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DACC NEWS

Volume 29, Number 3, December 2013

ANIMAL CLINICAL CHEMISTRY

2013 Fall/Winter Edition

Message from the Chair In This Issue:

Pg.4 Royden N. Rand Award

Pg.5 2013 Lunch & Learn Recap

Pg.5 DACC VIP Retires

Pg.6 DACC Best Poster Award

Pg.7 DACC Election Results

Pg.9 Recap of the 2013 Fall Webinar

Pg.10 A Survey of Current Industry Practices

Pg.11 Photos from Summer & Spring Mtgs

During the previous couple of months, a substan-tial amount of my time was consumed with leaf raking. I have to admit, Summer is my favorite time of the year because of the warm, sunny weather and excursions to the local beach, but I

also enjoy the Fall foliage here on the East Coast. The brilliant red and amazing orange and yel-low colors of the leaves are truly spectacular. However, once those bril-liant colors are gone, all that is left are the crispy brown leaves that accu-mulate all over the yard. I do realize that the leaf begins its life in the Spring, as the tree pushes

out the new leaf buds along the branches. The buds begin to make sugar sap that nourishes the tree which continues until late September or Octo-ber, when the change in the amount of daylight hours triggers the leaves to stop producing sap. The tree seals off the attachment point on the branch so that no water or minerals can be delivered to the leaf and no sugar sap can be delivered to the tree. The leaf begins to die from lack of nutrients. The leaves turn colors,

from red to yellow to purple, and then to brown. The skin and stem of the leaf becomes brittle and the leaf will then fall from the tree. The dead leaves will begin to break down in the elements, returning nutrients back into the soil for the next generation of leaves. This truly is the circle of life, and since Spring will be upon us shortly, I will look forward once again to the buds emerging and eventually new leaves being born. This is also the time of year when DACC mem-bers look forward to a preview of programs for 2014. In 2013, the DACC presented two free webinars that were hosted by Pfizer and were available to all DACC members. We have re-

ceived overwhelmingly positive feedback with one common request, to continue bringing these webinars to DACC members. I also found these two webinars very informative and I’m happy to announce that our webinars

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<Message from the Chair continued . . .>

will continue in 2014. Please stay tuned to the DACC Listserv for more information about future webinar dates and topics. If you have a particular topic of interest, please contact one of the Execu-tive Committee members. April is just around the corner, and on April 24th 2014, Siemens will be hosting the Multi-species User Group meeting at the Chauncey Hotel Con-ference Center in Princeton, NJ. On the evening of April 24th, the DACC Meet the Speakers Mixer will take place which is a great networking oppor-tunity. On April 25th, the DACC Spring symposium entitled “Bone Biomarkers and Bone Marrow” will be hosted by Bristol-Myers Squibb in Lawrence-ville NJ. The DACC Executive Committee would like to extend their gratitude and thank Dave Pav-lock and the staff at BMS for hosting this event at their site. I encourage members to mark their cal-endars and plan to attend this symposium, as it will be an excellent educational opportunity. September 2013 was the deadline to submit symposium proposals for the 2014 AACC Annual Meeting in Chicago. Once again, the AACC com-mittee had released a list of hot topics for 2014. One topic that was of interest was Inherited Dis-eases and Disorders. I submitted a symposium proposal on behalf of the DACC for a morning short course entitled “The Exploration and Treat-

ment of Inherited Disorders: Exploring the Pre-clinical and Clinical Features and Responding to the Medical Need of Hemophilia and Muscular Dystrophy”. I would like to take this opportunity to thank the Nominating Committee for their continued resolve in searching for volunteers for the DACC open po-sitions. Recruitment for officers is still a chal-lenge; however the committee this year was able to find two highly qualified individuals to place their names on the ballot for the Chair Elect posi-tion. Over the past year, it was evident to me that we have a core of dedicated individuals willing to dedicate time to make the DACC a successful and impactful division. The DACC continues to ask for individuals to step up, participate and volunteer for leadership roles. Our membership is the core to our success and is vital for us to continue to deliv-er high quality scientific educational programs. Lastly, I would like to thank the Executive Com-mittee and all members that have made this year as your DACC Chair a wonderful, fulfilling and re-warding experience. I have truly learned a great deal and have made many new and valuable con-tacts in our industry. I look forward in continuing my active participation in the division by support-ing our 2014 Chair, Dave Desmond. I look for-ward to working alongside Dave and support his vision.

