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Guide - AAALAC International

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Kathryn Bayne, M.S., Ph.D., D.V.M.,
DACLAM
Associate Director
Institutional Responsibility
To create an environment for a synergy
between research and animal care.
Components of a Quality Animal
Care and Use Program
пЃ¶The Research Team
пЃ¶Institutional Official
пЃ¶Researchers
пЃ¶IACUC
пЃ¶Animal Care Staff (AV and technical staff)
пЃ¶Policies, Procedures, Resources and
Facilities
Role of the IO
пЃ¶Be informed about the program
пЃ¶Be engaged in the program
пЃ¶Sustained and visible support
пЃ¶In a position to influence institutional priorities
пЃ¶Can assure sufficient monetary and personnel
resources are allocated
Role of the IACUC
пЃ¶Clearly articulate policies and procedures
so that everyone understands
expectations
пЃ¶Implement regulations using scientifically
sound, performance-based standards
пЃ¶Establish effective training programs that
are realistic
пЃ¶Assure the public of quality animal care
Role of Veterinarian and Staff
пЃ¶Ensure adequate and proper animal care
and use
пЃ¶Work in concert with the IACUC and
Investigators
пЃ¶Exercise professional judgment to
facilitate the science in the context of
animal welfare
The Scientist’s Role
J.R. Haywood, Ph.D., Chairman, Department of Pharmacology
and Toxicology Michigan State University
пЃ¶Plan research in the context of quality
animal care
пЃ¶Accept the responsibility
пЃ¶Work to strengthen your animal care and use
program
пЃ¶Engage in the process
пЃ¶IACUC participation
пЃ¶Know the regulations
The Scientist’s Role
J.R. Haywood, Ph.D., Chairman, Department of Pharmacology
and Toxicology Michigan State University
пЃ¶Be willing to communicate with
administrators, regulators, and Congress
пЃ¶Embrace change
пЃ¶Be proactive
Animal Care and Use Program
Components
AV & Staff
Administration
IACUC
Investigator
Each component must
make its contribution so
that the whole is greater
than the sum of the
parts.
In a Successful Animal Care and
Use Program…
…each
person in each component of an
animal care program must know and
understand his or her contribution as it
relates to the whole effort.
Keys to Successful AAALAC
Accreditation
пЃ¶Ensure adequate veterinary care and
compliance oversight
пЃ¶Ensure clear lines of authority
пЃ¶Ensure strong institutional commitment to
the animal care and use program
Roles and responsibilities
of the Institutional Official
The Journey and Perspective of a New IO
Stan Nosek, Vice Chancellor,
Administration, UC Davis
Program Accountability
 IO – An individual who
signs, and has the authority
to sign the institution’s
Assurance, making a
commitment on behalf of the
institution that the
requirements of the PHS
Policy on Humane Care and
Use of Laboratory Animals
will be met.
First Challenge: Acronyms
пЃ¶PHS
пЃ¶OLAW
пЃ¶NIH
пЃ¶IACUC
пЃ¶AAALAC
пЃ¶ARENA
пЃ¶AALAS
пЃ¶ARENA/OLAW IACUC Guidebook
Examining the Intricacies and
Expectations of the Institutional
Official (EI EI O)
пЃ¶The Office of Laboratory Animal Welfare
has a Guide: EI EI O
Mission
пЃ¶To ensure the
ethical and sensitive
care and use of
animals in research,
teaching and
testing.
Our Grand VISION
пЃ¶Through selfregulation and
oversight, we will
develop and maintain
a model animal care
program.
