Public
notification should occur via the Federal Register, the CVM web site, and other
avenues as may be appropriate. That
notification should be in a timely manner to allow for adequate public feedback
and consideration of public concerns prior to ruling on the import tolerance.
·
The FDA was seeking
information on whether setting of these import tolerances could have a
significant environmental impact that might disallow an exclusion relative to
the National Environmental Policy Act.
The VMAC could think of no instances relative to residues within animal
products that would have a significant environmental impact.
3. Pathogen load studies. FDA has required by
regulation (21 CFR 558.15) that “pathogen load” studies (more specifically, Salmonella shedding studies) for any
antibiotic being used for subtherapeutic purposes in animal feeds (use beyond
14 days). These studies were to address
the issue of whether subtherapeutic administration of the drug led to an increased
number of Salmonella in the GI tract
of the target species (and hence an increased risk of carcass contamination at
slaughter). In addition, the “558.15 studies” attempted to evaluate whether
such drug use led to increased resistance to antimicrobials. The FDA was seeking advice as to whether the
pathogen load studies in particular should continue to be applied to
subtherapeutic use applications and whether they should be expanded to include
therapeutic use applications.
Presentations
by a variety of speakers reviewed the benefits and flaws of pathogen load
studies. An outside consulting group,
on behalf of the FDA, also conducted a literature review and those results were
provided. Major limitations of the
558.15 study design were apparent and included: age groups and husbandry practices not representative of drug use
conditions, inordinately high bacterial challenges, not studying the effect of
the drug withdrawal time frame where pathogen numbers might reduce or
stabilize, and an inability to accurately quantify Salmonella numbers based
on present technology. The literature
review and the review of 558.15 studies failed to show consistent evidence of
antimicrobial use causing increasing pathogen numbers and in fact more commonly
showed pathogen number reductions. No
evidence of increased resistance due to drug use was found in any of the 558.15
studies nor the reviewed literature.
(Although most study designs from the literature did not specifically
address this issue.)
- While the concept of requiring pathogen load
studies for drug approval may seem reasonable in theory, the VMAC felt
that, as presently designed, pathogen load studies provided no consistent
value in protecting the public health.
Several members commented that resources would be better spent
relative to antimicrobial resistance issues rather than pathogen load
determinations. It was the
majority opinion (ten members) of the VMAC that such studies should be
discontinued for sutherapeutic drug approval purposes and that they not be
incorporated into the therapeutic drug approval process. Though acknowledging the limitations of
the present system, two members offered a dissenting opinion stating that
they felt pathogen load studies should be continued in some form.
Respectfully submitted
Cory Langston, DVM, PhD, Dip.
ACVCP
Chair, FDA VMAC and
President, AAVPT
langston@cvm.msstate.edu
***********
Secretary-Treasurer Report
Well, 2002 is well underway. I hope
everyone is getting through the winter.
The weather in Illinois here has remained magnificent – we have not had
any snow since early in November of last year.
I have never experienced such a mild winter. Hope you winter has not been too unpleasant.
The treasury shows a balance of
approximately $20,165 as of February 2002.
I am currently in the middle of getting the 2002 dues and journal
subscriptions and have received over half from the membership. I would like to thank everyone who has
returned their dues payment for 2002 and remind those who have not to try to
get their checks to me. To date, I have
received dues and/or journal subscriptions from 57 members. I would request those who want to continue
their subscription to the journal to get their payment in to me as soon as
possible. Final payment to the
publisher needs to be made soon. I have received payment for 33
subscriptions. I would like to thank T.Clark, G. Coppoc, J. Gloyd, A. Jernigan,
S. Malik, A. Neal, M. Papich, J. Clark, J. Oliver, D. Kochevar, C. Langston, K.
Varma, and R. Ehrich for their generous donations
to the award fund.
Our membership currently stands at
215 members (140 Fellows, 3 Distinguished Fellows, 31 Emeritus Fellows, 31
Associate Fellows, and 9 student members).
We welcome one new Fellow, Dr.
Sara Marley.
I am asking
again if any of you have a copy of either of copies of the first two symposia –
the one held at LSU (1978) and the one at Philadelphia (1980) – I would like to
ask for donations to our archive. Dr.
