Regulatory Pharmaceutical Fellowship
Food and Drug Administration/Industry/Academia Fellowship 2013-2015
Jointly Sponsored By: Food and Drug Administration (FDA), Purdue University, and Eli Lilly and Company
Introduction
The purpose of the Regulatory Pharmaceutical Fellowship is to train selected candidates in one of three tracks focused on the medical and regulatory aspects of drug information dissemination, marketing, or medication safety. 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, the regulatory oversight of prescription drug marketing practices and medication safety. The fellowship gives participants the unique opportunity to experience careers in the areas of government, academia and industry, thus, qualifying graduates to pursue career opportunities in each respective area.
The fellowship is a two-year program consisting of a 9-month rotation with FDA's Center for Drug Evaluation and Research, a 6-month rotation with Purdue University College of Pharmacy, and a 9-month rotation at Eli Lilly & Company.
The program has three positions available for 2013-2015: one in Drug Information and one in Drug Advertising and Promotion, and one in Medication Safety.
Fellowship Schedule
Drug Information Track - 1 position
July 2013 – December 2013 - Purdue University
January 2014 – September 2014 - Eli Lilly and Company
October 2014 - June 2015 - FDA, Division of Drug Information (DDI)
Drug Advertising and Promotion Track - 1 position
July 2013 – March 2014 - Eli Lilly and Company
April 2014 – December 2014 - FDA, Office of Prescription Drug Promotion
January 2015 - June 2015 - Purdue University
Medication Safety Track - 1 position
July 2013 – September 2014 - Center for Medication Safety Advancement and Eli Lilly and Company
October 2014 – June 2015 - FDA, Office of Surveillance and Epidemiology (OSE) Division of Pharmacovigilance and Division of Medication Errors Prevention and Analysis
Fellowship Benefits
Application Process
Contact Information
Fellowship - Drug Information
Purdue University, Indiana University (IU) Health, and Wishard Health Services - Indianapolis, IN
The 6-month academic drug information portion of the Regulatory Pharmaceutical 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 College of Pharmacy offers experience with the provision of drug information including formulary management, adverse drug event reporting, medication safety, and drug-use policy in conjunction with IU Health and Wishard Health Services. In addition, the fellow gains significant experience in academia, providing didactic and experiential training to Purdue University student pharmacists.
Eli Lilly and Company - Indianapolis, IN
The 9-month rotation at Lilly will provide an opportunity for the fellow to develop skills in the practice of drug information in the industry setting. The fellow will complete projects related to the creation and delivery of medical information to health care professionals and consumers. The program also offers practice and familiarity with information disclosure activities including Lilly’s strategy and use of digital channels to communicate medical answers to customers. The fellow will gain experience and insight into customer channel preferences, mobile technology, and social media
Food and Drug Administration, Division of Drug Information, Silver Spring, MD
The 9-month rotation at FDA will provide an opportunity for the fellow to respond to drug information requests, mentor pharmacy students and provide support for various FDA initiatives to health care professionals, consumers and industry. The program allows the fellow to work with Review Divisions to draft Drug Safety Communications for clinically significant drug safety alerts, and improve the risk assessment process through increasing voluntary reporting of serious spontaneous adverse events. The fellow will be a member of Division of Drug Information’s Social Media team, which utilizes tools such as Twitter, listservs, blogs, audio and video podcasts to disseminate the latest drug information to the public. The fellow will also be a member of GADIS, FDA’s Global Alliance of Drug Information Specialists, promoting partnerships among pharmacists for the advancement of public health.
Fellowship Program Director:
Catherine. Y. Chew, Pharm.D.
Deputy Director – Division of Drug Information
FDA Center for Drug Evaluation and Research
Current Fellows:
2012-2014: Andrea TenBarge, Pharm.D.
University of Illinois at Chicago College of Pharmacy, Class of 2012
2011-2012: Genevieve Lynn Ness, Pharm.D.
University of the Sciences in Philadelphia, Class of 2011
Past Fellows:
2010-2012: Kimberly Wu, Pharm.D.
Consumer Safety Officer – Division of Drug Information
FDA Center for Drug Evaluation and Research.
2009-2011: Lindsay Davison, Pharm.D.
