Strategic Research Institute, The Crowne Plaza Hotel
May 23-25, 2005
7:15 - 8:00
Registration, Networking & Continental Breakfast
8:00 - 8:30
Chairman's Opening Remarks
Norman M. Goldfarb
President & CEO
FIRST CLINICAL RESEARCH
Chairman, Model Agreement Group Initiative (MAGI)
8:30 - 9:00
Fundamentals of Contract Negotiation: Skills and Techniques
Negotiation is a science AND an art. Whether you are novice or an expert, reinforce your skills and pick up some negotiating tips. J. Michael Slocum
President
SLOCUM & BODDIE, P.C.
9:00 - 9:45
Managing Risk: Indemnification & Subject Injury
Indemnification and subject injury language is probably the most complex in the clinical trial agreement, and the least understood. The plaintiff’s bar is developing new strategies to take money out of our pockets. If something serious goes wrong, look here first. Richard Neff, Esq.
Attorney
SCHERING-PLOUGH RESEARCH INSTITUTE Michael Powers, Esq.
Associate Counsel
PHARMANET J. Mark Waxman, J.D.
General Counsel
BETH ISRAEL DEACONESS MEDICAL CENTER
9:45 - 10:15
Coffee & Networking
10:15 - 11:00
Reconciling Publication & Intellectual Property Rights
Publication is a primary mission of academic sites. Intellectual property is the lifeblood of medical products companies. When worlds collide, people don’t always speak the same language. What publication and intellectual property rights can you realistically expect? Melvyn Kassenoff
Corporate Intellectual Property
NOVARTIS PHARMACEUTICALS David King
Director, Office of Industry Contracts
UNIVERSITY OF LOUISVILLE
11:00 - 11:45
Practical Payment Terms
Sponsors can’t afford to pay for work that’s not done. On the other hand, sites need timely payment with a minimum of administrative overhead. A lot of creative language is being written to reconcile these objectives. Teri Cotton
Attorney
ELI LILLY & COMPANY Christine Pierre
CEO
RX TRIALS, INC.
11:45 - 12:45
Lunch
12:45 - 1:15
Developing Successful Clinical Trial Budgets
Sites see only a small part of the overall clinical trial budget. Learn how sponsors develop the total budget. What are the trade-offs? How do sponsors determine what is “fair”? Julia Santos
Worldwide Assoc. Director-Strategic Outsourcing, Consumer & Personal Products Worldwide
JOHNSON & JOHNSON
1:15 - 1:45
Developing & Negotiating Budgets Based on Objective Market
Industry data and empirical studies provide insights into how to
negotiate fair budgets that improve study performance and build longterm
relationships between sponsors and investigators. Harold Glass
Managing Director & Professor
TTC & UNIVERSITY OF THE SCIENCES IN PHILADELPHIA
1:45 - 2:30
Effective Clinical Trial Budget Negotiation
Everyone has negotiated a budget, but perhaps not in the most effective manner. Learn how a master negotiator does it. William Caskey
Director, Research & Grant Administration
CHILDREN’S MERCY HOSPITAL
2:30 - 3:00
Refreshments & Networking
3:00 - 4:00
The Other Agreements: Confidentiality, Materials Transfer, Data Use, and More
Every contract type has its day in the sun. You had best be prepared. Stacie Switzer
Counsel
TAKEDA PHARMACEUTICALS NORTH AMERICA Jeffrey J. Longe, J.D.
Project Representative, Division of Research Development and Administration
UNIVERSITY OF MICHIGAN
4:00 - 4:45
Saving Time with Master Agreements
Master agreements can streamline the clinical trial agreement negotiation process. Learn what they can and cannot do. Lauren Goldsmith
Clinical Contracts Manager
ABBOTT LABORATORIES Beth Lynn Maxwell
Office of General Counsel
UNIVERSITY OF TEXAS
CONCURRENT TRACKS – CHOOSE FROM TRACK A OR TRACK B
4:45 - 5:15
Good Ethics is Good Business: The Ethics of Clinical Trial
The clinical research industry talks a lot about ethics related to study subjects, but little about ethics between business partners. Because contracts are largely a statement of ethical principles, ethics can be a useful negotiating tool. Martin Letendre, LLB, LLM Director, Ethics and Government Affairs
ETHICA CLINICAL RESEARCH INC.
