Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
Open Access e-Scientific Publishing: Elected among 2018 Nature’s 10 Top Influencers – ROBERT-JAN SMITS: A bureaucrat launched a drive to transform science publishing
Science 07 Jun 2019:
Vol. 364, Issue 6444, pp. 919
DOI: 10.1126/science.364.6444.919
Plan S, the program to crack down on scientific journals’ paywalls led by European funders, last week fleshed out and relaxed some of the rules researchers will have to abide by. The update addresses concerns raised by researchers, librarians, and scientific publishers after initial guidelines came out in November 2018. It allows more time before researchers will have to publish their papers with full, immediate open access (OA) and drops, for now, the proposed cap on publishing fees that funders pay to OA journals.
The architects of Plan S “have engaged in a good quality dialogue” with the people who will deal with the plan’s consequences, says Lidia Borrell-Damián, director for research and innovation at the European University Association in Brussels. As a result, the revised guidelines seem “much more nuanced and more realistic” than the initial set, says astrophysicist Luke Drury, former president of the Royal Irish Academy in Dublin.
Still unclear is whether the changes will convince other funders to join the movement (Science, 4 January, p. 11). And they have not mollified the plan’s fiercest detractors, who maintain it restricts their freedom to publish. “The changes are cosmetic and trivial. They more or less ignored the critique,” says Lynn Kamerlin, a structural biologist at Uppsala University in Sweden who co-authored an open letter against Plan S in November 2018 that now has about 1800 signatories.
Launched in September 2018, Plan S will require immediate OA for scientific papers stemming from research funded by the members of cOAlition S, a group that now has 19 public and private funders. One of the main changes in the update is a 1-year extension: Plan S rules will apply at the latest to research proposals solicited by funders starting in 2021, instead of 2020. That means the mandate will apply to papers published starting in 2022 or 2023, John-Arne Røttingen, chief executive of the Research Council of Norway in Oslo and a Plan S leader, said last week.
In another big change that several critics had called for, Plan S has shelved the idea of capping the amount funders will pay for article-processing charges (APCs), which some journals charge to publish OA articles. Instead, the funders will require a breakdown of what’s behind APCs so that researchers can compare publishing venues before choosing one. (The funders may later introduce a cap “if unreasonable price levels are observed.”)
“It is significant that cOAlition S listened to feedback that different approaches to peer review, as part of publishing, require different APCs,” said Bill Moran, publisher of Science in Washington, D.C. (Science‘s News section is editorially independent.)
Many publishers are happy to provide transparency about their fees, says Niamh O’Connor, chair-elect of the Association of Learned and Professional Society Publishers in London. “It’s not uncommon for authors or referees to wonder about them.”
Plan S funders hope more transparency will help authors make efficient, evidence-based decisions about where to publish, rather than relying on journals’ perceived quality. That would support a secondary goal for cOAlition S—to shake up research assessment. Plan S now includes a pledge to base funding decisions on the intrinsic merit of researchers’ work—not the names or impact factors of journals where they published previously.
The revised guidelines also spell out Plan S funders’ support for the Open Access 2020 Initiative, which encourages national consortia of institutions to negotiate “read-and-publish” deals with publishers. The agreements allow researchers at those institutions to read paywalled content and publish OA papers for a single fee. But because the often-lengthy contract negotiations can be burdensome for publishers, cOAlition S now says it will develop model contracts to help smaller publishers enter these so-called “transformative agreements.” It also now offers a “transformative journal” option, in which Plan S funders pay OA fees for authors to publish in subscription journals, providing those publications reduce subscription fees to offset their income from APCs and commit to 100% OA within an agreed time frame.
The updated guidance also clarifies Plan S’s stance on hybrid journals—publications that charge subscription fees as well as APCs for authors who choose to publish OA—that lack the “transformative” commitment to full OA. The cOAlition S funders won’t pay hybrid journals’ APCs, but researchers can pay with other funds and remain Plan S compliant.
Finally, Plan S’s revamped rules give more prominence to its version of “green” OA, in which scientists post peer-reviewed papers in OA repositories (Science, 17 May, p. 620) as soon as they are published in a paywalled journal. The new guidelines also relax the technical requirements for such repositories.
Overall, cOAlition S “really seem[s] to have listened to the research community. There are no major sticking points anymore,” says Gareth O’Neill, a linguist at Leiden University in the Netherlands and past president of the European Council of Doctoral Candidates and Junior Researchers. “Now, we’ll watch them, see what works and what doesn’t, and hold them accountable.”
The editorial board of an influential scientometrics journal — the Journal of Informetrics — has resigned and launched a competing free-to-read journal. The board wanted Elsevier to offer free access to detailed citation data, among other things. “Elsevier needs to be able to continue investing in ways that add value to the research process, which it cannot do if it gives this value away for free,” said the publisher. The former editors have launched a competing free-to-read journal called Quantitative Science Studies.
ROBERT-JAN SMITS: Open-access leader: A bureaucrat launched a drive to transform science publishing.
BY HOLLY ELSE
Credit: Artur Eranosian/European Commission
The architect of this year’s bold push to get rid of paywalls in science publishing says he got his ideas from an unlikely source: the publishers themselves.
In March, Robert-Jan Smits was tasked by the European Union’s research commissioner, Carlos Moedas, with a special one-year mission: to get more research papers published outside journal paywalls, and fast. A veteran science-policy bureaucrat, Smits decided to go to the source: he asked big publishers how he could do it. They told him that if the organizations that pay for research insisted the findings had to be published openly, journals would have to adapt.
So that’s what Smits set out to persuade research funders to do — in a plan launched in September that has sent shock waves through science publishing.
Smits has spent decades pulling the science-policy strings at the European Commission, and, until his current assignment, had served eight years as the director-general of research. He was ideally connected to begin rallying Europe’s agencies with the idea, dubbed Plan S for ‘science, speed, solution, shock’, as he puts it. As Nature went to press, 16 funders had signed the plan; they require that the results of work they support be made freely available at the time of publication, starting in 2020.
Publishers have been dictating how research is published for decades, Smits says. “Now it is the funders calling the shots, and we will do things differently.”
It’s too early to know what the ultimate impact of Plan S on research publishing will be. Its details are open for consultation, and much might depend on how many other funders adopt the idea — but it will at least improve access to research, says Peter Suber, director of the Harvard Open Access Project and the Harvard Office for Scholarly Communication in Cambridge, Massachusetts. Smits has been overwhelmed with messages of support. But the initiative has also met with resistance: several publishers have said it could put them out of business, and some researchers have said that they don’t want their choice of where to publish to be restricted.
Smits is no stranger to disrupting the status quo in European science. In 2007, he was instrumental in setting up the excellence-focused European Research Council (ERC) funding agency — when, he says, very few member states wanted it. “We had to go country by country to convince people that we needed it,” he says.
Those who have worked with Smits are not surprised by his ability to get consensus on controversial policies. “Robert-Jan has a fantastic memory, of people, events, documents, policies. His networking capacity is spectacular,” says Helga Nowotny, a former president of the ERC.
Smits’ short tenure as open-access tsar is almost over. Next year, he will leave to become chair of the Eindhoven University of Technology in his native Netherlands. “It’s time for me to leave the commission at what I consider my height,” he says.
Other Related articles published in this Open Access Online Journal include the following:
University of California accounts for nearly 10% of all published research in the United States. It’s also a significant partner of Elsevier, which publishes about 18% of all UC output and collects more than 25% of the university’s $40-million overall subscription budget.
