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Archive for the ‘Scientific & Biotech Conferences: Press Coverage’ Category


Live Conference Coverage @Medcitynews Converge 2018 Philadelphia:Liquid Biopsy and Gene Testing vs Reimbursement Hurdles

9:25- 10:15 Liquid Biopsy and Gene Testing vs. Reimbursement Hurdles

Genetic testing, whether broad-scale or single gene-testing, is being ordered by an increasing number of oncologists, but in many cases, patients are left to pay for these expensive tests themselves. How can this dynamic be shifted? What can be learned from the success stories?

Moderator: Shoshannah Roth, Assistant Director of Health Technology Assessment and Information Services , ECRI Institute @Ecri_Institute
Speakers:
Rob Dumanois, Manager – reimbursement strategy, Thermo Fisher Scientific
Eugean Jiwanmall, Senior Research Analyst for Medical Policy & Technology Evaluation , Independence Blue Cross @IBX
Michael Nall, President and Chief Executive Officer, Biocept

 

Michael: Wide range of liquid biopsy services out there.  There are screening companies however they are young and need lots of data to develop pan diagnostic test.  Most of liquid biopsy is more for predictive analysis… especially therapeutic monitoring.  Sometimes solid biopsies are impossible , limited, or not always reliable due to metastasis or tough to biopsy tissues like lung.

Eugean:  Circulating tumor cells and ctDNA is the only FDA approved liquid biopsies.  However you choose then to evaluate the liquid biopsy, PCR NGS, FISH etc, helps determines what the reimbursement options are available.

Rob:  Adoption of reimbursement for liquid biopsy is moving faster in Europe than the US.  It is possible in US that there may be changes to the payment in one to two years though.

Michael:  China is adopting liquid biopsy rapidly.  Patients are demanding this in China.

Reimbursement

Eugean:  For IBX to make better decisions we need more clinical trials to correlate with treatment outcome.  Most of the major cancer networks, like NCCN, ASCO, CAP, just have recommendations and not approved guidelines at this point.  From his perspective with lung cancer NCCN just makes a suggestion with EGFR mutations however only the companion diagnostic is approved by FDA.

Michael:  Fine needle biopsies are usually needed by the pathologist anyway before they go to liquid biopsy as need to know the underlying mutations in the original tumor, it just is how it is done in most cancer centers.

Eugean:  Whatever the established way of doing things, you have to outperform the clinical results of the old method for adoption of a newer method.

Reimbursement issues have driven a need for more research into clinical validity and utility of predictive and therapeutic markers with regard to liquid biopsies.  However although many academic centers try to partner with Biocept Biocept has a limit of funds and must concentrate only on a few trials.  The different payers use different evidence based methods to evaluate liquid biopsy markers.  ECRI also has a database for LB markers using an evidence based criteria.  IBX does sees consistency among payers as far as decision and policy.

NGS in liquid biopsy

Rob: There is a path to coverage, especially through the FDA.  If you have a FDA cleared NGS test, it will be covered.  These are long and difficult paths to reimbursement for NGS but it is feasible. Medicare line of IBX covers this testing, however on the commercial side they can’t cover this.  @IBX: for colon only kras or nras has clinical utility and only a handful of other cancer related genes for other cancers.  For a companion diagnostic built into that Dx do the other markers in the panel cost too much?

Please follow on Twitter using the following #hash tags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

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5:00 – 5:45 PM Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing

Reporter: Stephen J. Williams, Ph.D.

 

Diagnosing cancer early is often the difference between survival and death. Hear from experts regarding the new and emerging technologies that form the next generation of cancer diagnostics.

Moderator: Heather Rose, Director of Licensing, Thomas Jefferson University
Speakers:
Bonnie Anderson, Chairman and CEO, Veracyte @BonnieAndDx
Kevin Hrusovsky, Founder and Chairman, Powering Precision Health @KevinHrusovsky

Bonnie Anderson and Veracyte produces genomic tests for thyroid and other cancer diagnosis.  Kevin Hrusovksy and Precision Health uses peer reviewed evidence based medicine to affect precision medicine decision.

Bonnie: aim to get a truth of diagnosis.  Getting tumor tissue is paramount as well as properly preserved tissue.  They use deep RNA sequencing  and machine learning  in their clinically approved tests.

Kevin: Serial biospace entrepreneur.  Two diseases, cancer and neurologic, have been diseases which have been hardest to get reproducible and validated biomarkers of early disease.  He concentrates on protein biomarkers.

Heather:  FDA has recently approved drugs for early disease intervention.  However the use of biomarkers can go beyond patient stratification in clinical trials.

Kevin: 15 approved drugs for MS but the markers are scans looking for brain atrophy which is too late of an endpoint.  So we need biomarkers of early disease progression.  We can use those early biomarkers of disease progression so pharma can target those early biomarkers and or use those early biomarkers of disease progression  for endpoint

Bonnie: exciting time in the early diagnostics field. She prefers transcriptomics to DNA based methods such as WES or WGS (whole exome or whole genome sequencing).  It was critical to show data on the cost savings imparted by their transcriptomic based thryoid cancer diagnostic test for payers to consider this test eligible for reimbursement.

Kevin: There has been 20 million  CAT scans for  cancer but it is estimated 90% of these scans led to misdiagnosis. Biomarker  development  has revolutionized diagnostics in this disease area.  They have developed a breakthrough panel of ten protein biomarkers in serum which he estimates may replace 5 million mammograms.

All panelists agreed on the importance of regulatory compliance and the focus of new research should be on early detection.  In addition they believe that Dr. Gotlieb’s appointment to the FDA is a positive for the biomarker development field, as Dr. Gotlieb understands the potential and importance of early detection and prevention of disease.  Kevin also felt Dr. Gotlieb understands the importance of incorporating biomarkers as endpoints in clinical trials.  Over 750 phase 1,2, and 3 clinical trials use biomarker endpoints but the pharma companies still need to prove the biomarkers clinical relevance to the FDA.They also agreed it would be helpful to involve advocacy groups in putting more pressure on the healthcare providers and policy makers on this importance of diagnostics as a preventative measure.

In addition, the discovery and use of biomarkers as disease endpoints has led to a resurgence of Alzheimer’s disease drug development by companies which have previously given up on these type of neurodegenerative diseases.

Kevin feels proteomics offers great advantages over DNA-based diagnostics, especially in cancer such as ovarian cancer, where a high degree of specificity for a diagnostic test is required to ascertain if a woman should undergo prophylactic oophorectomy.  He suggests that a new blood-based protein biomarker panel is being developed for early detection of some forms of ovarian cancer.

Please follow on Twitter using the following #hash tags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

 

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

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

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

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

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

https://pharmaceuticalintelligence.com/press-coverage/

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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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2018 Annual World Medical Innovation Forum Artificial Intelligence April 23–25, 2018 Boston, Massachusetts  | Westin Copley Place

https://worldmedicalinnovation.org/

https://www.youtube.com/channel/UCauKpbsS_hUqQaPp8EVGYOg

Announcement

Aviva Lev-Ari, PhD, RN,

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

@pharma_BI

@AVIVA1950

On 5/2015

4/2018

All TWEETS from LPBI’s Twitter.com handles at

#WMIF18

@pharma_BI

@AVIVA1950

Monday, April 23, 2018

 

7:00 am – 8:00 am
GE Foyer
7:00 am – 8:00 am
Nuance Foyer
8:00 am – 11:30 am
NVIDIA Ballroom
First Look: The Next Wave of AI Breakthroughs in Health Care

Early career Harvard Medical School investigators kick-off the 2018 World Medical Innovation Forum with rapid fire presentations of their high potential new technologies. Nineteen rising stars from Brigham Health and Massachusetts General Hospital will give ten-minute presentations highlighting their discoveries and insights that will disrupt the field of artificial intelligence. This session is designed for investors, leaders, donors, entrepreneurs and investigators and others who share a passion for identifying emerging high-impact technologies. To view speakers and topics, click here.

Moderator: Trung Do
  • VP, Business Development, Innovation, PHS
Moderator: Clare Tempany, MD
  • Vice Chair of Research at the Department of Radiology, BWH; Ferenc Jolesz MD Professor of Radiology, HMS
11:45 am – 1:00 pm
3rd Floor and 7th Floor
Discovery Café Workshops

Lunch with Top Leadership from across Partners HealthCare and Industry.

Seven intensive workshops addressing cutting-edge artificial intelligence topics. To view topics and speakers, click here

1:00 pm – 1:20 pm
1:20 pm – 1:45 pm
NVIDIA Ballroom
Opening Remarks
  • Governor of the Commonwealth of Massachusetts
  • Chief Academic Officer, PHS; Laurie Carrol Guthart Professor of Medicine, Academic Dean for Partners, HMS; 2018 Forum Co-Chair
  • CEO, PHS
1:45 pm – 2:25 pm
NVIDIA Ballroom
Reflecting on the Impact of AI at the Bed and the Bench: Chairs Roundtable

Senior clinical leaders, current and past Forum Chairs, will share perspectives on the range of impact of AI on clinical practice. Discussion will highlight the rapid evolution of AI as a practical clinical tool and short and mid-term prospects for adoption in cancer, cardiovascular and neurological care.

