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Archive for the ‘Health Law & Patient Safety’ Category

Digital Therapeutics: A threat or opportunity to pharmaceuticals


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

 

Digital Therapeutics (DTx) have been defined by the Digital Therapeutics Alliance (DTA) as “delivering evidence based therapeutic interventions to patients, that are driven by software to prevent, manage or treat a medical disorder or disease”. They might come in the form of a smart phone or computer tablet app, or some form of a cloud-based service connected to a wearable device. DTx tend to fall into three groups. Firstly, developers and mental health researchers have built digital solutions which typically provide a form of software delivered Cognitive-Behaviour Therapies (CBT) that help patients change behaviours and develop coping strategies around their condition. Secondly there are the group of Digital Therapeutics which target lifestyle issues, such as diet, exercise and stress, that are associated with chronic conditions, and work by offering personalized support for goal setting and target achievement. Lastly, DTx can be designed to work in combination with existing medication or treatments, helping patients manage their therapies and focus on ensuring the therapy delivers the best outcomes possible.

 

Pharmaceutical companies are clearly trying to understand what DTx will mean for them. They want to analyze whether it will be a threat or opportunity to their business. For a long time, they have been providing additional support services to patients who take relatively expensive drugs for chronic conditions. A nurse-led service might provide visits and telephone support to diabetics for example who self-inject insulin therapies. But DTx will help broaden the scope of support services because they can be delivered cost-effectively, and importantly have the ability to capture real-world evidence on patient outcomes. They will no-longer be reserved for the most expensive drugs or therapies but could apply to a whole range of common treatments to boost their efficacy. Faced with the arrival of Digital Therapeutics either replacing drugs, or playing an important role alongside therapies, pharmaceutical firms have three options. They can either ignore DTx and focus on developing drug therapies as they have done; they can partner with a growing number of DTx companies to develop software and services complimenting their drugs; or they can start to build their own Digital Therapeutics to work with their products.

 

Digital Therapeutics will have knock-on effects in health industries, which may be as great as the introduction of therapeutic apps and services themselves. Together with connected health monitoring devices, DTx will offer a near constant stream of data about an individuals’ behavior, real world context around factors affecting their treatment in their everyday lives and emotional and physiological data such as blood pressure and blood sugar levels. Analysis of the resulting data will help create support services tailored to each patient. But who stores and analyses this data is an important question. Strong data governance will be paramount to maintaining trust, and the highly regulated pharmaceutical industry may not be best-placed to handle individual patient data. Meanwhile, the health sector (payers and healthcare providers) is becoming more focused on patient outcomes, and payment for value not volume. The future will say whether pharmaceutical firms enhance the effectiveness of drugs with DTx, or in some cases replace drugs with DTx.

 

Digital Therapeutics have the potential to change what the pharmaceutical industry sells: rather than a drug it will sell a package of drugs and digital services. But they will also alter who the industry sells to. Pharmaceutical firms have traditionally marketed drugs to doctors, pharmacists and other health professionals, based on the efficacy of a specific product. Soon it could be paid on the outcome of a bundle of digital therapies, medicines and services with a closer connection to both providers and patients. Apart from a notable few, most pharmaceutical firms have taken a cautious approach towards Digital Therapeutics. Now, it is to be observed that how the pharmaceutical companies use DTx to their benefit as well as for the benefit of the general population.

 

References:

 

https://eloqua.eyeforpharma.com/LP=23674?utm_campaign=EFP%2007MAR19%20EFP%20Database&utm_medium=email&utm_source=Eloqua&elqTrackId=73e21ae550de49ccabbf65fce72faea0&elq=818d76a54d894491b031fa8d1cc8d05c&elqaid=43259&elqat=1&elqCampaignId=24564

 

https://www.s3connectedhealth.com/resources/white-papers/digital-therapeutics-pharmas-threat-or-opportunity/

 

http://www.pharmatimes.com/web_exclusives/digital_therapeutics_will_transform_pharma_and_healthcare_industries_in_2019._heres_how._1273671

 

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/exploring-the-potential-of-digital-therapeutics

 

https://player.fm/series/digital-health-today-2404448/s9-081-scaling-digital-therapeutics-the-opportunities-and-challenges

 

