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

11:30AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:30 a.m. – Keynote Speaker – Role of Genetics and Genomics in Pharmaceutical Development

 

Role of Genetics and Genomics in Pharmaceutical Development

There was a time when pharmaceutical companies attempted to develop drugs that could be used to treat large populations of individuals diagnosed with a particular disease. These drugs were used to treat large groups of patients and were not always effective for all patients. The paradigm of drug development is changing where highly targeted drugs that would be highly effective in specific sub populations of patients are becoming the new norm. Dr. Skovronsky will describe how the pharmaceutical industry as a whole and Lilly in particular is taking advantage of the new knowledge about the genetic basis of disease to develop highly effective therapies.

Role of Genetics and Genomics in Pharmaceutical Development

Daniel Skovronsky, M.D., Ph.D.
Vice President of Tailored Therapeutics, Lilly

@EliLillyCo

@LillyHealth

Alzheimer’s Disease

  •  early detection
  • how do drugs work in Alzheimer’s Disease (AD) – difficult to conduct Clinical Trials
  • Personalized the treatment as early on as possible: looking inside the brain and track the disease
  • images of the pathology of AD – Amyloid imaging using agents
  • diagnostics test on autopsy of AD brains after death
  • Risk of Progression
  • amyloid deposition over time – Dynamics of accumulations
  • Autopsy of brains of AD: MANY AD patients have negative scans
  • Clinical Trial definition of AD: 22% did not have amyloid — WERE TREATED WITH ANTI Amyloid DRUGS (22% Solanezumab, 16% Bapineuzumab)
  • 1/2 have DX of AD and treated with targeted drug — have negative Scans for Amyloid deposits — NOT PROGRESSING
  • those progressing are those with Positive Scans
  • 18 month and 36 month – Progression of Amyloid — Only at Positive scans
  • A4 Trial Dx Florbetapir
  • Rx solanezumab – symptomatic dementia vs AD
  • Markers o=for the disease – Neural degeneration – Tau in temporal lobe
  • Treat patient with start of Tau — avoid progression to amyloid deposition

 

CANCER

  • Companion Diagnostics (CD) vs Therapeutics – start to find the biomarkers at the same time: Drug and Diagnostics
  • DNA, RNA, Protein
  • Diagnostics –>> translation
  • CLIA lab at Eli Lilly for companion diagnostics
  • Biomarker Negative vs Positive ans a spectrum of results
  • Immunohistochemistry (IHC) for protein expression – simple assay, complicated test
  • two different agent at two different albs — give two different diagnostics
  • Tumor heterogeneity: Glioblastoma
  • Tissue scarce resource — it is separated in time Biopsy taken at different times
  • Detection of chromosomal – Liquid Biopsy – Exosomes
  • mRNA, miRNA
  • Summary: Prime key porters to quickly bring therapies to patients

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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10:15AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

10:15 a.m. Panel Discussion — IT/Big Data

IT/Big Data

The human genome is composed of 6 billion nucleotides (using the genetic alphabet of T, C, G and A). As the cost of sequencing the human genome is decreasing at a rapid rate, it might not be too far into the future that every human being will be sequenced at least once in their lifetime. The sequence data together with the clinical data are going to be used more and more frequently to make clinical decisions. If that is true, we need to have secure methods of storing, retrieving and analyzing all of these data.  Some people argue that this is a tsunami of data that we are not ready to handle. The panel will discuss the types and volumes of data that are being generated and how to deal with it.

IT/Big Data

   Moderator:

Amy Abernethy, M.D.
Chief Medical Officer, Flatiron

Role of Informatics, SW and HW in PM. Big data and Healthcare

How Lab and Clinics can be connected. Oncologist, Hematologist use labs in clinical setting, Role of IT and Technology in the environment of the Clinicians

Compare Stanford Medical Center and Harvard Medical Center and Duke Medical Center — THREE different models in Healthcare data management

Create novel solutions: Capture the voice of the patient for integration of component: Volume, Veracity, Value

Decisions need to be made in short time frame, documentation added after the fact

No system can be perfect in all aspects

Understanding clinical record for conversion into data bases – keeping quality of data collected

Key Topics

Panelists:

Stephen Eck, M.D., Ph.D.
Vice President, Global Head of Oncology Medical Sciences,
Astellas, Inc.

