10:45am - 12:15pm
(A104) Managing Risk: Indemnification,
Subject Injury & Insurance
Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first.

Jennifer A. Hochstrasser, Attorney, The Proctor & Gamble Company

Ronald Polizzi, Associate Director, Contracts, Office of Research Administration,
Thomas Jefferson University

Lorraine Spencer, Attorney,
Smith Moore LLP

10:45am - 11:25am
(B160) Budget Development & Analysis
How do sponsors develop study budgets? How do sites price their services?

Michael T. Cox, Manager, Global Investigator Contracting, Wyeth Research

Angela Fornataro McMahill, Director, Research Compliance Program,
UC San Diego Health Services

11:30am - 12:15pm
(B161) Budget Negotiation
Economic pressures make budget negotiation more
difficult every year.

Nicole Douglas, Sr. Contracts Associate, Genentech

Veronica Legg, Director of Clinical Studies, Fresenius Medical Care, North America

10:45am - 11:25am
(C242) Smart Documents
Intelligent source documents and CDASH
standardization of case report forms.

C. Leith Kelley, Clinical Study Leader, Teva Global
Respiratory Research

Patricia Ames, Clinical Research Project Leader,
Aptium Oncology

11:30am - 12:15pm
(C244) Clinical Trial Management Systems
Live demonstrations of how to streamline your operations with CTMS.

Bruce Schatzman, CEO & Founder, StudyManager

Mike Kamish, VP, R&D Director, Bio-Optronics

10:45am - 11:25am
(D144) Getting Started
Sponsors and sites can work together to produce regulatory packages quickly and efficiently.

Jenna Sallee, Director, Orthopaedic Research
Foundation

Lori Vivian, ARO Clinical Research Manager, Cleveland Clinic Foundation

11:30am - 12:15pm
(D139) Informed Consent Discussions with
Vulnerable Subjects
How to help vulnerable subjects make the right decision.

Cate Stasio, Director, Director, Clinical, Regulatory
& Quality Affairs, Posit Science Corporation

Quincy J. Byrdsong, Administrative Director, RCMI Clinical Research Infrastructure Initiative, Meharry Medical College

1:30 – 3:00
(A105) Publication & Intellectual Property Rights: Finding the Common Ground
Publication is a primary mission of academic sites. Intellectual property is the lifeblood of medical product companies. What publication and intellectual property rights can you realistically expect?

Diane G. Brown, Senior Director, Clinical Legal,
Elan Pharmaceuticals

Michael Redden, JD, Manager, Legal Agreements, Duke Clinical Research Institute

LaDale George, Partner, Foley & Lardner LLP

1:30 – 2:10
(B208) Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare.

Douglas Reichgott, Associate Director,
Clinical Research Office, Partners Healthcare

2:15 – 3:00
(B213) The Sponsor’s Role in Medicare Reimbursement for Device Trials
What the sponsor must do; what the sponsor should do.

Linda Johnson, Vice President, Clinical and Regulatory Affairs, Intelect Medical

1:30 – 3:00
(C305) The Three Rs: Reading, ’Riting & ’Rithmeticing Clinical Trial Agreements & Budgets
Learn the basics of clinical trial agreements and budgets. What are the key negotiating points? What are the common pitfalls?

Pamela Schroeder,
Paralegal Supervisor, Abbott Laboratories

Kristy Baker, CRA, Director, Office for Business & Industry Contracts,
Ohio State University

Melissa L. Markey, Attorney, Hall, Render, Killian, Heath & Lyman, PLLC

1:30 – 3:00
(D132) Working with IRBs
Foster a collaborative relationship with your IRB to ensure efficient, safe and compliant study initiation and conduct.

James Saunders,
Vice President,
New England IRB

Charles Schmidt MD, PhD, Director of Operations, Latin America, PRA International

Cheryl M. Chanaud, PhD, CCRP, Executive Director, Clinical Innovation & Research, Memorial Hermann Hospital

3:30 – 4:10
(A113) Clinical Trial Agreements outside the U.S.
Laws and practices are different outside the U.S.

Myrthe P. Rijswijk-Trompert, Associate Director Contracts, Europe, PharmaNet

4:15 – 4:55
(A217) Clinical Trial Agreements for Investigator-Initiated Trials
What agreements look like when the site comes asking.

Gary Grabow, Esq., Senior Corporate Counsel, Genentech

Barbara Keller, Contracts Manager, Mayo Clinic

5:00 – 5:45
(A260) Working with CRO Clinical Trial Agreement Templates
A large sponsor uses its CROs’ templates.

Mark Lange, Associate General Counsel, Clinical Regulatory Legal, Eli Lilly and Company

Mary Engel, Assistant General Counsel, Quintiles Transnational Corp.

3:30 – 4:10
(B114) Pricing Patterns & Trends
Where are prices high? Where are they low? How are they changing?

Jena Jankosky, Sr. Client Manager, TTC, LLC

4:15 – 4:55
(B119) Managing Currency Risks in International Trials
Minimize your financial exposure to currency fluctuations.

Cory Gutterman,
Associate Director, Outsourcing, Global Pharmaceutical R&D,
Abbott Laboratories

Michael Eckstein, President, World Currency Payments

5:00 – 5:45
(B317) Phase IV Study Budgets
How much is enough for simple studies?

Gina Morton, Sr. Contracts Manager, Late Stage Group, United BioSource Corporation

3:30 – 4:55
(C204) Profitable Clinical Research for Physician Offices & Clinics
Clinical research can be profitable…if you know what you’re doing. Learn the do’s and don’ts from business development, to subject recruiting, to employee staffing.