Rich

DACC Spring Meeting 2014

Bone Biomarkers and Bone Marrow Hosted by Bristol-Myers Squibb, Lawrenceville, NJ

Stay Tuned to the DACC Listserv for Details

April 24: Chauncey Hotel Conference Center, Princeton, NJ Siemens Multi-Species User Group Meeting DACC Executive Committee Meeting Meet the Speakers Reception & Mixer, sponsored

by IDEXX BioResearch and Sysmex America April 25: Bristol-Myers Squibb, Lawrenceville, NJ

DACC Spring Symposium

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DACC SupportersDACC Supporters

Sustaining SponsorsSustaining Sponsors Diagnostica Stago

IDEXX Laboratories Novartis Pharmaceuticals

Siemens Healthcare Diagnostics Sysmex America, Inc.

BenefactorsBenefactors GlaxoSmithKline

Hoffmann-LaRoche, Inc. Merck & Co., Inc.

Merck Research Laboratories Pfizer Global Research and Development

PatronsPatrons Kay A. Criswell, PhD, DABT, –Pfizer, Inc.

Nancy Everds, –Amgen, Inc. Richard P. Giovanelli, –Pfizer, Inc.

FriendsFriends Karissa Adkins, –Pfizer, Inc.

Leigh Anderson, –Plasma Proteome Institute

Nelly Aranibar, –Bristol-Myers Squibb

Steven R. Binder, –Bio-Rad Laboratories

Mark Fidock, –Huntingdon Life Sciences

Gregory Friedrichs, –Novartis

Warren Glaab, –Merck Research Laboratories

John Jakubczak, –Pfizer, Inc. Jon Kimball –The Potter-Hawkins Group

Igor Mikaelian, –Hoffmann-La Roche

Rounak Nassirpour, –Pfizer, Inc.

Jonathan Phillips, –Boehringer-Ingelheim

William J. Reagan, –Pfizer, Inc.

Sharon Sokolowski, –Pfizer, Inc.

Dirk Sprenger, –Sprenger Masimula LLC

A A BIGBIG DACCDACC

THANKS!THANKS!

— To —

Susan Emeigh Hart Susan Emeigh Hart from Boehringerfrom Boehringer--IngelheimIngelheim and Ellen Evans Ellen Evans from Pfizerfrom Pfizer for being candidates in our recent elections, running for the position of Chair-Elect

— and —

Peter SzczerbaPeter Szczerba from Merckfrom Merck and David PavlockDavid Pavlock from Bristolfrom Bristol--Myers SquibbMyers Squibb for being candidates in our recent elections, running for a seat on the Nominating Committee

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This named award honors the service of the Past-Chair and pays tribute to the memory of Dr. Royden N. Rand, the President of the AACC who initially sanctioned the formation of the original ad hoc Laboratory Animal Clinical Analysis Group in 1976. This award is given to the DACC’s im-mediate Past-Chair to honor his or her contributions to the field of ani-mal clinical laboratory science throughout their career, and to acknowledge the recipient's many contributions to the Division of Ani-mal Clinical Chemistry. Each Chair has sacrificed their time to pro-mote and provide education in the area of Animal Clinical Chemistry, foster communication and networking among division members in ac-cord with our Division’s mission. In Recognition of her Exemplary Leadership and Dedication as Chair of the AACC’s Division of Animal Clinical Chemistry the 2013 Royden N. Rand DACC Past-Chair’s Award recipient is Kay Criswell. Currently Kay is the Executive Director and Drug Safety Research Site Lead at Pfizer in Groton CT. Her current areas of leadership include Clinical Pathology, flow cytometry, bioanalytical development, biomarker development and translation, investigative toxicology, and investigative pathology.

Kay’s commendable service to the DACC includes: Chair-Elect 2004-2005 and 2011 Chair 2006-2007 and 2012 Past-Chair 2008 and 2013

Kay was also the recipient of the DACC’s Award for Outstanding Contributions to Animal Clinical Chemistry in 2009.

Kay Criswell Receives the Royden N. Rand Division of Animal Clinical Chemistry Past Chair Award

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Doug Neptun Retires from Antech GLP