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2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies

REAL TIME Press Coverage for http://pharmaceuticalintelligence.com 

by Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

Editor-in-Chief, Open Access Online Scientific Journal, http://pharmaceuticalintelligence.com

Editor-in-Chief, BioMed e-Series, 16 Volumes in Medicine, https://pharmaceuticalintelligence.com/biomed-e-books/

  • Cardiovascular Diseases, Volume Three: Etiologies of Cardiovascular Diseases: Epigenetics, Genetics and Genomics. On Amazon.com since 11/29/2015

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

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

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

  • VOLUME 2: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS & BioInformatics, Simulations and the Genome Ontology – Work-in-Progress

https://pharmaceuticalintelligence.com/biomed-e-books/genomics-orientations-for-personalized-medicine/volume-two-genomics-methodologies-ngs-bioinformatics-simulations-and-the-genome-ontology/

Logo, Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

 

2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies

AGENDA NOW AVAILABLE! 2019 Petrie-Flom Center Annual Conference image

 May 17, 2019 8:30 AM – 5:15 PM
 Conferences
 2018-2019
Harvard Law School, Wasserstein Hall, Milstein West (2019)
1585 Massachusetts Ave., Cambridge, MA

Register for this event

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2019 annual conference: “Consuming Genetics: The Ethical and Legal Considerations of Consumer Genetic Technologies.” This year’s conference is organized in collaboration with Nita A. Farahany, Duke Law School, and Henry T. Greely, Stanford Law School.

Description

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

Already the global genetic testing and consumer/wellness genomics market was valued at $2.24 billion in 2015 and is expected to double by 2025 to nearly $5 billion. The rise of direct-to-consumer genetic testing and DIY kits raise questions about the appropriate setting for these activities, including a concern that delivering health-related results directly to consumers might cause individuals to draw the wrong medical conclusions. At the same time, advances in CRISPR and other related technologies raise anxieties about the implications of editing our own DNA, especially as access to these technologies explode in the coming years.

In an age where serial killers are caught because their relatives chose to submit DNA to a consumer genealogy database, is genetic privacy for individuals possible? Does the aggregation of data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate already significant health care disparities? How can we prepare for widespread access to genetic editing tools?

As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics.

This event is free and open to the public, but space is limited and registration is required. Register now!

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:10am, Welcome Remarks

9:10 – 10:10am, Consumer Genetic Technologies: Rights, Liabilities, and Other Obligations

  • Gary Marchant, Regent’s Professor, Sandra Day O’Connor College of Law and Director, Center for Law, Science, and Innovation, Arizona State University (with Mark Barnes, Ellen Clayton, and Susan Wolf) – Direct to Consumer Genetics and Liability
  • Anya Prince,Associate Professor of Law, University of Iowa College of Law and Member of the University of Iowa Genetics Cluster – Consuming Genetics as an Insurance Consumer
  • Jessica Robertsa George Butler Research Professor and Director of the Health Law & Policy Institute, University of Houston Law Center – In Favor of a Limited Right of Genetic Conversion: An Argument for Genetic Property Rights

10:10 – 10:20am, Break

10:20 – 11:40am, Privacy in the Age of Consumer Genetics

  • Jorge Contreras, Professor, College Of Law and Adjunct Professor, Human Genetics, University of Utah – Direct to Consumer Genetics and Data Ownership
  • Seema MohapatraAssociate Professor of Law, Indiana University Robert H. McKinney School of Law – Abolishing the Facade of “Anonymous” Gamete Donation in the Age of Direct-to-Consumer Genetic Testing
  • Kayte Spector-Bagdady, Assistant Professor, Department of Obstetrics and Gynecology and Chief, Research Ethics Service, Center for Bioethics and Social Sciences in Medicine (CBSSM), University of Michigan Medical School – Improving Commercial Health Data Sharing Policy: Transparency, Accountability, and Ethics for Academic Use of Private Health Data Resources
  • Liza VertinskyAssociate Professor of Law, Emory University School of Law and Emory Global Health Institute Faculty Fellow (with Yaniv Heled) – Genetic Privacy and Public Figures

