Current and Alumni Fellows

Get to know our current fellows, and learn how IOTF is helping them achieve their professional goals in oncology product research and regulatory review. A list of all alumni fellows can be found below.

Current Fellows

Learn more about the experiences and research interests of our current fellows.

Danielle Brooks, Ph.D.

This fellowship provides invaluable experience to anyone interested in regulatory affairs. Performing FDA mission relevant research has provided me with strategies to improve experimental design throughout the research and development process.

Dr. Brooks received her Ph.D. in Biomedical Sciences with a concentration in Cancer and Developmental Biology at The University of Tennessee Health Science Center in Memphis, TN. Following her graduate training, Dr. Brooks completed three years of post-doctoral training in the laboratory of Dr. Patricia Steeg in the Women’s Malignancies Branch of the National Cancer Institute. In 2017, she joined the NCI-FDA Interagency Oncology Task Force Fellowship as a product quality research/review fellow.

Research Interests

Dr. Brooks’s research interest is to advance innovative therapies for patients with aggressive diseases and poor survival outcomes. As a graduate student, she focused on identifying novel genes that regulate breast cancer metastasis, and identified a candidate small molecule metastasis inhibitor. As a postdoctoral fellow, she continued this work and collaborated with multiple pharmaceutical companies to evaluate and validate different novel metastasis inhibitors in preclinical animal models to move the drugs into clinical trials. Upon being selected as an IOTF fellow, Dr. Brooks was presented with the opportunity to expand her research interests. She now focuses on biological therapies, specifically cellular therapies, and developing methods that can assess induced pluripotent stem cell quality and predict their behavior during the manufacturing process required to derive cellular products from them.

Fellowship Experience

“This fellowship provides invaluable experience to anyone interested in regulatory affairs. Performing FDA mission relevant research has provided me with strategies to improve experimental design throughout the research and development process. Additionally, this is the only opportunity where you get actual hands-on review experience, which has provided me with a more profound understanding of the relevant federal statutes and regulations involved in the FDA review and approval processes.”

Career Goals

“My long-term career goal is to obtain a position where I can directly contribute to the development of product standards and guidance documents to facilitate the productive movement of new ideas into approved therapeutic options, either within the FDA or in an industry or academic setting.”


Andrew W. Harmon, Ph.D.

The IOTF fellowship is a one-of-a-kind training program for researchers that are interested in regulatory science. As an IOTF fellow I have gained hands-on experience in the development and regulation of a fascinating class of biologic products.

Dr. Harmon received a B.S. in Biology from the University of Delaware and a Ph.D. in Molecular, Cell, and Developmental Biology from the University of California, Los Angeles (UCLA). Following his graduate studies, he conducted three years of post-doctoral training in the Gene Transfer and Immunogenicity Branch of the Center for Biologics Evaluation and Research (CBER) at the FDA. In September of 2017 Dr. Harmon joined the NCI/FDA Interagency Oncology Task Force Fellowship as a CMC (product quality) research and review fellow.

Research Interests

While performing graduate research in the field of cardiac progenitor cell biology in UCLA’s Broad Stem Cell Center, Dr. Harmon gained an interest in the use of viral gene therapy vectors as a tool for the treatment of debilitating genetic and malignant diseases. His postdoctoral work focused on the biology of intravenously delivered Adenovirus (Ad) gene therapy vectors, specifically whether pre-clinical studies in mice accurately predict the behavior of Ad products in human blood. As an IOTF fellow, he continues to study viral gene therapy, but has switched to studying VSV-G pseudotyped lentivirus vectors. This research involves studying the impact of incorporating small HCV-derived immunomodulatory peptides into lentivirus vectors, with the goal of developing strategies to modulate innate and adaptive immunity and enhance transgene expression.

Fellowship Experience

“The IOTF fellowship is a one-of-a-kind training program for researchers that are interested in regulatory science. As an IOTF fellow I have gained hands-on experience in the development and regulation of a fascinating class of biologic products. In addition to regulatory review training, the program has also allowed me to perform viral vector research relevant to cancer immunotherapies and present findings that aim to inform the regulatory process.”

Career Goals

“My short-term career goal is to use the hands on regulatory review experience I have gained through the IOTF program to transition off the bench and become a full-time CMC reviewer in the FDA’s Division of Cellular and Gene Therapies. I am motivated to be able to contribute to the development of safe and effective gene therapies for diseases with otherwise limited treatment options.”


Elizabeth Lessey-Morillon, Ph.D.

My training provides me with a first hand understanding of the life cycle of investigational applications, and the safety and quality requirements at each phase for cellular therapy regulatory submission.

