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Archive for the ‘Pharmaceutical R&D Informatics’ Category

Addendum to LPBI’s Vision

Curators:

Stephen J Williams, PhD,

Adam Sonnenberg, BSc and

Aviva Lev-Ari, PhD, RN

 

Our Logo

Pharma_BI-background0238

Our Team

Our Open Access Online Journal

http://www.pharmaceuticalIntelligence.com

is a scientific, medical and business, multi-expert authoring environment for information syndication in several domains of Life Sciences, Medicine, Pharmaceutical and Healthcare Industries, BioMedicine, Medical Technologies & Devices. Scientific critical interpretations and original articles are written by PhDs, MDs, MD/PhDs, PharmDs, Technical MBAs as Experts, Authors, Writers (EAWs) on an Equity Sharing basis.

Journal Content Descriptors on 6/29/2015

3,037 Posts

348 Categories of Research

6,948 Tags

676,420 Views – All Times

NIH Clicks 2,571

Nature Clicks 1,542

Our Competencies

  • Deals, Partnerships and Funding for Early Stage Biologics and Medical Devices Start Ups

http://pharmaceuticalintelligence.com/joint-ventures/

  • Scientific Curations in Medicine and Life Sciences

http://www.pharmaceuticalIntelligence.com

  • HealthCare Investor’s Corner

http://pharmaceuticalintelligence.com/options/

  • BioMed e-Series of e-Books

http://pharmaceuticalintelligence.com/biomed-e-books/

  • Scientific Delegations of US Patent Holders

http://pharmaceuticalintelligence.com/options/scientific-delegation/

  • Real Time Coverage of Scientific and Biotech Conferences

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

MultiMedia Presence

@pharma_BI

  • FaceBook Page

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

  • Launchers of a Professional Group on LinkedIn

http://www.linkedin.com/groups?gid=4346921&trk=hb_side_g

  • Company Page on LinkedIn

https://www.linkedin.com/company/9325543?trk=vsrp_companies_res_name&trkInfo=VSRPsearchId%3A875971435604472931%2CVSRPtargetId%3A9325543%2CVSRPcmpt%3Aprimary

social-media-free-vector_23-2147491559

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For more information about our Team please see our site at http://pharmaceuticalintelligence.com/contributors-biographies/

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For more information of LPBI Deals and Partnerships please see our site at http://pharmaceuticalintelligence.com/joint-ventures/

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For more information about our BioMed E-Series please see our site at http://pharmaceuticalintelligence.com/biomed-e-books/

E-Book Titles by LPBI

LPBI book titles slide

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For more information on Real-Time Conference Coverage including a full list of Conferences Covered by LPBI please go to http://pharmaceuticalintelligence.com/press-coverage/

For more information on Real-Time Conference Coverage and a full listing of Conferences Covered by LPBI please go to:

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

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Leaders in Pharmaceutical Intelligence Presentation at The Life Sciences Collaborative

Curator: Stephen J. Williams, Ph.D. Website Analytics: Adam Sonnenberg, BSc Leaders in Pharmaceutical Intelligence presented their ongoing efforts to develop an open-access scientific and medical publishing and curation platform to The Life Science Collaborative, an executive pharmaceutical and biopharma networking group in the Philadelphia/New Jersey area.

Our Team

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For more information on the Vision, Funding Deals and Partnerships please see our site at http://pharmaceuticalintelligence.com/vision/

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For more information about our Team please see our site at http://pharmaceuticalintelligence.com/contributors-biographies/

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For more information of LPBI Deals and Partnerships please see our site at http://pharmaceuticalintelligence.com/joint-ventures/

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For more information about our BioMed E-Series please see our site at http://pharmaceuticalintelligence.com/biomed-e-books/

E-Book Titles by LPBI

LPBI book titles slide Slide8Slide3

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For more information on Real-Time Conference Coverage including a full list of Conferences Covered by LPBI please go to http://pharmaceuticalintelligence.com/press-coverage/

For more information on Real-Time Conference Coverage and a full listing of Conferences Covered by LPBI please go to:

http://pharmaceuticalintelligence.com/press-coverage/ Slide7

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The Pennsylvania (PA) and New Jersey (NJ) Biotech environment had been hit hard by the recession and loss of anchor big pharma companies however as highlighted by our interviews in “The Vibrant Philly Biotech Scene” and other news outlets, additional issues are preventing the PA/NJ area from achieving its full potential (discussions also with LSC)