Program Values
пЃ¶Humane Treatment of
Animals
пЃ¶Benefits of animal
research to human
and animal health
пЃ¶Stewardship
пЃ¶Training
пЃ¶Striving for
Excellence
The Institutional Official’s Role
пЃ¶Taken from Arena IACUC 101 5/9/02
пЃ¶Key Components of an Effective Animal
Care and Use Committee presentation
Marky Pitts – UC San Diego
Molly Greene – University of Texas Health
Science Center, San Antonio
Recognized and
Respected Authority
пЃ¶Must have the
administrative and
operational authority to
commit institutional
resources to ensure
compliance with the PHS
Policy
Committed to a Quality Program
пЃ¶Provides leadership to
achieve the desired result
пЃ¶Provides a high level of
service
пЃ¶Makes decisions based on
our commitment to become
a model animal care
program
Provides Sufficient Resources
пЃ¶Occupational Health
& Safety
пЃ¶Personnel
пЃ¶Training
пЃ¶Technology/
Equipment
пЃ¶Maintenance of
Facilities
Ensures
Compliance
Supports Education
пЃ¶Understanding of the
mission and values –
the destination and
the route identified to
get there
пЃ¶Invests in people
through ongoing
training and
development that is
aligned with program
priorities
Partners
пЃ¶IACUC committee
members
пЃ¶IACUC professional
and administrative
staff
пЃ¶Attending Veterinarian
Full Support
пЃ¶IO needs the full
support of the CEO
пЃ¶IACUC Chair needs
the full support of the
IO
The IO Provides Leadership and
Support in to achieve the Mission
But it requires a team
effort to get there !
The Roles and Responsibilities
of the IACUC
Richard C. Van Sluyters, O.D., Ph.D.
Associate Dean, School of Optometry
& IACUC Chair
University of California, Berkeley
The Institutional Animal Care
and Use Program
пЃ¶Institutional Official (IO)
пЃ¶Attending Veterinarian (Vet)
пЃ¶Institutional Animal Care and Use
Committee (IACUC)
IACUC
“If Columbus had an advisory committee
he would probably still be at the dock.”
Justice Arthur Goldberg, 1908-1990
IACUC
“What is a committee? A group of the
unwilling, picked from the unfit, to do the
unnecessary.”
Richard Long Harkness, 1907
IACUC
пЃ¶Oversees and evaluates entire animal
care and use program
пЃ¶Ensures compliance with Guide, Policy,
AWRs
пЃ¶Represents institution and community
пЃ¶Serves as local oversight arm for
APHIS/AC, NIH/OLAW, AAALAC
Well-Balanced Program
Imbalanced Program
The “Weak” IACUC
пЃ¶Chair rotates annually
пЃ¶Inadequate relief/support for Chair
пЃ¶Members only serve 1 year
пЃ¶Few members who are PIs
The “Weak” IACUC
пЃ¶Insufficient staff
пЃ¶Insufficient/no office space
пЃ¶Insufficient funding
пЃ¶Inadequate computer expertise/equipment
The “Weak” IACUC
пЃ¶Inadequate/no member training
пЃ¶Inept protocol review
Staff “runs” the committee/meetings
пЃ¶Designated member review only
пЃ¶PHS applications not reviewed
The “Weak” IACUC
пЃ¶Deficient recordkeeping (minutes,
protocols, reports)
пЃ¶Delegated facility inspections
пЃ¶Inadequate semiannual facility
inspections/program reviews
The “Overpowering IACUC”
(no such thing!)
The “Overpowering IACUC”
IACUC ignores Vet’s recommendations
пЃ¶Dictatorial Chair
пЃ¶Overzealous facility
inspections/program reviews
The “Overpowering IACUC”
IACUC’s policies handcuff PIs, Vet, IO
пЃ¶Inflexibility (rigid deadlines, rules, etc.)
пЃ¶Refusal to use performance standards
пЃ¶Refusal to consider exceptions to the
Guide
AAALAC Site Visits
пЃ¶A retrospective analysis of recent AAALAC
site visit findings indicates how the IACUC
“leg” of the animal care and use program
needs to be strengthened.
