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REGULATORY PHARMACEUTICAL FELLOWSHIP
Government Industry Academia
2021-2023
Jointly sponsored by:
TABLE OF CONTENTS
Fellowship Overview
Application Process
Drug Information Track
Medication Safety Track
Regulatory Advertising and Promotion Track
Fellowship Alumni
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The purpose of the Regulatory Pharmaceutical Fellowship program is to trainselected candidates in one of three tracks focused on drug information,medication safety, or regulatory advertising & promotion. The program serves tomaintain and enhance a link among the US Food and Drug Administration (FDA),academia, and the pharmaceutical industry. Graduates of the fellowshipprogram are uniquely qualified to pursue careers in any of the three areas ofgovernment, academia, and industry.
PROGRAM DESCRIPTION
FELLOWSHIP BENEFITS• Competitive stipend• Reimbursement for relocation during fellowship and professional travel expenses• Enrollment in the Indiana Pharmacy Teaching Certificate (IPTeC) Program• Vacation and University holidays• Optional Purdue University benefits package (health, Rx, vision, and dental)
2021 – 2023 Recruitment
Drug Information: 2 positions
Medication Safety: 2 positions
Regulatory Advertising and Promotion: 1 position
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FELLOWSHIP OVERVIEW
APPLICATION PROCESS
The fellow must be a graduate from an ACPE-accredited college of pharmacy, orotherwise eligible for licensure as a pharmacist, prior to the start of thefellowship term. All applicants must be U.S. citizens to complete the program.Candidates who do not meet this requirement should not apply.
All interested applicants must submit the following via the online portal:
1. Letter of intent, specifying track and sponsor(s) of interest
2. Contact information for three references, including name, email, and phone
3. Curriculum Vitae
4. Official transcripts. You may also send transcripts directly to the emails below.
Please address all fellowship application materials to the Regulatory Pharmaceutical
Fellowship Program Director, Dr. Amy Sheehan.
All application materials should be submitted to the online portal below
no later than 11:59 pm EST on Monday, November 30th, 2020.
Preliminary interviews will be conducted virtually on a rolling basis,
starting November 2nd, 2020.
Application Portal: https://hiring.science.purdue.edu/pharm
Contact us: [email protected]
[email protected]@purdue.edu
Final interviews will be conducted virtually on
December 7th and 8th, 2020.
ELIGIBILITY REQUIREMENTS
Additional fellowship opportunities are available through Purdue University. Visit our website at: https://www.phpr.purdue.edu/fellowships/pharmaceutical-industry-affiliated-fellowships
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PURDUE UNIVERSITY FDA ELI LILLY AND COMPANY
College of PharmacyDivision of Drug
Information
Global Medical Information
Indianapolis, IN
6 months:
07/2021 – 12/2021
6 months:
01/2022 – 06/2022
12 months:
07/2022 – 06/2023
DRUG INFORMATION
PROGRAM OVERVIEW
RECRUITING 3 FELLOWS
PURDUE UNIVERSITY JANSSEN PHARMACEUTICALS FDA
College of PharmacyMedical Information
Titusville, NJ
Division of Drug
Information
6 months:
07/2021 – 12/2021
12 months:
01/2022 – 12/2022
6 months:
01/2023 – 06/2023
RECRUITING 2 FELLOWS
TRACK 1
TRACK 2
IND
US
TR
Y This experience provides
the opportunity for the
fellow to gain training as a
member of a medical
information team in the
pharmaceutical industry.
The fellow will develop skills
related to development and
delivery of drug information
to healthcare professionals,
payors, consumers, and
business partners through a
variety of methods.
See locations below.
FDA The FDA experience
provides an opportunity for
fellows to refine their drug
information skills in a
regulatory setting. Fellows
respond to drug information
inquiries from patients,
health care professionals,
and regulated industry;
create and disseminate
content; and assist with a
number of high-profile
initiatives.