Slide9Download the PowerPoint slides here: Presentationlsc

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Envisage-Wistar Partnership and Immunacel LLC Presents at PCCI

Reporter: Stephen J. Williams, PhD

The Pharmaceutical Consulting Consortium International (PCCI) June Meeting: Envisage-Wistar Partnership and Immunacel LLC

An early stage healthcare venture creation and management firm

Presenter: Vic Subbu, COO of Immunacel & Managing Partner of Envisage and Heather Steinman, VP of Business Development & Executive Director Tech Transfer Wistar Institute

Monday, June 8, 2015

Embassy Suites, Chesterbrook, Pennsylvania (directions)

Announcement from the PCCI website:

Much has been said lately about how to improve the tech transfer situation. Wistar is meeting this challenge. Immunacel is the first of a series of developmental challenges and the Envisage-Wistar partnership solution becomes the meat of the evening’s discussion.

The Wistar Institute is the nation’s first independent institution devoted to medical research and training. The Wistar Institute has evolved from its beginnings as an anatomical teaching museum to its present-day status as an international leader in basic biomedical research.

Envisage LLC is an early stage healthcare venture creation and management firm. By focusing on key healthcare segments, Envisage aims to identify and advance promising healthcare innovations into value-add ventures.

IMMUNACCEL LLC is a Wistar Institute spin-out focused on accelerating the development of immune-mediated treatments for cancer and other unmet medical needs:

MMUNACCEL’s 3-D cancer-immune cell organotypic culture system is a physiologically relevant culture system utilizing primary human cancer cells and cytotoxic T cells (CTL) generated from patient T-cells, amongst fibroblasts and collagen assembled in a 3-D organotypic model.

Other related articles on PCCI and Philadelphia Biotech were published in this Open Access Online Scientific Journal, include the following:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy

The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC

The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC

The Bioscience Crowdfunding Environment: The Bigger Better VC?

R&D Alliances between Big Pharma and Academic Research Centers: Pharma’s Realization that Internal R&D Groups alone aren’t enough

BIO Partnering: Intersection of Academic and Industry: BIO INTERNATIONAL CONVENTION June 23-26, 2014 | San Diego, CA

Diagnostics and Biomarkers: Novel Genomics Industry Trends vs Present Market Conditions and Historical Scientific Leaders Memoirs

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Pharmacogenetics Testing: Discussion of Industry Experts sponsored by Luminex

Reporter: Aviva Lev-Ari, PhD, RN

 

“Pharmacogenetics: A Discussion with Industry Experts about the State of Affairs and Clinical Application“

SOURCE

http://cdn2.hubspot.net/hubfs/128032/PGx/pharmacogenetics-a-discussion-with-industry-experts-about-the-state-of-affairs-and-clinical-application-luminex-corp.pdf?t=1433269929556

Sponsored by Luminex 

Luminex launched its first test to aid in personalized medicine in 2010. Since that time, Luminex has received Health Canada Approval and U.S. FDA clearance, and CE Mark for its xTAG® CYP2D6 Kit v3 and xTAG® CYP2C19 Kit v3 assays, and is a member of the Personalized Medicine Coalition.

For more information on Luminex’s pharmacogenetic assays, visit: www.luminexcorp.com/CYP2D6 or www.luminexcorp.com/CYP2C19. Learn more about the Personalized Medicine Coalition: www.personalizedmedicinecoalition.org

 

LIST OF EXPERTS

Scott W. Blevins, RPh, MBA; President and COO, GENETWORx: Mr. Blevins has over 20 years of experience in the healthcare industry, with an emphasis in providing consultative services to physicians, including clinical and physician practice management advice. Prior to becoming a healthcare business consultant, Mr. Blevins worked in various segments of the pharmacy industry, which included chain, independent, long-term care facility dispensing and consulting, and Pharmacy Benefit Management (PBM). Mr. Blevins also has a working knowledge of Healthcare Information Technology, Revenue Cycle Management, and Laboratory Services through his ownership interest in “Docs Billing Solutions.” Mr. Blevins is a co-founder of GENETWORx. Mr. Blevins received his Bachelors of Science degree in Pharmacy from the Medical College of Virginia (M.C.V.) School of Pharmacy, and his Master’s in Business Administration degree from the E. Claiborne Robins School of Business at the University of Richmond.

