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Archive for the ‘Population Health Management’ Category


The Rutgers Global Health Institute, part of Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, New Jersey – A New Venture Designed to Improve Health and Wellness Globally  

Author: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, Hospital CEOs, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

 

The newly formed Rutgers Global Health Institute, part of Rutgers Biomedical and Health Sciences (RBHS) of Rutgers University, New Brunswick, New Jersey (http://rbhs.rutgers.edu/), represents a new way of thinking by providing positive health outcomes to potential patients around the world affected by disease and/or by a negative environmental impact. The goal of the Institute is three-fold:

  • to improve the health and wellness of individuals and populations around the world,
  • to create a healthier world through innovation, engineering, and technology, and
  • to educate involved citizens and effective leaders in global health.

Richard G. Marlink, M.D., a former Harvard University professor recognized internationally for research and leadership in the fight against AIDS, was recently appointed as the inaugural Henry Rutgers Professor of Global Health and Director of the Rutgers Global Health Institute.

The Rutgers Global Health Institute was formed last year after research by the University into the most significant health issues affecting under-served and under-developed populations. While conducting research for its five-year strategic plan, the RBHS looked for bold and ambitious ways that they could take advantage of the changing health care environment and band together to tackle the world’s leading health and environmental causes, contributing to the betterment of society. One of the results was the formation of the Rutgers Global Health Institute, supporting cross-functionally Rutgers faculty, scientists, and clinicians who represent the best in their respective fields of health innovation, research and patient care related to global health.

More broadly, the RBHS, created in 2013, is one of the nation’s leading – and largest — academic health centers that provides health care education, research and clinical service and care. It is an umbrella organization that encompasses eight schools – Ernest Mario School of Pharmacy, Graduate School of Biomedical Sciences, New Jersey Medical School, Robert Wood Johnson Medical School, Rutgers School of Dental Medicine, School of Health Professions, School of Nursing and School of Public Health.

In addition, the RBHS encompasses six centers and institutes that provide cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health and health care policy and aging research. Those centers and institutes are the Brain Health Institute, Center for Advanced Biotechnology and Medicine, Environmental and Occupational Health Sciences Institute, Institute for Health, Health Care Policy and Aging Research, Rutgers Cancer Institute of New Jersey, and Rutgers Institute for Translational Medicine and Research. And lastly, the RBHS includes the University Behavioral Health Care.

 

Rutgers Institute For Health Building

Image SOURCE: Photograph courtesy of the Rutgers Global Health Institute, Rutgers Biomedical and Health Sciences, Rutgers University, New Brunswick, New Jersey.   

 

Below is my interview with the Inaugural Henry Rutgers Professor of Global Health and Director of the Rutgers Global Health Institute Richard G. Marlink, M.D., which occurred in April, 2017.

You were recently appointed as the inaugural Henry Rutgers Professor of Global Health and Director of the new Rutgers Global Health Institute at Rutgers Biomedical and Health Sciences (RBHS). What are the goals of the new Institute?

Dr. Marlink: The overarching goal of the Rutgers Global Health Institute is to improve the health and wellness of individuals and populations in need both here and around the world, to create a healthier world through innovation, engineering, and technology, and to educate involved citizens and effective leaders in global health. We will do that by building on the aspiration of our originating organization — RBHS, which is to be recognized as one of the best academic health centers in the U.S., known for its education, research, clinical care, and commitment to improving access to health care and reducing health care disparities.

As the newly formed Rutgers Global Health Institute, we are embarking on an ambitious agenda to take advantage of the changing health care environment. Working across schools and disciplines at Rutgers University, we plan to have a significant impact within at least four signature programs identified by RBHS, which are cancer, environmental and occupational health, infection and inflammation, and public health. We also will include all other parts of Rutgers, as desired, beyond RBHS.

My background as a global health researcher, physician, and leader of grassroots health care delivery will help develop programs to undertake global health initiatives that assist populations locally and around the world. I believe that involved citizens, including students, can greatly impact major societal issues.

A key role in the strategic growth of Rutgers Biomedical and Health Sciences – an umbrella organization for eight schools, four centers and institutes and a behavioral health network — is to broaden the Rutgers University’s presence in the public health community globally to improve health and wellness. How will the new Rutgers Global Health Institute be part of this growth?

Dr. Marlink: Our RBHS Chancellor Brian Strom [M.D., M.P.H.] believes that we are positioned to become one of the finest research universities in the country, working cross-functionally with our three campuses in Newark, Camden and New Brunswick. In developing the strategic plan, Dr. Strom notes that we become much stronger and more capable and productive by leveraging our strengths to collaborate and working together across disciplines to best serve the needs of our community locally and globally.

Specifically, we are formulating plans to focus on these areas: old and new infectious disease epidemics; the expanding burden of noncommunicable diseases in poor populations; the social and environmental threats to health, poverty and humanitarian crises; and inadequate local and developing country health systems. We will support the development of global health research programs university-wide, the recruitment of faculty with interests in global health, and the creation of a web-based global health resource center for faculty and students with interests in these areas.

We are still a very young part of RBHS, and of Rutgers overall, so our plans are a work in progress. As tangible examples of our commitment to improving health and wellness globally, we plan to enhance global public health by establishing links between global public health and environmental and occupational health faculty in studies related to air pollution, climate change, and pesticide health.

Another example the Institute has in the works is expanding links with the School of Engineering. In fact, we are creating a senior-level joint faculty position with the School of Engineering and Rutgers-New Brunswick. Still other plans involve forging collaborative relationships between the Rutgers Cancer Program, under the auspices of Rutgers Cancer Institute of New Jersey, which is New Jersey’s only National Cancer Institute (NCI)-designated comprehensive cancer center, and other organizations and partners around the world, especially in poor and less-developed countries.

How is the Rutgers Global Health Institute strategically prepared for changing the health care paradigm?

Dr. Marlink: We intend to be an international global health leader in the health sciences, in public health, and in other related, but non-biomedical professions. This means that we will incorporate our learnings from laboratory sciences and the clinical, behavioral, and public health sciences, as well as from engineering, business, economics, law, and social sciences. This broad approach is critical in this health care environment as accountability for patient care is shifting to large groups of providers. Health care will be more value-driven and our health care teams must work collaboratively to be innovative. Our focus on health care is now also population-based, rather than only individual-based, and we are moving from large regional centers toward community centers, even in small and remote areas of the world. We are encouraged by rapid changes in technology that will provide new opportunities for shared knowledge, patient care and research.

Additionally, we are exploring ways to identify and recruit key faculty who will increase our breadth and depth of key disease areas as well as provide guidance on how to pursue science grants from the National Institute of Health (NIH)-funded program project grants and specialized research programs.

Currently, Rutgers University receives NIH funding for research in public health, population health, health promotion, wellness, health behavior, preventive medicine, and global health.

