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Archive for the ‘Personalized and Precision Medicine & Genomic Research’ Category


Live Notes from @HarvardMed Bioethics: Authors Jerome Groopman, MD & Pamela Hartzband, MD, discuss Your Medical Mind

Writer: Stephen J. Williams, Ph.D.

As part of the Harvard Medical School Series on Bioethics: author, clinician and professor Jerome Groopman, MD and Pamel Harzband, MD gave an online discussion of their book “Your Medical Mind”, a part of Harvard Medical School Center for Bioethics Program’s Critical Reading of Contemporary Books in Bioethics Series. The Contemporary Authors in Bioethics series brings together authors and the community to discuss books that explore new and developing topics in the field. This was held as an online Zoom meeting on March 26, 2020 at 5 pm EST and could be followed on Twitter using #HarvardBioethics.  A recording of the discussion will be made available at the Harvard Med School Center for Bioethics.

 

Available at Amazon: From the Amazon book description:

An entirely new way to make the best medical decisions.

Making the right medical decisions is harder than ever. We are overwhelmed by information from all sides—whether our doctors’ recommendations, dissenting experts, confusing statistics, or testimonials on the Internet. Now Doctors Groopman and Hartzband reveal that each of us has a “medical mind,” a highly individual approach to weighing the risks and benefits of treatments.  Are you a minimalist or a maximalist, a believer or a doubter, do you look for natural healing or the latest technology?  The authors weave vivid narratives of real patients with insights from recent research to demonstrate the power of the medical mind. After reading this groundbreaking book, you will know how to arrive at choices that serve you best.

 

Doctors Groopman and Hartzband began the discussion with a recapping medical research studies and medical panels, which had reported conflicting results or reversal of recommendations, respectively.  These included studies on the benefits of statin therapy in cholesterol management, studies on whether or not Vitamin D therapy is beneficial for postmenopausal women, the ongoing controversy on the frequency with which women should get mammograms, as well as the predictive value of Prostate Specific Antigen and prostate cancer screening.  The authors singled out the research reports and medical panels reviewing the data on PSA in which the same medical panel first came out in support of using PSA levels to screen for prostate cancer and then later, after reconvening, recommended that PSA was not useful for mass screenings for prostate cancer.

In fact, both authors were

completed surprised of the diametrically opposed views within or between panels given similar data presented to those medical professionals.

The authors then asked a question:  Why would the same medical panel come to a reversal of their decision and more, importantly,  why are there such disparate conclusions from the same medical data sets, leading to varied clinical decision-making.

In general, Drs. Groopman and Hartzband asked how do physicians and patients make their decisions?

To answer this they looked at studies that Daniel Bernouli had conducted to model the economic behaviors of risk aversion in the marketplace. Bernouli’s theorem correlated market expectation with probability and outcomes

expectation = probability x utility of outcome

However, in medicine, one can measure probability (or risk) but it is very hard to measure utility (which is the value or worth of the outcome).

For example, they gave an example if a person was born blind but offered a risky to regain sight, the individual values their quality of life from their own perspective and might feel that, as their life is worthwhile as it is, they would not undergo a risky procedure. However a person who had suddenly lost their sight might value sight more, and be willing to undergo a risky procedure.

Three methods are used to put a value on utility or outcome worth with regards to medical decisions

  1. linear scale (life or death; from 0 to 1)
  2. time trade off:  e.g. how much longer do I have to live
  3. standard gamble:  let’s try it

All of these methods however are flawed because one doesn’t know their future medical condition (e.g. new information on the disease) and people values and perceptions change over time.

An example of choice of methods the medical community uses to make decisions include:

  • In the United Kingdom, their system uses a time trade off method to determine value in order to determine appropriate course of action which may inadvertently, result in rationed care
  • in the United States, the medical community uses the time trade off to determine cost effectiveness

 

Therefore Drs. Groopman and Harztband, after conducing multiple interviews with patients and physicians were able to categorize medical decision making based on groups of mindsets

  1. Maximalist: Proactive behavior, wants to stay ahead of the curve
  2. Minimalist: less intervention is more; more hesitant to try any suggested therapy
  3. Naturalist:  more prone to choose natural based therapies or home remedies
  4. Tech Oriented: wants to try the latest therapies and more apt to trust in branded and FDA approved therapeutics
  5. Believer:  trust in suggestions by physician; physician trusts medical panels suggestions
  6. Doubter: naturally inquisitive and more prone to investigate risk benefits of any suggested therapy

The authors also identified many Cognitive Traps that both physicians and patients may fall into including:

  • Relative versus Absolute Numbers: for instance putting emphasis on one number or the other without regard to context; like looking at disease numbers without taking into consideration individual risk
  • Availability: availability or lack of available information; they noticed if you fall in this trap depends on whether you are a Minimalist or Maximalist
  • Framing:  for example  when people talk to others about their conditions and hear stories about others treatments, conditions .. mainly anecdotal evidence

Stories can be helpful but they sometimes increase our overestimation of risk or benefit so framing the information is very important for both the patient as well as the physician (even doctors as patients)

Both authors have noticed a big shift in US to minimalism probably because of the rising costs of healthcare.

