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U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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CDER News Along the Pike
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By Jackie Barber
A total of 80 individuals and 49 groups from the Center received honors at ceremonies held by CDER and FDA in May.
At the Center's Spring Honor Awards ceremony May 31 in Gaithersburg, 76 individuals and 29 groups were recognized. The number included 25 Commissioned Corps officers who responded to the Sept. 11 terrorist attack or the anthrax crisis.
At the FDA ceremony held the same day in Rockville, four Center employees and 10 groups with CDER representatives were recognized.
At CDER's patriotically themed ceremony, Center Director Janet Woodcock, M.D., along with senior management presented the awards. The Montgomery County Police Color Guard presented the colors, and Kevin Barber sang the national anthem.
"Many of you provided support to the rescue and recovery efforts in New York City and at the Pentagon, while others worked diligently to strengthen our counterterrorism program," Dr. Woodcock said. "The heightened risk of such an attack has brought out the best in us as a nation and in CDER as a public health organization."
Rita Thompson, the director of the Division of Management Service in the Office of Management, introduced each award. Office directors provided an explanation of individual achievements, and Thompson read the citations for the group and team achievements.
FDA Outstanding Service Award
Charles P. Hoiberg, Ph.D.
Kathy P. Miracco
Crystal L. Rice
Victor F. Raczkowski, M.D.
Norman L. Stockbridge, M.D., Ph.D.
Development Team for Identification of Imported Products and APIs Derived from Potential BSE Ingredients: Amy L. Kaisler. PHS Unit Commendation: CAPT Joan C. Ginetis.
Patient Safety and Post-Marketing Risk Assessment Leadership Team: Martin H. Himmel, M.D., Peter Honig, M.D.
FDA Group Recognition Award
CDER Enantiomer Exclusivity Working Group: Wilson H. DeCamp, Ph.D., Elizabeth Dickinson, Donald B. Hare, Alexander W. Jordan, Ph.D., Shriniwas G. Nerurkar, Ph.D., Chandra G. Sahajwalla, Ph.D., Robert Temple, M.D. PHS Unit Commendation: CAPT Justina A. Molzon.
CDER's Accreditation Program Team: Sakti P. Mukherjee, M.D., D.Sc., Chris M. Nguyen, Dale F. Wilcox, Karen R. Zawalick.
Dissolutions Methods Electronic Database Team: Larry A. Ouderkirk, Nhan L. Tran, Ph.D. PHS Unit Commendation: CAPT David Holovac, LCDR Steven Mazzella, LT Nina Nwaba, CDR Aida L. Sanchez, LT Krista Scardina.
Division of Library and Information Services: Carol S. Assouad, Sylvia A. Bullock, Maddy D. Carolan, Wendy W. Cheng, Nichelle Cherry, Lois G. Chester, Wanda J. Clabaugh, Lynette V. Gray, Rhyonda M. Jackson, Eugene Jeffery Jr., Karen M. Kapust, Kathryn W. Kruse, Sandra J. Lee, Carol K. Lytle, Kathrin L. McConnell, Nancy L. Muir, Colleen A. Pritchard, Elizabeth C. Smith, Paul K. Stauffer, John W. Stephens, Monica A. Unger, Elizabeth A. Wack, Barry Wheeler, Sally Winthrop, William B. Woodard Jr.
FDA Medical Library Electronic Resource Acquisitions Unit: Lois G. Chester, Karen M. Kapust, Colleen A. Pritchard, Elizabeth C. Smith.
Guidance to Industry on Inhalational Anthrax Team: Renata Albrecht, M.D., Jane Axelrad, Shukal Bala, Ph.D., Philip M. Colangelo, Pharm.D., Ph.D., Nancy E. Derr, M. Dianne Murphy, M.D., John H. Powers, M.D.
Investigations and Preapproval Compliance Branch: Shawnte L. Adams, Anthony A. Charity, Kristin D. Cook, Janine M. D'Ambrogio, John M. Dietrick, Shirnette D. Ferguson, Melissa J. Garcia, Muralidhara B. Gavini, Ph.D., Bruce W. Hartman, Patricia Alcock Lefler, Edwin D. Melendez, Karen K. Moksnes, LuAnn M. Pallas, Edwin Rivera Martinez, Randall Woods.
