https://Isuggest.partners.org Department Representatives: We want - - PowerPoint PPT Presentation

Department Representatives:

We want YOUR suggestions! https://Isuggest.partners.org

90 Day Challenge Update

• We challenged the Department Representatives

to submit ONE suggestion each within the next 90 Days.

• Out of 54 Department Reps, a total of seven

suggestions have been submitted, by four unique representatives.

• The 90 Day Challenge started on Monday,

December 6, 2016. There are 27 days left to submit!

https://Isuggest.partners.org

For questions or program registration, email orcd@partners.org

MGH Research Council February 6, 2017 Responsibilities of Peer Reviewers

Office for Research Career Development: RCR Series

Thursday, February 9, 2017, 10:00 – 11:00 am Speakers: Dennis Brown, PhD & Hensin Tsao, MD, PhD

Lessons Learned: How to Write a Fellowship Application

Graduate Student Division: Career Advancement Series

Thursday, February 16 and Thursday March 16, 2017, 12:00 - 1:00 pm Speakers: Kristen K. Ellard, PhD & Tina Chou, MA, PhD student

Expanding from Basic to Translational Research

Office for Research Career Development: Career Advancement Series

Tuesday, February 28, 2017, 12:00 – 1:00 pm Panelists: Sylvie Breton, PhD, Mason Freeman, MD & Korkut Uygun, PhD

Managing Difficult Conversations

Center for Faculty Development: Negotiation Series

Monday, March 6, 2017, 12:00 – 3:00 pm Speaker: Gillien Todd, JD

For questions or program registration, email orcd@partners.org

MGH Research Council February 6, 2017

Research Fellow Poster Celebration

Thursday, May 18, 2017 Call for Abstracts opens this week!

Career Pathways for Postdocs Internships

April – June, 2017, short-term, part-time internships to explore careers away from the lab bench Call for Applications opens this week!

Opportunities for Postdoctoral Research Fellows

Suggestion of the Month

Suggestion: The floors in Simches building are in rough shape. I understand the lab areas need to be scheduled but the main halls used to be done on a regular basis but are never done and managers are never around to talk to. Trash is all over the floor and never picked up. Red bins are stacked in hallways instead of the back elevator area. This is becoming a safety concern. I suggest that whoever reads this takes a walk

• ver to have a look. The 3rd floor is the only

floor that gets done daily. Impact: The director of Environmental Services met with Research Administration to discuss the situation in Simches. Several measures were agreed upon to improve the cleanliness in Simches including weekly meetings with the ES manager. In addition, Environmental Services provided a “Text for Service” number for any issues that need to be immediately addressed. You will also receive a text back when the issue has been addressed.

Christopher Kelleher Center for Computational and Integrative Biology

2/6/2017

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Environmental Services Text Messaging System

See a spill or anything needing cleaning? TEXT: 617-596-8554 Please include the location, and a description of what needs to be done. Environmental Services will dispatch someone and text you back once the work is completed!

Electronic Laboratory Notebook – LabArchives

Website: https://rc.partners.org/eln Support: edcsupport@partners.org LabArchives is a web-based application designed for scientists to organize and share laboratory data within their study team, department, or external collaborators. Enhance your labs workflow and control your intellectual property while being able to access your lab notebooks from the bench, office or on the road. October 1, 2016: Enterprise Research Infrastructure & Services, ERIS, offers LabArchives at no cost to all researchers.

Mobile App

used in the lab to take pictures & document work

What is LabArchives?

• A secure

re, cloud-based (AWS Hosted Solution) collabo aborative ative platform for laboratory researchers, lab instructors, and students to organize, document, store, protect, share, collaborate, and publish their research and data.

• A “living repository” – combines the features of collabor

laboration tion software, are, wikis, s, search h engine nes, s, data stor

• rag

age, e, publi lishing shing and workf kflow low software.

• Web-based - Use from any comput

puter er or mobil ile device; Mobile App

• Advant

vantag ages es over r Pa Paper er Lab Noteboo books ks

– Reduce lost / misplaced / overwritten Data – Typed vs Handwritten (illegible) Data – Ease in sharing / collaboration – Transparency of laboratory staff entries – Auditing with standard date/time stamps – Search capabilities

Accessing LabArchives with Partners Username

https://rc.partners.org/eln http://www.labarchives.com/ >Sign In Select “Partners HealthCare”

Future End-User Engagement Plans

User Group Sessions (With Coffee & Snacks!!): FEB, MAY/JUN, SEP Engage ELN Discussion Group – Subscribe

http://researchlistweb.partners.org/list/w/eln/subscribe_eln.aspx

Partners Research Notebook – Knowledge Share ERIS / LabArchives Collaborations:

• Automate User access to Partners Research Notebook
• Explore LabArchives API Info
• LabArchives end-users customer service

Support Resources available:

• http://labarchives.kayako.com
• support@labarchives.com
• 30 minute response times during office hours

Support Model

ERIS supports compliance and security for institution Partners Related Questions: edcsupport@partners.org

Research Technical Lunch

Meets monthly with a break in July & August

• Interested in understanding new services,

directions and strategies from Partners technical teams?