How do these mindsets affect the patient-physician relationship?

A University of Michigan study revealed that patients who would be characterized as maximalists pushed their physicians to do more therapy and were more prone to seek outside advice.

Physicians need to understand and listen to their patients during the patients’s first visit and determine what medical mindset that this patient has.

About the authors:

Jerome Groopman, M.D. is the Dina and Raphael Recanati Professor of Medicine at Harvard Medical School, Chief of Experimental Medicine at Beth Israel Deaconess Medical Center, and one of the world’s leading researchers in cancer and AIDS. He is a staff writer for The New Yorker and has written for The New York TimesThe Wall Street Journal,The Washington Post and The New Republic. He is author of The Measure of Our Days (1997), Second Opinions (2000), Anatomy of Hope (2004), How Doctors Think (2007), and the recently released, Your Medical Mind.

Dr. Pamela Hartzband is an Assistant Professor at the Harvard Medical School and Attending Physician in the Division of Endocrinology at the Beth Israel Deaconess Medical Center in Boston. She specializes in disorders of the thyroid and pituitary glands. A magna cum laude graduate of Radcliffe College, Harvard University, she received her M.D. from Harvard Medical School. She served her internship and residency in internal medicine at the Massachusetts General Hospital, and her specialty fellowships in endocrinology and metabolism at UCLA.

More articles on BioEthics and Patient experiences in this Online Open Access Journal Include:

Ethics Behind Genetic Testing in Breast Cancer: A Webinar by Laura Carfang of survivingbreastcancer.org

Tweets and Re-Tweets by @Pharma_BI ‏and @AVIVA1950 at 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT @Harvard_Law

Innovation + Technology = Good Patient Experience

Drivers of Patient Experience

Factors in Patient Experience

Patient Experience Survey

Please also see our offering on Amazon at https://www.amazon.com/dp/B076HGB6MZ

“The VOICES of Patients, Hospital CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures,”

 

 

 

 

 

 

 

 

 

 

 

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Ethics Behind Genetic Testing in Breast Cancer: A Webinar by Laura Carfang of survivingbreastcancer.org

Reporter: Stephen J. Williams, PhD

The following are Notes from a Webinar sponsored by survivingbreastcancer.org  on March 12,2020.

The webinar started with a brief introduction of attendees , most who are breast cancer survivors.  Survivingbreastcancer.org is an organization committed to supplying women affected with breast cancer up to date information, including podcasts, webinars, and information for treatment, care, and finding support and support groups.

Some of the comments of survivors:

  • being strong
  • making sure to not feel overwhelmed on initial diagnosis
  • get good information
  • sometimes patients have to know to ask for genetic testing as physicians may not offer it

Laura Carfang discussed her study results presented at  a bioethics conference in Clearwater, FL   on issues driving breast cancer patient’s  as well as at-risk women’s decision making process for genetic testing.  The study was a phenomenological study in order to determine, through personal lived experiences, what are pivotal choices to make genetic testing decisions in order to improve clinical practice.

The research involved in depth interviews with 6 breast cancer patients (all women) who had undergone breast cancer genetic testing.

Main themes coming from the interviews

  • information informing decisions before diagnosis:  they did not have an in depth knowledge of cancer or genetics or their inherent risk before the diagnosis.
  • these are my genes and I should own it: another common theme among women who were just diagnosed and contemplating whether or not to have genetic testing
  • information contributing to decision making after diagnosis: women wanted the option, and they wanted to know if they carry certain genetic mutations and how it would guide their own personal decision to choose the therapy they are most comfortable with and gives them the best chance to treat their cancer (the decision and choice is very personal)
  • communicating to family members and children was difficult for the individual affected;  women found that there were so many ramifications about talking with family members (how do I tell children, do family members really empathize with what I am going through).  Once women were tested they felt a great strain because they now were more concerned with who in their family (daughters) were at risk versus when they first get the diagnosis the bigger concern was obtaining information.
  • Decision making to undergo genetic testing not always linear but a nonlinear process where women went from wanting to get tested for the information to not wanting to get tested for reasons surrounding negative concerns surrounding knowing results (discrimination based on results, fear of telling family members)
  • Complex decision making involves a shift or alteration in emotion
  • The Mayo Clinic has come out with full support of genetic testing and offer to any patient.

