News
Along the Pike
August 27, 2003
Volume 9, Issue
3
Center for Drug Evaluation and Research
Index
Center recognizes 52 individuals,
32 teams: FDA, Science Forum honor 10 CDER employees, 7
teams
By
Jackie Barber
At the Center’s Spring Honor Awards Ceremony held May
30 in Gaithersburg, 52 individuals and 32 teams were
recognized. An additional nine individuals and two teams
were recognized at the Agency-level ceremony held May 9 in
Rockville (below).
FDA’s 2003 scientific achievement awards were presented to
one CDER scientist and five teams with CDER scientists at
the annual Science Forum held April 24 and 25 in Washington’s
new convention center (below).
“You have continued to meet the challenges and surpass
expectations with your innovation and dedication to serving
the American people,” Center Director Janet Woodcock,
M.D., told the awardees at the CDER ceremony. “Your
superior leadership, scientific expertise and technical
skills demonstrated are second to none. You should feel
extremely proud of your accomplishments and even prouder
that your efforts have such a profound and positive impact
on health care for so many individuals in our country.”
Kevin Barber sang the national anthem. John L. Emelio,
who is the director of the Division of Management
Services in the Office of Management, was master of
ceremonies. Dr. Woodcock, Deputy Center Director Steven
Galson, M.D., and members of the Center’s senior
management presented the awards.
The awards were:
FDA
Outstanding Service Award
Richard C. Adams
Sarah J. Singer, R.Ph.
Judy A. Staffa, Ph.D., R.Ph.
Audrey A. Thomas
Postmenopausal Estrogen Labeling and Guidance Group: Mark
I. Avigan, M.D., Julie G. Beitz, M.D., Jeanine A. Best,
Sandra L. Birdsong, Debra E. Boxwell, Pharm.D., Eric Colman,
M.D., Bronwyn E. Collier, BSN, Susan M. Cruzan, Daniel
Davis, M.D., Lisa M. Davis, Nancy E. Derr, Evelyn R.
Farinas, Richard J. Friedman, Lesleyanne Furlong, M.D.,
Audrey L. Gassman, M.D., Brenda S. Gierhart, M.D., Maureen
A. Hess, Susan L. Honig, M.D., Florence Houn, M.D., MPH,
John K. Jenkins, M.D., Brenda J. Kiliany, Margaret M. Kober,
Carrie L. Lemley, Markham C. Luke, M.D., Norman S. Marks,
M.D., Katherine B. Meaker, Ph.D., Robert J. Meyer, M.D.,
Scott E. Monroe, M.D., S. Edward Nevius, Ronald J. Orleans,
M.D., Jayne E. Peterson, JD, Phill H. Price, M.D., Victor F.
Raczkowski, M.D., Lisa D. Rarick, M.D., Crystal L. Rice,
Leah W. Ripper, Daniel A. Shames, M.D., Shelley R.
Slaughter, M.D., Dornette D. Spell-LeSane, Bruce V. Stadel,
M.D., Paul K. Stauffer, Lisa L. Stockbridge, Theresa H. Van
Der Vlugt, M.D., Barbara D. Wesley, M.D., Gerald D. Willett,
M.D., Sally Winthrop, Susan F. Wood, Ph.D, and Diane
K. Wysowski, Ph.D. PHS Unit Commendation: LCDR
Gregory S. Davis, CAPT Rita R. Hassall, CDR David A.
Konigstein, CAPT Mary J. Kozmo-Fornaro, LCDR Mary E.
Kremzner, CAPT Sandra L. Kweder, CDR George A. Lyght, LCDR
Lisa L. Mathis, CAPT David G. Orloff, LT Sandeep S. Saini,
CDR Kassandra C. Sherrod, and LCDR Samuel Y. Wu.
FDA
Group Recognition Award
In Vitro Metabolism/Transport-Based Drug Interaction
Group: Sophia S. Abraham, Ph.D., Sayed Al Habet, Ph.D.,
R.Ph., Sang M. Chung, Ph.D., Philip M. Colangelo, Pharm.D.,
Ph.D., Jerry M. Collins, Ph.D., Shiew Mei Huang, Ph.D.,
Ronald E. Kavanagh, Pharm.D., Ph.D., Lawrence J. Lesko,
Ph.D., Wei Qiu, Ph.D., N.A.M. Atiqur Rahman, Ph.D., Kellie
S. Reynolds, Pharm.D., Sandip K. Roy, Ph.D., Solomon Sobel,
M.D., John M. Strong, Ph.D., Xiaoxiong Wei, M.D., Ph.D., Lei
K. Zhang, Ph.D., and Jenny H. Zheng, Ph.D.
Ketamine Neurotoxicity Investigative Group: William
Allaben, Ph.D., Nancy S. Chang, M.D., Hirsch D. Davis,
Joseph J. DeGeorge, Ph.D., Patrick J. Faustino, Ph.D., Neil
Grunberg, Ph.D., Kathy Haberny, Ph.D., Joseph P. Hanig,
Ph.D., David Lester, Ph.D., Thomas Papoian, Ph.D., Merle G.