As a researcher, scholar and leader of grassroots health care delivery, how have your past positions prepared you for this new challenge? Your last position was the Bruce A. Beal, Robert L. Beal, and Alexander S. Beal Professor of the Practice of Public Health at Harvard University’s T.H. Chan School of Public Health and Executive Director of the Harvard AIDS Initiative.

Dr. Marlink: I have been a global health practitioner, researcher, and executive leader for almost three decades. I am trained in medical oncology and HIV medicine and have conducted clinical, epidemiological and implementation research in Africa since 1985. I was first introduced to global health when finishing my Hematology/Oncology fellowship at what is now the Beth Israel Deaconess Medical Center in the mid-1980’s in Boston.

During my Hematology/Oncology fellowship and after the co-organizing the first, hospital-based AIDS care clinic in the New England region, I was trying to learn the ropes in virology and molecular biology in the laboratory group of Max Essex at Harvard University. During that time in the mid-1980s, our laboratory group along with Senegalese and French collaborators discovered the first evidence for the existence of a new human retrovirus, HIV-2, a distinct second type of human AIDS virus, with its apparent origins in West Africa.

As a clinician, I was able to assist in Senegal, helping set up clinical care and create a research cohort in Dakar for hundreds of women sex workers infected with this new human retrovirus and care for them and their families. I discovered that a little can go a long way in poor settings, such as in Senegal. I became hooked on helping create solutions to help people in poor settings in Africa and elsewhere. Long-term partnerships and friendships have subsequently been made in many developing countries. Throughout my career, I have built successful partnerships with many governments, companies, and non-profit organizations, and those relationships have been the foundation to build successful public health partnerships in poor regions of the world.

In the 1990s, I helped create the Botswana-Harvard Partnership for HIV Research and Education (BHP). Through this partnership, the Government of Botswana and BHP have worked together to combat the AIDS epidemic in Botswana. Under my direction, and in partnership with the Botswana Ministry of Health, BHP launched the KITSO AIDS Training Program in 1999. Kitso is the Setswana word for ‘knowledge.”

KITSO is the national training program for physicians, nurses, and pharmacists, which has trained more than 14,000 health professionals in HIV/AIDS care and antiretroviral treatment. KITSO training modules address issues, such as antiretroviral therapy, HIV/AIDS-related disease management, gender-specific HIV issues, task-sharing, supportive and palliative care, and various psychosocial and counseling themes.

In addition, I was the Botswana County Director for Harvard Chan School’s 3-country President’s Emergency Plan AIDS Relief (PEPFAR) grant, The Botswana PEPFAR effort includes a Clinical and Laboratory Master Training Program and the creation of the Botswana Ministry of Health’s Monitoring and Evaluation Unit. Concurrently, I was the Principal Investigator of Project HEART in five African countries with the Elizabeth Glaser Pediatric AIDS Foundation.

Also in Botswana, in 2000, I was a co-founder of a distinct partnership involving a large commitment to the Government of Botswana from the Bill and Melinda Gates and Merck Foundations.  This commitment continues as an independent non-governmental organization (NGO) to provide support for various AIDS prevention and care efforts in Botswana and the region.

All these global health experiences, it seems, have led me to my new role at the Rutgers Global Health Institute.

What is your advice for ways that the business community or university students can positively impact major societal issues?

Dr. Marlink: My advice is to be optimistic and follow that desire to want to make a difference. Margaret Mead, the American cultural anthropologist, said years ago, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” I believe that to be our guiding principle as we embark on this new initiative.

I also believe that students should become specialized in specific areas prior to going fully into “global health,” as they develop in their careers, since they will then add more value later. For example, students should be grounded in the theory of global health in their undergraduate studies and then develop a specialization, such as becoming a statistician, economist, or medical doctor, to make a longer and greater impact in improving global health. As for the business community, we are looking for committed individuals who are specialized in specific areas to bring their knowledge to our organization, as partners in the fight against disease, improving the environment, or helping with humanitarian issues. We are committed to improving health and wellness, increasing access to the best health care, and reducing health disparities.

What is it about your current role that you enjoy the most?

Dr. Marlink: I enjoy building research, learning, and clinical programs, as I have in the HIV arena since the early 1980s. At that time, there were limited resources and funding, but a willingness among universities, non-governmental organizations, hospitals and the pharmaceutical industry to make a difference. Today in my new role, I’d like all of us to have an impact on health and wellness for those in need – to build programs from the ground up while partnering with organizations with the same goal in mind. I know it can be done.

Over my career, when I have a patient here or in a developed country who has been diagnosed with cancer, but is cured or in remission, that puts a huge smile on my face and in my heart. It also impacts you for the rest of your life. Or when I see an infant born without HIV because of the local country programs that are put in place, that also makes me feel so fulfilled, so happy.

I have worked with many talented individuals who have become great friends and partners over my career who have helped create a positive life for under-served populations around the world. We need to remember that progress happens with one person at a time or one program at a time. That’s how you truly improve health around the world.

 

Headshot - 2016

Image SOURCE: Photograph of Inaugural Henry Rutgers Professor of Global Health and Director of the Rutgers Global Health Institute at Rutgers Biomedical and Health Sciences, courtesy of Rutgers University, New Brunswick, New Jersey.

Richard G. Marlink, M.D.
Inaugural Henry Rutgers Professor of Global Health

Director of the Rutgers Global Health Institute

Rutgers Biomedical and Health Sciences

Richard G. Marlink, M.D., a Harvard University professor recognized internationally for research and leadership in the fight against AIDS, was recently appointed as the inaugural Henry Rutgers Professor of Global Health and Director of a new Rutgers Global Health Institute at Rutgers Biomedical and Health Sciences (RBHS). His role is to develop the strategic growth of RBHS by broadening the Rutgers University’s presence in the public health community to improve health and wellness.

Previously, Dr. Marlink was the Bruce A. Beal, Robert L. Beal, and Alexander S. Beal Professor of the Practice of Public Health at Harvard’s T.H. Chan School of Public Health and Executive Director of the Harvard AIDS Initiative.

At the start of the AIDS epidemic, Dr. Marlink was instrumental in setting up the first, hospital-based HIV/AIDS clinic in Boston, Massachusetts, and studied the impact of the HIV virus in west and central Africa. After helping to start the Botswana-Harvard Partnership in 1996, he founded the Kitso AIDS Training Program, which would become Botswana’s national AIDS training program. Kitso means knowledge in the local Setswana language.

Dr. Marlink was the principal investigator for the Tshepo Study, the first large-scale antiretroviral treatment study in Botswana, in addition to conducting other clinical and epidemiological studies in the region. Also in Botswana, he was the country director for Harvard’s contribution to the joint Botswana and United States governments’ HIV/AIDS and TB training, monitoring and evaluation PEPFAR effort.