Moderator: Sue Siegel
  • CIO and CEO, Business Innovations, GE
  • Chief Data Science Officer, PHS; Vice Chairman, Radiology, MGH; Associate Professor, Radiology, HMS
  • Chief Academic Officer, PHS; Laurie Carrol Guthart Professor of Medicine, Academic Dean for Partners, HMS; 2018 Forum Co-Chair
  • Vice Chair for Scientific Innovation, Department of Medicine, BWH; Chief Executive, One Brave Idea, BWH; Associate Professor of Medicine, HMS; 2017 Forum Co-Chair
  • Chief Clinical Officer, PHS; Professor of Medicine, HMS; 2018 Forum Co-Chair
  • Chief, Cardiology Division, MGH; Professor of Medicine, HMS; 2017 Forum Co-Chair
2:25 pm – 3:15 pm
NVIDIA Ballroom
Can AI Based Drug Development Feed A Hungry Pipeline?

Given the scarcity of late-stage assets, prolonged timelines and enormous costs of bringing drugs to market, AI-based approaches to target discovery, drug design and drug repurposing hold significant promise to positively disrupt the existing R&D paradigm.

  • Chief Data Officer, Broad Institute; Cardiologist, BWH; Venture Partner, Google Ventures
  • CEO, Exscientia
  • Director, Center for Genomic Medicine, MGH; Ofer and Shelly Nemirovsky MGH Research Scholar; Associate Professor of Medicine, HMS
  • EVP and CSO, R&D, Bristol-Myers Squibb
  • CEO, BERG
  • SVP, Strategy, Commercialization & Innovation, Amgen
3:15 pm – 4:05 pm
NVIDIA Ballroom
Smart EHRs: AI for All

The first wave of EHR adoption has focused primarily on digitizing the patient record – with a more recent focus on building interactive clinical decision support capabilities. Development and implementation of CDS applications currently  requires  clinical staff to observe trends in data, develop protocols to act on these trends and work with technical staff to codify the logic into executable form. As NLP and computer vision capabilities become more advanced, algorithms will identify and propose actions reflecting patterns in the data. The panel will discuss existing challenges and whether AI technology will ultimately support an unsupervised learning approach in the EHR to identify trends and possible responses at both the patient and population level?

  • SVP and CMO, MGH
  • CEO, Health Catalyst
  • Director, Analytics & Machine Learning, Epic
  • President, Digital, Persistent Systems
  • CEO, Picnic Health
  • CEO, Wolters Kluwer Health
4:05 pm – 4:55 pm
NVIDIA Ballroom
AI and the Cost of Trials: The Impact of Real World and Real Time Evidence

AI based approaches to conduct faster and more efficient clinical trials are beginning to emerge. Current approaches include applying predictive tools to perform more targeted patient recruitment and more accurate eligibility assessment. Panelists will discuss timelines for AI technology to have a measurable effect on trial cost and time to conduct the trial. Bottlenecks to applying this technology at scale and whether there will be a measurable effect on the cost of bringing drugs to market over the next decade will also be examined.

  • Partner, Google Ventures; Instructor in Medicine, BWH
  • CMO, CSO & SVP Oncology, Flatiron Health
  • VP, Research IT, Eli Lilly and Company
  • CEO, GNS Healthcare
  • CEO, BenevolentAI
  • Senior Advisor, R&D, Bayer
  • Executive Director, Clinical Trials Office, PHS; Associate Professor of Medicine, HMS
5:00 pm – 6:00 pm
Nuance Foyer

Tuesday, April 24, 2018

 

7:15 am – 7:50 am
Nuance Foyer
7:50 am – 8:00 am
NVIDIA Ballroom
Opening Remarks
  • Chief Innovation Officer, PHS; President, Partners HealthCare International, PHS
8:00 am – 8:50 am
NVIDIA Ballroom
Will AI Bend the Cost and Access Curve

Historical barriers have driven increased medical costs and decreasing access since the 1960s. The “Iron Triangle of Healthcare” continues to represent a tenuous balance of quality, cost and accessibility – economists have lamented attempts to optimize one characteristic at the expense of the others. The accumulation of innovations in care delivery (e.g. shift to lower cost providers and settings), population management, value based reimbursement and hospital administration are having a measurable effect. Can AI based technologies accelerate the pace of innovation and finally bend the cost and access curves in the US?

Moderator: Timothy Ferris, MD
  • CEO, MGPO
  • SVP and CMO, Humana
  • CEO, Cyft, Inc.
  • Vice Chairman, Investment Banking and Managing Director, Lazard Freres
8:50 am – 9:40 am
NVIDIA Ballroom
Drug Therapy Redefined Through Machine Learning

The drug development process is highly complex and has many drivers. The panel will discuss the strategic impact of AI on the entire process and the implications for healthcare overall. How will the combination of factors – research strategy, drug development, regulatory approvals, reimbursement and clinical effectiveness – be influenced by the implementation of AI. Panelists will discuss short and mid-term prospects and whether AI will ultimately lead to a restructuring of the pharma model to develop new therapies.

  • Partner, Atlas Venture
  • President, Novartis Institutes for Biomedical Research
  • CSO, Relay Therapeutics
  • SVP, Global Head of Data Sciences, Johnson & Johnson
  • CSO, Datavant
  • Global Head of Digital and Personalized Health Care Partnering, Roche
9:40 am – 10:10 am
NVIDIA Ballroom
1:1 Fireside Chat: Atul Gawande, MD
Introduction by: John Fish
  • CEO, Suffolk; Chairman of Board Trustees, Brigham Health
  • President, Brigham Health; Professor of Medicine, HMS
  • Executive Director, Ariadne Labs; Samuel O. Thier Professor of Surgery, HMS; Surgeon, BWH
10:10 am – 10:25 am
Nuance Foyer
10:25 am – 11:15 am
NVIDIA Ballroom
Data Engineering in Healthcare: Liberating Value

The promise of machine learning and big data in in healthcare seems boundless – but healthcare data is massive and complex, and organizing and managing this data is the first step to an AI-empowered healthcare system.  Technology giants are investing in solutions to overcome these data engineering challenges, but with many visions of the future of healthcare data jockeying for dominance, what will the future of healthcare data really look like?  Can we finally liberate the value of data for patient care? And how will it happen?

Moderator: Mark Michalski, MD
  • Executive Director, MGH & BWH CCDS
  • ‎Director of Healthcare Research, Microsoft Research
  • VP and Global CTO, Sales, Dell EMC
  • SVP and CMO, Qualcomm Life
  • VP, Healthcare, Google Cloud
  • Chief Research Information Officer, PHS; Associate Professor of Neurology, HMS
  • CTO, Cognitive Collaboration Group, Cisco
11:15 am – 11:45 am
NVIDIA Ballroom
1:1 Fireside Chat: Jensen Huang, CEO, NVIDIA
Introduction by: Scott Sperling
  • Co-President, Thomas H Lee Partners; Chairman of the Board of Directors, PHS
  • Chief Data Science Officer, PHS; Vice Chairman, Radiology, MGH; Associate Professor, Radiology, HMS
  • CEO, NVIDIA
12:00 pm – 1:00 pm
GE Ballroom
12:30 pm – 1:00 pm
GE Ballroom
1:1 Fireside Chat: Paul Ricci, Former Chairman and CEO of Nuance Communications
Introduction by: Cathy Minehan
  • Managing Director, Arlington Advisory Partners; Chairman, Board of Trustees, MGH
Moderator: James Brink, MD
  • Chief, Department of Radiology, MGH; Juan M. Taveras Professor of Radiology, HMS
  • Former Chairman and CEO, Nuance Communications
1:00 pm – 1:10 pm
1:10 pm – 2:00 pm
NVIDIA Ballroom
AI and Gene Sequencing

Gene sequencing technology has evolved considerably over the last 10 years, dramatically decreasing the cost to sequence a human genome. As the costs associated with the technical assay continue to decrease, data interpretation and reporting has become the new bottleneck. Can AI and ML based approaches be applied to better understand how genetic mutations play a role in diseases like cancer – where the high rate of mutation makes treatment challenging? And will continued democratization of genetic information help to accelerate the pace of innovation in the field?

Moderator: Heidi Rehm, PhD
  • Chief Laboratory Director, Laboratory for Molecular Medicine, PHS Personalized Medicine; Associate Professor of Pathology, BWH and HMS
  • Executive Director, Worldwide R&D, Pfizer
  • Director, Bioinformatics Program, Cancer Center and Department of Pathology, MGH; Director, Institute Member, Broad Institute; Associate Professor of Pathology, HMS
  • Director, Computational Pathology and Director, Technology Development, Center for Integrated Diagnostics, MGH; Assistant Professor, Pathology, HMS
  • CEO, Freenome
  • SVP, Product Development, Illumina, Inc.
2:00 pm – 2:50 pm
NVIDIA Ballroom
Tangible Returns on the AI Value Proposition

Fueled by billions in venture investments, hundreds of new companies have emerged worldwide to develop and apply AI in health care. Beyond the US, China’s high AI priority has resulted in a vast array of technology driven start-ups. Global investors will discuss which area of machine learning will have the earliest meaningful impact? How do investors critically assess differentiation in such a crowded field? How are investment priorities set among the many divergent categories where AI will take hold?