Impact of the 1996 Guide
on site visit findings
80
70
60
50
PRE 1996
POST 1996
40
30
20
10
0
IACUC MANDATORY
IACUC SUGGESTION
AAALAC Site Visit Deficiencies
80
70
60
Institutional Policies
50
Laboratory Animal
Management
40
30
Veterinary Medical
Care
20
Physical Plant
10
0
1999
2000
2001
2002
IACUC Site Visit Findings
35
30
25
20
Percent
Mandatory Item
15
10
5
0
1999
2000
2001
2002
IACUC Deficiencies in Rank Order
пЃ¶ Protocol Review
пЃ¶ Semiannual Evaluations
пЃ¶ Committee Composition
& Member Participation
пЃ¶ Policies & Documentation
пЃ¶ Training
Protocol Review
пЃ¶Husbandry exceptions to Guide (e.g. wire-
bottom cages, cage cleaning intervals)
пЃ¶Justification for the numbers of animals used
пЃ¶Expedited review
пЃ¶Review of amendments/addenda
пЃ¶Alternatives to painful procedures (Policy #12)
пЃ¶* Management/evaluation of pain and distress *
Protocol Review:
Management/evaluation of pain and distress
(By far the greatest number of mandatory items
related to protocol review)
пЃ¶Inadequate justification for withholding analgesia
пЃ¶Inconsistency in evaluating pain categories or
inadequate evaluation of potential for pain and
distress
пЃ¶Humane endpoints
Semiannual Evaluations
пЃ¶Evaluation of animal activity areas
Classification of deficiencies as “minor” or
“significant”
пЃ¶Schedule and plan for correction
пЃ¶Follow-up to ensure schedule and plan met
Committee Composition
& Member Participation:
пЃ¶Nonaffiliated member not appointed
пЃ¶Nonaffiliated member not attending
meetings
пЃ¶Nonaffiliated member not participating in
semiannual evaluations
Policies and Documentation
пЃ¶Lack of policies/guidelines for common
experimental procedures (e.g., ascites
production, use of adjuvants, tail snips)
пЃ¶Failure to review policies/guidelines
regularly
пЃ¶Failure to record committee deliberations
Training
пЃ¶Failure to train (or to document the training
of) IACUC members
пЃ¶Failure to train (or to document the training
of) researchers
Well-Balanced Program
“The trouble with using
experience as a guide is that the
final exam often comes first and
then the lesson.”
Anonymous
The Roles and Responsibilities
of the Attending Veterinarian
Kathy Laber, D.V.M., M.S., DACLAM
Director, Animal Resource Program
Ralph H. Johnson VA Medical Center
Veterinary Oath
“…I solemnly swear to use my scientific
knowledge and skill for the benefit of
society through the protection of animal
health, the relief of animal suffering, the
conservation of animal resources, the
promotion of public health and the
advancement of medical knowledge.”
AAALAC’s Perspective
пЃ¶You must
пЃ¶Good if you could
пЃ¶This is the outcome
we want—you decide
Guide-Table of Contents
1) Institutional Policies and Responsibilities
General Intro: Veterinary Care
IACUC: Veterinary Care
2) Environment, Housing &Management
3) Veterinary Medical Care
4) Physical Plant
Role of the
Attending Veterinarian (AV)
Institutional Responsibilities: Two Charges
1. �generally’ give ACUP responsibility to
vet trained in LAS—’or’ another qualified
professional…qualified vet MUST be
associated with program
Role of the AV
Institutional Responsibilities:
1. �generally’ give ACUP responsibility to
vet trained in LAS—’or’ another qualified
professional…qualified vet MUST be
associated with program
Issues: Inadequate veterinary
involvement in program
Role of the AV
Institutional Responsibilities: 2 Charges
2. Adequate veterinary care MUST be
provided…have the authority to oversee
adequacy of �other’ aspects of animal
care and use
Note: AWA/PHS Policy:
“..direct or delegated authority for
activities involving animals”
Role of the AV
Institutional Responsibilities:
2. Adequate veterinary care MUST be
provided…have the authority to oversee
adequacy of �other’ aspects of animal
care and use
Issues: Professional oversight not
sufficiently intense and/or coordinated
to ensure routine vet care, husbandry,
physical plant oversight
Role of the AV
пЃ¶IACUC
• Appropriate sedation, analgesia, and anesthesia
• Post-procedure care and surgical care
• Euthanasia
• Oversee institutions program/procedures/facilities
пЃ¶Veterinary Medical Care-Chapter 3
• Appropriate sedation, analgesia, and anesthesia
• Post-procedure care and surgical care
• Euthanasia
пЃ¶ Attending Veterinarian Definition
• Oversee institutions program/procedures/facilities
Role of the AV
пЃ¶IACUC Role- overlaps with
пЃ¶Veterinary Medical Care Responsibilities
пЃ¶Attending Veterinarian Definition
Issues: CONFLICT or DISENGAGEMENT
Role of the AV
пЃ¶Width: Oversee activities involving animals
пЃ¶Depth: Laboratory Animal Management
Zoonosis Control, Disease Management,
Hazard Containment, Preventive
Medicine, A&A, Surgery/Postsurgical
Care, Euthanasia
Role of the AV
in Lab Animal Management
пЃ¶Physical Environment:
housing, space, light, noise
пЃ¶Behavioral Management:
structural, social, activity
пЃ¶Husbandry: food, water, bedding,
sanitation, pest, emergency plan
пЃ¶Population Management: records, animal I.D.