In the mid-1980s in Senegal, Dr. Marlink was part of the team of Senegalese, French and American researchers who discovered and then studied the second type of human AIDS virus, HIV-2. Since then, he has been involved in multiple HIV/AIDS care, treatment and prevention programs in many African countries, including in Botswana, Côte d’Ivoire (Ivory Coast), Democratic Republic of the Congo, Kenya, Lesotho, Malawi, Mozambique, Rwanda, Senegal, South Africa, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe. He has also organized initiatives to enhance HIV/AIDS care in Brazil, Puerto Rico and Thailand.

Dr. Marlink has served as the scientific director, the vice president for implementation and the senior adviser for medical and scientific affairs at the Elizabeth Glaser Pediatric AIDS Foundation, where he was principal investigator of Project HEART, a five-country CDC/PEPFAR effort in Africa. That project began in 2004 and by 2011 had placed more than 1 million people living with HIV into care clinics. More than 565,000 of these people were placed on life-saving antiretroviral treatment.

Since 2000, Dr. Marlink has been the founding member of the board of directors of the African Comprehensive HIV/AIDS Partnerships, a public-partnership among the government of Botswana and the Bill and Melinda Gates and Merck Foundations to provide ongoing support for numerous HIV/AIDS prevention, care and treatment efforts in that country.

He has authored or co-authored more than 130 scientific articles; written a textbook, Global AIDS Crisis: A Reference Handbook; and co-edited the book, AIDS in Africa, 2nd Edition. Additionally, he served as chief editor for two special supplements to the journal AIDS and as executive editor of the seminal 320-author, three-volume textbook, From the Ground Up: A Guide to Building Comprehensive HIV/AIDS Care Programs in Resource Limited Settings.

A trained fellow in hematology/oncology at the Beth Israel Deaconess Medical Center at Harvard Medical School, Dr. Marlink received his medical degree from the University of New Mexico and his bachelor’s degree from Brown University.

 

Editor’s note:

We would like to thank Marilyn DiGiaccobe, head of Partnerships and Strategic Initiatives, at the Rutgers Global Health Institute, for the help and support she provided during this interview.

 

REFERENCE/SOURCE

Rutgers Biomedical and Health Sciences (http://rbhs.rutgers.edu/)

Other related articles

Retrieved from https://aids.harvard.edu/ 

Retrieved from http://b.3cdn.net/glaser/515eaa8068b5e71d44_mlbrof7xw.pdf 

Other related articles were published in this Open Access Online Scientific Journal include the following: 

2016

CRISPR/Cas9 and HIV1 

https://pharmaceuticalintelligence.com/2016/04/16/crisprcas9-and-hiv1/

Concerns About Viruses

https://pharmaceuticalintelligence.com/2016/01/29/concerns-about-viruses/

CD-4 Therapy for Solid Tumors

https://pharmaceuticalintelligence.com/2016/05/02/cd-4-therapy-for-solid-tumors/

Novel Discoveries in Molecular Biology and Biomedical Science

https://pharmaceuticalintelligence.com/2016/05/30/novel-discoveries-in-molecular-biology-and-biomedical-science/

Scientists eliminate HIV1 DNA from the genome and prevent reinfection

https://pharmaceuticalintelligence.com/2016/03/23/scientists-eliminate-hiv1-dna-from-the-genome-and-prevent-reinfection/

Double Downside of HIV CRISPR therapy

https://pharmaceuticalintelligence.com/2016/04/09/double-downside-of-hiv-crispr-therapy/

2015

Where Infection meets with Cancer: Kaposi’s sarcoma (KS) is the most common cancer in HIV-1-infected persons and is caused by one of only 7 human cancer viruses, i.e., human herpesvirus 8 (HHV-8)

https://pharmaceuticalintelligence.com/2015/10/20/where-infection-meets-with-cancer-kaposis-sarcoma-ks-is-the-most-common-cancer-in-hiv-1-infected-persons-and-is-caused-by-one-of-only-7-human-cancer-viruses-i-e-human-herpesvirus-8-hhv/

Antibody shows promise as treatment for HIV

https://pharmaceuticalintelligence.com/2015/04/09/antibody-shows-promise-as-treatment-for-hiv/

2014

AIDS: Origin of HIV pandemic ‘was 1920s Kinshasa’

https://pharmaceuticalintelligence.com/2014/10/10/aids-origin-of-hiv-pandemic-was-1920s-kinshasa/

2013

Scientists discover how AIDS virus enters key immune cells

https://pharmaceuticalintelligence.com/2013/12/31/scientists-discover-how-aids-virus-enters-key-immune-cells/

Heroes in Medical Research: Dr. Robert Ting, Ph.D. and Retrovirus in AIDS and Cancer

https://pharmaceuticalintelligence.com/2013/04/17/heroes-in-medical-research-dr-robert-ting-ph-d-and-retrovirus-in-aids-and-cancer/

2012

Nanotechnology and HIV/AIDS treatment

https://pharmaceuticalintelligence.com/2012/12/25/nanotechnology-and-hivaids-treatment/

HIV vaccine: Caltech puts us One step further

https://pharmaceuticalintelligence.com/2012/08/31/hiv-vaccine-caltech-puts-us-one-step-further/

Bone Marrow Transplant Eliminates Signs of HIV Infection

https://pharmaceuticalintelligence.com/2012/07/29/bone-marrow-transplant-eliminates-signs-of-hiv-infection/

Getting Better: Documentary Videos on Medical Progress — in Surgery, Leukemia, and HIV/AIDS

https://pharmaceuticalintelligence.com/2012/08/23/getting-better-documentary-videos-on-medical-progress-in-surgery-leukemia-and-hivaids/

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

Scientists think excessive population growth is a cause of scarcity and environmental degradation. A male pill could reduce the number of unintended pregnancies, which accounts for 40 percent of all pregnancies worldwide.

 

But, big drug companies long ago dropped out of the search for a male contraceptive pill which is able to chemically intercept millions of sperm before they reach a woman’s egg. Right now the chemical burden for contraception relies solely on the female. There’s not much activity in the male contraception field because an effective solution is available on the female side.

 

Presently, male contraception means a condom or a vasectomy. But researchers from Center for Drug Discovery at Baylor College of Medicine, USA are renewing the search for a better option—an easy-to-take pill that’s safe, fast-acting, and reversible.

 

The scientists began with lists of genes active in the testes for sperm production and motility and then created knockout mice that lack those genes. Using the gene-editing technology called CRISPR, in collaboration with Japanese scientists, they have so far made more than 75 of these “knockout” mice.

 

They allowed these mice to mate with normal (wild type) female mice, and if their female partners don’t get pregnant after three to six months, it means the gene might be a target for a contraceptive. Out of 2300 genes that are particularly active in the testes of mice, the researchers have identified 30 genes whose deletion makes the male infertile. Next the scientists are planning a novel screening approach to test whether any of about two billion chemicals can disable these genes in a test tube. Promising chemicals could then be fed to male mice to see if they cause infertility.

