorders, individuals lose functioning of their voluntary muscles, with at best only eye movements to indicate consciousness or respond to stimuli. The device is designed to determine if the individual can respond to clinicians’ questions, and provide a basic level of interaction.

With MindBeagle, the patient wears headgear resembling a swim cap with electrodes recording EEG signals in the brain, as well as wrist bands that vibrate. In some cases, a third vibration point is also applied to the back or shoulder. For assessments, EEG signals are first calibrated for each individual, then the wrist bands are stimulated with vibrations, with one band receiving 7 times more stimulation than the other. The patient is asked to count the number of times the lesser-stimulated wrist is vibrated. The third vibrator on the back or shoulder is a distracter, used in assessments of consciousness and functioning.

MindBeagle also works with motor imagery. In this mode, patients are asked to imagine lifting their left or right hands for a few seconds. The vibration test takes about 2.5 minutes, while the motor imagery test takes about 9 minutes. Software on an attached laptop captures and interprets the EEG signals for responses from the individuals.

In the study, the research team recruited 12 individuals with ALS at a hospital in Palermo, Italy to test the MindBeagle. The individuals had locked-in syndrome, where they lost all physical movements, including speech, but still had voluntary eye movements, as well as visual and auditory senses, while 3 of the participants had complete locked-in syndrome, including the loss of even voluntary eye movements. (The patients’ legal guardians or representatives gave consent to take part.) The team also recruited 3 healthy individuals to participate in the tests for comparison, and to ascertain the system was working properly.

The tests included assessments of consciousness, as well as responses to simple questions, all of which were completed in 20 minutes or less. The MindBeagle system was able to successfully assess the individuals’ consciousness levels more than 70 percent of the time, with 10 of the 12 participants. With answering questions, the 2 wrist bands mode was accurate on average about three-quarters of the time (77%), compared to 63 percent accuracy for the three vibration points — 2 wrist bands, plus the back or shoulder — and 58 percent for motor imagery mode. The researchers believe the longer time for the motor imagery tests, about 9 minutes, could have caused more fatigue than the shorter wrist band tests, taking 2.5 minutes.

In the following video, co-author Rossella Spataro, a neurologist with the ALS Clinical Research Center at University of Palermo, and the daughter of a patient taking part in the study tell more about the MindBeagle system.

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Supreme Court Cuts Biosimilar Waiting Time

Supreme Court

U.S. Supreme Court (A. Kotok)

13 June 2017. The U.S. Supreme Court ruled yesterday that makers of biologic drugs similar to branded originals need not wait an additional 6 months to begin marketing their products. The case is a victory for Sandoz, the generics division of pharmaceutical company Novartis, that makes a form of filgrastim, a biologic drug for cancer similar to a branded drug made by biotechnology company Amgen.

Filgrastim is given to people receiving radiation or chemotherapy to build white blood cells needed to fight infections; it’s not by itself a treatment for cancer. The drug is a naturally occurring substance made from live cells that stimulates production and release of neutrophils, a type of white blood cell made in bone marrow, to reduce the period of time when people receiving cancer treatments are most susceptible to infections.

Amgen developed filgrastim and markets the drug under the brand name Neupogen. Sandoz produces a biologically similar form of filgrastim it sells under the Zarxio brand, which was the first biosimilar drug approved by FDA in March 2015. Biosimilars, the name for this type of drug, are bioengineered replacements for the original branded drug, and not one-to-one chemical substitutes, like generic drugs. As a result, biosimilars are more complex and must show they are interchangeable with the branded drugs they seek to replace. An Associated Press story about the decision says that market prices for Zarxio are about 15 percent less than Neupogen.

In the legal cases — Amgen and Sandoz filed suits against each other — the companies argued over provisions of the Biologics Price Competition and Innovation Act, which eventually became part of the Affordable Care Act in 2010. That law lays out an abbreviated review process for biosimilars, following the 12 years of patent exclusivity given to the branded drug. One of those provisions requires the biosimilar maker, in this case Sandoz, to give a 180-day notice to the branded drug maker of its intent to market the biosimilar drug. Amgen argued that period does not begin until FDA approves the biosimilar.

The legal, policy, and scientific cases turned out to be quite complex. Writing in the legal web site Scotusblog, intellectual property lawyer John Duffy noted on the day of oral arguments before the Supreme Court in April, “Together they are a giant Russian nesting doll, a matryoshka, of complication.” Those complexities are a result of the interactions between provisions in the Biologics Price Competition and Innovation Act dealing with biosimilars and more general language in the Patent Act that governs intellectual property overall, as well as the molecular complexity of biosimilars.

The Supreme Court’s unanimous decision, written by Justice Clarence Thomas, reverses an appeals court decision in favor of Amgen, and rules that companies like Sandoz making biosimilars can give their notice of marketing to original biologic developers before FDA approves the drug. The decision, in effect, removes the 180-day waiting period, but keeps the 12-year period of patent exclusivity given to biologic developers.

