About FDA

Regulatory Pharmaceutical Fellowship

Congratulations to our 2017 – 2019 Fellows!

Drug Information

  • Kiersten Walters, Purdue University PharmD Candidate

  • Jacqueline Wasynczuk, Butler University PharmD Candidate

Medication Safety

  • Kathryn Marwitz, PharmD (Drake University), Johns Hopkins MPH Candidate

Drug Advertising and Promotion

  • Nicole Sebahar, Purdue University PharmD Candidate

Recruitment for 2018 – 2020 positions will begin in the fall of 2017

Food and Drug Administration/Industry/Academia Fellowship 2017 – 2019 Jointly Sponsored by: Food and Drug Administration (FDA), Purdue University, Eli Lilly and Company, Janssen Scientific Affairs, LLC, and Johnson and Johnson

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, drug advertising and promotion, 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 processes of the FDA and the pharmaceutical industry in the delivery of drug information, the regulatory oversight of prescription drug marketing practices, and the assessment and enhancement of 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 rotations with FDA's Center for Drug Evaluation and Research, Purdue University College of Pharmacy, Eli Lilly and Company, Janssen Scientific Affairs, LLC or Johnson and Johnson. 

Fellowship - Drug Information

Purdue University College of Pharmacy, Indiana University (IU) Health, and Eskenazi Health – Indianapolis, IN

The 6-month academic drug information portion of the Regulatory Pharmaceutical Fellowship will expose the fellow to academia and the 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 and drug-use policy in conjunction with IU Health and Eskenazi Health. Fellows will conduct a research project suitable for presentation at a national meeting and publication in a peer-reviewed pharmacy journal and participate in the Indiana Pharmacy Teaching Certificate Program. The fellow gains significant experience in academia, providing didactic and experiential training to student pharmacists.

Janssen Scientific Affairs, LLC, Medical Information – Titusville, NJ

The 12-month rotation provides the opportunity for the fellow to gain experience as a member of a medical information team in a pharmaceutical industry setting. The program allows the fellow to develop skills related to development and delivery of drug information to healthcare professionals, payors, consumers, and business partners through a variety of methods. The fellow will have the option to participate in collaborative inter- and intra-departmental projects, mentor pharmacy students, and network with other pharmacists within the organization and through a pharmacist-focused resource group.

Eli Lilly and Company, Global Medical Information- Indianapolis, IN

The 12-month rotation in medical information will be focused within the Oncology Medical Affairs team to answer questions from healthcare professionals for newly launched products or new indications for existing products. The fellow will be trained in the development of medical information deliverables supporting the call center, field-medical personnel, medical websites, and other delivery channels. In addition, the fellow will have opportunities to contribute to other departmental projects, market research, and other initiatives to better the overall customer experience.

Food and Drug Administration, Division of Drug Information – Silver Spring, MD

The 6-month rotation at FDA will provide an opportunity for the fellow to respond to drug information requests, mentor student pharmacists, and provide support for various FDA initiatives to health care professionals, consumers, and industry. The fellow will 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 the Division of Drug Information’s Social Media team, which utilizes tools such as Twitter, Facebook, listservs, podcasts, and videos to disseminate the latest drug information to the public. The fellow will also lead the President’s Emergency Plan for AIDS Relief (PEPFAR) labeling initiative with the World Health Organization during their time at FDA. The fellow will assist with GADIS on LinkedIn, FDA’s Global Alliance of Drug Information Specialists, promoting partnerships among pharmacists for the advancement of public health.