Small data expert, great advantage to small data. Populations data allows for longitudinal studies,

Big Mac Big Data – Big is Good — Is data been collected suitable for what is it used, is it robust, limitations, of what the data analysis mean

Data analysis in Chemical Libraries – now annotated

Diversity data in NOTED by MDs, nuances are very great, Using Medical Records for building Billing Systems

Cases when the data needed is not known or not available — use data that is available — limits the scope of what Valuable solution can be arrived at

In Clinical Trial: needs of researchers, billing clinicians — in one system

Translation of data on disease to data object

Signal to Noise Problem — Thus Big data provided validity and power

 

J. Michael Gaziano, M.D., M.P.H., F.R.C.P.
Scientific Director, Massachusetts Veterans Epidemiology Research
and Information Center (MAVERIC), VA Boston Healthcare System;
Chief Division of Aging, Brigham and Women’s Hospital;
Professor of Medicine, Harvard Medical School

at BWH since 1987 at 75% – push forward the Genomics Agenda, VA system 25% – VA is horizontally data integrated embed research and knowledge — baseline questionnaire 200,000 phenotypes – questionnaire and Genomics data to be integrated, Data hierarchical way to be curated, Simple phenotypes, validate phenotypes, Probability to have susceptibility for actual disease, Genomics Medicine will benefit Clinicians

Data must be of visible quality, collect data via Telephone VA – on Med compliance study, on Ability to tolerate medication

–>>Annotation assisted in building a tool for Neurologist on Alzheimer’s Disease (AlzSWAN knowledge base) (see also Genotator , a Disease-Agnostic Tool for Annotation)

–>>Curation of data is very different than statistical analysis of Clinical Trial Data

–>>Integration of data at VA and at BWH are tow different models of SUCCESSFUL data integration models, accessing the data is also using a different model

–>>Data extraction from the Big data — an issue

–>>Where the answers are in the data, build algorithms that will pick up causes of disease: Alzheimer’s – very difficult to do

–>>system around all stakeholders: investment in connectivity, moving data, individual silo, HR, FIN, Clinical Research

–>>Biobank data and data quality

 

Krishna Yeshwant, M.D.
General Partner, Google Ventures;
Physician, Brigham and Women’s Hospital

Computer Scientist and Medical Student. Were the technology is going?

Messy situation, interaction IT and HC, Boston and Silicon Valley are focusing on Consumers, Google Engineers interested in developing Medical and HC applications — HUGE interest. Application or Wearable – new companies in this space, from Computer Science world to Medicine – Enterprise level – EMR or Consumer level – Wearable — both areas are very active in Silicon Valley

IT stuff in the hospital HARDER that IT in any other environment, great progress in last 5 years, security of data, privacy. Sequencing data cost of big data management with highest security

Constrained data vs non-constrained data

Opportunities for Government cooperation as a Lead needed for standardization of data objects

 

Questions from the Podium:

  • Where is the Truth: do we have all the tools or we don’t for Genomic data usage
  • Question on Interoperability
  • Big Valuable data — vs Big data
  • quality, uniform, large cohort, comprehensive Cancer Centers
  • Volume of data can compensate quality of data
  • Data from Imaging – Quality and interpretation – THREE radiologist will read cancer screening

 

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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8:30AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

8:30 a.m. Harvard Business School Case Study: 23andMe

Harvard Business School Case Study: 23andMe

It is now a tradition and a unique feature of the Harvard Personalized Medicine Conference that Richard Hamermesh, a professor at Harvard Business School,  ‟teaches” a case as he does for the students at HBS. This year Professor Hamermesh has selected a couple of cases that were written about the company 23andMe. As usual, this case study will be highly interactive and educational. If you have not participated in one of these case studies at our Conference, you do not want to miss it!

