 |
 |
 |
|
 | |||||
| |||||||||
 | |||||||||
|
|
 |
|
|
CDER News Along the Pike Volume 12, Issue 1 Print version: [Entire
issue] [Only this article]
CDER ceremony honors 70 individuals, 31 groupsDr. Galson cites resourcefulness, innovation, teamworkDuring CDER’s Fall 2005 Honor Awards Ceremony, the Center’s top managers presented 70 individual awards and 31 group or team awards. The ceremony was opened by the PHS Honor Corps, and Tracy O’Neill sang the National Anthem. Opening remarks presented by Center Director Steven K. Galson, M.D., MPH, encompassed CDER’s move to the new White Oak Campus and the deployment of many employees to assist with the hurricane and disaster relief effort and the implementation of organizational changes and new initiatives. He said that these additional responsibilities and challenges have been met with resourcefulness, innovation and teamwork by the CDER community Dr. Galson and Deputy Center Director Douglas Throckmorton, M.D., presented the awards along with CDER’s senior staff. The awards presented at the ceremony were: FDA Outstanding Service Award
Frederick
Blumenschein NSAID Scientific Review Team: Renan Bonnel, Pharm.D., MPH, Jonca Bull, M.D., Gerald Dal Pan, M.D., Jane Dean, Barbara Gould, Laura Governale, Pharm.D., David Graham, M.D., MPH, Brian Harvey, M.D., Ph.D., Sharon Hertz, M.D., John Jenkins, M.D., Lauren Lee, Pharm.D., Coralee Lemley, Qian, Li, Sc.D., Aaron Mendelsohn, Ph.D., MPH, Robert Meyer M.D., Robert O’Neill, Ph.D., Joel Schiffenbauer, M.D., Judy Staffa, Ph.D., Robert Temple, M.D., Yi Tsong, Ph.D., Maria Villalba, M.D., James Witter, M.D., Joann Zhang, Ph.D. PHS officers nominated for companion award: CAPT Sandra Kweder, CAPT Paul Seligman, CAPT Anne Trontell. Ortho-Evra Team: Evelyn Farinas, R.Ph., and Rita Ouellet-Hellstrom, Ph.D., MPH FDA Leveraging/Collaboration Award
Mandy Eisemann Pediatric Multi-Disciplinary Review Group: Paul Andreason, M.D., ShaAvhree Buckman, M.D., Ph.D., Kate Gelperin, M.D., Laura Governale, Pharm.D., Solomon Iyasu, M.D., MPH, Ronald Kavanagh, Ph.D., Cindy Kortepeter, Pharm.D., David Jacobson-Kram, Ph.D., Susan McCune, M.D., and Kathleen Phelan, R.Ph. PHS Commendation Medals
CAPT Paul
Andreason Center Director’s Special Citation
Ann Corken
Mackey, R.Ph., MPH BIMS to DMF Data Migration Team: Wendy Aaronson, Sharon Brownewell, Roger Eastep, Arthur Shaw, M.D., Linda Sigg, Lonnie Smith and CAPT Cathie Schumaker. BIMS to DMF Data Support Team: Eric Gonitzke, Jonathan Lenko, Bethany Lenko, Lisa Wilder, Charlene Do and CDR Kellie Clelland. CDER Situation Room Team: Rosemary Addy, ShaAhvree Buckman, M.D., Larry Cress, M.D., Joan Flaherty, Joanne Holmes, MPH, Brad Leissa, M.D., Susan McCune, M.D., Shirley Murphy, M.D., Frank Pelsor, Ph.D., Denise Pica-Branco, Rosemary Roberts, M.D., Hari Sachs, M.D., Lewis Schrager, M.D., Alan Shapiro, M.D., Alla Shapiro, M.D., Cheryl Turner, Dorothy Wawrose, M.D., and Su Yang. PHS officers nominated for companion award: LCDR Michael Bourg, LTJG