‘Plan S’ of Eleven research funders in Europe will make all scientific works free to read as soon as they are published – New policy if adopted could determine the Future of Global Journal Subscription as doomed
e-Scientific Publishing: The Competitive Advantage of a Powerhouse for Curation of Scientific Findings and Methodology Development for e-Scientific Publishing – LPBI Group, A Case in Point
Innovations in electronic Scientific Publishing (eSP): Case Studies in Marketing eContent, Curation Methodology, Categories of Research Functions, Interdisciplinary conceptual innovations by Cross Section of Categories, Exposure to Frontiers of Science by Real Time Press coverage of Scientific Conferences
Over the past 20 years, studies have shown that girls and possibly boys have been experiencing puberty at progressively younger ages. This is troubling news, as earlier age at puberty has been linked with increased risk of mental illness, breast and ovarian cancer in girls and testicular cancer in boys. Researchers found that daughters of mothers who had higher levels of diethyl phthalate and triclosan in their bodies during pregnancy experienced puberty at younger ages. The same trend was not observed in boys. So, researchers suspected that girls exposed to chemicals commonly found in toothpaste, makeup, soap and other personal care products before birth may hit puberty earlier.
Diethyl phthalate is often used as a stabilizer in fragrances and cosmetics. The antimicrobial agent triclosan — which the FDA banned from use in hand soap in 2017 because it was shown to be ineffective — is still used in some toothpastes. Researchers suspected that many chemicals in personal care products can interfere with natural hormones in human bodies, and studies have shown that exposure to these chemicals can alter reproductive development in rats. Chemicals that have been implicated include phthalates, which are often found in scented products like perfumes, soaps and shampoos; parabens, which are used as preservatives in cosmetics; and phenols, which include triclosan.
However, few studies have looked at how these chemicals might affect the growth of human children. This present study at UC Berkeley, USA recruited pregnant women living in the farm-working, primarily Latino communities of Central California’s Salinas Valley between 1999 and 2000. While the primary aim of the study was to examine the impact of pesticide exposure on childhood development, the researchers used the opportunity to examine the effects of other chemicals as well. The scientists measured concentrations of phthalates, parabens and phenols in urine samples taken from mothers twice during pregnancy, and from children at the age of 9. They then followed the growth of the children — 159 boys and 179 girls — between the ages of 9 and 13 to track the timing of developmental milestones marking different stages of puberty.
The vast majority — more than 90 percent — of urine samples of both mothers and children showed detectable concentrations of all three classes of chemicals, with the exception of triclosan which was present in approximately 70 percent of samples. The researchers found that every time the concentrations of diethyl phthalate and triclosan in the mother’s urine doubled, the timing of developmental milestones in girls shifted approximately one month earlier. Girls who had higher concentrations of parabens in their urine at age 9 also experienced puberty at younger ages. However, it is unclear if the chemicals were causing the shift, or if girls who reached puberty earlier were more likely to start using personal care products at younger ages.
The limitations are that these chemicals are quickly metabolized and one to two urinary measurements per developmental point may not accurately reflect usual exposure. The study population was limited to Latino children of low socioeconomic status living in a farmworker community and may not be widely generalizable. But, this study contributes to a growing literature that suggests that exposure to certain endocrine disrupting chemicals may impact timing of puberty in children.
Micronutrients, Macronutrients and Dietary Patterns: Nutrition and Fertility
Reporter: Aviva Lev-Ari, PhD, RN
Folic acid.Folic acid is important for germ cell production and pregnancy. The recommended daily dose to prevent neural tube defects is 400-800 µg. Women who take folic acid-containing multivitamins are less likely to be anovulatory, and the time to achieve a pregnancy is reduced. Those who consume more than 800 µg of folic acid daily are more likely to conceive with assisted reproductive technology (ART) than those whose daily intake is less than 400 µg.
Vitamin D. Vitamin D may affect fertility through receptors found in the ovaries and endometrium. An extremely low vitamin D level (< 20 ng/mL) is associated with higher risk for spontaneous miscarriage risk. Some reports suggest that women with adequate vitamin D levels (> 30 ng/mL) are more likely to conceive after ART when compared with those whose vitamin D levels are insufficient (20-30 ng/mL), or deficient (< 20 ng/mL). These findings, however, are inconclusive.
Carbohydrates. Dietary carbohydrates affect glucose homeostasis and insulin sensitivity, and by these mechanisms can affect reproduction. The impact is most pronounced among women with polycystic ovary syndrome (PCOS). In women with PCOS, a reduction in glycemic load improves insulin sensitivity as well as ovulatory function. Whole grains have antioxidant effects and also improve insulin sensitivity, thereby positively influencing reproduction.
Omega-3 supplements. Omega-3 polyunsaturated fatty acids lower the risk for endometriosis. Increased levels of omega-3 polyunsaturated fatty acids are associated with higher clinical pregnancy and live birth rates.
Protein and dairy. Some reports suggest that dairy protein intake lowers ovarian reserve. Other reports suggest improved ART outcomes with increased dairy intake. Meat, fish, and dairy products, however, can also serve as vehicles for environmental contamination that may adversely affect the embryo. Fish, on the other hand, has been shown to exert positive effects on fertility.
Dietary approach. In general, a Mediterranean diet is favored (high intake of fruits, vegetables, fish, chicken, and olive oil) among women diagnosed with infertility.
Recommendations
A well-balanced diet, rich in vegetables and fruits, is preferred for infertile women and should provide the required micro- and macronutrients. It remains common for patients consume a wide variety of vitamin, mineral, and micronutrient supplements daily.[4] Supplements should not replace food sources of vitamins and trace elements because of differences in bioavailability (natural versus synthetic), and inaccuracy of label declarations may result in suboptimal intake of important nutrients.[5,6] Furthermore, naturally occurring vitamins and micronutrients are more efficiently absorbed.
With respect to overall diet, women are advised to follow a caloric intake that won’t contribute to being overweight or obese. Obesity is on the rise among younger people, including children. Obese women have a lower chance of conceiving and are less likely to have an uncomplicated pregnancy.[7] Proper weight can be maintained with an appropriate diet and regular exercise.
Finally, women must abstain from substances that are potentially harmful to pregnancy (eg, smoking, alcohol, recreational drugs, high caffeine intake).
Causes of Infertility
ovulatory defect,
tubal occlusion,
low sperm counts), and many
Factors lower the chance of pregnancy
older age,
lower ovarian reserve,
endometriosis
Factors can’t be altered
age and
ovarian reserve
Modifiable Factors:
body weight and
lifestyle habits
REFERENCES
Zinaman MJ, Clegg ED, Brown CC, O’Connor J, Selevan SG. Estimates of human fertility and pregnancy loss. Fertil Steril. 1996;65:503-509. Abstract
Practice Committee of American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013;99:63. Abstract
Chiu YH, Chavarro JE, Souter I. Diet and female fertility: doctor, what should I eat? Fertil Steril. 2018;110:560-569. Abstract
Kantor ED, Rehm CD, Du M, White E, Giovannucci EL. Trends in dietary supplement use among US adults from 1999-2012. JAMA. 2016;316:1464-1474. Abstract
Carr AC, Vissers MC. Synthetic or food-derived vitamin C—are they equally bioavailable? Nutrients. 2013;5:4284-4304. Abstract
Yetley EA. Multivitamin and multimineral dietary supplements: definitions, characterization, bioavailability, and drug interactions. Am J Clin Nutr. 2007;85:269S-276S. Abstract
Practice Committee of American Society for Reproductive Medicine. Obesity and reproduction: an educational bulletin. Fertil Steril. 2008;90(5 Suppl):S21-S29. Abstract
Can Blockchain Technology and Artificial Intelligence Cure What Ails Biomedical Research and Healthcare, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)
Can Blockchain Technology and Artificial Intelligence Cure What Ails Biomedical Research and Healthcare
Curator: Stephen J. Williams, Ph.D.