23andMe – Harvard Business School Case Study

Leader:

Richard Hamermesh, D.B.A. @HarvardHBS

MBA Class of 1961 Professor of Management
Practice; Faculty Chair, HBS Healthcare Initiative, Harvard Business School

Two cases on 23andMe @23andMe

Active Group Discussion:

  • Customer very young in 20s and 30s – curiosity of sophisticated consumers
  • Personal interest in Private medical condition give illnesses in the family
  • Genotyping vs sequencing, only whole sequencing gives all variants
  • False Advertisement of the Service: on MNSBC, other
  • Do you allow your data to be used in Research vs and be sold to Pharma and be paid for sharing the data by the 23andMe
  • Price dropped from $250 to $99
  • 15 years from Now — No harm to Consumer, much data on Human Genome collected and Personal Medical Conditions improved by acting on information revealed by Genomics
  • 23andMe placed the Platform since genetic information was not otherwise available — They Pioneer with innovation on behalf of the Consumer
  • VC encourages Innovators to push the envelop – 23andMe did that with Private funding by Eugene Brin from Google
  • QUALITY OF INTERPRETATION OF GENOMICS information is key and it is improving

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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8:00AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

8:00 A.M. Welcome from Gary Gottlieb, M.D.

Opening Remarks:

Partners HealthCare is the largest healthcare organization in Massachusetts and whose founding members are Brigham and Women’s Hospital and Massachusetts General Hospital. Dr. Gottlieb has long been a supporter of personalized medicine and he will provide his vision on the role of genetics and genomics in healthcare across the many hospitals that are part of Partners HealthCare.

Opening Remarks and Introduction

Scott Weiss, M.D., M.S. @PartnersNews
Scientific Director, Partners HealthCare Personalized Medicine;
Associate Director, Channing Laboratory/
Professor of Medicine, Harvard Medical School 
@harvardmed

Welcome

Engine of innovations

  • lower cost – Accountable care
  • robust IT infrastructure on the Unified Medical Records
  • Lab Molecular Medicine and Biobanks
  • 1. Lab Molecular medicine
  • 2. Biobank
  • 3. Translations Genomics: RNA Sequencing
  • 4. Medical Records integration of coded diagnosis linked to Genomics

BIOBANKS – Samples and contact patients, return actionable procedures

LIFE STYLE SURVEY – supplements the medical record

GENOTYPING and SEQUENCING – less $50 per sequence available to researcher / investigators

RECRUITMENT – subject to biobank, own Consents – e-mail patient – consent online consenting — collects 16,000 patients per month – very successful Online Consent

LAB Molecular Medicine – CLIA — genomics test and clinical care – EGFR identified as a bio-marker to cancer in 3 month a test was available. Best curated medical exon databases Emory Genetics Lab (EMVClass) and CHOP (BioCreative and MitoMAP and MitoMASTER). Labs are renowned in pharmacogenomics and interpretability.

IT – GeneInsight – IT goal Clinicians empowered by a workflow geneticist assign cases, data entered into knowledge base, case history, GENEINSIGHT Lab — geneticists enter info in a codified way will trigger a report for the Geneticist – adding specific knowledge standardized report enters Medical Record. Available in many Clinics of Partners members.

Example: Management of Patient genetic profiles – Relationships built between the lab and the Clinician

Variety of Tools are in development

GenInsight Team –>> Pathology –>> Sunquest Relationship

The Future

Genetic testing –>> other info (Pathology, Exams, Life Style Survey, Meds, Imaging) — Integrated Medical Record

Clinic of the Future-– >> Diagnostics – Genomics data and Variants integrated at the Clinician desk

Gary Gottlieb, M.D. @PartnersNews
President and CEO, Partners HealthCare

Translational Science
Partners 6,000 MDs, MGH – 200 years as Teaching Hospital of HMS, BWH – magnets in HealthCare

2001  – Center for Genomics was started at Partners, 2008 Genomics and Other Omis, Population Health, PM – Innovations at Partners.