Paule, Ph.D., Patrick S. Pine, Andrea M. Powell, Ph.D.,
Andrew C. Scallet, Ph.D., and William Slikker Jr.,
Ph.D. PHS Officer Nominated for PHS Award: CAPT Frank
D. Sistare.
OCPB New Reviewers Course Team: Raman K. Baweja,
Ph.D., Brian P. Booth, Ph.D., Jogarao V. Gobburu, Ph.D.,
Andre J. Jackson, Ph.D., Patrick J. Marroum, Ph.D., Mehul U.
Mehta, Ph.D., N.A.M. Atiqur Rahman, Ph.D., Chandrahas G.
Sahajwalla, Ph.D., Ramana S. Uppoor, Ph.D., and Gene
M. Williams, Ph.D.
OGD Scientific Symposium Committee: Raman K. Baweja,
Ph.D., Karen A. Bernard, Ph.D., Chandra S. Chaurasia, Ph.D.,
Rebacca A. Decker, John D. Franolic, Ph.D., Carol Y. Kim,
Pharm.D., See Yan Lam, Pharm.D., Ph.D., Melissa A. Lamb,
Dominick C. Roselle, Ph.D., Arthur B. Shaw, Ph.D., Neeru B.
Takiar and Lawrence X. Yu, Ph.D.
OTCOM Federal Register/Code of Federal Regulations
Instructional Services Team: Muriel N. Cherry, Lois G.
Chester and Kathryn W. Kruse.
Review Support Branch, DLPS/OGD: Mark D. Anderson,
Elizabeth T. McNeal and Nadine Warren. PHS
Officers Nominated for Companion Award: CAPT Timothy W.
Ames, LT Peter Chen, LCDR Michelle Dillahunt, LT Thomas O.
Hinchliffe, LT Sarah H. Ho, LT Craig P. Kiester, LT Soojung
S. Kim, LT Jeen S. Min, LT Wanda Pamphile, LT Nicole Park,
LT Stanley M. Shepperson and LT Chi-Ann Y. Wu.
Voriconazole NDA Review Team: Renata Albrecht, M.D.,
M.R. Alivisatos, M.D., Shukal Bala, Ph.D., Marc W. Cavaille
Coll, M.D., Ph.D., Leo Chan, R.Ph., Philip M. Colangelo,
Pharm.D., Ph.D., Edward M. Cox, M.D., MPH, Barbara M. Davit,
Ph.D., Cheryl A. Dixon, Ph.D., Mark J. Goldberger, M.D.,
MPH, Linda L. Gosey, Kenneth L. Hastings, DPH, Karen M.
Higgins, D.Sc., Gene W. Holbert, Ph.D., Rosemary Johann
Liang, M.D., Karin M. Klunk, Owen G. McMaster, Ph.D., John
H. Powers, M.D., Rigoberto A. Roca, M.D., David L. Roeder,
Norman R. Schmuff, Ph.D., and Rosemary Tiernan, M.D.,
MPH PHS Unit Commendation: LCDR Ellen C. Frank
and LT Jouhayna S. Saliba.
FDA
Leveraging/Collaboration Award
Ramzi N. Dagher, M.D.
Equal
Opportunity Achievement Award
Frances V. LeSane
PHS
Commendation Medal
CDR Terri L. Crescenzi
CAPT Lillie D. Golson
LCDR Mitchell V. Mathis
Center
Director’s Special Citation
Edward M. Cox, M.D., MPH
Rosemary Roberts, M.D.
CDER
Special Recognition Award
Cynthia A. Bigger, Ph.D.
Charles R. Bonapace, Pharm.D.
Kuldeep R. Dhariwal, Ph.D.
Jennifer L. DiGiacinto, Pharm.D.
Cheryl A. Dixon, Ph.D.
Joan S. Flaherty
Tapash K. Ghosh, Ph.D.
Thomas S. Hammerstrom, Ph.D.