Moderator: Meg Tirrell
  • Reporter, CNBC
  • Managing Director, Santé Ventures
  • VP, Venture, Innovation, PHS
  • Partner, Polaris Partners
  • Partner, Andreessen Horowitz
  • Managing Director, Northern Light Venture Capital
2:50 pm – 3:40 pm
NVIDIA Ballroom
CEO Roundtable: The AI Opportunity as Foundational Change

Chief executives share perspectives on the impact of AI on their respective companies and industry segments. How prominently does AI figure into current investment strategies? And how are they measuring return on existing investments in AI? Panelist will be asked to take a position on whether AI is a truly transformational technology.

Moderator: Peter Slavin, MD
  • President, MGH
  • Chief Innovation Officer, GE Healthcare
  • CEO, Philips
  • CEO, Vertex
  • CEO, Siemens Healthineers
3:40 pm – 3:50 pm
NVIDIA Ballroom
Announcement of IDG Awardees
  • Chair, Department of Radiology, BWH; Philip H. Cook Professor of Radiology, HMS
  • Chief, Department of Radiology, MGH; Juan M. Taveras Professor of Radiology, HMS
3:50 pm – 4:40 pm
NVIDIA Ballroom
Regulating AI in Healthcare, Requirements and Challenges

The increasing application of AI in health products puts pressure on the historical model of regulation – among them the agile development cycles and continuous learning environment that support AI / machine learning based algorithms. Panelists will discuss the regulatory approaches including the FDA’s recently announced Software Precertification pilot program.

Moderator: Michael Jaff, DO
  • President, NWH, PHS, Professor of Medicine, HMS
  • CEO, Arterys
  • Chief Regulatory Officer, Sanofi
  • VP and GM, Healthcare Digital Solutions, GE Healthcare
  • Associate Director for Digital Health, FDA
4:40 pm – 5:30 pm
NVIDIA Ballroom
AI in Hospital Environments: The Learning Provider

Health systems are actively evaluating strategies to drive efficiency throughout hospital operations. The deployment of AI based technologies to automate organizational tasks (e.g. medical coding / billing, prior authorizations) and optimize resource utilization (e.g. smart scheduling, no-show prediction) promises to help hospital systems adapt to changing macro-economic factors. This panel will discuss the role of AI in hospital operations and assess various approaches to reduce healthcare administration costs and increase efficiency.

Moderator: Adam Landman, MD
  • VP and CIO, Brigham Health
  • Executive Director, IT, Personalized Medicine, PHS
  • Partner, Optum Ventures
  • CEO, Change Healthcare
  • CEO, Qventus
  • Co-Founder, Director, PokitDok
5:30 pm – 6:30 pm
GE Foyer

Wednesday, April 25, 2018

 

7:00 am – 7:30 am
Nuance Foyer
7:30 am – 8:20 am
NVIDIA Ballroom
Reconceiving Medical Devices in an AI Dominated Environment

Medical device companies are focused on developing smaller, faster and smarter devices. New technologies will enhance the function of medical devices throughout patient care. Leveraging AI technology to more effectively interact with patients and inform / facilitate outcomes enables smart devices that can learn and improve performance over time. The nature of AI panel based devices, the challenges inherent in developing them and how such devices can evolve over the next 5 years and beyond will be examined.

Moderator: Pat Fortune, PhD
  • VP, Market Sectors, Innovation, PHS
  • CEO, Bay Labs
  • SVP, Chief Medical and Scientific Officer, Medtronic
  • Founder and CEO, Butterfly Network
  • Associate Chief, Cardiology Division, MGH; Professor of Medicine, HMS
8:20 am – 8:50 am
NVIDIA Ballroom
Fireside Chat: Seema Verma, Administrator, Centers for Medicare and Medicaid Services
Moderator: Gregg Meyer, MD
  • Chief Clinical Officer, PHS; Professor of Medicine, HMS; 2018 Forum Co-Chair
  • Administrator, Centers for Medicare and Medicaid Services
8:50 am – 9:20 am
NVIDIA Ballroom
Fireside Chat: Paying for AI: Thinking Strategically About Reimbursements and Acceptance

Understanding how AI will be absorbed into a highly defined payment system is crucial to determining the rate and breadth that the technology will play in health care in the next decade. Two senior leaders will share their perspectives on how the technology will be paid for and what mechanisms will be used to arbitrate the scope and timing of those payments.

Moderator: Peter Markell
  • EVP Administration and Finance, CFO and Treasurer, PHS
  • CEO, BCBS of North Carolina
  • CEO, OptumInsight & Enterprise Growth Officer, Optum
9:20 am – 9:50 am
NVIDIA Ballroom
1:1 Fireside Chat: Vasant Narasimhan, MD, CEO, Novartis
Moderator: Gregg Meyer, MD
  • Chief Clinical Officer, PHS; Professor of Medicine, HMS; 2018 Forum Co-Chair
  • CEO, Novartis
9:50 am – 10:40 am
NVIDIA Ballroom
Machine Learning in Image Analysis: A Diagnostician’s Best Friend…or Replacement?

Diagnostic imaging is among the clinical fields receiving the greatest attention in the early stages of AI in healthcare. Even in this initial phase it appears that the technology may have profound effects on one of the most resource intensive fields in medicine. Panelists will consider the broad implications as well as topics such as how will role of radiologists evolve? Will AI tools ever become advanced enough to make decisions autonomously within the clinical workflow?

Moderator: Giles Boland, MD
  • Chair, Department of Radiology, BWH; Philip H. Cook Professor of Radiology, HMS
  • CEO, PathAI
  • VP, Medical Imaging Technology, Siemens Healthineers
  • Co-Founder and Chairman, Zebra Medical Vision
  • CEO, GE Healthcare Imaging
  • Chief, Breast Imaging Division, MGH; Professor of Radiology, HMS
10:40 am – 10:50 am
Nuance Foyer
10:50 am – 11:20 am
NVIDIA Ballroom
1:1 Fireside Chat: John Kelly, PhD, SVP, Cognitive Solutions and Research, IBM
Moderator: James Noga
  • VP and CIO, PHS
  • SVP, Cognitive Solutions and Research, IBM
11:20 am – 12:10 pm
NVIDIA Ballroom
Illuminating the Path to Clinician Empowerment

The sacred exchange between patient and clinician at the heart of medicine is increasingly under duress driven by a range of factors. Increasing clinician burnout is recognized as among the many negative consequences of this trend. Panelists will discuss how AI may improve the quality of the patient encounter, clinician workflow and ultimately clinician quality of life. Panelist will discuss how the new technology can meet these objectives when earlier information based technologies may have exacerbated the challenge.

Moderator: Sree Chaguturu, MD
  • VP, Population Health Management, PHS
  • SVP, New Business Development, Healthcare Division, Nuance
  • Chief Health Strategy Officer, US Health & Life Sciences, Microsoft
  • CEO, Robin AI
  • Chief Medical Information Officer, MGPO
12:10 pm – 1:10 pm
NVIDIA Ballroom
Disruptive Dozen: 12 AI Technologies That Will Reinvent Care

The culture of innovation throughout Partners HealthCare naturally fosters robust discussions about new “disruptive” technologies and which ones will have the biggest impact on health care. The Disruptive Dozen was created to identify and rank the technologies that Partners faculty feel will break through over the next decade to significantly improve health care. This year, the Disruptive Dozen focuses on relevant advances and opportunities in artificial intelligence (AI).

  • Director of Research Strategy and Operations, MGH & BWH CCDS; Associate Professor, Radiology, HMS
  • Chief Data Science Officer, PHS; Vice Chairman, Radiology, MGH; Associate Professor, Radiology, HMS
1:10 pm – 1:15 pm
NVIDIA Ballroom
Last Look
  • Chief Data Science Officer, PHS; Vice Chairman, Radiology, MGH; Associate Professor, Radiology, HMS
  • Chief Academic Officer, PHS; Laurie Carrol Guthart Professor of Medicine, Academic Dean for Partners, HMS; 2018 Forum Co-Chair
  • Chief Clinical Officer, PHS; Professor of Medicine, HMS; 2018 Forum Co-Chair

*Panels and speakers are subject to change.

