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Live 12:00 – 1:00 P.M  Mediterranean Diet and Lifestyle: A Symposium on Diet and Human Health : October 19, 2018

Reporter: Stephen J. Williams, Ph.D.

12.00 The Italian Mediterranean Diet as a Model of Identity of a People with a Universal Good to Safeguard Health?

Prof. Antonino De Lorenzo, MD, PhD.

Director of the School of Specialization in Clinical Nutrition, University of Rome “Tor Vergata”

It is important to determine how our bodies interacts with the environment, such as absorption of nutrients.

Studies shown here show decrease in life expectancy of a high sugar diet, but the quality of the diet, not just the type of diet is important, especially the role of natural probiotics and phenolic compounds found in the Mediterranean diet.

The WHO report in 2005 discusses the unsustainability of nutrition deficiencies and suggest a proactive personalized and preventative/predictive approach of diet and health.

Most of the noncommunicable diseases like CV (46%) cancer 21% and 11% respiratory and 4% diabetes could be prevented and or cured with proper dietary approaches

Italy vs. the US diseases: in Italy most disease due to environmental contamination while US diet plays a major role

The issue we are facing in less than 10% of the Italian population (fruit, fibers, oils) are not getting the proper foods, diet and contributing to as we suggest 46% of the disease

The Food Paradox: 1.5 billion are obese; we notice we are eating less products of quality and most quality produce is going to waste;

  •  growing BMI and junk food: our studies are correlating the junk food (pre-prepared) and global BMI
  • modern diet and impact of human health (junk food high in additives, salt) has impact on microflora
  • Western Diet and Addiction: We show a link (using brain scans) showing correlation of junk food, sugar cravings, and other addictive behaviors by affecting the dopamine signaling in the substantia nigra
  • developed a junk food calculator and a Mediterranean diet calculator
  • the intersection of culture, food is embedded in the Mediterranean diet; this is supported by dietary studies of two distinct rural Italian populations (one of these in the US) show decrease in diet
  • Impact of diet: have model in Germany how this diet can increase health and life expectancy
  • from 1950 to present day 2.7 unit increase in the diet index can increase life expectancy by 26%
  • so there is an inverse relationship with our index and breast cancer

Environment and metal contamination and glyphosate: contribution to disease and impact of maintaining the healthy diet

  • huge problem with use of pesticides and increase in celiac disease

12:30 Environment and Health

Dr. Iris Maria Forte, PhD.

National Cancer Institute “Pascale” Foundation | IRCCS · Department of Research, Naples, Italy

Cancer as a disease of the environment.  Weinberg’s hallmarks of Cancer reveal how environment and epigenetics can impact any of these hallmarks.

Epigenetic effects

  • gene gatekeepers (Rb and P53)
  • DNA repair and damage stabilization

Heavy Metals and Dioxins:( alterations of the immune system as well as epigenetic regulations)

Asbestos and Mesothelioma:  they have demonstrated that p53 can be involved in development of mesothelioma as reactivating p53 may be a suitable strategy for therapy

Diet, Tomato and Cancer

  • looked at tomato extract on p53 function in gastric cancer: tomato extract had a growth reduction effect and altered cell cycle regulation and results in apoptosis
  • RBL2 levels are increased in extract amount dependent manner so data shows effect of certain tomato extracts of the southern italian tomato (     )

Antonio Giordano: we tested whole extracts of almost 30 different varieties of tomato.  The tomato variety  with highest activity was near Ravela however black tomatoes have shown high antitumor activity.  We have done a followup studies showing that these varieties, if grow elsewhere lose their antitumor activity after two or three generations of breeding, even though there genetics are similar.  We are also studying the effects of different styles of cooking of these tomatoes and if it reduces antitumor effect

please see post https://news.temple.edu/news/2017-08-28/muse-cancer-fighting-tomatoes-study-italian-food

 

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Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

Real Time Conference Coverage for Scientific and Business Media: Unique Twitter Hashtags and Handles per Conference Presentation/Session

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

LIVE 2018 The 21st Gabay Award to LORENZ STUDER, Memorial Sloan Kettering Cancer Center, contributions in stem cell biology and patient-specific, cell-based therapy

HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future

Live 11:00 AM- 12:00 Mediterranean Diet and Lifestyle: A Symposium on Diet and Human Health : Opening Remarks October 19, 2018

Reporter: Stephen J. Williams, Ph.D.

11:00 Welcome

 

 

Prof. Antonio Giordano, MD, PhD.

Director and President of the Sbarro Health Research Organization, College of Science and Technology, Temple University

Welcome to this symposium on Italian lifestyle and health.  This is similar to a symposium we had organized in New York.  A year ago Bloomberg came out with a study on higher longevity of the italian population and this study was concluded that this increased longevity was due to the italian lifestyle and diet especially in the southern part of Italy, a region which is older than Rome (actually founded by Greeks and Estonians).  However this symposium will delve into the components of this healthy Italian lifestyle which contributes to this longevity effect.  Some of this work was done in collaboration with Temple University and sponsored by the Italian Consulate General in Philadelphia ( which sponsors programs in this area called Ciao Philadelphia).

Greetings: Fucsia Nissoli Fitzgerald, Deputy elected in the Foreign Circumscription – North and Central America Division

Speaking for the Consulate General is Francesca  Cardurani-Meloni.   I would like to talk briefly about the Italian cuisine and its evolution, from the influence of the North and South Italy, economic factors, and influence by other cultures.  Italian cooking is about simplicity, cooking with what is in season and freshest.  The meal is not about the food but about comfort around the table, and comparible to a cullinary heaven, about sharing with family and friends, and bringing the freshest ingredients to the table.

Consul General, Honorable Pier Attinio Forlano, General Consul of Italy in Philadelphia

 

11:30 The Impact of Environment and Life Style in Human Disease

Prof. Antonio Giordano MD, PhD.