Linda L. Lewis, M.D.
Patricia P. Harlow, Ph.D.
Thomas A. Marciniak, M.D.
Moheb M. Nasr, Ph.D.
Celia J. Winchell, M.D.
CDER’S Program Management Team: Tanya L. Abbott, Amy
M. Garvin, Jeremy R. Lowery, Jamie M. Metz, Bonita L. Moore,
Carol T. Norwood and Christine Shipe.
Hepatitis B Drug Development Working Group: Russell D.
Fleischer, PA-C., MPH, Katherine A. Laessig, M.D., Linda L.
Lewis, M.D., Lalji Mishra, Ph.D., Jeffrey S. Murray, M.D.,
MPH, Julian J. O Rear, Ph.D., Guoxing Soon, Ph.D., and
Barbara Styrt, M.D., MPH
Pharmacy Compounding Database Team: Kathleen R.
Anderson, Pharm.D., and Crystal A. King.
CDER Administrative/Program Management Excellence
Julie L. Basore
Raya S. McCree
Tammy L. Mueller
Renee V. Redd
CDER Excellence in Communication Award
Ayse N. Hisim
Division of Oncology Drug Products Pediatrics
Subcommittee: Ramzi N. Dagher, M.D., and Alla
Shapiro, M.D. PHS Unit Commendation: CDR Stephen I.
Hirschfeld.
CDER Information Technology Excellence Award
Paul Haustein (Booze-Allen & Hamilton)
Desktop Management Team: Wilberforce E. Brooks Jr.,
Gurminders J. Khalsa, James W. Marshall and Rodney K.
Smith.
Office of Drug Safety AERS Quarterly Update Team: Paul
F. Reinstein and Lynette Swartz.
CDER Leadership Excellence Award
Eric G. Colman, M.D.
Julieann DuBeau
Margaret M. Kober
Joyce A. Korvick, M.D.
Brad G. Leissa, M.D.
Timothy J. McGovern, Ph.D.
William W. Oswald
Khyati N. Roberts
Janice M. Soreth, M.D.
Robert L. West
Duu-Gong Wu, Ph.D.
CDER
Excellence in Mentoring Award
Marta L. Locklear
Kellie S. Reynolds, Pharm.D.
Diana M. Willard
CDER
Project Management Excellence
Christy L. Cottrell
Lorene M. Kimzey
DACCADP’s Project Management Team: Lisa E.
Basham-Cruz, Kimberly A. Compton, Parinda Jani, Victoria
Kao, Lisa M. Malandro and Sara E. Stradley.
DAVDP Project Managers: Marsha S. Holloman, Christine
K. Lincoln, Jeff D. O’Neill, Virginia L. Yoerg and
Karen A. Young. PHS Officers Nominated for Companion
Award: LT Sean J. Belouin, CAPT Anthony W. DeCicco, LCDR
Sylvia D. Lynche, LCDR Nitin K. Patel, LT Vasavi T. Reddy
and LT Destry M. Sillivan.
Project Managers in the Division of Anti-Viral Drug
Products: Grace N. Carmouse, Susan Cobb, Joean E. James,
Marsha S. Holloman, Christine K. Lincoln, Jeff D. O’Neill,
Khai M. Phi, Melissa M. Truffa, Virginia L. Yoerg and
Karen A. Young. PHS Officers Nominated for Companion
Award: LT Sean J. Belouin, LTJG Sean R. Byrd, CAPT
Anthony W. DeCicco, LCDR Sylvia D. Lynche, LCDR Nitin K.
Patel, LT Vasavi T. Reddy, LT Destry M. Sillivan and
LCDR Leslie A. Stephens.
CDER
Support Staff Excellence Award
Martha A. Carter
Rebacca A. Decker
Darlene T. Johnson
Kelly S. Phelan
Kim J. Robertson
Rose M. Smith
Barbara J. Townsend
CDER
Team Excellence Award
Antibiotic Resistance RFP Working Group: Leo Chan,
R.Ph., Charles K. Cooper, M.D., Edward M. Cox, M.D., MPH,
David L. Roeder, Albert T. Sheldon, Ph.D., and
Matthew A. Zell. PHS Unit Commendation: CAPT Hamilton
L. Brown.
Buprenorphine Review Team: Ali Al Hakim, Ph.D., Silvia
N. Calderon, Ph.D., Tien Mien Chen, Ph.D., Gerald Dalpan,
M.D., Suresh Doddapaneni, Ph.D., Jarilyn Dupont, J.D.,
Michael Klein, Ph.D., Dale L. Koble, Ph.D., Deborah B.