Doug served the DACC from 2002-2007 as Chair-Elect/Chair/Past-Chair, as well as being actively engaged in a variety of division programs, com-mittees, position papers and leadership roles. We wish him well in the next phase of his life. His dedication and contributions to the DACC have been many, and in 2003 he was awarded the DACC Award for Outstand-ing Contributions to Animal Clinical Chemistry. Doug served as a member of the DACC Long Rang Planning, Fund Raising, and Annual Meeting Program Committees. He also served the Division as DACC Liaison to the Clinichem or LabMed Organizing Com-mittee (2003), has been a chairperson or member of numerous Spring Meeting organizing committees, and was a member of the International Harmonization of Clinical Pathology Testing (IHCPT) Committee. The AACC has also benefited from his service as a member of the AACC An-nual Meeting Organizing Committee and as Selected Topics Chairman. Doug has further served the AACC as Chair of the North Carolina Section and as NC Section Program Chair, and as Program Chair, Treasurer, and then Chair of the AACC Pittsburgh Section. Early in his career Doug served as Automated Clinical Chemistry Super-visor, Department of Pathology, Evanston Hospital, Evanston, IL from 1971–1977. In 1977 he joined Baxter-Travenol as Clinical Chemistry Su-pervisor, and subsequently moved to the Chemical Industry Institute of Toxicology in Research Triangle Park, NC from 1978–1988. From 1988–1995, Doug served as Re-search Scientist and Supervisor at Bushy Run Research Center with responsibility for the Clinical Pathol-ogy, Analytical Chemistry, Genetic Toxicology, and Pharmacokinetics departments. In 1996, NC beck-oned and he returned to North Carolina as Manager of LabCorp's PreClinical Trials Laboratory. In 2004 he became Director of Antech GLP Laboratories in Research Triangle Park, NC, the position from which he is retiring. Doug will continue to serve on the DACC Awards committee.

Recap of the 2013 DACC Lunch and Learn

The 2013 DACC Lunch and Learn event occurred in Houston as part of the 2013 AACC Annual Meet-ing program. The theme was "Emerging Technologies in the Clinical Pathology Laboratory".

Our Division Chair, Richard Giovanelli of Pfizer, started things off with an update on DACC activities. The program continued with a video on the history of the AACC titled: “AACC, What a Great Idea" (a film by Third Avenue Productions in Association with the AACC History Division). The video was mod-erated by Dr. Joseph Dooley, the DACC’s 2013 recipient of the award for Outstanding Contributions to Animal Clinical Chemistry.

Two presentations on emerging technologies were given: Laboratory Information System Technology: Is Your Lab in the Driver’s Seat or Locked in the Trunk? – Johanna Wisniewski, Pfizer

Evaluation and Implementation of Hematology Auto-mation in Multispecies Clinical Pathology Laboratory

– Samantha Wildeboer, Pfizer

Hope to see you at the 2014 DACC Lunch & Learn

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Best Poster: 2013 Annual Meeting Animal Clinical Chemistry Division

Congratulations to Samantha Wildeboer and co-authors R. Giovanelli, W. Reagan, and J. Bock from Pfizer for winning the best poster competition for the Animal Division’s Travel Award at the 2013 AACC Annual Meeting. The poster was titled Validation of an Automated Cystatin C Assay in Canine Serum, Plasma, and Urine to Support Pre-Clinical Toxicology Studies. This award is given for solid, scientific work that progresses our understanding of attributes of animal la-boratory medicine. The award carries with it a $500 prize and travel to the DACC Spring Meeting.

Validation of an Automated Cystatin C Assay in Canine Serum, Plasma, and Urine to Support Pre-Clinical Toxicology Studies

Background: Cystatin C is a cysteine proteinase inhibitor formed at a constant rate and freely fil-tered by the healthy kidney, making it a desirable biomarker of renal function. Serum, plasma and urine concentrations of Cystatin C are dependent on the glomerular filtration rate (GFR) and a re-duction in GFR causes a rise in the concentration of Cystatin C. Unlike creatinine, Cystatin C has not been shown to be affected by factors such as muscle mass, age or nutrition. In addition, a rise in creatinine does not become evident until the GFR has fallen by approximately 50%, whereas Cysta-tin C is a more sensitive marker of kidney dysfunc-tion. Here, we validated an automated human Cystatin C assay for use in pre-clinical canine studies. Methods: The DakoCytomation Cystatin C im-munoparticles (LX002) is a purified immunoglobu-lin fraction of rabbit antiserum directed against Cystatin C covalently coupled to uniform polysty-rene particles. Immunoparticles are mixed with sample and a reaction buffer (S2361) and meas-ured by turbidity on the Siemens Advia 1800 ana-lyzer. Cystatin C concentration is extrapolated from a standard curve generated using DakoCyto-mation Cystatin C calibrator (X0974). DakoCyto-mation Cystatin C quality control (X0973) along with colony canine serum, sodium heparin plas-ma, EDTA plasma and urine with no additives were tested. Serum, plasma, and urine samples with varying levels of Cystatin C were created us-ing Cystatin C canine E. Coli recombinant protein (BioVendor LLC, RD472009100) to test the dy-namic range of the assay.