Updated 12/18/2018
In the efforts to reduce healthcare costs, provide increased accessibility of service for patients, and drive biomedical innovations, many healthcare and biotechnology professionals have looked to advances in digital technology to determine the utility of IT to drive and extract greater value from healthcare industry. Two areas of recent interest have focused how best to use blockchain and artificial intelligence technologies to drive greater efficiencies in our healthcare and biotechnology industries.
More importantly, with the substantial increase in ‘omic data generated both in research as well as in the clinical setting, it has become imperative to develop ways to securely store and disseminate the massive amounts of ‘omic data to various relevant parties (researchers or clinicians), in an efficient manner yet to protect personal privacy and adhere to international regulations. This is where blockchain technologies may play an important role.
A recent Oncotarget paper by Mamoshina et al. (1) discussed the possibility that next-generation artificial intelligence and blockchain technologies could synergize to accelerate biomedical research and enable patients new tools to control and profit from their personal healthcare data, and assist patients with their healthcare monitoring needs. According to the abstract:
The authors introduce new concepts to appraise and evaluate personal records, including the combination-, time- and relationship value of the data. They also present a roadmap for a blockchain-enabled decentralized personal health data ecosystem to enable novel approaches for drug discovery, biomarker development, and preventative healthcare. In this system, blockchain and deep learning technologies would provide the secure and transparent distribution of personal data in a healthcare marketplace, and would also be useful to resolve challenges faced by the regulators and return control over personal data including medical records to the individual.
The review discusses:
Recent achievements in next-generation artificial intelligence
Basic concepts of highly distributed storage systems (HDSS) as a preferred method for medical data storage
Open source blockchain Exonium and its application for healthcare marketplace
A blockchain-based platform allowing patients to have control of their data and manage access
How advances in deep learning can improve data quality, especially in an era of big data
Advances in Artificial Intelligence
Integrative analysis of the vast amount of health-associated data from a multitude of large scale global projects has proven to be highly problematic (REF 27), as high quality biomedical data is highly complex and of a heterogeneous nature, which necessitates special preprocessing and analysis.
Increased computing processing power and algorithm advances have led to significant advances in machine learning, especially machine learning involving Deep Neural Networks (DNNs), which are able to capture high-level dependencies in healthcare data. Some examples of the uses of DNNs are:
Prediction of drug properties(2, 3) and toxicities(4)
Generative Adversarial Networks (https://arxiv.org/abs/1406.2661): requires good datasets for extensive training but has been used to determine tumor growth inhibition capabilities of various molecules (7)
Recurrent neural Networks (RNN): Originally made for sequence analysis, RNN has proved useful in analyzing text and time-series data, and thus would be very useful for electronic record analysis. Has also been useful in predicting blood glucose levels of Type I diabetic patients using data obtained from continuous glucose monitoring devices (8)
Transfer Learning: focused on translating information learned on one domain or larger dataset to another, smaller domain. Meant to reduce the dependence on large training datasets that RNN, GAN, and DNN require. Biomedical imaging datasets are an example of use of transfer learning.
One and Zero-Shot Learning: retains ability to work with restricted datasets like transfer learning. One shot learning aimed to recognize new data points based on a few examples from the training set while zero-shot learning aims to recognize new object without seeing the examples of those instances within the training set.
Highly Distributed Storage Systems (HDSS)
The explosion in data generation has necessitated the development of better systems for data storage and handling. HDSS systems need to be reliable, accessible, scalable, and affordable. This involves storing data in different nodes and the data stored in these nodes are replicated which makes access rapid. However data consistency and affordability are big challenges.
Blockchain is a distributed database used to maintain a growing list of records, in which records are divided into blocks, locked together by a crytosecurity algorithm(s) to maintain consistency of data. Each record in the block contains a timestamp and a link to the previous block in the chain. Blockchain is a distributed ledger of blocks meaning it is owned and shared and accessible to everyone. This allows a verifiable, secure, and consistent history of a record of events.
Data Privacy and Regulatory Issues
The establishment of the Health Insurance Portability and Accountability Act (HIPAA) in 1996 has provided much needed regulatory guidance and framework for clinicians and all concerned parties within the healthcare and health data chain. The HIPAA act has already provided much needed guidance for the latest technologies impacting healthcare, most notably the use of social media and mobile communications (discussed in this article Can Mobile Health Apps Improve Oral-Chemotherapy Adherence? The Benefit of Gamification.). The advent of blockchain technology in healthcare offers its own unique challenges however HIPAA offers a basis for developing a regulatory framework in this regard. The special standards regarding electronic data transfer are explained in HIPAA’s Privacy Rule, which regulates how certain entities (covered entities) use and disclose individual identifiable health information (Protected Health Information PHI), and protects the transfer of such information over any medium or electronic data format. However, some of the benefits of blockchain which may revolutionize the healthcare system may be in direct contradiction with HIPAA rules as outlined below:
Issues of Privacy Specific In Use of Blockchain to Distribute Health Data
Blockchain was designed as a distributed database, maintained by multiple independent parties, and decentralized
Linkage timestamping; although useful in time dependent data, proof that third parties have not been in the process would have to be established including accountability measures
Blockchain uses a consensus algorithm even though end users may have their own privacy key
Applied cryptography measures and routines are used to decentralize authentication (publicly available)
Blockchain users are divided into three main categories: 1) maintainers of blockchain infrastructure, 2) external auditors who store a replica of the blockchain 3) end users or clients and may have access to a relatively small portion of a blockchain but their software may use cryptographic proofs to verify authenticity of data.
YouTube video on How #Blockchain Will Transform Healthcare in 25 Years (please click below)
In Big Data for Better Outcomes, BigData@Heart, DO->IT, EHDN, the EU data Consortia, and yes, even concepts like pay for performance, Richard Bergström has had a hand in their creation. The former Director General of EFPIA, and now the head of health both at SICPA and their joint venture blockchain company Guardtime, Richard is always ahead of the curve. In fact, he’s usually the one who makes the curve in the first place.
Please click on the following link for a podcast on Big Data, Blockchain and Pharma/Healthcare by Richard Bergström:
Mamoshina, P., Ojomoko, L., Yanovich, Y., Ostrovski, A., Botezatu, A., Prikhodko, P., Izumchenko, E., Aliper, A., Romantsov, K., Zhebrak, A., Ogu, I. O., and Zhavoronkov, A. (2018) Converging blockchain and next-generation artificial intelligence technologies to decentralize and accelerate biomedical research and healthcare, Oncotarget9, 5665-5690.
Aliper, A., Plis, S., Artemov, A., Ulloa, A., Mamoshina, P., and Zhavoronkov, A. (2016) Deep Learning Applications for Predicting Pharmacological Properties of Drugs and Drug Repurposing Using Transcriptomic Data, Molecular pharmaceutics13, 2524-2530.
Wen, M., Zhang, Z., Niu, S., Sha, H., Yang, R., Yun, Y., and Lu, H. (2017) Deep-Learning-Based Drug-Target Interaction Prediction, Journal of proteome research16, 1401-1409.
Gao, M., Igata, H., Takeuchi, A., Sato, K., and Ikegaya, Y. (2017) Machine learning-based prediction of adverse drug effects: An example of seizure-inducing compounds, Journal of pharmacological sciences133, 70-78.
Putin, E., Mamoshina, P., Aliper, A., Korzinkin, M., Moskalev, A., Kolosov, A., Ostrovskiy, A., Cantor, C., Vijg, J., and Zhavoronkov, A. (2016) Deep biomarkers of human aging: Application of deep neural networks to biomarker development, Aging8, 1021-1033.
Vandenberghe, M. E., Scott, M. L., Scorer, P. W., Soderberg, M., Balcerzak, D., and Barker, C. (2017) Relevance of deep learning to facilitate the diagnosis of HER2 status in breast cancer, Scientific reports7, 45938.
