Original Tweets Re-Tweets and Likes by @pharma_BI and @AVIVA1950 at #kisymposium for 17th annual Summer Symposium: Breakthrough Cancer Nanotechnologies: Koch Institute, MIT Kresge Auditorium, June 15, 2018, 9AM-4PM



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


The CRISPR-Cas9 system has proven to be a powerful tool for genome editing allowing for the precise modification of specific DNA sequences within a cell. Many efforts are currently underway to use the CRISPR-Cas9 system for the therapeutic correction of human genetic diseases. CRISPR/Cas9 has revolutionized our ability to engineer genomes and conduct genome-wide screens in human cells.


CRISPR–Cas9 induces a p53-mediated DNA damage response and cell cycle arrest in immortalized human retinal pigment epithelial cells, leading to a selection against cells with a functional p53 pathway. Inhibition of p53 prevents the damage response and increases the rate of homologous recombination from a donor template. These results suggest that p53 inhibition may improve the efficiency of genome editing of untransformed cells and that p53 function should be monitored when developing cell-based therapies utilizing CRISPR–Cas9.


Whereas some cell types are amenable to genome engineering, genomes of human pluripotent stem cells (hPSCs) have been difficult to engineer, with reduced efficiencies relative to tumour cell lines or mouse embryonic stem cells. Using hPSC lines with stable integration of Cas9 or transient delivery of Cas9-ribonucleoproteins (RNPs), an average insertion or deletion (indel) efficiency greater than 80% was achieved. This high efficiency of insertion or deletion generation revealed that double-strand breaks (DSBs) induced by Cas9 are toxic and kill most hPSCs.


The toxic response to DSBs was P53/TP53-dependent, such that the efficiency of precise genome engineering in hPSCs with a wild-type P53 gene was severely reduced. These results indicate that Cas9 toxicity creates an obstacle to the high-throughput use of CRISPR/Cas9 for genome engineering and screening in hPSCs. As hPSCs can acquire P53 mutations, cell replacement therapies using CRISPR/Cas9-enginereed hPSCs should proceed with caution, and such engineered hPSCs should be monitored for P53 function.


CRISPR-based editing of T cells to treat cancer, as scientists at the University of Pennsylvania are studying in a clinical trial, should also not have a p53 problem. Nor should any therapy developed with CRISPR base editing, which does not make the double-stranded breaks that trigger p53. But, there are pre-existing humoral and cell-mediated adaptive immune responses to Cas9 in humans, a factor which must be taken into account as the CRISPR-Cas9 system moves forward into clinical trials.




SYNOPSIS – 17th annual Summer Symposium: Breakthrough Cancer Nanotechnologies: Koch Institute, MIT Kresge Auditorium, June 15, 2018, 9AM-4PM


Aviva Lev-Ari, PhD, RN,

Founder and Director of LPBI Group will be in attendance covering the event in





All TWEETS from LPBI’s handles at


  • Friday, June 15, 2018
8:00 AM – 9:00 AM Registration/Check-In


9:00 AM – 9:10 AM Introductory Remarks: Tyler Jacks and Sangeeta Bhatia


o   Sangeeta Bhatia,

  • Challenge meet Opportunity – Future Cancer Research Priorities
  • Prevention and early detection of Cancer for improved outcomes
  • Global cancer burden – Cancer diagnosis in Low-resources settings
  • 2000 microchip became nanoscale – other materials in nanoscale: 1994 – Present advancement in material and devices

o   Tyler Jacks

  • Nanotech, Diagnostics, Therapeutics, Cancer Care, Cancer Biology
  • New Center for NanoMedicine @MIT aka, @MIT.NANO
  • Sponsored: J&J, Sanofi, Thermo Scientific


9:10 AM – 10:40 AM Session I: Imaging and Diagnostics

·       Sanjiv Sam Gambhir, MD, PhD, Stanford University

Bubble Based Nanodiagnostics

  • Companies involved: Endra Inc, Bracco, Visualsonics
  • Canary Center Vision: Imaging: identify, isolate, Intervene
  • Value of early cancer detection: Survival is high ONLY in very very early vs tail of the distribution where 90% of funds goes for therapy: Prostate and Breast cancers — ARE detected early
  • Technology: Ultrasound Imaging ($1500 – low cost solution, for molecular level
  • Bubble based Nanodiognostics: Molecular level, gas pore shell made of lipids or albomin – provide information on location of cancer – molecular events, atomical modelity
  • Bubble size nanobubbles vs microbubbles targeted for Vascular Endothilium In vivo
  • Angiogenesis: KDR (molecule)/VEGFR2 (receptor)- over expressed only in neovascularized: Molecular targer is KDR – over expressed in ovarian and breast cancers
  • ability of bubbles to identify cancer, toxicity monitored , bubble arrive, bind, cleared
  • blind to histology – examine the binding, blind pathology
  • bubbles well correlated
  • histological diagnosis few mm to few cm — correlation of lesions benign
  • 1 cm lesion targeted present in KDR, normal tissue clears more rapidly vs in malignant tissue: ductal adenocarcenoma – 11 minutes after injection
  • Duration of US Molecular Imaging Signal
  • First-in-man – Bubble Transrectal US Photoaccustic detection modality
  • Enzyme activation nanobubbles – nano microbubbles to aggregate and create mass impact vs nanobubbles that are weak in signal potential
  • Synthesis of PA/US nanosize RF-acoustic imaging  – target Saline nanodroplets

