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  1. Center for Drug Evaluation and Research | CDER

Regulatory Pharmaceutical Fellowship

Congratulations to our 2020 – 2022 Fellows!

Drug Information

  • Kathryn Comanici, PharmD Candidate, University of North Carolina at Chapel Hill Eshelman School of Pharmacy
  • Anes Karic, MS, MBA, PharmD Candidate, East Tennessee State University Bill Gatton College of Pharmacy
  • Shannon Alexander, PharmD Candidate, University of Georgia College of Pharmacy

Medication Safety

  • Morgan Nicolas, PharmD Candidate, The Ohio State University College of Pharmacy
  • Irene Lin, PharmD Candidate, University of Minnesota College of Pharmacy

The 2020 – 2022 Regulatory/Industry/Academia Fellowship is jointly sponsored by: Food and Drug Administration (FDA); Purdue University; Astellas Pharma US; Eli Lilly and Company; Janssen Scientific Affairs, LLC; and AbbVie. 

Recruitment for 2021 – 2023 positions will begin in the fall of 2020

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 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 opportunity to experience these unique practice settings and qualifies graduates to pursue careers in the areas of government, academia, and industry.

The fellowship is a two-year program consisting of rotations with FDA's Center for Drug Evaluation and Research; Purdue University College of Pharmacy; and pharmaceutical industry.

Fellowship Program Director:

Lindsay Wagner, PharmD, BCPS
LCDR, U.S. Public Health Service
Branch Chief | Division of Drug Information
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Fellowship - Drug Information

Purdue University College of Pharmacy and Indiana University (IU) 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. Fellows will conduct a longitudinal 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, pharmacy student precepting, and other initiatives to better the overall customer experience.

Astellas Pharma US, Inc., Medical Information – Northbrook, IL
During the 12-month rotation, the fellow will develop skills related to development and delivery of drug information to external stakeholders, such as healthcare professionals, payors, consumers, as well as internal stakeholders, including pharmaceutical representatives, medical science liaisons and the Medical Information team. The fellow will be given opportunities to develop the skills for marketed products as well as newly launched and/or investigational products in therapeutic areas, including oncology, urology/nephrology, immunology and neuroscience.

Food and Drug Administration, Division of Drug Information – Silver Spring, MD
The 6-month FDA rotation will provide an opportunity for fellows to refine their drug information skills in a regulatory setting. Fellows will respond to dozens of drug information inquiries from patients, health care professionals, and regulated industry daily. Fellows will create and disseminate content on Twitter and LinkedIn and respond to questions on Facebook as part of FDA’s Social Media team. Fellows will work on video, podcast, and listserv content as well. Fellows will serve as liaisons to specific Review Divisions and assist with a number of high-profile initiatives including the Generic Drug User Fee Amendments, Expanded Access, and writing campaign responses. Additionally, fellows will have opportunities to support various FDA initiatives based on fellow’s interest and Agency needs.

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Current Fellows:

PGY1

  • 2019-2021: Minh Tran, PharmD
    Creighton University School of Pharmacy and Health Professions, Class of 2019
  • 2019-2021: Dylan Vo, PharmD
    University of Arizona College of Pharmacy, Class of 2019

PGY2

  • 2018-2020: Megan Cuomo, PharmD
    University of North Carolina Eshelman School of Pharmacy, Class of 2018
  • 2018-2020: Kaitlin Montagano, PharmD
    Manchester University College of Pharmacy, Natural & Health Sciences, Class of 2018

Past Fellows:

2017-2019: Kiersten (Walters) Rybakov, PharmD
Purdue University College of Pharmacy, Class of 2017

2017-2019: Jacqueline Wasynczuk, PharmD
Butler University College of Pharmacy and Health Sciences, Class of 2017

2016-2018: Sandra R. Bai, PharmD
Pharmacist, Division of Drug Information
U.S. Food and Drug Administration

2015-2016: Megan N. Freeland, PharmD
Owner, Healthcare Digital Marketing Consultant
StockRose Creative, LLC

2014-2016: Jay R. Fajiculay, PharmD
Designated Federal Officer, Division of Advisory Committee and Consultant Management
U.S. Food and Drug Administration