11:40am – 12:40pm, Tinkering with Ourselves: The Law and Ethics of DIY Genomics

  • Barbara J. EvansMary Ann & Lawrence E. Faust Professor of Law and Director, Center on Biotechnology & Law, University of Houston Law Center; Professor, Electrical and Computer Engineering, Cullen College of Engineering, University of Houston – Programming Our Genomes/Programming Ourselves: The Moral and Regulatory Limits of Self-Harm When Consumers Wield Genomic Technologies
  • Maxwell J. MehlmanDistinguished University Professor, Arthur E. Petersilge Professor of Law, and Director of the Law-Medicine Center, Case Western Reserve University School of Law, and Professor of Biomedical Ethics, Case Western Reserve University School of Medicine (with Ron Conlon) – Governance of Do-It-Yourself Genomics
  • Patricia J. ZettlerAssociate Professor, Center for Law Health and Society, Georgia State University College of Law (with Christi Guerrini and Jacob S. Sherkow) – Finding a Regulatory Balance for Genetic Biohacking

12:40 – 1:20pm, Lunch

Lunch will be provided.

1:20 – 2:40pm, Consumer Genetics and Identity

  • Kif Augustine-AdamsIvan Meitus Chair and Professor of Law, BYU Law School – Generational Failures of Law and Ethics: Rape, Mormon Orthodoxy, and the Revelatory Power of Ancestry DNA
  • Jonathan KahnJames E. Kelley Chair in Tort Law and Professor of Law, Mitchell-Hamline School of Law – Precision Medicine and the Resurgence of Race in Genomic Medicine
  • Emily LargentAssistant Professor, Department of Medical Ethics and Health Policy and Senior Fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania – Losing Our Minds? Direct-to-Consumer Genetic Testing and Alzheimer’s Disease: Consumer Education, Informed Consent, and Open Legal Questions
  • Natalie RamAssistant Professor of Law, University of Baltimore School of Law – Genetic Genealogy and the Problem of Familial Forensic Identification

2:40 – 2:50pm, Break

2:50 – 3:50pm, Regulating Consumer Genetic Technologies

  • James Hazelpostdoctoral fellow, Center for Genetic Privacy and Identity in Community Settings (GetPreCiSe), Vanderbilt University Medical Center – Privacy Best Practices for Consumer Genetic Testing Services: Are Industry Efforts at Self-Regulation Sufficient?
  • Scott SchweikartSenior Research Associate, Council on Ethical and Judicial Affairs, American Medical Association and Legal Editor, AMA Journal of Ethics – Human Gene Editing: An Ethical Analysis and Arguments for Regulatory Guidance at Both the National and Global Levels
  • Catherine M. SharkeyCrystal Eastman Professor of Law, NYU School of Law (with Kenneth Offit) – Regulatory Aspects of Direct-to-Consumer Genetic Testing: The Emerging Role of the FDA

3:50 – 4:00pm, Break

4:00 – 5:00pm, The Impact of Genetic Information

  • Benjamin Berkmanfaculty member and head of section on the ethics of genetics and emerging technologies, NIH Department of Bioethics and Deputy Director of the NHGRI Bioethics Core, National Human Genome Research Institute, National Institutes of Health (with Leila Jamal and Will Schupmann) – Reexamining Non-Directiveness in Genetic Counseling
  • Emily Qian, Genetic Counselor, Veritas Genetics (with Magalie Leduc, Rebecca Hodges, Ryan Durigan, Laurie McCright, Doug Flood, and Birgit Funke) – Physician-Mediated Elective Whole Genome Sequencing Tests: Impacts on Informed Consent
  • Vardit RavitskyAssociate Professor, Bioethics Programs, Department of Social and Preventive Medicine, School of Public Health, University of Montreal; Director, Ethics and Health Branch, Center for Research on Ethics – Non-Invasive Prenatal Whole Genome Sequencing: Ethical and Regulatory Implications for Post-Birth Access to Information

5:00 – 5:15pm, Closing Remarks

Register

This event is free and open to the public, but registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Center for Bioethics at Harvard Medical School and the Oswald DeN. Cammann Fund at Harvard University.