Fellowship Program Director:
LCDR Lindsay E. Wagner, PharmD

U.S. Public Health Service
Team Leader | Division of Drug Information
Office of Communications | Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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Current Fellow:

2016-2018: Sandra R. Bai, PharmD
Butler University College of Pharmacy and Health Sciences, Class of 2016

Past Fellows:

2015-2017: Megan N. Brown, PharmD
Health Communications Specialist, Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)

2014-2016: Jay R. Fajiculay, PharmD
Designated Federal Officer, Division of Advisory Committees and Consultants Management
Center for Drug Evaluation and Research, U.S. Food and Drug Administration

2013-2014: Bhavini T. Parikh, PharmD
Senior Manager, Medical Information
AstraZeneca

2012-2014: Andrea M. TenBarge, PharmD
Associate Consultant, Medical Channels & Visual Media
Eli Lilly and Company

2011-2013: Genevieve Lynn Ness, PharmD
Director, Christy Houston Foundation Drug Information Center
Assistant Professor of Pharmaceutical, Social and Administrative Sciences
Belmont University College of Pharmacy

2010-2012: Kimberly (Wu) Chiu, PharmD
Consumer Safety Officer, Division of Drug Information
Food and Drug Administration

2009-2011: Lindsay E. (Davison) Wagner, PharmD
Lieutenant Commander, U.S. Public Health Service
Team Leader, Division of Drug Information
Food and Drug Administration

2007-2009: Jean Cunningham, PharmD
Clinical Content Specialist
Truven Health Analytics

2005-2007: Sanjeev K. Bhanot, PharmD
Associate Director, Medical Affairs
Merz Pharma Canada, Ltd.

2003-2005: Tanya Nelson, PharmD
Manager, Medical Information
Janssen Scientific Affairs, LLC

Preceptors:

Amy Heck Sheehan, PharmD
Associate Professor of Pharmacy Practice
Purdue University College of Pharmacy

Samina Ali, PharmD
Associate Director, Medical Information
Janssen Scientific Affairs, LLC

Kathy Mybeck, PharmD
Consultant, Global Medical Information
Eli Lilly and Company

Lindsay E. Wagner, PharmD
Lieutenant Commander, U.S. Public Health Service
Team Leader, Division of Drug Information
Food and Drug Administration

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Fellowship – Medication Safety Purdue University, Center for Medication Safety Advancement – Indianapolis, IN

The 8-month rotation at Purdue University College of Pharmacy’s Center for Medication Safety Advancement (CMSA) will provide the fellow with exposure to academia and the various medication safety initiatives undertaken by CMSA. The fellow will actively participate in practice-based research to foster the discovery and delivery of information and practices to enhance medication safety. There will be numerous opportunities to publish original research and deliver presentations. Additionally, the fellow will have the opportunity to educate students, both didactically and through preceptorship.

Eli Lilly and Company, Surveillance and Global Patient Safety – Indianapolis, IN

The fellow will spend an 8 month rotation at Eli Lilly and Company working on the Surveillance team within Global Patient Safety. During this time, the fellow will have opportunities to work cross-functionally between pre- and post-marketed compounds to detect and evaluate adverse effects and other problems to determine if they are drug-related. The fellow will be involved in routine surveillance work as well as participating in the development of regulatory documents to gain a foundational understanding of pharmacovigilance responsibilities within industry.

Food and Drug Administration, Office of Surveillance and Epidemiology –Silver Spring, MD

The fellow will spend the last 8 months of their tenure working in the Office of Surveillance and Epidemiology (OSE) at the FDA. During this time, the fellow will have the opportunity to participate in intra- and inter-center projects in both the pre- and post-market arenas. Additionally, the fellow will utilize adverse drug event reporting data, medical literature, and established knowledge of marketed drug products to assess postmarket safety-related issues and conduct active surveillance work.

Current Fellow:

2016-2018: Kaitlyn Dana, PharmD
University of Connecticut, Class of 2016

Past Fellows:

2013 – 2015: Katelyn Brown, PharmD
Consultant, Diabetes Real World Outcomes
Eli Lilly and Company

Preceptors:

John Hertig, PharmD, MS
Associate Director, Center for Medication Safety Advancement
Courtesy Clinical Assistant Professor of Pharmacy Practice
Purdue University

Kyle Hultgren, PharmD
Director, Center for Medication Safety Advancement
Courtesy Clinical Assistant Professor of Pharmacy Practice
Purdue University

Jennifer B. Mouser, PharmD
Manager, Safety Surveillance
Global Patient Safety
Eli Lilly and Company