Results: Limit of Blank was established by ana-lyzing 10 replicates of 0.9% NaCl (w/v) diluent down to 0.1 mg/L. The lower limit of quantitation was verified with canine urine performed in dupli-cate for 10 days at 0.3 mg/L, with an acceptable %CV of 16.2. Intra-assay precision was per-formed with 20 replicates of spiked (recombinant) sample and % CV was ≤ 5.6 for canine serum, plasma and urine. Acceptable inter-assay preci-sion was established with three levels of quality control, all values falling within ± 2SD and %CV ≤ 5.9, similar to results obtained for intra-assay pre-cision. Spiked recovery was established using each sample matrix spiked with 10% calibrator material, and all results were within 20% of the expected value. Sample frozen (-80°C) stability was performed on sample pools spiked with re-combinant Cystatin C protein, at low, mid and high values along the assay calibration curve. Serum and plasma samples were considered stable out to 6 months and for three freeze-thaw cycles. The urine pools showed increased variability, and it was concluded that the recombinant protein that was spiked in the urine matrix was contributing to the variability seen. To further test urine stability, all timepoints and freeze-thaw cycles were repeat-ed with urine samples spiked with calibrator (10%). Follow-up testing confirmed stability out to 3 months and three freeze-thaw cycles. Conclusion: The DakoCytomation Cystatin C assay met all outlined criteria for validation and is appropriate for use in canine serum, plasma and urine samples to support pre-clinical toxicology studies.

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DACC ELECTIONS & NEW OFFICERS Very close results were obtained in this Fall’s division election.

DACC membership is very appreciative of all candidates who run for elected office.

Pete received a BS in Medical Tech-nology (Minoring in Biology) from the University of Delaware and went on to get his MS in Clinical Chemistry from West Chester University. He worked as a Generalist Medical Technologist at Saint Francis Hospital in Wilmington, Delaware, before joining Merck Re-search Laboratories (West Point, PA) in 2001. Starting as a Staff Biologist within the Laboratory Animal Resources (LAR) Di-agnostic Laboratory encompassing Clinical Chemis-try, Hematology, Microbiology, Molecular Diagnos-

tics, and Environmental Monitoring Pete is currently an Associate Princi-pal Scientist responsible for the daily operations and scientific oversight of the Diagnostic Support Laboratory within the Safety Assessment Clinical Pathology Department. While at Merck he has worn many hats and gained val-uable exposure to multiple technolo-gies, methodologies, and areas of re-search. The one reassuring constant he has had during this time is being

able to rely upon the incredibly valuable resource that is the DACC. (...continued on the next page)

Susan is an ACVP board certified veteri-nary anatomic and veterinary Clinical Pathologist, who is also ABT certified in General Toxicology. Her 21 year career in industry has provided her with broad-based experience in all aspects of preclin-ical drug development for both small mol-ecule pharmaceutical agents and biotech-nology products. Her areas of expertise include renal, hematologic and ocular pa-thology and physiology, biomarker devel-opment, mechanistic toxicology, mito-chondrial pathology, interstitial matrix biol-ogy, and cell-matrix interactions. Susan received her undergraduate degree from the Pennsylvania State University, her veterinary degree from the University of Pennsylvania, and then com-pleted a combined veterinary pathology residency and PhD program in the Department of Pathobiology at the University of Connecticut, with a postdoctoral fellowship through their School of Pharmacy’s Sec-tion of Toxicology. She started her career at Ciba-Geigy, then joined Pfizer as a Sr. Pathologist in Drug Safety. She then joined DuPont as a Principal Research Scientist in Safety Assessment and from there joined Astra-

Zeneca as a Preclinical Project Direc-tor. It was while working at AstraZene-ca that Susan attained her certification in clinical pathology. From there, Su-san went to Genaera to serve in Direc-torship capacities in Safety Assess-ment. She then went to Auxilium Phar-maceuticals, where in her role as the Sr. Director she was responsible for the execution of all non-clinical drug discovery, development and regulatory programs in support of compound reg-istration. Susan then joined Intrexon Corp. as the VP of Preclinical Develop-

ment. Currently, Susan is the Director of Experi-mental Pathology at Boehringer Ingelheim Phamraceuticals in Ridgefield, CT, where she leads the anatomic pathology, clinical pathology and his-tology/necropsy sections. Susan is an active member of a number of profes-sional organizations (AACC, ABT, ACVP, ASVCP, BioSafe, STP, SOT), for which she has held numer-ous offices, served on committees, and has been invited to present on a variety of topics at local, na-tional and international meetings.

