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  1. About Science & Research at FDA

Excellence in Review Science–GROUP

This category recognizes a group involved in a review science collaborative effort which includes, but is not limited to, new and/or uniquely applied approaches to regulatory decision- making and ability to interpret scientific information submitted to the agency, e.g., application of scientific expertise to the review process, national and international standards development and harmonization, development of regulatory policies and guidance, etc. Laboratory- based accomplishments are not eligible for this award.

2024

Menthol Cigarettes and Cigar Flavors Product Standards Workgroup (CTP)

For outstanding multidisciplinary collaboration & expertise in developing the scientific foundation for landmark regulations prohibiting menthol cigarettes & flavored cigars to protect public health.

Susana Addo Ntim, Ph.D. (CTP)
Apostolos Alexandridis, Ph.D., M.P.H. (CTP)
Rudaina Alrefai-Kirkpatrick, Ph.D. (CTP)
Bridget Ambrose, Ph.D., M.P.H. (CTP)
Andrew Anesetti-Rothermel, Ph.D. (CTP)
Benjamin Apelberg, Ph.D. (CTP)
Jennifer Bernat, Ph.D. (CTP)
Salome Bhagan, Ph.D. (CTP)
Aaron Blakney, M.P.H. (CTP)
Joanne Chang, Ph.D., M.P.H. (CTP)
Iris Chen, Ph.D. (CTP)
Yu-Ching Cheng, Ph.D. (CTP)
Colin Cunningham, Ph.D. (CTP)
Ana DePina, Ph.D. (CTP)
Elisabeth Donaldson, Ph.D., M.H.S. (CTP)
Willa Dong, Ph.D., M.S.P.H. (CTP)
LCDR Lacreisha Ejike-King, Ph.D., M.S. (CTP)
Erin Ellis, Ph.D., M.P.H., M.S. (CTP)
Martha Engstrom, M.S. (CTP)
Reema Goel, Ph.D., M.S. (CTP)
Michael Halenar, M.P.H. (CTP)
Jonathan Hannings, M.A. (CTP)
Matthew Hassink, Ph.D. (CTP)
Naa Inyang, M.P.H. (CTP)
Habibah Jackson (CTP)
Kia Jackson, Ph.D. (CTP)
Moronke Johnson, M.P.H. (CTP)
Azieb Kidanu, Ph.D., M.P.H. (CTP)
Sherry Liu, Ph.D. (CTP)
Marjorie Margolis, Ph.D. (CTP)
Chelsea McKinney, Ph.D., M.P.H. (CTP)
Khemry Min, M.H.A. (CTP)
Aura Lee Morse, M.P.H. (CTP)
Caryn Nagler, M.P.H. (CTP)
Lauren Pacek, Ph.D. (CTP)
Eunice Park-Lee, Ph.D., M.S. (CTP)
Roshitha Paul, M.P.H. (CTP)
LT Stephanie Pitts, Ph.D. (CTP)
Joanna Randazzo, D.C. (CTP)
LT Jazmin Reed, Ph.D., M.P.H. (CTP)
Jacqueline Reuben, Ph.D., M.H.S. (CTP)
Esther Roh, Ph.D., M.S. (CTP)
Ashley Ross, M.P.H. (CTP)
Brian Rostron, Ph.D., M.P.H. (CTP)
Andrea Ruybal, Ph.D. (CTP)
Christine Saba, M.P.A., M.P.H. (CTP)
Sandra Salido, Ph.D. (CTP)
Michael Sawdey, Ph.D., M.P.H. (CTP)
Jennifer Schmitz, M.P.H. (CTP)
Megan Schroeder, Ph.D. (CTP)
Dale Slavin, Ph.D. (CTP)
Kimberly Snyder, M.P.H. (CTP)
LCDR Roberto Valverde, M.P.H. (CTP)
Samantha Venrick, Ph.D. (CTP)
Jia Wang, M.P.H. (CTP)
LCDR Kerui Xu, Ph.D., M.P.H. (CTP)
Xin Xu, Ph.D. (CTP)
Ronald Edwards, M.Sc. (CTP)
Amy Gross, Ph.D., M.H.S. (CTP)
Anuja Majmundar, Ph.D., M.A., M.B.A. - Visiting Associate (CTP)
Hyungsik Shin, Ph.D. (CTP)
Haijun Xiao, M.S. (CTP)

 

2023

Botanical Review Team (CDER)

For providing a novel comparative review of state level cannabis quality testing and cGMPs, resulting in rapid publication and extremely valuable commentary to the field.

 

Schuyler Pruyn, M.S.

Cassandra Taylor, Ph.D.

Charles Wu, Ph.D.