·       Ralph Weissleder Developing Next Generation Diagnostics for Cancer @MGH

  • translational diagnostics: Precision oncology (1) Imaging (2) Tumor biopsy (3) Liquid biopsy
  • Enable earlier detection
  • Visualization for affordable cost
  • NEW Technologies at MGH with use of AI
  1. Rapid cellular protein profiling – Fine needle aspirates (FNA): DNA Barcode: Epitope – monoclonal antibodies: Sampling, Barcoding, Imaging, Analysis with AI: Pathways in single cells – protein level in different patient:

x axis patient number

y-axis: Protein type

Vesicles from Host vs from Tumor

2, Exosome

surface – Label-free detection and molecualr profiling of exosome : Pancreatic cancer detection – vesicle express  – they are heteroginous micro vesicles

3. POC testing (AI- Defraction Analysis)

Remote diagnosis:

  • Molecular diagnosis – 2015 (PNAS) – nano bids defract patterns – smart phone vs proprietary box – BioMed Eng
  • Algorithms – identify molecules and decision tree Clinical Trial at MGH: 24 Lymphoma patients, rest no-Lymphoma, higher precision than microspectrometry
  • Automated diagnosis – aspirate – subject to dioagnosis in the Box
  • From tissue to single cell
  • multiplex pathways
  • early detection
  • affordability
  • visualization/connectivity for interpretation

·       Angela Belcher New Approaches for Finding Tiny Tumors: Towards Early Detection and Treatment of Ovarian Cancer

  • Nano material and Biomaterial the intersection of
  • Genetic control of materials
  • Carbon nano tubes – Using Bacteriophage or phage – A virus that infect bacteria
  • from DNA to devices
  • Lincoln Labs + MGH + MIT – Carbon Nanotubes used in inexpensive diagnostics: Biomedical imaging: MI, PET: Optical imaging in vivo: Trade-fee: Resolution vs Depth
  • Ovarian Cancer: Minimal increase in overall survival over 30 years : Fallopian tubesmaximum reduction in tumor better survival rate
  • submillimiter detection: Carbon nanotube multiple tubes
  • Pre-surgical planning locates hard-to-detect ovarian tumor – find tumors that are hidden
  • Detection od Optically Luminescent – RT tracking T-cells in Cancer Immmunotherapy – following injection in mice remain for 2 days


·       Angela Belcher,

·       Sanjiv Sam Gambhir,

·       Ralph Weissleder

10:40 AM – 11:00 AM Coffee Break


11:00 AM – 12:30 PM Session II: Therapeutics

·       Mark Davis Designing Nanoparticles to Safely Cross the Blood-Brain Barrier for Treating Brain Cancers

  • Engineer particles for treating solid tumors
  • Intracellular drug delivery
  • 30-50nm
  • Improve PK properties
  • Limit Toxicity
  • Cyclodex
  • Interspecies translation – Nanoparticles can function to design in Humans
  • Combination of Avastin and nanoparticle component
  • PARP Inhibitor + CRLX101 – in clinical trial by AstraZeneka
  • PK in human been presicted if PK known in non-humans
  • Therapeutic escape from the exosome polymer end group chemistry
  • Tumor localization of Nanoparticles
  • Nanoparticles can function in Human NOT in the brain
  • better clinical trial design and combination drugs in small clinical trials
  • Brain primary vs mestasis in th ebrain
  • 50% HER2 positive will have metastesis in the brain
  • BBB TfP Receptor-mediate Transcytosis : Antibody affinity, monodenriate
  • Nanoparticles behave similarity to antibodies in the brain Nanoparticles characteristics: decreased
  • Improved Uptake of Nanoparticles  – fast release of NP during transcytosis
  • bring nanoparticles in combination therapy to the brain using transcytosis

·       Suzie Pun Modulating Tumor-Associated Macrophage

  • TAM – Targeting Tumor-associated macrophages
  • blood monocytes, immunosuppression, metastasis, invasion
  • Can we potentiated therapeutics delivery using TAM
  • wiin tumors, M2pep is internalized by TAMs
  • Cytotoxic KLA peptide – reduce inflammatory of the tumor – M2pepKLA reduces tumor growth rate and improves survival
  • increase avidity binding
  • Immunomodulation – Marophage targeting for
  • Targeting TAM for translation to Humans
  • improve drug potency
  • synthetic Nucleocapsids  —
  • Biomaterials for modulating tumor extracellular matrix
  • FSP integrates into fibrin, increasing its half-life – delay degradation of FSP-fibrin
  • Polymer cross linking – fibrin deposition in brain metastases
  • Fibrin stabilization by FSP alters TAM chronic FSP treatment increases brain metastasis