Silver Spring, MD
AC
AD
EM
IA
The Purdue University experience exposes the fellow to academia and an institutional-based drug information center at Indiana University Health. Fellows will conduct a research project for presentation at a national meeting and publication in a peer-reviewed pharmacy journal. Significant teaching experience in and out of the classroom is provided.
West Lafayette & Indianapolis, IN
FELLOWSHIP SCHEDULE: 2 TRACKS, 1 FELLOW EACH
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Shannon Alexander, PharmD
Industry Sponsor:
Astellas Pharma US, Inc.
First Year Fellow: 2020-2022 Cycle
University of Georgia
Katie Comanici, PharmD, MPH
Industry Sponsor:
Eli Lilly and Company
First Year Fellow: 2020-2022 Cycle
University of North Carolina at Chapel Hill
Dylan Vo, PharmD
Industry Sponsor:
Eli Lilly and Company
Second Year Fellow:
2019-2021 Cycle
University of Arizona
Anes Karic, PharmD, MBA, MS
Industry Sponsor:
Janssen Scientific Affairs, LLC
First Year Fellow: 2020-2022 Cycle
East Tennessee State University
Minh Tran, PharmD
Industry Sponsor: Janssen
Scientific Affairs, LLC
Second Year Fellow:
2019-2021 Cycle
Creighton University
CURRENT FELLOWS
Katie Comanici
First Year Drug Information Fellow
“I have learned so much in just a few short
months since starting this fellowship program
and I am excited to see what more I can learn
about drug information through my FDA and
pharmaceutical industry rotations. The
opportunities available through this program
are incredibly unique and I am very thankful to
have had this experience.“
Shannon Alexander
First Year Drug Information Fellow
“As a recent graduate, I was looking for a
fellowship program that would allow for a
scientific application of my clinical knowledge
in a drug information setting. I have had the
opportunity to learn more than I could have
imagined in the past few months, and I am
incredibly thankful for the invaluable skills,
connections, and experiences I am acquiring
during this program.“
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PROGRAM PRECEPTORS
Samina Ali, PharmD | Janssen Scientific Affairs, [email protected]
Samina earned her BS and PharmD degrees from Rutgers University College of Pharmacy and completed a Pharmacy Practice
Residency at Mount Sinai Medical Center in New York City. Samina has led and supported Medical Information activities for
multiple Janssen products in oncology, diabetes, virology, GI, women’s health and urology. She is currently responsible for
strategy and review of scientific content, promotional and sales training materials for prostate cancer products..
Payal Desai, PharmD | Janssen Scientific Affairs, [email protected]
Payal Desai earned a PharmD degree from the University of Sciences in Philadelphia. In her current role at Janssen, she is the
Associate Director of Medical Information, where she is responsible for the successful launch of cardiovascular products. She
provides strategic medical support, develops internal education plans, and participates in several cross-functional teams.
Payal was recognized with a 1-year rotation within the Medical Information Leadership team. She has mentored several Post-
doc Fellows and pharmacy students throughout her career.
DRUG INFORMATION
Amy H. Sheehan, PharmD | Purdue [email protected]
For over twenty years, Amy has worked with Purdue University College of Pharmacy and the Indiana University (IU) Health
Center for Medication Management, where she contributes to the provision of comprehensive drug information services for all
IU Health-affiliated hospitals. She has published over 40 peer reviewed articles in the pharmacy literature and authored book
chapters for therapeutics and drug information textbooks. Amy serves on the Indiana Pharmacy Teaching Certificate (IPTeC)
Program Executive Committee and is currently a member of the Editorial Board for the Annals of Pharmacotherapy. She serves
as course coordinator for a drug information and advanced literature evaluation class, and is chair of the professional program
curriculum committee.
Sandra Bai, PharmD | FDAPast Fellow 2016 - 2018 Cycle
Sandra earned her PharmD degree from Butler University College of Pharmacy. Following graduation, she completed the two-
year Regulatory Pharmaceutical Fellowship in Drug Information with rotations at Purdue University, Janssen Scientific Affairs,
LLC, and FDA. Following the fellowship, she accepted a position with the Division of Drug Information (DDI) at FDA. In her current
role at DDI, Sandra provides timely, complete, and accurate responses to inquiries from consumers, health care professionals,
and industry. Sandra is also a member of DDI’s Social Media team and leads the Drug Info Rounds video program.