Gary Koritz has kindly donated his copy from the 1978 symposia. If you have a couple and would be willing to
donate them, please give me a call (217-359-0661) or email me at
cdavis@shout.net. I would really like
to get at least one copy or each for our archives.
Debbie Kochevar continues as our
website liaison and continues to work with our new webmaster (Brett Rose) at
Texas A&M. The website continues to
progress and we encourage you to contact with you thoughts on how it might be
improved. There is a place on the
website for your comments and we encourage you to send us suggestions, comments
or corrections.
In addition to your dues, I would
ask you to include any changes you would like to make to your directory listing
on the dues form. Remember to let us
know if you have any change in your mailing, phone, fax or email
information. Please check the website
to verify your current information. If
you do not remember the ID and password, please email me. I will pass it on to you. If you see any errors or omissions, please
let me know.
I continue to look forward to
serving as your Secretary-Treasurer and I encourage you to contact me
concerning any questions or any AAVPT business. I hope everyone has a wonder
spring.
Carol Davis
Secretary/Treasurer
(cdavis@shout.net).
************
AAVPT
Biennial Symposium 2003
A
committee has been formed to develop a program and to arrange a venue for the
next Biennieal Symposium: Randy Lynn (IDEXX), Ralph Claxton (Novartis), Terry
Clark (Pfizer) and myself. We invite interested members to volunteer to join us
in planning the Cutting Edge Symposium. Please send to any member of the
Symposium committee your suggestions for Speakers who can present their
knowledge of the cutting edge of veterinary
pharmacology.
The
symposium will be held in Charlotte, North Carolina, from June 3 - 4, 2003,
immediately preceding the ACVIM Annual Forum on June 4 - 7, 2003. People who
wish to nominate for the Program Committee or who wish to recommend speakers
and speaker topics, should contact Ted Whittem
AAVPT
President-Elect and Chair, 2003 Symposium Committee (mailto:tedw@jurox.com.au)
2002 AAVPT/ACVCP
Symposium
The AAVPT/ACVCP Annual Scientific Symposium and Annual
Meeting will be once again held in conjunction with the ACVIM Annual Forum,
this year to be held in Dallas May 29-June 1. The AAVPT/ACVCP morning session
this year will focus on clinical trial design, regulation, implementation, and
evaluation. The afternoon session will include therapeutic discussions about
parvovirus, parasitology, oncology, and pain and inflammation. We will be
welcoming Drs. Smothers, Oeller, Heit, Wang, Otto, Blagburn, Vail, and Martinez
to the podium for their insights in these areas. Please plan on attending not
only the AAVPT/ACVCP sessions, but other parts of the ACVIM Forum as well.
For the first time this year, a $500 award will be presented
to the best resident/graduate student abstract (poster or oral presentation)
presented at the Forum. To be eligible
for the award, a candidate must be in a training program leading toward
certification by the ACVCP. To certify
eligibility, candidates should send a copy of their accepted abstract signed by
their mentor to the following address by May 1, 2002:
ACVCP Scientific Programs Committee
c/o Terrence P. Clark, D.V.M., Ph.D., DACVCP
Veterinary Medicine - Pharmaceutical Clinical Development
P.O. Box 8200-40
Pfizer Global Research and Development
Eastern Point Road
Groton, CT 06340
**************
Meeting
Announcement
The AAVPT has a joint workshop coming up with the American
Association of Pharmaceutical Scientists and the Controlled Release Society
The American Association of Pharmaceutical Scientists (AAPS)
has announced the following upcoming workshop: Collaboration in the Research
and Development of Veterinary Pharmaceuticals, co-sponsored with the Controlled
Release Society and the American Academy of Veterinary Pharmacology and
Therapeutics. This is a first of its kind event bringing together scientists
from the veterinary pharmacology and pharmaceutical science research areas.
Participants in this AAPS Workshop will share knowledge and practical
experiences; learn important concepts and applications; and, interact with
professionals from industry, academia, and the FDA. Workshop attendees can
expect to better understand the research, current issues, future objectives and
directions in veterinary medicine. This exciting Workshop will be held May 6-8,
2002 at the Anderson Center for Professional Education, in St. Charles, IL. Go to www.aapspharmaceutica.com/meetings
or call 703-243-2800 for the most up-to-date meeting and registration
information.