Leiderman, M.D., Timothy J. McGovern, Ph.D., Thomas J.
Permutt, Ph.D., Sara E. Stradley, Ana Szarfman, Ph.D., Lynn
A. Whipkey, J.D., and Celia J. Winchell, M.D.
Cancer Drug Development Patient Consultant Program Team: Brenda
J. Atkins, Amy C. Baird, Christy L. Cottrell, Ramzi N.
Dagher, M.D., Patricia Delaney, Clare Gneeco, Ph.D., David
J. Graham, M.D., Donna J. Griebel, M.D., Patricia Keegan,
M.D., Richard T. Lostritto, Ph.D., Joann Minor, Richard
Pazdur, M.D., Dorothy W. Pease, Maureen A. Pelosi, Lilliam
A. Rosario, Ph.D., Daniel Schultz, M.D., Alla Shapiro, M.D.,
Dianne P. Spillman, Grant A. Williams, M.D., and
Alexandra Worobec, M.D. PHS Unit Commendation: LCDR
Sean K. Bradley, LCDR Patricia N. Garvey, CDR Steven I.
Hirschfeld, LCDR Ann M. Staten and CAPT Paul F.
Zimmerman.
CDER Barcode Working Team: Jane A. Axelrad, Virginia
G. Beakes, Phillip L. Chao, Mary C. Gross, Diane M. Maloney,
Melodi J. McNeil, R.Ph., Olivia A. Pritzlaff and
Steven A. Tucker. PHS Unit Commendation: CAPT Steven
K. Galson, CDR Carol A. Holquist, CAPT Thomas J. McGinnis,
CAPT Thomas G. Phillips and CAPT Paul J. Seligman.
Ciprofloxacin Team: James F. Brower and Duckhee
Y. Toler.
Claritin OTC Review Team: Marina Y. Chang, Emmanuel O.
Fadiran, Ph.D., Matthew R. Holman, Ph.D., Linda S. Hu, M.D.,
Chong-Ho Kim, Ph.D., Shinja Kim, Ph.D., Cazemiro R. Martin,
Ph.D., Timothy J. McGovern, Ph.D., Luqi Pei, Ph.D., and
Guiragos K. Poochikian, Ph.D. PHS Unit Commendation:
CAPT Elaine G. Abraham, LCDR Charles E. Lee, CDR Houda
Mahayni, CAPT Mary E. Purucker, CAPT Ching-Long Sun and
LCDR Anthony M. Zeccola.
Division of Pharmaceutical Evaluation II Metabolic and
Endocrine Review Team: Hae Young Ahn, Ph.D., Sang M.
Chung, Ph.D., Steven B. Johnson, Pharm.D., Sze W. Lau,
Ph.D., Wei Qiu, Ph.D., and Xiaoxiong Wei, Ph.D.
DMETS Medication Error News and Resources Team: Tia
Harper-Velazquez, R.Ph. PHS Unit Commendation: CAPT
Kevin R. Dermanoski, CDR Charles V. Hoppes and LCDR
Marci A. Lee.
DNA Microarray Team: Patrick S. Pine, Barry A.
Rosenzweig, CAPT Frank D. Sistare and Karol L.
Thompson, Ph.D.
Lindane Team: James F. Brower, Larry K. Revelle,
Ph.D., Nakissa Sadrieh, Ph.D., and Benjamin J.
Westenberger.
MedWatch Process Improvement Team: Norman S. Marks,
M.D., and Toni Piazza-Hepp, Pharm.D. PHS Unit
Commendation: CAPT Roger A. Goetsch, CDR David A.
Konigstein and CDR James W. Wilson, III.
Network Team: Tony T. Chuo and Richard J.
Johnson.
Neuropharmacology Review Team: Raman K. Baweja, Ph.D.,
Wen Hwei Chou, Ph.D., Ronald E. Kavanagh, Ph.D., and
Ramana S. Uppoor, Ph.D.
Potassium Iodide 65-milligram Tablet Review Team: Shirley
Berryman, Shirley S. Brown, Ph.D., LT Peter Chen, John F.
Grace, CAPT Harvey A. Greenberg, LT Sarah H. Ho, Shing Hou
Liu, Ph.D., LT Wanda Pamphile, Parul Patel, LCDR Angel M.
Payne, Paul Schwartz, Ph.D., and Michael Smela, Jr.,
Ph.D.