5:15 - 6:45
Networking Reception
Tuesday, May 24, 2005 (Day 2)
7:00 - 8:00
CLINICAL RESEARCH CONTRACT PROFESSIONAL (CRCP) CERTIFICATION EXAM
MAGI is now offering certification for clinical research contract
professionals. Certification is available only at SRI’s Contracting &
Negotiating Clinical Trials conferences. Attending the conference is
excellent preparation for the certification exam. The exam is optional
and open to all speakers and attendees. There is an additional $369
fee to take the exam. Information is at
http://www.firstclinical.com/magi/certification.html.
8:00 - 8:30
Registration, Networking & Continental Breakfast
8:30 - 8:45
Chairman's Remarks
8:45 - 9:30
Going International: Global Issues in Clinical Contract Agreements
Negotiating contracts within one country is hard enough. When the site and sponsor are in different countries, they have to accommodate different laws, regulations, cultures and languages. Multinational trials are the ultimate test of the contract negotiator. SPONSOR TBA Ellen Teplitzky
Director, Contracts and Legal Affairs
PRA INTERNATIONAL
9:30 - 10:00
Lessons from Overseas: Clinical Trial Agreements in the United Kingdom
In 2003, the Association of the British Pharmaceutical Industry (ABPI) negotiated a hugely successful model CTA with the National Health Service Trusts. Since then, what has gone right? What has gone wrong? What are the lessons for clinical trial agreements in this country? Mark Lewis
Director of Analysis and Clinical Development and Head of Governance
NORTHWEST LONDON STRATEGIC HEALTH AUTHORITY
10:00 - 10:30
Coffee & Networking
10:30 - 11:15
Can’t We All Just Get Along? The Role of CROs in Clinical Trials
CROs are often caught in the middle between sponsors and sites. What does a good sponsor/CRO contract look like? What can you expect from your CRO? What can you demand? Serena Lau
Commercial Attorney
PPD DEVELOPMENT
11:15 - 12:00
Understanding your Partner: Behind the Scenes
Behind the negotiator, there can be a large of team of people working together smoothly to ensure an effective process, or maybe not. Janis Witzleb
Manager, Contracts
WYETH RESEARCH (INVITED) David Ehlert
Manager of Grants & Contracts
UNIVERSITY HOSPITALS OF CLEVELAND
12:00 - 1:00
Lunch
1:00 - 2:00
TRACK A: OTHER RELATED CONTRACTING CLINICAL TRIAL TOPICS
1:00 - 1:30 The Big Picture: Contract Negotiation in an Industry Under Stress The clinical research industry is undergoing dramatic changes.
Understand where the industry is today and where it is going. There may be a reason why your negotiation partner is being "unreasonable." Joseph Cosico
Executive Director. Office of Grants & Research
ATLANTIC HEALTH SYSTEMS 1:30 - 2:00 Financial Checks & Balances: Making Sure You're Getting What You Negotiate Everyone is concerned with negotiating the best Clinical Trial Agreement with the most favorable payment terms and budget. But how does a site, SMO or Academic Medical Center know if it's
getting paid the correct amount? Due to the complexity of different Agreements, errors are more likely to occur in the clinical trials industry than most others. We will explore this issue and discuss some accounting techniques that can be applied to assure that all hard-earned research dollars are accounted for, paid in a timely manner and paid in full...and why it's important. James M. Wynn III
Director, Business Development
CLINICAL FINANCIAL SERVICES
1:00 - 2:00
TRACK B: CLINICAL RESEARCH CONTRACT PROFESSIONAL (CRCP) CERTIFICATION EXAM
MAGI is now offering certification for clinical research contract professionals. Certification is available only at SRI’s Contracting & Negotiating Clinical Trials conferences. Attending the conference is excellent preparation for the certification exam. The exam is optional and open to everyone. There is an additional $369 fee to take the exam. Additional information is at http://www.firstclinical.com/magi/certification.html
2:00 - 2:30
Refreshments & Networking
2:30 - 3:15
The Contract is Just the Beginning: Administering Contracts & Payments
Clinical trial agreements are the “rules of the road” for the site-sponsor relationship. Well-crafted agreements anticipate potential questions and issues, but not always. Effective contract and payment administration is key to a constructive relationship. Kristine Freind
Sr. Manager, Purchasing Services,
ASTRAZENECA Pam Schroeder
Director of Bids, Contracts & Proposals
ESSENTIAL GROUP, INC.