Kadurin, A., Nikolenko, S., Khrabrov, K., Aliper, A., and Zhavoronkov, A. (2017) druGAN: An Advanced Generative Adversarial Autoencoder Model for de Novo Generation of New Molecules with Desired Molecular Properties in Silico, Molecular pharmaceutics14, 3098-3104.
Ordonez, F. J., and Roggen, D. (2016) Deep Convolutional and LSTM Recurrent Neural Networks for Multimodal Wearable Activity Recognition, Sensors (Basel)16.
December 5, 2018 | The boom of blockchain and distributed ledger technologies have inspired healthcare organizations to test the capabilities of their data. Quest Diagnostics, in partnership with Humana, MultiPlan, and UnitedHealth Group’s Optum and UnitedHealthcare, have launched a pilot program that applies blockchain technology to improve data quality and reduce administrative costs associated with changes to healthcare provider demographic data.
The collective body, called Synaptic Health Alliance, explores how blockchain can keep only the most current healthcare provider information available in health plan provider directories. The alliance plans to share their progress in the first half of 2019.
Providing consumers looking for care with accurate information when they need it is essential to a high-functioning overall healthcare system, Jason O’Meara, Senior Director of Architecture at Quest Diagnostics, told Clinical Informatics News in an email interview.
“We were intentional about calling ourselves an alliance as it speaks to the shared interest in improving health care through better, collaborative use of an innovative technology,” O’Meara wrote. “Our large collective dataset and national footprints enable us to prove the value of data sharing across company lines, which has been limited in healthcare to date.”
O’Meara said Quest Diagnostics has been investing time and resources the past year or two in understanding blockchain, its ability to drive purpose within the healthcare industry, and how to leverage it for business value.
“Many health care and life science organizations have cast an eye toward blockchain’s potential to inform their digital strategies,” O’Meara said. “We recognize it takes time to learn how to leverage a new technology. We started exploring the technology in early 2017, but we quickly recognized the technology’s value is in its application to business to business use cases: to help transparently share information, automate mutually-beneficial processes and audit interactions.”
Quest began discussing the potential for an alliance with the four other companies a year ago, O’Meara said. Each company shared traits that would allow them to prove the value of data sharing across company lines.
“While we have different perspectives, each member has deep expertise in healthcare technology, a collaborative culture, and desire to continuously improve the patient/customer experience,” said O’Meara. “We also recognize the value of technology in driving efficiencies and quality.”
Following its initial launch in April, Synaptic Health Alliance is deploying a multi-company, multi-site, permissioned blockchain. According to a whitepaper published by Synaptic Health, the choice to use a permissioned blockchain rather than an anonymous one is crucial to the alliance’s success.
“This is a more effective approach, consistent with enterprise blockchains,” an alliance representative wrote. “Each Alliance member has the flexibility to deploy its nodes based on its enterprise requirements. Some members have elected to deploy their nodes within their own data centers, while others are using secured public cloud services such as AWS and Azure. This level of flexibility is key to growing the Alliance blockchain network.”
As the pilot moves forward, O’Meara says the Alliance plans to open ability to other organizations. Earlier this week Aetna and Ascension announced they joined the project.
“I am personally excited by the amount of cross-company collaboration facilitated by this project,” O’Meara says. “We have already learned so much from each other and are using that knowledge to really move the needle on improving healthcare.”
November 29, 2018 | The US Department of Health and Human Services (HHS) is making waves in the blockchain space. The agency’s Division of Acquisition (DA) has developed a new system, called Accelerate, which gives acquisition teams detailed information on pricing, terms, and conditions across HHS in real-time. The department’s Associate Deputy Assistant Secretary for Acquisition, Jose Arrieta, gave a presentation and live demo of the blockchain-enabled system at the Distributed: Health event earlier this month in Nashville, Tennessee.
Accelerate is still in the prototype phase, Arrieta said, with hopes that the new system will be deployed at the end of the fiscal year.
HHS spends around $25 billion a year in contracts, Arrieta said. That’s 100,000 contracts a year with over one million pages of unstructured data managed through 45 different systems. Arrieta and his team wanted to modernize the system.
“But if you’re going to change the way a workforce of 20,000 people do business, you have to think your way through how you’re going to do that,” said Arrieta. “We didn’t disrupt the existing systems: we cannibalized them.”
The cannibalization process resulted in Accelerate. According to Arrieta, the system functions by creating a record of data rather than storing it, leveraging machine learning, artificial intelligence (AI), and robotic process automation (RPA), all through blockchain data.
“We’re using that data record as a mechanism to redesign the way we deliver services through micro-services strategies,” Arrieta said. “Why is that important? Because if you have a single application or data use that interfaces with 55 other applications in your business network, it becomes very expensive to make changes to one of the 55 applications.”
Accelerate distributes the data to the workforce, making it available to them one business process at a time.
“We’re building those business processes without disrupting the existing systems,” said Arrieta, and that’s key. “We’re not shutting off those systems. We’re using human-centered design sessions to rebuild value exchange off of that data.”
The first application for the system, Arrieta said, can be compared to department stores price-matching their online competitors.
It takes the HHS close to a month to collect the amalgamation of data from existing system, whether that be terms and conditions that drive certain price points, or software licenses.
“The micro-service we built actually analyzes that data, and provides that information to you within one second,” said Arrieta. “This is distributed to the workforce, to the 5,000 people that do the contracting, to the 15,000 people that actually run the programs at [HHS].”
This simple micro-service is replicated on every node related to HHS’s internal workforce. If somebody wants to change the algorithm to fit their needs, they can do that in a distributed manner.
Arrieta hopes to use Accelerate to save researchers money at the point of purchase. The program uses blockchain to simplify the process of acquisition.
“How many of you work with the federal government?” Arrieta asked the audience. “Do you get sick of reentering the same information over and over again? Every single business opportunity you apply for, you have to resubmit your financial information. You constantly have to check for validation and verification, constantly have to resubmit capabilities.”
Wouldn’t it be better to have historical notes available for each transaction? said Arrieta. This would allow clinical researchers to be able to focus on “the things they’re really good at,” instead of red tape.
“If we had the top cancer researcher in the world, would you really want her spending her time learning about federal regulations as to how to spend money, or do you want her trying to solve cancer?” Arrieta said. “What we’re doing is providing that data to the individual in a distributed manner so they can read the information of historical purchases that support activity, and they can focus on the objectives and risks they see as it relates to their programming and their objectives.”
Blockchain also creates transparency among researchers, Arrieta said, which says creates an “uncomfortable reality” in the fact that they have to make a decision regarding data, fundamentally changing value exchange.
“The beauty of our business model is internal investment,” Arrieta said. For instance, the HHS could take all the sepsis data that exists in their system, put it into a distributed ledger, and share it with an external source.
“Maybe that could fuel partnership,” Arrieta said. “I can make data available to researchers in the field in real-time so they can actually test their hypothesis, test their intuition, and test their imagination as it relates to solving real-world problems.”
Blockchain-based genomic data hub platform Shivom recently reached its $35 million hard cap within 15 seconds of opening its main token sale. Shivom received funding from a number of crypto VC funds, including Collinstar, Lateral, and Ironside.
The goal is to create the world’s largest store of genomic data while offering an open web marketplace for patients, data donors, and providers — such as pharmaceutical companies, research organizations, governments, patient-support groups, and insurance companies.
“Disrupting the whole of the health care system as we know it has to be the most exciting use of such large DNA datasets,” Shivom CEO Henry Ines told me. “We’ll be able to stratify patients for better clinical trials, which will help to advance research in precision medicine. This means we will have the ability to make a specific drug for a specific patient based on their DNA markers. And what with the cost of DNA sequencing getting cheaper by the minute, we’ll also be able to sequence individuals sooner, so young children or even newborn babies could be sequenced from birth and treated right away.”