 

Female birth control pills use hormones to inhibit a woman’s ovaries from releasing eggs. But hormones have side effects like weight gain, mood changes, and headaches. A trial of one male contraceptive hormone was stopped early in 2011 after one participant committed suicide and others reported depression. Moreover, some drug candidates have made animals permanently sterile which is not the goal of the research. The challenge is to prevent sperm being made without permanently sterilizing the individual.

 

As a better way to test drugs, Scientists at University of Georgia, USA are investigating yet another high-tech approach. They are turning human skin cells into stem cells that look and act like the spermatogonial cells in the testes. Testing drugs on such cells might provide more accurate leads than tests on mice.

 

The male pill would also have to start working quickly, a lot sooner than the female pill, which takes about a week to function. Scientists from University of Dundee, U.K. admitted that there are lots of challenges. Because, a women’s ovary usually release one mature egg each month, while a man makes millions of sperm every day. So, the male pill has to be made 100 percent effective and act instantaneously.

 

References:

 

https://www.technologyreview.com/s/603676/the-search-for-a-perfect-male-birth-control-pill/

 

https://futurism.com/videos/the-perfect-male-birth-control-pill-is-coming-soon/?utm_source=Digest&utm_campaign=c42fc7b9b6-EMAIL_CAMPAIGN_2017_03_20&utm_medium=email&utm_term=0_03cd0a26cd-c42fc7b9b6-246845533

 

http://www.telegraph.co.uk/women/sex/the-male-pill-is-coming—and-its-going-to-change-everything/

 

http://www.mensfitness.com/women/sex-tips/male-birth-control-pill-making

 

http://health.howstuffworks.com/sexual-health/contraception/male-bc-pill.htm

 

http://europe.newsweek.com/male-contraception-side-effects-study-pill-injection-518237?rm=eu

 

http://edition.cnn.com/2016/01/07/health/male-birth-control-pill/index.html

 

http://www.nhs.uk/Conditions/contraception-guide/Pages/male-pill.aspx

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

During pregnancy, the baby is mostly protected from harmful microorganisms by the amniotic sac, but recent research suggests the baby could be exposed to small quantities of microbes from the placenta, amniotic fluid, umbilical cord blood and fetal membranes. One theory is that any possible prenatal exposure could ‘pre-seed’ the infant microbiome. In other words, to set the right conditions for the ‘main seeding event’ for founding the infant microbiome.

When a mother gives birth vaginally and if she breastfeeds, she passes on colonies of essential microbes to her baby. This continues a chain of maternal heritage that stretches through female ancestry for thousands of generations, if all have been vaginally born and breastfed. This means a child’s microbiome, that is the trillions of microorganisms that live on and in him or her, will resemble the microbiome of his/her mother, the grandmother, the great-grandmother and so on, if all have been vaginally born and breastfed.

As soon as the mother’s waters break, suddenly the baby is exposed to a wave of the mother’s vaginal microbes that wash over the baby in the birth canal. They coat the baby’s skin, and enter the baby’s eyes, ears, nose and some are swallowed to be sent down into the gut. More microbes form of the mother’s gut microbes join the colonization through contact with the mother’s faecal matter. Many more microbes come from every breath, from every touch including skin-to-skin contact with the mother and of course, from breastfeeding.

With formula feeding, the baby won’t receive the 700 species of microbes found in breast milk. Inside breast milk, there are special sugars called human milk oligosaccharides (HMO’s) that are indigestible by the baby. These sugars are designed to feed the mother’s microbes newly arrived in the baby’s gut. By multiplying quickly, the ‘good’ bacteria crowd out any potentially harmful pathogens. These ‘good’ bacteria help train the baby’s naive immune system, teaching it to identify what is to be tolerated and what is pathogen to be attacked. This leads to the optimal training of the infant immune system resulting in a child’s best possible lifelong health.

With C-section birth and formula feeding, the baby is not likely to acquire the full complement of the mother’s vaginal, gut and breast milk microbes. Therefore, the baby’s microbiome is not likely to closely resemble the mother’s microbiome. A baby born by C-section is likely to have a different microbiome from its mother, its grandmother, its great-grandmother and so on. C-section breaks the chain of maternal heritage and this break can never be restored.

The long term effect of an altered microbiome for a child’s lifelong health is still to be proven, but many studies link C-section with a significantly increased risk for developing asthma, Type 1 diabetes, celiac disease and obesity. Scientists might not yet have all the answers, but the picture that is forming is that C-section and formula feeding could be significantly impacting the health of the next generation. Through the transgenerational aspect to birth, it could even be impacting the health of future generations.

References:

https://blogs.scientificamerican.com/guest-blog/shortchanging-a-babys-microbiome/

https://www.ncbi.nlm.nih.gov/pubmed/23926244

https://www.ncbi.nlm.nih.gov/pubmed/26412384

https://www.ncbi.nlm.nih.gov/pubmed/25290507

https://www.ncbi.nlm.nih.gov/pubmed/25974306

https://www.ncbi.nlm.nih.gov/pubmed/24637604

https://www.ncbi.nlm.nih.gov/pubmed/22911969

https://www.ncbi.nlm.nih.gov/pubmed/25650398

https://www.ncbi.nlm.nih.gov/pubmed/27362264

https://www.ncbi.nlm.nih.gov/pubmed/27306663

http://www.mdpi.com/1099-4300/14/11/2036

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4464665/

https://www.ncbi.nlm.nih.gov/pubmed/24848255

https://www.ncbi.nlm.nih.gov/pubmed/26412384

https://www.ncbi.nlm.nih.gov/pubmed/28112736

http://ndnr.com/gastrointestinal/the-infant-microbiome-how-environmental-maternal-factors-influence-its-development/

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genomicsinpersonalizedmedicinecovervolumeone

Content Consultant: Larry H Bernstein, MD, FCAP

Genomics Orientations for Personalized Medicine

Volume One

http://www.amazon.com/dp/B018DHBUO6

electronic Table of Contents

Chapter 1

1.1 Advances in the Understanding of the Human Genome The Initiation and Growth of Molecular Biology and Genomics – Part I

1.2 CRACKING THE CODE OF HUMAN LIFE: Milestones along the Way – Part IIA

1.3 DNA – The Next-Generation Storage Media for Digital Information

1.4 CRACKING THE CODE OF HUMAN LIFE: Recent Advances in Genomic Analysis and Disease – Part IIC

1.5 Advances in Separations Technology for the “OMICs” and Clarification of Therapeutic Targets

1.6 Genomic Analysis: FLUIDIGM Technology in the Life Science and Agricultural Biotechnology

Chapter 2

2.1 2013 Genomics: The Era Beyond the Sequencing of the Human Genome: Francis Collins, Craig Venter, Eric Lander, et al.