• Are you looking for an opportunity to interact

with Partners IS and colleagues to ask questions and express concerns?

Website: rc.partners.org/events/techlunch Contact: rcc@partners.org

• ”The Anatomy of a Breach, ” Esmond Kane
• “The IS Infrastructure Process Modernization Program,” Ruth

Lawlor, Team Lead TSO

• “The Partners Biobank Portal,” Victor Castro, RISC
• “Container Technology using RedHat OpenShift and Docker, ”

MGH Lab of Computer Science + TSO

• “Office 365 Deployment at Partners,” Jim Marra, ISS
• “GitLab,” Dimo Dimitrov, ERIS
• ”Partners Research IT at the Crossroads,” Anne Klibanski

Past and Upcoming Topics:

March 2, 2017 Speakers

Rich Bertone

Account Technology Strategist

Srini Armbati

Cloud Solution Architect

Microsoft

Allan Harris

ERIS Cloud Architect

Partners HealthCare Noon - 2p.m. Lunch served at the Pru or join via WebEx

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Scientific Computing

ERISOne Linux Cluster Training

These courses are designed to familiarize researchers with the Linux OS and learn how to work on the ERISOne Linux Cluster. ERISOne is a computing cluster used for data processing and analysis. Each hands-on course has limited space, and registration is required. Visit rc.partners.org/events to register

Location: Assembly Row Training Room, Somerville Intro to the ERISOne Linux Cluster

Thursday, March 23 from 3– 5p.m.

Intermediate ERISOne Linux Cluster

Thursday, April 6 from 3– 5p.m.

IDEA 101 Training

Now available to early adopters of the Integrated Data Environment for Analytics (IDEA) Platform.

rc.partners.org/idea

Clinical Trials Registration and Results Reporting Requirements

MGH - ECOR 2/6/17

PHS QI Program

Sarah White Emily Ouellette Isabel Chico Calero

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• New Requirements

– 42 CFR Part 11 (HHS Final Rule)

• Regulations expands requirements under federal law FDAAA

– NIH Policy: Dissemination of NIH-funded Clinical Trial Information

• NIH policy applies to all new application and proposals submitted

after 1/18

• Important Dates

– Published: 9/16/16 – Effective date: 1/18/17 Final Rule - compliance date April 18, 2017

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Highlights of New Requirements

• Increase in the scope of trials that must register and

report results

– Final Rule expands results reporting to trials with unapproved products – NIH Policy requires registration for all “clinical trials” funded in part of whole by NIH

• NIH Clinical Trial definition: a research studyin which one or more

human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes

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Highlights of Final Rule

• Clarification of Applicable Clinical Trial definition

– Clarification of ‘controlled’ – all intervention studies with pre- specified outcome measures – Includes additional data elements to clarify primary purpose of trial

• Clarification of Secondary Outcome Measure

– “…outcome measure that is of lesser importance than a primary

• utcome measure” but that is included in the statistical analysis

plan for evaluating the effect of a studied intervention. – Results due: 1 year after final subject examined or receives intervention for the purpose of final collection of data for that secondary outcome measure…

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Highlights of Final Rule

• Additional data elements such as:

– Baseline Characteristics: Race and ethnicity (if recorded) required – AE Module: Table of number and frequency of all cause mortality; timeframe and method for AE collection

• New uploading requirement

– A copy of the protocol & statistical analysis plan will be required at same time as results posting

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Highlights of Final Rule

Changes re: ClinicalTrials.gov QA Review Process

• ClinicalTrials.gov did not post any submitted information that did

not fulfill its quality-control review criteria.

• Under Final Rule:

– ClinicalTrials.gov will post all submitted information on the public database no later than 30 days after receipt even if there are

• utstanding quality issues;

– Information will be posted publically with a disclaimer that information posted does not meet the quality control review criteria; – When QA Comments are provided, RP will have 15 days to correct registration records and 25 days to correct results information.

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Which Requirements Apply?