·       Daniel Anderson Nanoparticle Formulations for RNA Therapy and Gene Editing

  • can we make drugs to repair our DNA for therapy
  • barriers for systemic delivery of nanaoparticles
  • RNA THERAPEUTICS sIRNA – interference: Turning Genes Off: Modular Pharmacology: sequence Selection, Chemical Modification, Encapsulation (like artificial viruses)
  • What material can be used for RNA delivery? – How can we increase diversity?
  • combinatorial synthesis of lipid-like materials
  • RNA Interference – RNA Tx for Liver: Transthyretin-(TTR)
  • TTR in primates, in Humans – Delivery of sRNAi – new class of machines
  • Chylomicron metabolism: The rate of dietary : Mechanism of APoE mediated iLNP delivery
  • sRNAi are not limited for hypatocytes
  • One injection – 5 genes silencing in lung endothelial cells
  • Repaired liver cells in mouth: repopulation of the liver
  • How do we deliver Cas9 in vivo?
  • Modular Pharmacology: Deliver mRNA to inside cells? using nanoparticles
  • chemistry of nanoparticles will delivery to lungs not to liver or to liver not to lungs
  • inhaled nanoparticles for mRNA delivery
  • Cas9 – for gene editing – – Inject AAV-Virus — >> AAV +Cas( mRNA
  • Chemical modification for siRNA: guiding siRNA delivery
  • Guide RNA improve Genome editing
  • Full modification abolishes the function of sgRNA: Cas9-sgRNA
  • e-sgRNA – edited
  • PCKS9- hyperlipidemia — Nanoparticle for in vivo  Genome Editing
  • Delivery to Immune system – Genome editing in vivo of CAR-Ts


·       Daniel Anderson,

·       Mark Davis,

·       Suzie Pun


12:30 PM – 2:00 PM Lunch Break


2:00 PM – 3:00 PM Panel ‘Translation of Nanomedicine to Patients’

Noubar Afeyan, John Maraganore, Bob Langer, Paula Hammond, Michelle Bradbury, Cristianne Rijcken

Moderated by Rebecca Spalding

Noubar Afeyan,

John Maraganore,

Bob Langer,

Paula Hammond,

Michelle Bradbury,

Cristianne Rijcken



3:00 PM – 4:30 PM Session III: Nanosystems and Devices

Sangeeta Bhatia Activity-based biomarkers for non invasive Cancer Detection, Classification and Monitoring

    • Biomarker paradigm for clinical decisions – Endogenous, singular, blood
    • Synthetic Biomarker paradigm for clinical decisions – Exogenous, multiples, urine
    • Endoprotease in Cancer: MMP9, MMP4
    • Synthetic Biomarkers: Sensitivity
    • Enzyme-responsive nanosensors and PK switch [acitvation fluorescence]
    • Benchmarking synthetic biomarkers against a blood biomarker: Urinary synthetic biomarkers outperform CEA
    • multi-compartment modeling for predicting PK
    • Enhancing sensitivity by nanosensor engineering for ovarian cancer detection
    • Mass barcodes enable multiplexing
    • Mass encoded synthetic biomarkers
    • Differentiating similar diseases with protease activity
    • Paper-based microfluidics in urine biomarker
    • synthetic breath biomarkers for lung disease
    • Protease-Responsive Imaging Sensor for Metastasis (PRISM) – localization of Tumor
    • In vivo Enzyme Profiling by Syntahtic Biomarkers

Rashid Bashir Micro and Nanotechnologies for Analysis of Tissues and Molecules

  • liquid biopsy, molecualar analysis of the tumor
  • spatial map of nuclei acids in tissue – Intra tumor heterogeniety
  • subclonal genetic diversity is important
  • laser capture microdissection
  • fluoresence in situ hybridization
  • Cryo-section on microwell array, pixelate and fix tissue inside wells amplification reagents loaded on chip – amplification reaction: Advantages over PCR
  • procees flow on chip
  • On-chip RT-LAMP: Spatial fluorescence analysis
  • ON CHIP RT-LAMP CONTROL: CANCER (red) VS NON-CANCER (blue)  – FTIR control same section
  • Single cell spatial RNA Seq
  • Hematology Analyzer – complete blood celll count  vs FLow cytometry
  • Cells and Proteins from a Drop of Blood

Convergence : The Future of Health – Cancer Center at Illinois

    • Medical Schools MUST Change  CurrentCurriculum vs Future Curriculum
    • NOW: Yr 1: Basic Science Yr 2: Basic Science Yr 3: Clinical Science +  Required rotation Yr 4: Clinical Science +  elective rotation

Jim Heath A Molecular View of Immuno-Oncology, Institute of System Biology

  • Analytical Chemistry challenge:
  • Fundamental Immunology
  • Challenge CRISPR knocking out genes not for knocking in genes
  • Mutated proteins and NEO antiagens: mostly a computational task