While there are many solutions examining DNA data to explain heritage, intellectual capabilities, health, and fitness, the potential of genomic data has largely yet to be unlocked. A few companies hold the monopoly on genomic data and make sizeable profits from selling it to third parties, usually without sharing the earnings with the data donor. Donors are also not informed if and when their information is shared, nor do they have any guarantee that their data is secure from hackers.
Shivom wants to change that by creating a decentralized platform that will break these monopolies, democratizing the processes of sharing and utilizing the data.
“Overall, large DNA datasets will have the potential to aid in the understanding, prevention, diagnosis, and treatment of every disease known to mankind, and could create a future where no diseases exist, or those that do can be cured very easily and quickly,” Ines said. “Imagine that, a world where people do not get sick or are already aware of what future diseases they could fall prey to and so can easily prevent them.”
Shivom’s use of blockchain technology and smart contracts ensures that all genomic data shared on the platform will remain anonymous and secure, while its OmiX token incentivizes users to share their data for monetary gain.
Blockchain will secure the DNA database for 50 million citizens in the eighth-largest state in India. The government of Andhra Pradesh signed a Memorandum of Understanding with a German genomics and precision medicine start-up, Shivom, which announced to start the pilot project soon. The move falls in line with a trend for governments turning to population genomics, and at the same time securing the sensitive data through blockchain.
Andhra Pradesh, DNA, and blockchain
Storing sensitive genetic information safely and securely is a big challenge. Shivom builds a genomic data-hub powered by blockchain technology. It aims to connect researchers with DNA data donors thus facilitating medical research and the healthcare industry.
With regards to Andhra Pradesh, the start-up will first launch a trial to determine the viability of their technology for moving from a proactive to a preventive approach in medicine, and towards precision health. “Our partnership with Shivom explores the possibilities of providing an efficient way of diagnostic services to patients of Andhra Pradesh by maintaining the privacy of the individual data through blockchain technologies,” said J A Chowdary, IT Advisor to Chief Minister, Government of Andhra Pradesh.
Other Articles in this Open Access Journal on Digital Health include:
Non pure motives for pushing recertification: The American Board of Internal Medicine attempted to expand its recertification process and keep its medical monopoly that abuses its immense power.
Reporter: Aviva Lev-Ari, PhD, RN
“It is incumbent upon The American Board of Internal Medicine (ABIM) and/or the American Board of Medical Specialties (ABMS) to engage a respected independent party to assess the impact of The Maintenance of Certification, (MOC) program and make the findings publicly available” required by The American College of Rheumatology
ABIM’s survival as a medical monopoly that abuses its immense power seems less probable with each passing day. And, because of its arrogance and the appearance of corruption it allowed to metastasize inside the organization, the officials there have no one to blame but themselves.
It’s a horror story that has played out for years throughout the U.S. as the ABIM abuses its monopoly power to force doctors to do whatever it decrees, while ignoring the many doctors who have demanded for years that independent researchers conduct comprehensive studies to determine if ABIM’s requirements do anything to improve patient care. This medical protection racket has made millionaires of ABIM top officers, financed a ritzy condominium, limousines and first-class travel, all while sucking huge sums of cash out of the health care system.
But now, after decades of unchecked rule by ABIM, cracks are appearing in the organization’s facade of power. Thousands of doctors began a widespread revolt months ago and, in the last few weeks, evidence that their efforts are succeeding has started rolling in. ABIM officials have proclaimed that they are rushing to make changes—and indeed have announced some changes—but it seems they waited too long and are changing too little.
Rheumatologists, who must fulfill ABIM’s requirements for maintenance of certification, or MOC, recently slapped down the process—and hard.
“There is evidence that many of the MOC requirements have no beneficial impact on clinical care,” the statement says. “Moreover, the direct and indirect costs of the MOC program to physicians and the health care system is excessive.”
The study concluded that internists incur an average of $23,607 in MOC costs over 10 years—with doctors who specialize in cancers and blood diseases out $40,495. All told, the study concluded, MOC will suck $5.7 billion out of the health care system over 10 years, including $5.1 billion in time costs (resulting from 32.7 million physician-hours spent on MOC) and $561 million in testing costs. And remember—all that time and expense is for a program that has not been proven to accomplish anything.
And the NBPAS process is completely different than the one required by ABIM. A two-year recertification through NBPAS costs $169 (a single review course for the ABIM test costs more than $1,000.) It requires that physicians obtain initial certification through ABIM or one of its affiliated organizations. Then, for recertification, it requires physicians to attend 50 hours of what are known as qualified continuing medical education programs every two years. That way, doctors choose what education programs most benefit their practice by attending about 25 hours of those courses and conferences each year. No time is wasted learning about items that have no relevance to the work of a particular doctor.
And the National Board of Physicians and Surgeons (NBPAS) process is completely different than the one required by ABIM. A two-year recertification through NBPAS costs $169 (a single review course for the ABIM test costs more than $1,000.) It requires that physicians obtain initial certification through ABIM or one of its affiliated organizations. Then, for recertification, it requires physicians to attend 50 hours of what are known as qualified continuing medical education programs every two years. That way, doctors choose what education programs most benefit their practice by attending about 25 hours of those courses and conferences each year. No time is wasted learning about items that have no relevance to the work of a particular doctor.
University of California accounts for nearly 10% of all published research in the United States. It’s also a significant partner of Elsevier, which publishes about 18% of all UC output and collects more than 25% of the university’s $40-million overall subscription budget.
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 3/31/2021
Breaking: University of California strikes landmark open access deal with publishing giant Elsevier
Library Communications
TO: The UC Berkeley academic community
FROM: Paul Alivisatos, Executive Vice Chancellor and Provost
Jeff MacKie-Mason, University Librarian and Professor
Jennifer Johnson-Hanks, Chair, Academic Senate, Berkeley Division
Thomas Dandelet, Chair, Academic Senate Library Committee
Tuesday, March 16, 2021 RE: University of California strikes landmark open access deal with Elsevier
Ultimately, UC’s goal is to make it possible for all authors to publish their work open access in whatever journal they choose — letting even more people enjoy the fruits of UC’s research. This month, we have made a tremendous stride in that direction.
Dear campus community,
The University of California has struck a deal with Elsevier, the largest academic publisher in the world — a landmark victory for the university and for open access publishing.
The transformative agreement comes after a much-publicized split between UC and the publishing giant, and more than two years of negotiations. The deal is the culmination of UC faculty members, librarians, and leaders coming together and standing strong in our efforts to make UC research freely available to everyone, and to transform scholarly publishing for the better.
The four-year agreement — going into effect on April 1, 2021 — restores UC’s direct online access to Elsevier journals and doubles the number of articles covered by UC’s open access agreements.
The outcome aligns with the university’s goals of making UC research freely available for all and containing the excessive costs that come with licensing journals. These goals support UC as a responsible steward of public funds and as a public university that strives to make knowledge available for everyone.
What the agreement means for the UC community
Reading access: Effective April 1, UC will regain access to articles published in Elsevier journals the libraries subscribed to before, plus additional journals.
Open access publishing in Elsevier journals: The four-year deal will also provide for open access publishing of UC research in nearly 2,300 Elsevier journals from day one. Open access publishing in the Cell Press and Lancet families of journals will be available as early as April 2022. UC’s deal is the first in the world to provide for open access publishing across the entire suite of these prestigious journals.
Library support for open access publishing: All articles with a UC corresponding author will be open access by default, with the Library automatically paying the first $1,000 of the open access fee (also known as an article publishing charge or APC). Authors will be asked to pay the remainder of the APC if they have research funds available to do so.