Elected as DACC’s 2014 Chair-Elect Susan G. Emeigh Hart, VMD, PhD, DACVP, DABT, ERT

Boehringer-Ingelheim

Elected to DACC’s 2014 Nominating Committee Peter Szczerba, MS, CLS, MT(ASCP)

Merck Research Laboratories

Pending

Receipt

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DACC ELECTIONS & NEW OFFICERS Continued . . .

Samantha Wildeboer MT BS (ASCP) received her Masters of Clinical Labora-tory Science from Rush University in Chicago, Illinois after attending Baylor University for her undergraduate de-gree. In May 2013, she graduated from Brown University with a Masters in Biol-ogy. Samantha’s background includes medical technology generalist in the hospital laboratory environment, medical device pre-clinical study director, and antibacterial and cardiovascular therapeutic area project support. Samantha officially joined Pfizer in 2008, and cur-rently works as a scientist in Clinical Pathology, part of Drug Safety Research and Development in Groton, CT and is currently an AACC/DACC mem-ber. Within Clinical Pathology, Samantha is a key operator in the Hematology discipline and is the pri-mary contact for College of American Pathologist accreditation checklists in Hematology. Samantha is proficient in all aspects of the Clinical Pathology laboratory including hematology, clinical chemistry, urinalysis, coagulation, immunoassay and

bone marrow analysis. She has per-formed and authored multiple instrument and assay validations and user guides, has provided mentorship and training to new colleagues within the Clinical Pa-thology team and serves as a Cerner Laboratory Informatics System adminis-trator, performing appropriate training and system support. Samantha is integral to the support of a summer internship program within the

Clinical Pathology group, developing the content and objectives and mentoring the summer intern. Sa-mantha works closely with investigators to arrange sample analysis within the Clinical Pathology labora-tory and providing excellent customer support. Additionally, Samantha works as a Project Manag-er for the Antibody Drug Conjugate Investigative Project team. Samantha attended the 2013 AACC meeting in Houston, TX where she presented at the DACC Lunch and Learn and prepared two posters for the DACC poster session.

Pete joined the DACC in 2001 and has attended a number of Spring DACC meetings as well as the AACC Annual Meeting and contributes when possi-ble to the DACC ListServ. DACC meetings, educa-tional programs, networking discussions, and the

ListServ topics have provided him additional direc-tion for growth and development. He is excited to become more involved in the DACC and give back to our unique organization.

Appointed as DACC’s 2014 Treasurer to Fill a Mid-Term Resignation Samantha Wildeboer, MS, MA, MT(ASCP) Pfizer Global Research and Development

Elected to DACC’s 2014 Nominating Committee Peter Szczerba, MS, CLS, MT(ASCP)

Merck Research Laboratories Continued . . .

The membership of the DACC extends its gratitude to Lila Ramaiah of Huntingdon Life Sciences, who served on the Executive Committee as our division’s Treasurer. Lila was elected to this office for the 2011-2012 term, and selflessly volunteered to stay on for another term. She has decided to relinquish the office at the end of this year, as she becomes the Chair of the American Society for Veterinary Clinical Pathol-ogy’s (ASVCP) Regulatory Affairs Committee (RAC). In this capacity she will be busy collaborating with 17 members representing industry and academia. The RAC had a impactful year in 2013 with the publication of an important manuscript that Lila co-authored (Tomlinson, L. et al., 2013. Best Practices for Veterinary Toxicologic Clin-ical Pathology, With Emphasis on the Pharmaceutical and Biotechnology Indus-tries. Vet Clin Pathol, 42(3), pp.252–269) http://onlinelibrary.wiley.com/doi/10.1111/vcp.12059/pdf

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Recap of the DACC’s Fall 2013 Webinar Speaker: Nancy Everds, DVM, DACVP

Pathology Director and ClinPath Lead, Amgen, Seattle, WA

The DACC and invited speaker Dr. Nancy Everds, Amgen, Inc., Seattle, WA hosted and pre-sented a DACC Fall Webinar on October 30th, 2013 entitled Clinical Pathology Aspects of Stress. Stress often occurs during toxicity studies. The perception of sensory stimuli as stressful primarily results in catecholamine release and activation of the hypothalamic–pituitary–adrenal (HPA) axis to increase serum glucocorticoid concentrations. Downstream effects of these neuroendocrine sig-nals may include effects on hematologic and clini-cal chemistry measurements as well as effects on other commonly measured parameters such as decreased total body weights or body weight gain; food consumption and activity; altered organ weights (e.g., thymus, spleen, adrenal); lympho-cyte depletion in thymus and spleen; and altered reproductive functions. Typically, only some of the-se findings occur in a given study. Determining whether effects are the result of stress requires a weight-of-evidence approach. Understanding clini-cal pathology changes associated with the stress of procedures and toxicities is important for accu-rate attribution of data to test article. Acute stressors can transiently increase red cell mass and increases in reticulocytes. For example, epinephrine infusion, transportation, exercise, or restraint can be associated with a 5-10% increase in red cell mass with a 2-6x increase in reticulo-cytes due to splenic contraction and release of re-ticulocytes from bone marrow. In contrast to acute stress, chronic stressors such as severe dietary restriction, severe traumatic injuries, and/or chronic diseases and catheterization can result in de-creased red cell mass. For white cell parameters,