Highlighted Presenters

Jensen Huang

CEO, NVIDIA

Vasant Narasimhan MD

CEO, Novartis

Paul Ricci

Former Chairman and CEO, Nuance Communications

Atul Gawande MD

Executive Director, Ariadne Labs; Samuel O. Thier Professor of Surgery, HMS; Surgeon, BWH

Seema Verma

Administrator, Centers for Medicare and Medicaid Services

Sue Siegel

CIO and CEO, Business Innovations, GE

Frans van Houten

CEO, Philips

Bernd Montag PhD

CEO, Siemens Healthineers

Terri Bresenham

Chief Innovation Officer, GE Healthcare

John Kelly PhD

SVP, Cognitive Solutions and Research, IBM

Karim Karti

CEO, GE Healthcare Imaging

Jonathan Rothberg PhD

Founder and CEO, Butterfly Network

Jay Bradner MD

President, Novartis Institutes for Biomedical Research

Colin Hill

CEO, GNS Healthcare

Amy Abernethy MD, PhD

CMO, CSO & SVP Oncology, Flatiron Health

Thomas Lynch MD

EVP and CSO, R&D, Bristol-Myers Squibb

Diana Nole

CEO, Wolters Kluwer Health

Roy Beveridge MD

SVP and CMO, Humana

Fabien Beckers PhD

CEO, Arterys

Peter Orszag PhD

Vice Chairman, Investment Banking and Managing Director, Lazard Freres

Georgia Papathomas PhD

SVP, Global Head of Data Sciences, Johnson & Johnson

Punit Soni

CEO, Robin AI

Dan Burton

CEO, Health Catalyst

Jean-François Formela MD

Partner, Atlas Venture

Patrick Conway MD

CEO, BCBS of North Carolina

Jackie Hunter PhD

CEO, BenevolentAI

Greg Moore MD, PhD

VP, Healthcare, Google Cloud

Noga Leviner

CEO, Picnic Health

Leonard D’Avolio PhD

CEO, Cyft, Inc.

Vijay Pande PhD

Partner, Andreessen Horowitz

Iain Buchan MD

‎Director of Healthcare Research, Microsoft Research

Mark Murcko PhD

CSO, Relay Therapeutics

Andrew Hopkins

CEO, Exscientia

Gabriel Otte

CEO, Freenome

Joseph Scheeren PharmD

Senior Advisor, R&D, Bayer

Susan Tousi

SVP, Product Development, Illumina, Inc.

Lisa Maki

Co-Founder, Director, PokitDok

Timothy Tuttle PhD

CTO, Cognitive Collaboration Group, Cisco

Seth Hain

Director, Analytics & Machine Learning, Epic

Featured Speakers

Note: speakers are subject to change.

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Tweets by @pharma_BI and @AVIVA1950 for #PMConf  at The 13th Annual Personalized Medicine Conference, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

Curator: Aviva Lev-Ari, PhD, RN

 

@pharma_BI

@AVIVA1950

 

All TWEETS from LPBI’s Twitter.com handles at #PMConf 

@pharma_BI

@AVIVA1950

  1. Aviva Lev-Ari Retweeted Gary An

    nice comment

    Aviva Lev-Ari added,

  2. Narrative plan unsupported by facts

  3. Robert C. Green, M.D., M.P.H., Director, Genomes2People Research Program, Professor of Medicine (Genetics), Brigham and Women’s Hospital, Broad Institute and Harvard Medical School pharmacogenomics can harm if odds are so low adherence will be lower

  4. Michael Snyder, Ph.D., Stanford W. Ascherman Professor, Chair, Department of Genetics, Director, Center of GenomiPersonalized Medicine, Stanford University School of Medicine Personal sequencing for multiple etiologies rich people are sequenced

  5. Tom Miller, M.S., Founder, Managing Partner, GreyBird Ventures LLC duty to call up therapies that will not work, balance addressed by PM – diagnostics in PM clinical utility from patient selection for the therapy the patient will respond to

  6. Sandro Galea, M.D., School of Public Health, Boston University US expense on Health care the highest in the World comes on the expense of housings, mental health, education – curative vs preventive care MDs are insentiviced to keep patients sick

  7. Robert C. Green, M.D., Broad Institute and HMS Platinum vs gold standard 59 genes will identify 80,000 will get the disease and 47,000 will never get the disease, is the technology the reason for investment vs Family history?

  8. Bryce Olson, Global Marketing Director, Health and Life Sciences Group, Intel Corporation Genome sequencing found his Pi3K Pathway – PIK3CA p.E54 – Anti Inhibitor for Pi3K = Precision Medicine

  9. Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA 21st Century – metastatic solid tumors – 900 patients: accommodated plan Lab developed Tests: new approach Efficiency, transparency

  10. innovation INFORMS at NIH Center of Excellence – data collection and analysis of multiple data types Biometric sensors collecting data on cancer patients collaboration with Academia, single arm vs randomized decentralized devices are collecting data

  11. FDA considers N of One, small samples, EGFR drug was approved in 2 1/2 years since Phase 1 of NDA New trial designs: reduce bias and alternative end points narrow criteria for participation, more personalized and more patient-centered innovation

  12. Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA Advances of technology of biomarkers, disease indication Accelerated approval by FDA a collaborative of speeding the process companion diagnosis assays

  13. Unmet need, commitment is there, innovation and connectivity drive access, collaboration not competition – helps Precision medicine in emerging nations. Access to PM anywhere in the world suggested Kristin Pothier, MS, Global Head, Life Sciences EY

  14. Stephen L. Eck, M.D., Ph.D., President, CEO, Aravive Biologics; Board Chairman, PMC Laxo – A molecular target to be found by diagnostics TEST — as a basis to develop a drug Pricing and value – dimensions of Value to society How PM is done today?

  15. Marc S. Williams, MD Geisinger Clinical Genomics vs Physician specialist (i.e.,hypercholestoralemia), both in same place – paper and EMR Outcomes – tracking patients over decades – systems in place to capture the data Virtual Cycle Clinical data

  16. Timothy Cannon, M.D., Inova Molecular Tumor Board, 5 hospital in VA, Precision Genomics Cancer Therapy Poor understanding of molecular results by MDs, Refractory Patients no Forum to discuss other options 220 patients presented beyond InovaOncologi

  17. Scott A. Beck, Mayo Clinic, MN, AZ PM, Genomics sequencing, BioEthics, IT, Translational Perspective in Epi-genomics, Discovery to Translation Applicattions Pharmacy- Formulary – EMR – Champions from Disease areas to practice environment Testing

  18. payment dominates delivery of care, future PM from Genomics cost to patients Transform acceptability of PM suggested Ronald A. Paulus, M.D., M.B.A., President, CEO, Mission Health, NC, ex-Geisinger, CIO

  19. Genomics based PM to be turned into Wellness Strategy – the path not yet knows said Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center, Nashville, TN

  20. Millianlian Diabetics NOT on Medicare, Analytics: iPhone telling patient dishes to order since SYSTEM KNOWS BLOOD SUGER 24×7 – target care by Analytics Genomics paid by NIH PM Analytics is built at Vanderbilt University MC, Jeffrey R. Balser, CEO

  21. Survival of patient with mutation and targeted drug LIVE LONGER David B. Roth, M.D., Ph.D., Simon Flexner Professor Chair, Pathology and Laboratory Medicine, Perelman School of Medicine at University of Pennsylvania

  22. Lotte Steuten, Ph.D., School of Pharmacy at University of Washington, Seattle aggregate big data , models as evidence, has value to clinical, the model under development NGS Profile of Patient vs current standard of care.

  23. David B. Roth, M.D., Ph.D., UPenn Director, Penn Center for Precision Medicine 5000 patients underwent genome sequencing Interpretation is the issue that is hard Health IT are still in silos: Pharmacy data, financial data, EMR

  24. Michael Pellini, M.D., M.B.A., Chairman, Board of Directors, Foundation Medicine; Board Member, Personalized Medicine Coalition, we know there is value in PM we need to work together on the challenges — to prove the value in PM

  25. Andrea Stern Ferris, M.B.A., President, Chairman of the Board, LUNGevity Foundation – PATIENT to be included in the conversation patient after successful treatment have hope work pay taxes pay to health plans continue family life

  26. Molecular Era, NEJM, 2017, 377, 1813-1823, BRAF in Melanoma – 80% do not need additional therapy vs 20% benefitted in the Non-Molecular Era, data by Dane J. Dickson, CureOne (formerly MED-C); Oregon Health and Science University

  27. CURES – CAR-T are they cures??? A teen-ager’s Value-based Price: $475,000 x years lived suggests  Steven D. Pearson, M.D., M.Sc., Founder, President, Institute for Clinical and Economic Review (ICER)

  28. Of 134 drugs in development – 42 have the potential to become Personalized medicine therapies, said Stephen J. Ubl, President, CEO, PhRMA

  29. Transplantation vs enhancement – resistance to senescence and pathogens to be achieved by gene editing suggests George M. Church, Ph.D., Professor of Genetics

  30. Regulatory oversight on engineering embrios is coming, metric of success in recruitment of patients said Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair, Director, Division of Medical Ethics, New York Univ

  31. CRISPR does not handle all mutation many require a different editing tool said George M. Church, Ph.D., Professor of Genetics, Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology

  32. understand well enough  the gentic application where CRISPR will assist medicine: Retinal degeneration, two aspects one worked in Japan said Katrine Bosley, CEO, Editas Medicine