Thomas Christl, CDR Narayan Nair, LCDR Tracy MacGill, CDR Lisa Mathi and CDR Mitchell Mathis Jr. Isotretinoin Small Working Group: Jeanine Best, Kalyani Bhatt, Allen Brinker, M.D., Jill Lindstrom, M.D., Claudia Karwoski, Pharm.D., Cynthia Kornegay, Ph.D., Lauren Lee, Pharm.D., Gerard Nahum, M.D., Parivash Nourjah, Ph.D., Toni Piazza-Hepp, Pharm.D., Marilyn Pitts, Pharm.D., and Janice Steinschnieder. PHS officers nominated for companion award: CAPT Rita Hassall and CAPT Dianne Kennedy CDER Special Recognition
Paul Brown,
Ph.D. Oncology Team: Sophia Abraham, Ph.D., Brian Booth, Ph.D., Angela Men, Ph.D., Roshni Ramchandani, Ph.D., and Gene Williams, Ph.D. CDER Dr. Frances O. Kelsey Drug Safety Excellence Award Alice Hughes, M.D. CDER Administrative/Program Management Excellence Award
Candee Chadwick CDER Excellence in Community Service/Citizenship Award Tammie Massie, Ph.D. USPHS Pharmacists Professional Advisory Committee Workgroup: Gururaj Bykadi, Ph.D., and Kimberly Compton. PHS officers nominated for companion award: LT Kristina Arwine, LCDR Michelle Dillahunt, LCDR Tia Harper-Velazquez, CDR Carol Holquist, LCDR Jinhee Jahng, LCDR Brenda Marques, LCDR Nina Mezu-Nwaba, LT Paras Patel, LCDR Laura Pincock, CDR John Quinn, LCDR Nora Roselle, LCDR Melanie Shin, LCDR Tara Turner, LCDR Hawyee Yan and LT Zeo Zadecky. CDER Excellence in Communication Award
Kathleen Frost CDER Oncology Small Business Working Group: Robert Kane, M.D., Anne Pilaro, Ph.D., Haleh Saber-Mahloogi, Ph.D., and William Timmer, Ph.D. CDER Packaging Technical Committee: Albert Mueller, Ph.D., Hullahalli Prasanna, Ph.D., Joseph Prograr, Lorenzo Rocca, Mujahid Shaikh, James Vidra, Ph.D., Geoffrey Wong, Ph.D., Maria Ysern, Ph.D., and Susan Zuk. Pediatric Research Information Team: Rosemary Addy and Grace Carmouze. CDER Leadership Excellence Award
Dale Conner,
Pharm.D. CDER Excellence In Mentoring Award
David Frucht,
M.D. The Mentoring Machine: Tanya Clayton, Julieann DuBeau, Ruyi He, M.D., Alice Kacuba, Lolita Lopez, M.D., Kathie Robie-Suh, M.D., Ph.D., George Shashaty, M.D., and Ann Marie Trentacosti, M.D. CDER Project Management Excellence Award Joan Flaherty CDER Regulatory Science Excellence Award Barbara Rellahan, Ph.D. CDER Support Staff Excellence Award
Joan Broadwater CDER Team Excellence Award AtoZ Team: Jennifer Coakley, Rebecca Jacob and Gary Masters. CDER Perrigo Infant Drops Recall Team: Susan Allen, M.D., Kevin Budich, Walter Ellenberg, Ph.D., Robert Heller, Andrea Leonard-Segal, M.D., Curtis Rosebraugh, M.D., Daiva Shetty, M.D., Steven Silverman and Michael Verdi. CDER Visiting Professor Lecture Series Representatives: Sonya Armstrong, Vikram Arya, Ph.D., Charles Bonapace, Pharm.D., Chandra Chaurasia, Ph.D., R.Ph., Ling Chen, Ph.D., Joan Flaherty, Ph.D., Federico Goodsaid, Ph.D., Mary Gross, Ruyi He, M.D., Shiew-Mei Huang, Ph.D., Leonard Kapacala, M.D., Mansoor Khan, Ph.D., Bing Li, Ph.,D., Jill Lindstrom, M.D., Markham Luke, M.D., Ph.D., Ann Corken Mackey, R.Ph., MPH, Patrick