acute stressors can increase both neutrophils and lymphocytes. These early effects (within minutes) are mediated by epinephrine, and include in-creased neutrophils (mediated mostly by α-adrenergic receptors) and increased lymphocytes (mediated by β2-adrenergic receptors). Glucocorti-coid-mediated effects of stress include increased neutrophils and decreased lymphocytes and eosin-ophils; these changes are generally first observed within 30 minutes to a few hours after a stressor. Changes in clinical chemistry parameters related to stress are less consistent than those of hematology and are most consistently observed with acute stress. Most stress research involves either short term (minutes/hours) or intermittent application of stressors. Under these conditions, circulating cate-cholamines and hormones of the hypothalamic-pituitary-adrenal axis are relatively good markers of stress. In contrast, stress observed in repeat dose toxicity studies tends to be more chronic rather than acute. Under chronic conditions, circulating hormones are often normal despite the presence of stress. Key points from this webinar were that preanalyti-cal procedures are stressful and every attempt should be made to put practices in place to mini-mize stress including maintaining consistent proce-dures; that effects of stressors are dependent on variables such as species, stimulus, duration, tim-ing, magnitude, and habituation; and that clinical pathology changes can provide support for stressor-related effects. In toxicity studies, no one parame-ter consistently indicates stress –scientists should take a weight of evidence approach to determine whether stress occurred during a study.

See related 2013 review article:

Interpreting Stress Responses During Routine Toxicity Studies: A Review of the Biology, Impact, and Assessment

Toxicologic Pathology, 41:560-614, 2013 http://tpx.sagepub.com/content/41/4/560.full.pdf+html

Authors of this important publication, representing the Society of Toxicologic Pathology (STP)

Working Group, include: Nancy E. Everds (Amgen Inc.), Paul W. Snyder (Purdue University),

Thomas J. Rosol (Ohio State University), Dianne M. Creasy (Huntingdon Life Sciences),

Keith L. Bailey (Oklahoma State University), Brad Bolon (Ohio State University),

George L. Foley (AbbVie), and Teresa Sellers (GlaxoSmithKline)

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Harnessing the Power of the DACC Network

During 2013 Mike Bieraugel, Allergan, Irvine CA, surveyed DACC colleagues across several facilities on multiple occasions to benchmark industry practice on certain issues related to

drug safety toxicology studies, both conducted internally, and sponsored at CROs.

Survey Questions Response: Incidence

1) How many prestudy Clin Path col-lections does your facility routinely request on studies involving non-rodent species?

One: 5/13

Two: 7/13

1 or 2: 1/13 (one if K9, two if NHP)

2) Does your facility routinely request an interim in-life Clin Path collection within a week or so of initiation of dosing on non-rodent studies of ≥2 weeks in duration?

Yes: 3/12

Y/N: 5/12 (1 facility: Yes if NBE, No if NCE)

(1 facility: Only if study duration ≥4 weeks) (1 facility: Only upon suspicion of early onset toxicity) (2 facilities: Only if no Week 1 data from a previous study exists)

No: 4/12

3) Does your facility’s routine prac-tice regarding interim in-life Clin Path collections change if the study has a local or dermal route of admin rather than systemic?

Yes: 2/12 No: 9/12

4) Does your facility report ONLY absolute values from leukocyte dif-ferential and reticulocyte counts?

Yes: 10/15

Y/N: 1/15 (reports both relative AND absolute counts, yet only absolute

counts cited in the narrative and statistically analyzed)

No: 4/15 (reports both relative AND absolute counts)

5) Does your facility provide detailed guidance to internal Pathologists specifying a preferred uniformed study report writing style/approach?

Yes: 10/11 No: 1/11

6) Does your facility provide detailed guidance to your CRO Pathologists specifying a preferred uniformed study report writing style/approach?