  33. Aviva Lev-Ari Retweeted Aviva Lev-Ari

    Amazing Power in hands of informed patients

    Aviva Lev-Ari added,

  34. Patients input and sophistication increased – IRB is not aware of the engagement of Patients and their challenging feedback say Deborah Schrag, M.D., M.P.H, Dana Farber

  35. Physicians needs interfaces, dashboard information delivered to MDs, data sits unused, new tools are needed for the data display by relevance to the MDs – clinicians needs decision support in their office

  36. Standards: Toxicity criteria – library of 882 symptoms, Patient reported outcomes by Patients, Resist criteria applied to imaging data criteria for brain tumors said Deborah Schrag, M.D., M.P.H., Chief Medical Oncology, Dana-Farber

  37. drafting document on Verify data integrity in clinical trials, detect discrepancies compromise the integrity of the data – audits by FDA said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  38. pre-existing autoimmune disease – not indicated for them Immunotherapy even though patients wish to try said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute

  39. Drug approved for one indication, provide new data for supplemental indications said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  40. Eric G. Klein, Pharm.D, Eli Lilly Aggregate burden of disease, existence of co-morbidities Genomics: WHY is explained – precise tools data vs intelligence – interoperability Past clinical trial, replicate studies retrospective data

  41. linkages vs computational techniques we do not have consistent data, data structured Vital sign or WBC count – we have data standardization is evolving said Deborah Schrag, M.D., M.P.H., Chief, Dana-Farber Cancer Institute

  42. use data sets prospective vs retrospective studies asked Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Flatiron Health; Board Member, Personalized Medicine Coalition

  43. Clinical sense vs research context, FDA is more comfortable with other than oncology products beyond drugs, namely diagnostics, diagnostics company seeking partnership with many drug areas Thermo FIscher and Novartis partnership

  44. Cost of CT Scan vs an NGS Test – Genomic testing is much cheaper yet volume is still low said Jacob S. Van Naarden, Chief Business Officer, Loxo Oncology

  45. NGS – time results come back what the mutation mean? NOW results come in few days, data analysis assist the said Joydeep Goswami, Ph.D., M.B.A., M.S., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientifi

  46. 3D BioPrinting of Drugs and the innovation storm of agents — are both benefits, value based pricing, elasticities, is that price sufficient to support R&D, dynamic environment said Joshua Ofman, SVP, Global Value, Access, Amgen

  47. Awardee of Leadership in PM, Illumina, HC system not yet ready for Precision Medicine

  48. Amgen and Harvard Pilgrims interpretation of Values related to partnerships: Novartis

  49. at Illimina – Consumer Advocacy added to Technology breakthroughs in genome sequencing said Jay T. Flatley, M.S., Executive Chairman, Illumina

  50. National Genomic Service – Sequencing becoming STANDARD of Care, phynotypes, $10 million to be spent NIH said Jay T. Flatley, M.S., Executive Chairman, Illumina

  51. 13th Annual Leadership in Personalized Medicine Award AWARDEE | Jay T. Flatley, M.S., Executive Chairman, Illumina

  52. 13th Annual Leadership in PM Award to Jay T Flatlet, Illumina

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LIVE Day Two – 13th Annual Personalized Medicine Conference, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

 

JOSEPH B. MARTIN CONFERENCE CENTER

HARVARD MEDICAL SCHOOL, BOSTON, MA 02115

http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/13th_Annual_PM_Conference37.pdf

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

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will cover in REAL TIME the 13th Annual Personalized Medicine, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

In attendance, covering LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

@pharma_BI

@AVIVA1950

#PMConf

Agenda · Part II  NOVEMBER 16, 2017 · CONFERENCE PROGRAM | AGENDA

7:00 am Registration and Breakfast

8:00 am Opening Remarks

SPEAKER | Stephen L. Eck, M.D., Ph.D., President, CEO, Aravive Biologics; Board Chairman, Personalized Medicine Coalition

  • 2005 at Pfizer new initiative on Personalized Medicine
  • Left to go to Lilly – not to give a drug to  Patients with KRAS mutation – beginning of PM
  • Laxo – A molecular target to be found by diagnostics TEST  — as a basis to develop a drug
  • Pricing and value – dimensions of Value to society
  • How PM is done today

8:10 am Clinical Adoption of Personalized Medicine: A Two-Part Discussion Pioneering health care providers have begun to explore the business models, operational processes, IT infrastructure and educational programs that are needed to catalyze the paradigm shift toward personalized medicine. This two-part session on clinical adoption will examine the strategic and day-to-day challenges clinical organizations face as they seek to integrate personalized medicine in clinical settings — and the solutions they employ to address those challenges.

SESSION CHAIR | Marcia A. Kean, M.B.A., Chairman, Strategic Initiatives, Feinstein Kean Healthcare

Discussion Part 1

8:15 am The Case for Personalized Medicine in the Clinic: The View From the Corner Office Inspiring an organizational commitment to a new way of practicing medicine requires visionary leadership. This fireside chat will highlight the viewpoints and approaches of leaders who are spearheading efforts to adopt personalized medicine at clinical institutions, with an eye on the value proposition for changing existing norms and practices.

MODERATOR | Howard L. McLeod, Pharm.D., Medical Director, The DeBartolo Family Personalized Medicine Institute, Chair, Department of Individualized Cancer Management, Senior Member, Division of Population Sciences, Moffitt Cancer Center; Board Member, Personalized Medicine Coalition

Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center, Nashville, TN

  • Vanderbilt University Medical Center [$500 Million in Grants] is a HealthCare System, split from Vanderbilt University School of Medicine [1200 Medical Residents], now they are like Partners
  • BioMedical Informatics very strong at Vanderbilt University School of Medicine
  • Jeffrey R. Balser, M.D., Ph.D. was first student of Dan, A pioneer in Personalized Medicine
  • PM and Non-Oncology: PLAVIX – DSS when MD order drugs DSS trigger No PLAVIX to this patient, made second decision in real time by MDs
  • Nashville – four flagship hospitals, largest HMO not for profit in the country
  • PM at Vanderbilt University Medical Center – 25 drugs – given ONLY after Genomic sequencing
  • Millianlian Diabetics NOT on Medicare, Analytics: iPhone telling patient what dishes to order since SYSTEM KNOWS BLOOD SUGER 24×7 – target care by Analytics
  • Genomics paid by NIH
  • PM Analytics is built at Vanderbilt University Medical Center said Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center
  • what is the economics benefit of Genomic sequencing: DSS on Drugs – Peterson is documenting drug class by economic benefit – bundle to show value
  • Genomics based PM is on drugs — polimorthism – this drug will not work
  • Disease counseling is harder than drug = wellness strategy is the Fututre
  • Genomics based PM to be turned into Wellness Strategy – the path not yet knows said Jeffrey R. Balser, M.D., Ph.D., Dean, Vanderbilt University School of Medicine; President, CEO, Vanderbilt University Medical Center, Nashville, TN
  • Research Investment is R&D, decisions made to guide all research and investment in PM initiative – not generating money. Pilot studies leads to grants. One study is on Economic benefit of PM

Ronald A. Paulus, M.D., M.B.A., President, CEO, Mission Health, NC, ex-Geisinger, CIO

  • 8 most western counties in NC
  • small group of Genetists:
  1. PM and Oncology and – Cancer therapy from a Genomics stand point
  2. PM and Non-Oncology – Drug-Drug interactions
  3. Clinicians needs actionable information
  4. Primary care practices to adopt PM – HOW, where, why? what will be out of pocket expense to the individual
  5. subsidization is a must
  6. payment dominates delivery of care, future PM from Genomics cost to patients
  7. Transform acceptability of PM suggested Ronald A. Paulus, M.D., M.B.A., President, CEO, Mission Health, NC, ex-Geisinger, CIO

Discussion Part 2

9:00 am Practicing Personalized Medicine: Lessons From the Front Lines To successfully integrate personalized medicine into a health system, administrators and clinicians must also design and implement new processes related to program infrastructure and informatics; help educate physicians and patients about the field; and inspire cultural change within the institution. During this panel discussion, a group of early adopters will share lessons learned from implementing pilot programs across the United States.