Additional resources discussed was a book by Leslie Ferris Yerger “Probably Benign” which discusses misdiagnoses especially when a test comes back as “probably benign” and how she found it was not.

 

for more information on further Podcasts and to sign up for newsletters please go to https://www.survivingbreastcancer.org/

and @SBC_org

More articles on this Online Open Access Journal on Cancer and Bioethics Include:

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

Tweets and Re-Tweets by @Pharma_BI ‏and @AVIVA1950 at 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT @Harvard_Law

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

Study Finds that Both Women and their Primary Care Physicians Confusion over Ovarian Cancer Symptoms May Lead to Misdiagnosis

 

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The Algorithm for Precision Medicine – Best Talk on that Topic – Watch this Video

 

Reporter: Aviva Lev-Ari, PhD, RN

 

SOURCE

https://www.youtube.com/watch?v=Rt3XyeFHvt4

 

KnowledgeGraphs we need to build from our three CORPUSES

 

In Details

Our venture shares several industries, we have identified 12 economic segments where an acquirer can be identified. The content created using the methodology of curation of scientific findings with clinical interpretation by experts was developed in house to mitigate the information explosion in the Life Sciences and the information obsolescence. The content lands its attribution to electronic Scientific Publishing and to Pharmaceutical Media. Please review the business functions that this content could contribute to by the value drivers in each economic segment https://pharmaceuticalintelligence.com/2019-vista/opportunities-map-in-the-acquisition-arena/

Introduction to Three Intellectual Property Asset Classes of Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

http://pharmaceuticalintelligence.com 

 

  •  LPBI Scientific Journal: 1.7Million eReaders, 5700 scientific articles [Pharmaceutics, Life Sciences, Medicine], 690 categories of research, 10,154Tags

https://lnkd.in/eEw5q7N

  • BioMed e-Series: 16 Volumes in Medicine and Life Sciences

https://lnkd.in/ekWGNqA

  •  e-Proceedings: Corpus of +70 Biotech & Medical Conferences, events covered in real time by a methodology developed in house yielding the e-Proceeding with one click at the end of the Conference.

https://lnkd.in/dc2qGAK

 

 

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Reporter: Gail S. Thornton, M.A.

LPBI Update

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Newsletter #1 – February 2020

Welcome to the premier issue of LPBI Group News, where readers can find relevant news and updates about science, business and medical innovation. This newsletter is distributed as a service for our readers.

The Conference Forum Highlights Immuno-Oncology 360° in New York

The Conference Forum is hosting Immuno-Oncology 360°, which reports on current data and developments of immuno-oncology in the science and business communities. The summit takes place on February 26-28 at the Crowne Plaza Times Square in New York.

Please visit www.io360summit.com to register and use code LPBI20 for a 20% discount. 

Ahead of the conference, Immuno-Oncology 360° has created a series celebrating their women speakers in the work they are doing to fight cancer. To read the series, visit: https://theconferenceforum.org/conferences/immuno-oncology-360/io360%cb%9a-leadership-interviews/

This information is published in conjunction with the Immuno-Oncology 360° Summit.

  •  

Venture Summit Attracts Top Innovators in Silicon Valley

Leaders in Pharmaceutical Business Intelligence (LPBI) Group is one of the sponsors of Venture Summit | West, “Where Innovation Meets Capital.”

The meeting will be held on March 23-24 at the Santa Clara Convention Center, Silicon Valley.

 

Special offer:  Register Now & Save $450 off (Use discount code “LPBI-VIP”)

For more information, please visit: https://pharmaceuticalintelligence.com/2019/12/17/venture-summit-west-where-innovation-meets-capital-march-23rd-24th-2020-santa-clara-convention-center-silicon-valley/

  •  

e-Proceedings of 15th Annual Personalized Medicine Conference at Harvard Medical School

The 15th Annual Personalized Medicine Conference at Harvard Medical School, Boston last year [November 13-14, 2019], entitled  The Paradigm Evolves, explored the science, business and policy issues facing personalized medicine. In today’s world, scientists need to understand how molecular diagnostics augmented by artificial intelligence, data analytics and digital health empowers physicians and patients in their health care decisions.