Investigator Inquiry Tracking Group: Gelind H. Grable, Barry W. Poole. PHS Unit Commendation: LCDR Mary E. Kremzner.
Pediatric Exclusivity Board: Kim Dettelbach, J.D., Elizabeth Dickinson, J.D., Mary M. Fanning, M.D., Ph.D., John K. Jenkins, M.D., M. Dianne Murphy, M.D., Rosemary Roberts, M.D., Sonal Vaid, J.D., Paul C. Varki, J.D. PHS Unit Commendation: CDR Terrie L. Crescenzi, CDR Mary A. Holovac.
FDA Leveraging/Collaboration Award
Jane A. Axelrad
Christina H. Chi, Ph.D.
Douglas N. Shaffer, M.D.
Ana Szarfman, M.D., Ph.D.
International Regulatory Communication Facilitation Team: Sharon Sheehan, J.D. PHS Unit Commendation: CAPT Justina A. Molzon, LCDR Ann M. Staten.
PHS Commendation Medals
CDR Paul A. David
CAPT Harvey A. Greenberg
LCDR Andrew S. Haffer
LCDR Mary E. Kremzner
Crisis Response Service Award
For participation in the anthrax response:
CDR Terri L. Crescenzi
LCDR Ellen C. Frank
LT Patricia N. Garvey
LCDR Andrew S. Haffer
CDR Durand M. Hedin
LCDR Lisa M. Hubbard
CDR Lydia V. Kieffer
LT Marci C. Kiester
LCDR Hye-Joo Kim
CDR William C. Koch Jr.
LCDR Houda Mahayni
LT Laura L. Pincock
LCDR James R. Rogers
LT Spencer S. Salis
CAPT Margaret A. Simoneau
LT Samuel Y. Wu
LCDR Anthony M. Zeccola
For work following the terrorist attack on Sept. 11:
LCDR Kevin A. Prohaska
LCDR Mark A. Scheper
CAPT Paul J. Seligman
For combined efforts in responding to the Sept. 11 terrorist attack and the anthrax crisis:
CAPT Timothy W. Ames
LT Sean K. Bradley
LT David T. Diwa
CAPT William A. Hess
LCDR Koung U. Lee
Center Director's Special Citation
Jennie T. Chang, Pharm.D.
CERTS Teaching Module Team: Peter Honig, M.D., Curtis J. Rosebraugh, M.D.
Drug Safety and Risk Management Advisory Committee Working Group: Julie G. Beitz, M.D., Kathleen F. Bongiovanni, David J. Graham, M.D., Martin H. Himmel, M.D., Peter Honig, M.D., Kimberly L. Topper. PHS Unit Commendation: CAPT Thomas G. Phillips.
Staff of the Division of Drug Information: Barbara J. Daciek, Harold Davis, Donald Q. Dobbs, Gelind H. Grable, Parinda Jani, Peter E. Khalaf, Brenda J. Kiliany, Larry P. Lim, Frederick L. Lockwood, Kelly S. Phelan, Joan K. Powers, Brenda L. Stodart. PHS Unit Commendation: LCDR Mary E. Kremzner, LCDR Brenda L. Stodart, LT Catherine C. Yu.
CDER Special Recognition Award
Charles R. Bonapace, Pharm.D.
Paul C. Brown, Ph.D.
Michael S. Furness, Ph.D.
Frank O. Holcombe Jr., Ph.D.
Edward Miracco
Kathryn A. O'Connell
Mujahid L. Shaikh
Sonal Vaid, J.D.
Xiaoxiong "Jim" Wei, M.D., Ph.D.
Jenny J. Zheng, Ph.D.
Naloxone Review Team: Suliman I. Al Fayoumi, Ph.D., Nancy S. Chang, M.D., Suresh Doddapaneni, Ph.D., Dale L. Koble, Ph.D., Thomas Papoian, Ph.D., Bob Rappaport, M.D., Sara E. Shepherd.
September 11 Supplement Review Team: Anthony Abel, Maureen P. Dillon-Parker, David B. Katague, Ph.D., Patricia Alcock Lefler, Milton J. Sloan, Ph.D.
