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  1. About Science & Research at FDA

Outstanding Intercenter Scientific Collaboration–GROUP

This category recognizes a group involved in an outstanding Intercenter/ORA collaborative effort that makes a significant contribution to the development and/or application of scientific information for solving problems related to the agency’s public health mission. This award recognizes that collaborative efforts were required to achieve the public health objective.  Group must consist of individuals from two or more FDA Centers/Offices.

2024
Harmonized Analysis for Chemotherapeutics in Seafood Group (ORA)

For the development and validation of a harmonized multiclass multiresidue LC-MS/MS method for the analysis of 110 chemotherapeutic drug residues in aquacultured seafood.

Connie Drake, B.S. (ORA)
Christine Casey, M.S. (ORA)
Wendy Andersen, Ph.D. (ORA)
Sherri Turnipseed, Ph.D. (ORA)
Himansu Vyas, M.S. (ORA)
Brian Veach, B.S. (ORA)
John Kibbey, B.S. (ORA)
Barbara Montwill, M.S. (CFSAN)
Pak Sin Chu, Ph.D. (CVM)
Julia Oriani, Ph.D. (CVM)
Tong Zhou, Ph.D. (CVM)
Li You, Ph.D. (CVM)
Yin Guo, Ph.D. (CVM)
Andrew Kwegyir-Afful, Ph.D. (CVM)
Steve Yan, Ph.D. (CVM)
Frank Johnson, Ph.D. (CDER)
Macy McCall, B.S. - Contractor (ORA)

2023
Microbubble Characterization Group (CDRH)

For outstanding inter-center collaboration to characterize ultrasound contrast agent microbubbles.

Yunbo Liu, Ph.D. (CDRH)
Jiwen Zheng, Ph.D. (CDRH)
Darby Kozak, Ph.D. (CDER)
Bin Qin, Ph.D. (Senior Staff Fellow - CDER)
Bonhye Koo, Ph.D. (Senior Staff Fellow - CDRH)
Heba Degheidy, M.D., Ph.D. (CBER)

2022
The Smart Template System Group

For modernizing the FDA review process and helping Reviewers by providing an innovative solution to capture, maintain and re-utilize institutional knowledge.

Joe Meehan, BA (NCTR)
Jae Hyun Kim, PhD (Visiting Scientist - NCTR)
Weida Tong, PhD (NCTR)
Lilliam Rosario, PhD (CDER)
Isaac A. Chang, PhD (CDER)
Jose Delgado Donayre, MD (CDER)
Shraddha Thakkar, MPH, PMP® (Visiting Associate – CDER)
Matthew Wiley, MPH, PMP® (CDER)
Benita Dharmaraj, MD (CDER)
Kimberly A. Miller, BS (CDER)
Vannessa Williams, PhD (CDER)
Jesse Anderson, MPH (CDER)
Stephanie Leuenroth-Quinn, PhD (CDER)
Robert Dorsam, PhD (CDER)
Melanie Mueller, PhD (CDER)
Dan Li, PhD (NCTR)
Yifan Zhang, PhD (NCTR)
Yue Wu, PhD (Visiting Scientist – NCTR) 
Romeo Klamadji, BS (ORISE Fellow – NCTR)
Felecia Hagood (CDER)

2021
FDA COVID-19 AI Drug Repurposing Team (NCTR)

For AI-powered drug repurposing for combating COVID-19.

Zhichao Liu, PhD (NCTR)
Weida Tong, PhD (NCTR)
Asiyah (Yu) Lin, PhD, MD (Sr. Staff Fellow - NIH)
Leonard Sacks, PhD, MD (CDER)
Sean J. Belouin, PharmD (SAMHSA)
Heather Stone, MS (CDER)
Mili Duggal, PhD (Staff Fellow - CDER)
Wendy Carter, PhD (CDER)
Takashi Komatsu, PhD (CDER)
Alicia Moruf, MPH, PharmD (CDER)
Sonia Pahwa, PhD (CDER)
Kirk Chan-Tack, PhD (CDER)
Kevin Snyder, PhD (CDER)
Nicholas Petrick, PhD (CDRH)
Kenny Cha, PhD (CDRH)
Madhu Lal-Nag, PhD (CDER)
Qais Hatim, PhD (Staff Fellow - CDER)
Shraddha Thakkar, PhD (Visiting Associate- CDER)
Dong Wang, PhD (Sr. Staff Fellow - NCTR)
Xi Chen (ORISE Fellow - NCTR)