Please visit for LPBI Group coverage of the meeting, including social media activities at the conference:

https://pharmaceuticalintelligence.com/2019/07/19/15th-annual-personalized-medicine-conference-at-harvard-medical-school-the-paradigm-evolves-november-13-14-2019-%e2%80%a2-harvard-medical-school-boston-ma/

https://pharmaceuticalintelligence.com/2019/11/15/tweets-and-retweets-by-aviva1950-and-by-pharma_bi-for-15th-annual-personalized-medicine-conference-at-harvard-medical-school-the-paradigm-evolves-november-13-14-2019-%e2%80%a2/

  •   3D Medical BioPrinting Technology Featured in Podcast

LPBI Group leaders, Aviva Lev-Ari, Ph.D., R.N., Stephen Williams, Ph.D., and Irina Robu, Ph.D., spoke with Partners in Health and Biz, a half-hour audio podcast that reaches 40,000 listeners, about the topic of 3D Medical BioPrinting Technology: A Revolution in Medicine.

Please click on this link to hear the podcast. https://www.youtube.com/watch?v=laozyrfi29c.

The topic is also the title of a recently offered e-book by the LPBI Group on 3D BioPrinting, available on Amazon/Kindle Direct [https://www.amazon.com/Medical-BioPrinting-Technologies-Patient-centered-Patient-Centered-ebook/dp/B078QVDV2W]. 

The 3D BioPrinting technology is being used to develop advanced medical practices that will help with previously difficult processes, such as delivering drugs via micro-robots, targeting specific cancer cells and even assisting in difficult eye operations.

The table of contents in this book includes: Chapter 1: 3D Bioprinting: Latest Innovations in a Forty year-old Technology. Chapter 2: LPBI Initiative on 3D BioPrinting, Chapter 3: Cardiovascular BioPrinting, Chapter 4: Medical and Surgical Repairs – Advances in R&D Research, Chapter 5: Organ on a Chip, Chapter 6: FDA Regulatory Technology Issues, Chapter 7: DNA Origami, Chapter 8: Aptamers and 3D Scaffold Binding, Chapter 9: Advances and Future Prospects, Chapter 10: BioInks and MEMS, Chapter 11: BioMedical MEMS, Chapter 12: 3D Solid Organ Printing and Chapter 13: Medical 3D Printing: Sources and Trade Groups – List of Secondary Material. 

  •  

New e-Book: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS & BioInformatics, Simulations and the Genome Ontology

LPBI Group’s latest e-book entitled, Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS & BioInformatics, Simulations and the Genome Ontology, offers the reader content curation with embedded videos and audio podcasts, real-time conference e-Proceedings by LPBI’s scientists and professors and archived tweets of quotes from speakers at leading biotechnology conferences.

Please click on this link on Amazon/Kindle Direct: https://www.amazon.com/dp/B08385KF87

 

The book integrates in a single volume four distinct perspectives: basic science, technologies and methodologies, clinical aspects and business and legal aspects of genomics research. “The materials in this book represents the scientific frontier in Biological Sciences and Medicine related to the genomics aspects of disease onset,” said Aviva Lev-Ari, Ph.D., R.N., and founder of LPBI Group.

The book addresses:

  • aspects of life: the Cell, the Organ, the Human Body and Human Populations;
  • methodologies of genomic data analysis: Next Generation Sequencing, Gene Editing, AI, Single Cell Genomics, Evolution Biology Genomics, Simulation Modeling in Genomics, Genotypes and Phenotypes Modeling, measurement of Epigenomics effects on disease, and developments in Pharmaco-Genomics.

Additionally, artificial Intelligence in medicine is covered in Part 3 of the e-Book, which represents the frontier in this emerging field, with topics, such as the science, technologies and methodologies, clinical aspects, business and legal implications as well as the latest machine learning algorithms harnessed for medical diagnosis.

This e-book is significant because it:

  • contains 326 articles on topics, such as gene editing, bioinformatics and genome ontology;
  • incorporates 74 e-Proceedings created in real time by the Book’s authors and editors
  • includes four collections of Tweets representing quotes from speakers at global leading conferences on Genomics
  • has 13 locations of Videos and Audio Podcasts that serve to enrich the e-Reader’s experience.

We welcome your comments and suggestions. Please send them to Aviva Lev-Ari at avivalev-ari@alum.berkeley.edu.

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

 

Parkinson’s Disease (PD), characterized by both motor and non-motor system pathology, is a common neurodegenerative disorder affecting about 1% of the population over age 60. Its prevalence presents an increasing social burden as the population ages. Since its introduction in the 1960’s, dopamine (DA)-replacement therapy (e.g., L-DOPA) has remained the gold standard treatment. While improving PD patients’ quality of life, the effects of treatment fade with disease progression and prolonged usage of these medications often (>80%) results in side effects including dyskinesias and motor fluctuations. Since the selective degeneration of A9 mDA neurons (mDANs) in the substantia nigra (SN) is a key pathological feature of the disease and is directly associated with the cardinal motor symptoms, dopaminergic cell transplantation has been proposed as a therapeutic strategy.