Kristen Johnson, RRT, CCRC, President, Mountain View Clinical Research

Delos Jones, RN, BSN, CCRC, Research Department Manager, Rocky Mountain Diabetes and Osteoporosis Center

5:00 – 5:45
(C180) The Best Sponsors & CROs
What sites are looking for.

David Heck, Senior Director, CenterWatch

Scott Ballenger, General Manager, Clinical Collaborator

3:30 – 4:10
(D148) Adverse Events
Current regulatory requirements; difficult classifications.

Ali Nourbakhsh, MD,
Medical Director, Millennium Pharmaceuticals

Dennis P. West PhD, FCCP,CIP, Professor of Dermatology and Pediatrics, Northwestern University

4:15 – 4:55
(D146) Protocol Deviations & Violations
Controlling damage and learning from mistakes.

Jenia Booth, Study Manager, Pfizer Urology

5:00 – 5:45
(D290) IRB Outsourcing: Faster Better, Cheaper?
Can a central IRB really do the job of a local IRB?

Lysa Triantafillou, Director, QA & Regulatory Compliance, Copernicus Group IRB

Suzanne Coleman, PhD, Director, Office of Research, Kettering Medical Center

Barry Mangum, PharmD, Associate Professor, Clinical Pharmacology, Duke University Medical Center

10:45 – 11:25
(A202) Sensible Payment Terms
When budgets are tight, payment terms become more important. 12 payment terms you need to know.

Marilee A. Rose, MS, BSN, Administrative Director, Metro-MN Community Clinical Oncology Program, Park Nicollet

Leann Frankel, Associate Director - Vendor Relations, Astellas Pharma US, Inc.

11:30 – 12:15
(A108) Don’t Forget the Other Contract Terms
There’s a reason we call it “boilerplate.” Twenty contract clauses you need to understand.

Jann Mouer, Contract Administration Manager, Sucampo Pharmaceuticals

Monica Sveen-Ziebell, Contract Manager,
Mayo Clinic

10:45 – 11:25
(B118) Billing Compliance in Practice
Policies, processes and systems that will keep sites out of trouble.

Mary Veazie, CPA, Director, Clinical Research Finance, MD Anderson

Lisa Murtha, Managing Director, Huron Consulting Group

11:30 – 12:15
(B112) Making, Tracking & Collecting Payments
How sponsors can pay sites efficiently and how sites can make sure they collect what they earn.

James D. Barbret, Associate Vice President for Research, Wayne State University

10:45 – 12:15
(C116) NIH Grant Proposals
Developing budgets for NIH grants that get funded.

Karl Goodkin M.D., Ph.D., Director of Clinical Research, Dept of Psychiatry and
Behavioral Neurosciences, Cedars-Sinai Medical Center

Luis Angel Cubano, Ph.D., Associate Dean for Research and Graduate Studies, Universidad Central del Caribe

10:45 – 12:15
(D138) FDA Inspections of Research Sites
What to expect, what to do, and what not to do. How to make FDA inspections as painless as possible.

Michael E. Marcarelli, Director, Division of
Bioresearch Monitoring, Office of Compliance,
CDRH, Food & Drug Administration

Michael R. Hamrell, President, MORIAH Consultants

1:30 – 2:10
(A212) Clinical Trial Agreements in Canada
How do Canadian and U.S. clinical trial agreements and processes differ?

Olga Farman, Attorney, Lavery, De Billy

2:15 – 2:55
(A215) Understanding Your Insurance Policy
What is and is not covered may surprise you.

Peter Sullivan, Vice President, Sullivan Insurance Group

3:00 – 3:45
(A121) Standardizing Material Transfer Agreements
Applying Lessons from CTAs to MTAs and from MTAs to CTAs.

Alan Jakimo, Partner,
Sidley Austin LLP

1:30 – 2:10
(B107) Investigator-Initiated Trial Budgets
How do the costs and budgets compare to industry-funded trials?

Dana Deyette, RN, CCRP, Clinical Research Manager, DePuy Mitek

Melissa Kadar, Research Manager, Cleveland Clinic Foundation

2:15 – 2:55
(B205) Inside the OIG’s Toolbox
Anti-kickback, Stark, false claims, beneficiary inducements, and more!

David Vulcano, Assistant Vice President, Clinical Research, HCA, Inc.

3:00 – 3:45
(B106) Budgeting for International Trials
Different countries – different costs.

Lori Shields, VP, Operations, Trial Planning Solutions, Medidata Solutions Worldwide

1:30 – 2:10
(C171) Medical Device Regulations
How are drug and device regulations different?

Kathi Durdon, MA, CCRP, Clinical Operations Associate, Welch Allyn

2:15 – 2:55
(C141) Investigator-Initiated Drug Trials
When investigators become sponsors, they accept additional responsibilities.

Harvey M. Arbit, PharmD, MBA, RAC, CCRP, Director IND/IDE Assistance Program, University of Minnesota

Elizabeth Gobeil, Partner, Thompson Hine LLP

3:00 – 3:45
(C143) Data Quality
New methods for minimizing data queries, finding discrepancies, and correcting them efficiently.

Kit Howard, Principal, Kestrel Consultants

1:30 – 2:10
(D137) Delegation of Authority at Research Sites
Who can do what: How to work within GCP & FDA guidances.

Linda Mottle, Director, Center for Healthcare Innovation and Clinical Trials, Arizona State University

2:15 – 2:55
(D133) Drafting a Policy for Conflicts of Interest Practical solutions for difficult situations.

Jeremy Stoloff, Research Contracts Attorney, Banner Health Research Institute

3:00 – 3:45
(D344) Vulnerable Subjects: Children as a Special Case
Practical aspects of pediatric research

Robert M Jacobson, MD, Chair, Department of Pediatric and Adolescent Medicine, Mayo Clinic