Yes: 9/11 No: 2/11

7) Does your facility typically cite numeric magnitudes of change in your study report narrative Results sections? (i.e. in addition to communi-

cating severity modifiers)

Yes: 11/11 (1 of these does this instead of using severity modifiers) No: 0/11

8) Does your facility typically cite numeric magnitudes of change in your study report narrative Summary sections? (i.e. in addition to communi-

cating severity modifiers)

Yes: 5/11 (1 of these does this instead of using severity modifiers)

Y/N: 1/11 (This responder does this only for ALT and AST)

No: 5/11

Note: Responses were obtained from the following facilities. Not all companies responded to all questions. Question No.8 was the only one that incorporated responses from CROs: AbbVie, Alcon, Allergan, Amgen, Antech GLP, Astra Zeneca, Baxter, Bristol-Myers Squibb, Boehringer Ingelheim, CRL, Dupont, GlaxoSmithKline, Hoffmann-La Roche, Johnson & Johnson, Lilly, Merck, MPI, Novartis, Pfizer, and Sanofi Aventis

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Images from the 2013 Annual Meeting

Kay Criswell (Pfizer), Stephan Sultana (Novartis), Nancy Everds (Amgen), and Stefan Ho (Pfizer)

Rich Giovanelli Joseph Dooley

Joseph Dooley

Dave Desmond

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2014 Division of Animal Clinical Chemistry2014 Division of Animal Clinical Chemistry2014 Division of Animal Clinical Chemistry Travel Award for DACC Best Poster PresentationTravel Award for DACC Best Poster PresentationTravel Award for DACC Best Poster Presentation

At the AACC Annual MeetingAt the AACC Annual MeetingAt the AACC Annual Meeting

DACC Travel Award Recognition Award for DACC Poster Presentations

The AACC Division of Animal Clinical Chemistry (DACC) Executive and Awards Committees have established a Travel Award to be given in recognition of outstanding research in the area of Animal Clinical Laboratory Medicine for an abstract accepted and a poster presented at the AACC Annual Meeting. This DACC Travel Award is for the presenters of the best abstract & poster by DACC members, associates, or trainees (in academia or industry) in multi-species Clinical Pathology that has been accepted and presented at the AACC Annual Meeting. Up to two posters & abstracts may be selected each year for this award based on merit and recommendation of the Abstract Review Committee. The Travel Award consists of a certificate of scientific merit, a $500 monetary cash award, and travel reimbursement (up to $1000) to support the awardees' expenses to attend (registration fee waived) the DACC Spring Meeting.

This Award is Sponsored by the DACC Executive and Awards Committees

A REMINDER to Submit 2014 AACC Annual Meeting Poster Abstracts

The DEADLINE for poster abstract submission is 6pm EST, February 26, 2014

It seems like it’s only been a short time since last summer’s

AACC Annual Meeting, but time flies when you are as busy as we’ve all been these past few months. Time will seem to accelerate

as we become involved with departmental initiatives related to the new year. Thus, this note is to serve as a reminder that you only have a couple of months remaining to submit your DACC poster abstracts

for next year’s annual AACC meeting in July. Stay tuned for AACC

announcements regarding online abstract submission procedures.

Be sure to submit your abstract to be included with those in the Animal Clinical Chemistry Division

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Call for NominationsCall for Nominations

2014 Division of Animal Clinical Chemistry Award for2014 Division of Animal Clinical Chemistry Award for2014 Division of Animal Clinical Chemistry Award for Outstanding Contributions to Animal Clinical ChemistryOutstanding Contributions to Animal Clinical ChemistryOutstanding Contributions to Animal Clinical Chemistry

The DACC has established a Division Award which recognizes Outstanding Contributions in the field of Animal Clinical Chemistry. This Award consists of a plaque, an honorarium and a reception for the individual so honored, and is usually presented at the AACC Annu-al Meeting. The DACC Awards Committee would like to invite all members and friends of the DACC to nominate such an honoree. The Award is to recognize the achievements of an individual who has made significant contributions in the field of animal clinical chemistry in its broadest sense including teach-ing, training, practicing and research. Activities and achievements of this person, which have significantly benefited the science and advancement of this discipline, as well as en-hanced the public awareness and understanding, are also taken into consideration. The recipient of this prestigious award will be selected from nominations submitted by an AACC member or group of members such as division, local section, committee or commis-sion. Nominations will also be considered from non‑member individuals and organiza-tions. Please submit your nomination by letter or e-mail. The submission should consist of a statement of the nominee’s accomplishments and a current curriculum vitae and bibliog-raphy. Two seconding letters of support from colleagues detailing the candidate’s accom-plishments not given in the primary letter of nomination should be included. The latter will play an important role in the Awards Committee deliberations. Previous recipients of the DACC award were: Nominations must be received no later than March 30, 2014. Please submit completed nomination documents by email or surface mail to: Jon P. Kimball, PhD, DACC Awards Committee 1732 Old Lystra Road, Chapel Hill, NC 27517, 919-967-4016 eMail: JonKimball@msn.com

