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Regulatory Pharmaceutical Fellowship
Contents:
Regulatory Pharmaceutical Fellowship
FDA/Industry/Academia Fellowship 2009-2011
Jointly Sponsored By: Purdue University, FDA, Ortho-McNeil Janssen Scientific Affairs and Eli Lilly and Company
Introduction
The purpose of the Regulatory Pharmaceutical Fellowship is to expose selected candidates to one of two tracks focused on the medical and regulatory aspects of drug information dissemination or marketing. The program serves to maintain and enhance a scientific link among the Food and Drug Administration (FDA), academia, and the pharmaceutical industry; the program also provides an opportunity for the fellow to develop an understanding of the process and practices of the FDA and the pharmaceutical industry in the delivery of drug information and the regulatory oversight of prescription drug marketing practices. The fellowship will allow participants to have an opportunity to experience careers in the area of academia, government, and industry. Graduates of the program will be qualified to pursue career opportunities in pharmaceutical industry, FDA, or academia.
The fellowship is a two-year program consisting of a 9-month rotation with the Center for Drug Evaluation and Research (CDER) (Silver Spring, MD); a 9-month
rotation at Eli Lilly and Company (Indianapolis, IN) or Ortho-McNeil Janssen Scientific Affairs, LLC. (Raritan, NJ), and a 6-month rotation with Purdue University School of Pharmacy and Pharmaceutical Sciences (Indianapolis, IN). The program has two positions available: one drug information track and one drug advertising and promotion track.
Fellowship Schedule
Drug Information Track
July 2009 – Dececember 2009
January 2010 – September 2010
October 2010- June 2011
Drug Advertising and Promotion Track
July 2009 – March 2010
April 2010 – December 2010
January 2011- June 2011
Fellowship - Drug Information
Purdue University – Department of Pharmacy Practice, Indianapolis, IN
Wishard Health Services, Indianapolis, IN
Clarian Health, Indianapolis, IN
The 6-month academic drug information portion of the Pharmaceutical Drug Development Fellowship will provide the fellow with exposure to academia and the different functions and responsibilities of institutional-based drug information centers. The program with Purdue University offers experience with the provision of drug information including formulary management, adverse drug event reporting, medication safety, and drug-use policy in conjunction with Wishard Health Services
and Clarian Health. In addition, the fellow gains significant experience in academia providing didactic and experiential training of Purdue University pharmacy students.
Ortho-McNeil Janssen Scientific Affairs, LLC., Raritan, NJ.
The 9-month rotation will offer the opportunity to gain experience in providing drug information to consumers, healthcare professionals, regulated industry and others through a variety of methods. The fellow will be responsible for responding to medical information requests, creating and updating medical responses, mentoring pharmacy students and collaborating on numerous inter- and intra-departmental projects. The fellow will also have a chance to explore the various opportunities that exist for pharmacists within the pharmaceutical industry.
Food and Drug Administration, Division of Drug Information, Silver Spring, MD
The 9-month rotation will offer the fellow an opportunity to gain experience in providing drug information to health care professionals, consumers and regulated industry. The fellow will be responsible for responding to drug information requests, mentoring pharmacy students and providing support for various FDA-CDER initiatives. In addition, the fellow will continue to develop written and verbal communication skills through document preparation and presentations for internal and external customers. The fellow will also become familiar with the Federal Food and Drug Cosmetic Act, Federal Register and the Code of Federal Regulations as they relate to human drugs. The fellow will also experience unique internal environments and learning opportunities for pharmacists.
Current Fellow:
Jean Cunningham, Pharm.D.
Graduated: University of Toledo, Class of 2007
A highlight of this program is the flexibility it provides, because it allows you to develop and refine your interests. When I selected this position, I knew I was interested in academia, industry, and government, but I had no idea what I wanted to do with that interest. This program has enabled me to experience various career paths in each field, while providing challenging projects that tie all three areas together. The most beneficial part of this program, by far, is the vast amount of experience the fellow can gain while spending time working in each function.