Sarah Jacobs-Helber, PhD, HCLD (ABB); Laboratory Director, GENETWORx: Dr. Jacobs-Helber has over 20 years of clinical and laboratory experience in the field of genetics. She has authored a large number of peer-reviewed papers in the course of her research into the biology and genetics of cancer at both the National Institutes of Health and Virginia Commonwealth University. She has been in the clinical genetic testing area since 2006. She holds board-certification as a High-Complexity Clinical Laboratory Director (HCLD) from the American Board of Bioanalysts and is certified in molecular genetic testing by the State of New York.

Joan Kegerize, MS, JD, CPC; Principal Consultant, GMBI Consulting: Ms. Kegerize specializes in reimbursement and coding strategies, with emphasis in genetic services and diagnostic laboratory molecular pathology procedures. She has extensive experience in molecular diagnostic testing and reimbursement and works closely with manufacturers, laboratories, and industry to direct and implement reimbursement strategies for Medicare, Medicaid, and commercial payers. Ms. Kegerize received her genetic counseling training at the University of Pittsburgh Genetic Counseling Program. She earned her Juris Doctor degree from New York Law School and is admitted to the Bar in the state of New Jersey. Ms. Kegerize obtained certification as a Certified Professional Coder by the American Academy of Professional Coders.

The Panelists SB SJH 5 © 2015 Luminex Corporation. All rights reserved. The trademarks mentioned herein are the property of Luminex or their respective owners.

ANSWERS to the following questions are to be found at

http://cdn2.hubspot.net/hubfs/128032/PGx/pharmacogenetics-a-discussion-with-industry-experts-about-the-state-of-affairs-and-clinical-application-luminex-corp.pdf?t=1433269929556

LIST OF QUESTIONS

  1. Why do laboratories decide to offer pharmacogenetic testing and services in the first place?
  2. What does GENETWORx do to increase utilization of pharmacogenetic testing by physicians and providers?
  3. What are the challenges of pharmacogenetics implementation, and how are different laboratories overcoming these obstacles?
  4. How does using an FDA-cleared assay simplify the implementation process?
  5. How have the changes in reimbursement affected the landscape?
  6. How have changes in reimbursement affected the way laboratories perform?
  7. What is the future of pharmacogenetics testing?

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LIVE Plenary Session 2015 BioIT, April 21, 2015, 4:00 – 5:00PM – Cambridge HealthTech Institute’s 14th Annual Meeting BioIT World – Conference & Expo ’15, April 21 – 23, 2015 @Seaport World Trade Center, Boston, MA, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)

LIVE Plenary Session 2015 BioIT, April 21, 2015, 4:00 – 5:00PM – Cambridge HealthTech Institute’s 14th Annual Meeting BioIT World – Conference & Expo ’15, April 21 – 23, 2015 @Seaport World Trade Center, Boston, MA

Dr. Aviva Lev-Ari will be in attendance on April 21, 22, 23

 

Leaders in Pharmaceutical Business Intelligence (LPBI) are Covering the Event in REALTIME using Social Media

http://pharmaceuticalintelligence.com

#biotech

#investment

@MassBio

@BostonBizJournl

@BioWorld

@BiotechNews

@bioitworld

Tuesday, April 21, 2015 * 4:00 – 5:00 pm

4:00 Event Chairperson’s Opening Remarks

Cindy Crowninshield, RDN, LDN, Senior Conference Director, Cambridge Healthtech Institute

IT and Pharmaceutical 3000 delegates, commitment to support the conversation.

EMC2

4:05 Plenary Session

Introduction

Sanjay Joshi, CTO – Life Sciences, Emerging Technologies Division, EMC

Ten Rules to win a Nobel Prize

  • Negative results vs Positive results
  • Randomized Clinical Trials — the era is OVER
  • Experimental Design: New approaches
  • The Case of Junk DNA: Size does not matter
  • Human Microbiome: Metabolic Reconstruction for Metagenomic Data and its Application to
  • Methylation vs. Mutation: Human Hypomethylation in the Human Germline Associates wiht selective Structural Mutability in the hUman Genome
  • Rare Variants Synthetic Genomic-Wide Association
  • PLOS – most downloaded apper: COrollary 6: “Why most published research findings are false”

4:15 The Vision for Data at the NIH

Philip Bourne

Philip E. Bourne, Ph.D., Associate Director for Data Science (ADDS), National Institutes of Health; Founding Editor in Chief, PLOS

