Join us in Detroit, Michigan on June 29-30, 2004 for a special 2-day
conference:

**"Balancing Animal Welfare and Regulatory Compliance Issues\
in Preclinical Studies"**

> Preclinical safety studies required for regulatory approval of new
> drugs and chemicals have different scientific objectives than efficacy
> studies and pose challenges for scientists, regulators, and the public
> concerned about animal welfare. International efforts have greatly
> reduced animal use both through standardization of regulations and
> study designs and by promoting the principles of reduction,
> replacement, and refinement (the 3Rs). These efforts continue, but
> animal studies will continue to play an important role in safety
> assessment and risk management well into the 21st century. Though
> scientists, veterinarians, regulators, and the public will determine
> how those research activities are conducted, current positions and
> thinking within and between these stakeholders are not congruent and
> potentially impact research quality, animal welfare standards and
> public trust. This conference brings together internationally
> recognized leaders of the scientific and regulatory communities to
> identify the issues and to propose harmonization of animal welfare in
> biomedical research.
>
> **Target audience**: study directors, investigators, veterinarians,
> animal facility managers, quality assurance, IACUC members and staff,
> regulators

**Sponsored by:**

> NIH Office of Laboratory Animal Welfare
>
> USDA Animal and Plant Health Inspection Service, Animal Care
>
> AstraZeneca Pharmaceuticals
>
> Michigan State University

Association for Assessment and Accreditation of Laboratory Animal Care
International

> Michigan Society for Medical Research

**Additional support provided by:**

Eli Lilly and Company

Safety Pharmacology Society

Sanofi-Synthelabo

US Food & Drug Administration

\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

**Location**: The Westin Detroit Michigan Metropolitan Airport Hotel

\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*

***[For information about Monday's IACUC
101](http://www.mismr.org/services/IACUC/program2004.html):
\<http://www.mismr.org/services/IACUC/\>\
or send a note to \<<mismr@umich.edu>\>.***

**TENTATIVE PROGRAM**

**Tuesday, June 29, 2004**

**Viewpoints on Animal Studie****s Required for Human Protection**

> 8:00 Registration
>
> 9:00 Welcome
>
> 9:30 **Keynote**: Balancing Animal Welfare with Scientific Need Using
> an Ethical Cost-Benefit Assessment
>
> 10:15 Break
>
> 10:30 **Panel** 1: Agency perspectives on regulatory and compliance
> issues: FDA, EPA, NIH, USDA, AAALAC
>
> 12:00 Lunch
>
> 1:00 **Keynote**: Animal Efficacy & Safety Studies: Criteria for
> Experimental Endpoints
>
> 1:45 **Panel** 2: Principal investigators perspectives on regulatory
> and compliance issues: GLP safety studies, Toxicology, Safety
> pharmacology, Devices
>
> 3:15 Break
>
> 3:30 **Panel** 3: Roles & Responsibilities in regulatory and
> compliance issues: Study Director, Attending Veterinarian, Quality
> Assurance, IACUC
>
> 5:00 Wrap-up of Day 1

#### 

#### Wednesday, June 30, 2004

**Related and Emerging Issues**

> 8:00 Recap & Summary of Day 1
>
> 8:30 **Keynote**: Public Perceptions
>
> 9:15 **Panel** 4: International Perspectives on the Application of
> GLPs to Animal Studies: Compliance, Animal Welfare, and Harmonization
> Issues
>
> 10:45 Break
>
> 11:00 **Panel** 5: Integration of Academic, Contract, and Industrial
> Animal Research Activities: Entrepreneurial academic initiatives
> focusing on cooperative programs with biotechnology and pharmaceutical
> companies, GLP in the academic research environment, Industrial
> research perspectives, Contract facility perspectives
>
> 12:30 Lunch
>
> 1:30 **Keynote**: Bioterrorism Research: What can we expect?
>
> 2:15 **Panel** 6: Animal Welfare Issues in Research in Homeland
> Defense, Security and Bioterrorism: Terrorism and its effects on
> Biomedical Research Facilities; Bioterrorism and the Subpart 1 "animal
> rule" exception effect on development of vaccines: the risk-rewards in
> creating them; Bioterrorism risks for America: real or imagined
> threat; Bioterrorism Research: a Pandora's box or a future insurance
> policy ?
>
> 3:45 Break
>
> 4:00 Conference conclusions and future directions
>
> 5:00 Adjournment

**Program Committee:**

Co-Chairs: Lewis B Kinter PhD, Senior Director, Safety Assessment,
AstraZeneca Pharmaceuticals

J R Haywood PhD, Chair, Pharmacology & Toxicology, Michigan State
University

Michael Ballinger DVM MS, Director, Global Laboratory Animal Resources,
Amgen Inc.

Awadh Binhazim DVM PhD, Director, Animal Care Facility, Meharry Medical
College

Marilyn Brown DVM MS, Director, Animal Welfare and Training, Charles
River Inc.