·       Rashid Bashir,

·       Sangeeta Bhatia,

·       James Heath

  • Personalized Immuno-Oncology


4:30 PM – 4:50 PM Vladimir Bulović: MIT.nano Nanoscale Discoveries for Transformative Breakthroughs


·       Vladimir Bulović

    • MIT.nano
    • color depend on the size of the molecule
    • Drugs & Vitamins are nano-sized:
    • Scents are nano-sized – a fraction of an atom – ethylene – plant hormone – Pheromones – are nanosized
    • Nanoscale will define many future discoveries
    • 51% of the recently tenured SOS faculty – use nano
    • 67% of the recently tenured SOE faculty with benefits – use nano


4:50 PM – 5:00 PM Closing Remarks


·       Sangeeta Bhatia



Daniel Anderson

Nanoparticle Formulations for RNA Therapy and Gene Editing

Daniel Anderson, PhD
Samuel A. Goldblith Professor of Applied Biology, MIT
Associate Professor, Chemical Engineering and Institute for Medical Engineering and Science, MIT
Member, Koch Institute, MIT

Rashid Bashir

Micro and Nanotechnologies for Analysis of Tissues and Molecules

Rashid Bashir, PhD
Executive Associate Dean and Chief Diversity Officer, Carle Illinois College of Medicine
Grainger Distinguished Chair in Engineering, Professor of Bioengineering, Electrical and Computer Engineering, Mechanical Science and Engineering, Materials Science and Engineering, and Molecular and Integrative Physiology, University of Illinois at Urbana-Champaign

Angela Belcher

New Approaches for Finding Tiny Tumors: Towards Early Detection and Treatment of Ovarian Cancer

Angela Belcher, PhD
James Mason Crafts Professor and Professor of Biological Engineering, MIT
Member, Koch Institute, MIT

Sangeeta Bhatia

Protease Nanosensors for Cancer Detection, Classification and Monitoring

Sangeeta Bhatia, MD, PhD
Director, Marble Center for Cancer Nanomedicine
John J. and Dorothy Wilson Professor of Health Sciences and Technology and of Electrical Engineering and Computer Science, MIT
Member, Koch Institute, MIT
Investigator, Howard Hughes Medical Institute

Vladimir Bulović, PhD

Nanoscale Discoveries for Transformative Breakthroughs

Vladimir Bulović, PhD
Director, MIT.nano
Associate Dean for Innovation, MIT School of Engineering
Fariborz Maseeh (1990) Professor of Emerging Technology, Department of Electrical Engineering and Computer Science (EECS), MIT

Mark E. Davis, PhD

Designing Nanoparticles to Safely Cross the Blood-Brain Barrier for Treating Brain Cancers

Mark E. DavisPhD  
Warren and Katharine Schlinger Professor of Chemical Engineering, California Institute of Technology
Member of the City of Hope Comprehensive Cancer Center
Member of the UCLA Jonsson Comprehensive Cancer Center

Sanjiv Sam Gambhir, MD, PhD

Bubble Based Nanodiagnostics

Sanjiv Sam GambhirMD, PhD  
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Professor of Bioengineering, Professor of Materials Science and Engineering, Stanford University

James R. Heath

A Molecular View of Immuno-Oncology

James R. Heath, PhD
President and Professor, Institute for Systems Biology
Professor of Molecular and Medical Pharmacology, UCLA

Suzie H. Pun

Modulating Tumor-Associated Macrophage

Suzie H. Pun, PhD
Robert F. Rushmer Professor of Bioengineering, Adjunct Professor of Chemical Engineering, University of Washington

Ralph Weissleder

Developing Next Generation Diagnostics for Cancer

Ralph Weissleder, MD, PhD
Thrall Professor of Radiology and Professor of Systems Biology, Harvard Medical School
Director of the Center for Systems Biology at Massachusetts General Hospital


Panelists: Translation of Nanomedicine to Patients

Noubar Afeyan

Noubar Afeyan, PhD
Founder and CEO, Flagship Pioneering

Michelle S. Bradbury, MD, PhD

Michelle S. Bradbury, MD, PhD
Co-Director, MSK-Cornell Center for Translation of Cancer Nanomedicines & Director, Intraoperative Imaging Program
Member, Molecular Pharmacology Program, Sloan Kettering Institute
Attending, Radiology, Memorial Sloan Kettering Cancer Center
Professor, Gerstner Sloan Kettering Graduate School of Biomedical Sciences & Weill Medical College of Cornell University

Paula Hammond

Paula Hammond, PhD
Head, Department of Chemical Engineering, MIT
David H. Koch Professor of Engineering, MIT
Member, Koch Institute, MIT

Robert Langer

Robert Langer, ScD
David H. Koch Institute Professor
Member, Koch Institute, MIT

John Maraganore

John Maraganore, PhD
CEO and Director, Alnylam

Cristianne Rijcken

Cristianne Rijcken, PhD
Founder and Chief Scientific Officer, Cristal Therapeutics