Please Click on Link  Video on 20 years of PartnersHealthcare

Video of Dr. Gottlieb at ECRI conference 2012

Why is personalized medicine  important to Partners?

From Healthcare system to the Specific Human Conditions

  • Lab translate results to therapy
  • Biobank +50,000 specimens links to Medical Records of patients – relevant to Clinician, Genomics to Clinical Applications

Questions from the Podium

  • test results are not yet available online for patients
  • clinicians and liability – delays from Lab to decide a variant needs to be reclassified – alert is triggered. Lab needs time to accumulated knowledge before reporting a change in state.
  • Training Clinicians in above type of IT infrastructure: Labs around the Nations deal with VARIANT RECLASSIFICATION- physician education is a must, Clinicians have access to REFERENCE links.
  • All clinicians accessing this IT infrastructure — are trained. Most are not yet trained
  • Coordination within Countries and Across Nations — Platforms are Group specific – PARTNERS vs the US IT Infrastructure — Genomics access to EMR — from 20% to 70% Nationwide during the Years of the Obama Adm.
  • Shakeout in SW linking Genetic Labs to reach Gold Standard

Click to see Advanced Medical Education Partners Offers

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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4:00PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

4:00 p.m. Panel Discussion Novel Approaches to Personalized Medicine

Novel Approaches to Personalized Medicine

Genetic and genomic knowledge is helping the development of new drugs, therapies and prognostic tests. As a result, there are new approaches, new partnerships and new business models that are emerging. In some cases, diseases that were considered incurable not too long ago are now being tackled with highly targeted therapies. In other cases the uncertainties associated with assessing potential aggressiveness of disease are being eliminated. This panel will provide examples of new business paradigms that are emerging from the application of personalized medicine.

Novel Approaches to Personalized Medicine

Moderator:

Meghan FitzGerald, Ph.D. @cardinalhealth
President, Cardinal Health Specialty Solutions

Chief Genome Officer – next steps in companies, Genomics Index will replace the Biotech Index

Most Interesting person in Genomics: Marc Levin,

Panelists:

2. Chris Garabedian @Sarepta
President and CEO, Sarepta

  • Applications of genomics to Infectious diseases, therapeutics – design of drugs, Duchenne Muscular Dystrophy (DMD)
  • technology safe working, one drug very effective, 60 alternative drugs, not enough patients to power clinical trials

 

4. Shawn Marcell
President & CEO, Metamark Genetics

  • Prostatic Cancer – Use of genomics tools to diagnose and treat Prostate cancer
  • US market is the best for Genomics innovations because venture capital Market is mature, FDA is negotiable, CMP well established
  • Business model: platform, good test big market, commercialize, clinical data — PM has a different Business model: Delivery of Test results need to be different
  • IPO 2016

 

1. Scott Schell, M.D., Ph.D. – surgical oncology @KEWGroup
President and CEO, KEW Group

  • Large scale platform, strategic partnerships with Oncology Practices,
  • Immuno oncologists, repository of data
  • 80% of cancers are treated in the community 20% at Academic centers. Integration of knowledge, patients wish to stay in the community
  • phase I approval at record high levels

3. Gabriel Bien-Willner, M.D., Ph.D. @MolecularHealth
Medical Director, MolecularHealth, Inc.

  • Diagnostics Tools in Analytics. Clinicians do not have the training in Genomics – position firm to create Lab reports and consulting MDs using Analytics for Clinicians

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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3:15PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

3:15 p.m. Discussion Complex Disorders

Complex Disorders

During the past 30-40 years, it has become well established that most human disorders affecting large groups of individuals have a genetic basis. Based upon this information there are several efforts to conduct genetic analysis on very large populations of individuals to identify genetic factors that cause susceptibility to complex disorders. In this session, two examples where such studies are bearing fruit will be discussed.