 

Researchers showed that mammalian fibroblasts can be converted into embryonic stem cell (ESC)-like induced pluripotent stem cells (iPSCs) by introducing four transcription factors i.e., Oct4, Sox2, Klf4, and c-Myc. This was then accomplished with human somatic cells, reprogramming them into human iPSCs (hiPSCs), offering the possibility of generating patient-specific stem cells. There are several major barriers to implementation of hiPSC-based cell therapy for PD. First, probably due to the limited understanding of the reprogramming process, wide variability exists between the differentiation potential of individual hiPSC lines. Second, the safety of hiPSC-based cell therapy has yet to be fully established. In particular, since any hiPSCs that remain undifferentiated or bear sub-clonal tumorigenic mutations have neoplastic potential, it is critical to eliminate completely such cells from a therapeutic product.

 

In the present study the researchers established human induced pluripotent stem cell (hiPSC)-based autologous cell therapy. Researchers reported a platform of core techniques for the production of mDA progenitors as a safe and effective therapeutic product. First, by combining metabolism-regulating microRNAs with reprogramming factors, a method was developed to more efficiently generate clinical grade iPSCs, as evidenced by genomic integrity and unbiased pluripotent potential. Second, a “spotting”-based in vitro differentiation methodology was established to generate functional and healthy mDA cells in a scalable manner. Third, a chemical method was developed that safely eliminates undifferentiated cells from the final product. Dopaminergic cells thus produced can express high levels of characteristic mDA markers, produce and secrete dopamine, and exhibit electrophysiological features typical of mDA cells. Transplantation of these cells into rodent models of PD robustly restored motor dysfunction and reinnervated host brain, while showing no evidence of tumor formation or redistribution of the implanted cells.

 

Together these results supported the promise of these techniques to provide clinically applicable personalized autologous cell therapy for PD. It was recognized by researchers that this methodology is likely to be more costly in dollars and manpower than techniques using off-the-shelf methods and allogenic cell lines. Nevertheless, the cost for autologous cell therapy may be expected to decrease steadily with technological refinement and automation. Given the significant advantages inherent in a cell source free of ethical concerns and with the potential to obviate the need for immunosuppression, with its attendant costs and dangers, it was proposed that this platform is suitable for the successful implementation of human personalized autologous cell therapy for PD.

 

References:

 

https://www.jci.org/articles/view/130767/pdf?elqTrackId=2fd7d0edee744f9cb6d70a686d7b273b

 

https://www.ncbi.nlm.nih.gov/pubmed/31714896

 

https://www.ncbi.nlm.nih.gov/pubmed/23666606

 

https://www.ncbi.nlm.nih.gov/pubmed/27343168

 

https://www.ncbi.nlm.nih.gov/pubmed/21495962

 

https://www.ncbi.nlm.nih.gov/pubmed/28083784

 

https://www.ncbi.nlm.nih.gov/pubmed/20336395

 

https://www.ncbi.nlm.nih.gov/pubmed/28585381

 

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Tweets and Retweets by @AVIVA1950 and by @pharma_BI for 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA

Real Time Press Coverage: Aviva Lev-Ari, PhD, RN

see also,

eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA

https://pharmaceuticalintelligence.com/2019/07/19/15th-annual-personalized-medicine-conference-at-harvard-medical-school-the-paradigm-evolves-november-13-14-2019-%e2%80%a2-harvard-medical-school-boston-ma/

 

 

Tweets by @AVIVA1950 and by @pharma_BI

Aviva Lev-Ari
@AVIVA1950

#PMConf

Donald L. Siegel, Ph.D., M.D., Director, Division of Transfusion Medicine & Therapeutic Biology, Director, Clinical Cell and Vaccine Production Facility, UPenn’s Perelman School of Medicine no relations explored between Immune T cells and microbiome

2
1

Aviva Lev-Ari
@AVIVA1950

#PMConf

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson Impact of Mirobiome it plays a key role in many diseases difficult to develop therapeutics derived from microbiome data

1
1

Aviva Lev-Ari
@AVIVA1950

#PMConf

Harpreet Singh, Ph.D., CEO, Immatics T Cell peptide started 15 years ago Peptonomics,  tumors of solid cancer – cell therapies selected from libraries  off the shelf cells from health donors Biologics bridges tumor cells and solid cells