Discounts on publishing: To lower those costs even further for authors, UC has negotiated a 15 percent discount on the APCs for most Elsevier journals. The discount is 10 percent for the Cell Press and Lancet families of journals.
Full funding support for those who need it: To ensure that all authors have the opportunity to publish their work open access, the Library will cover the full amount of the APC for those who do not have sufficient research funds for the author share. Authors may also opt out of open access publishing if they wish.
Open access journals get a boost from librarians—much to Elsevier’s dismay
Move to cut fees adds pressure to funding model already under strain.
ALEX BARKER AND PATRICIA NILSSON, FT.COM –
Volunteers
Elsevier’s previous foot-dragging may be no surprise given the blessed commercial model of academic publishing. Typically scholars have submitted their research for free to publishers, who use volunteers to vet it, before selling the edited journals back, at a premium price, to the universities that footed the bill for the original scholarship.
While prominent funders such as the Wellcome Trust and the Bill & Melinda Gates Foundation have backed moves to open access publishing, some academics have worried it could prevent their work appearing in the most prestigious journals, an important factor in career assessment.
One of the old system’s weak points was the university libraries. Elsevier executives note that their content budgets simply failed to keep up with the 3 to 4 percent increases in research funding, or the even bigger increases in Elsevier’s workload and output: it received 1.8 million submissions last year for 470,000 articles. “Tensions resulting from these issues have eroded trust between scholarly publishers and the research community that we serve,” said Ms. Bayazit last month. She even offered an extraordinary apology to librarians still angry over double-digit price rises in the 1980s and 1990s.
Ivy Anderson, co-chair of the University of California’s publishing negotiations team, which cancelled its $11 million contract with Elsevier in March, said at the time that academics were “getting fed up with high prices and paywall journals, they’re standing up and saying we are willing to bear the inconvenience [of not having journal access]”.
High profile scientists from University of California are stepping down from the editorial boards of some of the most prominent scientific journals like Cell. A major blow to publisher Elsevier.
More than two dozen researchers at various University of California campuses have stepped back from their positions on the editorial boards of Elsevier journals, ScienceInsider reports.
The University of California and Elsevier have been at odds over subscriptions and open-access costs during their contract renewal negotiations. UC wanted a “read-and-publish” contract in which journal subscription and open-access publishing fees are combined, while Elsevier preferred to keep the current model. This led UC in March to announce it was not going to renew its contract with Elsevier. ScienceInsider notes that UC’s access to Elsevier journals was cut off in July.
According to ScienceInsider, about 30 UC researchers, including CRISPR researcher Jennifer Doudna and Nobel Laureate Elizabeth Blackburn, are taking hiatuses from the editorial boards of a range of Elsevier journal, such as Cell, Molecular Cell, and Current Biology. “We … wish to express our concern at the current lack of a contract between UC and Elsevier, and the decision to deny our UC colleagues access to research published in Cell Press and other Elsevier journals,” the researchers write in a letter.
Berkeley’s Matthew Welch says in a statement that this move will not affect the journals much, but that it “sends a message.”
UPDATED on 3/2/2019
The costs of academic publishing are absurd. The University of California is fighting back.
The UC system just dropped its $10 million-a-year subscription to the world’s largest publisher of academic journals.
University of California and Elsevier Locked in Negotiations
The UC system is pushing to change the subscription model and accelerate open access, but if there’s no contract agreement by December 31, faculty and students lose access altogether.
Dec 13, 2018
CAROLYN WILKE
The University of California, Los Angeles, has asked its faculty to help apply the pressure, The Chronicle of Higher Educationreports. In a letter, a university provost asked faculty to consider holding off on reviewing articles for Elsevier until the negotiations become more favorable and to look for options to publish their research elsewhere, including in open-access journals.
University of California System is playing hardball with Elsevier in negotiations that could transform the way it pays to read and publish research. But does the UC system have the clout to pull it off?
To facilitate this, the UC system is pursuing a new kind of arrangement with Elsevier and several other publishers, Anderson said. Rather than paying separately to access subscription journals and make articles immediately available in OA, the UC system wants to roll both costs into one annual fee, which could potentially be higher than what the UC system currently pays for subscriptions only.
This arrangement, called a “read-and-publish” deal, would mean that the public would have immediate, free access to final versions of UC research papers, with no additional article-processing fees to the UC system.
In pursuing such an arrangement with Elsevier, the UC system is “trying to fundamentally change the ecosystem of scholarly communication,” said Rick Anderson, associate dean for colleges and scholarly communications in the Marriott Library at the University of Utah.
Tananbaum said that what the UC system is trying to do is unusual. “Historically, libraries have been vocal in their dissatisfaction with the lock-in and spend associated with many forms of the big deal,” he said.
“In this instance, UC is not simply bemoaning the status quo; they are working proactively to change it,” said Tananbaum. “This effort is not limited to simply trying to hold the line on pricing. It also seeks to reset the university’s relationship with publishers, promoting a partnership approach to create a glide path to OA.”
Lisa Hinchliffe, professor and coordinator of information literacy services at the University of Illinois at Urbana-Champaign, said that many institutions would be interested in read-and-publish deals if the terms were favorable to them.
“The concern is that any read-and-publish deal is likely to have a higher price than an institution’s current read deal,” said Hinchliffe. “Given that [article-processing charges] are usually not paid from a central fund, adding this expense to the library’s budget could be a challenge even if the overall cost to the institution declined as expenses were bundled.”
UC policy has been explicitly committed to open access since 2013, when the university’s Academic Senate adopted the policy. UC authors are required to deposit versions of their papers or links in the university’s eScholarship online repository, which currently holds more than 200,000 items available to the public for free. (Compliance by researchers is thought to be spotty as yet, however, in part because there’s no enforcement system.)
No one knows yet how the showdown between UC and Elsevier will play out. Some observers expect that the deadline will be extended so the two sides can continue negotiating, though Elsevier would have the right to shut off access to new journal issues as of Jan. 1. (Access to prior publications already paid for wouldn’t be affected.)
As for the longer time frame, the research community expects the big publishers to stay in business, but perhaps with narrower profit margins and an evolved model more reliant on preparation fees than subscriptions.
Researchers have begun to sense that they may have more leverage against the publishers than they assumed. “As authors, we do have a choice of where we send our articles and invest our time as peer reviewers,” Bales says. “If enough of the publishers’ customers end their subscriptions… they’ll have to change.”
SOURCE
In UC’s battle with the world’s largest scientific publisher, the future of information is at stake
e-Scientific Publishing: The Competitive Advantage of a Powerhouse for Curation of Scientific Findings and Methodology Development for e-Scientific Publishing – LPBI Group, A Case in Point
Innovations in electronic Scientific Publishing (eSP): Case Studies in Marketing eContent, Curation Methodology, Categories of Research Functions, Interdisciplinary conceptual innovations by Cross Section of Categories, Exposure to Frontiers of Science by Real Time Press coverage of Scientific Conferences
Gene-editing Second International Summit in Hong Kong: George Church, “Let’s be quantitative before we start being accusatory”
Reporter: Aviva Lev-Ari, PhD, RN
2.1.4.3 Gene-editing Second International Summit in Hong Kong: George Church, “Let’s be quantitative before we start being accusatory”, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair
UPDATED on 11/30/2018
Gene editing takes a foreboding leap forward
He Jiankui. Photo: Zhang Wei/Chinese News Service/VCG via Getty Images
China is temporarily suspending the work of scientists who claimed twins were born after being genetically edited as embryos.
Why it matters: The scientific consensus is that gene editing embryos at this stage of science is “irresponsible.” But, while this particular experiment has not been verified, the fact is the technology is available to researchers, so there’s a growing call for international limitations on its use.