 

 

 

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Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

Real Time Conference Coverage for Scientific and Business Media: Unique Twitter Hashtags and Handles per Conference Presentation/Session

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

LIVE 2018 The 21st Gabay Award to LORENZ STUDER, Memorial Sloan Kettering Cancer Center, contributions in stem cell biology and patient-specific, cell-based therapy

HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future

Innovators in Therapeutics: John Maraganore, the CEO of Alnylam, and Sara Nochur, Alnylam’s Senior VP Regulatory Affairs, November 15, 2018, 4:30 PM – 6:30 PM, HMS

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Innovators in Therapeutics, a Student Speaker Series

by Harvard-MIT Center for Regulatory Science

Free

Actions and Detail Panel

Innovators in Therapeutics, a Student Speaker Series

Thu, November 15, 2018, 4:30 PM – 6:30 PM EST

LOCATION

Cannon Room, Building C, Harvard Medical School

240 Longwood Ave

Boston, MA 02115

View Map

 

Free

 

REGISTER

Event Information

DESCRIPTION

Please join us for the Innovators in Therapeutics student speaker series organized by the Harvard-MIT Center for Regulatory Science and the Harvard Program in Therapeutic Science. The first installment of this series will feature John Maraganore, the CEO of Alnylam, and Sara Nochur, Alnylam’s Senior Vice President for Regulatory Affairs. Dr. Maraganore and Dr. Nochur will describe Alnylam’s path through development and FDA approval of the first RNAi therapeutic, ONPATTRO™ (patisiran), for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis. Dr. Maraganore and Dr. Nochur will focus on the regulatory science aspects of gaining approval for this innovative therapeutic.

Prior to the seminar, please join us for a networking session that brings together faculty, students and trainees who are interested in translational research, pharmacology, biotechnology, and regulatory science. Following the speaking program, there will be a small group discussion for students and trainees to engage directly with the expert about the topic at hand. Participation in the small group discussion is limited to students who register and are confirmed prior to the event.

This event is free and open to the Boston research community. Please help us to plan by RSVPing here!

 

AGENDA

4:30 – 5:00pm: Pre-event reception (outside Cannon Room)

5:00 – 5:45pm: Innovators in Therapeutics with Alnylam’s John Maraganore & Sara Nochur (Cannon Room)

5:45 – 6:15pm: [Limited Space] Student and Trainee Q&A with John Maraganore & Sara Nochur (Folin Wu Room)

SOURCE

https://www.eventbrite.com/e/innovators-in-therapeutics-a-student-speaker-series-tickets-50806305026

Announcement 11AM- 5PM: Live Conference Coverage  from Mediterranean Diet and Lifestyle: A Symposium on Diet and Human Health @S.H.R.O. and Temple University October 19, 2018

Reporter: Stephen J. Williams, Ph.D.

 

 The Sbarro Health Research Organization, in collaboration with the Consulate General of Italy in Philadelphia will sponsor a symposium on the Mediterranean Diet and Human Health on October 19, 2018 at Temple University in Philadelphia, PA.  This symposium will discuss recent finding concerning the health benefits derived from a Mediterranean-style diet discussed by the leaders in this field of research.

Mediterranean Diet

The description of the Mediterranean Diet stems from the nutritionist Ancel Keys, who in 1945, in the wake of the US Fifth Army, landed in Southern Italy, where he observed one of the highest concentrations of centenarians in the world. He also noticed that cardiovascular diseases, widespread in the USA, were less frequent there. In particular, among the Southern Italians, the prevalence of “wellness” diseases such as hypertension and diabetes mellitus, was particularly associated with fat consumption, suggesting that the main factor responsible for the observations was the type of diet traditionally consumed among people facing the Mediterranean Sea, which is low in animal fat, as opposed to the Anglo-Saxon diet. The link between serum cholesterol and coronary heart disease mortality was subsequently demonstrated by the Seven Countries Study. Later, the concept of Mediterranean Diet was extended to a diet rich in fruits, vegetables, legumes, whole grains, fish and olive oil as the main source of lipid, shared among people living in Spain, Greece, Southern Italy and other countries facing the Mediterranean basin …

Prof. Antonino De Lorenzo, MD, PhD.

   

 

The Symposium will be held at:

Biolife Science Building, Room 234

Temple University, 1900 North 12th street

Philadelphia, PA 19122

 

For further information, please contact:

Ms. Marinela Dedaj – Sbarro Institute,  Office #: 215-204-9521

 

11:00 Welcome

Prof. Antonio Giordano, MD, PhD.

Director and President of the Sbarro Health Research Organization, College of Science and Technology, Temple University

 

Greetings

Fucsia Nissoli Fitzgerald

Deputy elected in the Foreign Circumscription – North and Central America Division

 

Consul General, Honorable Pier Attinio Forlano

General Consul of Italy in Philadelphia

 

11:30 The Impact of Environment and Life Style in Human Disease

Prof. Antonio Giordano MD, PhD.

 

12.00 The Italian Mediterranean Diet as a Model of Identity of a People with a Universal Good to Safeguard Health?

Prof. Antonino De Lorenzo, MD, PhD.

Director of the School of Specialization in Clinical Nutrition, University of Rome “Tor Vergata”

 

12:30 Environment and Health

Dr. Iris Maria Forte, PhD.

National Cancer Institute “Pascale” Foundation | IRCCS · Department of Research, Naples, Italy

 

13:00 Lunch

 

2:30 Mediterranean Diet, Intangible Heritage and Sustainable Tourism?

Prof. Fabio Parasecoli, PhD.

Nutrition and Food Department, New York University

 

3.00 Italy as a Case Study: Increasing Students’ Level of Awareness of the Historical, Cultural, Political and Culinary Significance of Food

Prof. Lisa Sasson

Nutrition and Food Department, New York University

 

3:30 Italian Migration and Global Diaspora

Dr. Vincenzo Milione, PhD

Director of Demographics Studies, Calandra Institute, City University of New York

 

4:00 Pasta Arte: New Model of Circular Agricultural Economy: When an Innovated Tradition Takes Care of You and of the Environment

Dr. Massimo Borrelli

CEO and Founder of Arte

 

4:15 Conclusions

Prof. Antonio Giordano, MD, PhD.