Final Rule vs. Statute

• Registration information determined by Study Start Date

– Start date on or after 1/18/17: Final Rule – Start date before 1/18/17: Statute/FDAAA, Sec 801

• Results information determined by Primary Completion Date

– Primary completion date on or after 1/18/17: Final Rule – Primary completion date before 1/18/17: Statute/FDAAA, Sec 801

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Updates re: Consequences of Non-compliance

Final Rule*:

– Identifying non-compliant records on ClinicalTrials.gov – Withholding of NIH funds – Monetary fines: $11,383/day/infraction

NIH Policy:

– Identifying non-compliant records on ClinicalTrials.gov – Suspension or termination of grant funding – Withhold future funding

*HHS has always has the authority to levy monetary fines under FDAAA, this is unchanged.

Further details on next slides

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Update FDA’s Role: Compliance with 42 CFR Part 11

• Compliance/enforcement incorporated into FDA’s Bioresearch

Monitoring Program (BIMO);

• FDA plans to investigate/enforce on a case by case basis:

– Analysis of public/non-public data

• FDA/NIH will ensure compliance/enforcement activities are

coordinated.

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Updates re: Consequences of Non-compliance

Final Rule*:

– Identifying non-compliant records on ClinicalTrials.gov – Withholding of NIH funds – Monetary fines: $11,383/day/infraction

NIH Policy:

– Identifying non-compliant records on ClinicalTrials.gov – Suspension or termination of grant funding – Withhold future funding

*HHS has always has the authority to levy monetary fines under FDAAA, this is unchanged.

Further details on next slides

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NIH’s Role: Compliance with 42 CFR Part 11

• NIH will require dissemination plans (compliance with

ClinicalTrials.gov registration and/or reporting requirements) in all new applications and proposals submitted after 1/18/17.

• NIH will require certification of the grantee institution’s

ClinicalTrials.gov compliance in new applications/proposals and annual Progress Reports of existing awards subject to the new policy.

• NIH will not release funding for any new clinical research

awards or continuing awards if the grantee institution is not compliant with its ClinicalTrials.gov obligation.

• NIH will notify institutions of non-compliance.

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NIH policy sample language

Disclaimer announced PHS wide on 12/20/16:

• This is suggested language to include in NIH grant applications.

There is no one-size fits all dissemination plan, this can be considered an

• utline what the PI and/or study staff should do at a minimum.

Dissemination of study results through ClinicalTrials.gov registration and reporting at a minimum will include the following components:

• X (insert name or role, can be a designee) will be responsible for

handling ClinicalTrials.gov requirements for this project under the PI’s oversight. S/he will register the trial prior to enrolling the first

• subject. Once a record is established, s/he will confirm accuracy of

record content; resolve problems; and maintain records including content update and modifications. S/he will also be responsible for aggregate results reporting and AE reporting at the conclusion of the project.

• Add specifics related to this trial.

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Activity Update

Managing the backlog

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Managing the Backlog: Resources

External Resources (temporary):

• Hired per diem MGH Biostatistician for 8 week period.

– For studies that have not analyzed data – Respond to tricky CTgov QA comments

• Hired external Clinical Trials Disclosure vendor - Xogene

– For studies that have analyzed data and/or manuscript

Continued QI Support:

• QI Program consults via WebEx

– Conducted by Isabel Chico Calero – Assistance with any aspect of results reporting

• Email & telephone assistance = TMTC

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Managing the Backlog: Investigators

Areas that we are currently identifying best resources for:

• Investigators who said they would complete results data entry
• n their own in Nov 2016…and haven’t to date
• Investigators that are non-responsive
• Investigators that are no longer at MGH

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Status of Late Results at MGH per FDAAA

As of 2/3/17

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CT.gov: 02/03/17

Total # studies late for results per FDAAA

• As of 10/1/16, including studies that will require results by

4/18/17

156 Records published to ClinicalTrials.gov public website – NO further action

• Identified late for results on 10/25/16

41 Late Results per FDAAA:

• Currently under CTgov review

53 Late Results per FDAAA:

• Data entry not complete or not started

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17 20 40 60 80 100 120 140 160 180 2016 1/1/2017 1/11/2017 2/2/2017

Number of Records Time

Metrics ClinicalTrials.gov Records at MGH

• Released. No further action

Under CT.gov Review Out of compliance Potentially out of compliance

Challenges:

• Lack of awareness/no experience with ClinicalTrials.gov
• Not familiar with ClinicalTrials.gov interface
• It’s released, but it’s not done; re-engaging Investigators with