2013-2015: Bhavini T. Parikh, PharmD
Director, Global Medical Information
AstraZeneca

2012-2014: Andrea M. TenBarge, PharmD
Consultant, Medical Digital Strategy and Capabilities
Eli Lilly and Company

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

2010-2012: Kimberly (Wu) Chiu, PharmD
Science Policy Analyst, Clinical Outcome Assessments Staff, Office of New Drugs
U.S. Food and Drug Administration

2009-2011: Lindsay Wagner, PharmD, BCPS
Lieutenant Commander, U.S. Public Health Service
Branch Chief, Division of Drug Information
U.S. Food and Drug Administration

2007-2009: Jean Cunningham, PharmD
Senior Clinical Content Specialist, Value-Based Care
IBM Watson Health

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

2003-2005: Tanya Nelson, PharmD
Senior Medical Science Liaison
Janssen Scientific Affairs, LLC

2001-2003: John Ng, PharmD
Consumer Safety Officer, Division of Clinical Compliance Evaluation
Office of Scientific Investigations
U.S. Food and Drug Administration

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

Payal Desai, PharmD
Associate Director, Medical Information
Janssen Scientific Affairs, LLC

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

Lindsay Wagner, PharmD, BCPS
Lieutenant Commander, U.S. Public Health Service
Branch Chief, Division of Drug Information
U.S. Food and Drug Administration

Sandra R. Bai, PharmD
Pharmacist, Division of Drug Information
U.S. Food and Drug Administration

Jeanette Jiang, PharmD
Associate Director, Medical Information
Astellas Pharma US, Inc

Derek Varga, PharmD
Medical Information
Astellas Pharma US, Inc

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Fellowship – Medication Safety

Purdue University College of Pharmacy and Butler University College of Pharmacy and Health Sciences – Indianapolis, IN
The 5-month academic rotation will consist of time spent at both Purdue University College of Pharmacy and Butler University College of Pharmacy and Health Sciences. This experience will provide the fellow with exposure to academia and the various medication safety initiatives. 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.

AbbVie, Pharmacovigilance and Patient Safety – North Chicago, IL or Eli Lilly and Company, Surveillance and Global Patient Safety – Indianapolis, IN
The fellow will spend a 12-month rotation at Eli Lilly and Company or AbbVie working within the company’s pharmacovigilance department. During this time, the fellow will have opportunities to work cross-functionally on pre- and post-marketed compounds to assess and evaluate adverse events in the context of biological plausibility, indication for use, concomitant medications, and comorbid conditions to determine if the adverse events are drug-related. The fellow will be involved in safety signal detection and evaluation 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 7 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, each fellow will utilize adverse drug event reporting data, medical literature, and established knowledge of marketed drug products to assess post-market safety related issues and conduct active surveillance work.

Current Fellows:

PGY1

  • 2019-2021: Charlotte Moureaud, PharmD
    Ernest Mario School of Pharmacy at Rutgers, Class of 2019
  • 2019-2021: Jonell Nwabueze, PharmD
    Manchester University College of Pharmacy, Natural & Health Sciences, Class of 2019

PGY2

  • 2018-2020: Danya Faruqi, PharmD
    Midwestern University Chicago College of Pharmacy, Class of 2018

Past Fellows:

2017-2019: Kathryn K. Marwitz, PharmD, MPH
Drake University College of Pharmacy & Health Sciences, Class of 2016

2016-2018: Kaitlyn N. Dana, PharmD
Project Planning Manager
Pfizer

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

Preceptors:

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

Dan Degnan, PharmD, MS, CPPS, FASHP
Associate Director for the Professional Program Laboratory
Clinical Assistant Professor of Pharmacy Practice (Courtesy), Purdue University College of Pharmacy

Alissa L. Russ, PhD
Assistant Professor
Purdue University College of Pharmacy

John B. Hertig, PharmD, MS, CPPS, FASHP
Associate Professor and Vice-Chair of Pharmacy Practice
Butler University College of Pharmacy and Health Sciences

Rachel Booze, PharmD
Clinical Surveillance Scientist, Global Patient Safety
Eli Lilly and Company (tentative)

Adrienne M. Rothstein, PharmD
Director, Safety Data Sciences, Pharmacovigilance and Patient Safety 
AbbVie