Complex Disorders

Discussion Leader:

Anna Barker, Ph.D.
Director, Transformative Healthcare Knowledge Networks;
Co-Director, Complex Adaptive Systems Initiative:
Professor, School of Life Sciences, Arizona State University

World of Biomarkers following NIH Career – Molecular based Medicine

get all the facts right straight then distort them

Speakers:

Roy Perlis, MGH, Bipolar Specialty, Prof of Psychiatry

Specialist in Schizophrenia, Autism

  • Complexity – overlapping diseases, genomics discovery
  • Psychiatry Genomics – Susceptibility, variance explained by common variation, intervention studies for susceptibility
  • depression is hereditary
  • 2000 schizophrenics genome,
  • phenotype models is only partially indicative of help if you are on Klonopin, is this enough for the diagnosis
  • CRISPR — HOW to use it — not discovered yet for psychiatry disorder — it may be the solution, though

Joe Vockley

COO, Inova Health System

CSO, Inova Translational Medicine Institute

  • Preeclempsia – preterm Birth is a complex disease many factor can cause it, 12% of birth are Preterm birth
  • 10,000 genome vs full term birth, clinical phenotypes,
  • model 81% predictive — triage screening based on markers – genomics to follow phenotyping.
  • Genomics — indicative — not fully used from diagnostics to therapy
  • ancestor data (familial info) of the 10,000 in the cohort was done filter variant
  • whole genome sequencing, reimbursement does not support  to path to therapy based on genomics

Robert Plenge, M.D., Ph.D.   @rplenge
Vice President and Worldwide Head Genetics and Pharmacogenomics
Merck Research Laboratories – Specialist RA

ex- Pharmacogenetics at MGH

  • sample size 100,000 genomes completely sequenced  – PM is at present in Oncology – use Genetics to discover diagnostics markers, clinical diagnosis, protocols – worst in cancer
  • genetic effect are important component requires big cohort to identify large effect
  • dysfunctional variant
  • Proteomic predictors, in drug discovery not sufficient, marker of disease  it is helpful

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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1:45PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

1:45 p.m. Panel Discussion – Oncology

Oncology

There has been a remarkable transformation in our understanding of the molecular genetic basis of cancer and its treatment during the past decade or so. In depth genetic and genomic analysis of cancers has revealed that each cancer type can be sub-classified into many groups based on the genetic profiles and this information can be used to develop new targeted therapies and treatment options for cancer patients. This panel will explore the technologies that are facilitating our understanding of cancer, and how this information is being used in novel approaches for clinical development and treatment.

Oncology

Opening Speaker & Moderator:

Lynda Chin, M.D.
Department Chair, Department of Genomic Medicine
MD Anderson Cancer Center     @MDAnderson   #endcancer

  • Who pays for personalized medicine?
  • potential of Big data, analytics, Expert systems, so not each MD needs to see all cases, Profile disease to get same treatment
  • business model: IP, Discovery, sharing, ownership — yet accelerate therapy
  • security of healthcare data
  • segmentation of patient population
  • management of data and tracking innovations
  • platforms to be shared for innovations
  • study to be longitudinal,
  • How do we reconcile course of disease with personalized therapy
  • phenotyping the disease vs a Patient in wait for cure/treatment

Panelists:

Roy Herbst, M.D., Ph.D.    @DrRoyHerbstYale

Ensign Professor of Medicine and Professor of Pharmacology;
Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital     @YaleCancer

Development new drugs to match patient, disease and drug – finding the right patient for the right Clinical Trial

  • match patient to drugs
  • partnerships: out of 100 screened patients, 10 had the gene, 5 were able to attend the trial — without the biomarker — all 100 patients would participate for the WRONG drug for them (except the 5)
  • patients wants to participate in trials next to home NOT to have to travel — now it is in the protocol
  • Annotated Databases – clinical Trial informed consent – adaptive design of Clinical Trial vs protocol
  • even Academic MD can’t read the reports on Genomics
  • patients are treated in the community — more training to MDs
  • Five companies collaborating – comparison of 6 drugs in the same class
  • if drug exist and you have the patient — you must apply personalized therapy

 

Lincoln Nadauld, M.D., Ph.D.
Director, Cancer Genomics, Huntsman Intermountain Cancer Clinic @lnadauld @intermountain