SOURCE

http://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

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CMS initiative in Modernizing Medicare to lead to Lower Prescription Drug Costs

Reporter: Aviva Lev-Ari, PhD, RN

 

CMS Takes Action to Lower Prescription Drug Costs by Modernizing Medicare

 

     

CMS Takes Action to Lower Prescription Drug Costs by Modernizing Medicare 
Proposed regulation for Medicare Parts C & D would strengthen negotiations with prescription drug manufacturers to lower costs and increase transparency for patients

Today, the Centers for Medicare & Medicaid Services (CMS) proposed polices for 2020 to strengthen and modernize the Medicare Part C and D programs. The proposal would ensure that Medicare Advantage and Part D plans have more tools to negotiate lower drug prices, and the agency is also considering a policy that would require pharmacy rebates to be passed on to seniors to lower their drug costs at the pharmacy counter.

“President Trump is following through on his promise to bring tougher negotiation to Medicare and bring down drug costs for patients, without restricting patient access or choice,” said HHS Secretary Alex Azar. “By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need, and expand their choice of plans. The Part D proposals complement efforts to bring down costs in Medicare Advantage and in Medicare Part B through negotiation, all part of the President’s plan to put American patients first by bringing down prescription-drug prices and out-of-pocket costs.”

In the twelve years since the Part D program was launched, many of the tools outlined in today’s proposal have been developed in the commercial health insurance marketplace, and the result has been lower costs for patients. Seniors in Medicare also deserve to benefit from these approaches to reducing costs, so today CMS is proposing to modernize the Medicare Advantage and Part D programs and remove barriers that keep plans from leveraging these tools.

“In designing today’s proposal, foremost in the agency’s mind was the impact on patients, and the proposal is yet another action CMS has taken to deliver on President Trump and Secretary Azar’s commitment on drug prices,” said CMS Administrator Seema Verma. “Today’s changes will provide seniors with more plan options featuring lower costs for prescription drugs, and seniors will remain in the driver’s seat as they can choose the plan that works best for them. The result will be increasing access to the medicines that seniors depend on by lowering their out-of-pocket costs.”

Private plan options for receiving Medicare benefits are increasing in popularity, with almost 37 percent of Medicare beneficiaries expected to enroll in Medicare Advantage in 2019, and Part D enrollment increasing year-over-year as well. The programs are driven by market competition; plans compete for beneficiaries’ business, and each enrollee chooses the plan that best meets his or her needs. Consumer choice puts pressure on plans to improve quality and lower costs.  Premiums in both Medicare Advantage and Part D are projected to decline next year.

Today’s proposed changes include:

  • Providing Part D plans with greater flexibility to negotiate discounts for drugs in “protected” therapeutic classes, so beneficiaries who need these drugs will see lower costs;
  • Requiring Part D plans to increase transparency and provide enrollees and their doctors with a patient’s out-of-pocket cost obligations for prescription drugs when a prescription is written;
  • Codifying a policy similar to the one implemented for 2019 to allow “step therapy” in Medicare Advantage for Part B drugs, encouraging access to high-value products including biosimilars; and
  • Implementing a statutory requirement, recently signed by President Trump, that prohibits pharmacy gag clauses in Part D.

CMS is also considering for a future plan year, which may be as early as 2020, a policy that would ensure that enrollees pay the lowest cost for the prescription drugs they pick up at a pharmacy, after taking into account back-end payments from pharmacies to plans.

Medicare Advantage and Part D will continue to protect patient access, as both programs are embedded with robust beneficiary protections. These include CMS’s review of Part D plan formularies, an expedited appeals process, and a requirement for plans to cover two drugs in every therapeutic class.

CMS looks forward to receiving comments on these proposals and other policies under consideration.

For a blog post on the proposed rule by Secretary Azar and Administrator Verma, please visit: https://www.cms.gov/blog/proposed-changes-lower-drug-prices-medicare-advantage-and-part-d.

For a fact sheet on the proposed rule, please visit: https://www.cms.gov/newsroom/fact-sheets/contract-year-cy-2020-medicare-advantage-and-part-d-drug-pricing-proposed-rule-cms-4180-p.