**************
Membership Committee
Despite exciting advances in
veterinary pharmacology, the AAVPT continues to face a decline in membership.
As a consequence of this decline, it is becoming increasing difficult to meet
our objective of providing “a powerful force in the promotion of the science of
veterinary pharmacology and therapeutics”.
Consequently, to remain a vital organization, we must identify
mechanisms for recruiting new members and for increasing the level of
involvement of the existing membership.
The first step in this
process is to examine reasons why individuals actively participate in any
professional organization. In that
regard, the following attributes appear to consistently be of high-level
importance:
1. Networking opportunities: exchange of ideas, research collaborations, job
opportunities, etc.
2. Proactive efforts: development of workshops, position papers,
research opportunities, etc. that can influence the direction of science and
drug regulation.
3. Informative newsletters: the exchange of scientific current events
through newsletters or emails.
4. Continuing education: opportunities for the working professional to
keep current in an ever-changing scientific environment.
5. Training: opportunities to reach young scientists with state-of-the-art
information through both predoctoral and postdoctoral training efforts.
6. Dialogue: opportunities to exchange opinions and influence drug use and
regulatory policies.
While these items are
consistent with the AAVPT objectives, reductions in membership and overwhelming
job responsibilities have substantially reduced the number of innovative
activities we have to offer. Therefore,
to refresh the vibrancy of this organization, the following initiatives are
being considered by the Executive Council:
1. The creation of subcommittees based upon areas of
specialization:
i.
Manufacturing
Technologies
ii.
Clinical
Pharmacology
iii.
Pharmacokinetics/Bioequivalence
iv.
Human Food
Safety/Public Safety
v.
Microbiology
Members would identify their preferred area of focus. Subcommittee chairs would work with their
members to select a topic that will serve as their focus of discussion for that
year. Each group would be responsible
for writing a yearly “article” for AAVPT Newsletter, and these articles could
range from a summary of some of the year’s most important literature and
events, white papers, problems encountered/unresolved issues, pivotal
regulatory activities, etc. These articles would then serve not only as a
history of events within the individual areas but also provide a springboard
for future meetings, JVPT manuscripts, lectures, educational CD’s, etc.
2. Develop grassroots training
opportunities through academic graduate programs. In this regard, the activities of the Educational Committee will
be vital to attracting new members. For
example, the AAVPT could develop educational programs (CD’s, web-based lecture
series, workshops, etc). When “buying”
or “attending” one of these educational offerings, a one-year membership would
be included in the “package”. Please
note that years ago, this is how the
American Association of Pharmaceutical Scientist, which is today a very large
and very powerful organization, attracted new members.
3. Initiate a web-based discussion group, either
independently through the AAVPT website or as a portal that links with the
soon-to-be-available Animal Health Consortium discussion group.
By having an AAVPT portal, we can maintain a log of the questions raised by our
membership to ensure that the AAVPT keep appraised of what our members consider
to be “hot topics”.
4. Revise our membership directory so that
individuals are listed not only alphabetically but also by type of employment
(government, academia, private consultant, regulated industry) and area of
expertise. This will facilitate the
networking of AAVPT members, and may be particularly helpful to graduate students
or to those individuals who are new to the profession and our organization.
Finally, we need to revise
our membership forms such that they encourage rather than discourage
applications. The need to include a
curriculum vitae and letters of recommendation can be burdensome. Therefore, a simplified application process
needs to be developed.
Clearly, the Membership
Committee faces multifaceted challenges as we work at the materialization of
these initiatives. That is where
everyone’s contribution is necessary.
There are many opportunities for involvement, and hopefully this will
not become the effort of a few. With
that in mind, it is essential that people express a willingness to volunteer
their time and effort. Please forward any comments, suggestions, or offers to
support this effort to Marilyn Martinez at MMartin1@cvm.fda.gov.
-
Cyril Clarke (mailto:Clarke@okstate.edu)
************
News from the
Pharmaceutical
Industry
|
|
The
Animal Health Institute (AHI) reports some interesting trends in the animal
pharmaceutical industry. Worldwide,
animal health sales total $16.1 billion.