ClinicalTrials.gov QA comments

• Accurately reflecting the protocol and research in CTgov

database

• ‘Gaming the system’ - inappropriately changing the primary

completion/end date

• No data for the study

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Education

• MGH

– SRAG: 12/7/16 – Clinical Research Council: 12/13/16 – DCR: 1/5/17 – RADG: 1/10/16 – ECOR: 2/6/17

• BWH

– BRISC: 12/8/16 – CCI: 12/20/16

• McLean

– Town Hall: 11/30/16 – General presentation: 1/9/16 – Research Committee Meeting 2/1/17

• SRH - TBD

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Implementing systems for prospective compliance

• Systems in place:

– Updates to QI website, including FAQs – Revised eIRB module to trigger registration – Revised CTgov Delegation of Responsibility letter – Consent forms for new NIH studies to include ClinicalTrials.gov information – Collaboration with PHS Pre-Award team (ongoing)

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Future Enhancements

We have LOTS of ideas and will get there!

• Including ClinicalTrials.gov into research process

– Budgets – Outcome measures – Data collection

• Tools to help with:

– Uploading protocol – standard coversheet and redaction method – Adverse events – Baseline characteristics/participant flow

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Increasing Your Visibility with Industry and Beyond

Gabriela Apiou, PhD MGH Research Council February 6th, 2017

Strategic Alliance Microbiome Program

Mass General Research Institute

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Strategic Alliance Microbiome Program

Promoting Your Science

Marketing Development Strategic Alliance

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Strategic Alliance Microbiome Program

Portfolio Development: Goal

• Build common understanding of the ongoing research at

MGH

• Comprehensive scientific foundation
• Give our investigators visibility
• Internal:

MGH leadership MGH Development Office Partners HealthCare Innovation Each other

• External:

Commercial partners Academic research institutions Philanthropic sources Foundations General public

4

Strategic Alliance Microbiome Program

Portfolio Development: Portfolio Definition

A collection of creative works that can be shown to potential customers

(general public, philanthropy, industry)

A living document !

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Strategic Alliance Microbiome Program

Portfolio Development: Portfolio Content

One paragraph pitch

• Containing the essence of the clinical

and/or scientific problem to solve

One page outline

• Non-confidential
• Stating the problem and the need for a

solution

• Describes the key specific aims (1 to 3)

and their significance

• Includes one figure

From Each Lab at MGH !

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Strategic Alliance Microbiome Program

Strategic Alliance: Mission Help scientists at Mass General to engage in more productive collaborations with industry at ALL stages of their work

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• The Research Institute is taking a systematic

approach towards unmet needs in major as well as rare diseases to create both long term and near term commercial opportunities.

• MGH has world-class fundamental research

and clinical capabilities. The Strategic Alliance initiative is focusing on collaborative innovation across this broad scientific/clinical spectrum.

Our Message to Industry:

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Strategic Alliance Microbiome Program Strategic Alliance: Implementation Plan

• Portfolio Development
• Strategic Alliance Programs
• Translational Research

Training Program

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Departments Centers Labs Mass General Research Institute INDUSTRY Partners Innovation Market Sectors RESEARCH PORTFOLIO RIAC Strategic Alliance

Strategic Alliance Microbiome Program

How it Works

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Strategic Alliance Committee, Outside Members Jean-François Formela, MD, Atlas Venture Robert I. Tepper, MD, Third Rock Ventures Rajiv Kaul, Fidelity Investments Deborah Dunsire, MD, Southern Cross Biotech Consulting Ansbert Gadicke, MD, MPM Capital Michael Rosenblatt, MD, Flagship Pioneering George A. Scangos, PhD, Biogen Mason Tenaglia, IMS Health

Research Plan

Research Plan: MGH Investigators, MGH Research Institute, Translational and Clinical Research Center (TCRC), Division of Clinical Research (DCR), Partners HealthCare Innovation, RIAC-SA

Business Plan

Business Plan: MGH Investigators, MGH Research Institute, Translational and Clinical Research Center (TCRC), Division of Clinical Research (DCR), Partners HealthCare Innovation, RIAC-SA

Translation Plan

Translation Plan: MGH Investigators, MGH Research Institute, Translational and Clinical Research Center (TCRC), Division of Clinical Research (DCR), Partners HealthCare Innovation, RIAC-SA

Research Market Regulatory Economics Intellectual Property

Strategic Alliance Microbiome Program

A Team Approach

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Since Aug 2015

• 21 Departments and 7 Research Centers provided 71 “themes”
• 74 outlines collected representing 66 scientists from 15 departments/

centers

• Launched the portfolio wrap-up sessions in collaboration with MGH

Development Office and Partners HealthCare Innovation Office: Four sessions organized: 16 scientists presented from 8 departments/ centers

Strategic Alliance Epigenetics Program Strategic Alliance Microbiome Program

Portfolio Development: Status

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Increase your visibility at MGH by helping us build our research portfolio!