  • @Stanford, all patients get Tumor profiles Genomic results, interpretation – deliver personalized therapy
  • Outcomes from Genomics based therapies
  • Is survival superior
  • Targeted treatment – Health economic impact is cost lower or not for same outcome???
  • genomic profiling of tumors: Genomic information changes outcome – adverse events lower
  • Path ways and personalized medicine based on Genomics — integration not yet been worked out

Question by Moderator: Data Management

  • Platform development, clinical knowledge system,
  • build consortium of institutions to share big data – identify all patients with same profile

 

 

 

 

See more at  http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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1:15PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

1:15 p.m. – Keynote Speaker – International Genetics Health and Disease

International Genetics Health and Disease

The principles of personalized medicine and how they affect the lives of people acknowledge no national boundaries. Although there are some differences among the diverse populations around the world in terms of their genetic variation, the general principles of personalized medicine apply uniformly across many populations. Dr. Periz will discuss how personalized medicine is viewed across the many European countries with particular emphasis on how Spain is implementing it into its medical care.

Keynote Speaker

Antonio L. Andreu Periz, M.D.
Director, Instituto de Salud Carlos III, Madrid

@insalud_es  @CIBER-BBN

Governmental & Public Health National Organization like a combination of CDC and “Hybrid NIH in the US”

Personalized Medicine (PM) in Europe

Europe and Spain — PM is changing Medical Practice, regulations standard of care.

 

In Europe 28 National systems in Spain alone 17 systems

Implementation of PM in Europe: Hospitals, Regulation,

  • develop proof of concept
  • identify mechanisms
  • bring basic research to clinical
  • incorporation into a Portfolio of policies on PM

Horizon 2020 in EU – 2016 launch action on PM in various countries in EU

  • Translational level for all EC members
  • Coalition of 28 Research Centers in Europe to promote PM
  • Sharing Databases, Data on HC, infrastructure for Translational research
  • OMICS
  • Biomarkers
  • clinical trials

CSA – Coordination Support Action

  • PerMed 500,000 Euro for 5 years, 9 operating partners, representatives of Ministry of Health, Israel and Canada Ministry of Health are included
  • Research Agenda for PM in Europe – SWOT Analysis
  • Recommendations for UC to start PM in 2016
  • – basic research
  • – translation
  • – ICTs
  • – Regulatory

SPAIN – Initiatives on PM: Aggregation of Knowledge

  • One single organization collaborates with 22 Institutions on Biomedical research – Concentration in Barcelona and in Madrid
  • Projects of Excellence: PhD level Projects – Clinical Practice: Imaging, Endocrinology, genomics, cardiology
  • 2014 — 35 Applicants – not all are on Cancer 25% are in Cancer 75% are in other clinical Fields
  • 12Million Euros will fund 1/4 of the applicants
  • PhD Thesis on PM – common project 2 yr governmental institute and 2 years in biotech industry

EAPM – Europe Alliance for PM

  • raise awareness on HOW PM CAN SHAPE Healthcare in Europe: Diagnosis, Treatment,
  • Specialized Treatment for Europe’s Patient (STEPs) – Five Steps

Global alliances to shape Medical Practice based on PM – Collaboration Industry and Academia

  • PMC in the US (Personalized Medical Coalition)
  • PerMEd in Europe (coalition  in Europe  supporting innovation in personalized medicine)
  • EAPM (European Alliance for Personalized Medicine)

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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11:30AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:30 Personalized Medicine Coalition Award &  Award Recipient Speech

Presentation of Personalized Medicine Coalition’s 10th Annual Award for Leadership in Personalized Medicine.