Kathy Mybeck, PharmD | Eli Lilly and [email protected]
Throughout her 20+ year career at Eli Lilly and Company, Kathy has held various roles within Medical Information and Regulatory
Affairs. Kathy has provided global medical information support and led development of launch portfolio medical information
responses and strategies for endocrine and oncology products. Kathy also served as an Implementation Lead for the Regulatory
Transformation initiative by partnering with the Labeling department on process and system updates. Kathy continues to coach
her team members on medical information-related activities and precept PharmD students from a variety of schools.
Lindsay Wagner, PharmD, BCPS | CDR, USPHS | FDAPast Fellow 2009 - 2011 Cycle
CDR Wagner received her PharmD degree from the Albany College of Pharmacy and Health Sciences. She has been with the
FDA in the Division of Drug Information since graduating from the fellowship. In her current role as Branch Chief, she supervises
other pharmacists to help the public get the accurate, science-based information they need about human drugs. Lindsay
provides leadership for many additional programs, including Expanded Access and social media, and precepts students.
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Irene Lin
First Year Medication Safety Fellow
“Medication safety is a field that enables me to consolidate my clinical knowledge
with my extensive research skills. With the training from this fellowship, I am able to
contribute to maximizing patient safety in the context of global pharmacovigilance,
academia, and regulatory science.“
Morgan Nicholas
First Year Medication Safety Fellow
“This fellowship is the perfect first step in my career because it will provide me with
a wide range of experiences in academia, industry, and the FDA. In turn, I can
leverage my experiences to propel my career even further.“
PURDUE UNIVERSITY NOVARTIS FDA
College of PharmacyName Creation and Regulatory Strategy
East Hanover, NJ
Division of Medication Error Prevention and
Analysis
4 months:
07/2021 – 10/2021
12 months:
11/2021 – 10/2022
8 months:
11/2022 – 06/2023
PURDUE UNIVERSITY ABBVIE FDA
College of PharmacyPharmacovigilance and Patient Safety
North Chicago, IL
Division of Medication Error Prevention and
Analysis
4 months:
07/2021 – 10/2021
12 months:
11/2021 – 10/2022
8 months:
11/2022 – 06/2023
TRACK 2
MEDICATION SAFETY
PROGRAM OVERVIEW
RECRUITING 2 FELLOWS
AC
AD
EM
IA
The fellow will have unique experiences in academia, such as publishing original research, delivering presentations, and teaching. The fellow will actively participate in practice-based research to foster the discovery and delivery of information and practices to enhance medication safety.
West Lafayette & Indianapolis, IN
INDUSTRY The fellow at AbbVie will
gain experience in safety signal detection and evaluation as well as the development of regulatory documents. The fellow at Novartis will gain experience in patient safety considerations for naming conventions, and global regulatory strategy for ensuring safe and consistent naming standards.
See locations below.
FDA The fellow will participate in
intra- and inter-center projects in pre- and post-market arenas. The fellow will focus on research opportunities to address medication error issues related to drug packaging, nomenclature, labels and labeling. The fellow will utilize adverse drug event reporting data, medical literature, and more to assess safety related issues.
