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Program Participant Testimonials


CFP Program Participant Testimonials

 

Former Preceptors:

 
Ira Berkhower, M.D., Ph.D. (Class of 08 and 2011) – CBER
 
 Ira Berkhower, M.D., Ph.D. 

FDA has many advantages for a research/reviewer like myself, including our contribution to reaching regulatory decisions based on informed scientific opinion. However, since we are not a university, we lack a ready supply of graduate students and post doctoral fellows who can carry on the research and provide a resource for the future.

The CFP is one of the best ways to address this problem. I've seen the best applicants, coming from NIH and other first-rate graduate programs through the CFP. For the first time, I've received calls from NIH lab chiefs and professors at leading universities recommending fellows who were competing for the program.The results have been gratifying for the mentors and the fellows. The fellows have brought the new talents and skills that we needed in our research. They've been well prepared to fill a vital regulatory science niche. Instead of depending on scarce resources for academic research, fellows face a bright future at FDA, where they will facilitate the timely approval of new drugs and biological agents. Others, who migrate to industry, will improve the quality of applications to FDA.
 
Stefano Luccioli, M.D. (Class of 2010) - CFSAN
 
 Stefano Luccioli, M.D.

Many people may not realize that FDA has a richness of data and information at its disposal that can be used to generate interesting public health research ideas and projects.  When my project was accepted for the Fellowship program, I was amazed not only by the number of applicants interested in my project but by the superior quality of these applicants – most of whom already had exceptional training and experience in a variety of scientific fields. Since my project required someone to develop a new modeling scheme to answer regulatory questions, I was looking to find an experienced scientist who had a solid regulatory focus but could also think outside of the box. The Commissioner’s Fellowship offered the best of both.

 
Markham Luke, M.D., Ph.D. (Class of 2010, 2011, and 2012) - CDRH
 
 Markham, Luke, M.D.

As a regulatory scientist and clinician working in the medical device arena, I have been impressed with the quality, dedication, and the positive contributions provided by our selected Commissioner's Fellows. The fellows that I precepted have received training, completed work products, and participated in projects that have allowed them to develop their regulatory chops and function confidently in the FDA environment. 

Our fellows at CDRH were stationed in various Divisions where their interest and skills could be maximally used and where they had interest.  Since coming on board, many of our fellows have been hired into various capacities at FDA that befit their dedication to mission and their skillsets. 

 

Former Fellows

 
Ernest Kwegyir-Afful, Ph.D. (Class of 2010) – CFSAN
 
 Ernest Kwegyir-Afful, Ph.D.As a bench scientist with a background in biochemistry, psychology, software development, and neuroscience, I have always been interested in how science can directly improve people's everyday lives. The Commissioner's Fellowship Program gave me a unique opportunity to put all these disciplines to use because it encourages a multidisciplinary approach to solving public health issues. Under a senior FDA scientist's direction, the fields of epidemiology, clinical trials, and regulatory and public policy are brought to bear on specific regulatory policy challenges for which fellows are encouraged to design new solutions. 

My fellowship project involved using quantitative risk assessment methods to assess the feasibility of physiologically relevant thresholds for food allergens in conformity with U.S. allergen labeling laws. The research was awarded the Public Health Impact Award at the 2nd Annual Foods Program Science and Research Conference. I continue to use my training at FDA's Office of Food Additive Safety, where I employ the skills that I've acquired and my neuroscience background to lead risk assessment projects and design better predictive models that use artificial neural networks.

 

Khaled Bouri, Ph.D., M.P.H. (Class of 2009) – OC

 
 Bouri, Khaled, Ph.D. 
As a research scientist, with a focus on the use of genomic technologies, I was struck by the lack of progress in medical product development, despite the enormous advances seen in scientific knowledge and medical technologies over the last decade.  I wanted to identify the reasons behind this gap and participate in building a bridge from bench to bedside. The Fellowship Program gave me a deep appreciation of the complexity of the medical product development process and provided me with the tools and knowledge to more effectively help FDA achieve its mission.
 
