© 2007 trustees of the university of pennsylvania how to navigate research resources at penn...

© 2007 Trustees of the University of Pennsylvania

How to Navigate Research Resources at Penn

Symposium for Early Investigators

Friday, December 11, 2009

© 2007 Trustees of the University of Pennsylvania

Panelists:

• Emma Meagher, MD, Associate Professor of Medicine

• Kurt Barnhart, MD, Associate Professor of Medicine

• Ian Blair, PhD A. N. Richards Professor of Pharmacology, Scientific Director Proteomics and Systems Biology Facility

• Jim Eberwine, PhD, Elmer Holmes Bobst Professor of Pharmacology 

© 2007 Trustees of the University of Pennsylvania

© 2007 Trustees of the University of Pennsylvania

Provost

Vice Provost for ResearchSteven J. Fluhartyvpr@pobox.upenn.edu

Center for Technology

TransferMike Cleare

mikecleare@ctt.upenn.edu

Environmental Health & Radiation

SafetyMatt Finucane

ehrs@ehrs.upenn.edu

Office of Regulatory

Affairs

Office of Research Services

Pam Caudillcaudill@upenn.edu

University Laboratory Animal

ResourcesDiane Gaertner

gaertner@exchange.upenn.edu

Research Compliance

Joanne Rosenthaljoro@upenn.edu

PA Small Business Development

CenterChristian Conroy

cconroy@wharton.upenn.edu

IndustryRelations

Vice President for Finance & Treasury

Vice President for Development &

Alumni Relations

Intellectual Property,

Protection & Management

Network-wide Center

Management

Environmental Management

Assistant Program

IACUCTroy Hallman

thallman@upenn.edu

IRBYvonne Higgins

yhiggins@upenn.edu

Clinical & Diagnostic

Services

Facilities & Husbandry

Procurement

Training

Industrial Programs,

Biosafety & Environmental

Programs

Radiation Safety

Training

Corporate Contracts

MTAs

PennERA

Pre-AwardPost-Award

Research Operations &

Cash Management

Research Conflict of

Interest

Responsible Conduct of Research

Research Misconduct

Profiler

CorporateDon Bone

donbone@upenn.edu

Foundation

November 2009

UNIVERSITY OF PENNSYLVANIAOFFICE OF THE VICE PROVOST FOR RESEARCH

© 2007 Trustees of the University of Pennsylvania

Collaborations

Basic Research

Clinical Research

Research Plan

Research Plan

IACUC

SampleAnalysis

in mice

in humans

Biomedical Lab

Animal Facilities

External Scientific Adviser and Industry

Biochemistry Core LabResearch Nurse Core

Biostatistics Core

InstitutionalReview Board

CTRC Advisory Council

ITMAT Clinical Trials Unit

Food and Drug Administration (IND)

Bioinformatics CoreCRCU Data Management

Center for Clinical Epidemiology and Biostatistics

Investigational Drug Service

Post-Doctoral Researcher

Collaborators# involved: 60# close contact: 9/60 # ‘day-to-day’ contact: 6/60

Kinetics Modeling and Simulation

Clinical Translational Research Center

Bionutritional Research Core

Physician-Scientist

Administration / Office of Human Research

LC-MS/MS Core

Development of unbiased

markers

© 2007 Trustees of the University of Pennsylvania

Central resourceCentral resource

• http://www.med.upenn.edu/research/faculty/index.shtml

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

How do I get students/post-docs onto training grants?

• Find out what training grants exist in your Dept, Grad Group or area of expertise

• You must nominate your student for the training grant

• Training grants have requirements that must be met

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

What research cores are available to me and how do I access them?

• Abramson Cancer Center Proteomics Core: http://www.penncancer.org/shared_resources.cfm

• Center for Cancer Pharmacology Proteomics Core Facility: http://www.med.upenn.edu/ccp/proteomonics/index.shtml

• Center of Excellence in Environmental Toxicology: http://www.med.upenn.edu/ceet/research.shtml#facility_cores

• Institute for Translational Medicine and Therapeutics: http://www.itmat.upenn.edu/cores.shtml

• Penn Genome Frontiers Institute (PGFI): http://www.genomics.upenn.edu/facilities/core-facilities

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

What statistical support is available to me?

• The Biostatistics and Epidemiology Consulting Center (BECC) provides study design and biostatistical consultation and advice to researchers within the health system on matters related to proposal development.

• http://www.cceb.upenn.edu/services/studydesign.php– Biostatistics Analysis Center (BAC)• Short-term consultations (first visit free)• Newly funded federal, foundation and industry-funded projects • Pilot analysis (with limited funding available for select projects)

(<20 hrs)– Biostatistics Epidemiology Center (BECC)

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

What statistical support is available to me?

• http://www.itmat.upenn.edu/ctrc– Study Design and Biostatistics (SDAB)

ITMAT member CTSA supported investigators planning and analytic services, which include study design, sample size estimation, analysis planning, as well as production of statistical reports and graphical displays.

Adult: Andy Cucchiara, PhD: Email: andy@mail.med.upenn.edu Pediatric: Justine Shults, PhD: Email: jshults@mail.med.upenn.edu

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

What are some of the internal PENN funding opportunities?