Biomedical research and resultant health outcomes are increasingly defined by how we effectively use an ever increasing amount of digital data. This has become a focus at NIH as part of what we term the digital enterprise. That enterprise is based on community engagement, policies that make sense and a workable infrastructure all of which embraces both the public and private sector, the need to train the next generation of data scientists and is motivated by new research possibilities using data at different scales. Our progress and how this community can engage will be discussed. Biographical Profile

  • DATA and NIH:
  • Ten simple rules to write a Grant
  • Ten simple rules to get published – How to get a Nobel Prize?
  • Digital enterprise – an ecosystem – efficient system to capture outcomes from the multiple projects funded
  • The Second Machine Age by Erik Brynjolfsson @MIT
  • BOLD – DIgitization of Basic and Clinical Research and EMRs:
  1. 6Ds of exponational growth – context of HealthCare: Diception, Disruption, Demonitazation Dematerialization Democratization
  2. SAS Analytics – 3rd Sage Bionetworks Commens Congress: Democratization will follow The Story of Meredith
  3. How DREAM Challenge Recognition Can Help
  4. Embrace Disruptions @NIH
  5. Raise standards for preclinical cancer research – 47/53 “landmark” publications could not be replicated [Begley, Ellis Nature, 483, 2012]
  6. $1 Billion budget of NIH — Research can’t be reproduced/replicate
  7. Precision Medicine Initiative — emerged pn 1/30/2015 President Initiative, Speech.Announcement of 250 million dollars to start Precision Medicine
  8. Francis Colin: Precision Medicine can be bigger than the Human Genome: 1 million volunteers, numerous existing cohorts,  – share genomic data, lifestyle information, biological samples, all linked to their electronic health records
  9. OUTcome Sought after:
  • pharmacogenomics
  • matching conditions wiht therapies derived from the cohort data
  • tiny implentable chips for data collection in vivo.
  • altering drug doses based on data collected from cohort from invivo
  1. data Science: The Big Dadta 2K Program in Central to the Mission: NIIH Data Initiative
  2. Elements of the Digital Enterprise: Policies, COmmunities, Infrastructure: Research Cycle: Sustainability efficiency
  3. NIH – ENIGMA — 12 Centers of Excellence
  • MRI Images & GWAS – 30,000 people – 300 researcher around the World — Translation spectrum is covered
  • Collaboration: Dat acomes fro ENIGMA Consortium
  •  – accessibility to data
  •  – standards for SW developemnt
  • Genotype and Phynotype : Brain
  • Data Discovery Index Coordinstion COnsortium (DDICC)
  • Training awards
  • WOrkshops to inform future funding
  • softward indexing and discoverability — Gaming
  1. COMMUNITIES 2015 Activities: Math, CS, Statistics
  2. IDEAS lab with NSF
  3. Competition with international funders
  4. Softward carprntry, hackathons, PiDay
  5. work without borders: GA4GH, RDA, FORCE11
  6. SOcieties of the Modern Age, How to enable this age
  7. POLICIES
  • Genomics data sharing policies
  • Data sharing plans on all research award not only for >$500,000
  • Data Sharing plans Machine readable on all research awards
  • data sharing plan enformats
  1. Data Citations – Policies
  • PubMed – Machine readable citation allowed, CItation Network – Data Citiation
  • Paper are cited no  one read it — a Reference to  DB
  • work into NLM/NCBI workflow
  • Example formats for human readable data citation
  1. Data Discovery: Software and Data
  2. Standards – Announcing Development standards

ECOSYSTEM – Infrastructure The Commons

  1. Digital Objects (with UIDs)
  2. Search across all objects
  3. Computing platform – Public Cloud Platform, SUper computing, Other Platforms
  4. Business Model – no mapping of supply and demand of the dat as a Resource
  5. Driving Competition – Common Compliance – Data Rich Computing poor, Data poor Computing rich
  6. BROKER concept — aggregate across  users for most efficient use of NIH Funds – Grant run out — continue to measure use of data models if it sits in the common vs atrophy on PI desktop

INFRASTRUCTURE

  1. Training, Collborations, Efficienncy and sustainability
  2. Problem: Lack of Biomedical Data Science Specialists
  3. Career path workshops – NIH Workforcce Development Center
  4. Community -sources cataloging and indexing of training opportunities

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