 

Coordinator of the Symposium, Dr. Alessandra Moia, PhD.

 

Prof. Antonio Giordano, MD, PhD.

Professor of Molecular Biology at Temple University in Philadelphia, PA where he is also Director of the Sbarro Institute for Cancer Research and Molecular Medicine. He is also Professor of Pathology at the University of Siena, Italy. He has published over 500 articles, received over 40 awards for his contributions to cancer research and is the holder of 17 patents.

 

Prof. Antonino De Lorenzo, MD, PhD.

Full Professor of Human Nutrition and Director of the Specialization School in Food Science at the University of Rome “Tor Vergata”. He is the Coordinator of the Specialization Schools in Food Science at the National University Council and Coordinator of the PhD. School of “Applied Medical-Surgical Sciences” Director of UOSD “Service of Clinical Nutrition, Parenteral Therapy and Anorexia”. He also serves as President of “Istituto Nazionale per la Dieta Mediterranea e la Nutrigenomica”.

 

Dr. Iris Maria Forte, PhD.

Iris Maria Forte is an oncology researcher of INT G. Pascale Foundation of Naples, Italy. She majored in Medical Biotechnology at the “Federico II” University of Naples, earned a PhD. in “Oncology and Genetics” at the University of Siena in 2012 and a Master of II level in “Environment and Cancer” in 2014. Iris Maria Forte has worked with Antonio Giordano’s group since 2008 and her research interests include both molecular and translational cancer research. She published 21 articles mostly focused in understanding the molecular basis of human cancer. She worked on different kinds of human solid tumors but her research principally focused on pleural mesothelioma and on cell cycle deregulation in cancer.

 

Prof. Fabio Parasecoli, PhD.

Professor in the Department of Nutrition and Food Studies. He has a Doctorate in Agricultural Sciences (Dr.sc.agr.) from Hohenheim University, Stuttgart (Germany), MA in Political Sciences from the Istituto Universitario Orientale, Naples (Italy), BA/MA in Modern Foreign Languages and Literature from the Università La Sapienza, Rome (Italy). His research explores the intersections among food, media, and politics. His most recent projects focus on Food Design and the synergies between Food Studies and design.

 

Prof. Lisa Sasson, MS

Dietetic Internship Director and a Clinical Associate Professor in the department. She has interests in dietetic education, weight and behavior management, and problem-based learning. She also is a private practice nutritionist with a focus on weight management. She serves as co-director of the Food, Nutrition and Culture program in Florence Italy, the New York State Dietetic Association and the Greater New York Dietetic Association (past president and treasurer).

 

Dr. Vincenzo Milione, PhD.

Director of Demographic Studies for The John D. Calandra Italian American Institute, Queens College, City University of New York. He has conducted social science research on Italian Americans. His research has included the educational and occupational achievements; Italian language studies at the elementary and secondary levels, high school non-completion rates; negative media portrayals of ethnic populations including migration studies and global diaspora.

 

Dr. Massimo Borrelli

Agricultural entrepreneur, Manager of the Italian Consortium for Biogas (CIB) and delegate for the Bioeconomy National Department of Confagricoltura. He developed A.R.T.E based on a model of agricultural circular economy, beginning and ending in the ground. He constructed the first biogas plant in the territory creating a new way to make agriculture, investing in research and development, experimentation and most of all, in people. In a few short years, he succeeded to close the production chain producing goods characterized by their high quality and usage of renewable energy.

 

Dr. Alessandra Moia, PhD.

Vice-President for Institutional and International Relations of the Istituto Nazionale per la Dieta Mediterranea e la Nutrigenomica (I.N.D.I.M.). Has managed relations with the academic institutions to increase awareness and develops projects for the diffusion of the Mediterranean Diet. She served as Director of Finance for the National Institute of Nutrition, for the Ministry of Agriculture and Forestry.

 

About the Sbarro Health Research Organization

The Sbarro Health Research Organization (SHRO) is non-profit charity committed to funding excellence in basic genetic research to cure and diagnose cancer, cardiovascular diseases, diabetes and other chronic illnesses and to foster the training of young doctors in a spirit of professionalism and humanism. To learn more about the SHRO please visit www.shro.org

To follow or Tweet on Twitter please use the following handles (@) and hashtags (#):

@ handles


@S_H_R_O 

@SbarroHealth

@Pharma_BI 

@ItalyinPhilly

@WHO_Europe

@nutritionorg

# hashtags


#healthydiet

#MediterraneanDiet

#health

#nutrition

Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

Real Time Conference Coverage for Scientific and Business Media: Unique Twitter Hashtags and Handles per Conference Presentation/Session

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

LIVE 2018 The 21st Gabay Award to LORENZ STUDER, Memorial Sloan Kettering Cancer Center, contributions in stem cell biology and patient-specific, cell-based therapy

HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future

 

LIVE 2018 The 21st Gabay Award to LORENZ STUDER, Memorial Sloan Kettering Cancer Center, contributions in stem cell biology and patient-specific, cell-based therapy

REAL TIME Reporter: Aviva Lev-Ari, PhD, RN

AWARD LECTURE

Tue., Oct. 9, 2018
4:00 PM
Shapiro Campus Center Theater
Brandeis University

CURRENT WINNER

lorenzstuder.jpgLORENZ STUDER

MACARTHUR FELLOWS PROGRAM

Lorenz Studer

Stem Cell Biologist | Class of 2015

Pioneering a new method for large-scale generation of dopaminergic neurons that could provide one of the first treatments for Parkinson’s disease and prove the broader feasibility of stem cell–based therapies for other neurological disorders.

https://www.macfound.org/fellows/947/

118 publications on PubMed

https://www.ncbi.nlm.nih.gov/pubmed/?term=LORENZ+STUDER

 

PRESIDING

Dagmar Ringe Professor of Biochemistry, Chemistry and Rosenstiel Basic Medical Sciences Research Center