Nwakama, Pharm.D., Chris Nguyen, Jody Payne, Edwin Rock, M.D., Ph.D., Donald Stanski, M.D., Dianne Spillman, Orhan Suleiman, Ph.D., Sue Jane Wang, Ph.D., Huiquan Wu, Ph.D., Sally Yasuda, Pharm.D. PHS officers nominated for companion award: CAPT E. Jane McCarthy, CDR Virginia Giroux, CAPT John Kelsey, LCDR Tracy MacGill and LCDR Devvrat Patel. Center-Wide Scanning Project Team: Rosanna Alston, Anthony Baldwin, Jared Barnhardt, Joshua Barnhardt, Lori Benner, Joy Bennett, Kyle Boyd, Martha Carter, Betty Clark, Tamika Conerly, Mary Cook, Nicole Cooper, Allison Dietz, Velma Cunningham, Eric Gonitzke, Patrick Gunn, Rita Hecker, Rhonda Hill, Mina Hohlen, Zei-Pao Huang, Norma Jiggetts, Heather Jones, Bethany Lenko, Jonathan Lenko, Monica Lewis, Linda Livingston, Jamie Metz, Diane Moore, Sheila Moore, Dolores Pinkney, Kim Robertson, Carol Rochester, Alexander Schaub, Lonnie Smith, Fayleen Susinno, Tisha Washington, Ellen White and Adam Zetts. Cilansetron Review Team: Suliman Al-Fayoumi, Ph.D., Mark Avigan, M.D., Julie Beitz, M.D., Allen Brinker, M.D., Jeanine Best, Sushanta Chakder, Ph.D., Howard Chazin, M.D., Jasti Choudary, B.V.Sc., Ph.D., Bronwyn Collier, Ann Corken-Mackey, Gerald Dal Pan, M.D., Susan Daugherty, Gary Della’Zanna, Suresh Doddapaneni, Ph.D., Julieann DuBeau, Eric Duffy, Ph.D., Milton Fan, Ph.D., Ray Frankewich, Ph.D., Hugo Gallo-Torres, M.D., Ph.D., Laura Governale, Lahn Green, Pharm.D., MPH, Stella Grosser, Ph.D., Florence Houn, M.D., MPH, Russell Katz, M.D., Joyce Korvick, M.D., Claudia Korwoski, Thomas Marciniak, M.D., Khairy Malek, M.D., Ph.D., Parvish Nourjah, Ph.D., Kathy Robie-Suh, M.D., Ph.D., George Shashaty, M.D., Linda Wisniewski, Feng Zhou, Liang Zhou, Ph.D. PHS officers nominated for companion award: LCDR Shannon Benedetto, CDR Carol Holquist, CDR Quynh Nguyen, CAPT Anne Trontell and LT Kendra Worthy. Cluster ANDA Bioequivalence Review Team: James Chaney, Kuldeep Dhariwal, Ph.D., Xiaojiang Jiang, Ph.D., Jenny Lee, Shirley Lu, Ph.D., Moheb Makary, Ph.D., Shriniwas Nerurkar, Ph.D., Hoainhon Nguyen, Sikta Pradhan, Ph.D., Surendra Shrivastava, Ph.D., Gur Singh, Ph.D., Ethan Stier, Ph.D. PHS officers nominated for companion award: CDR Beth Fabian-Fritsch, LT Sheryl Gunther, LCDR Connie Jung, CDR Steven Mazzella, LCDR James Osterhout, LCDR Devvrat Patel, LT Paul Seo and LCDR Aaron Sigler. Division of Bioequivalence Review Seminar Organizing Committee: Barbara Davit, Ph.D., and Ethan Stier, Ph.D. PHS officers nominated for companion award: CDR Beth Fabian-Fritsch, LT Sheryl Gunther, LCDR Connie Jung and LCDR James Osterhout. Healthcare Antiseptic Review Team: Tia Frazier, Michelle Jackson, Ph.D., Debbie Lumpkins, Steven Osborne, M.D., Colleen Rogers, Ph.D., Thamban Valappil, Ph.D., and Eric Zhou, Ph.D. Hematology Review Team: Ryan Barraco, Andrew Dmytrijuk, M.D., Ali Hakim, Ruyi He, M.D., Ron Honchel, David Joseph, Alice Kacuba, Min Lu, M.D., Diane Moore, Kathy Robie-Suh, M.D., Ph.D., George Shashaty, M.D. and Liang Zhou. Late Radiation