Rebecca Spalding


Rebecca Spalding
Biotech Reporter, Bloomberg

Survival Calls during Careers in the Digital Age

Curator: Aviva Lev-Ari, PhD, RN


As I shared with my friend, Aviva Brecher, MIT’68, an article that featured my career in May 2018 in the Alumni Spotlight of the Hebrew University,

My friend wrote the following:

From: Aviva Brecher
Date: Tuesday, May 8, 2018 at 9:40 AM
To: Aviva Lev-Ari
Subject: Re: Article about Aviva Lev-Ari ­in Spotlight of American Friends of the Hebrew University


You have an impressive education and career track with major reorientations. I too have reoriented and “reinvented” my career within the Applied Physics realm: from solid state physics and magnetism, to Lunar and Planetary Science and meteoritics in the Apollo age, to Earth Sciences and to applied topics like nuclear waste isolation and their advanced transportation technologies and environmental impacts.


I was very intrigued to further elucidate what actually are the Survival Calls during Careers in the Digital Age. That exploration was inspired by an additional new direction added to MIT Tech Review called: Clocking In, A daily look at the workplace of the future. 

In their 2/21/2018 article The fastest transition humankind has experienced” 

The reader is welcome to their annual list of the 10 technology advances they think will shape the way we work and live now and for years to come.

  • Genetic Fortune-Telling

We spotted Genomics technology and published a book about it

  • VOLUME 1: Genomics Orientations for Personalized Medicine. On since 11/23/2015


In Clocking In article on 3/9/2018 Robert Rubin is interviewed on How to prepare for the future of workHe runs the Hamilton Project, a DC-based think tank.

Rubin: McKinsey Global Institute put out a report recently in which they projected roughly one-third of American workers might have to change jobs or vacate the jobs they have by 2030. They also said that they thought that there would be opportunity for all kinds of increased employment in existing areas—like education, management, and technology—that will need more people. But, you need a lot of public policy to support that transition.


Labor Productivity and Automation

Autor, David, and Anna Salomons. 2018. “Is automation labor-displacing? Productivity growth, employment, and the labor share.” BPEA Conference Draft, Spring.


Technology Pipeline and Gender

  • The US tech talent pipeline shows promising signs for a more gender diverse future. (TR)
  • Women do hold the majority of STEM jobs—in Iran. (Quartz)


Clocking In, in their article on 6/7/2018, How we measure the gig economy matters

The Aspen Institute has put together its own data repository on gig work, and found that roughly 30 percent of the US workforce depends on the gig economy in some form.

The Bureau of Labor Statistics released its long-awaited 2017 Contingent Worker Supplement this morning—a huge event for us data nerds!—giving us a “current” (the data is from May 2017) view of gig work in the US. But there are a few problems with the findings.

Why it matters: Had the BLS report found a large jump in nontraditional workers, it might have caught the eye of Congress and motivated lawmakers to pass legislation that to protect and support gig economy workers (emphasis on the “might,” but still). Instead the report could be used to argue the gig economy isn’t as big or important as it’s cracked up to be.


We foresee the future to have major opportunities in the Expert Consultancy private sector. By 2030 freelance consultants with very deep expertise will hold the knowledge that corporations need for in-house technology development. It will bring a golden age to a new breed of PhD level experts foot loose providing services to multiple employers. It is a version of the gig economy at the highest pay rate per hour.


With generous funding and top-tier jobs, China seeks to lure science talent from abroad


We foresee the future of Markets experiencing brain drain and other Markets experiencing brain influx. The knowledge worker will trade his skills on a global scale and will be geographically, foot loose.

The knowledge worker will be subjected to unique survival calls, will have multiple careers in a life time and will re-invent their avocation and the skill offering per an unprecedented fast pace of structural changes in the economy and fluctuation in demand for ever newly minted talent.

  • While “Agility” was the pace of the 90s,
  • the 2020s will be the decade of “re-orientation driven by technological innovation of Artificial intelligence embedded in tools performing tasks by automation and a new era for robotics empowered by rule-based decision support software, actually, autonomous decision making, remotely supervised. 


In that light, I submitted a story pitch to Clocking In:

From: MIT Technology Review <

To: Aviva Lev-Ari <>
Wednesday, June 13, 2018 at 3:37 PM

Subject: Re: It is a Case Study for Clocking In about Survival Calls during Careers in the Digital Age – An AGE like no Other, also known as, DIGITAL

We have received your news tip or story pitch. Thank you!

Our editors review every item submitted, and we’ll be in touch if we’d like to pursue your submission or learn more. 

Thanks for your interest in MIT Technology Review.


Supporting material to the story pitch include the following:


  • Thriving at the Survival Calls during Careers in the Digital Age – An AGE like Other, also known as, DIGITAL


  • Reflections on a Four-phase Career: Aviva Lev-Ari, PhD, RN, March 2018


  • Pioneering implementations of analytics to business decision making: contributions to domain knowledge conceptualization, research design, methodology development, data modeling and statistical data analysis: Aviva Lev-Ari, UCB, PhD’83; HUJI MA’76


  • Recollections: Part 2 – “While Rolling” is preceded by “While Enrolling” Autobiographical Alumna Recollections of Berkeley – Aviva Lev-Ari, PhD’83


  • Professional Self Re-Invention: From Academia to Industry – Opportunities for PhDs in the Business Sector of the Economy


  • Key Opinion Leader (KOL) in Pharmaceutical Business Intelligence – Aviva Lev-Ari, PhD, RN, as evidenced by


  • Data Science is the Greatest Science! It is the Greatest Science for Women, as well


Contact: Christopher J. Wells

Personalized Medicine Coalition




New York Times vs. Personalized Medicine?