1

Aviva Lev-Ari
@AVIVA1950

#PMConf

Donald L. Siegel, Ph.D., M.D., Director, Division of Transfusion Medicine & Therapeutic Biology, Director, Clinical Cell and Vaccine Production Facility, UPenn’s Medicine CAR-T therapy started the Transfusion Medicine & Therapeutic Biology industry

Aviva Lev-Ari
@AVIVA1950

#PMConf

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson Combination therapy emerges, MOA partnerships: cell therapy can transform cancer treatment INFECTIOUS disease had Global impact need stop the virus

Aviva Lev-Ari
@AVIVA1950

#PMConf

Paul Stoffels, M.D., #CSO

Platforms are established, every 20-30 another one emergences access to data – critical platform AI for diagnostics and decision making biomarkers J&J try to learn on every disease: Lungs and GI Diagnosis HIV Vaccine

Aviva Lev-Ari
@AVIVA1950

#PMConf

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson Goals of medicine in 2019 early detection Vaccines in disease prevention Longevity

Aviva Lev-Ari
@AVIVA1950

#PMConf

Joseph B. Martin, M.D., Ph.D., Dean Emeritus

fascinating personal history story on development of interest in genetic analysis

Aviva Lev-Ari
@AVIVA1950

#PMConf

Michael J. Pellini, MD Diagnostics Pain management  Patients can fight more broadly F for sharing data and data exchange 80% patients do not access Academic Centers for treatment

Aviva Lev-Ari
@AVIVA1950

#PMConf

Michael J. Pellini, MD surgery, chemo, radiation – cost, harmful, INEFFECTIVE, Dr. Reza Columbia Medical School Oncologist 35 years How are we doing with technology? Very remarkable Clinical Utility to the Payer Regulatory – a super star in ten years

Aviva Lev-Ari
@AVIVA1950

#PMConf

Stephen L. Eck, Carl June, UPenn Beyond Cancer: Chronic diseases have systemic of specific immune or autoimmune components: CNS, neurodegenerative and Diabetes, Sickle cell anemia – treatment by cell therapy microphages

Aviva Lev-Ari
@AVIVA1950

#PMConf

Stephen L. Eck, Carl June, UPenn Cost of cell transfection therapy: Cost of Goods, Cost of Labor – pay for performance,  Manufacture in NJ shipped to Europe – not effective

Aviva Lev-Ari
@AVIVA1950

#PMConf

Stephen L. Eck, Carl June, UPenn Similarity between Transfusion Medicine industry and Cell therapy – Transfection of cells therapy  Manufacturing of Cells for transfection: Over regulation like in small molecules vs too little regulation

Aviva Lev-Ari
@AVIVA1950

#PMConf

Stephen L. Eck, Carl June, UPenn engineering T cells life farming – innovation is the driver, FDA is evolving in handling patents involved in Cell engineering Regulatory science needs to evolve in light of gene therapy in Human cell line in China

Aviva Lev-Ari
@AVIVA1950

#PMConf

Stephen L. Eck, Carl June, UPenn Children vs Adults 2011 reported better results in Adults, children’s immune system is evolving  In 2019 – 13 biotech companies in CAR-T cell therapies, Gene therapy is growing FDA, drug cycle T cells vs stem cells

Aviva Lev-Ari
@AVIVA1950

#PMConf

15th Annual meeting is at a historic moment in Boston where Prof. Church launched the Human Genome Project and Eric Launder at MIT and the Cancer Genome Project. Genzyme conceived gene therapy sold to Sanofi for $ Billion  Foundation Medicine

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Aviva Lev-Ari
@AVIVA1950

#PMConf

Edward Abrahams, Ph.D., President, PMC 170 drugs with biomarkers, up 15% from 2000 in Biomarker strategy Gene therapy started in 2005, today personalized medicine is becoming standard of care. Science & Technology need additional friendly environment

1

Aviva Lev-Ari
@AVIVA1950

#PMConf

Kenna R. Mills Shaw, Ph.D., MD Anderson Institute does not sequence genome of each patient unlike Dana Farber clinicians need to access information for decision making when disease progresses – what new test to order data sharing inside the institute

Aviva Lev-Ari
@AVIVA1950

#PMConf

Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, PMC Genomic sequencing for a single test that covers many biomarkers Improve treatment efficiency Growing recognition of the need to demonstrate value, evidence for Payers to pay

1

Aviva Lev-Ari
@AVIVA1950

#PMConf

Ammar Qadan, Vice President, Global Head of Market Access, Illumina Illumina is building evidence for Harvard Pilgrim on theirs patient data on risk pregnancies Illumina is expanding  building evidence for ALL rare diseases for all Test diagnostics