Personalized Medicine Coalition Award Recipient

Mark J. Levin
Co-Founder and Partner
Third Rock Ventures, LLC

Presenter:

Brian Munroe
PMC Founder and Senior Vice President, Government Affairs
Endo

 Award in Science, Business Policy to individual to lead PM – Mark Levin

 

 

  • was at Ely Lilly in the 70s leading supplier of Insulin in the 20s and antibiotics in the 30s,Factor 8, pain drugs, chemotherapy
  • was at Genentech – Human growth Hormone and Human Insulin — both are PM, Interferon,
  • was at Mayfield Ventures
  • was at Millenium, CEO, early 90s, monoclonal antibodies
  • 2000 discussion on the need for PMC
  • Founder of Foundation Medicine – molecular informatics – expands therapeutics and PM
  • NOW — with Third Rock Ventures, LLC

 

Mark Levin – award acceptance speech – Team accomplishments most important

We need to thank the patients participating in Clinical Trials

  1. How I got involved in personalized medicine (PM): High School – Human Biology
  2. Genetics – drive
  3. PM – All diseases – genetic disorders — combination with extreme phenotyping, Muscular Dystrophy – splicing a gene for treatment
  4. Drugability and PM – gene therapy, replace factor, deliver a gene to the brain and the drug. inside CSF
  5. Gene editing – deliver to the Brain correct the gene in the Brain – therapy for ALS, Schizophrenia – understanding the genes involved in this disease, same
  6. Cancer cure – treatment of combination therapies several at the same time vs present time treat one other emerges
  7. cancer vaccine
  8. Sample of blood – proteomics — in Annual Exams at MDs Annual physical
  9. Convergent — comparison of Mutation across to 1000 patient’s mutations
  10. Future is MOST exciting
  11. Challenges of the Future: Biology and Technology, cells in microbiome, 10 million genes, SYSTEM BIOLOGY — will lead the way,
  12. FUNDING SCIENCE via NIH Scientist is the most important National task
  13. Preventative and Prognostics Medicine -need be part of DRUG development
  14. Justification – maximize value for patient vs $$ spent – maximum value – waste and no leadership
  15. Concern — Affordability of Healthcare to All, access to care vs economic Inequality
  16. Leadership and Management: We truly need NATIONAL CONVERSATION — with a Leader with set of goals to solve a problem in certain time
  17. Insurance, Pharma, HMO — budget challenge — attendees inn the room, need to provide leadership at the National Level

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

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11:00AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:00 Keynote Speaker – Past, Present and Future of Personalized Medicine

Past, Present and Future of Personalized Medicine

Keynote Speaker

Mirella Marlow, M.A., M.B.A.
Programme Director, Centre for Health Technology Evaluation,
National Institute for Health and Clinical Excellence (NICE) @NICEcomms

PM in the UK

Clinical evidence and cost effectiveness needed for PM

UK Government life sciences policy

Scale of PM:

2013 – 10 million pound

2020 – 60 million pound

Innovative healthcare to promote economic growth

  • Genomics England 100,000  – new scientific discovery and kick start the UK genomics industry
  • BIS – accelerate Skills & Training for the Genomics Industries
  • UK Precision Medicine Catapult development of tests and commercialization of innovation in diagnostics

1 Billion Pound NIHR in UK

  • tissue banks – Biobank
  • Farr Institute – “big data”
  • develop methodologies for starter research

National Institute Care Excellence

– standards for NP

Benefits of PM

  • right treatment
  • responding subgroups
  • earlier treatments
  • dosing
  • reduce side effects

Companion Diagnostics in NICE – Technology Appraisals

  • elevate a test like evaluate a drug ad part of Diagnostics
  • Treatment: GIST — >>Biomarker: KitCD117

Diagnostics assessment Program

  • 9 EGFR-TK – mutation testing –
  • Mutation Analysis Services

NICE support to Companies – Company engagement

  • discuss product pipeline and value proposition
  • orientation to the process
  • Scientific Advice on Clinical Trial Design
  • workshops for Pharma and for Diagnostics — are different
  • online tool being developed – standardize the Advise for Fee — get Accredited Advisors in the Fields of Genomics, Diagnostics
  • Post guidance – evidence gaps, clinical utility and economic evidence
  • Update guidance – research questions guiding Guidance for the industry
  • Indirect Research facilitation: protocol external funding identify clinical context ethics +GCP leading to Publication within 2 years

UK and Genetics: Kirk and Watson on DNA

UK – 60 million patients under one National Universal Health Care System

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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#PMConf

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