2.2 DNA structure and Oligonucleotides

2.3 Genome-Wide Detection of Single-Nucleotide and Copy-Number Variation of a Single Human Cell 

2.4 Genomics and Evolution

2.5 Protein-folding Simulation: Stanford’s Framework for Testing and Predicting Evolutionary Outcomes in Living Organisms – Work by Marcus Feldman

2.6 The Binding of Oligonucleotides in DNA and 3-D Lattice Structures

2.7 Finding the Genetic Links in Common Disease: Caveats of Whole Genome Sequencing Studies

Chapter 3

3.1 Big Data in Genomic Medicine

3.2 CRACKING THE CODE OF HUMAN LIFE: The Birth of Bioinformatics & Computational Genomics – Part IIB 

3.3 Expanding the Genetic Alphabet and linking the Genome to the Metabolome

3.4 Metabolite Identification Combining Genetic and Metabolic Information: Genetic Association Links Unknown Metabolites to Functionally Related Genes

3.5 MIT Scientists on Proteomics: All the Proteins in the Mitochondrial Matrix identified

3.6 Identification of Biomarkers that are Related to the Actin Cytoskeleton

3.7 Genetic basis of Complex Human Diseases: Dan Koboldt’s Advice to Next-Generation Sequencing Neophytes

3.8 MIT Team Researches Regulatory Motifs and Gene Expression of Erythroleukemia (K562) and Liver Carcinoma (HepG2) Cell Lines

Chapter 4

4.1 ENCODE Findings as Consortium

4.2 ENCODE: The Key to Unlocking the Secrets of Complex Genetic Diseases

4.3 Reveals from ENCODE Project will Invite High Synergistic Collaborations to Discover Specific Targets  

4.4 Human Variome Project: encyclopedic catalog of sequence variants indexed to the human genome sequence

4.5 Human Genome Project – 10th Anniversary: Interview with Kevin Davies, PhD – The $1000 Genome

4.6 Quantum Biology And Computational Medicine

4.7 The Underappreciated EpiGenome

4.8 Unraveling Retrograde Signaling Pathways

4.9  “The SILENCE of the Lambs” Introducing The Power of Uncoded RNA

4.10  DNA: One man’s trash is another man’s treasure, but there is no JUNK after all

Chapter 5

5.1 Paradigm Shift in Human Genomics – Predictive Biomarkers and Personalized Medicine – Part 1 

5.2 Computational Genomics Center: New Unification of Computational Technologies at Stanford

5.3 Personalized Medicine: An Institute Profile – Coriell Institute for Medical Research: Part 3

5.4 Cancer Genomics – Leading the Way by Cancer Genomics Program at UC Santa Cruz

5.5 Genome and Genetics: Resources @Stanford, @MIT, @NIH’s NCBCS

5.6 NGS Market: Trends and Development for Genotype-Phenotype Associations Research

5.7 Speeding Up Genome Analysis: MIT Algorithms for Direct Computation on Compressed Genomic Datasets

5.8  Modeling Targeted Therapy

5.9 Transphosphorylation of E-coli Proteins and Kinase Specificity

5.10 Genomics of Bacterial and Archaeal Viruses

Chapter 6

6.1  Directions for Genomics in Personalized Medicine

6.2 Ubiquinin-Proteosome pathway, Autophagy, the Mitochondrion, Proteolysis and Cell Apoptosis: Part III

6.3 Mitochondrial Damage and Repair under Oxidative Stress

6.4 Mitochondria: More than just the “Powerhouse of the Cell”

6.5 Mechanism of Variegation in Immutans

6.6 Impact of Evolutionary Selection on Functional Regions: The imprint of Evolutionary Selection on ENCODE Regulatory Elements is Manifested between Species and within Human Populations

6.7 Cardiac Ca2+ Signaling: Transcriptional Control

6.8 Unraveling Retrograde Signaling Pathways

6.9 Reprogramming Cell Fate

6.10 How Genes Function

6.11 TALENs and ZFNs

6.12 Zebrafish—Susceptible to Cancer

6.13 RNA Virus Genome as Bacterial Chromosome

6.14 Cloning the Vaccinia Virus Genome as a Bacterial Artificial Chromosome 

6.15 Telling NO to Cardiac Risk- DDAH Says NO to ADMA(1); The DDAH/ADMA/NOS Pathway(2)

6.16  Transphosphorylation of E-coli proteins and kinase specificity

6.17 Genomics of Bacterial and Archaeal Viruses

6.18  Diagnosing Diseases & Gene Therapy: Precision Genome Editing and Cost-effective microRNA Profiling

Chapter 7

7.1 Harnessing Personalized Medicine for Cancer Management, Prospects of Prevention and Cure: Opinions of Cancer Scientific Leaders @ http://pharmaceuticalintelligence.com

7.2 Consumer Market for Personal DNA Sequencing: Part 4

7.3 GSK for Personalized Medicine using Cancer Drugs Needs Alacris Systems Biology Model to Determine the In Silico Effect of the Inhibitor in its “Virtual Clinical Trial”

7.4 Drugging the Epigenome

7.5 Nation’s Biobanks: Academic institutions, Research institutes and Hospitals – vary by Collections Size, Types of Specimens and Applications: Regulations are Needed

7.6 Personalized Medicine: Clinical Aspiration of Microarrays

Chapter 8

8.1 Personalized Medicine as Key Area for Future Pharmaceutical Growth

8.2 Inaugural Genomics in Medicine – The Conference Program, 2/11-12/2013, San Francisco, CA

8.3 The Way With Personalized Medicine: Reporters’ Voice at the 8th Annual Personalized Medicine Conference, 11/28-29, 2012, Harvard Medical School, Boston, MA

8.4 Nanotechnology, Personalized Medicine and DNA Sequencing

8.5 Targeted Nucleases

8.6 Transcript Dynamics of Proinflammatory Genes

8.7 Helping Physicians identify Gene-Drug Interactions for Treatment Decisions: New ‘CLIPMERGE’ program – Personalized Medicine @ The Mount Sinai Medical Center

8.8 Intratumor Heterogeneity and Branched Evolution Revealed by Multiregion Sequencing[1]

8.9 Diagnosing Diseases & Gene Therapy: Precision Genome Editing and Cost-effective microRNA Profiling

Chapter 9

9.1 Personal Tale of JL’s Whole Genome Sequencing

9.2 Inspiration From Dr. Maureen Cronin’s Achievements in Applying Genomic Sequencing to Cancer Diagnostics

9.3 Inform Genomics Developing SNP Test to Predict Side Effects, Help MDs Choose among Chemo Regimens

9.4 SNAP: Predict Effect of Non-synonymous Polymorphisms: How Well Genome Interpretation Tools could Translate to the Clinic