3:15 - 4:00
Don’t Forget The Other Contract Terms
The "boilerplate" in a clinical trial agreement is there for a reason. Ignore it at your own peril. Greg Thomas
Senior Contract Analyst
GLAXOSMITHKLINE Owen Lewis
Corporate Counsel
INVERESK Cheryl Chanaud
Vice President, Clinical Research
ST. JUDE CHILDREN'S HOSPITAL
4:00 - 4:45
How U.S. State and Federal Agency Laws & Regulations Impact Clinical Trial Agreements
It’s hard enough to know all the relevant U.S. federal laws and regulations, but states and federal agencies have their own idiosyncrasies. Both sites and sponsors can get in trouble if they don’t know the rules. On the other hand, they can turn them to their advantage. Barbara West
Executive Director
NATIONAL ASSOCIATION OF VETERAN'S RESEARCH AND EDUCATION FOUNDATIONS David Bloomer, MHA, CCRA
Director of Clinical Research Administration
LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER-SHREVEPORT George R. Tady
VA Attorney
SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH (SIBCR)
4:45 - 5:30
When Good Contracts Go Bad
When something goes wrong in a clinical trial, it’s time to pull out the agreement: True stories about what can go wrong, and how to dodge the bullets. Wayne Bond
Partner
WOMBLE CARLYLE SANDRIDGE & RICE Michael Smith, Jr.
Assistant Vice President
COMMERCE INSURANCE SERVICES Marilyn Skrocki
Director of Risk Management and Corporate Compliance
ST. MARY'S MEDICAL CENTER OF SAGINAW, INC.
5:30 - 5:35
Day Two Concludes – Main Conference Concludes
Wednesday, May 25, 2005 (Day 3)
7:15 - 8:00
Post-Conference Workshop Registration, Networking & Continental Breakfast
8:00 - 8:05
Chairman's Remarks
8:05 - 12:00
CONCURRENT WORKSHOPS – CHOOSE FROM WORKSHOP A, B or C
WORKSHOP A:
DISSECTING A CLINICAL TRIAL AGREEMENT Sometimes the wording does make a difference. We will examine a clinical trial agreement under a business and legal microscope. If you think you know what you’re signing, think again; it’s ugly in there. Have you considered this scenario… WORKSHOP LEADERS:
Penny Smith
Attorney
SOLVAY PHARMACEUTICALS Kristine Freind
Manager, Purchasing Services, Central Labs and PAR&D
ASTRAZENECA Barbara Longmire
Director, Office of Clinical Trials
UNIVERSITY OF NORTH CAROLINA
WORKSHOP B:
NEGOTIATION 101 THROUGH 999
The contract negotiation is a major step in forming a constructive long-term relationship. Expert negotiators get better contracts, they get them faster, AND they form stronger partnerships. Learn skills you can use in all aspects of your life. WORKSHOP LEADER:
J. Michael Slocum
President
SLOCUM & BODDIE, P.C. WORKSHOP C:
CLINICAL RESEARCH LAW FOR NON-LAWYERS Clinical trial agreements are legal documents. In this workshop, learn about fundamental legal principles and how they apply to clinical trial agreements. Untangle the mysteries of equitable relief, severability, latches, force majeur, and many other legal concepts that matter in clinical trial agreements. WORKSHOP LEADER:
Thomas Quinlan
Partner
REED SMITH CROSBY HEAFEY LLP
12:00 - 12:05
Conference Concludes
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