Carol Lynch, who heads Sandoz’s global biopharmaceuticals division, says in a company statement, “The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments.” Neither Amgen nor Biotechnology Innovation Organization, which represents biotech companies in the U.S. and filed a friend-of-court brief in the case, issued comments.

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Institutions to Apply AI Models to Type 1 Diabetes

Diabetes devices

(stevepb, Pixabay)

12 June 2017. A children’s hospital and diabetes research center are evaluating techniques using artificial intelligence to better identify and manage the care of people with type 1 diabetes. The 3-year program is assessing a technology developed by Cyft Inc. in Cambridge, Massachusetts that derives insights for patient care from unstructured medical records in multiple sources with machine learning and related processes from artificial intelligence.

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. In 2012, about 1.25 million people in the U.S. were estimated to have type 1 diabetes, or T1D, about 5 percent of people with diabetes of any kind.

The project, funded by a grant from the Helmsley Charitable Trust, is evaluating Cyft’s technology at Children’s Mercy Kansas City and Joslin Diabetes Center, a research institute in Boston affiliated with Harvard Medical School. Cyft is a spin-off enterprise from Harvard Medical School founded with others by Leonard D’Avolio, a professor at Harvard and Brigham and Women’s Hospital. The dollar amount of the Helmsley grant was not disclosed.

“The goal of this project,” says Mark Clements, medical director for the Pediatric Clinical Research Unit at Children’s Mercy Kansas City in a Helmsley trust statement, “is to not only prove we can generate accurate T1D learning models, but also use this information to proactively improve health outcomes and impact the wider T1D community.” Clements adds that, “Advancing care for T1D has traditionally been difficult as we worked to better understand clinical and socio-demographic risk factors while also incorporating these insights into patient management strategies.”

The Cyft technology applies artificial intelligence techniques, such as machine learning and natural language processing, to analyze largely unstructured information found in electronic medical records. The company says up to half of clinically relevant information in health records is in free text form, and even structured data, such as patients’ diseases can be as much as 80 percent incorrect. Cyft uses these techniques to collect and process medical data, then construct models to find underlying patterns and provide predictive insights for medical professionals. The company says these technologies have been used successfully across a number of medical specialties including cancer prognosis, orthopedic surgery, neurosurgery, transplant surgery, and trauma care.

The study team believes these same techniques can be applied to type 1 diabetes as well. They cite earlier findings show that proactive control of blood glucose levels early in the course of the disease has a continuing influence on long-term outcomes. The researchers expect to identify clusters of factors associated with type 1 diabetes patients that can identify early those at high risk for future deterioration.

“This learning health system,” notes Sanjeev Mehta, chief medical information officer at Joslin Diabetes Center, “represents the ability to leverage the power of our data and use it to reach the patients who are most at-risk, not just for day-to-day care but to impact their health for years to come.”

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Cancer Center to Test Focused Radiation Therapy

Breast cancer clinic

(M.D. Anderson Cancer Center)

12 June 2017. MD Anderson Cancer Center is testing new radiation treatments for cancer designed to reduce adverse side effects of conventional radiation therapy. The collaboration with Convergent Radiotherapy and Radio Surgery, or CRnR Ltd., in Tirat Carmel, Israel, may eventually provide MD Anderson in Houston with milestone payments and royalties, but further financial details were not disclosed.

A team from MD Anderson, part of the University of Texas system, led by radiation physicist Mohammad Salehpour, is studying the feasibility of the Mercy Beam system developed by CRnR. The system, says the company, uses a combination of lower-energy X-ray beams that penetrate the body at a specified angle enabling the beams to converge at a designated point allowing the radiation dose to build up only in the targeted tumor area, and not in surrounding healthy tissue.

The key to the technology, says CRnR, is a converging lens reversing the usually diverging X-ray beams that decrease in intensity as distance increases from the radiation source. The lens is made of crystals in circular concentric rings that capture the diverging X-ray beams and focus the beams at a specific point, with increasing intensity as they converge. The company adds that the technology is an offshoot of techniques developed for NASA to detect radiation in space.

Conventional cancer radiation therapy employs a linear accelerator sending higher-energy X-ray beams that conform to the shape of the tumor. Doses need to be carefully monitored to make sure the patient does not receive more than safe levels of radiation. CRnR says linear accelerators require special expensive housing to prevent radiation from leaking out that Mercy Beams do not, thus making its technology potentially less costly and a better option for smaller hospitals and clinics.

At MD Anderson, Salehpour and colleagues will first evaluate Mercy Beam technology with smaller tumors, particularly in sensitive head and neck regions as well as with children, then progress to larger tumors. CRnR will provide a research chamber for the MD Anderson team to study Mercy Beams in simulations and preclinical tests. The MD Anderson researchers will also develop treatment protocols and procedures for the technology in clinical practice.

If the technology reaches beyond preclinical stages, MD Anderson will be eligible for  payments based on CRnR’s market capitalization, progress in achieving FDA approval, and royalties on sales for cancer treatments.