MODERATOR | Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, Personalized Medicine Coalition

Bonnie J. Addario, Founder, Chair, Bonnie J. Addario Lung Cancer Foundation; Board Member, Personalized Medicine Coalition; Lung Cancer Survivor

Scott A. Beck, M.B.A., Administrator, Center for Individualized Medicine, Mayo Clinic, MN, AZ

  • PM, Genomics sequencing, BioEthics, IT, Translational Perspective in Epi-genomics,
  • Discovery to Translation Applicattions
  • Pharmacy- Formulary – EMR – Champions from Disease areas to practice environment
  • Testing offering, approve value
  • 25 Projects: PharmacoGenomics Testing to patients, change drug before repeat endoscopy

Timothy Cannon, M.D., Clinical Director, Inova Schar Cancer Institute Molecular Tumor Board

  • 5 hospital in VA,
  • Precision Genomics Cancer Therapy
  • Poor understanding of molecular results by MDs, Refractory Patients – no Forum to discuss other options
  • Molecular Tumor Board for Inova Health System: 220 patients presented beyond Inova
  • Oncologists had concerned that patients are aware of drug that MD can’t deliver to client

Peter Hulick, M.D., M.M.Sc., Medical Director, Center for Personalized Medicine, NorthShore University HealthSystem

  • 4 hospitals – 950 MDs
  • PCP to get engaged
  • Neurology
  • Genetic Assessment tool DSS offers PCP option for electronic ordering of the Genetic Testing, Results appear in Patients’ charts
  • Proactive testing
  • 20,000 patients in the system to be tested for pharmaco-genomics testing

Marc S. Williams, M.D., F.A.A.P., F.A.C.M.G., F.A.C.M.I., Director, Genomic Medicine Institute, Geisinger – Central PA

  • 30% of providers are Geisinger the rest are not
  • Genomics: PM — Microbiome bank – broad user consent: recontact and return results
  • Genomics Medicine Institute – 2014 Partnership with Regeneron – genomics sequencing and profiling — all result to be used by Geisinger
  • 170,000 patient consented – 90% responded, 8,000 sequences available
  • 80 gene with potential actionability – interpretation by Scientists
  • Pathologic calls return results –
  • Clinical Genomics vs Physician specialist (i.e.,hypercholestoralemia), both in same place – paper and EMR
  • Outcomes – tracking patients over decades – systems in place to capture the data
  • Virtual Cycle Clinical data – dashboards were created to deliver results per week.
  • 1/2 people do not need criteria
  • Geisinger will disseminate internationally

10:15 am Networking Break (sponsored by Moffitt Cancer Center)

10:45 am Harvard Business School Case Study — Intermountain Healthcare: Pursuing Precision Medicine Intermountain has a long history of being at the forefront of health care quality improvement and the development of treatment protocols. In 2013, Intermountain Precision Genomics (IPG) was started with Dr. Lincoln Nadauld as its Executive Director. IPG focused on stage 4 cancer patients and performed three distinct functions: genomic sequencing, interpretation of sequencing results with recommendations for precision therapies, and drug acquisition and reimbursement. A paper published in February 2017 reported that in addition to having a higher quality of life, patients who received the targeted therapies had progression-free survival rates of almost twice as long as other patients. The purpose of our case discussion will be to assess these efforts, to consider their broader applicability and to review IPG’s plans for the future.

PRESENTER | Richard Hamermesh, D.B.A., Co-Faculty Chair, Harvard Business School Kraft Precision Medicine Accelerator

12:00 pm Overview of the International Landscape for Personalized Medicine

PRESENTER | Kristin Pothier, M.S., Global Head, Life Sciences, Parthenon-EY

  • Precision Medicine in the Globe – stackholder ecosystem
  • India
  • Latin America
  • USA
  • Africa
  • EU
  • APAC
  • Middle East

Regional Spotlight:

China – strength emerging 1.4 Billion people, 4.2 million annual incidence of Cancer – systemic challenges will limit access

Brazil – 440,000 cancer incidents a year, 207 Million Corporate, Hospital, Government, Academic research, collaboration vs competition, collaboration will win

Dubai – 28.5 Million population

Qatar

UAE – Initiative to sequence the entire population, 6,000 done

Saudi Arabia

Middle East – 0.4 oncologist for 100,000

Summary – Unmet need, commitment is there, innovation and connectivity drive access, collaboration not competition – helps Precision medicine in emerging nations. Access to PM anywhere in the world suggested Kristin Pothier, M.S., Global Head, Life Sciences, Parthenon-EY

12:30 pm Bag Lunch

1:30 pm Personalized Medicine at FDA: An Inside Look at the Agency’s Priorities for the Field

INTRODUCTION | Cynthia A. Bens, Vice President, Public Policy, Personalized Medicine Coalition

KEYNOTE | Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  • Advances of technology of biomarkers, disease indication
  • Accelerated approval by FDA a collaborative of speeding the process
  • companion diagnosis assays and drug or biologics
  • FDA considers N of One, small samples, EGFR drug was approved in 2 1/2 years since Phase 1 of NDA
  • New trial designs: reduce bias and alternative end points
  • narrow criteria for participation, more personalized and more patient-centered
  • innovation INFORMS at NIH Center of Excellence – data collection and analysis of multiple data types
  • Biometric sensors collecting data on cancer patients
  • collaboration with Academia, single arm vs randomized, decentralized
  • devices are collecting data in clinical trials
  • 21st Century – metastatic solid tumors – 900 patients: accommodated plan
  • Lab developed Tests: new approach
  • Efficiency, transparency

2:00 pm The Patient Perspective on Personalized Medicine

INTRODUCTION | Susan McClure, Founder, Publisher, Genome magazine; Board Member, Personalized Medicine Coalition

  • Precision medicine and relevant information for Patients
  • Genomic sequencing is the Opening Gate to PM

KEYNOTE | Bryce Olson, Global Marketing Director, Health and Life Sciences Group, Intel Corporation

  • genome sequencing found his Pi3K Pathway – PIK3CA p.E54 – Anti Inhibitor for Pi3K = Precision Medicine

2:30 pm Patient 2.0: Exploring the Future of Personalized Medicine Many observers speculate that the coming wave of gene editing, gene therapy, direct-to-consumer genetic tests and the personalized use of wearables will change the psychology, sociology, economy and efficacy of health care. Informed by the previous panel discussions, this conversation will examine the future of personalized medicine and the merits of these emerging trends.

MODERATOR | Robert C. Green, M.D., M.P.H., Director, Genomes2People Research Program, Professor of Medicine (Genetics), Brigham and Women’s Hospital, Broad Institute and Harvard Medical School

  • Neurologist first , Geneticist thereafter
  • Platinum vs gold standard
  • 59 genes will identify 80,000 will get the disease and 47,000 will never get the disease
  • is the technology the reason for investment vs Family history
  • pharmacogenomics can harm, if odds are so low than adherence will be lower

Sandro Galea, M.D., M.P.H., Dr.P.H., Dean, Robert A. Knox Professor, School of Public Health, Boston University

  • Skeptical of societal aspects: race, 50% of the country health getting better vs 50% getting worse but enthusiast on technology
  • US expense on Health care the highest in the World comes on the expense of housings, mental health, education – curative vs preventive care
  • MDs are insentiviced to keep patients sick
  • Folic Acid
  • Nudge behavior
  • invest in long livivng

Tom Miller, M.S., Founder, Managing Partner, GreyBird Ventures LLC

  • duty to call up therapies that will not work, balance addressed by PM – diagnostics in PM
  • clinical utility from patient selection for the therapy the patient will respond to
  • fantasy: Medical decision making to be made to avoid un neccesary care

Michael Snyder, Ph.D., Stanford W. Ascherman Professor, Chair, Department of Genetics, Director, Center of Genomics and Personalized Medicine, Stanford University School of Medicine

  • Personal sequencing for multiple etiologies
  • rich people come to get sequenced
  • libraries
  • Providers to be incentivized if patients are health

3:30 pm Closing Remarks

SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

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LIVE Day One – 13th Annual Personalized Medicine Conference, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

 

JOSEPH B. MARTIN CONFERENCE CENTER

HARVARD MEDICAL SCHOOL, BOSTON, MA 02115

http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/13th_Annual_PM_Conference37.pdf

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

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will cover in REAL TIME the 13th Annual Personalized Medicine, From Concept to the Clinic, November 14–16, 2017, Joseph B. Martin Conference Center, Harvard Medical School, 77 Avenue Louis Pasteur Boston, MA 02115

In attendance, covering LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

@pharma_BI

@AVIVA1950

#PMConf

Agenda · Part I  NOVEMBER 15, 2017 · CONFERENCE PROGRAM | AGENDA

7:00 am Registration and Breakfast

8:00 am Opening Remarks SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

  • 13th Annual PM Conference at HMS
  • Paradigm shift from One medicine FITS ALL – 13 years ago was a promise in 2017 it is a REALITY
  • Liquid biopsies, read and write gene therapy
  • Value, Pricing, Access
  • Evidence for reimbursement and FDA directions
  • Introduction od PM to the Clinic
  • Case study on Value and Healthcare System
  • Future of PM Stanford, BU, Investor
  • Translation to Chinese, 50 guests from 20 countries and 21 from CA

 

8:10 am The State of Personalized Medicine

INTRODUCTION |

Steven D. Averbuch, M.D., Head, Precision Medicine Research & Development, Bristol-Myers Squibb; Board Member, Personalized Medicine Coalition

  • Known Tom for few decades, collecting tissue on lung cancer.
  • EGFR – discovered at HMS

KEYNOTE |

Thomas J. Lynch, Jr., M.D., Executive Vice President, Chief Scientific Officer, Research & Development, Bristol-Myers Squibb