Physical Environment
SPACE
Behavioral Management
Enrichment Program
Increased emphasis—
need veterinary input
пЃ¶Structural environment
пЃ¶Social environment
Husbandry
Sanitation
пЃ¶Implement
пЃ¶Validate
Population Management
Animal
Identification
Role of Attending Veterinarian
in Occupational Health & Safety
Zoonosis Control
Issues:
пЃ¶Provide
training/
information on
allergies/
zoonosis
Role of Attending Veterinarian
in Occupational Health & Safety
Hazard Containment
Issues:
пЃ¶Identification of
hazards
Awareness i.e. signage
пЃ¶Assessing risk from
hazards
пЃ¶Provide/use PPE
Role of Attending Veterinarian
in Disease Management
Issues:
пЃ¶Failure to report/id
health problems
пЃ¶Ineffective sentinel
programs
пЃ¶Inadequate daily
animal surveillance
пЃ¶Inadequate record
keeping
Role of Attending Veterinarian
in Surgical Programs
Issues:
пЃ¶Inadequate
monitoring and
documentation of
surgical and postoperative care
пЃ¶Lack of aseptic
technique
Role of Attending Veterinarian
in Anesthesia & Analgesia
Issues:
пЃ¶No or inappropriate
A&A use, lack of
oversight
Attending Veterinarians
Role in Euthanasia
Issues:
пЃ¶Inappropriate
methods of
euthanasia, i.e. dry
ice CO2, other
animals present etc…
Roles and Responsibilities of AV
пЃ¶Roles:
Manager, Director,
Clinician, Surgeon,
Architect, Inventor,
Investigator
пЃ¶Responsibilities:
The Animal Care and Use
Program as shared with
the IACUC
Issues and Challenges in
Centralized and De-Centralized
Programs
Joseph D. Thulin, DVM, MS, DACLAM
Attending Veterinarian and Manager
Veterinary Services
3M Company, St. Paul, MN, USA
Disclaimer
пЃ¶AAALAC International does not require a
specific management structure for
accreditation of the animal care and use
program, except to the extent that some
aspects of the organizational structure are
recommended by the Guide or prescribed by
applicable regulations and/or policies.
пЃ¶AAALAC International accredited units
include institutions with either centralized or
decentralized management and oversight of
the animal care and use program.
Centralized vs. Decentralized
пЃ¶What is meant by these terms?
пЃ¶It is not always clear.
Typical unit with centralized
management
пЃ¶Singular management for the animal resource
(whether one or multiple facilities)
пЃ¶Direct line of reporting into the responsible
institutional administrator/IO
пЃ¶One IO, one IACUC, one
institutional/attending veterinarian
Sample Centralized Program
C h ie f E x e c utiv e O ffic er
In s titu tio n a l O ffic ial
IA C U C
A tte n d in g V e terin a rian
D ire c to r/M a n a g er
A n im a l R es o u rc e De p a rtm e nt
A n im a l H us b an d ry S ta ff
C lin ic a l V e te rin ary S ta ff
Units with decentralized
management
пЃ¶Multiple organizational units responsible
for providing animal care and/or
oversight (whether one or multiple
facilities)
пЃ¶Indirect reporting lines into the
responsible institutional administrator/IO
пЃ¶Sometimes multiple IACUCs, AVs, or
IOs
Sample
Decentralized
V ice P re side n t A
Program
D ire cto r A
A n im al C a re U n it A
D r. X Y Z 's M o u se C o lo ny
D ire cto r B
A n im al C a re U n it B
D ire cto r C
A n im a l Ca re U n it C
D r. A B C 's C a t C o lo ny
C h ie f E x e c utiv e O ffic er
V ice P re side n t B
In s titu tio n a l O ffic ial
IA C U C
A tte n d in g V e terin a rian
Many programs are a hybrid,
having both centralized and
decentralized components.