The proposed rule (CMS-4180-P) can be downloaded from the Federal Register at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-25945.pdf

###

Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter CMS Administrator @SeemaCMS

SOURCE

https://www.cms.gov/newsroom/press-releases/cms-takes-action-lower-prescription-drug-costs-modernizing-medicare?mc_cid=ca8901d1c5&mc_eid=32328d8919

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Reporter: Stephen J. Williams, PhD

10:00-10:45 AM The Davids vs. the Cancer Goliath Part 1

Startups from diagnostics, biopharma, medtech, digital health and emerging tech will have 8 minutes to articulate their visions on how they aim to tame the beast.

Start Time End Time Company
10:00 10:08 Belong.Life
10:09 10:17 Care+Wear
10:18 10:26 OncoPower
10:27 10:35 PolyAurum LLC
10:36 10:44 Seeker Health

Speakers:
Karthik Koduru, MD, Co-Founder and Chief Oncologist, OncoPower
Eliran Malki, Co-Founder and CEO, Belong.Life
Chaitenya Razdan, Co-founder and CEO, Care+Wear @_crazdan
Debra Shipley Travers, President & CEO, PolyAurum LLC @polyaurum
Sandra Shpilberg, Founder and CEO, Seeker Health @sandrashpilberg

Belong Life

  • 10,000 cancer patients a month helping patients navigate cancer care with Belong App
  • Belong Eco system includes all their practitioners and using a trigger based content delivery (posts, articles etc)
  • most important taking unstructured health data (images, social activity, patient compilance) and converting to structured data

Care+Wear

personally design picc line cover for oncology patients

partners include NBA Major league baseball, Oscar de la Renta,

designs easy access pic line gowns and shirts

OncoPower :Digital Health in a Blockchain Ecosystem

problems associated with patient adherence and developed a product to address this

  1. OncoPower Blockchain: HIPAA compliant using the coin Oncopower security token to incentiavize patients and oncologists to consult with each other or oncologists with tumor boards; this is not an initial coin offering

PolyArum

  • spinout from UPENN; developing a nanoparticle based radiation therapy; glioblastoma muse model showed great response with gold based nanoparticle and radiation
  • they see enhanced tumor penetration, and retention of the gold nanoparticles
  • however most nanoparticles need to be a large size greater than 5 nm to see effect so they used a polymer based particle; see good uptake but excretion past a week so need to re-dose with Au nanoparticles
  • they are looking for capital and expect to start trials in 2020

Seeker Health

  • tying to improve the efficiency of clinical trial enrollment
  • using social networks to find the patients to enroll in clinical trials
  • steps they use 1) find patients on Facebook, Google, Twitter 2) engage patient screen 3) screening at clinical sites
  • Seeker Portal is a patient management system: patients referred to a clinical site now can be tracked

11:00- 11:45 AM Breakout: How to Scale Precision Medicine

The potential for precision medicine is real, but is limited by access to patient datasets. How are government entities, hospitals and startups bringing the promise of precision medicine to the masses of oncology patients

Moderator: Sandeep Burugupalli, Senior Manager, Real World Data Innovation, Pfizer @sandeepburug
Speakers:
Ingo ​Chakravarty, President and CEO, Navican @IngoChakravarty
Eugean Jiwanmall, Senior Research Analyst for Medical Policy & Technology Evaluation , Independence Blue Cross @IBX
Andrew Norden, M.D., Chief Medical Officer, Cota @ANordenMD
Ankur Parikh M.D, Medical Director of Precision Medicine, Cancer Treatment Centers of America @CancerCenter

Ingo: data is not ordered, only half of patients are tracked in some database, reimbursement a challenge

Eugean: identifying mutations as patients getting more comprehensive genomic coverage, clinical trials are expanding more rapidly as seen in 2018 ASCO

Ingo: general principals related to health outcomes or policy or reimbursement.. human studies are paramount but payers may not allowing for general principals (i.e. an Alk mutation in lung cancer and crizotanib treatment may be covered but maybe not for glioblastoma or another cancer containing similar ALK mutation; payers still depend on clinical trial results)

Andrew: using gene panels and NGS but only want to look for actionable targets; they establish an expert panel which reviews these NGS sequence results to determine actionable mutations

Ankur:  they have molecular tumor boards but still if want to prescribe off label and can’t find a clinical trial there is no reimbursement

Andrew: going beyond actionable mutations, although many are doing WES (whole exome sequencing) can we use machine learning to see if there are actionable data from a WES