Small Pox Vaccination Complications Team: Barbara Styrt, M.D. PHS Unit Commendation: LCDR Kimberly Struble.
CDER Administrative/Program Management Excellence Award
Susan M. Banks
Aleta A. Crane
Merla Rae Matheny
Matthew A. Zell
CDER Excellence in Communication Award
Isagani M. Chico
Cynthia P. Fitzpatrick
John Franolic, Ph.D.
Kathrin L. McConnell
Paul S. Stinavage, Ph.D.
BACPAC I Training Group: Eric P. Duffy, Ph.D., Stephen P. Miller, Ph.D., John L. Smith, Ph.D., Kasturi Srinivasachar, Ph.D.
CMC GRP Training Group: Karen A. Bernard, Ph.D., Jon E. Clark, Peter H. Cooney, Ph.D., Bonnie B. Dunn, Ph.D., Michael M. Folkendt, Charles P. Hoiberg, Ph.D., Eldon E. Leutizinger, Ph.D., Moo-Jhong Rhee, Ph.D., Bryan S. Riley, Ph.D., Joseph Sieczkowski, Ph.D., John C. Smith, Ph.D.
CMC Presentation Team at AAPS: Daniel C. Boring, Rajendra Uppoor, Ph.D.
CMC Symposium Team: Karen A. Bernard, Ph.D., June S. Cory, Charlotte Henning, See Lam, Ph.D., Dominick Roselle, Ph.D., John E. Simmons, Ph.D., Laurie C. Watson Mona R. Zarifa, Ph.D.
Prescription Painkiller Risk Communication Team: Ayse N. Hisim, Ellen Shapiro.
Rebetron Labeling Supplement Review Team: Russell D. Fleisher. PHS Unit Commendation: LT Destry M. Sillivan.
CDER Information Technology Excellence Award
Monif Alqarshi
Margaret S. Cates
James L. Minter, Ed.D.
LAN and Systems Team: Charles C. Burdette, Craig R. Eatmon, Corrine E. Gomez, Mary Beth Kleinhen, Wendy A. Lee, Stacey L. Nichols, Timothy L. Rigg, Debbie L. Selbert, Scott M. Shippey.
CDER Leadership Excellence Award
Shukal Bala, Ph.D.
Guirag K. Poochikian
Frederic J. Richman
Rigoberto A. Roca
CDER Excellence in Mentoring Award
Kevin M. Budich
Christine K. Lincoln
Maureen A. Pelosi
CDER Project Management Excellence Award
Kathleen F. Bongiovanni
Barbara J. Gould
Marsha S. Holloman, R.Ph., J.D.
Susmita Samanta, M.D.
Christy L. Wilson
Division of Oncology Drug Products Project Management Team: Brenda J. Atkins, Amy C. Baird, LT Sean Bradley, LT Patricia Garvey, Dorothy W. Pease, Maureen A. Pelosi, Diane D. Spillman, Erica Sugar, Debra J. Vause, Christy L. Wilson, CAPT Paul F. Zimmerman.
CDER Support Staff Excellence Award
Patricia E. Carr
Nancy Ann Hansen
Delores Y. Pinkney
CDER Team Excellence Award
Antisense Oligonucleotide Team: Nallaperumal Chidambaran, Ph.D., Gregory K. Frykman, M.D., NAM, Atiqur Rahman, Ph.D., Lilliam A. Rosario, Ph.D.
Bosentan Review Team: Julie G. Beitz, M.D., Maryann Gordon, M.D., Cindy M. Kortepeter, Pharm.D., Karen J. Lechter, Ph.D., Susan Lu, R.Ph., Zelda R. McDonald, Norman L. Stockbridge, M.D., Ph.D., Douglas C. Throckmorton, M.D. PHS Unit Commendation: LCDR Andrew Haffer, CDR Kathleen Uhl.
Desktop Services Building Leads Team: Peggy L. Goebel, Johnnie Griffin, Ellen B. Messersmith, Colleen F. Ratliffe, Hartsell L. Whitacre Jr.