2020

The FDA liver toxicity working group

The liver toxicity working group promotes interdisciplinary collaborations to improve risk management of FDA regulated products with a potential for drug-induced liver injury.

 

Minjun Chen, PhD (Staff Fellow)

Shashi Amur,  PhD

Frank Anania, MD

Jesse Anderson, MPH

Andrea Arbelaez        

Mark Avigan,  MDCM

Tina Burgess,  DVM

Keith Burkhart, MD

Si Chen, PhD (Staff Fellow)

Tracy Chen, PhD

Victor Crentsil, MD, MHS

Lara Dimick, MD

Hong Fang, PhD (Staff Fellow)

Lei Guo, PhD

Qais Hatim, PhD (Visiting Associate)

Huixiao Hong, PhD

Kapil Khadka, PhD (ORISE Fellow)

Imran Khan, PhD

Insook Kim, PhD

Madhu Lal-Nag, PhD

Catherine Li

Dongying Li, PhD (ORISE Fellow)

Rui Li,

Xin (Joy) Li, MS

Michelle Luo, MD, PhD

William Mattes, PhD

Kristin McEuen, PhD (ORISE Fellow)

Ruby Mehta, MD

Poonam Mishra, MD, MPH

Eileen Navarro, MD

Anil Nayyar

Baitang Ning,  PhD

Stephanie Omokaro, MD

Tejas Patel, MD, MPH

Yang Veronica Pei,   

Frank Pucino, PharmD, MPH

Zhen Ren, PhD

Lilliam Rosario, PhD

Amy Rosenberg, MD

Alan Shapiro,  MD, PhD

Weida Tong, PhD

Dong Wang, PhD

Tao Wang, PhD

Leihong Wu, PhD (Visiting Scientist)

Yue Wu, PhD (ORISE Fellow)

Guangxu Zhou, PhD

Shraddha Thakkar, PhD

 

2019

 

Heparin Bovine Spongiform Encephalopathy (BSE) CBER-CDER Risk Assessment Group

The project demonstrated the value of Cross-Center collaboration at the FDA by combining relevant expertise from CBER and CDER to address an important public health issue. It also demonstrated the value of establishing interdisciplinary teams with expertise in biology, medicine, regulatory policy, and quantitative risk assessment modeling. 

  

Richard Forshee, PhD (Title 42 employee)

Steven Anderson, PhD, MPP

Yin Huang, PhD (Visiting Scientist)

Hong Yang, PhD

David Asher, MD

Luisa Gregori, PhD

Sau Lee, PhD

David Keire, PhD

Scott Brubaker

Cyrus Bett, PhD, MSc (Staff Fellow)

Brian Niland

 

2018

 

OPANA ER Safety Review Working Group

For multi-disciplinary, inter-Center collaborative efforts to support the first withdrawal of a marketed opioid analgesic due to the public health consequences of abuse.

 

Corinne Woods, BS, PharmD, MPH

Paul W Buehler, PharmD., PhD

Stephanie Lynn Begansky, PharmD (C)

Ayla Yalamanoglu, MD (Orise)

Howard R Phillips, JD

David Tyler Coyle, MD, MS

Chava Kimchi-Sarfaty, PhD

Rajdeep Gill, PharmD

Lisa Ellen Basham, MS

Erika E. Englund, PhD

Morgan L. Jerrick

Grace Chai, PharmD (C)