Searching PubMed Instructional Services Team: Nichelle
Cherry, Lois G. Chester, Nancy L. Muir and Colleen A.
Pritchard.
White Oak Laboratory Research Building Planning Team: Almetia
L. Hoskins, Patricia E. Long-Bradley, Robbe C. Lyon, Ph.D.,
Edward B. Radden, CAPT Frank D. Sistare, John M. Strong,
Ph.D., and James L. Weaver, Ph.D.
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FDA awards ceremony
These awards were presented to CDER employees May 30 at
the FDA ceremony in Rockville:
FDA
Award of Merit
Raymond F. Anthracite, M.D.
Russell J. Abbott
Debra L. Birenbaum, M.D.
Paula G. Bourkland
Rita J. Thompson
Artesunate Review Team: Renata Albrecht, M.D., Matthew
A. Bacho, Shukal Bala, Ph.D., David J. Cummings, Ph.D.,
Ruthanna C. Davi, Barbara M. Davit, Ph.D., Antoine N. El
Hage, Ph.D., Mark J. Goldberger, M.D., MPH, Kenneth L.
Hastings, Dr.P.H., Karen M. Higgins, Sc.D., Rosemary Johann
Liang, M.D., Karin M. Klunk, Steven C. Kunder, Ph.D., Joette
M. Meyer, Pharm.D., Sumathi Nambiar, M.D., Rigoberto A.
Roca, M.D., David L. Roeder, Leonard V. Sacks, M.D., Norman
R. Schmuff, Ph.D., Robert B. Shibuya, M.D., Ramesh K. Sood,
Ph.D., and Kalavati C. Suvarna, Ph.D. PHS Unit
Commendation: LCDR Ellen C. Frank.
Nitazoxanide Review Team: Renata Albrecht, M.D.,
Shukal Bala, Ph.D., Leo Chan, R.Ph., Dakshina Chilikuri,
Ph.D., Barbara M. Davit, Ph.D., Antoine N. El Hage, Ph.D.,
Mark J. Goldberger, M.D., MPH, Kenneth L. Hastings, Dr.P.H.,
Karen M. Higgins, Sc.D., Gene W. Holbert, Ph.D., Rosemary
Johann Liang, M.D., Steven C. Kunder, Ph.D., Rigoberto A.
Roca, M.D., David L. Roeder, Norman R. Schmuff, Ph.D.,
Robert B. Shibuya, M.D., Kalavati C. Suvarna, Ph.D., and
Jyoti Zalkikar, Ph.D. PHS Unit Commendation: LCDR
Ellen C. Frank and LT Kristen Miller.
PHS
Outstanding Service Medal
CAPT Tan T. Nguyen
40
Years of Career Service
Don C. Cox
Robert Heller
Larence Sturghill
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Scientific achievement
These CDER scientists were honored for scientific
achievement at the FDA Science Forum held April 24 and 25 in
Washington:
Excellence
in Analytical Science
Noninferiority Clinical Trial Statistics Development
Group: Sue-Jane Wang, Ph.D., Hsien-Ming James Hung,
Ph.D., and Yi Tsong, Ph.D.
Excellence
in Laboratory Science
CDER Vasculitis Research Unit: Jun Zhang, M.D., Eugene
H. Herman, Ph.D., Alan D. Knapton and Frank D.
Sistare, Ph.D.
Excellence
in Review Science
Zili Li, M.D., MPH
Outstanding
Intercenter Scientific Collaboration
Chromatography Media Decay Evaluation Team: Janice
Brown, M.S.
OP-1 Implant HDE Review Team: James G. Farrelly, Ph.D.
Coronary Drug-Eluting Stent Regulatory Review Team: Xiao-Hong
Chen, Ph.D., Nallaperumal Chidambaram, Ph.D., Patrick John
Marroum, Ph.D., Kasturi Srinivasachar, Ph.D., Belay
Tesfamariam, Ph.D., and Douglas C. Throckmorton, M.D.
Jackie Barber is
CDER’s incentive awards officer.
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FDA’s McGinnis receives
pharmacy group’s award
The Pharmacists Planning Service Inc., a non-profit
organization that promotes consumer public health education
and pharmaceutical information, presented its Distinguished
Person of the Year Award to CAPT Thomas J. McGinnis
at the American Pharmaceutical Association Annual Meeting in
April 2003.
McGinnis, director of pharmacy affairs in FDA’s Office
of Policy, joins the ranks other distinguished federal
employees who have received the group’s award, including
former FDA Commissioner Frank E. Young and former Surgeon
General C. Everett Coop.
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