9.5  LEADERS in Genome Sequencing of Genetic Mutations for Therapeutic Drug Selection in Cancer Personalized Treatment: Part 2

9.6 The Initiation and Growth of Molecular Biology and Genomics – Part I

9.7 Personalized Medicine-based Cure for Cancer Might Not Be Far Away

9.8 Personalized Medicine: Cancer Cell Biology and Minimally Invasive Surgery (MIS)

 Chapter 10

10.1 Pfizer’s Kidney Cancer Drug Sutent Effectively caused REMISSION to Adult Acute Lymphoblastic Leukemia (ALL)

10.2 Imatinib (Gleevec) May Help Treat Aggressive Lymphoma: Chronic Lymphocytic Leukemia (CLL)

10.3 Winning Over Cancer Progression: New Oncology Drugs to Suppress Passengers Mutations vs. Driver Mutations

10.4 Treatment for Metastatic HER2 Breast Cancer

10.5 Personalized Medicine in NSCLC

10.6 Gene Sequencing – to the Bedside

10.7 DNA Sequencing Technology

10.8 Nobel Laureate Jack Szostak Previews his Plenary Keynote for Drug Discovery Chemistry

Chapter 11

11.1 mRNA Interference with Cancer Expression

11.2 Angiogenic Disease Research Utilizing microRNA Technology: UCSD and Regulus Therapeutics

11.3 Sunitinib brings Adult acute lymphoblastic leukemia (ALL) to Remission – RNA Sequencing – FLT3 Receptor Blockade

11.4 A microRNA Prognostic Marker Identified in Acute Leukemia 

11.5 MIT Team: Microfluidic-based approach – A Vectorless delivery of Functional siRNAs into Cells.

11.6 Targeted Tumor-Penetrating siRNA Nanocomplexes for Credentialing the Ovarian Cancer Oncogene ID4

11.7 When Clinical Application of miRNAs?

11.8 How mobile elements in “Junk” DNA promote cancer. Part 1: Transposon-mediated tumorigenesis,

11.9 Potential Drug Target: Glycolysis Regulation – Oxidative Stress-responsive microRNA-320

11.10  MicroRNA Molecule May Serve as Biomarker

11.11 What about Circular RNAs?

Chapter 12

12.1 The “Cancer Establishments” Examined by James Watson, Co-discoverer of DNA w/Crick, 4/1953

12.2 Otto Warburg, A Giant of Modern Cellular Biology

12.3 Is the Warburg Effect the Cause or the Effect of Cancer: A 21st Century View?

12.4 Hypothesis – Following on James Watson

12.5 AMPK Is a Negative Regulator of the Warburg Effect and Suppresses Tumor Growth In Vivo

12.6 AKT signaling variable effects

12.7 Rewriting the Mathematics of Tumor Growth; Teams Use Math Models to Sort Drivers from Passengers

12.8 Phosphatidyl-5-Inositol signaling by Pin1

Chapter 13

13.1 Nanotech Therapy for Breast Cancer

13.2 BRCA1 a tumour suppressor in breast and ovarian cancer – functions in transcription, ubiquitination and DNA repair

13.3 Exome sequencing of serous endometrial tumors shows recurrent somatic mutations in chromatin-remodeling and ubiquitin ligase complex genes

13.4 Recurrent somatic mutations in chromatin-remodeling and ubiquitin ligase complex genes in serous endometrial tumors

13.5 Prostate Cancer: Androgen-driven “Pathomechanism” in Early onset Forms of the Disease

13.6 In focus: Melanoma Genetics

13.7 Head and Neck Cancer Studies Suggest Alternative Markers More Prognostically Useful than HPV DNA Testing

13.8 Breast Cancer and Mitochondrial Mutations

13.9  Long noncoding RNA network regulates PTEN transcription

Chapter 14

14.1 HBV and HCV-associated Liver Cancer: Important Insights from the Genome

14.2 Nanotechnology and HIV/AIDS treatment

14.3 IRF-1 Deficiency Skews the Differentiation of Dendritic Cells

14.4 Sepsis, Multi-organ Dysfunction Syndrome, and Septic Shock: A Conundrum of Signaling Pathways Cascading Out of Control

14.5  Five Malaria Genomes Sequenced

14.6 Rheumatoid Arthritis Risk

14.7 Approach to Controlling Pathogenic Inflammation in Arthritis

14.8 RNA Virus Genome as Bacterial Chromosome

14.9 Cloning the Vaccinia Virus Genome as a Bacterial Artificial Chromosome

Chapter 15

15.1 Personalized Cardiovascular Genetic Medicine at Partners HealthCare and Harvard Medical School

15.2 Congestive Heart Failure & Personalized Medicine: Two-gene Test predicts response to Beta Blocker Bucindolol

15.3 DDAH Says NO to ADMA(1); The DDAH/ADMA/NOS Pathway(2)

15.4 Peroxisome Proliferator-Activated Receptor (PPAR-gamma) Receptors Activation: PPARγ Transrepression for Angiogenesis in Cardiovascular Disease and PPARγ Transactivation for Treatment of Diabetes

15.5 BARI 2D Trial Outcomes

15.6 Gene Therapy Into Healthy Heart Muscle: Reprogramming Scar Tissue In Damaged Hearts

15.7 Obstructive coronary artery disease diagnosed by RNA levels of 23 genes – CardioDx, a Pioneer in the Field of Cardiovascular Genomic  Diagnostics

15.8 Ca2+ signaling: transcriptional control

15.9 Lp(a) Gene Variant Association

15.9.1 Two Mutations, in the PCSK9 Gene: Eliminates a Protein involved in Controlling LDL Cholesterol

15.9.2. Genomics & Genetics of Cardiovascular Disease Diagnoses: A Literature Survey of AHA’s Circulation Cardiovascular Genetics, 3/2010 – 3/2013

15.9.3 Synthetic Biology: On Advanced Genome Interpretation for Gene Variants and Pathways: What is the Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

15.9.4 The Implications of a Newly Discovered CYP2J2 Gene Polymorphism Associated with Coronary Vascular Disease in the Uygur Chinese Population

15.9.5  Gene, Meis1, Regulates the Heart’s Ability to Regenerate after Injuries.

15.10 Genetics of Conduction Disease: Atrioventricular (AV) Conduction Disease (block): Gene Mutations – Transcription, Excitability, and Energy Homeostasis