William P. Brookfield, MS
Consultant, Safety Surveillance
Global Patient Safety
Eli Lilly and Company

Irene Z. Chan, PharmD, BCPS
Commander, U.S. Public Health Service
Deputy Director, Division of Medication Error Prevention and Analysis
Office of Surveillance and Epidemiology
Food and Drug Administration

Chris Jones, PharmD, MPH
Commander, U.S. Public Health Service
Deputy Director, Division of Pharmacovigilance
Office of Surveillance and Epidemiology
Food and Drug Administration

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Purdue University College of Pharmacy– Indianapolis, IN

This 4 month Purdue rotation will provide the fellow with exposure to academia and the different functions and responsibilities of institutional-based pharmacy administration.  The fellow will have experiences in formulary management, medication safety, and drug-use policy.  The fellow will gain significant experience in academia providing didactic and experiential training of students.

Johnson and Johnson—Titusville, NJ

This 12 month rotation will provide an opportunity to develop an understanding of FDA regulations, industry codes, Healthcare Compliance policies, and Federal and State laws as it relates to prescription drugs and biologics advertising and promotion activities.  The fellow will also have an opportunity to work directly with internal business partners such as marketing, sales training, medical affairs, field based commercials and medical representatives, and Law department to ensure compliance with promotional activities.

Food and Drug Administration, Office of Prescription Drug Promotion—Silver Spring, MD

During this 8 month rotation, the fellow will gain experience in the government promotional review process and become familiar with sections of the Federal Food, Drug, and Cosmetic Act 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 will be mentored by a senior member of OPDP and will work collaboratively to develop departmental projects tailored to the fellow’s interests.

Current Fellow:

2015-2017: John Riehl, PharmD
Jefferson College of Pharmacy—Thomas Jefferson University, Class of 2015

Past Fellows:

2013-2015: Sam Davis, PharmD
Senior Medical Information Specialist
Med Communications

2011-2013: Ankur Kalola, PharmD
Regulatory Review Officer, Office of Prescription Drug Promotion
Food and Drug Administration

2009-2011: Nital Patel, PharmD, MBA
Medical Science Director
Relypsa, Inc.

2007-2009: Sheetal Patel, PharmD
Head, Regulatory Advertising and Promotion
Johnson & Johnson Health Care Compliance & Privacy

2005-2007: Samuel Skariah, PharmD
Team Leader, Office of Prescription Drug Promotion
Food and Drug Administration
CDR, United States Public Health Service

2003-2005: Amit Patel, PharmD
Head, Material Approval Process
Alcon, a Novartis company

Preceptors:

Gloria Sachdev, BS Pharm, PharmD
Clinical Assistant Professor
Purdue University College of Pharmacy
President and CEO
Employers’ Forum of Indiana

Samuel Skariah, PharmD
Team Leader, Office of Prescription Drug Promotion
Food and Drug Administration
CDR, United States Public Health Service

Carrie Newcomer, PharmD
Regulatory Review Officer, Office of Prescription Drug Promotion
Food and Drug Administration

Sheetal Patel, PharmD
Head, Regulatory Advertising and Promotion
Johnson & Johnson Health Care Compliance & Privacy

Jia-Huey Huey, PharmD
Regulatory Compliance Lead
Johnson & Johnson Health Care Compliance & Privacy

James Burrus
Director, Regulatory Advertising and Promotion
Johnson & Johnson Health Care Compliance & Privacy

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Fellowship Benefits

  • Competitive stipend
  • Reimbursement for relocation and professional travel expenses
  • Enrollment in Indiana Pharmacy 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)

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Eligibility and Application Process

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. U.S. citizenship is not required and VISA sponsorship may be possible.

Preliminary interviews will be conducted during the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting (MCM) in Orlando, Florida from December 3-6, 2017.  Recruitment efforts will begin in the fall of 2017.

Contact Information:

To reach our current fellows, ask questions, and submit applications, write to:

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Page Last Updated: 01/18/2017
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