WELCOME

Lisa Lynch Provost and Maurice B. Hexter Professor of Social and Economic Policy Brandeis University

 

RESPONSE Lorenz Studer, MD Director, Center for Stem Cell Biology Memorial Sloan Kettering Cancer Center Member, Developmental Biology Program Memorial Sloan Kettering Cancer Center

Fully defined protocol for all ectodermal lineage

  • Nervous system: Forebrain, Midbrain, Spinal cord:
  • CNS lineage to PNS Lineage
  • Excitatory cortical neurons
  • cortical interneurons Astrocytes
  • microglia
  • Age-reset disease – late-onset during reprogramming – Is age reversible?
  • Loss of age-related markers
  • iPSC-derived cells yield stage cell upon differentiation
  • In vitro differentiation techniques: 2D Directed Differentiation 3D- Organoids
  • Graded MORPHOGEN SIGNALING
  • DOXYCYLINE: ISHH-ORGANIZER – 5 discrete forebrain regions
  • Building Human brain cells in 2D and in 3D
  • Organized cells –>>>  directed organoids –>> Organized Organoids
  • Parkinson, 1817 – Essay on Shaky Palsy (Niagrostaterial pathway)
  • Genetics and related dysfunction: affecting PD
  • Charckot, 1889
  • PD – new approach following drugs and deep brain stimulation failure in advanced disease: Fetal tissue transplant trials: Fetal Grafting
  • graft-induced dyskinesia
  • Long term, 15 years positive effects
  • Stem-cell-based regenerative therapy could transform PD therapy
  • 1995  Fetal DA neuron grafting for PD in Switzerland
  • 1998 – midbrain stem cell derived DA neuron
  • 200-2003 – Stem cell in brain implantation in WashDC
  • 2011 – Behavioral assays that are restored in mice
  • Optogenetics: manipulating – Light on the brain – control animal’s neurons
  • MOA of Graft function
  • Dopamine neurons – Stratium area of the human brain
  • From bench to bedside – WNT boost enhances EN1 expression
  • Neuron melanin induction
  • Manufacturing and QA testing: GMP – Off the shelf Allogenic Product
  • 1,000 human dose equivalents
  • cryopreserve
  • MSK-DA01 is highly enriched for mDA neuron precursors without detectable hESC Contaminants
  • FDA feedback and final steps to IND – PRE-IND MEETING: 2014, 2016
  • GLP STUDIES:
  • TUMORIGENICITY, BIODISTRIBUTION AND TOXISITY
  • HISTOLOGY OF FINAL PRODUCT
  • CLINICAL TRIAL DESIGN – STEM-PD – MSK and Weill Cornell Medicine
  • HLA expression is absent in edited iPSC with expression of HLA-E to block NK clearance
  • FUTURE: CRISPR
  • ATLaS-PD – assessing the longitudinal Symptoms/signs to moderate of severe stage
  • Development of a new PD therapy from Pluripotent Stem Cells
  • BlueRock Therapeutics – MSK-PD – Start up – $240Million funding
  • Stem cell based dopamine therapy for PD
  • Immunosuppression for 12 months
  • defined levodopa response > 45% improvement
  • Conclusions
  • Cell banks for clinical trials
  • NY state Stem cell science consortia

http://www.brandeis.edu/rosenstiel/images/pdfs/gabbay21program.pdf

Surgical Aortic Valve Replacement (SAVR) vs Transcatheter Aortic Valve Implantation (TAVI): Results Comparison for Prosthesis-Patient Mismatch (PPM) – adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year

 

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 4/13/2023

TAVR vs. SAVR in patients with pure aortic regurgitation: Key insights from a new Cleveland Clinic study
Michael Walter | April 11, 2023 | TAVR

Overall, TAVR and SAVR patients were linked to comparable in-hospital mortality, 30-day mortality and 30-day stroke rates. After a median follow-up period of 31 months, however, TAVR patients were associated with a higher mortality rate and higher risk of redo aortic valve replacement.

“The poorer intermediate-term outcomes with TAVR in our study could potentially be due to residual unmeasured differences and surgical risk between the two groups, but could also be related to the anatomical differences between pure severe AR and aortic stenosis,” the authors wrote. “The increased prevalence of bicuspid leaflets and annular/aortic root dilation in AR patients, with relatively less leaflet and annular calcification, pose a challenge with transcatheter heart valve anchoring and adequate positioning and increase the risk of paravalvular leak and device embolization. Abnormal hemodynamics across prosthetic valves and paravalvular leakage, whether mild or moderate/severe, are known predictors of poor outcomes, including death. The recommendation to oversize the THV during implantation is also associated with increased risk of aortic rupture and conversion to open heart surgery, a complication that was observed in 1% of TAVR patients in our study.”

UPDATED on 11/27/2018

Journal of the American College of Cardiology

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients

Abstract

Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients.

Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.

Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.

Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.

Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)

SOURCE

http://www.onlinejacc.org/content/72/22/2687

J Am Coll Cardiol. 2018 Sep 18. pii: S0735-1097(18)38287-1. doi: 10.1016/j.jacc.2018.09.001. [Epub ahead of print]

Prosthesis-Patient Mismatch in 62,125 Patients Following Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry.

Abstract

BACKGROUND:

Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (AVR) for aortic stenosis is generally associated with worse outcomes. Transcatheter AVR (TAVR) can achieve a larger valve orifice and the effects of PPM after TAVR are less well studied.

OBJECTIVES:

The authors utilized the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry to examine the frequency, predictors, and association with outcomes of PPM after TAVR in 62,125 patients enrolled between 2014 and 2017.

METHODS:

On the basis of the discharge echocardiographic effective valve area indexed to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65 to 0.85 cm2/m2), or none (>0.85 cm2/m2). Multivariable regression models were utilized to examine predictors of severe PPM as well as adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year in 37,470 Medicare patients with claims linkage.