The animal health industry in the United States totaled $4.2 billion in
2000. In the U.S., companies spend
approximately 11-12 percent of their annual sales revenue on research and
development. In 1993, it was 17.5
percent. Two trends are clear: R&D as a percentage of sales is trending
down, and more of the R&D dollar is being spent on "defensive"
rather than "innovative" research.
The
decrease in R&D spending is attributable to an uncertain regulatory
environment. Development of a new
animal drug takes 7-10 years, and costs $80-100 million dollars. A product is considered a "blockbuster"
in animal health with sales of $50-100 million. The vast majority of animal health products - some 85 percent -
have sales under $1 million.
Industry
consolidation: Worldwide, the top 10
companies (sales) had 30 percent of the market in 1980; in 1995 it was 56
percent and in 2000 it was 65 percent.
Another way of looking at consolidation is number of companies with
membership in AHI:
1985 54
1990 38
1995 25
2002 17
Respectfully
submitted,
Dave
Kowalczyk
************
The Washington Scene
FDA
extends comment period for import tolerances ANPRM
FDA extended the comment period for
the advance notice of proposed rulemaking (ANPRM) on import tolerances to March
11, 2002. The ANPRM first appeared in the August 10, 2001, Federal Register.
According to the ANPRM, FDA intends
to propose a regulation for establishing import tolerances, and solicited
comments on issues related to the implementation of the import tolerances
provision in section 4 of the Animal Drug Availability Act of 1996 (ADAA).
The ADAA authorizes FDA to
establish drug residue tolerances (import tolerances) for imported food
products of animal origin for drugs that are used in other countries, but that
are unapproved new animal drugs in the U.S. Food products of animal origin that
are in compliance with the import tolerance will not be considered adulterated
under the Federal Food, Drug, and Cosmetic Act and may be imported into the
United States.
Written or electronic comments on
the ANPRM should be submitted to the Dockets Management Branch (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by
March 11, 2002. Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.
Comments should reference Docket No. 01N-0284.
CVM amends rules on
ADE records and reports
CVM is amending the requirements, effective August 5, 2002,
for records and reports of adverse experiences (ADE) and other information for
approved new animal drugs.
This interim final rule more clearly defines the kinds of
information to be maintained and submitted by new animal drug applicants for a
new animal drug application (NADA) or an abbreviated new animal drug
application (ANADA). In addition, the interim final rule revises the timing and
content of certain reports to enhance their usefulness. The regulation will
provide for protection of public and animal health and reduce unnecessary
record keeping and reporting requirements.
This interim final rule was published in the February 4,
2002, Federal Register and may be found on the FDA Home Page. Single
copies of the guidance may be obtained by writing to the Communications Staff
at the address listed above.
************
Meeting Announcements
• The International Conference on
Antimicrobial Agents in Veterinary Medicine (AAVM) will be held in Helsinki,
Finland, August 4-8, 2002. Topics
including clinical use of antimicrobial agents, antibiotic use in farm animals
and companion or racing animals, extralabel use, pharmacokinetics and residues
of antimicrobials will be presented.
Abstracts will be due April 1, 2002.
For more information, visit http://www.aavm2002.com.
Job Postings
¶ The Center for Veterinary Medicine/Food and
Drug Administration seeks veterinarians to work in the Office of New Animal
Drug Evaluation in
Rockville,
MD. Use your pharmacology and internal
medicine knowledge to evaluate toxicology and clinical trials submitted by
pharmaceutical
companies
to support new canine, feline, and equine drug approvals. You will review research proposals and final
study reports to assess scientific
validity. You will interact frequently with
pharmaceutical companies and have a significant impact on the development of
new animal health products. Critical
thinking, good writing skills, and ability to work as part of a
multi-disciplinary scientific team are essential. Requirements are a DVM degree
and at least one year of current clinical
practice
experience. Starting salary is GS-12 ($55,694 - $72,400) with promotion
potential to a
GS-13($66,229
- $86,095) after one year of successful job performance. Relocation expenses
will not be paid. Please contact Dr. Melanie Berson at mberson@cvm.fda.gov or
301- 827-7543
for
further information.