Dionna Green, M.D. (Class of 2009) – CDER
 
 Dionna Green, M.D.I came to the program seeking experience in the drug development process from the unique perspective that only the FDA can offer.  As a clinician with training in pediatrics, I was interested in the regulatory and scientific considerations that are pertinent when developing drugs and biologics to treat diseases and conditions affecting neonates, infants, children, and adolescents.  In the Fellowship program, I participated in the extensive work underway at FDA to advance pediatric therapeutics.  The program gave me a comprehensive understanding of how all of the agency components work together toward the goal of promoting and protecting the public’s health.
 
Francesca Joseph, M.D. (CFP Class of 2008) – OC
 

 Francesca JosephWhat appealed to me most about the fellowship program was the opportunity to learn about regulatory science and participate in public health initiatives for children.  As a pediatrician, I came from the clinical side of health care and was eager to apply my experience to the broader public health arena.
 

Uros V. Djekic, Ph.D. (Class of 2008) – CBER
 
 Uros V. DjekicThe Commissioner’s Fellowship program creates a unique environment which allows for the development of crucial skills and acquisition of pertinent knowledge that, in turn, guides our understanding and appreciation of the intricacies of FDA regulatory science and its relationship to protecting public health.
 
John Rossi, V.M.D. (Class of 2008) – OC
 
 John Rossi, VMDThe Commissioner’s Fellowship Program provides broad exposure to many aspects of regulatory science, while still affording me significant time to pursue my research interests in bioethics. It’s a combination that I don’t think I could get elsewhere.
 

Juandria V. Williams, Ph.D. (Class of 2008) – CDER

 Juandria V. Williams, Ph.D.FDA sees us as valuable assets and a gateway to its success.
 

Lester “Jao” Lacorte, M.D. (Class of 2008) – CDRH

 Lester Lacorte, M.D.The Commissioner’s Fellowship provides a hands-on approach to understanding theinner workings of FDA regulatory science and policy. This invaluable experience allows me to gain specific knowledge regarding the protection of human subjects in international clinical trials.
 
 
Paramjeet Kaur, Ph.D. (Class of 2008) – CDER
 
 Paramjeet Kaur, Ph.D.I am very appreciative of the congenial and encouraging work environment where I can share my thoughts and contribute to the team effort.
  
Nicole Mahoney, Ph.D. (Class of 2009 Fellow - CDER) Senior Officer, Antibiotics and Innovation Project, Pew Charitable Trusts
 
 Nicole Mahoney, Ph.D.I am a scientist by training, but work on technology transfer helping move scientific discoveries from the bench to the bedside sparked my interest in drug innovation. This left me eager to learn the regulatory process and what it takes to get products to market.
 
The Fellowship Program exceeded my expectations. Not only did it teach me about regulatory requirements, it provided me with an appreciation of the difficulties facing antibiotic innovation. This understanding is critical in my current position, where I advocate for policies to spur antibiotic development. The Fellowship Program and the knowledge I gained at FDA provided me with the tools to craft practical solutions to address an important public health problem.
 
Rosalee Hellberg, Ph.D. (Class of 2010 Fellow - ORA) Professor, Chapman University
 
 Rosalee Hellberg, Ph.D.

After completing my Ph.D. in Food Science and Technology, I was interested in pursuing research at a government institution. The Commissioner's Fellowship position provided me with the opportunity to apply my research abilities to FDA's mission of protecting and promoting public health. 

During my time as a fellow, I contributed to the development of laboratory protocols related to food safety testing, published a number of research studies on these topics, and presented this research at scientific meetings. In addition, I was able to build a strong network of contacts that I continue to collaborate with in my current position as a tenure-track faculty member of Chapman University. 

 

Advisory Board Members:

 
Norman Marks, M.D., M.H.A. (CFP Advisory Board Member) – OC 

 Norman Marks, M.D.As a physician who joined FDA after 22 years of community practice, I welcomed the chance to support the Commissioner’s Fellowship Program when it was launched in 2008.  I saw its potential for introducing FDA's crucial public health role to physicians, scientists, and the health care community at large. Having served as a preceptor for Fellows in the program’s first two classes and as a member of the program’s Advisory Board, I’ve seen that vision come to pass. 

The Program develops a cadre of highly trained and committed scientists who can join our ranks as colleagues or, pursuing a career at other organizations, introduce FDA’s critical work in regulatory science to the nation’s health care communities.