Judith A. Racoosin, MD, MPH

Zongming Gao, MS, PhD

Jana Katherine McAninch, MD, MPH, MS

Kang Chen, PhD

Julia C. Pinto, PhD

Ciby J. Abraham, PhD

David A. Keire, PhD

Elizabeth Ann Bolan, PhD

LaToya Bonner, PharmD

Tamra E Meyer, PhD, MPH

Minh-Huong Lu Doan, PharmD (C)

Anh T. Vu, MCPM

Laura C. Pogue, PhD

Cynthia Kornegay, PhD

Nicole Zelenak, PharmD, MPH (C)

Megan E. Larkin, JD (Excepted Service)

Jamie D. Mans, MS, PhD

Daniel Joseph Mans, PhD

Chaitali Patel, PharmD

Wendy B. Brown, PharmD, BCACP

Diem-Kieu H. Ngo, PharmD (C)

Sharon Hertz, MD

Ellen Fields, MD, MPH

Joshua Lloyd, MD

Sara Camilli, PharmD (C)

Steven Christopher Jones, PharmD, MS, MPH (C)

Joanna Elizabeth Malsch

Judy A. Staffa, PhD, RPh

Swati Patwardhan, MS, RAC

Jay R. Fajiculay, PharmD

 

2017
Complex Generic Drug Product Bioequivalence Guidance Development Team

For the outstanding Intercenter group effort in developing bioequivalence guidance for complex generic drug products containing nano materials.

Jiwen Zheng, PhD
Stephanie Choi, PhD
Peter Petrochenko, PhD
Yong, Wu, PhD
Darby Kozak, PhD
Mohammad (Abir) Absar, PhD
Yan Wang, PhD

2016
FDA Label Team

Developed a bioinformatics tool and relational database for FDA drug labeling to aid
regulatory decision making and drug review in advancing translational and regulatory sciences

Crystal Allard
Byron Antee
Eric Brodsky, MD
Minjun Chen, PhD
Hong Fang, PhD
Stephen Harris
Paul Howard, PhD
Zhichao Liu, PhD
Joe Meehan
Eileen Navarro Almario, MD
Lilliam Rosario, PhD
Qiang Shi, PhD
Farrokh Sohrabi, MD
Robin Stingley, PhD
Helena Sviglin, MS
Weida Tong, PhD
Steven Turner
Tonya Vyas
Daniel Wakefield
Donny White
Joshua Xu, PhD
Guoping Zhang, PhD
Guangxu Zhou, MS

2015
Antiviral and Antibiotic Residues in Imported Pet Treats: Development and Implementation of Analytical Methods Working Group

For the outstanding intercenter group effort in developing and implementing analytical methods for the analysis of antiviral and antibiotic residues in imported chicken pet treats.

Wendy Andersen, PhD, ORA
Patrick Ayres, MS, ORA
Justin Carr, ORA
Mary Carson, PhD, CVM
Christine Casey, MS, ORA
Olgica Ceric, PhD, CVM
Thomas Conley, ORA
Yolanda Drake, MS, ORA
Andrea Heise, ORA
Aaron Johnson, ORA
Philip Kijak, PhD, CVM
Jack Lohne, MS, ORA
Renate Reimschuessel, PhD, VMD, CVM
Joseph Storey, ORA
Selen Stromgren, PhD, ORA
Terri Thomas, MBA, ORA
Sherri Turnipseed, PhD, ORA

2014
CFSAN-ORA Next-Generation Sequencing Group

For exceptional inter-center collaboration to form the CFSAN-ORA next-generation whole genome sequencing network