Dr. Lessey-Morillon received her Ph.D. in Cell and Developmental Biology from The University of North Carolina at Chapel Hill. She conducted her post-doctoral training in the Laboratory of Pathology at the National Cancer Institute. Dr. Lessey-Morillon became a NCI-FDA Interagency Oncology Task Force Fellow in September 2017 in the Division of Cellular and Gene Therapies.

Research Interests

Dr. Lessey-Morillon’s research interests have focused on how cells responded to biochemical and physical extracellular cues in their microenvironment. Her graduate work centered on mechanobiology and determining the contribution of external and cell generated forces on endothelial cells during leukocyte transendothelial migration. In her postdoctoral work, she examined the role of CD47 in the tumor microenvironment. In her current research at the FDA in Dr. Bauer’s laboratory, she is characterizing the role of the bone microenvironment on multipotent stromal cell differentiation and identifying critical quality attributes.

Fellowship Experiences

“As an IOTF fellow, I review investigational submissions of cell therapy products. I attend regulatory courses, regulatory review staff meetings, and cell and gene therapy conferences. My training provides me with a first-hand understanding of the life cycle of investigational applications, and the safety and quality requirements at each phase for cellular therapy regulatory submission.”

Career Goals

“My goal is to apply the knowledge and experience gained from this fellowship to continue as a full-time cell therapy product reviewer at the FDA.”


Jun Zhao, Ph.D.

This fellowship provided me not only with a strong background in regulatory science and policies but also with a big picture of the development of biological drugs.

Dr. Zhao received his Ph.D. in Chemical Engineering at the University of Akron. He conducted his post-doctoral training in the National Institute on Deafness and Other Communication Disorders (NIDCD) in the National Institutes of Health (NIH) and the Cancer and Inflammation Program of the Center for Cancer Research at the National Cancer Institute (NCI). Dr. Zhao joined the NCI-FDA Interagency Oncology Task Force (IOTF) Fellowship in September, 2017 as a product quality research/review fellow at CDER, FDA.

Research Interests

Dr. Zhao’s research was focused on the structural basis of antibody-antigen recognition, antibody engineering, protein mis-folding and computational biology. His graduate research focused on the mechanism of protein mis-folding and aggregation. As a postdoctoral fellow at NIDCD, Dr. Zhao studied the polymerization mechanism of the tight junction protein claudin, which is an important biomarker in cancer metastasis. He then continued his postdoctoral research training at NCI, where he studied the allosteric effect in the antibody-antigen recognition process and the protein engineering for binding affinity maturation of therapeutic antibodies. As an IOTF fellow, he focused on the allosteric regulation of trastuzumab, the first-line therapeutic antibody in HER2-positive metastatic breast cancer, on the ErbB family proteins.

Fellowship Experiences

“The IOTF program has provided me with a unique opportunity to gain both regulatory training and scientific research experience on the evaluation of quality, safety and efficacy of drugs. As an IOTF fellow, I have obtained invaluable regulatory training on the Chemistry, Manufacturing, and Controls (CMC) though FDA courses, regulatory conferences and reviewing real cases of Investigational New Drug (INDs). This fellowship provided me not only with a strong background in regulatory science and policies but also with a big picture of the development of biological drugs.”

Career Goals

“Upon the completion of the IOTF fellowship, I plan to pursue a full-time position as a full-time reviewer or a research reviewer at FDA, focusing on the targeted cancer therapy where I want to apply my interdisciplinary scientific skills to make important regulatory decisions.”


Andrea George, Ph.D.

The IOTF fellowship provides a unique opportunity for fellows to learn the process of regulatory review while allowing them to continue pursuing laboratory based novel research. It literally is the best of both worlds.

Dr. George received her Ph.D. in Microbiology and Immunology at New York Medical College. She conducted three years of post-doctoral training in the Mammary Stem Cell Biology Section of the Center for Cancer Research at the National Cancer Institute. Dr. George joined the NCI-FDA Interagency Oncology Task Force Fellowship in September, 2016 as a product quality research/review fellow

Research Interests

Dr. George’s research interest is to understand the molecular mechanisms of tumor progression and how the microenvironment plays a role. Her graduate studies focused on how estrogen modulation of hypoxia signaling pathways influences cellular cross-talk in the breast cancer development and metastasis. As a postdoctoral fellow, Dr. George investigated the role of tissue-specific stem cells in the mammary gland niche and sought to unravel the regulatory and molecular control of gland development using in vivo transgenic animal models. As an IOTF fellow, her current research focuses on the role of the p53 homologue p63, specifically the DNP63a isotype, on keratinocyte stem cell maintenance and modulation of the INK4A/ARF locus and subsequent p16/p19 signaling pathways.