Originally, the focus of my track was drug information, which served as a very important foundation as I progressed through my program. While with Purdue University, Clarian Drug Information Center, and Wishard Health Systems, I developed and provided verbal and written drug information responses, prepared and led class discussions on various drug information topics and led journal clubs. I also contributed to and researched formulary decisions and participated in hospital management. The time I spent at Eli Lilly and Company broadened my skill set by exposing me not only to medical information, but also to extensive work in drug promotion and advertising. Because teaching was an area of great interest for me, I was able to work with my preceptor to develop and implement an original training guide for new hires into the Regulatory Affairs department at Lilly. I also spent time working in various departments, including Medical Information and Sales and Marketing, working with and interviewing associates in different roles like Medical Liaisons and Regulatory Consultants, and working on projects like product label submissions, sales aid creation, and much more. While I have yet to begin my work with FDA at the Division of Drug Information, I have already been in contact with my preceptors and others with whom I will be working, and am very excited about the roles and responsibilities I will assume while I am there.
The Regulatory Affairs Drug Information Track Program has helped me develop my competence as a Drug Information and Regulatory Affairs Specialist. While much of the training has occurred during my time as the Regulatory Affairs Fellow, candidates who wish to apply are strongly encouraged to have the following: self motivation, a mind open to gaining new experiences in academia, government, and industry, a willingness and ability to adapt to new environments and work situations, strong verbal and written communications skills, and the commitment necessary to complete a two-year program.
To quote Sanjeev (Sonny) Bhanot, the 2005 Regulatory Affairs Fellow, “I feel that this experience has helped strengthen my professional skills and [has] provide[d] me with the opportunities and further training needed to be successful in any area of pharmacy, be it academia, government, institutional practice, or within the pharmaceutical industry.” I wanted to include this quote because it spoke to me when I was applying for this position two years ago, and now that I am nearing the end of my own program, I can confirm that I can be successful in the areas Mr. Bhanot referenced. In fact, I have already been offered positions in those areas upon the completion of this program.
Past Fellows:
Sanjeev K. Bhanot, Pharm.D.
Clinical Specialist
The Medical Affairs Company
Tanya Nelson, Pharm.D.
Manager
Medical Communications - Primary Care
Preceptors:
Amy Heck Sheehan, Pharm.D.
Associate Professor of Pharmacy Practice
Purdue University School of Pharmacy and Pharmaceutical Sciences
Payal Desai, Pharm.D.
Associate Director, Medical Communications
Ortho-McNeil Janssen Scientific Affairs, LLC.
Kavita Dada, Pharm.D.
Senior Health Promotion Officer
Food and Drug Administration, Division of Drug Information
Catherine. Y. Chew, Pharm.D.
Senior Health Promotion Officer
Food and Drug Administration, Division of Drug Information
Fellowship - Advertising & Promotion
Eli Lilly and Company, Indianapolis, IN
The 9-month rotation will provide an opportunity for the fellow to develop skills to evaluate prescription drug advertising and promotion to healthcare professionals and consumers through different media such as print, television and the Internet. The fellow will be mentored by a member of the Regulatory Advertising and Promotion staff, and be responsible for providing regulatory guidance and support to the brand marketing teams. In addition, the fellow will provide support to the Regulatory Advertising and Promotion group by participating in a variety of departmental projects. Exposure to other areas of the pharmaceutical industry and professional networking will also be a major focus of the 9-month experience.
Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, Silver Spring, MD
The 9-month rotation will offer the fellow a unique opportunity to gain experience in the government promotional review process. The fellow will become familiar with sections of the Federal Food, Drug, and Cosmetic Act pertaining to prescription drug advertising and promotion and relevant FDA Guidance documents. The fellow will assist in the review of promotional materials, evaluate draft product labeling (package inserts), research and evaluate industry complaints, and work with the trade name review group or the patient-related outcome claim evaluation team. The fellow may attend both departmental and interdepartmental meetings. The fellow will be mentored by a senior member of DDMAC and the two will work collaborate to develop departmental project(s) tailored to the fellow’s interests. Exposure to other areas of the agency and professional networking will also be a major focus.
Purdue University – Department of Pharmacy Practice, Indianapolis, IN
Wishard Health Services, Indianapolis, IN
Clarian Health, Indianapolis, IN
The 6-month academic portion of the Pharmaceutical Drug Development Fellowship will provide the fellow with exposure to academia and the different functions and responsibilities of institutional-based pharmacy administration. The program offers experiences in formulary management, medication safety, and drug-use policy in conjunction with Wishard Health Services and Clarian Health. In addition the fellow gains significant experience in academia providing didactic and experiential training of Purdue University students.
Current Fellow:
Sheetal Patel, Pharm.D.
Graduated: University of the Sciences in Philadelphia, Class of 2007
The Regulatory Advertising and Promotion Fellowship is a unique program that allowed me to gain experience within three different functional environments; the pharmaceutical industry, the government, and academia. This program not only provided me with opportunities to develop key regulatory skills, but it also allowed me to apply these skills and grow professionally. In addition, I have truly benefited from the knowledge and dedication of my mentors who have exhibited expertise in their respective functional areas. The experiences with this Fellowship have, thus far, exceeded my expectations.