Doxycycline Anthrax Evaluation Team: Charles Anello, Sc.D., Daniel H. Briggs, James F. Brower, Alan S. Carlin, Christopher D. Ellison, Neil R. Hartman, Ph.D., Robbe C. Lyon, Ph.D., Stella G. Machado, Ph.D., Terry W. Moore, Agnes A. Nguyenpho, John C. Reepmeyer, Ph.D., Rosemary Roberts, M.D., Donald J. Schuirmann, Arzu Selen, Ph.D., Donna A. Volpe, Ph.D., Lawrence X. Yu, Ph.D.
DPADP/ODS Antihistamine Rx-to-OTC Safety Working Group: Julie G. Beitz, M.D., Min C. Chen, R.Ph., Badrul A. Chowdry, M.D., Charlene M. Flowers, R.Ph., Lydia I. Gilbert-McClain, M.D., Patrick F. Guinn, Susan S. Johnson, Pharm.D., Ph.D., Claudia B. Karwoski, Pharm.D., Cindy M. Kortepeter, Pharm.D., Lois A. LaGrenade, M.D., Ph.D., Charles Lee, M.D., Susan Lu, R.Ph., Richard A. Nicklas, M.D., Kathleen M. Phelan, R.Ph., Marilyn R. Pitts, Pharm.D., Gretchen Trout, Joyce P. Weaver, Pharm.D. PHS Unit Commendation: CAPT Michael Johnston, CDR Mary E. Purucker, CDR Anne E. Trontell, CAPT Joslyn R. Swann.
Network Team: Tony T. Chuo, Richard J. Johnson.
ODE IV Labeling Initiative Group: Renata Albrecht, M.D., Mercedes Albuerne, M.D., CDR Robin E. Anderson, Elizabeth A. Duvall-Miller, CDR Steven Hirschfeld, Khai M. Phi, Melissa M. Truffa, R.Ph.
ODS Strategic Transition Planning Group: Julie G. Beitz, Kathleen Bongiovanni, Martin Himmel, M.D., Peter Honig, M.D. PHS Unit Commendation: CAPT Jerry Phillips, CDR Anne Trontell.
Office of Biostatistics Readjudication Survey Team: Charles Anello, Sc.D., Karen M. Higgins, Sc.D., Roswitha E. Kelly, Thomas J. Permutt, Ph.D., Yi Tsong, Ph.D. PHS Unit Commendation: CAPT Stephen E. Wilson.
Office of Generic Drugs Regulatory Support Branch Bioterrorism Team: Margo L. Bartle, LT Gregory Davis, LCDR Beth Fritsch, CAPT Harvey Greenberg, Norma J. Grimes, Eda E. Howard, Saundra T. Middleton, LTJG Paras Patel, LCDR Martin H. Shimmer II, LTJG Emily S. Thomas.
OxyContin Response Team: Suliman I. Al Fayoumi, Ph.D., Lisa E. Basham-Cruz, Laura Bradbard, Silvia N. Calderon, Ph.D., Patrick S. Durkin, Sharon H. Hertz, M.D., Dale L. Koble, Ph.D., Kathleen M. Kolar, Deborah B. Leiderman, M.D., Mary E. Ortuzar, Martin L. Pollock, Pharm.D., Bob A. Rappaport, M.D., Michael Theodorakis, Kimberly L. Topper. PHS Unit Commendation: CDR Mark W. Askine, LT Spencer Salis.
Regulatory Project Management Team of DGCDP: Alice Marie Kacuba, Paul Everette Levine Jr., R.Ph., Melodi J. McNeil, R.Ph., Karen Oliver, Cheryl Perry, Brian K. Strongin, R.Ph., Maria R. Walsh, Helen A. Wilson.
Reorganization Administrative Team: Tanya L. Abbott, Mary Anne Carter, Bibi F. Jakrali, Maureen D. Majors, Sandy Van Buskirk.