Alexandra Terry, PharmD, BCPS
Associate Safety Data Scientist, Pharmacovigilance and Patient Safety
AbbVie

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

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

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Fellowship – Drug Advertising and Promotion

Eli Lilly and Company, Regulatory Advertising and Promotion - Indianapolis, IN
This 9-month rotation will provide an opportunity to develop an understanding of FDA regulations and guidance, industry codes, and Federal and State laws as it relates to prescription drug advertising and promotional materials and activities. The fellow will also have the opportunity to work directly with internal business partners such as marketing, legal, medical affairs, and other commercial and corporate representatives to ensure that a broad range of promotional materials are in compliance with applicable regulations and internal policies.

Food and Drug Administration, Office of Prescription Drug Promotion - Silver Spring, MD
This 9-month rotation will provide experience in the government promotional review process and provide overviews 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 other functions in the Office of Prescription Drug Promotion (OPDP). 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.

Purdue University - Indianapolis, IN
This 6-month rotation will provide the fellow with exposure to upper level academia and the different functions and responsibilities of academic administrators. The fellow will gain significant teaching experience through provision of didactic education including coordination of a core PharmD management and marketing course and experiential training of students.


Current Fellow:

PGY1

  • 2019-2021: Jennifer Chen, PharmD
    Purdue University College of Pharmacy, Class of 2017

Past Fellows:

2017-2019: Nicole Sebahar, PharmD
Senior Regulatory Affairs Specialist, Advertising and Promotion
Abbott Laboratories

2015-2017: John Riehl, PharmD
Regulatory Affairs, Advertising and Promotion Manager
Allergan

2013-2015: Samuel Davis, PharmD
Consultant, Global Regulatory Affairs
Eli Lilly and Company

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

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

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

2005-2007: Samuel Skariah, PharmD
Commander, U.S. Public Health Service
Team Leader, Office of Prescription Drug Promotion
U.S. Food and Drug Administration

2003-2005: Amit Patel, PharmD
Senior Director, Regulatory Advertising and Promotion
ACADIA Pharmaceuticals, Inc.


Preceptors:

Mike Sauers
Director, Global Regulatory Affairs, US Advertising, Promotion, and Policy
Eli Lilly and Company

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

Samuel Skariah, PharmD
Commander, U.S. Public Health Service
Team Leader, Office of Prescription Drug Promotion
Food and Drug Administration

Steven Abel, PharmD, FASHP
Associate Provost for Engagement
Purdue University College of Pharmacy

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Fellowship Benefits

  • Competitive stipend
  • Reimbursement for relocation during fellowship and professional travel expenses 
  • Enrollment in Indiana Pharmacy Teaching Certificate (IPTeC) Program
  • Optional Purdue University benefits package
    • Health insurance
    • Prescription coverage
    • Vision plan
    • Dental
  • Vacation and University holidays
  • One-year membership in the Regulatory Affairs Professionals Society (RAPS) and a copy of Fundamentals of Regulatory Affairs

Eligibility

The fellow must be a graduate from an ACPE-accredited college of pharmacy, or otherwise eligible for licensure as a pharmacist, prior to the start of the fellowship term. All applicants must be U.S. citizens to complete the program. Candidates who do not meet this requirement should not apply.

Preliminary Interviews

Preliminary interviews will be conducted during PPS at the American Society of Health-System Pharmacists Midyear Clinical Meeting.  Preliminary interviews are encouraged but not required to apply.  Interested candidates should request interviews through PPS online.

Application Process 

All interested applicants must submit the following:

  1. Letter of intent for one of three tracks – specify track and sponsor(s) of interest
  2. Contact information for three references, including email and phone number
  3. Curriculum Vitae
  4. Official transcripts (electronic copies accepted)

The application deadline will be announced in fall 2020. Candidates may apply to more than one track and more than one sponsor, however, on-site interview offers will be specific to track and sponsor (meaning candidates will need to select their track and sponsors of interest if pursued for on-site interviews by multiple tracks or multiple sponsors).

On-site interviews will be announced when recruitment opens in fall 2020.

Contact Information:

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

Contact the Program Director LCDR Lindsay Wagner at Lindsay.Wagner@fda.hhs.gov

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