During the first part of my Fellowship, I served as a regulatory reviewer with one of the leading pharmaceutical companies, Johnson & Johnson. Within Johnson & Johnson Pharmaceutical Services (JJPS), I had the opportunity to learn fundamentals of the advertising and promotion regulations and how they are implemented to promote products from a business perspective. While at JJPS, I worked with various teams throughout the company and was able to provide strategic input to different functional areas. Two of the most rewarding experiences I had at JJPS was participating in launching a product from marketing concept reviews through FDA submission for advisory comments as well as developing training materials for new Regulatory professionals. Overall, this experience built my confidence in providing regulatory guidance to key business partners within JJPS.
The second part of the Fellowship was with the Division of Drug Marketing, Advertising, and Communications (DDMAC) at the FDA. At DDMAC, I had many opportunities to garner experiences in providing advisory comments for promotional materials, participating in trade name reviews, and learning how regulations and guidances are developed. Most importantly, I gained an understanding of how regulations are implemented from a public health perspective. These were only a few of the many areas where I gained insight and knowledge to further refine my understanding of this profession.
During the third and final portion of the Fellowship, I will be serving as an adjunct faculty member in the Pharmacy Practice Department at Purdue University. At Purdue University, I will be working on various departmental projects and be given the opportunity to participate in research. I will also be using the knowledge I gained throughout the previous 18 months to help coordinate a class for third and fourth year professional pharmacy students. Upon completion of the third portion of the Fellowship, I will have built my teaching portfolio and be awarded the Indiana Pharmacy Resident Teaching Certificate.
Overall, the most significant learning I obtained was that knowledge and perspective is developed through experience. I am confident that after completing this Fellowship, I will have gained the advantage of knowing how to apply advertising and promotion regulations from three different viewpoints. This program has allowed me to build a life-long network of mentors and colleagues and I know that the experience has truly prepared me to be a well-rounded Regulatory Advertising and Promotion professional.
Past Fellows:
Samuel Skariah, Pharm.D.
Regulatory Review Officer
Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications
Amit Patel, Pharm.D.
Associate Director, Regulatory Advertising and Promotion
Johnson & Johnson Pharmaceutical Services
Preceptors:
Brian E. Wagner, Pharm.D.
Associate Director,
US Regulatory Affairs, US Affiliate
Eli Lilly & Company
Carrie Newcomer, Pharm.D.
Consumer Promotion Analyst
Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications
Amy Toscano, Pharm.D., CPA
Regulatory Review Officer
Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications
Sheila Ryan, Pharm.D.
Professional Group Leader
Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications
Steven R. Abel, Pharm.D., FASHP
Bucke Professor and Head of Pharmacy Practice
Purdue University School of Pharmacy and Pharmaceutical Sciences
Fellowsip Benefits
- Competitive stipend
- Relocation expenses
- Travel expenses to one national meeting per year
- Enrollment in Indiana Pharmacy Resident Teaching Certificate (IPTeC) Program
- Purdue University benefit package
- Health insurance
- Prescription coverage
- Vision plan
- Dental (optional)
- Vacation and University holidays
Application Process
The fellow must hold a Doctor of Pharmacy degree from an
ACPE accredited school or college of pharmacy prior to the
start of the fellowship term.
Preliminary interviews are conducted during the American
Society of Health System Pharmacists (ASHP) Midyear
Clinical Meeting (MCM) in Orlando, Florida. Participation in
PPS is not required to apply to this program. Following the
ASHP MCM, all interested applicants should submit the following:
- Letter of intent (indicating preferred track)
- Three letters of recommendation (in sealed envelopes)
- Curriculum Vitae
All application materials should be collected by the applicant
and submitted as one package. Address the package to:
Mary E. Kremzner, Pharm.D.
CDR, USPHS
Deputy Director, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO-51 Rm 2262
Silver Spring, MD 20993
Phone: 301 796 3144
Fax: 301 847 8715
Email: Mary.Kremzner@fda.hhs.gov
The deadline for receipt of a complete application is Jan. 2, 2009.
Contact Information
For further information, please contact Sheetal Patel (Sheetal.Patel@fda.hhs.gov) or Jean Cunningham (jeo@iupui.edu ).
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Date created: November 17, 2008 |