Stability Technical Committee and Statistics Working Group in CDER: Michael Adams, Richard C. Adams, Ali H. Al Hakim, Charles Anello, Sc.D., Chi-wan Chen, Ph.D., Wen Jen Chen, Ph.D., Peter H. Cooney, Ph.D., David J. Cummings, Kenneth J. Furnkranz, Hsien Ming J. Hung, Roswitha E. Kelly, Hossein S. Khorshidi, Ph.D., Dale L. Koble, Ph.D., David B. Lewis, Ph.D., Karl K. Lin, Ph.D., Tsae Yun Daphne Lin, Ph.D., Nashed E. Nashed, Ph.D., Robert T. O'Neill, Ph.D., Shrikant N. Pagay, Ph.D., Ernest G. Pappas, Guirag K. Poochikian, Ph.D., Mohammad A. Rahman, Ph.D., Barry Rothman, Donald J. Schuirman, Ph.D., Robert Seevers, Ph.D., Harold V. Silver, Kasturi Srinivasachar, Ph.D., Jeb S. Taylor, Ph.D., Michael Theodorakis, Ph.D., Yi Tsong, Ph.D., Charlotte Yaciw, Florian W. Zielinski, Ph.D. PHS Unit Commendation: CAPT David Hussong, CAPT Yana Mille.
Commissioner's Special Citation
Ciprofloxacin Review Team: Funmi Ajayi, Ph.D., Renata Albrecht, M.D., Shukal Bala, Ph.D., Leo Chan, R.Ph., Gary Chikami, M.D., Peter A. Dionne, Ken Hastings, Ph.D., Karen M. Higgins, Sc.D., Stephen G. Hundley, Ph.D., Joette M. Meyer, Pharm.D., M. Dianne Murphy, M.D., Andrea Myerhoff, M.D., Terry S. Peters, DVM, Rigoberto A. Roca, M.D. PHS Award (pending approval): LCDR Valerie E. Jensen.
FDA Award of Merit
M. Dianne Murphy, M.D.
Caspofungin Review Team: Funmi Ajayi, Ph.D., Renata Albrecht, M.D., Shukal Bala, Ph.D., Marc W. Cavaille-Coll, M.D., Ph.D., Leo Chan, R.Ph., Mary Dempsey, Cheryl A. Dixon, Mark J. Goldberger, M.D., MPH, Kenneth L. Hastings, Karen M. Higgins, Sc.D., Gene W. Holbert, Ph.D., Karin M. Klunk, Dorota M. Matecka, Ph.D., Owen G. McMaster, Ph.D., Eileen E. Navarro Almario, M.D., Rigoberto A. Roca, M.D., David L. Roeder, Leonard V. Sacks, M.D., Norman R. Schmuff, Ph.D., Judy A. Staffa, Ph.D., R.Ph. PHS Award (pending approval): LCDR Ellen C. Frank, LCDR Houda Mahayni, LCDR James R. Rogers, CDR Kathleen Uhl.
CDER Counter-Terrorism Response Team: Funmi Ajayi, Ph.D., Renata Albrecht, M.D., John J. Alexander, M.D., Raman K. Baweja, Ph.D., Charles R. Bonapace, Ph.D., David C. Bostwick, Philip M. Colangelo, Ph.D., Chuck K. Cooper, M.D., Edward M. Cox, M.D., Rose E. Cunningham, Sandra N. Folkendt, Joanne M. Holmes, Alice Kacuba, Russell G. Katz, M.D., Joyce A. Korvick, M.D., MPH, John A. Lazor, Pharm.D., Brad G. Leissa, M.D., Patricia Y. Love, M.D., Min Lu, M.D., Fred Marsik, Ph.D., Joette M. Meyer, Ph.D., Andrea Meyerhoff, M.D., Christine Moser, M. Dianne Murphy, M.D., Robbin M. Nighswander, R.Ph., Francis R. Pelsor, Ph.D., Kellie S. Reynolds, Ph.D., David L. Roeder, David B. Ross, M.D., Ph.D., Leonard Sacks, M.D., Alfredo R. Sancho, Ph.D., Arzu Selen, Ph.D., Janice Soreth, M.D., Paul Stauffer, Barbara Styrt, M.D., Jean W. Temeck, M.D., Susan D. Thompson, M.D., Monica A. Unger, Sally Winthrop, Hong Zhao, Ph.D. PHS Award (pending approval): CDR Mark W. Askine, CAPT Harry W. Haverkos, CAPT Dianne L. Kennedy, CAPT Robert K. Leedham Jr., CAPT David G. Orloff, LCDR Jim R. Rogers, CDR Kathleen Uhl.