Strategic Alliance Microbiome Program

Strategic Alliance Programs: Status

Since Aug 2015

• 4 Strategic Alliance programs developed on

Epigenetics, Cancer Immunotherapy, Neuroinflammation in Neurodegeneration and Microbiome

• The 4 programs brought together 61 investigators

from 12 Department/Thematic Centers

• Organized 4 Program Review Sessions with Advisory

Council Strategic Alliance Committee, and 2 Industry Focus Sessions with pharma representatives

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Strategic Alliance Epigenetics Program

MGH Disease Epigenetics

Brain tumors

Batchelor, Louis, Nahed, Suva, Wakimoto

Lymphoma/Leukemia

Hochberg, Graubert, Ryan, Nardi, Sohani

Multiple Solid Tumors

Bernstein, Fisher, Mostoslavsky, Whetstine

Molecular Profiling

Epigenome, transcriptome, diagnostics Bernstein, Iafrate

Molecular Mechanism

Chromatin/RNA biology Kingston, Lee

Therapeutics

Epigenetic drugs, combination therapy, precision medicine Benes, Flaherty, Joung, Mazitscheck

Computation/Integration

Circuits, drivers, dependencies Aryee, Getz

Neurodegeneration

Haggerty, MacDonald

Psychiatry

Daly, Haggerty, Perlis

Autoimmunity

Daly, Hacohen

Cancer Biology

Mutations, Heterogeneity Fisher, Mostoslavsky, Whetstine

Inflammation

Shaw, Xavier

Strategic Alliance Microbiome Program Strategic Alliance Epigenetics Program

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Conditionally Active Bispecifics

Cobbold

Immune cell interactions

Luster, Mempel, Lee, Hacohen

Systemic effects of cancer on immunity

Pittet

Therapy with other radiation sources

Manstein, Fisher

Antigens and vaccines

Cobbold, Hacohen

Myeloid cells in tumor immunity

Pittet, Luster, Hacohen

Innate immune detection of tumors

Hacohen

Early immune response to cancer

Demehri, Lee

Adoptive Cellular Therapy and CAR-T

Maus

CPB mechanisms in mice and humans

Hacohen, Pittet

Predictors

Higgins, Tsao, Hacohen Sullivan, Termeer Center

UV induction of melanoma and immunity

Tsao

Migration of T cells into tumors

Luster, Mempel, Pittet

CPB Clinical Trials

Lawrence, Sullivan, Gainor, Flaherty

Strategic Alliance Microbiome Program

Strategic Alliance Cancer Immunotherapy Program

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HSPC leukocytes

Cell Biology

Tanzi, Hyman, Swirski, Nahrendorf, Griciuc, Maguire

Peripheral Biomarkers

Ayata, Toner, Evans, Gomez-Isla

Imaging

Mainero, Atassi, Klawiter, Alt, Lin, Chen, Hooker, Loggia

Strategic Alliance Microbiome Program

Strategic Alliance Neuroinflammation In Neurodegeneration Program

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Microbiome and Chronic Inflammation

Alessio Fasano, Nitya Jain, Christopher Moran, Wayne Shreffler, Elsie Taveras, Harland Winter, Qian Yuan

The Druggable Microbiome

Ramnik Xavier, Cammie Lesser, Richard Hodin

Microbiome Tools & Capabilities

Gary Tearney, Alessio Fasano, Allan Goldstein, Bryan Hurley

Example 1: Infant/pediatric/prenatal mothers Example 2: Adult IBD Example 3: Imaging & sampling technologies

Strategic Alliance Microbiome Program Strategic Alliance Microbiome Program

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ACADEMIA Development Transfer Proof

• f Concept

MARKET PATIENT CARE Early Discovery

Strategic Alliance Microbiome Program Translational Research Training Program

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• 1. Translational Research Strategy and Tactics
• 2. Translational Research Project

Strategic Alliance Microbiome Program

Goals for 2017

• Continue to build the research portfolio by working with

Departments and Centers; continue our Research Portfolio Wrap Sessions – put investigators in front of Leadership/Development/Innovation

• Continue developing Strategic Alliance programs; creating new

programs and continuing developing focus sessions with large pharmaceuticals, biotech, and venture

• Seek funding for translational research training program;

prepare for launch in fall 2017

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GET INVOLVED!

THANK YOU ! QUESTIONS ? SUGGESTIONS ?

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