Jiro J. Kaneko, DVM, PhD 1993 Charles C. Capen, DVM, PhD 2004

Eitan Bogin, PhD 1994 John H. (Tim) Lumsden, DVM, DACVP 2005

Donald T. Forman, PhD 1995 Douglas J. Weiss, DVM, PhD, DACVP 2006

Robert E. Emmons, BS 1996 W. Jean Dodds, DVM 2007

Walter F. Loeb, DVM, PhD 1997 N. Leigh Anderson, PhD 2008

Thomas J. Reimers, PhD 1998 Kay A. Criswell, PhD, DABT 2009

Jon P. Kimball, PhD 1999 P. David Eckersall, BSc, MBA, PhD 2010

Dai T. Davies, PhD 2000 Peter J. O'Brien, DVM, DVSc, PhD 2011

Walter E. Hoffmann, DVM, PhD 2001 Jean-Pierre Braun, Dr Vét, Dr Sc, 2012

John W. Harvey, DVM, PhD 2002 Joseph F. Dooley, PhD, DABCC, FACB 2013

Douglas A. Neptun, BS, MT/ASCP 2003

15

SOCIETY OF TOXICOLOGY

ANNUAL MEETING

MARCH 23-27, 2014

PHOENIX, AZ

AACC / DACC ANNUAL MEETING

July 27-31, 2014

Chicago, IL

AMERICAN COLLEGE of

TOXICOLOGY

ANNUAL MEETING

November 9-12, 2014

Orlando, FL

ACVP / ASVCP ANNUAL MEETING

November 8-12, 2014

Atlanta, GA

The Membership of the DACC

Extends a Huge THANK YOU

to its Outgoing Officers:

2011–2013’s Chair-Elect, Chair, Past-Chair

Kay Criswell, Pfizer

2011–2013’s Treasurer

Lila Ramaiah, Huntingdon Life Sciences

2013’s Nominating Committee Chair

Doug Thudium, Merck

The DACC is Seeking a Volunteer to Serve as the Archivist of Our Division’s Historical Records

Every Aspect of the DACC Depends on the Volunteerism of People Like YOU!

ISACP 16TH

BIENNIAL CONGRESS

JUNE 25-29, 2014

COPENHAGEN, DENMARK

WWW.ISACP2014.ORG ABSTRACT DEADLINE 3/1/14

16

DACC 2013 Executive Committee Chair

Richard P. Giovanelli Pfizer Global Res. & Dev.

860-686-2176 richard.p.giovanelli@pfizer.com

Past-Chair Kay Criswell

Pfizer Global Res. & Dev. 860-686-9430

kay.criswell@pfizer.com

DACC NEWS AACC’s Division of Animal Clinical Chemistry

DACC NEWS Editor Mike Bieraugel

714-246-6051 bieraugel_michael@allergan.com

DACC NEWS Editor Emeritus Robert E. Emmons

585-924-5019 reemmons@frontiernet.net

DACC NEWS Associate Editor Jon P. Kimball

919-967-4016 jonkimball@msn.com

Chair-Elect David Desmond

AbbVie, Inc. 847-935-6540

david.desmond@abbvie.com

Treasurer Lila Ramaiah 732-371-2550 ext 2683 lramaiah@mac.com

Secretary David F. Adams

GlaxoSmithKline R&D 610-270-7228

david.f.adams@gsk.com

DACC 2013 Committees Membership

Volunteers Needed!

Fund Raising Jon Kimball

Doug Neptun Chris Perigard

Lila Ramaiah (Exec Rep)

Awards Jon Kimball (Chair)

Kay Criswell Bob Emmons Doug Neptun

Nominating (Year as Chair) Doug Thudium (2013) Karen Lynch (2014)

Dirk Sprenger (2015) Tammy Lambert (2016) Kay Criswell (Exec Rep)

Scientific Program & Long Range Planning

Richard Giovanelli1,3

Kay Criswell2

David Desmond4

Doug Thudium Jon Kimball

Volunteers Needed!

Principal Organizer: 1: 2013 Spring Symposium, 2: 2013 Annual Meeting Symposium, 3: 2014 Annual Meeting Symposium, 4: 2013 Annual Meeting Lunch & Learn