Aviva Lev-Ari
@AVIVA1950

#PMConf

Roy J. Gandolfi, M.D., Medical Director, SelectHealth, UT is the Payer of Intermountain Healthcare, UT Regional approach vs National perspective medical policies requires experts for Payer to approve a treatment Consumer in the health plan

Aviva Lev-Ari
@AVIVA1950

#PMConf

Lincoln Nadauld, M.D., Ph.D., Chief, Precision Health, Intermountain Healthcare, UT Precision Oncology Program: Need, study, analysis outcome, publish dataPharmacogenetics testing will be covered for all employees & Neonatal

Aviva Lev-Ari
@AVIVA1950

#PMConf

Peter J. Neumann, Sc.D., Tufts Medical Center clinical utility evidence of value: saving by diagnostics cost for quality cost of diagnostics cost effectiveness – characterize utility cost effectiveness – study Value to families value of knowledge

Aviva Lev-Ari
@AVIVA1950

#PMConf

Ammar Qadan, Vice President, Global Head of Market Access, Illumina Illumina is partnering with providers and Payer Illumina & Blue Cross Blue Shield 150 Million are covered for genomics 2500 genomics test done Under utilization educate physician

Aviva Lev-Ari
@AVIVA1950

#PMConf

Mark P. Stevenson, COO Thermo Fisher Scientific Context: Therapy selection in personalized medicine navigate diagnostics in use and policies when implementations is considered Physicians need precise testing now Payers evidence of utility is needed

1

Aviva Lev-Ari
@AVIVA1950

#PMConf

Mark P. Stevenson, Executive Vice President, Chief Operating Officer, Thermo Fisher Scientific Patient Outcome – Data analytics, ML, AI for genomics, proteomics, metabolomics, Tests must be precise and inform the diagnosis by diagnostics Solutions

Aviva Lev-Ari
@AVIVA1950

#PMConf

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson Passion of Scientists pharmaceutics development is based on insights looking into the future – important goal to solve

Aviva Lev-Ari
@AVIVA1950

#PMConf

best conference on Personalized Medicine in 15 years eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA

eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM…
eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA   The 15th Annual …
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Aviva Lev-Ari
@AVIVA1950

Your synopsis of the best Personalized Medicine Conference organized to date #PMConf

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Aviva Lev-Ari
@AVIVA1950
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#PMConf @pharma_BI @AVIVA1950 best conference on Personalized Medicine in 15 years eProceedings 15th Annual Personalized Medicine Conference at Harvard Medical School – THE PARADIGM EVOLVES, November 13 – 14, 2019 • Harvard Medical School, Boston, MA pharmaceuticalintelligence.com/2019/07/19/15t

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Aviva Lev-Ari
@AVIVA1950

A true leader in Pharmaceutical domain, also Member of the National Academy of Art and Sciences #PMConf

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Cynthia Bens
@bens_cynthia
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Introducing the amazing @ScottGottliebMD was a highlight of #pmconf. His vision for balanced regulatory and coverage policies is desperately needed now to support the future of #personalizedmedicine @permedcoalition

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Aviva Lev-Ari
@AVIVA1950

#PMConf

Best Case study

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PMC
@permedcoalition
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This year’s #PMConf case study on the @TheDDFund puts a spotlight on what one can do to combine modern entrepreneurial finance approaches to tackle a very complex problem such as Alzheimer’s Disease. @RHamermesh @HarvardHBS #PMConf

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Aviva Lev-Ari
@AVIVA1950

#PMConf

Edward Abrahams, Ph.D., President, PMC 170 drugs with biomarkers, up 15% from 2000 in Biomarker strategy Gene therapy started in 2005, today personalized medicine is becoming standard of care. Science & Technology need additional friendly environment

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Genomic Health®
@GenomicHealth

We’re proud to announce Steve Shak is the recipient of the Leadership in Personalized Medicine Award at the 15th Annual Personalized Medicine Conference: The Paradigm Evolves. Please come and see him speak at the conference. bit.ly/2lMAteZ #PMConf

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An Intelligent DNA Nanorobot to Fight Cancer by Targeting HER2 Expression

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

 

HER2 is an important prognostic biomarker for 20–30% of breast cancers, which is the most common cancer in women. Overexpression of the HER2 receptor stimulates breast cells to proliferate and differentiate uncontrollably, thereby enhancing the malignancy of breast cancer and resulting in a poor prognosis for affected individuals. Current therapies to suppress the overexpression of HER2 in breast cancer mainly involve treatment with HER2-specific monoclonal antibodies. However, these monoclonal anti-HER2 antibodies have severe side effects in clinical trials, such as diarrhea, abnormal liver function, and drug resistance. Removing HER2 from the plasma membrane or inhibiting the gene expression of HER2 is a promising alternative that could limit the malignancy of HER2-positive cancer cells.