Health Promotion Officer – Division of Drug Information
FDA Center for Drug Evaluation and Research.
2007-2009: Jean Cunningham, Pharm.D.
Associate Professor of Pharmacy Practice
University of Findlay
2005-2007: Sanjeev K. Bhanot, Pharm.D.
Medical Science Liaison
Merz Pharma Canada, Ltd.
2003-2005: Tanya Nelson, Pharm.D.
Manager - Medical Information - Primary Care
Ortho-McNeil Janssen Scientific Affairs, L.L.C
Preceptors:
Amy Heck Sheehan, Pharm.D.
Associate Professor of Pharmacy Practice
Purdue University College of Pharmacy
Jennifer L. Riggins, Pharm.D.
Director, Global Information Disclosure
Global Medical Communications
Eli Lilly and Company
Lindsay E. Davison, Pharm.D.
Health Promotion Officer - Division of Drug Information
FDA Center for Drug Evaluation and Research
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, social media, and the internet. The fellow will be mentored by a senior member of the Regulatory Advertising and Promotion staff and will 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 such as Health Care Compliance, and professional networking will be a major focus of the 9-month experience.
Food and Drug Administration, Office of Prescription Drug Promotion, 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 applicable sections of the Federal Food, Drug, and Cosmetic Act and relevant FDA Guidance documents. The fellow will assist in the review of promotional materials directed towards both healthcare providers and consumers, evaluate draft product labeling, research and evaluate complaints from industry, healthcare providers and consumers, 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 senior members of the Office of Prescription Drug Promotion (OPDP) and will work collaboratively to develop departmental projects tailored to the fellow’s interests. Exposure to other areas of the Agency and professional networking will also be a major focus.
Purdue University – 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. In addition the fellow gains significant experience in academia providing didactic and experiential training of Purdue University students.
Current Fellow:
2011-2011: Ankur Kalola, Pharm.D.
Rutgers University, Class of 2011
Past Fellows:
2009-2011: Nital Patel, Pharm.D., MBA
Medical Liaison
Sanofi
2007-2009: Sheetal Patel, Pharm.D.
Associate Director, Regulatory Compliance Lead
Johnson & Johnson International Inc.
2005-2007: Samuel Skariah, Pharm.D.
Regulatory Review Officer
Food and Drug Administration, Office of Prescription Drug Promotion
2003-2005: Amit Patel, Pharm.D.
Director, Health Care Compliance
Johnson & Johnson Healthcare Compliance & Privacy Group
Preceptors:
David L. Riggs, Pharm.D.
Director, Global Regulatory Affairs – US
Eli Lilly and Company
Samuel Skariah, Pharm.D.
Regulatory Review Officer
Food and Drug Administration, Office of Prescription Drug Promotion
Carrie Newcomer, Pharm.D.
Regulatory Review Officer
Food and Drug Administration, Office of Prescription Drug Promotion
Amy Toscano, Pharm.D., CPA
Consumer Team Leader
Food and Drug Administration, Office of Prescription Drug Promotion
Sheila Ryan, Pharm.D.
Professional Team Leader
Food and Drug Administration, Office of Prescription Drug Promotion
Steven R. Abel, Pharm.D., FASHP
Associate Vice Provost for Faculty Affairs, Office of the Provost
Associate Dean for Clinical Programs, College of Pharmacy
Bucke Professor of Pharmacy Practice
Purdue University
Fellowship – Medication Safety
Purdue University, Center for Medication Safety Advancement, Indianapolis, IN
The Purdue University College of Pharmacy’s Center for Medication Safety Advancement (CMSA) is committed to serving the citizens of Indiana, the nation, and the world through enhancing the discovery of safe medication use practices and delivering this knowledge to all who may benefit. Innovation and collaboration at the CMSA between faculty, staff, and students link actionable discovery to entrepreneurial delivery, ultimately helping achieve a vision of making safe medication use common practice. The academic-focused medication safety portion of the Regulatory Pharmaceutical Fellowship will provide the fellow with exposure to academia, project management, and medication safety initiatives in institutional and community practice. The Fellow will be involved in various CMSA-led initiatives, will participate in state and national meetings, and will be an integral member of the medication safety team. In addition, the fellow gains significant experience in academia, providing didactic and experiential training to Purdue University student pharmacists.