RESULTS:

  • Severe and moderate PPM were present following TAVR in 12% and 25% of patients, respectively. Predictors of severe PPM included small (≤23-mm diameter) valve prosthesis, valve-in-valve procedure, larger body surface area, female sex, younger age, non-white/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation.
  • At 1 year, mortality was 17.2%, 15.6%, and 15.9% in severe, moderate, and no PPM patients, respectively (p = 0.02).
  • HF rehospitalization had occurred in 14.7%, 12.8%, and 11.9% of patients with severe, moderate, and no PPM, respectively (p < 0.0001).
  • There was no association of severe PPM with stroke or quality of life score at 1 year.

CONCLUSIONS:

Severe PPM after TAVR was present in 12% of patients and was associated with higher mortality and HF rehospitalization at 1 year. Further investigation is warranted into the prevention of severe PPM in patients undergoing TAVR.

KEYWORDS:

aortic stenosis; prosthesis–patient mismatch; transcatheter aortic valve replacement

PMID:
30257798
DOI:
10.1016/j.jacc.2018.09.001

SOURCE

https://www.ncbi.nlm.nih.gov/pubmed/30257798

 

Prior Meta Analysis Study

Ann Thorac Surg. 2016 Mar;101(3):872-80

 

Ann Thorac Surg. 2016 Mar;101(3):872-80. doi: 10.1016/j.athoracsur.2015.11.048. Epub 2016 Jan 29.

Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Implantation.

Abstract

BACKGROUND:

We reviewed currently available studies that investigated prosthesis-patient mismatch (PPM) in transcatheter aortic valve implantation (TAVI) with a systematic literature search and meta-analytic estimates.

METHODS:

To identify all studies that investigated PPM in TAVI, MEDLINE and EMBASE were searched through August 2015. Studies considered for inclusion met the following criteria: the study population included patients undergoing TAVI and outcomes included at least post-procedural PPM prevalence. We performed three quantitative meta-analyses about (1) PPM prevalence after TAVI, (2) PPM prevalence after TAVI versus surgical aortic valve replacement (SAVR), and (3) late all-cause mortality after TAVI in patients with PPM versus patients without PPM.

RESULTS:

We identified 21 eligible studies that included data on a total of 4,000 patients undergoing TAVI. The first meta-analyses found moderate PPM prevalence of 26.7%, severe PPM prevalence of 8.0%, and overall PPM prevalence of 35.1%. The second meta-analyses of six studies, including 745 patients, found statistically significant reductions in moderate (p = 0.03), severe (p = 0.0003), and overall (p = 0.02) PPM prevalence after TAVI relative to SAVR. The third meta-analyses of five studies, including 2,654 patients, found no statistically significant differences in late mortality between patients with severe PPM and patients without PPM (p = 0.44) and between patients with overall PPM and patients without PPM (p = 0.97).

CONCLUSIONS:

Overall, moderate, and severe PPM prevalence after TAVI was 35%, 27%, and 8%, respectively, which may be less than that after SAVR. In contrast to PPM after SAVR, PPM after TAVI may not impair late survival.

Comment in

 

Other related studies published on TAVR, TAVI in this Open Access Online Scientific Journal include the following:

 

  • New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/31/new-method-for-performing-aortic-valve-replacement-transmural-catheter-procedure-developed-at-nih-minimally-invasive-tissue-crossing-transcaval-access-abdominal-aorta-and-the-inferior-vena-cava/

 

  • Second in the United States to implant Edwards Newly FDA-Approved Aortic Valve “Intuity Elite” Sutureless Valve at Northwestern Medicine

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/13/second-in-the-united-states-to-implant-edwards-newly-fda-approved-aortic-valve-intuity-elite-sutureless-valve-at-northwestern-medicine/

 

  • Medtronic’s CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/09/15/medtronics-corevalve-system-sustains-positive-outcomes-through-two-years-in-extreme-risk-patients/

 

  • One year Post-Intervention Mortality Rate: TAVR and AVR – Aortic Valve Procedures 6.7% in AVR, 11.0% in AVR with CABG, 20.7 in Transvascular (TV-TAVR) and 28.0% in Transapical (TA-TAVR) Patients

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/08/04/one-year-post-intervention-mortality-rate-tavr-and-avr-aortic-valve-procedures-6-7-in-avr-11-0-in-avr-with-cabg-20-7-in-transvascular-tv-tavt-and-28-0-in-transapical-ta-tavr-patients/

 

  • Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/01/26/developments-on-the-frontier-of-transcatheter-aortic-valve-replacement-tavr-devices/

 

  • Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/06/22/off-label-tavr-procedures-1-in-10-associated-with-higher-in-hospital-30-day-mortality-1-year-mortality-was-similar-in-the-off-lavel-and-the-on-label-groups/

 

  • First U.S. TAVR Patients Treated With Temporary Pacing Lead (Tempo Lead)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/21/first-u-s-tavr-patients-treated-with-temporary-pacing-lead-tempo-lead/

 

  • SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients with Severe Aortic Stenosis: One-Year Clinical Outcomes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/14/sapien-3-transcatheter-aortic-valve-replacement-in-high-risk-and-inoperable-patients-with-severe-aortic-stenosis-one-year-clinical-outcomes/

 

  • TAVR with Sapien 3: combined all-cause death & disabling stroke rate was 8.4% and 16.6% for the surgery arm

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/04/05/tavr-with-sapien-3-combined-all-cause-death-disabling-stroke-rate-was-8-4-and-16-6-for-the-surgery-arm/

 

  • Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/hadassah-opens-israels-first-heart-valve-disease-clinic/

  • Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/

 

  • Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/

 

  • Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis


Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/09/03/transcatheter-aortic-valve-replacement-for-inoperable-severe-aortic-stenosis/

 

  • Updated Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

Reporter: Aviva Lev-Ari, PhD,RN

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

 

  • The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

 

  • Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

 

  • Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

 

 

HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #257: HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future. Published on 10/8/2018

WordCloud Image Produced by Adam Tubman

3.4.6

3.4.6   HUBweek 2018, October 8-14, 2018, Greater Boston – “We The Future” – coming together, of breaking down barriers, of convening across disciplinary lines to shape our future, 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

HUBweek 2018

Hi Aviva,

 

At HUBweek and in this community, we believe a brighter future is built together. In these times of division, particularly when many are feeling excluded from the benefits brought forth by rapid technological development, there is critical importance in the act of coming together, of breaking down barriers, of convening across disciplinary lines to shape our future.