15.11 How Might Sleep Apnea Lead to Serious Health Concerns like Cardiac and Cancers?

Chapter 16

16.1 Can Resolvins Suppress Acute Lung Injury?

16.2 Lipoxin A4 Regulates Natural Killer Cell in Asthma

16.3 Biological Therapeutics for Asthma

16.4 Genomics of Bronchial Epithelial Dysplasia

16.5 Progression in Bronchial Dysplasia

Chapter 17

17.1 Breakthrough Digestive Disorders Research: Conditions Affecting the Gastrointestinal Tract.

17.2 Liver Endoplasmic Reticulum Stress and Hepatosteatosis

17.3 Biomarkers-identified-for-recurrence-in-hbv-related-hcc-patients-post-surgery

17.4  Usp9x: Promising Therapeutic Target for Pancreatic Cancer

17.5 Battle of Steve Jobs and Ralph Steinman with Pancreatic cancer: How We Lost

Chapter 18

18.1 Ubiquitin Pathway Involved in Neurodegenerative Disease

18.2 Genomic Promise for Neurodegenerative Diseases, Dementias, Autism Spectrum, Schizophrenia, and Serious Depression

18.3 Neuroprotective Therapies: Pharmacogenomics vs Psychotropic Drugs and Cholinesterase Inhibitors

18.4 Ustekinumab New Drug Therapy for Cognitive Decline Resulting from Neuroinflammatory Cytokine Signaling and Alzheimer’s Disease

18.5 Cell Transplantation in Brain Repair

18.6 Alzheimer’s Disease Conundrum – Are We Near the End of the Puzzle?

Chapter 19

19.1 Genetics and Male Endocrinology

19.2 Genomic Endocrinology and its Future

19.3 Commentary on Dr. Baker’s post “Junk DNA Codes for Valuable miRNAs: Non-coding DNA Controls Diabetes”

19.4 Therapeutic Targets for Diabetes and Related Metabolic Disorders

19.5 Secondary Hypertension caused by Aldosterone-producing Adenomas caused by Somatic Mutations in ATP1A1 and ATP2B3 (adrenal cortical; medullary or Organ of Zuckerkandl is pheochromocytoma)

19.6 Personal Recombination Map from Individual’s Sperm Cell and its Importance

19.7 Gene Trap Mutagenesis in Reproductive Research

19.8 Pregnancy with a Leptin-Receptor Mutation

19.9 Whole-genome Sequencing in Probing the Meiotic Recombination and Aneuploidy of Single Sperm Cells

19.10 Reproductive Genetic Testing

Chapter 20

20.1 Genomics & Ethics: DNA Fragments are Products of Nature or Patentable Genes?

20.2 Understanding the Role of Personalized Medicine

20.3 Attitudes of Patients about Personalized Medicine

20.4  Genome Sequencing of the Healthy

20.5   Genomics in Medicine – Tomorrow’s Promise

20.6  The Promise of Personalized Medicine

20.7 Ethical Concerns in Personalized Medicine: BRCA1/2 Testing in Minors and Communication of Breast Cancer Risk

 20.8 Genomic Liberty of Ownership, Genome Medicine and Patenting the Human Genome

Chapter 21

Recent Advances in Gene Editing Technology Adds New Therapeutic Potential for the Genomic Era:  Medical Interpretation of the Genomics Frontier – CRISPR – Cas9

Introduction

21.1 Introducing CRISPR/Cas9 Gene Editing Technology – Works by Jennifer A. Doudna

21.1.1 Ribozymes and RNA Machines – Work of Jennifer A. Doudna

21.1.2 Evaluate your Cas9 gene editing vectors: CRISPR/Cas Mediated Genome Engineering – Is your CRISPR gRNA optimized for your cell lines?

21.1.3 2:15 – 2:45, 6/13/2014, Jennifer Doudna “The biology of CRISPRs: from genome defense to genetic engineering”

21.1.4  Prediction of the Winner RNA Technology, the FRONTIER of SCIENCE on RNA Biology, Cancer and Therapeutics  & The Start Up Landscape in BostonGene Editing – New Technology The Missing link for Gene Therapy?

21.2 CRISPR in Other Labs

21.2.1 CRISPR @MIT – Genome Surgery

21.2.2 The CRISPR-Cas9 System: A Powerful Tool for Genome Engineering and Regulation

Yongmin Yan and Department of Gastroenterology, Hepatology & Nutrition, University of Texas M.D. Anderson Cancer, Houston, USADaoyan Wei*

21.2.3 New Frontiers in Gene Editing: Transitioning From the Lab to the Clinic, February 19-20, 2015 | The InterContinental San Francisco | San Francisco, CA

21.2.4 Gene Therapy and the Genetic Study of Disease: @Berkeley and @UCSF – New DNA-editing technology spawns bold UC initiative as Crispr Goes Global

21.2.5 CRISPR & MAGE @ George Church’s Lab @ Harvard

21.3 Patents Awarded and Pending for CRISPR

21.3.1 Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method

21.3.2 The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

2.4 CRISPR/Cas9 Applications

21.4.1  Inactivation of the human papillomavirus E6 or E7 gene in cervical carcinoma cells using a bacterial CRISPR/Cas 

21.4.2 CRISPR: Applications for Autoimmune Diseases @UCSF

21.4.3 In vivo validated mRNAs

21.4.6 Level of Comfort with Making Changes to the DNA of an Organism

21.4.7 Who will be the the First to IPO: Novartis bought in to Intellia (UC, Berkeley) as well as Caribou (UC, Berkeley) vs Editas (MIT)??

21.4.8 CRISPR/Cas9 Finds Its Way As an Important Tool For Drug Discovery & Development

Summary

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CMS releases MACRA rule proposal: Will HHS force physicians to drop fee for service for fee for outcome?

Streamlined implementation aims to increase flexibility, decrease reporting burden for physicians

The U.S. Department of Health and Human Services unveiled a proposed ruletackling the initial implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

According to an HHS announcement accompanying the rule, the primary aim is to simplify and streamline the existing patchwork of value-based payment models that have increasingly replaced the traditional fee-for-service system via a new framework dubbed the Quality Payment Program. This structure provides doctors with two paths for compliance:

The Centers for Medicare & Medicaid Services expects most providers to opt for the MIPS track initially, according to CMS Acting Principal Deputy Administrator and Chief Medical Officer Patrick Conway, M.D., who spoke on a conference call announcing the rule.

Participation in Advanced Alternative Payment models would exempt doctors from MIPS reporting requirements while also qualifying them for financial bonuses in exchange for taking on the risks related with providing “coordinated, high-quality care,” according to CMS. The agency expects both the number of physicians participating in this track and the number of payment models available to grow over time.

CMS also reports that doctors will have the flexibility to switch among various components of the Quality Payment Program as dictated by the needs of their patients or their practices.

Opinions from around the web

In this video, Gilberg, senior vice president for the Medical Group Management Association’s Government Affairs Office, discusses CMS’ Physician Value-based Payment Modifier. In 2015, Medicare will begin applying the modifier under the physician fee schedule to various providers to show value of care.

“Cost and quality … make up the value equation, in the mind of the payer, in terms of Medicare,” said Gilberg.