Hybrid Program A
C h ie f E x e c utiv e O ffic er
V ice P re side n t A
D ire c to r A
An im a l Ca re U n it A
V ice P re side n t B
In s titu tio n a l O ffic ial
IA C U C
A tte n d in g V e terin a rian
P ro g ram D irec to r/M a n a g er
D r. X Y Z 's M o u se C o lo ny
C e n tra l An im a l Ca re U n it
D ire c to r B
An im a l Ca re U n it B
D ire c to r C
An im a l Ca re U n it C
D r. AB C 's C a t C o lo n y
Hybrid Program B
C h ie f E x e c utiv e O ffic er
V ice P re side n t A
D ire c to r A
D r. D E F 's F ro g C o lo ny
V ic e P re s ide n t B
In s titu tio n a l O ffic ial
IA C U C
A tte n d in g V e terin a rian
P ro g ram D irecto r/M a n a g er
D r. X Y Z 's M o u se C o lo ny
C e n tra l An im a l Ca re U n it
D ire c to r B
D r. G H I's S h ee p B a rn
D ire c to r C
D r. J KL 's Inh a la tio n L ab
D r. AB C 's C a t C o lo n y
Centralized or
Decentralized?
C h ie f E xe cutive O fficer
C h ie f A d m in istra tive O fficer
In s titu tio n a l O ffic ial
An im a l P ro g ram C o m m ittee
In s titutio n a l V e te rin a rian
V ice Pre side n t A
IA C U C A
V ice Pre side n t B
IA C U C B
A tte n d ing V e te rin a ria n A
A tte n d ing V e te rin a ria n B
A n im al C a re U n it A
A n im al C a re U n it B
V ice Pre side n t C
IA C U C C
V ice Pre side n t D
IA C U C D
A tte n d ing V e te rin a ria n C
A n im a l Ca re U n it C
A tte n d ing V e te rin a ria n D
A n im a l Ca re U n it D
Some questions…
пЃ¶Is there a relationship between management
structure (centralized vs. decentralized) and
outcomes of AAALAC site visits?
пЃ¶Are there certain programmatic areas in which the
management structure impacts (positively or
negatively) an institution’s ability to meet AAALAC
accreditation standards and/or regulatory
expectations?
пЃ¶In what ways does the management structure
influence the functioning of the IO, IACUC, and AV?
Some answers…
пЃ¶Very few hard data
пЃ¶No shortage of opinion and anecdote
What are the problem areas
for programs in general?
 AAALAC trends data (1999 – 2002) show:
пЃ¶ Approximately 25% of site re-visits resulted in less than
Continued Full Accreditation.
пЃ¶ Approximately 70% of the deficiencies were in the
“Institutional Policies and Responsibilities”
group (Guide Chap 1)
пЃ¶ Institutional oversight/IACUC
пЃ¶ Occupational Health and Safety Program
пЃ¶ Program of Adequate Veterinary Care
пЃ¶ Personnel Qualifications and Training
Survey of Present and Emeritus Members
of the Council on Accreditation
пЃ¶Opinion poll sent to all current COA
members and some Emeritus members.
пЃ¶Asked to provide opinions/commentary
on management structure (centralized
or decentralized) as it relates to
achieving and maintaining AAALAC
accreditation.
A majority of respondents
expressed greater concern
for decentralized than for
centralized programs.
Areas of vulnerability for
decentralized programs
пЃ¶Veterinary care and oversight
пЃ¶Occupational health and safety
пЃ¶IACUC function/oversight
пЃ¶Animal environment/housing/management
пЃ¶Other (satellites/labs, institutional resources,
physical plant, record keeping, security,
training)
Challenges for the
Decentralized Program
1. Establishing CONSISTENCY among/across units
пЃ¶ Penetrance of IACUC oversight, veterinary oversight
and care, and OHSP
пЃ¶ Standards of care
 Distribution of staffing and resources (“haves and havenots”)
пЃ¶ Leadership
пЃ¶ Training
пЃ¶ Record Keeping
Challenges for the
Decentralized Program (cont)
2. Ensuring no organizational barriers for IO,
IACUC, and AV
пЃ¶ Pairing responsibility with authority
пЃ¶ Ability to implement corrective actions
пЃ¶ Encouraging programmatic
engagement and balance
Sample Decentralized
Program
C h ie f E x e c utiv e O ffic er
V ice P re side n t A
D ire cto r A
A n im al C a re U n it A
D r. X Y Z 's M o u se C o lo ny
D ire cto r B
A n im al C a re U n it B
D ire cto r C
A n im a l Ca re U n it C
D r. A B C 's C a t C o lo ny
V ice P re side n t B
In s titu tio n a l O ffic ial
IA C U C
A tte n d in g V e terin a rian
Challenges for the Decentralized
Program (cont)
3. Managing conflicts of interest
пЃ¶ Investigator provided animal husbandry
пЃ¶ Investigator provided veterinary care
Areas of vulnerability for the
centralized program
пЃ¶Institutional policies and responsibilities
пЃ¶Institutional oversight/IACUC
пЃ¶Program of adequate veterinary care
пЃ¶Occupational health and safety program
The same as for decentralized programs!