That’s why this year’s theme for HUBweek is We the Future. It is a call to action and an invitation. Throughout the week, we’ll bring together innovators, artists, and curious minds to explore the ways in which we can shape a more inclusive and equitable future for all.

Today, HUBweek kicks off with dozens of events taking place across the city–from public art tours, a drone zoo, and discussions on nuclear weapons and the impact of emerging technologies on people with disabilities, to a policy hackathon hosted by MIT and the first ever Change Maker Conference.

There are 225+ more experiences to take part in throughout HUBweek–a three-day Forum and a documentary film festival; open dialogues with leading thinkers; a robot block party; and collaborative and participatory art. And we’ve got a little fun in store for you, too–make sure you sign up and stop by The HUB later this week to check it all out.

At its core, HUBweek is a collaboration. If not for our partners and the unwavering support of this community, this would not be a reality. A big thank you to our presenting partners Blue Cross Blue Shield of Massachusetts, Liberty Mutual Insurance, and Merck KGaA, to our sponsors, and to the hundreds of collaborating organizations, speakers, artists, and creative minds that are behind this year’s festival.

On behalf of the HUBweek team and our founders The Boston Globe, Harvard University, Mass. General Hospital, and MIT, we’re thrilled to invite you to join us at HUBweek 2018.

 

Linda Pizzuti Henry

 

 

SOURCE

 

From: Linda Pizzuti Henry <hello@hubweek.org>

Reply-To: <hello@hubweek.org>

Date: Monday, October 8, 2018 at 9:38 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Welcome to HUBweek

Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers

Reporter: Aviva Lev-Ari, PhD, RN

 

BackBeat’s CNT is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS).  Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers.

For more information: www.orchestrabiomed.com

October 2, 2018 — Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat cardiac neuromodulation therapy (CNT) was used in patients with persistent hypertension (office BP > 150mmHg). Patients in the study had persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker.

Results of the multicenter clinical trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, by Daniel Burkhoff, M.D., Ph.D., director, heart failure, hemodynamics and mechanical circulatory support research for the Cardiovascular Research Foundation (CRF).

“The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70 percent of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Prof. Petr Neuzil, M.D., head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the principal investigators of the study.

The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:

  • Efficacy Outcomes: Immediate, substantial and sustained reduction in blood pressure.
    • 14.2 mmHg decrease from baseline (p<0.001) in 24 hours ambulatory systolic blood pressure (AMB BP) at 3 months
    • 23.4 mmHg decrease from baseline (p < 0.001) in systolic blood pressure (SBP) sustained out to 2 years
  • High responder rate in a population where 78 percent of patients had isolated systolic hypertension.
    • 85 percent AMB BP reduced >5mmHg
    • 74 percent AMB BP reduced >10 mmHg
  • Safety Outcomes: The study met the safety endpoint.
    • Observed reduction in end systolic and diastolic volumes with no change to ejection fraction suggests improvement of cardiac function
    • Observed reduction in heart rate out to 2 years indicative of reduced sympathetic activity

“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”

To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy trial, Moderato II. The study will enroll patients with uncontrolled blood pressure (office systolic > 140, day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control.  The company is expecting results on the first cohort of patients in 2019.

SOURCE

https://www.dicardiology.com/content/backbeat-cardiac-neuromodulation-therapy-reduces-blood-pressure-two-years?eid=333021707&bid=2258792

Forthcoming in 2018 – Volume V (Drugs in Treatment of Heart Disease) and Volume VI (Cardiac Imaging & Surgery and Interventional Cardiology)

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 8/2/2022

Forthcoming in Spanish Audio all SIX volumes

  • Cardiovascular Diseases, Volume Five: 
  • Pharmacological Agents in Treatment of Cardiovascular Diseases. On Amazon.com since 12/23/2018

https://www.amazon.com/dp/B07MGSFDWR

 

 

  • Cardiovascular Diseases, Volume Six:
  • Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment. On Amazon.com since 12/24/2018

https://www.amazon.com/dp/B07MKHDBHF

 

See already published on Amazon.com

Volumes I, II, III, IV

 

Series A: e-Books on Cardiovascular Diseases

 

  • Cardiovascular Diseases, Volume One: Perspectives on Nitric Oxide in Disease Mechanisms. On Amazon.com since 6/21/2013

http://www.amazon.com/dp/B00DINFFYC

Perspectives on Nitric Oxide in Disease Mechanisms (Biomed e-Books Book 1) by [Baker PhD, Margaret, Barliya PhD, Tilda , Sarkar PhD, Anamika, Saxena PhD, Ritu , Williams PhD, Stephen J. ]

Perspectives on Nitric Oxide in Disease Mechanisms (Biomed e-Books Book 1)

Jun 20, 2013 | Kindle eBook

by Margaret Baker PhD and Tilda Barliya PhD
Subscribers read for free.
Get it TODAY, Oct 3
Sold by: Amazon Digital Services LLC

 

  • Cardiovascular Diseases, Volume Two: Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation. On Amazon.com since 11/30/2015

http://www.amazon.com/dp/B018Q5MCN8

“,”width”:”460″}” data-action=”a-modal”>Ad feedback 

Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation: The Art of Scientific & Medical Curation by [Bernstein MD FCAP, Larry H., Lal MBBS MD F.Cl.R., Vivek, Williams PhD, Stephen J., Lev-Ari PhD RN, Aviva]

Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation: The Art of Scientific & Medical Curation