  • Apply right drug to right patient
  • Gefitinig (AstraZeneca) vs Carboplatin/Paclitaxel – lung cancer – advanced NSCLC
  • Gene mutation – EGFR negative vs Positive – cost of sequencing inverse to Moore’s Law
  • Genome Sequenced at <$1,000
  • Lung Adenocarcinoma: 2016: PIK3CA, KRAS, BRAF
  • 2015NEJM – Design drugs: Resistance mutation vs. negative – no mutation EGFR
  • Immune -Biology of Cancer is Complex – Tumor, Effector Cells, Immune regulatory & APGs
  • NEXT opportunities: Novel I-O mechanisms, patient selection is key
  • Biomarkers: PDL-1, MSI – H Tumor mutation Burden (TMB) LAG-3
  • Future: Gene signature
  • Pembrolizumab Free survivsls – 50%
  • BMS – FoundationOne – calibration used by BMS: Mutational Burden: FoundationOne assey: Exploratory analysis: High TMB (Nivoluman vs Chemo, Nivo id bettervs LowTMB
  • Combination Drug Therapy: Nivo +Ipi
  • Assessment of TMB: coding regions of 21K genes: WES vs FoundationOne (F1)
  • TMB in Blood (bTMB) in 2L + NSCLC (POPLAR and OAK)
  • bTMB <16 vs bTMB >16
  • PM – molecular profiling of Hundreds of Cancers and PM of drug treatment driven by molecular profiles
  • F1 is promising

8:40 am 13th Annual Leadership in Personalized Medicine Award

AWARDEE | Jay T. Flatley, M.S., Executive Chairman, Illumina

  • Precision Medicine – still inpact is limited
  • Regulatory and Reimbursement are BARRIERS in the HealthCare system,
  • Kidney Cancer treated off-label – great
  • less 10% of tumors have been sequenced, sufficient tissue needed, physician voted not to sequence deeming it un-actionable
  • Cystic Fibrosis – only sequencing lead to FDA approval, POST marketing required significant resources
  • Translational researchers validated 200 genes
  • 400 genes at FoundationOne
  • DIagnostics companies – reimbursement process is TOO LONG
  • Regulatory – emerging diagnostics: Product in use in clinical trials
  • Risk models to be shared with Diagnostics companies – reimbursement at end of period when results are available
  • Blockchain technology is promising for handling data
  • Rare diseases in Cancer  – One milion genomes sequenced
  • National Genomic Service – Sequencing becoming STANDARD of Care, phynotypes, $10 million to be spent NIH said Jay T. Flatley, M.S., Executive Chairman, Illumina
  • at Illimina – Consumer Advocacy added to Technology breakthroughs in genome sequencing said Jay T. Flatley, M.S., Executive Chairman, Illumina

9:10 am Networking Break

9:35 am Progress in Partnerships: A Two-Part Discussion Aligning the constructs of the health system with the principles of personalized medicine will require stakeholders to scale the most promising cross-sector partnership models. This series of conversations will examine the potential of several of the most promising models that have emerged thus far.

Discussion

Part 1 9:35 am A Model for Risk-Sharing Agreements Between Payers and the Pharmaceutical Industry Many payers are reluctant to assume that covering personalized medicines will help mitigate costs associated with major medical events that require hospitalization. During this fireside chat, however, representatives from Amgen and Harvard Pilgrim Health Care will discuss the logic and implications of their groundbreaking agreement to share the financial risks of covering a targeted medicine based on that premise. Under the terms of the agreement, Amgen agreed to cover treatment costs for patients who have a heart attack or stroke while taking its personalized therapy for familial hypercholesterolemia.

MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC

Joshua Ofman, M.D., M.S.H.S., Senior Vice President, Global Value, Access and Policy, Amgen

  • Hyperlipidemia – Partnering, Amgen with Harvard Pilgrim Health Care
  • Arrangements: Patients who need the medication will get access to the medication
  • effective stuards: Co-Pay not too high, replacement of medication by generics
  • Medicare has requirements
  • Migraine medications are coming out from Amgen – novel payment
  • Combination drug therapy – Payment system not ready for it yet
  • 3D BioPrinting of Drugs and the innovation storm of agents — are both benefits, value based pricing, elasticities, is that price sufficient to support R&D, dynamic not linear environment said Joshua Ofman, M.D., M.S.H.S., Senior Vice President, Global Value, Access and Policy, Amgen

Michael Sherman, M.D., M.B.A., M.S., Chief Medical Officer, Senior Vice President, Harvard Pilgrim Health Care; Board Member, Personalized Medicine Coalition

  • complications,  cost, outcome work vs does not work
  • Gene therapies coming from Novartis and Partnership with Harvard Pilgrims
  • Value proposition for one drug and one cancer – to assure access Pharma and Payers Partnership
  • Drug and Outcome, high cost drug coming, very expensive, life saver for who needs them

Discussion

  • Pharma’s revenue stream is international, it is in the US that payers require Value

 

Part 2 10:05 am Models for the Development of Personalized Medicine Diagnostics Pharmaceutical and diagnostics companies have responded to a host of complex scientific, regulatory and reimbursement challenges partly by developing innovative partnership models around companion diagnostics. This panel discussion will feature representatives from the pharmaceutical and diagnostics industries, who will discuss the challenges partnerships have helped industry overcome as well as the obstacles that continue to inhibit the development of the diagnostic tools upon which personalized medicine depends. Agenda ·

 

MODERATOR | Alexander Vadas, Ph.D., Managing Director, L.E.K. Consulting

Joydeep Goswami, Ph.D., M.B.A., M.S., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientific

  • monitor disease , biopsy changes in 6 month and repeat is needed
  • NGS – results come back in a month what the mutation mean? NOW results come in few days, data analysis  assist the MDs for action in treatment said Joydeep Goswami, Ph.D., M.B.A., M.S., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientific
  • How to accelerate the need for safety and the avalangue of innovations
  • Clinical sense vs research context, FDA is more comfortable with other than oncology products beyond drugs, namely diagnostics

Jacob S. Van Naarden, Chief Business Officer, Loxo Oncology

  • Increase in need of drugs in NGS World, Tissue agnostics, ALL the drugs and all the tumors
  • reduction in cost with technology, can’t be too expensive,
  • LOXO drug development  – each testing addresses a focused medical issue  – cancer alterations  for ALL extremely aggressive cancer
  • DNA and RNA based events detected by tools
  • cost of test need to be low, Reference Labs need to collaborate to standarize technology and explain to the Payers
  • Cost of CT Scan vs an NGS Test – Genomic testing is much cheaper said Jacob S. Van Naarden, Chief Business Officer, Loxo Oncology
  • Educational

10:35 am Real-World Personalized Medicine: Examining the Role of Real-World Evidence in Personalizing Health Care FDA has offered a definition of real-world evidence, but the community continues to debate what is needed to fully integrate it into decision-making. This panel will explore what real-world evidence is, how it is being used and what regulatory requirements are needed to realize its potential.

MODERATOR | Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Flatiron Health; Board Member, Personalized Medicine Coalition

  • Collection of evidence to accelerate from lab to the Clinic
  • use data sets prospective vs retrospective studies asked Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Flatiron Health; Board Member, Personalized Medicine Coalition

Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA

  • 3/2017 established to have an integrative approach by FDA – real world dat ais important to FDA
  • Drug approved for one indication, provide new data for supplemental indications said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA
  • co-morbidities cause EXCLUSION from clinical trials, i.e., HIV patients, experience of patients excluded to learn how differently they can be treated
  • drafting a document on Verify data integrity in clinical trials, detect discrepancies compromise the integrity of the data – audits by FDA said Sean Khozin, M.D., M.P.H., Associate Director (Acting), Oncology Center of Excellence, FDA
  • Validation of devices- FDA Innovation Initiative,

Eric G. Klein, Pharm.D., Senior Director, Oncology, Global Patient Outcomes and Real-World Evidence, Eli Lilly and Company

  • Aggregate burden of disease, existence of co-morbidities
  • Why it was occurring – Genomics: WHY is explained – precise tools
  • data vs intelligence – interoperability
  • Past clinical trial – replicate studies with retrospective data
  • finding the responding patients – pragmatic trial, not randomized, collect end point – very expensive and requires statisticians
  • end pint definition changed

Eleanor M. Perfetto, Ph.D., M.S., Senior Vice President, Strategic Initiatives, National Health Council

  • How patients  wish to see usage of their experience – how side effect information can be used.
  • New indication
  • reimbursement
  • improved used of existing drug higher rating vs new indications
  • clinical trial design gets input from patients, Patient can announce, dropping participation if a change is not made

Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute

  • Major gene mutation and Drugs
  • Drug exposure correlate with evidence, Worldwide,
  • linkages vs computational techniques we do not have consistent data, data structured or not, respond to medication: symptoms, prospects vs Vital sign or WBC count – we have data standardization is evolving said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute
  • clinical decision support what is structured is data upon admission, monitoring the drugs given in this period, turning to patients willing to offer feedback and cooperate
  • pre-existing autoimmune disease – not indicated for them Immunotherapy even though patients wish to try said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute
  • Standards: Toxicity criteria – library of 882 symptoms, Patient reported outcomes by Patients, Resist  criteria applied to imaging data criteria for brain tumors said Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute
  • Physicians needs interfaces, dashboard information delivered to MDs, data sits unused, new tools are needed for the data display by relevance to the MDs
  • Patients input and sophistication increased – IRB is not aware of the engagement of Patients and their challenging feedback say Deborah Schrag, M.D., M.P.H, Dana Farber

11:50 am Luncheon

1:00 pm The Designer Genome: Exploring the Implications of Gene Editing and Gene Therapy for the Future of Medicine and Humanity Many scientists believe the clustered regularly interspaced short palindromic repeats (CRISPR) genetic engineering tool and recent developments in gene therapy will dramatically alter the trajectory of medicine, but the specific implications of these developments for health systems around the world remain unclear. During this session, a panel of experts will discuss the status of these new technologies and how the medical community and regulatory agencies may have to adapt to keep up with forthcoming developments.