Toxicity Team: Siham Biade, Ph.D., Tushar Kokate, Ph.D., Adebayo Laniyonu, Ph.D., Sally Loewke, M.D., George Mills, M.D., Yanli Ouyang, Ph.D., Renee Tyson and Robert Yaes, M.D., Ph.D. MedDRA Terminology Team: Linda Kim-Jung, Pharm.D., and Maria Thomas, M.D. OPS Level III Detail Coordination Group: Ali Afnan, Ph.D., Ralph Bernstein, Ph.D., Eileen Cole, David Cummings, Mark Darj, Ph.D., Lynne Ensor, Ph.D., Yung Hsieh, Ph.D., Mansoor Khan, Ph.D., Joseph Kutza III, Ph.D., Stephen Langille, Ph.D., Larry Ouderkirk, Sarah Pope, Ph.D., Mark Seggel, Ph.D., David Skanchy, Ph.D., Rajendra Uppoor, David Watts, Ph.D., Benjamin Westenberger, Ph.D., Kathy Woodland-Outlaw and Huiquan Wu, Ph.D. Palladone Working Group: Lucinda Bushe, Ph.D., Mei-Ling Chen, Ph.D., Andrew Fussner, Zongming Gao, Ph.D., Abhay Guypta, Ph.D., Ajaz Hussain, Ph.D., Ravindra Kasliwal, Ph.D., Mansoor Khan, Ph.D., Vincent Lee, Ph.D., Mehul Mehata, Ph.D., Robert Meyer, Ph.D., Terry Moore, Moheb Nasr, Ph.D., Hullahalli Prassana, Ph.D., Nakissa Sadrieh, Ph.D., Vilayat Sayeed, Ph.D., Rakhi Shah, Ph.D., Edward Sherwood, John Simmons, Ph.D., Anjanette Smith, Solomon Sobel, M.D., Mobin Tawakkul, Ramana Uppoor, Ph.D., Benjamin Westenberger, Ph.D., and Lawrence Yu, Ph.D. Pharmakon Litigation Team: Deborah Autor, Marc Caden, Robert Eshelman, Brian Hasselbalch, Linda Hu, M.D., Rosa Motta, Steven Silverman, Janice Steinschneider and Sakinah Walther. Process/Transition Focus Group: Mamta Gautam-Basak, Ph.D., Michael Folkendt, Rao Kambhampatai, Rapti Madurawe, Amit Mitra, James Vidra, Ph.D., Yvonne Yang. PHS officer nominated for companion award: CAPT Alan Schroeder. Subcommittee of the Reviewer Education Committee: Ruthanna Davi, Cheryl Kaiser, Joette Meyer, Terri Rumble, Edward Sherwood and Jennifer Snellings. Today Sponge Review Team: Julie Beitz, M.D., Jonca Bull, M.D., Helen Cothran, Jinhui Dou, Ph.D., Karen Feibus, M.D., Tia Fraizer, Charles Ganley, M.D., David Hilfiker, Linda Hu, M.D., Claudia Karwoski, Ph.D., Moheb Nasr, Ph.D., Rao Puttagunta, Ph.D., Andrea Leonard-Segal, M.D., John Smith, Ph.D., and Arlene Solbeck. Tygacil Review Team: John Alexander, M.D., Charles Cooper, M.D., Edward Cox, M.D., Maureen Dillion Parker, Mark Goldberger, M.D., MPH, Jarugual Venkat, Ph.D., Frances LeSane, Daphne Lin, Ph.D., Frederick Marsik, Robert Osterberg, Ph.D., Shrikant Pagay, Ph.D., David Roeder, Wendelyn Schmidt, Janice Soreth, M.D., Ana Szarfman, M.D., Mathew Thomas, M.D., Thamban Valappil, Ph.D., James Vidra, Ph.D., and Yaning Wang, Ph.D. PHS officers nominated for companion award: CAPT Lillian Gavrilovich and LCDR Jeffery Tworzyanski. Jackie Barber-Washington is CDER’s incentive awards officer.
Views and opinions expressed are those of the authors and do not necessarily reflect official FDA or CDER policies. All material in the Pike is in the public domain and may be freely copied or printed. Deadline for submitting articles is the 15th of each month. Date created: September 14, 2006 |
|
|
||||||
 | ||||||
|
||||||