Ingo: we forget in datasets is that patients have needs today and we need those payment systems and structures today

Eugean: problem is the start from cost (where the cost starts at and was it truly medically necessary)

Norden: there are not enough data sharing to make a decision; an enormous amount of effort to get businesses and technical limitations in data sharing; possibly there are policies needed to be put in place to assimilate datasets and promote collaborations

Ingo: need to take out the middle men between sequencing of patient tumor and treatment decision; middle men are taking out value out of the ‘supply chain’;

Andrew: PATIENTS DON’T OWN their DATA but MOST clinicians agree THEY SHOULD

Ankur: patients are willing to share data but the HIPAA compliance is a barrier

 

11:50- 12:30 AM Fireside Chat with Michael Pellini, M.D.

Building a Precision Medicine Business from the Ground Up: An Operating and Venture Perspective

Dr. Pellini has spent more than 20 years working on the operating side of four companies, each of which has pushed the boundaries of the standard of care. He will describe his most recent experience at Foundation Medicine, at the forefront of precision medicine, and how that experience can be leveraged on the venture side, where he now evaluates new healthcare technologies.

Speaker:
Michael Pellini, M.D., Managing Partner, Section 32 and Chairman, Foundation Medicine @MichaelPellini

Roche just bought Foundation Medicine for $2.5 billion.  They negotiated over 7 months but aside from critics they felt it was a great deal because it gives them, as a diagnostic venture, the international reach and biotech expertise.  Foundation Medicine offered Roche expertise on the diagnostic space including ability to navigate payers and regulatory aspects of the diagnostic business.  He feels it benefits all aspects of patient care and the work they do with other companies.

Moderatore: Roche is doing multiple deals to ‘own’ a disease state.

Dr. Pellini:  Roche is closing a deal with Flatiron just like how Merck closed deals with genomics companies.  He feels best to build the best company on a stand alone basis and provide for patients, then good things will happen.  However the problem of achieving scale for Precision Medicine is reimbursement by payers.  They still have to keep collecting data and evolving services to suit pharma.  They didn’t know if there model would work but when he met with FDA in 2011 they worked with Precision Medicine, said collect the data and we will keep working with you,

However the payers aren’t contributing to the effort.  They need to assist some of the young companies that can’t raise the billion dollars needed for all the evidence that payers require.  Precision Medicine still have problems, even though they have collected tremendous amounts of data and raised significant money.  From the private payer perspective there is no clear roadmap for success.

They recognized that the payers would be difficult but they had a plan but won’t invest in companies that don’t have a plan for getting reimbursement from payers.

Moderator: What is section 32?

Pellini:  Their investment arm invests in the spectrum of precision healtcare companies including tech companies.  They started with a digital path imaging system that went from looking through a scope and now looking at a monitor with software integrated with medical records. Section 32 has $130 million under management and may go to $400 Million but they want to stay small.

Pellini: we get 4-5 AI pitches a week.

Moderator: Are you interested in companion diagnostics?

Pellini:  There may be 24 expected 2018 drug approvals and 35% of them have a companion diagnostic (CDX) with them.  however going out ten years 70% may have a CDX associated with them.  Payers need to work with companies to figure out how to pay with these CDXs.

 

 

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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

https://pharmaceuticalintelligence.com/2018/06/13/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 Twitter.com 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 twitter.com 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 Twitter.com account

The Aviva Lev-Ari, PhD, RN Twitter.com 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

https://pharmaceuticalintelligence.com/2018/06/11/original-tweets-by-pharma_bi-and-by-aviva1950-from-bio2018-iambiotech-bioconvention-bio-2018-boston-june-4-7-2018-bcec/

 

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

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/06/12/reactions-to-original-tweets-by-pharma_bi-and-by-aviva1950-from-bio2018/

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

https://pharmaceuticalintelligence.com/2018/06/11/re-tweets-and-likes-by-pharma_bi-aviva1950-from-bio2018-iambiotech-bioconvention-bio-2018-boston-june-4-7-2018-bcec/

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.