Rebecca Ellish-Stengle MPH, Ex Director, Michigan Society for Medical
Research

Stephen Frantz PhD DABT, Senior Study Director, MPI Research

Nelson L Garnett DVM, DACLAM, Director, Office of Laboratory Animal
Welfare, NIH

Chester Gipson DVM, USDA, APHIS, Animal Care

Betty Goldentyer DVM, USDA, APHIS, Animal Care

Molly Greene, IACUC Advisor

Steven W Hachtman PhD, VP of Business Development, Data Sciences
International

Herod Howard DVM MPVM DACLAM, Director, LAMD, SRI International

Mary Lou James, Consultant, Regulatory Compliance, Research Animal
Welfare

David K Johnson DVM, Scientific Advisor, Harlan

James F. McCormack, PhD, Director, Nonclinical Laboratory Compliance, US
Food & Drug Administration

Virginia Moser PhD DABT, Neurotoxicology Division, US Environmental
Protection Agency

William Stokes DVM DACLAM, Dir. NTP Interagency Ctr Evaluation of
Alternative Toxicological Methods NIEHS

Carol Wigglesworth, Senior Policy Analyst, Office of Laboratory Animal
Welfare, NIH

**Tentative & Partial List of Conference Faculty:**

Andrew Aldridge PhD

Lynn Anderson DVM DACLAM

Michael Ballinger DVM

Richard Briscoe PhD

Marilyn Brown DVM MS

Gilles Demers DVM MSc

Louis DeTolla VMD PhD

Stephen Frantz PhD

Nelson Garnett DVM

Steven Hachtman PhD

Elizabeth Hausner DVM DABT

J R Haywood PhD

Herod Howard DVM DACLAM

Kirk Huber MS

David Johnson DVM

Lewis Kinter PhD

Jodie Kulpa-Eddy DVM

James McCormack PhD

Virginia Moser PhD DABT

Stephen Porter PharmD FCP MRCP

Ernest Prentice PhD

Douglas S Reed

Barbara Rich BA

Robert Shade PhD

Kathleen Smiler DVM

William Stokes DVM DACLAM

Kirk Tarlo MPH PhD DABT

**REGISTRATION:**

> Early Registration: \$400.00/participant for registration postmarked
> by June 1, 2004.
>
> Late Registration: Add \$25.00/participant for registration postmarked
> after June 1, 2004.
>
> Registration fee includes attendance at all sessions, continental
> breakfast, refreshment breaks, lunch, evening reception, course
> syllabus and hard copy materials, and other amenities involved in
> creating a rewarding learning experience.
>
> Participation of women, racial/ethnic minorities and persons with
> disabilities, and other individuals, who have been traditionally
> underrepresented in science, is encouraged.

**CANCELLATIONS**:

> Cancellations submitted in writing prior to June 15, 2004 are
> necessary for reimbursement of the registration fee minus a \$25.00
> administration fee. Cancellations after June 15, 2004 will not be
> refunded.

**SPECIAL NEEDS AND/OR QUESTIONS:**

> If you have questions about registration, please contact Jeff Nobis at
> 517.353.8858 or E-mail: <nobisj@msu.edu>. If you have special needs,
> require special accommodations; contact Mary Lou James, Consultant,
> Regulatory Compliance, Research Animal Welfare, St. Louis, MO at
> 314.997.6896, <mljames@socket.net>, or Molly Greene, 517.974.4979,
> <mollygreene@comcast.net>.

**CONFERENCE LOCATION AND LODGING:**

> Westin Detroit Metropolitan Airport Hotel, 2501 Worldgateway Place,
> Detroit, Michigan 48242. A limited number of rooms are available at a
> conference rate and government rate (if applicable). Reservations MUST
> be made by June 14, 2004 to secure these rates. For reservations, call
> 734.942.6500 or 1.800.937.8461 or contact Angela Lanzini at
> 734.229.6708 or \<angela.lanzini@westin.com\> and refer to the
> Michigan Society for Medical Research (MISMR) conference rate of
> \$149.00 per night (+ tax) or \$110 per night government rate (if
> applicable). See the Westin Detroit Metro Airport website for
> additional information:
> <http://www.starwood.com/westin/search/hotel_detail.html?propertyID=1415>

**REGISTRATION FORM: - PLEASE TYPE OR PRINT CLEARLY**

NAME as you would like it to appear on your name badge:

SPECIALTY / DEGREE:

COMPANY/INSTITUTION:

ADDRESS:

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**CANCELLATIONS**:

Cancellations submitted in writing prior to June15, 2004 are necessary
for reimbursement of the registration fee minus a \$25.00 administration
fee. Cancellations after June15, 2004 will not be refunded.

**PAYMENT OPTIONS**: Sorry, no credit cards can be accepted.

> Check or Money Order: PAYABLE to MSU
>
> Payments must be in US funds and payable on a US bank.

Amount enclosed:

\_\_\_ \$400.00/participant - Balancing Animal Welfare and Regulatory
Compliance Issues in Preclinical Studies on June 28-29, 2004

\_\_\_ \$25.00 if postmarked after June1, 2004

\_\_\_ Total Amount enclosed

**Mail payment with completed registration form to:**

> Jeff Nobis
>
> B440 Life Sciences Bldg.
>
> Michigan State University
>
> East Lansing, MI 48824
>
> Tel: 517.353.6658
>
> Fax: 517.353.8915
>
> <nobisj@msu.edu>