Marc Allard, PhD, CFSAN
Junia Jean-Gilles Beaubrun, PhD
Jennifer Brzezinski, PhD, ORA
Kai-Shun Chen, PhD, ORA
Jessica Christman, MS, ORA
Laura Ewing
Gopal Gopinathrao, PhD, CFSAN
Christopher Grim, PhD, CFSAN
Darcy Hanes, PhD, CFSAN
Sunee Himathongkham , PhD, ORA
Karen Jarvis, MS, CFSAN
Karen Jinneman, PhD, ORA
Okumu Kaluoch, ORA
Kuppuswamy N. Kasturi, DSc, ORA
Michelle M Moore, PhD, ORA
Kimberly Peterson
Allison Rodriguez, MS, ORA
Errol A. Strain, PhD, CFSAN
Irshad M. Sulaiman, PhD, ORA
Ruth Timme, PhD, CFSAN
Wen-Hsin Wu, PhD, ORA
Ken J. Yoshitomi, PhD, ORA

2013
CSI-Feed: Contamination with Salmonella Investigation Team

For exceptional inter-center collaboration in the development of methods for the isolation, detection, and serotyping of Salmonella enterica in animal feed.

Junia Jean-Gilles Beaubrun, Ph.D., CFSAN
Laura Ewing, CFSAN
Karen Jarvis, CFSAN
Kim Dudley, CFSAN
Wen Syi Lin, Ph.D., ORA
Kai-Shun Chen, Ph.D., ORA
Chorng-Ming Cheng, Ph.D., ORA
Maureen Davidson, Ph.D., CVM
Faiza Benahmed, CVM
Stuart Gaines, CVM
Mark Rasmussen, Ph.D., CVM
Sherry Ayers, CVM
Hua Wang, Ph.D., CFSAN
Thomas Hammack, CFSAN 
 
2012
Renal Biomarkers Research Group

For leadership, collaboration, and outstanding teamwork in the application of the renal biomarker approaches to address important regulatory issues in FDA

Richard Beger, Ph.D., NCTR
Frederick A. Beland, Ph.D., NCTR
Thomas N. Black, B.S., CFSAN
Ronald P. Brown, M.S., CDRH
Luisa Camacho, Ph.D., NCTR
Parvaneh Espandiari, Ph.D., CDER
Goncalo Gamboa da Costa, Ph.D., NCTR
Peter L. Goering, Ph.D., CDRH
Zachary M. Keltner, CFSAN
Nicholas Olejnik, B.S., CFSAN
Lisa M. Pence, Ph.D., NCTR
Barry Rosenzweig, B.S., CDER
Rodney L. Rouse, Ph.D., CDER
Laura Schnackenberg, Ph.D., NCTR
Michael Scott, CFAN
Robert L. Sprando, Ph.D., CFSAN
Sharron R. Stewart, CDER
Jinchun Sun, Ph.D., NCTR
Xing Tang, Ph.D., CDRH
Karol L. Thompson, Ph.D., CDER
Linda S. von Tungeln, B.S. NCTR
Jun Zhang, M.D., CDER
Qin Zhang, Ph.D., CDRH

 
2011
Deepwater Horizon Oil Spill Emergency Chemical Response Team

For the exceptional collaborative contribution to the agency Deepwater Horizon Oil Spill emergency response in chemical testing