SOURCE

https://www.theguardian.com/books/2018/may/30/top-10-books-to-help-you-survive-the-digital-age?utm_source=esp&utm_medium=Email&utm_campaign=Bookmarks+-+Collections+2017&utm_term=277690&subid=25658468&CMP=bookmarks_collection

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

https://pharmaceuticalintelligence.com/2018/05/22/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 

https://pharmaceuticalintelligence.com/2018/05/28/pioneering-implementations-of-analytics-to-business-decision-making-contributions-to-domain-knowledge-conceptualization-research-design-methodology-development-data-modeling-and-statistical-data-a/

 

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

https://pharmaceuticalintelligence.com/category/scientist-career-considerations/

 

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

https://bitesizebio.com/38498/ways-to-pursue-the-business-of-science-after-a-ph-d/?utm_source=facebook&utm_medium=social&utm_campaign=SocialWarfare

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

https://pharmaceuticalintelligence.com/2018/03/06/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

https://pharmaceuticalintelligence.com/2018/03/15/recollections-my-days-at-berkeley-9-1978-12-1983-about-my-doctoral-advisor-allan-pred-other-professors-and-other-peer/

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

https://pharmaceuticalintelligence.com/2018/05/24/recollections-part-2-while-rolling-is-preceded-by-while-enrolling-autobiographical-alumna-recollections-of-berkeley-aviva-lev-ari-phd83/

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

 

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Where Does Kaiser Permanente Stand on Doctor Choice? Interview with George Halvorson, CEO, Kaiser Permanente, CA

 Reporter: Aviva Lev-Ari, PhD, RN

 

George Halvorson – All Videos

SOURCE

https://www.sharecare.com/video/healthmakers/george-halvorson/all-videos

34 Videos

 

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The Future of Hospitals – How Medical Care and Technology Work Together to Advance Patient Care 

Curator: 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

 

Gap Medics (https://www.gapmedics.com/blog/), the world’s leading provider of hospital work experience placements for high school and university students, recently released their “Futuristic Hospitals” infographic. The infographic reviews a collection of top hospitals in the world based on several key factors:

  • overall patient care,
  • innovative medical and technological excellence,
  • efforts toward sustainability,
  • environmental stewardship, and
  • social responsibility, as well as
  • other innovative health care features

to help advance the field of medicine and, ultimately, patient care.

Futuristic Hospitals Infographic

Image SOURCE: Infographic of Futuristic Hospitals courtesy of Evolved Digital and Gap Medics. Reprinted here with Permission from the Source.

 

“Many leading hospital facilities are now rolling out significant improvements and changes that couldn’t have been envisioned 10 years ago,” said Ian McIntosh, Director, Evolved Digital (http://evolveddigital.co.uk/), a U.K.-based digital marketing company specializing in search engine optimization and content marketing, whose team created the infographic for Gap Medics.

Science and innovation are working together to help convey higher expectations for quality medical and health care and advancements in the hospital experience for health care providers, patients and their families.

Particularly, the infographic analyzed prominent hospitals around the world so patients and their families can learn about the latest advances and efforts in patient care and hospital and medical technology.

In this infographic, we investigated the most cutting-edge hospital facilities in the world, where best-in-class technology and innovative medical care are making a difference in providing a quality experience all over the world.

“Gap Medics creates programs offered to thousands of students from Europe, Asia and the United States so they have the opportunity to gain insights into the work of doctors, nurses, physician assistants, midwives and dentists before the students begin their clinical training,” said Dave Brown, Director, Gap Medics, a U.K.-based company that provides hospital work experience between 1-8 weeks to students 16 years of age and older.

This one-in-a-lifetime opportunity helps students better understand their chosen career path, develop as people, and strengthen their university application process.

 

REFERENCE/SOURCE

http://evolveddigital.co.uk/

https://www.gapmedics.com/blog/2017/03/27/futuristic-hospitals/

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

 

“Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/02/10/sudden-cardiac-death-sudd-is-in-ferrer-incodes-suite-of-cardiovascular-genetic-tests-to-be-commercialized-in-the-us/

 

Hybrid Cath Lab/OR Suite’s da Vinci Surgical Robot of Intuitive Surgical gets FDA Warning Letter on Robot Track Record

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/hybrid-cath-labor-suites-da-vinci-surgical-robot-of-intuitive-surgical-gets-fda-warning-letter-on-robot-track-record/

 

3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

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