Eli Lilly and Company - Indianapolis, IN
The 9-month rotation at Lilly will be integrated with the 6-month rotation at Purdue University in order to provide overlapping experiences. The 9 months at Lilly will provide an opportunity for the fellow to develop skills and acquire an overall understanding of medication safety in the pharmaceutical industry setting. The fellow will be exposed to the worldwide regulatory environment, including the FDA, through projects related to management of post-marketing safety profiles, the development of Risk Management Plans, Risk Evaluation and Mitigation Strategies and the benefit-risk balance considerations for the Lilly pharmaceutical products. An exposure to both post-marketing safety profile and development phase compound safety profile considerations will be provided. The fellow will primarily be a member of the safety surveillance group and the program will offer interactions with a variety of functions within Lilly including Health Outcomes, The Lilly Answers Center (call center), Pharmacoepidemiology, Global Labeling Department, Safety Advisory Committees and Business Unit Medical teams. In addition, the program will offer mentoring interactions with Pharm.D. students on rotation at Lilly.
Food and Drug Administration, Office of Surveillance and Epidemiology (OSE), Silver Spring, MD
The 9-month rotation at FDA will provide the fellow an opportunity to assist in the medication safety reviews performed by FDA’s Divisions of Pharmacovigilance and the Division of Medication Error and Prevention Analysis. The fellow will learn the skills required for analyzing post-marketing adverse event data, how to identify drug safety concerns, and ways to recommend actions to improve product safety. The fellow will work collaboratively with medical reviewers in the Office of New Drugs so that potential safety signals are placed in the context of existing preclinical, clinical, or pharmacologic knowledge of the drugs in question. The fellow will also gain experience in the pre-marketing reviews of proprietary drug names, labels and labeling in order to reduce the medication error potential of a proposed product.
Preceptors:
John B. Hertig, PharmD, MS
Medication Safety Project Manager
Assistant Clinical Professor of Pharmacy Practice
Center for Medication Safety Advancement
Purdue University College of Pharmacy
Kyle E. Hultgren, PharmD
Managing Director
Assistant Clinical Professor of Pharmacy Practice
Center for Medication Safety Advancement
Purdue University College of Pharmacy
William P. Brookfield
Consultant- Safety Surveillance
Global Patient Safety
Eli Lilly and Company
Peter Diak, PharmD, MPH
Safety Evaluator Team Leader – Division of Pharmacovigilance II
FDA Center for Drug Evaluation and Research
Irene Z. Chan, PharmD, BCPS
Team Leader – Division of Medication Error Prevention and Analysis
FDA Center for Drug Evaluation and Research
Fellowship Benefits
- Competitive stipend
- Reimbursement for relocation and professional travel expenses
- 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
One year membership in the Regulatory Affairs Professionals Society (RAPS) and a copy of Fundamentals of Regulatory Affairs (US)
Application Process
The application process will begin in late 2012 for the 2013-2015 cycle.
The fellow must be a graduate from an ACPE-accredited college of pharmacy, or otherwise eligible for licensure, 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) annually. Participation in PPS is not required for application.
All interested applicants should submit the following:
- Letter of intent (indicating preferred track)
- Curriculum Vitae
- Official Transcripts
- Three references with contact information. We will call the references instead of requesting letters of recommendation.
All application materials should be submitted electronically no later than midnight EST on Wednesday, December 12, 2012 to:
Drug Information Applicants - DrugInformationFellowship@gmail.com
Drug Marketing and Advertising Applicants - DrugMarketingFellowship@gmail.com
Medication Safety Applicants - MedicationSafetyFellowship@gmail.com
On-site interviews will take place at FDA in Silver Spring, Maryland on Friday, January 11, 2013. Travel will be coordinated by the FDA Division of Drug Information.
Contact Information
For further information, please contact Catherine Chew (Catherine.Chew@fda.hhs.gov) or any of our current fellows at DrugInformationFellowship@gmail.com, DrugMarketingFellowship@gmail.com or MedicationSafetyFellowship@gmail.com
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