¶ Pfizer Veterinary Medicine in Groton, CT is
recruiting for the position of Clinical Research Investigator. A DVM/VMD degree is required
with
at least two years experience as a clinical veterinarian or related experience
in an area related to veterinary pharmaceutical development. Specific
responsibilities for the position include: (1) preparation of study protocols,
including data capture forms, and study reports; (2) liaise with investigators
responsible for conducting field and laboratory studies to ensure active
enrollment, accurate data capture and protocol and regulatory compliance; (3) liaise with participating contract research
organizations (CROs) to ensure consistency in communications with
investigators, adherence
to
Pfizer standard operating procedures (SOPs) and regulatory compliance; (4)
assist in maintenance of study budgets and timely payments to
investigators/CROs; (5) ensure correct and timely entry of study data into the
database; (6) ensure that study files are constructed and maintained in
accordance
with SOPs and regulatory requirements; and (7) maintain up-to-date awareness of
medical and therapeutic issues for the animal population used in assigned
studies and on a broader scientific front.
Position
may require travel to study sites for up to 50% of time. For information, please contact:
Terrence
P. Clark, D.V.M., Ph.D., Dip. ACVCP
Veterinary
Medicine - Pharmaceutical Clinical Development, P.O. Box 8200-40, Pfizer Global Research and Development, Eastern
Point Road
Groton,
CT 06340.
¶ Jurox is a 100% Australian owned research
based Company operating in the Animal Health and Rural Industries. New products
currently in development
will
result in substantial sales growth in the near future. Our products are sold to
Veterinarians, Consumers and Rural merchandise outlets. The Company spends over
12% of its revenue on research in Australia. Research Programme Manager
Jurox
has a vacancy for a veterinary scientist to work in our Research and
Development department. This opportunity will suit a veterinarian who wishes
to
develop and apply skills in research management. This is a permanent fulltime
position located in our Rutherford Facility in the Hunter Valley of
NSW.
The position includes responsibility for research and development of
traditional pharmaceutical products and novel biotechnology-derived therapeutic
products, working within and leading teams which include chemists,
veterinarians, agricultural scientists and marketing personnel.
Ideal
applicants will have a degree in veterinary science and either further research
experience or alternate post-graduate qualifications in any
discipline.
Knowledge of GLP and GCP, modern biotechnology methods and statistics and
demonstrated skills in scientific writing would be an
advantage.
An excellent salary and incentive package will be negotiated. Applications or
requests for further information should be sent to Dr. Ted
Whittem,
85 Gardiners Road, Rutherford 2320, NSW, phone +61 (0)2 4931 8229 mailto:tedw@jurox.com.au.
¶
Research Assistant Professor of Pharmacology
The
Center for Chemical Toxicology Research and Pharmacokinetics (CCTRP) at North
Carolina State University (NCSU) (http://cctrp.ncsu.edu) in the
Department
of Farm Animal Health and Resource Management (FAHRM) is primarily involved in
assessing percutaneous absorption and cutaneous
toxicology
of chemical mixtures and the prediction of drug residues in tissues of food
animal origin. A primary task of the center is management
of
the Food Animal Residue Avoidance Databank (FARAD) Eastern Regional Access
Center at NCSU-CVM. The incumbent to this position will manage and respond to
food animal residue queries that are submitted to FARAD by veterinarians,
producers,
and
other national and international agencies, as well as promote FARAD at regional
and national veterinary meetings. This individual will also be
involved
in research areas relevant to the research mission of the CCTRP and teaching in
the FAHRM Dept. Allocation of effort in this non-tenure
track
position is best described as 60% FARAD service, 30% Research, and 10%
Teaching.
Individuals
must have a. D.V.M. Additional graduate training in pharmacology/toxicology
and/or residency training with eligibility for board certification in a
relevant discipline (e.g., DABVT, DACVCP).
Candidates
with specific expertise & experience in one or several of the following
areas are encouraged to apply: drug metabolism; HPLC; statistics;
pharmacokinetic
modeling, and risk assessment. Candidates will be required to work
independently on projects pertinent to the mission of the Center
for
Chemical Toxicology Research and
Pharmacokinetics (CCTRP). The
position offers competitive salary and benefits. NCSU is located just
minutes
from Research Triangle Park, an internationally recognized center for
biomedical research. Substantial collaborations between the CCTRP, neighboring
Universities, national research laboratories, and major pharmaceutical
companies are on going. Technical
questions may be directed to Dr. Jim Riviere (mailto:Jim_Riviere@ncsu.edu). Applicants should provide the following:
curriculum vitae, list of publications, along with three references and a
concise statement of research accomplishments and future plans. Application
review will begin on 04/30/2002.
