Leaders in Pharmaceutical Business Intelligence (LPBI) Group

11/18/2015 8:30 a.m. – Keynote Address: Kathy Hudson, Ph.D. NIH – 11th Annual Personalized Medicine Conference, November 18-19, 2015, Harvard Medical School

 

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Aviva Lev-Ari, PhD, RN

Director & Founder, Leaders in Pharmaceutical Business Intelligence, Boston

Co-Founder, GDE

 

8:30 a.m. – Keynote Address

The Impact of Precision Medicine on the Future of Healthcare

• DIFFERENCES among individuals: GENES, LIFESTYLE, ENVIRONMENT
• MUST look beyond the Genome: diet, environment, behavior

FNIH Survey of Public Opinion on large US Cohort – 79% agree cohort probably need be done

54% participate in the Cohort

Participants as “Partners” not as “Subjects”

2015: President Obama launched $215 Million in the PMI for the NIH

• PMI Cohort $130
• PMI for Oncology $70
• FDA $10
• Health IT $5

PMI Working Group – 20 members

• Partners
• Harvard Pilgrims
• GE
• Intel

Assembling the PMI Cohort

• Recruitment denovo
• Lonngitudinal Cohort
• One Million Volumteers

1. Direct volunteer – any one can sign up
2. Healthcare provider Organizations

• Initial Core Data Set
• Policy for PMI Cohort Program

1. IRB – Single Institutional Review Boards
2. Privacy and Security
3. Share results Clarify CLIA and HIPPA

• Information Flow In
• Participants will receive: Individual Data, individual Health Information, Ongoing study updates Aggregate results

• Required single institutional
• PMI Cohort Program Governance

1. Program director
2. executive committee
3. steering v=committiee with 5 sub committiees

• data
• biobank
• resource access

IMPLEMENTATION

• underserved communities
• start with Volunteer ONLINE enrollement not with HC Provider Organizations

ANNOUNCMENT Four Funding Announcement for Cooperative Agreement

• Transaction Award Announcements
• National Search Outstanding Scientist to LEAD the PMI Cohort Program
• Appointment committee members
• Synch-4-Science Pilot

QUESTIONS from the AUDIENCE

• Q – Direct Volunteer Program – 1 Million  Volunteer
• A – Pilot launched
• Q – Consumers of Health Care
• A –

9:00 a.m. – Panel Discussion

Investments in Personalized Medicine

During the past several years there have been increased levels of financial investments in fields related to Personalized Medicine. The new initiative on Precision Medicine by President Obama is also fueling discussions about new types of investments. This panel will explore the reasons for interest in investing in Personalized Medicine products and how both large and small companies are developing programs to expand their interest in this area.

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.O4Znb9kq.dpuf

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8:30 AM	Special Guest Keynote Speaker Kathy Hudson, Ph.D. Deputy Director for Science, Outreach and Policy National Institutes of Health	#NIH #AER15 #personalizedmedicine #pharma #healthcare #PublicHealth #HealthPolicy #clinicaltrial	@KathyHudsonNIH @nihdirector
9:00 AM	9:00 a.m. – Panel Discussion Investments in Personalized Medicine Sue Siegel CEO, GEVentures & healthymagination Sean George, Ph.D. President, COO, and Co-Founder, Invitae Mark Levin Partner, Third Rock Venture Kimberly Popovits Chairman of the Board, CEO and President, Genomic Health	#personalizedmedicine #GeneticTesting #venturecapital #startups #startup   #biotech #biopharma	@_SueSiegel @GE_Ventures @Invitae @GenomicHealth @VCapitalGuide @MassBio @MALifeSciences @FierceBiotech