In addition to explaining how the modifier works, Gilberg also highlights other quality measures facing providers under the Physician Quality Reporting System and via the EHR Incentive Programs, better known as meaningful use.

View Video at

http://www.physicianspractice.com/mgma14/understanding-medicare-value-based-payment-models

When the Medicare Access and CHIP Reauthorization Act (MACRA) legislation passed in April 2015, everyone cheered the repeal of the Sustainable Growth Rate (SGR) formula for Medicare physician payment. Now, even before the MACRA regulations are even promulgated, it’s time to pay attention because Medicare physician payments in 2019 will be impacted by their performance in 2017, just a year from now.

Other related articles

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Chemotherapy Benefit in Early Breast Cancer Patients

Larry H Bernstein, MD, FCAP, Curator

LPBI

 

Agendia’s MammaPrint® First and Only Genomic Assay to Receive Level 1A Clinical Utility Evidence for Chemotherapy Benefit in Early Breast Cancer Patients

http://www.b3cnewswire.com/201604191373/agendias-mammaprintr-first-and-only-genomic-assay-to-receive-level-1a-clinical-utility-evidence-for-chemotherapy-benefit-in-early-breast-cancer-patients.

  • Clinical high-risk patients with a low-risk MammaPrint® result, including 48 percent node-positive, had five-year distant metastasis-free survival rate in excess of 94 percent, whether randomized to receive adjuvant chemotherapy or not
  • MammaPrint could change clinical practice by substantially de-escalating the use of adjuvant chemotherapy and sparing many patients an aggressive treatment they will not benefit from
  • Forty-six percent overall reduction in chemotherapy prescription among clinically high-risk patients

April 19, 2016 / B3C newswire / Agendia, Inc., together with the European Organisation for Research and Treatment of Cancer (EORTC) and Breast International Group (BIG), announced results from the initial analysis of the primary objective of the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) study at the American Association for Cancer Research Annual Meeting 2016 in New Orleans, LA.

Using the company’s MammaPrint® assay, patients with early-stage breast cancer who were considered at high risk for disease recurrence based on clinical and biological criteria had a distant metastasis-free survival at five years in excess of 94 percent.The MammaPrint test—the first and only genomic assay with FDA 510(k) clearance for use in risk assessment for women of all ages with early stage breast cancer—identified a large group of patients for whom five-year distant metastasis–free survival was equally good whether or not they received adjuvant chemotherapy (chemotherapy given post-surgery).

“The MINDACT trial design is the optimal way to prove clinical utility of a genomic assay,” said Prof. Laura van ’t Veer, CRO at Agendia, Leader, Breast Oncology Program, and Director, Applied Genomics at UCSF Helen Diller Family Comprehensive Cancer Center. “It gives the level 1A clinical evidence (prospective, randomized and controlled) that empowers physicians to clearly and confidently know when chemotherapy is part of optimal early-stage breast cancer therapy.  In this trial, MammaPrint (70-gene assay) was compared to the standard of care physicians use today, to decide what is the best treatment option for an early-stage breast cancer patient.”

The MINDACT trial is the first prospective randomized controlled clinical trial of a breast cancer recurrence genomic assay with level 1A clinical evidence and the first prospective translational research study of this magnitude in breast cancer to report the results of its primary objective.

Among the 3,356 patients enrolled in the MINDACT trial, who were categorized as having a high risk of breast cancer recurrence based on common clinical and pathological criteria (C-high), the MammaPrint assay reduced the chemotherapy treatment prescription by 46 percent.Using the 70-gene assay, MammaPrint, 48 percent of lymph-node positive breast cancer patients considered clinically high-risk (Clinical-high) and genomic low-risk (MammaPrint-low) had an excellent distant metastasis-free survival at five years in excess of 94 percent.

“Traditionally, physicians have relied on clinical-pathological factors such as age, tumor size, tumor grade, lymph node involvement, and hormone receptor status to make breast cancer treatment decisions,” said Massimo Cristofanilli, MD, Associate Director of Translational Research and Precision Medicine at the Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Chicago. “These findings provide level 1A clinical utility evidence by demonstrating that the detection of low-risk of distant recurrence reported by the MammaPrint test can be safely used in the management of thousands of women by identifying those who can be spared from a toxic and unnecessary treatment.”

MINDACT is a randomized phase III trial that investigates the clinical utility of MammaPrint, when compared (or – “used in conjunction with”) to the standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy. From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer enrolled in the trial (111 centers in nine countries). Participants were categorized as low or high risk for tumor recurrence in two ways: first, through analysis of tumor tissue using MammaPrint at a central location in Amsterdam; and second, using Adjuvant! Online, a tool that calculates risk of breast cancer recurrence based on common clinical and biological criteria.

Patients characterized in both clinical and genomic assessments as “low- risk” are spared chemotherapy, while patients characterized as “high- risk” are advised chemotherapy. Those with conflicting results are randomized to use either clinical or genomic risk (MammaPrint) evaluation to decide on chemotherapy treatment.

The MINDACT trial is managed and sponsored by the EORTC as part of an extensive and complex partnership in collaboration with Agendia and BIG, and many other academic and commercial partners, as well as patient advocates.

“These MINDACT trial results are a testament that the science of the MammaPrint test is the most robust in the genomic breast recurrence assay market.  Agendia will continue to collaborate with pharmaceutical companies, leading cancer centers and academic groups on additional clinical research and in the pursuit of bringing more effective, individualized treatments within reach of cancer patients,” said Mark Straley, Chief Executive Officer at Agendia. “We value the partnership with the EORTC and BIG and it’s a great honor to share this critical milestone.”

Breast cancer is the most frequently diagnosed cancer in women worldwide(1). In 2012, there were nearly 1.7 million new breast cancer cases among women worldwide, accounting for 25 percent of all new cancer cases in women(2).

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Problem of Science Doctorate Programs

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

 

The Problem in Biomedical Education

Henry Bourne (UCSF)

Dr. Henry Bourne has trained graduate students and postdocs at UCSF for over 40 years. In his iBiology talk, he discusses the imminent need for change in graduate education. With time to degrees getting longer, the biomedical community needs to create experimental graduate programs to find more effective and low cost ways to train future scientists and run successful laboratories. If we don’t start looking for solutions, the future of the biomedical enterprise will grow increasingly unstable.

Watch Henry Bourne’s iBioMagazine: The Problem in Biomedical Education

https://youtu.be/V9peRqNr-L0

Henry Bourne is Professor Emeritus and former chair of the Department of Pharmacology at the University of California – San Francisco. His research focused on trimeric G-proteins, G-protein coupled receptors, and the cellular signals responsible for polarity and direction-finding of human leukocytes. He is the author of several books including a memoir, Ambition and Delight, and has written extensively about graduate training and biomedical workforce issues. Now Dr. Bourne’s research focuses on the organization and founding of US biomedical research in the early 20th century.

Related Talks

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