Nov 29, 2015 | Kindle eBook

by Larry H. Bernstein MD FCAP and Aviva Lev-Ari PhD RN
Subscribers read for free.
Get it TODAY, Oct 3
Sold by: Amazon Digital Services LLC
  • Cardiovascular Diseases, Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics. On Amazon.com since 11/29/2015

http://www.amazon.com/dp/B018PNHJ84

Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics by [Williams PhD, Stephen J., Pearlman MD ME PhD MA FACC, Justin D., Barliya PhD, Tilda, Stoicescu MD PhD, Manuela, Saha PhD, Sudipta, Vatsa PhD, Aviral]

Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics

Nov 28, 2015 | Kindle eBook

by Justin D. Pearlman MD ME PhD MA FACC and Stephen J. Williams PhD
Subscribers read for free.
Get it TODAY, Oct 3
Sold by: Amazon Digital Services LLC
  • Cardiovascular Diseases, Volume Four: Regenerative and Translational Medicine: The Therapeutics Promise for Cardiovascular Diseases. On Amazon.com since 12/26/2015

http://www.amazon.com/dp/B019UM909A

Regenerative and Translational Medicine: The Therapeutic Promise for Cardiovascular Diseases by [Pearlman MD ME PhD MA FACC, Justin D., Saxena PhD, Ritu, Saha PhD, Sudipta, Sag PhD, Demet, Williams, Stephen J., Baker PhD, Margaret]

Regenerative and Translational Medicine: The Therapeutic Promise for Cardiovascular Diseases

Dec 26, 2015 | Kindle eBook

by Justin D. Pearlman MD ME PhD MA FACC and Ritu Saxena PhD
Subscribers read for free.
Get it TODAY, Oct 3
Sold by: Amazon Digital Services LLC

‘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

 

 

Reporter: Aviva Lev-Ari, PhD, RN

 

 

UPDATED on 11/5/2018

On 5 November, the London-based Wellcome Trust and the Bill and Melinda Gates Foundation in Seattle, Washington, announced they were both endorsing ‘Plan S’, adding their weight to an initiative already backed by 13 research funders across Europe since its launch in September. The plan was spearheaded by Robert-Jan Smits, the European Commission’s special envoy on open access.

The Wellcome Trust, which gave out £1.1 billion (US$1.4 billion) in grants in 2016–17, is also the first funder to detail how it intends to implement Plan S. Its approach suggests that journals may not need to switch wholesale to open-access (OA) models by 2020 to be compliant with Plan S — if the initiative’s other backers decide on a similar line.

The biomedical charity already has an OA policy, but in some cases it allows an embargo of up to six months after publication before papers have to be made free to read. The organization says that by 1 January 2020, it will ban all such embargoes.

Wellcome-funded work will not be able to appear in NatureScience and other influential subscription journals unless these publications permit Wellcome-funded papers to be published under OA terms (Nature’s news team is editorially independent of its publisher, Springer Nature).

SOURCE

https://www.nature.com/articles/d41586-018-07300-5?utm_source=briefing-dy&utm_medium=email&utm_campaign=briefing&utm_content=20181105

 

Open Access Online Scientific Journal in Healthcare, Pharmaceuticals, MedTech, BioMed was launched by me in 4/2012, http://pharmaceuticalintelligence.com

  • Because I believe that scientific works must be free to read as soon as it is published !!!!

Site statistics on 10/1/2018

  • 1,496,665 e-Readers

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In Nature 561, 17-18 (2018) doi: 10.1038/d41586-018-06178-7

Radical open-access plan could spell end to journal subscriptions – Eleven research funders in Europe announce ‘Plan S’ to make all scientific works free to read as soon as they are published.

04 SEPTEMBER 2018

Robert-Jan Smits, the European Commission’s special envoy on open access, spearheaded the Plan S initiative.Credit: Nikolay Doychinov/EU2018BG

Research funders from France, the United Kingdom, the Netherlands and eight other European nations have unveiled a radical open-access initiative that could change the face of science publishing in two years — and which has instantly provoked protest from publishers.

The 11 agencies, who together spend €7.6 billion (US$8.8 billion) in research grants annually, say they will mandate that, from 2020, the scientists they fund must make resulting papers free to read immediately on publication (see ‘Plan S players’). The papers would have a liberal publishing licence that would allow anyone else to download, translate or otherwise reuse the work. “No science should be locked behind paywalls!” says a preamble document that accompanies the pledge, called Plan S, released on 4 September.

“It is a very powerful declaration. It will be contentious and stir up strong feelings,” says Stephen Curry, a structural biologist and open-access advocate at Imperial College London. The policy, he says, appears to mark a “significant shift” in the open-access publishing movement, which has seen slow progress in its bid to make scientific literature freely available online.

As written, Plan S would bar researchers from publishing in 85% of journals, including influential titles such as Nature and Science. According to a December 2017 analysis, only around 15% of journals publish work immediately as open access (see ‘Publishing models’) — financed by charging per-article fees to authors or their funders, negotiating general open-publishing contracts with funders, or through other means. More than one-third of journals still publish papers behind a paywall, and typically permit online release of free-to-read versions only after a delay of at least six months — in compliance with the policies of influential funders such as the US National Institutes of Health (NIH).

And just less than half have adopted a ‘hybrid’ model of publishing, whereby they make papers immediately free to read for a fee if a scientist wishes, but keep most studies behind paywalls. Under Plan S, however, scientists wouldn’t be allowed to publish in these hybrid journals, except during a “transition period that should be as short as possible”, the preamble says.

Source: Universities UK

“Hybrid journals were always viewed as a step towards full open access. They haven’t succeeded as a transitionary measure,” says David Sweeney, who chairs Research England, one of the funding agencies subsumed under UKRI, the United Kingdom’s national research funder. The plan also states that funders will cap the amount they are willing to pay for open-access publishing fees, but doesn’t lay out what charge would be too much.

Putting the ‘s’ in Plan S

The initiative is spearheaded by Robert-Jan Smits, the European Commission’s special envoy on open access. (The ‘S’ in Plan S can stand for ‘science, speed, solution, shock’, he says). In addition to the French, British and Dutch funders, national agencies in Austria, Ireland, Luxembourg, Norway, Poland and Slovenia have also signed, as have research councils in Italy and Sweden.