PMC President: Times’ Critique of Streamlined Regulatory Approval for Personalized Treatments ‘Ignores Promising Implications’ of Field

WASHINGTON (June 13, 2018) — In response to an editorial published on June 9 by the New York Times titled “Easier Drug Approval, at What Price?,” Personalized Medicine Coalition (PMC) President Edward Abrahams today defends a series of decisions by the U.S. Food and Drug Administration (FDA) over the last several years that have streamlined the regulatory review process for personalized medicines.

“Unlike FDA, which has been an engine for innovation under the direction of Scott Gottlieb and his predecessors, ‘Easier Drug Approval, at What Price?’ ignores the promising implications of reforms in regulatory science that FDA has put in place to facilitate a new appreciation of how different individuals respond to selected treatments,” Abrahams said.

As PMC underlined earlier this year in a report titled Personalized Medicine at FDA: 2017 Progress Report, personalized medicines now account for one of every four drugs the agency approves. The Times’ editorial, which was also published online under the headline “Easier Drug Approval Isn’t Cutting Drug Prices,” contends that “it’s not clear that people, as opposed to drug companies, are feeling much benefit” from the streamlined regulatory review pathways that bring personalized treatments to market faster.

Abrahams disagrees, noting that in non-small cell lung cancer, for example, a disease that was nearly untreatable 20 years ago, there are now multiple drugs on the market that target a patient’s particular tumor. As indicated by the U.S. National Cancer Institute (NCI), these treatments “improve the survival of subsets of patients with metastatic disease.”

Furthermore, because targeted therapies zero in on specific cancerous mutations, doctors can use diagnostic tests to identify with much greater certainty the patients who will likely benefit from them, sparing expenses and side effects for those will not. That logic underpins FDA’s decision to streamline its regulatory processes, to ensure that patients who will benefit from promising targeted therapies — many of whom have few remaining options — can access those treatments without unnecessary delay.

“By putting in place smarter policies to encourage the efficient development of personalized drugs whose safety and efficacy profiles are often higher than one-size-fits-all, trial-and-error treatments, FDA serves the interests not only of patients but also the health system, which spends too much money on ineffective treatments,” Abrahams said.

To evaluate the American public’s interest in personalized medicine, PMC and GenomeWeb recently commissioned Public Perspectives on Personalized Medicine: A Survey of U.S. Public Opinion, which was published in May. Two-thirds of Americans indicated in the survey that they appreciate personalized medicine’s potential, and the majority expressed concerns about whether they will have access to personalized tests and treatments in the future.


About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information, please visit


From: “Christopher Wells (PMC)” <>

Date: Wednesday, June 13, 2018 at 3:15 PM

To: Aviva Lev-Ari <>

Subject: Re: New York Times vs. Personalized Medicine?


Reactions to Original Tweets by @Pharma_BI and by @AVIVA1950 from #BIO2018

Curator: Aviva Lev-Ari, PhD, RN


Please review:

  • Re-Tweets and Likes by @Pharma_BI and by @AVIVA1950 from #BIO2018 @IAmBiotech @BIOConvention – BIO 2018, Boston, June 4-7, 2018, BCEC


  • Original Tweets by @Pharma_BI and by @AVIVA1950 from #BIO2018 @IAmBiotech @BIOConvention – BIO 2018, Boston, June 4-7, 2018, BCEC


  • Thriving at the Survival Calls during Careers in the Digital Age – An AGE like no Other, also known as, DIGITAL


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Thriving at the Survival Calls during Careers in the Digital Age – An AGE like no Other, also known as, DIGITAL

Author and Curator: Aviva Lev-Ari, PhD, RN


The source for the inspiration to write this curation is described in

Survival Calls during Careers in the Digital Age


In this curation, I present the following concepts in three parts:

  1. Part 1: Authenticity of Careers in the Digital Age: In Focus, the BioTechnology Sector
  2. Part 2: Top 10 books to help you survive the Digital Age

  3. Part 3: A case study on Thriving at the Survival Calls during Careers in the Digital Age: Aviva Lev-Ari, UCB, PhD’83; HUJI, MA’76 


Part 1: Authenticity of Careers in the Digital Age: 

In Focus, the BioTechnology Sector


Lisa LaMotta, Senior Editor, BioPharma Dive wrote in Conference edition | June 11, 2018

Unlike that little cancer conference in Chicago last week, the BIO International convention is not about data, but about the people who make up the biopharma industry.