 

DNA origami is an emerging field of DNA-based nanotechnology and intelligent DNA nanorobots show great promise in working as a drug delivery system in healthcare. Different DNA-based nanorobots have been developed as affordable and facile therapeutic drugs. In particular, many studies reported that a tetrahedral framework nucleic acid (tFNA) could serve as a promising DNA nanocarrier for many antitumor drugs, owing to its high biocompatibility and biosecurity. For example, tFNA was reported to effectively deliver paclitaxel or doxorubicin to cancer cells for reversing drug resistance, small interfering RNAs (siRNAs) have been modified into tFNA for targeted drug delivery. Moreover, the production and storage of tFNA are not complicated, and they can be quickly degraded in lysosomes by cells. Since both free HApt and tFNA can be diverted into lysosomes, so,  combining the HApt and tFNA as a novel DNA nanorobot (namely, HApt-tFNA) can be an effective strategy to improve its delivery and therapeutic efficacy in treating HER2-positive breast cancer.

 

Researchers reported that a DNA framework-based intelligent DNA nanorobot for selective lysosomal degradation of tumor-specific proteins on cancer cells. An anti-HER2 aptamer (HApt) was site-specifically anchored on a tetrahedral framework nucleic acid (tFNA). This DNA nanorobot (HApt-tFNA) could target HER2-positive breast cancer cells and specifically induce the lysosomal degradation of the membrane protein HER2. An injection of the DNA nanorobot into a mouse model revealed that the presence of tFNA enhanced the stability and prolonged the blood circulation time of HApt, and HApt-tFNA could therefore drive HER2 into lysosomal degradation with a higher efficiency. The formation of the HER2-HApt-tFNA complexes resulted in the HER2-mediated endocytosis and digestion in lysosomes, which effectively reduced the amount of HER2 on the cell surfaces. An increased HER2 digestion through HApt-tFNA further induced cell apoptosis and arrested cell growth. Hence, this novel DNA nanorobot sheds new light on targeted protein degradation for precision breast cancer therapy.

 

It was previously reported that tFNA was degraded by lysosomes and could enhance cell autophagy. Results indicated that free Cy5-HApt and Cy5-HApt-tFNA could enter the lysosomes; thus, tFNA can be regarded as an efficient nanocarrier to transmit HApt into the target organelle. The DNA nanorobot composed of HApt and tFNA showed a higher stability and a more effective performance than free HApt against HER2-positive breast cancer cells. The PI3K/AKT pathway was inhibited when membrane-bound HER2 decreased in SK-BR-3 cells under the action of HApt-tFNA. The research findings suggest that tFNA can enhance the anticancer effects of HApt on SK-BR-3 cells; while HApt-tFNA can bind to HER2 specifically, the compounded HER2-HApt-tFNA complexes can then be transferred and degraded in lysosomes. After these processes, the accumulation of HER2 in the plasma membrane would decrease, which could also influence the downstream PI3K/AKT signaling pathway that is associated with cell growth and death.

 

However, some limitations need to be noted when interpreting the findings: (i) the cytotoxicity of the nanorobot on HER2-positive cancer cells was weak, and the anticancer effects between conventional monoclonal antibodies and HApt-tFNA was not compared; (ii) the differences in delivery efficiency between tFNA and other nanocarriers need to be confirmed; and (iii) the confirmation of anticancer effects of HApt-tFNA on tumors within animals remains challenging. Despite these limitations, the present study provided novel evidence of the biological effects of tFNA when combined with HApt. Although the stability and the anticancer effects of HApt-tFNA may require further improvement before clinical application, this study initiates a promising step toward the development of nanomedicines with novel and intelligent DNA nanorobots for tumor treatment.

 

References:

 

https://pubs.acs.org/doi/10.1021/acs.nanolett.9b01320

 

https://www.ncbi.nlm.nih.gov/pubmed/27939064

 

https://www.ncbi.nlm.nih.gov/pubmed/11694782

 

https://www.ncbi.nlm.nih.gov/pubmed/27082923

 

https://www.ncbi.nlm.nih.gov/pubmed/25365825

 

https://www.ncbi.nlm.nih.gov/pubmed/26840503

 

https://www.ncbi.nlm.nih.gov/pubmed/29802035

 

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