Fellowship Experiences

“The ITOF fellowship provides a unique opportunity for fellows to learn the process of regulatory review while allowing them to continue pursuing laboratory based novel research. It literally is the best of both worlds. The fellowship has allowed me to gain an understanding of how the regulatory process could be better integrated into early research study design and development. Further, it’s easy to see how this dual training of research and review will quickly foster cancer treatment strategies and lead to more safe, effective and ground breaking therapeutics for patients.”

Career Goals

“My goal is to utilize the training and experience the IOTF fellowship has afforded me to continue as a full time reviewer or research/reviewer at the FDA. I plan to pursue a career in which I can contribute to public health and education by ensuring safe and effective therapeutics reach the market.


Mayumi Takahashi, Ph.D.

The IOTF fellowship has provided me with a unique and invaluable opportunity to gain a rigorous regulatory training experience to acquire the skills and knowledge necessary for regulatory review activities while conducting scientific research.

Dr. Takahashi received her M.S. in Pharmaceutical Sciences and Ph.D. in Life Science in the field of Biomedical and Pharmaceutical Sciences at the Department of Pharmaceutical Sciences at Hokkaido University, Japan. She conducted four years of post-doctoral training at City of Hope National Medical Center, Duarte, CA. Dr. Takahashi joined the NCI-FDA Interagency Oncology Task Force Fellowship in September, 2016 as a product quality research/review fellow.

Research Interests

Dr. Takakahashi’s research interest is to discover highly potent oligonucleotide therapeutics, such as small interfering RNAs (siRNAs), antisense oligonucleotides and aptamers, for the treatment of various diseases, such as cancer and infectious diseases, and their targeted delivery strategies. Dr. Takahashi’s research during her postdoctoral fellowship encompasses the basic science and development of nucleic acid-based therapeutics and gene therapy against HIV-1 and lymphoma/leukemia, including development of chemically modified ASOs, and cell-type specific aptamers for targeted disease therapy. Her current research as an IOTF fellow focuses on establishment of synthetic methods for preparation of novel thermolytic groups, which will be used for phosphate protection of nucleic acid-based drugs to improve their bioavailabililty.

Fellowship Experiences

“The IOTF fellowship has provided me with a unique and invaluable opportunity to gain a rigorous regulatory training experience to acquire the skills and knowledge necessary for regulatory review activities while conducting scientific research. The program has also allowed me to participate in regulatory courses, training sessions, seminars and conferences, all of which are useful to tackle the review of pre-IND and IND submissions from a CMC perspective and make appropriate regulatory assessments and decisions.”

Career Goals

“My goal upon the completion of the IOTF program is to pursue a career in scientific research and regulatory review of drugs and biologics at the FDA, where I can apply the unique laboratory and review skills acquired during the course of the IOTF training. I intend to make the most of each and every available opportunity from the program to make the most appropriate decision to achieve my goal. 

 


Current and Alumni Fellows

Here is a list of IOTF fellows, listed by cohort year.

2005

  • Jee Chung
  • Arundham Dhar
  • Sarah Kenneth
  • Robert Lechleider
  • Haruhiko Murata
  • Chris Sasiela
  • Jeffrey Smith
  • Stacy Ticci

2006

  • Elizabeth Hsu
  • Yifen Jia
  • Bedri Karakas
  • Joyson Karakunnel
  • Tahira Khan
  • Dubravka Kufrin
  • Ashutosh Rao

2007

  • Milos Dokmanovic
  • Linan Ha
  • Lei Huang
  • Iram Quraishi
  • Abeba Tesfaye

2008

  • Caryl Giuliano

2009

  • Tabetha Bonacci
  • Jennifer Dickey
  • Nehal Lakhani
  • Edyta Pawelczyk
  • Jennifer She
  • Ian Waxman

2010

  • Tura Camilli
  • Himabindhu Ghaddipati
  • Ramesh Leon
  • Yan Wang
  • Qing Zhuo

2011

  • Genesis Butler
  • Rachel Novak
  • Frances Anne Qin
  • Leslie Rivera Rosado

2012

  • Tracy Denison
  • William Hallet
  • Avin Lalmansingh
  • Massod Rahimi
  • Nozomi Sakakibara

2013

  • Xu Di
  • Kristen Nickens
  • Willie Wilson
  • Haoheng Yan

2014

  • Gopal Abbeneni
  • Ashwin Bhirde
  • Fabiola Gomez
  • Rong Guo
  • Eric Hales

2015

  • Ekaterina Allen
  • Aysegul Ergen
  • Anna Kwilas
  • Sandhya Sanduja
  • Nailing Zhang

2016

  • Andrea George (current)
  • Karol Szczepanek
  • Mayumi Takahasi (current)
  • Yong Luo

2017 (current)

  • Danielle Brooks 
  • Andrew Harmon
  • Elizabeth Lessey Morillon
  • Jun Zhao
  • Updated: July 26, 2018

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