CDER Drug Shortage Team: Barbara J. Daciek, R.Ph., Mark J. Goldberger, M.D., MPH, Lorene M. Kimzney, Larry P. Lim, Pharm.D., Barry W. Poole, R.Ph., Michael J. Verdi. PHS Award (pending approval): CAPT Harvey A. Greenberg, LCDR Lisa M. Hubbard, LCDR Valerie E. Jensen.
Drug GMP Training Group: Arlene Badillo, Mildred Barber, Nicholas Buhay, Concepcion Cruz, Jorge Guadalupe, Edwin D. Melendez, Ivis Negron, Rafael Nevarez, Edwin Rivera-Martinez, Rebecca Rodriguez, Margarita Santiago, Myriam Sosa, Andres Toro, Maridalia Torres. PHS Award (pending approval): CAPT Justina A. Molzon, CAPT James P. Stumpff.
Federal Register Notice on Doxycycline and Penicillin G Procaine Group: Funmi Ajayi, Ph.D., Renata Albrecht, M.D., Shukal Bala, Ph.D., Martha A. Carter, Nichelle Cherry, Philip M. Colangelo, Pharm.D., Ph.D., Edward M. Cox, M.D., MPH, Peter A. Dionne, Rosemary Johann-Liang, M.D., Joette M. Meyer, Wayne H. Mitchell, Christine Moser, Nancy L. Muir, M. Dianne Murphy, M.D., John H. Powers, Rigoberto A. Roca, M.D., Sarah J. Singer, Joseph Toerner, M.D., Ron T. Wassel, Pharm.D. PHS Award (pending approval): LCDR Ellen C. Frank.
Prescription Drug User Fee Waivers Team: Andrea C. Masciale, Susan H. O'Malley, Olivia A. Pritzlaff, Tawni M. Schwemer. PHS Outstanding Unit Citation, CAPT Beverly J. Friedman, CDR Michael D. Jones
FDA Group Recognition Award
FDA/NIH Antibiotic Working Group: Renata Albrecht, M.D., Philip M. Colangelo, Ph.D., Richard Davey, M.D., Dennis Dixon, Ph.D., Sandra N. Folkendt, Vee J. Gill, Ph.D., Mark J. Goldberger, M.D., Joanne M. Holmes, Brad G. Leissa, Fred J. Marsik, Ph.D., Henry Masur, M.D., Andrea Meyerhoff, M.D., M. Dianne Murphy, M.D., Robert E. Osterberg, Ph.D., Alice Pau, Pharm.D., Christine Sizemore, Ph.D., Janice M. Soreth, M.D., Susan Thompson, M.D., Mary Wright, M.D., Sarah Wynne, M.D. PHS Award (pending approval): CAPT Philip Coyne Jr., RADM Henry C. Lane.
Post-Marketing Surveillance Working Group: Jim F. Allgire, Charles M. Breen, Sarah Bristow, Rick L. Friedman, Ravi S. Harapanhali, Ph.D., Samuel K. Mathew, Michael C. Olson, Jim Rowell, Thomas Savage, Andrea J. Schaub, Ralph J. Schmid, Michael J. Smela Jr., Rona J. Stromberg, Vaiyapuri Subramaniam, Pharm.D., Yi Tsong, Ph.D., Leonard Valenti, Benjamin Westenberger.
Potassium Iodide Guidance Working Group: David Becker, Andre Bouville, Ph.D., Rose E. Cunningham, Alfred Eric Jones, M.D., Jacob Robbins, M.D., Daiva Shetty, M.D., Bruce V. Stadel, M.D., Jean W. Temeck, M.D., Donald L. Thompson, Jan Wolff, M.D., Robert J. Yaes. PHS Unit Commendation: CAPT Robert K. Leedham Jr.
2002 DHHS Secretary's Award for Distinguished Service
Steven I. Hirschfeld, M.D., Ph.D.
PHS Outstanding Service Medal
CAPT David G. Orloff
Forty Years of Career Service
Charles R. Brownell
Jackie Barber is the Center's incentive awards officer.
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