Qiang Wang, Ph.D.(Staff Fellow)

2022
Statistical Team Supporting Drug Trials Snapshots, Complex and Innovative Design, and Pediatric Drug Development (CDER)

For outstanding contribution to support new legal requirements to clarify impact of demographic differences on drug efficacy and to expedite drug development with innovative design

 

Mark Rothmann, PhD
Robert Abugov, MPH, PhD
James Travis, PhD

2021

OFAS/DFCS PFAS Team (CFSAN)

The OFAS/DFCS PFAS review team's scientific review on short-chain PFAS has led the FDA to take the lead to protect public health.

 

Penelope Rice, PhD, DABT

Shruti Kabadi, PhD

Jessica Cooper

Sharon Koh-Fallet, PhD

 

2020

Fentanyl Reservoir Transdermal System (TDS) Reference Report Team

For providing the scientific foundation to remove reservoir Fentanyl Transdermal Systems from the US market and answering a Citizen's Petition submitted in 2005.

 

Caroline Strasinger, PhD

Cedar Boakye, PhD (Staff Fellow)

Anna Wokovich

Alicia Hoover, PhD

 

2019

MRI Compatibility Review Group

For sustained efforts to improve MRI labeling for all medical devices and in particular, for MR-Conditional devices.

 

Devashish Shrivastava, PhD

Finn Donaldson, PhD

Brent Showalter, PhD

Nicole Larsen, MME

Vasant Dasika, PhD

Daniel Krainak, PhD, MS

Samuel Raben, PhD

Amir Razjouyan, MS

David Soltysik, PhD

Donald Witters, MS

Eriko Yoshimaru, PhD

Howard Bassen, MS

Jana Delfino, PhD

Leornardo Angelone, PhD

Sunder Rajan, PhD

Ting Song, PhD, MPhil

Terry Woods, PhD, MS

Wilfgant Kainz, PhD, MS

 

2018

Emerging Technology Team

The Office of Pharmaceutical Quality Emerging Technology Team provides leadership in promoting and facilitating the development and implementation of innovative pharmaceutical product and manufacturing technologies to advance product quality, safety and efficacy.

 

Geoffrey Wu, PhD (C)

Kurt A Brorson, PhD

Rick Friedman, MS

Celia N. Cruz, PhD

Min Li, PhD

Thomas Francis O’Connor, PhD

Rapti D. Madurawe, PhD

Mohan Sapru, PhD

Mahesh Ramanadham, PharmD, MBA

Bryan Riley, PhD

Cheryl Kaiser, MA

Sharmista Chatterjee, PhD

Juandria Williams, PhD

Tara Gooen Bizjak, M.NmSCI (C)

Sau L. Lee, PhD

 

2017

Zika Virus Review Team

For the timely application of collaborative scientific review expertise in the face of a national public health emergency caused by the emerging Zika virus threat.

 

Peyton Hobson, PhD

David A. Leiby, PhD

Pradip N. Akolkar, PhD

 

2016

Zarxio Review Team

For scientific innovation, excellence in regulatory review, and highest level of collaboration and teamwork leading to the first FDA approved bio similar product, Zarxio

 

Monsurat Lara Akinsanya, MS;  Kassa Ayalew, MD, MPH;  Jibril Bin Mikail Abdus-Samad, PharmD;  Jessica Boehmer, MBA;  Theresa Carioti, MPH

Nathan Caulk, MS, BSN (C); Bo Chi, MD, PhD; Haw-Jyh Chiu, PhD; Lea Christl, PhD; Albert Deisseroth, MD, PhD

Marlene Schultz-DePalo, MS, MA; Xiaoyu Dong, PhD; Ann Farrell, MD; Steven Fong, PhD; Barbara Fuller, MSN, BSN

CAPT Patricia Garvey, RPh (C); Adam George, PharmD; Nicole Gormley, MD; LaShawn Griffiths, MSHS-PH, BSN

Thomas Gwise, PhD; Gregory H. Reaman, MD; Sam Haidar, PhD, RPh; Sarah Harris, PharmD; Patricia Hughes, PhD

Gibbes Johnson, PhD; Edvardas Kaminskas, MD; Susan Kirshner, PhD; Steven Kozlowski, MD;Virginia Kwitkowski, MS, ACNP-BC

Emanuela Lacana, PhD; Carla Lankford, MD, PhD; Maria-Teresa Gutierrez-Lugo, PhD; John Leighton, PhD; Sue Lim, MD

Christopher M. Sheth, PhD;  Anshu Marathe, PhD;  Yelena Maslov, PharmD;  Ryan McGowan; Lubna Merchant, MS, PharmD