The meeting brings together scientists, board members, business development heads and salespeople, from the smallest virtual biotechs to the largest of pharmas. It allows executives at fledgling biotechs to sit at the same tables as major decision-makers in the industry — even if it does look a little bit like speed dating.

But it’s not just a partnering meeting.

This year’s BIO also sought to shine a light on pressing issues facing the industry. Among those tackled included elevating the discussion on gender diversity and how to bring more women to the board level; raising awareness around suicide and the need for more mental health treatments; giving a voice to patient advocacy groups; and highlighting the need for access to treatments in developing nations.

Four days of meetings and panel discussions are unlikely to move the needle for many of these challenges, but debate can be the first step toward progress.

I attended the meetings on June 4,5,6, 2018 and covered in Real Time the sessions I attended. On the link below, Tweets, Re-Tweets and Likes mirrors the feelings and the opinions of the attendees as expressed in real time using the platform. This BioTechnology events manifested the AUTHENTICITY of Careers in the Digital Age – An AGE like no Other, also known as, DIGITAL.

The entire event is covered on by the following hash tag and two handles:


I covered the events on two tracks via two Twitter handles, each handle has its own followers:

The official LPBI Group account

The Aviva Lev-Ari, PhD, RN account

Track A:

  • Original Tweets by @Pharma_BI and by @AVIVA1950 for #BIO2018 @IAmBiotech @BIOConvention – BIO 2018, Boston, June 4-7, 2018, BCEC

Curator: Aviva Lev-Ari, PhD, RN


  • Reactions to Original Tweets by @Pharma_BI and by @AVIVA1950 from #BIO2018

Curator: Aviva Lev-Ari, PhD, RN

Track B:

  • Re-Tweets and Likes by @Pharma_BI and by @AVIVA1950 from #BIO2018 @IAmBiotech @BIOConvention – BIO 2018, Boston, June 4-7, 2018, BCEC

Curator: Aviva Lev-Ari, PhD, RN

Part 2: Top 10 books to help you survive the digital age

From Philip K Dick’s obtuse robots to Mark O’Connell’s guide to transhumanism, novelist Julian Gough picks essential reading for a helter skelter world

Here are 10 of the books that did help me [novelist Julian Gough]: they might also help you understand, and survive, our complicated, stressful, digital age.

  1. Marshall McLuhan Unbound by Marshall McLuhan (2005)
    The visionary Canadian media analyst predicted the internet, and coined the phrase the Global Village, in the early 1960s. His dense, complex, intriguing books explore how changes in technology change us. This book presents his most important essays as 20 slim pamphlets in a handsome, profoundly physical, defiantly non-digital slipcase.
  2. Ubik by Philip K Dick (1969)
    Pure pulp SF pleasure; a deep book disguised as a dumb one. Dick shows us, not a dystopia, but a believably shabby, amusingly human future. The everyman hero, Joe Chip, wakes up and argues with his robot toaster, which refuses to toast until he sticks a coin in the slot. Joe can’t do this, because he’s broke. He then has a stand-up row with his robot front door, which won’t open, because he owes it money too … Technology changes: being human, and broke, doesn’t. Warning: Dick wrote Ubik at speed, on speed. But embedded in the pulpy prose are diamonds of imagery that will stay with you for ever.
  3. The Singularity Is Near by Ray Kurzweil (2005)
    This book is what Silicon Valley has instead of a bible. It’s a visionary work that predicts a technological transformation of the world in our lifetime. Kurzweil argues that computer intelligence will soon outperform human thought. We will then encode our minds, upload them, and become one with our technology, achieving the Singularity. At which point, the curve of technological progress starts to go straight up. Ultimately – omnipotent, no longer mortal, no longer flesh – we transform all the matter in the universe into consciousness; into us.
  4. To Be a Machine by Mark O’Connell (2017)
    This response to Kurzweil won this year’s Wellcome prize. It’s a short, punchy tour of transhumanism: the attempt to meld our minds with machines, to transcend biology and escape death. He meets some of the main players, and many on the fringes, and listens to them, quizzically. It is a deliberately, defiantly human book, operating in that very modern zone between sarcasm and irony, where humans thrive and computers crash.
  5. A Visit from the Goon Squad by Jennifer Egan (2011)
    This intricately structured, incredibly clever novel moves from the 60s right through to a future maybe 15 years from now. It steps so lightly into that future you hardly notice the transition. It has sex and drugs and rock’n’roll, solar farms, social media scams and a stunningly moving chapter written as a PowerPoint presentation. It’s a masterpiece. Life will be like this.
  6. What Technology Wants by Kevin Kelly (2010)
    Kelly argues that we scruffy biological humans are no longer driving technological progress. Instead, the technium, “the greater, global, massively interconnected system of technology vibrating around us”, is now driving its own progress, faster and faster, and we are just caught up in its slipstream. As we accelerate down the technological waterslide, there is no stopping now … Kelly’s vision of the future is scary, but it’s fun, and there is still a place for us in it.
  7. The Meme Machine by Susan Blackmore (1999)
    Blackmore expands powerfully and convincingly on Richard Dawkins’s original concept of the meme. She makes a forceful case that technology, religion, fashion, art and even our personalities are made of memes – ideas that replicate, mutate and thus evolve over time. We are their replicators (if you buy my novel, you’ve replicated its memes); but memes drive our behaviour just as we drive theirs. It’s a fascinating book that will flip your world upside down.
  8. Neuromancer by William Gibson (1984)
    In the early 1980s, Gibson watched kids leaning into the screens as they played arcade games. They wanted to be inside the machines, he realised, and they preferred the games to reality. In this novel, Gibson invented the term cyberspace; sparked the cyberpunk movement (to his chagrin); and vividly imagined the jittery, multi-screened, anxious, technological reality that his book would help call into being.
  9. You Are Not a Gadget: A Manifesto by Jaron Lanier (2010)
    Lanier, an intense, brilliant, dreadlocked artist, musician and computer scientist, helped to develop virtual reality. His influential essay Digital Maoism described early the downsides of online collective action. And he is deeply aware that design choices made by (mainly white, young, male) software engineers can shape human behaviour globally. He argues, urgently, that we need to question those choices, now, because once they are locked in, all of humanity must move along those tracks, and we may not like where they take us. Events since 2010 have proved him right. His manifesto is a passionate argument in favour of the individual voice, the individual gesture.
  10. All About Love: New Visions by bell hooks (2000)
    Not, perhaps, an immediately obvious influence on a near-future techno-thriller in which military drones chase a woman and her son through Las Vegas. But hooks’s magnificent exploration and celebration of love, first published 18 years ago, will be far more useful to us, in our alienated digital future, than the 10,000 books of technobabble published this year. All About Love is an intensely practical roadmap, from where we are now to where we could be. When Naomi and Colt find themselves on the run through a militarised American wilderness of spirit, when GPS fails them, bell hooks is their secret guide.