ICYMI: Chinese scientist He Jiankui announced earlier this week that twins were born after he used the gene-editing tool CRISPR-Cas9 to cut the CCR5 gene that’s known to play a role in HIV infection.
He stirred even more dismay when he mentioned the possibility of a second pregnancy.
China currently bans human implantation of gene-edited embryos. Its Ministry of Science and Technology is investigating the claims, per Xinhua.
There are concerns about the safety, efficacy and possible mosaicism, where a person can contain genes in both its edited and unedited forms, from cutting genes.
Editing embryos raises an even bigger concern: The genetic changes and all the unknowns around them can be passed down to future generations.
Between the lines: Not everyone viewed it as a complete disaster. For instance, Harvard Medical School’s George Daley suggested that it may be time to reconsider the massive amounts of research done over the past several years and look for plausible methods of moving forward.
What to watch: Scientists are cautious about predicting what the impact will be, in part because the details of this claim are thin. However, the debate is heating up and one concern is it will dampen important research.
Medical ethicist Jonathan Moreno from the University of Pennsylvania says the situation reminds him of other times in history where there were tremors in the science world, like the death of 18-year-old Jesse Gelsinger in 1999 from a gene therapy trial that led to years of diminished research.
The bottom line: The alarm over what could be next is real. But scientists hope the current debate will promote consensus on firm limits and promote transparency.
Meanwhile, prominent geneticist George Church is one of the few scientists who seem to be looking on the bright side of He’s controversial claim. “Let’s be quantitative before we start being accusatory,” Church told Science. “As long as these are normal, healthy kids it’s going to be fine for the field and the family.”
The ethical red flags of genetically edited babies
Driving the news: Chinese scientist He Jiankui announced Sunday night that a pair of twin girls had been born from embryos he modified using the gene-editing tool known as CRISPR.
He hasn’t provided solid proof, but if it‘s true, it would be the first time the technology has been used to engineer a human.
What they’re saying: The inventors of CRISPR technology did not seem pleased with the development — one called for a moratorium on implantation edited embryos into potential mothers.
“I hope we will be more cautious in the next thing we try to do, and think more carefully about when you should use technology versus when you could use technology,” said Jessica Berg, a bioethicist at Case Western Reserve University.
Between the lines: Several specific factors in He’s work sent up ethical red flags.
Many scientists had assumed that, when this technology was first used in humans, it would edit out mutations tied to a single gene that were certain to cause a child pain and suffering once it was born — essentially, as a last resort.
But He used CRISPR to, as he put it, “close a door” that HIV could have one day traveled through. That has prompted some speculation that this project was more about testing the technology than serving an acute medical need.
“That should make us very uneasy about the whole situation,” Berg said. “Of all the things to have started with, it does make you a little suspicious about this particular choice.”
The intrigue: There’s a lot we still don’t know about He’s work, and that’s also contributing to an attitude of skepticism.
How many embryos did he edit and implant before these live births?
How will he know it worked? As the children age, they’ll likely have their blood drawn and those samples will be exposed to HIV in a lab, but researchers aren’t going to tell them to go out and have unprotected sex or use intravenous drugs — another reason HIV seems like an odd starting place for human gene editing.
How did this even happen? The university where He worked said he was on leave, and Chinese officials have said he’s under investigation. But gene editing is a pretty hard thing to freelance.
The other side: He defended his work in avideo message, saying, “I understand my work will be controversial but I believe families need this technology and I’m willing to take the criticism for them.”
“Their parents don’t want a designer baby, just a child who won’t suffer from a disease which medicine can now prevent,” He said.
Yes, but: Now that this threshold may have been crossed, attempts to create “designer babies” — within the limitations of what CRISPR can do — probably aren’t far off, some experts fear.
There are “likely to be places that are less regulated than others, where people are going to attempt to see what they can do,” Berg said. “I wouldn’t say everything in the world has changed now, but it’s certainly the next step.”
The Future of Precision Cancer Medicine, Inaugural Symposium, MIT Center for Precision Cancer Medicine, December 13, 2018, 8AM-6PM, 50 Memorial Drive, Cambridge, MA
Reporter: Aviva Lev-Ari, PhD, RN
#CPCM2018 @AVIVA1950 @pharma_BI
Aviva Lev-Ari, PhD, RN, Editor-in-Chief, will attend and cover this event in REAL TIME for
Over the past decade, there have been major advancements in the field of precision medicine, leading to exciting new treatments for some cancer patients. Much attention has been focused on genomic profiling of tumors to identify genomic alterations that might guide selection of specific therapies for individual patients. Beyond genomics, however, there is a variety of other precision approaches that can identify and exploit cancer-specific biological mechanisms including proteomics, metabolomics, and computational modeling, resulting in the more effective use of existing cancer medicines. On Thursday, December 13, 2018, the MIT Center for Precision Cancer Medicine will hold its inaugural annual symposium in the Samberg Conference Center at MIT. This full-day event will feature leading researchers and clinicians, who will highlight recent advances in precision cancer medicine and share perspectives on the future. An industry panel will also discuss the barriers to instituting precision medicine into current and future clinical trials.
Keynote Address
Charles Sawyers, MD
Chair, Human Oncology and Pathogenesis Program
Memorial Sloan Kettering Cancer Center
Speakers
Andrea Califano, PhD
Clyde and Helen Wu Professor of Chemical Systems Biology, Columbia University
Chair, Department of Systems Biology, Columbia University
Director, JP Sulzberger Columbia Genome Center
Associate Director, Herbert Irving Comprehensive Cancer Center
J. Christopher Love, PhD
Professor of Chemical Engineering, MIT
Associate Member, Ragon Institute of MGH, MIT and Harvard
Member, Koch Institute, MIT
Richard Marais, PhD
Professor of Molecular Oncology
Director, CRUK Manchester Institute
The University of Manchester
Kenna Mills Shaw, PhD
Executive Director
Sheikh Khalifa Bin Zayed al Nahyan Institute for Personalized Cancer Therapy
MD Anderson Cancer Center
Alice Shaw, MD, PhD
Professor, Harvard Medical School
Director, Thoracic Cancer Program, Massachusetts General Hospital
Matthew Vander Heiden, MD, PhD
Associate Professor of Biology, MIT
Associate Director, Koch Institute
Member, MIT Center for Precision Cancer Medicine
Michael B. Yaffe, MD, PhD
David H. Koch Professor of Science, MIT
Professor of Biology and Biological Engineering, MIT
Director, MIT Center for Precision Cancer Medicine
Director, Koch Institute Clinical Investigator Program
Jean Zhao, PhD
Professor of Biological Chemistry and Molecular Pharmacology
Harvard Medical School and Dana-Farber Cancer Institute
Panelists: Barriers to Instituting Precision Medicine in Clinical Trials
Peter Hammerman, MD, PhD
Global Head, Translational Research
Oncology Disease Area
Novartis Institutes for BioMedical Research
Steffan N. Ho, MD, PhD
Vice President, Head of Translational Oncology
Pfizer Global Product Development
Shiva Malek, PhD
Director and Principal Scientist
Department of Discovery Oncology
Genentech Inc
Kevin Marks, PhD
VP of Biology
Agios Pharmaceuticals
S. Michael Rothenberg, MD, PhD
Vice-President, Research and Development
Loxo Oncology, Inc.