MODERATOR | Kevin Davies, Ph.D., Co-Author, DNA: The Story of the Genetic Revolution (with Jim Watson and Andrew Berry); Executive Editor, The CRISPR Journal

Katrine Bosley, CEO, Editas Medicine

  • spectrum of ease to correct a mutation, some mutation are easier than others for editing,
  • understand well enough  the gentic application where CRISPR will assist medicine: Retinal degeneration, two aspects one worked in Japan said Katrine Bosley, CEO, Editas Medicine

Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair, Director, Division of Medical Ethics, New York University Langone Medical Center

  • Bioethics, super babies, engineering embrios,
  • Regulatory oversight on engineering embrios is coming, metric of success in recruitment of patients said Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair, Director, Division of Medical Ethics, New York University Langone Medical Center
  • cell repair is cheaper that transplantation,
  • clone of super person next door
  • Bioterrorism accomplished by gene engineering !!

George M. Church, Ph.D., Professor of Genetics, Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology; Director, Harvard Medical School NHGRI-Center of Excellence in Genomic Science; Director, Harvard Medical School Personal Genome Project; Founding Member, Wyss Institute for Biologically Inspired Engineering at Harvard University

  • Delivery, more precise,
  • Longevity and aging – one blockbuster is needed
  • Engineered mutation, machine learning
  • CRISPR does not handle all mutation many require a different editing tool said George M. Church, Ph.D., Professor of Genetics, Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology; Director, Harvard Medical School NHGRI-Center of Excellence in Genomic Science; Director, Harvard Medical School Personal Genome Project; Founding Member, Wyss Institute for Biologically Inspired Engineering at Harvard University
  • over regulation – Do not touch germ line – is not desired
  • Transplantation vs enhancement – resistance to senescence and pathogens to be achieved by gene editing suggests George M. Church, Ph.D., Professor of Genetics
  • Bringing back genes – elephants with fur

Jeffrey D. Marrazzo, M.B.A., M.P.A., CEO, Spark Therapeutics

  • Retina degeneration causes blindness, deliver drug to back of the retine, inject genetic material and achieved remarkable results, drug approval of genetic therapy in the US for a genetic disorder in Retina causing blindness
  • 21st Century schema of Payment and benefits

 

2:15 pm Pricing Personalized Medicines The increasing pressure on industry stakeholders to alter their drug pricing practices has particular significance for personalized medicines, which must recoup research and development costs from smaller patient populations. This conversation will explore the pharmaceutical industry’s strategies for facilitating sustainable access to these innovative therapies.

MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC

Stephen J. Ubl, President, CEO, PhRMA

  • minimum 10% invested in R&D at each Pharma
  • Of 134 drugs in development – 42 have the potential to become Personalized medicine therapies, said Stephen J. Ubl, President, CEO, PhRMA
  • Icer methodology – average patient aggregate data, value pricing is a better model: RA targeted to subset of patients
  • Price gauging is a problem – bring solutions to the table, Patients asks for incentives
  • amortizing costs like mortgage
  • Outcome-based arrangements: If money-based guaranteed it negate Medicaid negotiation power. If transportation is covered – it leads to locking product in use

2:45 pm Networking Break (sponsored by GreyBird Ventures)

3:15 pm Precision Valuation: A Discussion of How Value Assessment Frameworks Can Account for Personalized Medicine Payers control access to personalized medicine, and some have begun to take an interest in findings from value assessment frameworks that are challenged to account for developments in the field. In addition to exploring their potential impact on individualized care, this session will examine how value assessment frameworks can and should consider personalized medicine as part of their processes for evaluating therapeutic options.

MODERATOR | Jennifer Snow, M.P.H., Director, Health Policy, Xcenda, AmerisourceBergen

  • Quality Era moved to Value Era

 

Dane J. Dickson, M.D., CEO, Founder, CureOne (formerly MED-C); Director, Precision Medicine Policy and Registries, Knight Cancer Institute at Oregon Health and Science University

Molecular Era

  • NEJM, 2017, 377, 1813-1823
  • BRAF in Melanoma – 80% do not need additional therapy vs 20% benefitted in the Non-Molecular Era

data by Dane J. Dickson, M.D., CEO, Founder, CureOne (formerly MED-C); Director, Precision Medicine Policy and Registries, Knight Cancer Institute at Oregon Health and Science University

 

Robert Dubois, M.D., Ph.D., Executive Vice President, Chief Science Officer, National Pharmaceutical Council

  • Value Assessment and PM: ACC, ASCO, ICER< Memorial Sloan,
  • The patient: survival, QOL, Adverse events, Out of pocket cost, extra survival by disease, treatment burden,
  • PAYERS: One size does not fit all – AVERAGE is meaningless
  • MDs vs Patients – are different in preference

Andrea Stern Ferris, M.B.A., President, Chairman of the Board, LUNGevity Foundation

  • PATIENT to be included in the conversation

Steven D. Pearson, M.D., M.Sc., Founder, President, Institute for Clinical and Economic Review (ICER)

  • Precision Medicine vs Value Assessment
  • Novartis CAR-T Kymriah:  relapsed B-cell precursor ALL under 25 – 5 yr survival – 10%
  • Changes associated with Gene therapies: single arm trials, surrogate outcomes, less certainty safety and benefits
  • Gene therapy – >> innovations Kymriah – $475,000 price
  • Long term value for money vs Short term affordability

PRICE-based on Value – discount from prices after rebate to meet ICER value-based Price range

  • More targeted = higher value more favorable cost-effectiveness
  • Rare/ultra-rare populations: broader value range:
  1. Use EARLIER
  2. will it work for patients without genetic marker?
  • Years of Life weighted by an INDEX of quality of life (1=perfect health;  0=dead)
  • willingness to pay: WHO and ACC: 1-3x
  • individual x2 salary
  • Opportunity cost x1 per capita GDP in UK
  • Future of value assessment and precision medicine
  • CURES – CAR-T are they cures???
  • A teen-ager’s Value-based Price: $475,000 x years lived suggestsSteven D. Pearson, M.D., M.Sc., Founder, President, Institute for Clinical and Economic Review (ICER)

4:30 pm The Utility Proposition: An Analysis of Case Studies in the Economic Value of Personalized Medicine Although personalized medicine’s proponents contend that the field can deliver economic value by helping doctors avoid prescribing costly but ineffective therapies, the field lacks literature testing that hypothesis. This session will highlight recent studies on the clinical and economic value of personalized medicine, shedding light on what we know about personalized medicine’s clinical and economic utility — and what we don’t.

MODERATOR | Michael Pellini, M.D., M.B.A., Chairman, Board of Directors, Foundation Medicine; Board Member, Personalized Medicine Coalition

  • we know there is value in Personalized Medicine
  • we need to work together to acknowledge the challenges — to prove the value in PM

Lincoln Nadauld, M.D., Ph.D., Executive Director, Precision Medicine, Precision Genomics, Intermountain Healthcare

  • Interpretation by Medical Oncologists beyond: KRAS, BRAF
  • Measuring the value and presenting that to the payers and inside the organizations
  • 2013 –

David B. Roth, M.D., Ph.D., Simon Flexner Professor Chair, Pathology and Laboratory Medicine, Perelman School of Medicine at University of Pennsylvania; Director, Penn Center for Precision Medicine

  • 5000 patients underwent genome sequencing
  • Interpretation is the issue that is hard
  • Health IT are still in silos: Pharmacy data, financial data, EMR are not integrated yet
  • Survival of patient with mutation and targeted drug LIVE LONGER

Lotte Steuten, Ph.D., M.Sc., Associate Faculty Member, Hutchinson Institute for Cancer Outcomes Research (HICOR), Fred Hutchinson Cancer Research Center; Affiliate Associate Professor, Pharmaceutical Outcomes Research and Policy Program, School of Pharmacy at University of Washington, Seattle

  • aggregate big data , models as evidence, has value to clinical, the model under development NGS Profile of Patient vs current standard of care. Model Payer advisor committee, Oncologist Advisory Committee great benefit to PM on the cost side data is for targeting treatment using the promise of PM

5:45 pm Elements Café Cocktail Reception

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