Current and Alumni Fellows

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

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.

Andrea George, Ph.D.

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.

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.


Yong Luo, Ph.D.

The IOTF program has given me with an invaluable opportunity to understand how interdisciplinary sciences are integrated into FDA regulatory decisions for promoting and protecting the public health.

Dr. Luo received his Ph.D. degree in Microbiology at Kansas University Medical Center. He conducted post-doctoral training at the National Center for Toxicological Research (NCTR)/FDA and Yale University. Dr. Luo joined the NCI-FDA Interagency Oncology Task Force Fellowship in 2016 as a product quality research/review fellow.

 

Research Interests

Dr. Luo’s research was focused on virus-host interactions and system toxicology. His graduate research focused on investigating the roles of DNA damage response in parvovirus infection. As a postdoctoral fellow at NCTR, Dr. Luo studied cancer drug toxicity and received regulatory sciences training. He continued his postdoctoral research training at Yale University, where he studied tumor viruses and identified a mechanism for SV40-induced vacuolization, a phenotype led to the discovery of this historically important virus as a contaminant of polio virus vaccine in 1960s. As an IOTF fellow, he is focused on reviewing and documenting the regulatory history of proton and carbon ion therapy devices and analyzing FDA decision making process.

Fellowship Experiences

"The IOTF program has given me with an invaluable opportunity to understand how interdisciplinary sciences are integrated into FDA regulatory decisions for promoting and protecting the public health. It provides me with generous funding and freedom for taking different regulatory courses within the FDA. More importantly, it allows me to get hands on experience in reviewing product submissions from industry. The comprehensive training from this program is essential for me to build up skills for my career transition from a scientist to a regulator."

Career Goals

“My long-term goal is to become a regulator in biomedical field to promote and protect the public health. After the training, I plan to pursue a career at FDA as a lead reviewer for oncology-related products.”

 


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. 

 


Karol Szczepanek, Ph.D.

The IOTF fellowship has been a unique opportunity to obtain an extensive training in the regulatory review process while conducting analytical research addressing product quality, safety and efficacy.

Dr. Szczepanek received his Ph.D. degree in Biochemistry from the Jagiellonian University in Poland. He conducted his post-doctoral training in the Division of Cardiology at the Virginia Commonwealth University in Richmond, VA and the National Cancer Institute in Bethesda, MD. In addition to his research career, he did internships in a technology transfer office and a life sciences consulting firm. Dr. Szczepanek joined the NCI-FDA Interagency Oncology Task Force Program in September 2016 as a product quality research/review fellow in the Division of Biotechnology Products at CDER, FDA.

Research Interests

Dr. Szczepanek’s graduate work and initial post-doctoral training focused on molecular mechanisms of cardiotoxicity in response to oxidative stress conditions. During his time at the National Cancer Institute, he conducted transcriptomic and genomic characterization of breast cancer metastases for the development of novel anti-metastatic therapies. As an IOTF fellow, his regulatory research focuses on studying the effects of degradation of polysorbate excipients on the stability of protein drugs approved for clinical use in oncology.

Fellowship Experiences

“The IOTF fellowship has been a unique opportunity to obtain an extensive training in the regulatory review process while conducting analytical research addressing product quality, safety and efficacy. As an IOTF fellow, I have received invaluable regulatory training though numerous FDA training courses, attending international regulatory conferences and reviewing Investigational New Drug (IND) and pre-IND applications. The IOTF fellowship has provided me not only with a strong foundation in regulatory science and policies but also with an overall view on how biotechnology drugs are developed and what it takes to have them approved for clinical use.”

Career Goals

Upon successful completion of the IOTF fellowship, my long-term goal is to pursue a career in regulatory affairs as a product quality reviewer at the FDA or in the biopharmaceutical industry. Ultimately, I want to serve the public’s health needs by ensuring the transition of safe and effective biotherapeutics from the bench to the bedside.”

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 (current)

  • Andrea George
  • Karol Szczepanek
  • Mayumi Takahasi
  • Yong Luo

2017 (current)

  • Daniel Brooks
  • Andrew Harmon
  • Elizabeth Lessey Morillon
  • Jun Zhao

Most text on the National Cancer Institute website may be reproduced or reused freely. The National Cancer Institute should be credited as the source and a link to this page included, e.g., “Current and Alumni Fellows was originally published by the National Cancer Institute.”

Please note that blog posts that are written by individuals from outside the government may be owned by the writer, and graphics may be owned by their creator. In such cases, it is necessary to contact the writer, artists, or publisher to obtain permission for reuse.

We welcome your comments on this post. All comments must follow our comment policy.