Moderator:
Angela Koehler, PhD
Goldblith Career Development Professor in Applied Biology, MIT
Member, Koch Institute for Integrative Cancer Research
Member, MIT Center for Precision Cancer Medicine
8:45 am Opening remarks by Michael Yaffe (MIT’s Koch Institute)
Season of great expectation, tumor genetics is just the beginning, beyond: science, engineering, medicine: beyond genomics: immunology, cell biology, early detection, new drug development for the undrugable, system biology, RNAi
Jack Tyler was the initiator to find a donor for CPCM
9:00 am Keynote Address by Charles L. Sawyers (Memorial Sloan Kettering Cancer Center)
developed a drug for prostate cancer
Clinical trained oncologist/genomics
Lineage Plasticity:
luminal cells in histology of origin and basal cells and require androgen receptor AR) function
CMS Takes Action to Lower Prescription Drug Costs by Modernizing Medicare Proposed regulation for Medicare Parts C & D would strengthen negotiations with prescription drug manufacturers to lower costs and increase transparency for patients
Today, the Centers for Medicare & Medicaid Services (CMS) proposed polices for 2020 to strengthen and modernize the Medicare Part C and D programs. The proposal would ensure that Medicare Advantage and Part D plans have more tools to negotiate lower drug prices, and the agency is also considering a policy that would require pharmacy rebates to be passed on to seniors to lower their drug costs at the pharmacy counter.
“President Trump is following through on his promise to bring tougher negotiation to Medicare and bring down drug costs for patients, without restricting patient access or choice,” said HHS Secretary Alex Azar. “By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need, and expand their choice of plans. The Part D proposals complement efforts to bring down costs in Medicare Advantage and in Medicare Part B through negotiation, all part of the President’s plan to put American patients first by bringing down prescription-drug prices and out-of-pocket costs.”
In the twelve years since the Part D program was launched, many of the tools outlined in today’s proposal have been developed in the commercial health insurance marketplace, and the result has been lower costs for patients. Seniors in Medicare also deserve to benefit from these approaches to reducing costs, so today CMS is proposing to modernize the Medicare Advantage and Part D programs and remove barriers that keep plans from leveraging these tools.
“In designing today’s proposal, foremost in the agency’s mind was the impact on patients, and the proposal is yet another action CMS has taken to deliver on President Trump and Secretary Azar’s commitment on drug prices,” said CMS Administrator Seema Verma. “Today’s changes will provide seniors with more plan options featuring lower costs for prescription drugs, and seniors will remain in the driver’s seat as they can choose the plan that works best for them. The result will be increasing access to the medicines that seniors depend on by lowering their out-of-pocket costs.”
Private plan options for receiving Medicare benefits are increasing in popularity, with almost 37 percent of Medicare beneficiaries expected to enroll in Medicare Advantage in 2019, and Part D enrollment increasing year-over-year as well. The programs are driven by market competition; plans compete for beneficiaries’ business, and each enrollee chooses the plan that best meets his or her needs. Consumer choice puts pressure on plans to improve quality and lower costs. Premiums in both Medicare Advantage and Part D are projected to decline next year.
Today’s proposed changes include:
Providing Part D plans with greater flexibility to negotiate discounts for drugs in “protected” therapeutic classes, so beneficiaries who need these drugs will see lower costs;
Requiring Part D plans to increase transparency and provide enrollees and their doctors with a patient’s out-of-pocket cost obligations for prescription drugs when a prescription is written;
Codifying a policy similar to the one implemented for 2019 to allow “step therapy” in Medicare Advantage for Part B drugs, encouraging access to high-value products including biosimilars; and
Implementing a statutory requirement, recently signed by President Trump, that prohibits pharmacy gag clauses in Part D.
CMS is also considering for a future plan year, which may be as early as 2020, a policy that would ensure that enrollees pay the lowest cost for the prescription drugs they pick up at a pharmacy, after taking into account back-end payments from pharmacies to plans.
Medicare Advantage and Part D will continue to protect patient access, as both programs are embedded with robust beneficiary protections. These include CMS’s review of Part D plan formularies, an expedited appeals process, and a requirement for plans to cover two drugs in every therapeutic class.
CMS looks forward to receiving comments on these proposals and other policies under consideration.
Cardiovascular (CV) Disease and Diabetes: New ACC Guidelines for use of two major new classes of diabetes drugs — sodium-glucose cotransporter type 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs) for reduction of adverse outcomes
Reporter: Aviva Lev-Ari, PhD, RN
Updated on 10/24/2022
Diabetes Becoming Less Potent Risk Factor for CVD Events
Richard Mark Kirkner
Shift in Practice
The study noted that the shift in diabetes as a risk factor for heart attack and stroke is “a change that likely reflects the use of modern, multifactorial approaches to diabetes.”
“A number of changes have occurred in practice that really focus on this idea of a multifactorial approach to diabetes: more aggressive management of blood sugar, blood pressure, and lipids,” Ke said. “We know from the statin trials that statins can reduce the risk of heart disease significantly, and the use of statins increased from 28.4% in 1999 to 56.3% in 2018 in the United States,” Ke said. He added that statin use in Canada in adults ages 40 and older went from 1.2% in 1994 to 58.4% in 2010-2015. Use of ACE inhibitors and angiotensin receptor blockers for hypertension followed similar trends, contributing further to reducing risks for heart attack and stroke, Ke said.
Ke also noted that the evolution of guidelines and advances in treatments for both CVD and diabetes since 1994 have contributed to improving risks for people with diabetes. SGLT2 inhibitors have been linked to a 2%-6% reduction in hemoglobin A1c, he said. “All of these factors combined have had a major effect on the reduced risk of cardiovascular events.”
Prakash Deedwania, MD, professor at the University of California, San Francisco, Fresno, said that this study confirms a trend that others have reported regarding the risk of CVD in diabetes. The large database covering millions of adults is a study strength, he said.
And the findings, Deedwania added, underscore what’s been published in clinical guidelines, notably the American Heart Association scientific statement for managing CVD risk in patients with diabetes. “This means that, from observations made 20-plus years ago, when most people were not being treated for diabetes or heart disease, the pendulum has swung,” he said.
However, he added, “The authors state clearly that it does not mean that diabetes is not associated with a higher risk of cardiovascular events; it just means it is no longer equivalent to CVD.”
Managing diabetes continues to be “particularly important,” Deedwania said, because the prevalence of diabetes continues to rise. “This is a phenomenal risk, and it emphasizes that, to really conquer or control diabetes, we should make every effort to prevent diabetes,” he said.
Ke and Deedwania have no relevant financial relationships to disclose.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
“The main aim for this report is to educate cardiologists, who might not otherwise think about prescribing diabetes drugs, about these two new classes of medications that have important cardiovascular benefits for their patients,” cochair of the writing committee for the new consensus document, Brendan Everett, MD, assistant professor of medicine, Brigham and Women’s Hospital, Boston, commented to theheart.org | Medscape Cardiology.
“We hope to help them understand which of their patients might benefit, and to help them understand how to prescribe these new drugs appropriately to their patients with both atherosclerotic cardiovascular disease and diabetes.”
The document is published online November 26 in the Journal of the American College of Cardiology, and is endorsed by the American Diabetes Association.
2018 ACC Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes and Atherosclerotic Cardiovascular Disease
A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways Writing Committee:
Sandeep R. Das, Brendan M. Everett, Kim K. Birtcher, Jenifer M. Brown, William T. Cefalu, James L. Januzzi Jr., Rita Rastogi Kalyani, Mikhail Kosiborod, Melissa L. Magwire, Pamela B. Morris and Laurence S. Sperling
4 Pathway Summary Graphic
Figure 1 provides an overview of what is covered in the Expert Consensus Decision Pathway. See each section for more detailed considerations and guidance.
Figure 2 offers 1 approach to deciding which drug to use in which patient, Table 11 outlines patient and clinician preferences to consider when selecting an SGLT2 inhibitor or GLP-1RA. Table 12 provides an overview of considerations for initiating and monitoring an SGLT2 inhibitor. Table 13 provides an overview of considerations for initiating and monitoring a GLP-1RA.
2012pharmaceutical
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