Position open until filled. Please send
the
above information to: Ms. Vickie Vick,
Administrative
Assistant to the Director,
Center
for Cutaneous Toxicology and Residue Pharmacology, North Carolina State
University, Raleigh, NC 27606. Individuals with disabilities desiring
reasonable accommodations in the application process should notify Vickie Vick,
CCTRP, 919-513-6398, FAX 919-513-6358, TTY 919-515-9617.
Obituary 
We lost one of our oldest Fellows, Dr. Ray S. Smith on
November 5, 2001. Dr. Ray became a
Fellow in 1978 when the Academy was first organized and became an Emeritus
Fellow 1981 upon his retirement. Dr.
Ray taught at The Ohio State University College of Veterinary Medicine for more
than 25 years. He began his long
association with OSU in 1955 as an instructor teaching veterinary pharmacology
and physiology, the year he received his DVM degree. In 1963, Dr. Ray became one of the first to earn a Ph.D. degree
in the OSU Department of Physiology. Dr.
Ray was a chemist by heart, and loved physiology. He taught veterinary clinical sciences and veterinary physiology
and pharmacology eventually becoming a full professor. In addition to his teaching
responsibilities, Dr. Ray was also Director of Pre- and Post-Race Testing
Laboratories at Ohio State from 1969 to 1981.
He helped establish testing facilities at both Scioto Downs in Columbus
and Northfield Park in Cleveland. After
retirement in 1981, Dr. Ray pursued his passion for photography and his
interest in antique cameras and development techniques. Dr. Ray also kept busy working with his son,
Dr. David Ray, an orthodontist in Westerville, Ohio. He helped with radiology and chemical hygiene in the
practice. He is survived by his wife,
Diane, and their three children, Kathleen, David and Elizabeth.
************
Journal
of Veterinary Pharmacology and Therapeutics
Your Journal
of Veterinary Pharmacology and Therapeutics continues to do well. You will
notice a new look in 2002 as the publisher, Blackwell
Press,
revitalizes its line of journals. The Chapter of Veterinary Pharmacology of the
Australian College of Veterinary Scientists is in the process of adopting JVPT
as their official journal. This should increase readership and impact. I urge
you to submit your pharmacology studies to your journal, as this is the only
way it will serve its function to publish the best veterinary pharmacology
research available.
Our
article submission rate was the same as last year, with a final acceptance rate
holding at 2/3. We need to try and
increase submissions, especially in areas of clinical pharmacology. The average
turnaround time for initial review holds at about two months, although
this
can be longer around holidays and vacation times (as our member reviewers
know!). If you have any desire to contribute an in-depth review article, which
will be refereed by our editorial board members, please get in touch with me to
discuss topics. Finally, subscriptions keep this journal in print. Please make
every effort to insure that your institution maintains a subscription. Also
visit the publisher's website
(www.blackwell-science.com)
for additional information.
I
must stress that this is your journal and only with your active involvement, in
the form of article submission, subscription and aiding the review process,
will it thrive.
Thanks,
Jim
Riviere, Editor
(Jim_Riviere@ncsu.edu).
AAVPT Newsletter Staff 
Editor: Scott Anthony
Brown
Correspondents
Industry: David F. Kowalczyk
Washington: Jon Scheid
J.V.P.T.: Jim Riviere
Program:
Ted Whittem
The
Newsletter is published three times
a year by the American Academy of
Veterinary Pharmacology and Therapeutics, at Pharmacia Animal Health. Please kindly address all correspondence to:
Scott Anthony Brown, DVM, PhD, 7926-190-045, Pharmacia Animal Health, 7000
Portage Road, Kalamazoo, MI 49001, U.S.A., phone 616.833.2412, FAX
616.833.3295, or e-mail scott.a.brown@pharmacia.com.
************