• http://www.med.upenn.edu/research/faculty/grantscontracts.shtml

• Internal Funding for Faculty – OVP Limited Applications – Funding Opportunities - Faculty – McCabe – Pilot and Seed Grants (27 seed program)– SOM Bridge Funding Program – Penn's Global Initiatives Fund – Provost Interdisciplinary Seminar Fund

© 2007 Trustees of the University of Pennsylvania

How do you deal with Conflict of Interest issues related to your work and grant submission? 

• Process

• CISC

• Extramural Effort reporting– Honor code

• Deliberative process

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

How do I get a contract approved?

• A contract can be from NIH, a foundation, a public company or a private company

• Contract should be discussed with Dept. Chairman and then ORS. ORS will help negotiate the contract

• All regulatory and COI issues must be appropriately addressed

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

How do I write a budget?

• Key resources important to budget development– A well written protocol

(i.e. not just the science, but also include detailed operational elements)

– Standardized rates for tests/procedures– Your Clinical Research Coordinator– Your departmental Business Administrator– Carefully organized budget spreadsheets

• Additional support– Budget development workshops– Departmental standards– Sign off: Department, ORSS (SOM), OHR (PRA), ORS (Univ)

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

How do I write a budget?

Well-written protocol

Penn Manual for Clinical Research- https://somapps.med.upenn.edu/pennmanual

Protocol Templates (Forms/Templates Library)- Tabbed section of Penn Manual

Standardized rates for tests/procedures

CostFinder- www.med.upenn.edu/apps/my/costfinder

Clinical Research Coordinators (CRC)

Departmental CRCs- CRCs are familiar with the “inner workings” of research

operations, and therefore extremely helpful in budget development

- If you don’t have a CRC for your study, Departmental CRCs are often still able to help you in aspects of budget

development

Business Administrators (BA)

Departmental BAs- Develop a good working relationship with your BA. They

are responsible for finalizing & submitting budgetsOffice of Research Support Services

- www.med.upenn.edu/orss- ORSS has expertise in all aspects of NIH budget

requirements

© 2007 Trustees of the University of Pennsylvania

Clinical and Translational Research CenterClinical and Translational Research Center

• Clinical Space to conduct in pt and out pt studies:

• Research Nursing and support

• Investigational Drug Service

• Biostatistical support prior to submission and upon completion of studies

• Translational Research Laboratory: Centralized facilities for measurements of biomarkers and physiological assessments

• Junior Investigator Pilot Grant (JIPG) Program

• http://www.itmat.upenn.edu/ctrc/index.shtml

© 2007 Trustees of the University of Pennsylvania

Clinical and Translational Research CenterClinical and Translational Research Center

• Clinical research space

• HUP: 1 Dulles inpatient and outpatient

• PMC: Mutch—currently 4th floor outpatient unit

• CHOP: inpatient in Main Bldg, outpatient on Market St

© 2007 Trustees of the University of Pennsylvania

Submission of Protocols to Penn CTRC

• Prepare clinical protocol using OHR or IRB template with adequate justification and detail

• Contact Statistician, Nurse Manager and Administrative Manager prior to submission

• Submit electronically to IRB for IRB-CTRC review

• Protocols reviewed once per month by review committee

• Deadline for submission last business day of every month for review by IRB#3 on the second Thursday of every month

© 2007 Trustees of the University of Pennsylvania

Important CTRC Contacts

• Ronnie Mazzaccaro, MBA Pediatric: BA mazzaccaro@email.chop.edu

• Linda McCrae, BA Adult mccrae@spirit.gcrc.upenn.edu

• Michael McNicholas: Adult Nurse Manager

Michael.McNicholas@uphs.upenn.edu

• Audrey L Kamrin Pediatric Nurse Manager kamrin@email.chop.edu

© 2007 Trustees of the University of Pennsylvania

How do I navigate the IRB?

• http://www.upenn.edu/regulatoryaffairs

• On line application process

• Types of review

• Process

• Key Personal– ziolekt@pobox.upenn.edu– yhiggins@pobox.upenn.edu– mkasimat@pobox.upenn.edu

© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania

How do I apply for an IND/IDE?

Office of Human Research• A SOM & ITMAT office providing an array offerings to support clinical research

www.med.upenn.edu/ohrohr@mail.med.upenn.edu215-746-7400

• OHR IND/IDE regulatory support services– IND/IDE consultations– IND exemption determinations– FDA interface facilitation– IND application development & submission support – Regulatory Master File organization– Monitoring plan development– Training of study monitors (and assistance with subcontracting monitors)– Data Safety & Monitory Board organization & set-up– Sponsor SOP maintenance and training (SOP link: www.med.upenn.edu/ohr/secure/sop)

• More Information, Tools, & Templates– Penn Manual for Clinical Research: text search “IND” or “IDE”– Forms & Templates Library: text search “IND” or “IDE”

© 2007 Trustees of the University of Pennsylvania

Is there help available for grant submission?

• No formalized structure for early career development awards

• Business manager in division will help in guidelines

• Central office of Grants management will help direct specific question– Marianne Achenbach

achenbac@mail.med.upenn.edu

© 2007 Trustees of the University of Pennsylvania

Closing remarks

• The most useful website to which you direct your initial questions

• http://www.med.upenn.edu/research/faculty/index.shtml