“Paywalls are not only hindering the scientific enterprise itself but also they are an obstacle [to] the uptake of research results by the wider public,” says Marc Schiltz, president of Science Europe, a Brussels-based advocacy group that represents European research agencies and which officially launched the policy.

PLAN S PLAYERS

So far, 11 national funding agencies in Europe have signed up to Plan S.

  • Austrian Science Fund
  • French National Research Agency
  • Science Foundation Ireland
  • National Research Fund (Luxembourg)
  • Italian National Institute for Nuclear Physics
  • Netherlands Organisation for Scientific Research
  • Research Council of Norway
  • National Science Centre (Poland)
  • Slovenian Research Agency
  • Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning
  • UK Research and Innovation

Smits says he took inspiration from the open-access policy of the Bill & Melinda Gates Foundation, the global health charity based in Seattle, Washington, which also demands immediate open-access publishing. Because Plan S forbids hybrid publishing — and because it involves multiple funders — its impacts could be even more far-reaching than the Gates policy, which by itself has nudged several influential journals to change their publishing models.

Not quite all aboard

Despite Smits’ role, the European Commission hasn’t itself signed the plan. But Smits says that he expects the requirements to be integrated into the terms and conditions of future research grants from the commission. That hasn’t happened yet because policymakers are still debating the details of its next research and innovation programme, Horizon Europe, which begins in 2021 and will be worth €100 billion over 7 years. Smits says he expects more funding agencies to join, and that he will discuss the plan in the United States next month with White House officials, scientific academies and universities.

“The plan is roughly what one would want after about 15 years of funder experimentation with weaker policies,” says Peter Suber, director of the Harvard Open Access Project and the Harvard Office for Scholarly Communication in Cambridge, Massachusetts. “We are very supportive of the ambition set out in Plan S,” adds Jeremy Farrar, director of the Wellcome Trust, a large private biomedical charity in London. He says the funder is finalizing a new open-access policy.

But national research agencies in some of Europe’s leading scientific nations, such as Switzerland, Sweden and Germany, have not yet signed. In Sweden’s case, this is because it has doubts over the tight timetable, says Sven Stafström, head of the country’s research council. He says the council agrees with the aims of Plan S and will review its position on the document at a board meeting later this month. Peter Strohschneider, president of Germany’s national research council, the DFG, says his council hadn’t signed because of the way the plan mandates recipients of public funding to specific forms of open access. “We request our researchers to publish their findings from DFG grants open access but we do not mandate them,” he said. He also cautioned that if researchers were all told to publish in open-access journals, costs of publishing could increase.

Sweeney says that, in the United Kingdom, it isn’t possible to calculate how much funders will need to pay under open-access publishing without a fuller picture of how publishers will respond. “What it costs depends on the reaction of the industry. This is a statement about principles, it is not a statement about [publishing] models,” he says.

And for Stan Gielen, president of the Netherlands Organisation for Scientific Research (NWO), Plan S goes beyond the economics of publishing. “This is part of a bigger transition towards open science and a re-evaluation of how we measure science and the quality of scientists,” he says.

Publisher concerns

Asked for comments ahead of the plan’s launch, publishers said they had serious concerns — particularly around the banning of hybrid journals. A spokesperson for the International Association of Scientific, Technical and Medical Publishers (STM), based in Oxford, UK, which represents 145 publishers, told Nature’s news team that although it welcomed funders’ efforts to expand access to peer-reviewed scientific works, some sections of Plan S “require further careful consideration to avoid any unintended limitations on academic freedoms”. In particular, the STM spokesperson said, banning hybrid journals — which have delivered a lot of growth in open-access articles (see ‘Growth in open access’) — could “severely slow down the transition”. The publishing giant Elsevier said it supported the STM’s comments.

Source: UUK (2017)/BMC Med. 10, 124 (2012).

In another statement, a spokesperson for Springer Nature said: “Research, and the communication of it, is global. We urge research funding agencies to align rather than act in small groups in ways that are incompatible with each other, and for policymakers to also take this global view into account.” Removing publishing options from researchers “fails to take this into account and potentially undermines the whole research publishing system”, the statement added. (Nature’s news team is editorially independent of its publisher).

Meanwhile, the American Association for the Advancement of Science (AAAS), a non-profit organization that publishes the journal Science, said that the model outlined in Plan S “will not support high-quality peer-review, research publication and dissemination”. Implementing the plan would “be a disservice to researchers” and “would also be unsustainable for the Science family of journals”, the AAAS says.

Smits, however, says that it is essential that high-quality peer review remains part of the science publishing system under Plan S. “Publishers are not the enemy. I want them to be part of the change,” he says.

S for sanction?

Only a few funding agencies currently punish researchers who decide not to follow their open-access policies — including the Wellcome Trust and the NIH. But under Plan S, funders promise to “sanction non-compliance”, the initiative states. Smits suggests that a possible sanction for researchers who don’t comply could be withholding the final instalment of a grant, which is usually paid once a project is completed. But this, and other details such as the amount that funders are willing to pay to publish each article, will be worked out by the coalition in the run-up to 2020, he says.

Many European funders have been trying to make research free to read by brokering new ‘read-and-publish’ contracts with publishers, in which a single fee is paid to cover both the costs of reading paywalled research and of authors publishing under open-access terms. But some of the funders who have signed Plan S — including those in the Netherlands and Norway — now say they don’t intend to pay any more subscription fees beyond a transitionary period.

If other funders follow the Plan S idea, it could spell the end of scientific publishing’s dominant subscription business model, says John-Arne Røttingen, the head of Norway’s research council. “Subscription journals will see the opportunity to flip their business models into a system where what is paid for is the solid peer review, editorial reviewing and electronic dissemination of research results,” he says.

But Curry cautions that shifting from a subscription to an open-access business model around the world, as Plan S signers advocate, could bring a new challenge — how scientists in poorer nations will be able to afford to publish open-access work. “That has to be part of the conversation,” he says.

Nature 561, 17-18 (2018)

doi: 10.1038/d41586-018-06178-7