Part 3: A case study on Thriving at the Survival Calls during Careers in the Digital Age:  Aviva Lev-Ari, UCB, PhD’83; HUJI, MA’76


On June 10, 2018


Following, is a case study about an alumna of HUJI and UC, Berkeley as an inspirational role model. An alumna’s profile in context of dynamic careers in the digital age. It has great timeliness and relevance to graduate students, PhD level at UC Berkeley and beyond, to all other top tier universities in the US and Europe. As presented in the following curations:

Professional Self Re-Invention: From Academia to Industry – Opportunities for PhDs in the Business Sector of the Economy


Pioneering implementations of analytics to business decision making: contributions to domain knowledge conceptualization, research design, methodology development, data modeling and statistical data analysis: Aviva Lev-Ari, UCB, PhD’83; HUJI, MA’76


This alumna is Editor-in-Chief of a Journal that has other 173 articles on Scientist: Career Considerations


In a 5/22/2018 article, Ways to Pursue Science Careers in Business After a PhD by Ankita Gurao,

Unemployment figures of PhDs by field of science are included, Ankita Gurao identifies the following four alternative careers for PhDs in the non-academic world:

  1. Science Writer/Journalist/Communicator
  2. Science Management
  3. Science Administration
  4. Science Entrepreneurship

My career, as presented in Reflections on a Four-phase Career: Aviva Lev-Ari, PhD, RN, March 2018

has the following phases:

  • Phase 1: Research, 1973 – 1983
  • Phase 2: Corporate Applied Research in the US, 1985 – 2005
  • Phase 3: Career Reinvention in Health Care, 2005 – 2012
  • Phase 4: Electronic Scientific Publishing, 4/2012 to present

These four phases are easily mapped to the four alternative careers for PhDs in the non-academic world. One can draw parallel lines between the four career opportunities A,B,C,D, above, and each one of the four phases in my own career.

Namely, I have identified A,B,C,D as early as 1985, and pursued each of them in several institutional settings, as follows:

A. Science Writer/Journalist/Communicator – see link above for Phase 4: Electronic Scientific Publishing, 4/2012 to present 

B. Science Management – see link above for Phase 2: Corporate Applied Research in the US, 1985 – 2005 and Phase 3: Career Reinvention in Health Care, 2005 – 2012 

C. Science Administration – see link above for Phase 2: Corporate Applied Research in the US, 1985 – 2005and Phase 4: Electronic Scientific Publishing, 4/2012 to present 

D. Science Entrepreneurship – see link above for Phase 4: Electronic Scientific Publishing, 4/2012 to present  

Impressions of My Days at Berkeley in Recollections: Part 1 and 2, below.

  • Recollections: Part 1 – My days at Berkeley, 9/1978 – 12/1983 –About my doctoral advisor, Allan Pred, other professors and other peers

  • Recollections: Part 2 – “While Rolling” is preceded by “While Enrolling” Autobiographical Alumna Recollections of Berkeley – Aviva Lev-Ari, PhD’83

The topic of Careers in the Digital Age is closely related to my profile, see chiefly: Four-phase Career, Reflections, Recollections Parts 1 & 2 and information from other biographical sources, below.

Other sources for my biography