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Could Your Medical Business Operations Be More Efficient?

– Contributed content –

People in hallway

(Oles kanebckuu, Pexels)

12 June 2017. In business, you can often always be striving to be performing to the best of your abilities. Not only does this mean you’re going to want to be producing the best possible product or service and staying ahead of medical trends, but you also want to make sure that you’re keeping your clients happy and maximizing your profits. But, how to go about making that happen on a regular basis? You need to be able to boost your efficiency to ensure that your productivity levels are where they should be. To do that, it’s worth considering each area of your medical operations.

Customer service

Regardless of whether you produce a product for the healthcare industry, or provide a medical service, you’re going to have clients, customers, or patients that you need to keep happy. So, you need to make sure that your customer service department is running as efficiently as possible. Timescales for a response can be necessary here, meaning that you may need to hire more staff or ensure that your procedure for dealing with queries is bullet proof.

Human resources

Your staff are crucial to your operations. So, you need to make sure that you’re always hiring the right people. That can often be easier said than done, but if you really want to make sure that your human resources are as efficient as possible, you’re going to want to make sure that you have a suitable hiring process for weeding out the wrong candidates and ensuring that you hire the right ones. This may mean that you need to spend a bit of time redoing your current process, but if it makes it more efficient, it will be completely worth it.

Manufacturing

If you produce products, it will be important for you to make sure that you’re able to keep your manufacturing process as efficient as possible. If you want to keep your costs as low as possible to maximize profits, you’re going to want to be sure that errors as at a minimum. You might find that a laser micromachining service like LaserLight.com can streamline your production. But, you’re going to need to make sure you do enough research to know that it’s right for your operations.

Marketing

Your marketing department might seem as if it runs itself, but you do need to make sure that it’s really performing if you’re going to see the benefit. Not only is this department responsible for your promotions, but it can also be a huge influencer for your sales too. Being on top of healthcare marketing trends and news like these on dmn3.com can ensure that you’re doing what you can to make your marketing efforts count.

Sales

And finally, it’s time to look at your sales processes to see if you can improve them. Arguably one of your most important departments, you need to be sure that you’re accessing the right markets, customers and even the right decision makers with the efforts your team makes. Sometimes, top sales training is all that you need to see a more efficient improvement.

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Taking a Break

Lighthouse and swan

(A. Kotok)

4 June 2017. We’re taking a break, thus will not be publishing all this week. Our regular postings will resume on Monday, 12 June.

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Symptom Alerts Linked to Longer Cancer Survival

Networked devices

(Gerd Altmann, Pixabay)

4 June 2017. A clinical trial shows cancer patients using an online system to report their symptoms have somewhat longer survival times than patients not using this service. Findings from the trial appear in today’s issue of Journal of the American Medical Association, and reported yesterday at a meeting of American Society of Clinical Oncology in Chicago.

The team led by cancer specialist and researcher Ethan Basch at University of North Carolina in Chapel Hill sought to determine more key clinical benefits of using online reporting systems with cancer patients. The authors cite earlier studies showing related benefits of these systems, such as higher satisfaction and quality of life by patients, and more efficient use of emergency room resources, but overall survival time had not yet been measured.

The technology assessed in this case is the Symptom Tracking and Reporting, or STAR, system at Memorial Sloan-Kettering Cancer Center in New York. The system uses terminals in waiting rooms for patients at Memorial Sloan-Kettering arriving for chemotherapy treatments, where they can report on 12 common adverse effects as determined by National Cancer Institute, as well as quality of life and other factors. Patients can also use the STAR system over the Internet between visits. When severe or worsening symptoms are reported, an e-mail alert is sent to a clinical nurse responsible for the patient, with the symptoms listed in a report for the patient’s cancer physician.

The clinical trial evaluated the system among 766 patients receiving treatment for metastatic solid tumor cancers. Participants were randomly assigned to use the STAR system to report on their symptoms and related issues, or the usual cancer care, which included paper questionnaires. The trial looked primarily at clinical benefits and quality of life factors for patients. The study ran from 2007 to 2011, but patients could continue using the STAR system, with some patients voluntarily tracked for as long as 7 years, or until they ceased cancer care, dropped from the trial, entered hospice care, or died.

Among participants using the STAR system, the median overall survival time was 31 months, compared to a median of 26 for patients receiving the usual care. The 5 month difference in survival time was large enough to be statistically reliable. An earlier report from the trial shows greater improvements in health-related quality of life reported by participants using the system than those receiving the usual care. Participants ranged in age from 26 to 91, with a median age of 61. About 2 in 10 participants (22%) had less than a high school education and 3 in 10 (30%) were inexperienced with computers.

The authors attribute the longer survival time to more timely and responses by clinicians. Basch and colleagues report that nurses responded to e-mail alerts 77 percent of the time, with  counseling, medications, changes in chemotherapy, or other actions. Users of the STAR system also reported a longer tolerance of chemotherapy, 8.2 months on average, compared to 6.3 months for patients receiving the usual care.

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