Frederick Mills, PhD; Tyree Newman; Lei Nie, PhD; Anthony Orencia, MD; Neel Patel, PharmD

Zhihao Peter Qiu, PhD; Janice Pohlman, MD, MPH;  Ranjani Prabhakara, PhD;  Donna Przepiorka, MD, PhD;  Nama Rahman, PhD

Sripal Reddy Mada, PhD;  Haleh Saber, PhD; Sarah, Schreiber, PharmD;  Faruk Sheikh, PhD;  Meiyu Shen, PhD; 

Vikram Sinha, PhD;  Michael Skelly, PhD;  Rajeshwari Sridhara, PhD;  Alan Stevens, ME; Kellie Taylor, PharmD, MPH

Yi Tsong, PhD; Sonal Vaid, JD; Neil Vora, PharmD, MBA;  Janice Weiner, JD, MPH;  Kyung Yul Lee, PhD 

2015
Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs Development Group, CDER

For the development of an innovative bioequivalence approach to evaluate generic narrow therapeutic index drugs.

 

Mei-Ling Chen, PhD
Dale Conner, PharmD
Wenlei Jiang, PhD
Fairouz Makhlouf, PhD
Laurie Muldowney, MD
Robert Lionberger, PhD
Donald Schuirmann, PhD
Lawrence X Yu, PhD
Xinyuan Zhang, PhD
Nan Zheng, PhD

 

2014

Center for Devices and Radiological Health (CDRH) EMC and Wireless Work Group

For outstanding scientific vision, leadership, and public health impact in the development and publication of the Radio Frequency Wireless Technology in Medical Devices Guidance document.

 

Heather Agler, PhD, CDRH

Vasant K. Dasika, PhD, CDRH

Eva Ellsworth, CDRH

Charles Ho, PhD, CDRH

George Kraus, CDRH

Bakul Patel, MBA, CDRH

Nancy Pressly, MS, CDRH

Linda Ricci, MS, CDRH

Seth Seidman, MSEE, CDRH

Jeffrey L. Silberberg, MSEE, CDRH

Linda Weir

Donald M. Witters, MS, CDRH

2013

Bioabsorbable Group

For excellence in review science of the bioabsorbable materials and their complexities in cardiovascular stent applications.

 

Ji Guo, Ph.D., CDRH

Nicholas Benetatos Ph.D., CDRH

Maureen Dreher Ph.D., CDRH 

 

2012

The Finasteride and Dutasteride Review Team, OHOP/OND/CDER

For outstanding assessments of the risk-benefit ratio of 5A-reductase inhibitors with regard to proposed use of prevention of prostate cancer in men

 

John R. Johnson, M.D., CDER

Marc Theoret, M.D., CDER

Yang-Min Ning, M.D., Ph.D., CDER

Jenny Zhang, Ph.D., CDER

Kun He, Ph.D., CDER

Chia-Wen Ko, Ph.D., CDER

Shenghui Tang, Ph.D., CDER

 

2011

CFSAN/OFAS Trans Fat Intake Assessment Work Group

For development of an updated intake estimate of trans fat in the diet and regulatory options to address further reduction of trans fat in the diet

 

Diana I. Doell, Ph.D.

Daniel E. Folmer, Ph.D.

Mical E. Honigfort, Ph.D.

Hyoung S. Lee, Ph.D.

 

2010

Hematopoietic Stem/Progenitor Cell Task Group, CBER

For outstanding collaborative analysis of data submitted to a public docket in a precedent-setting leveraging activity to develop licensure criteria for cord blood

 

Tami Belouin, J.D.

Kimberly Benton, Ph.D.

Peter Bross, M.D.

Changting Haudenschild, M.D.

CAPT. Ellen F. Lazarus, M.D.

Laurie Norwood

Mercy Quagraine

Donna Przepiorka, M.D.

Anita Richardson

Chinying Wang

Denise Zavagno, J.D.

 

2009

Generic Calcitonin Review Group, CDER

For developing a novel, science-based regulatory pathway to evaluate and approve high quality, safe and effective generic salmon calcitonin.

 

Raj Bykadi, PhD
Bing Cai, PhD
Barry W. Cherney, PhD
Dale P. Conner, PhD
Barbara M. Davit, PhD
Kuldeep R. Dhariwal, PhD
Devinder S. Gill, PhD
Wei Guo, PhD
Sau L. Lee, PhD
Benjamin B. Lim, PhD
Shing H. Liu, PhD
Moheb H. Makary, PhD
Rashmikant Patel, PhD
Andre S. Raw, PhD
Amy S. Rosenberg, MD
Vilayat A. Sayeed, PhD
Paul Schwartz, PhD
Lawrence X. Yu, PhD

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