Challenges for the
Centralized Program
1. Establishing and maintaining
programmatic engagement and
balance among the organizational
pillars
пЃ¶ IO
пЃ¶ IACUC
пЃ¶ AV
The IO, IACUC, and
AV must function as
a team!
Challenges for the
Centralized Program (cont)
2. Maintaining flexibility and ability to
support diverse needs
пЃ¶ Diversity in species
пЃ¶ Diversity in programs
Challenges for the
Centralized Program (cont)
3. Achieving excellence and avoiding
complacency
You’ve achieved consistency in the program…
but is it the consistent high quality desired?
Summary
пЃ¶The type of organizational structure
(centralized or decentralized) may affect the
quality of the animal care and use program.
пЃ¶Centralized and decentralized programs face
the same overall challenge пЃ¶Achieving and maintaining a uniformly high quality
animal care and use program.
пЃ¶However, the specific challenges and
necessary approaches may be quite different.
“Any structure can and does work
when the people involved want it
to work and are willing to work
together for the greater good.”
Thanks to:
пЃ¶Council on Accreditation
пЃ¶AAALAC Staff
пЃ¶Lori Wieder
Industry Perspective
Michael Ballinger, D.V.M., M.S., DACLAM
Director, Global Animal Research Programs
Amgen Inc.
President, Council on Accreditation
AAALAC International
What are Industry
Animal Programs?
пЃ¶Pharmaceutical/Biotech/Animal
Health/Devices
Chemical Co’s w/ in-house Industrial
Toxicology
пЃ¶Contract Lab (CRO)
пЃ¶Animal Supplier/Breeder
Industry Animal Programs
Have Distinct Differences
пЃ¶Advantages and Disadvantages
пЃ¶Broad range of financial resources
пЃ¶Different regulatory drivers
Most all are “for profit” by definition
General Distinctions
of Industry Programs
пЃ¶Regulatory Oversight and Focus differs
from academia
“Repetitive” protocols are common
“Committee” oversight doesn’t easily fit
management model
пЃ¶Profitability is the bottom line
Unique Regulatory Oversight
пЃ¶Many industry programs do not have PHS
Animal Welfare Assurance
пЃ¶Others have no USDA oversight (some
Biotechs and mice/rat suppliers)
пЃ¶Many have only USDA & AAALAC
oversight (no PHS)
FDA GLP’s are the Primary Regulatory
Focus (CRO’s and Pharma)
Creates confusion on “hierarchy” of
regulatory mandates
пЃ¶May tempt organizations to apply
GLP/GMP demands to general animal
programmatic areas (far outside the FDA’s
areas of concerns)
Quality Assurance is a Major Focus
FDA driver for Med/Chem & CRO’s
пЃ¶Product Quality driver for animal suppliers
Repetitive and Screening
Animal Protocols Common
пЃ¶Justifying animal use numbers is
challenge
пЃ¶May be totally driven by chemical throughput
пЃ¶Emphasis should be on study design for
individual trial
пЃ¶Endpoints for safety/toxicology protocols
are special challenge
How Does IACUC Role Fit Into
Corporate or Small Business Model?
пЃ¶Top-down, hierarchical management
пЃ¶Committee oversight shoehorned into the
hierarchy and power structure
IO – IACUC relationship must be well
defined (beyond regulatory guidance)
Fiscal Management – “for profit”
пЃ¶May make capital investments more timely
пЃ¶Animal care operations may be very lean
(in lean times)
пЃ¶Administrative & Support staff often a
difficult justification
Pharmaceutical/Biotech Picture
пЃ¶Broad range in size and scope of programs
пЃ¶Small single site
пЃ¶Multi-site, multi-national
пЃ¶Animal use focus varies
пЃ¶Health vs. non-health products
пЃ¶Human vs. animal health
пЃ¶Pure research
пЃ¶Applied research
пЃ¶Safety Assessment (toxicology)
FDA GLP’s are the overwhelming regulatory
focus
Pharma/Biotech Picture
пЃ¶Multi-site, multi-state is common setting w/ big
Pharma
пЃ¶USDA has recently demanded single IO, single
USDA registration, and a single annual report
from several multi-site Pharma companies
Most multi-site Pharma’s (w/ significant
geographic separation and independent
management) have elected to limit IACUC
oversight to single site (or group of closely
associated sites)
IO – Pharma/Biotech
IO’s relative position in management
hierarchy varies w/ Co.