Wendy C. Andersen, Ph.D. Jeffrey C. Archer, M.S. Patrick R. Ayres, M.S.
Paula Barnes
Timothy H. Begley, M.S. Tomika L. Bivens
Justin R. Carr
Christine R. Casey, M.S. Narong Chamkasem, Ph.D. Laura A. Ciolino, Ph.D. Celeste V. Cole
Daniel Connors, Ph.D. Lowri DeJager, Ph.D. Gregory Diachenko, Ph.D. Rachel Dietzel, Sc.D. Yolanda Drake, M.S.
David Eide, Sc.D.
Aref El‐Demerdash, Ph.D. Russell D. Fairchild
Travis Falconer, Ph.D. Bryan Gamble, Ph.D. James M. Gentry Michael Goerger, Ph.D. Steven A. Gonzales
Jill M. Gracie, M.S. Samuel Gratz, Ph.D. Mary Halbert, Ph.D. Tiffany M. Harmon Andrea S. Heise
Douglas Heitkemper, Ph.D. Stacy C. Hetz, Sc.D.
Jason W. Hill Jim R. Holcomb Edward T. Iannuzzi David S. Jackson Lisa R. Jennings Tonya R. Johnson Elizabeth J. Kelley
Megan M. Kirk Katie L. Korchinski Ronald Laurent, M.S. Marta Limberg, M.M. Mark R. Madson Heather A. McCauley Michelle A. McLain
CAPT Michael McLaughlin, Ph.D. LaTonya Mitchell, M.S.
Robert Mobley, Jr., M.S. Angela S. Mohrhaus Douglas Monroe, M.S. Randy D. Moore
Patricia J. Nyman, Ph.D.
Alesia Parker, Ph.D. Keshav Patel, M.S. Gracia Perfetti, Ph.D. Marian A. Pounders Sharna D. Pratt
Kristy M. Richards
Scott A. Roaf John P. Roetting Mark S. Ross, Sc.D.
Franklin Russell, M.S. George W. Salem Tara J. Salmon
Gregory E. Satterfield
Martha H. Schwartz
Carl J. Sciacchitano, M.S. Sina Shojaee
Barbara Spring‐Robinson Ryan Stadtmuller, M.S. Pamela R. Stehle
Selen Stromgren, Ph.D. Jennifer T. Szymanski Richard Thompson, M.S. Kevin Tran, Sc.D., Ph.D. Michael D. VanSickle
Victor A. Vega Himansu J. Vyas, M.S. Lisa M. Wiesman
Anthony D. Williams, M.S.
Marian Paige Wilson, M.S. Lauren V. Yeung

2010
Pharmacogenomics Working Group

For outstanding performance contributing to the development of the Guidance to Industry: Clinical Pharmacogenomics: Study Design and Pre-marketing Evaluation

Aloka G. Chakravarty, Ph.D.
Changting C. Haudenschild, M.D.
Chava Kimchi-Sarfaty, Ph.D.
Francis Kalush, Ph.D.
Gilbert Burckart, Pharm.D.
Gene A. Pennello, Ph.D.
Iris P. Masucci, Pharm.D., B.C.P.S.
Issam Zineh, Pharm.D., M.P.H.
Jang-Ik Lee, Pharm.D., Ph.D.
Janet Norden, M.S., R.N.
Jeffrey J. Tworzyanski, Pharm.D.
Lawrence Lesko, Ph.D.
Lei K. Zhang, Ph.D.
Mark I. Avigan, M.D., C.M.
Michael A. Pacanowski, Pharm.D., M.P.H.
Mimi T. Phan, Pharm.D.
Padmaja Mummaneni, Ph.D.
Rubynell Jordan, B.S.N., M.P.A.
Robert C. Kane, M.D.
Robert T. O’Neill, Ph.D.
Rajeshwari Sridhara, Ph.D.
Robert Temple, M.D.
Shashi G. Amur, Ph.D.
Silvana Borges, M.D.
ShaAvhree Y. Buckman, M.D., Ph.D., F.A.A.P.
Shiew Mei Huang, Ph.D.
Sue-Jane Wang, Ph.D.
Sally Yasuda, M.S., Pharm.D.
Venkatesh Atul Bhattaram, Ph.D.

 
2009
CBER & CVM ATryn Intercenter Review Group

For approval of the first recombinant biologic produced by transgenic animals – Opening the frontiers of new technologies used for the production of biological product.

CBER
Faith Barash, MD, MPH
Roman Drews, PhD
Maryann Gallagher, BA
Nisha Jain, MD
Iftekhar Mahmood, PhD
Joseph Manik, BA
Philip Joseph Snoy, DVM
Evi Struble, PhD
Chiang Syin, PhD
Pratibha Rana, MS
Kathleen M. Jones, Ph.D.

CVM
Joseph W. Cormier, PhD
Kevin J. Greenlees, PhD, DABT
Harlan J. Howard, PhD
Jeffrey S.  Jones, DVM, PhD
Larisa Rudenko, Ph. D., DABT
Eric M. Silberhorn, PhD, MPH
Haile F. Yancy, PhD

 

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