пЃ¶Some have senior R&D executive as IO
(and direct line management responsibility
for all animal use under the IO’s control)
пЃ¶Other units use mid-level executive as IO
without direct control of all users.
пЃ¶Senior Exec model makes oversight
simpler
IACUC – Pharma/BT
пЃ¶How is committee authority perceived in power
structure?
пЃ¶IACUC service may be a challenge due to the
business drivers and demands for research
results, e.g., new compound discovery and
successful commercial launch.
пЃ¶Committee (of any type) membership not
commonly viewed as career enhancing in
Pharma/BT in contrast to academia.
IACUC Chair – Pharma/BT
пЃ¶IACUC leadership often either an R&D
lower level executive or a senior scientist
пЃ¶Chair role is some settings is becoming
appreciated as a position of significant
power in the Pharma R&D
пЃ¶Other settings - it is quite the opposite.
пЃ¶Off-site CE for chair and members may be
a challenge
AV – Pharm/BT I
пЃ¶AV role well developed.
пЃ¶AV commonly reports to the Drug Safety
executive but major users (Discovery or
research) often report via different
executive.
пЃ¶Reporting relationship may or may not
create challenges for AV authority.
AV – Pharma/BT II
пЃ¶AV commonly leads a centralized vivarium
staff.
пЃ¶Decentralized animal care is rare in this
setting.
пЃ¶Although it still exists, territorialism is less
prevalent in industry – resources are
“corporate” rather than
purchased/supported by PI grants.
AV – Pharma/BT III
пЃ¶Role and authority of AV versus Tox Study
Director (SD)
пЃ¶Especially challenging when SD has
DVM/VMD
Study pathologist’s role (independent of AV)
CRO-Specific Challenges
CRO – Sponsor relationship creates special
challenges
пЃ¶ Sponsor may send challenging protocols to CRO
пЃ¶ Economic/business pressure to do study as dictated by sponsor
must be balanced w/ CRO IACUC’s ethical responsibilities
пЃ¶ AV role is a special challenge
пЃ¶Compliance record (especially w/ USDA, FDA
and AAALAC) is key selling point to sponsors.
Compliance is under scrutiny by QA reps from
sponsor organizations, but focus is usually GLPcentric
CRO IO
пЃ¶Typically a senior manager or executive
(depending on size and complexity of
unit).
пЃ¶CRO IO commonly has management
control of all animal users.
CRO IACUC Challenges
пЃ¶Independence (versus business drivers)
пЃ¶Composition (AWA limits on # from dept)
пЃ¶Leadership
пЃ¶Demand for quick turnaround
CRO IACUC
пЃ¶May be the most challenging setting for an
animal committee.
пЃ¶Virtually all protocols are specified by the folks
paying the bills (sponsors).
пЃ¶Quick turnaround is a major demand by sponsor.
пЃ¶Independent review is challenge in a CRO
setting. At least one CRO uses an outside chair
(scientist from nearby college) to help w/ this
challenge.
AV - CRO
пЃ¶A real balancing act to be the attending
veterinarian in a busy contract lab.
пЃ¶Lack personal contact or relationship w/
sponsors’ scientists may limit influence.
пЃ¶AV often only involved w/ sponsor when
adverse events occur.
Tough timing for an “introduction”
Industry Programs for Animal Care
and Use Differ from Academia
пЃ¶Much of CE for IACUC & IO is driven by
PHS Assurance issues
пЃ¶Unique settings demand unique and novel
solutions
пЃ¶One size does NOT fit all
Simple Test for All of These
Settings & Challenges
пЃ¶Who is the animal advocate in the
program/facility?
пЃ¶Does the animal advocate have a voice?
пЃ¶Can the animal advocate challenge the
status quo?
www.aaalac.org
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