Silver Spring, MD
FELLOWSHIP SCHEDULE: 2 TRACKS, 1 FELLOW EACHTRACK 1
Morgan Nicholas, PharmD
Industry Sponsor:
Eli Lilly and Company
First Year Fellow: 2020-2022 Cycle
The Ohio State University
CURRENT FELLOWS
Charlotte Moureaud, PharmD
Industry Sponsor:
AbbVie
Second Year Fellow: 2019-2021 Cycle
Rutgers University
Jonell Nwabueze, PharmD
Industry Sponsor:
Eli Lilly and Company
Second Year Fellow: 2019-2021 Cycle
Manchester University
Irene Lin, PharmD
Industry Sponsor:
AbbVie
First Year Fellow: 2020-2022 Cycle
University of Minnesota
PROGRAM PRECEPTORS
Dorothy Linvill-Neal | Novartis
Dorothy Linvill-Neal joined Novartis in October 2012, as Global Head of Name Creation & Regulatory Strategy. Immediately prior
to joining Novartis, Ms. Linvill-Neal served as Head of Global Trademark Development at Johnson & Johnson. She has over 34
years of experience in Global Trademark/Nomenclature Development, Regulatory Nomenclature Clearance, and Strategic
Planning. She currently serves as Trademark/Regulatory Expert to the EFPIA Group that meets regularly with the EMA Name
Review Group and as a member of the FDLI Global Committee. She presently serves as a Clinical Adjunct Professor and
preceptor for Temple University School of Pharmacy.
Kyle Hultgren, PharmD | Purdue [email protected]
Kyle Hultgren is the director of the Purdue University College of Pharmacy’s Center for Medication Safety Advancement. Dr.
Hultgren’s current research includes extensive work on dashboards and measurement systems for the evaluation and
improvement of medication use systems as well as large adverse event data set analysis. He holds multiple copyrights on mobile
computer simulation technology and two patents on medical devices designed to improve patient safety. Dr. Hultgren lectures
nationally and internationally on safe medication use practices and teaches regularly in the Doctor of Pharmacy curriculum
where he is the 2016 Dr. Aziz Teaching Award recipient.
Alissa Jara, PhD | Purdue [email protected]
Alissa L. Jara is an Assistant Professor of Pharmacy Practice, Purdue University and Affiliate Investigator with Regenstrief
Institute, Inc. Her office is in West Lafayette, IN, and she teaches “Patient Safety and Informatics” to third-year pharmacy
students. Dr. Jara integrates health services research with human factors engineering methods to improve the design of health
information technologies (IT) for healthcare professionals and patients. Dr. Jara leads federally-funded research to evaluate the
design of medication alerts, including drug-allergy, drug-drug interaction, and drug-disease alerts. Dr. Jara has given over thirty
invited presentations and her research has received special recognition from the International Medical Informatics Association.
Dan Degnan, PharmD, MS, CPPS, FASHP | Purdue [email protected]
Dan Degnan currently serves as the Associate Director for the Professional Program Laboratory and is a Clinical Assistant
Professor of Pharmacy Practice (Courtesy) at the Purdue University College of Pharmacy. He has an appointment at the
Regenstrief Center for Healthcare Engineering at Purdue as a Clinical Research Associate with expertise and research interests
in the area of medication safety technology, advanced pharmacy automation, pharmacy operations and high reliability in
healthcare. Prior to his role at Purdue, Dr. Degnan served as the Medication Safety Officer at Community Health Network in
Indianapolis for almost 10 years. He has held leadership positions in national organizations for both pharmacy and healthcare
quality.
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PROGRAM PRECEPTORS
MEDICATION SAFETY
Ashleigh Lowery, PharmD, BCCCP | [email protected]
Ashleigh is currently a team leader in DMEPA where she is responsible for increasing the safe use of CDER-regulated drug
products by minimizing use error related to their naming, labeling, packaging, or design. She has also worked on postmarket and
policy projects on DMEPA's Rapid Response Team. She is a graduate of the University of Maryland School of Pharmacy and
completed her PGY-1 Pharmacy Practice and PGY-2 Critical Care residencies at the University of Maryland Medical Center
(UMMC) and the R Adams Cowley Shock Trauma Center. Prior to joining FDA, she worked as a clinical pharmacy specialist and
clinical assistant professor in the Cardiac Surgery ICU at UMMC.
Irene Z. Chan, PharmD, BCPS | CAPT, USPHS | [email protected]
CAPT Chan received her B.S. and Doctorate degrees in Pharmacy from Rutgers University Ernest Mario School of Pharmacy.
Upon graduation, she was called to active duty and assigned to Gallup Indian Medical Center where she completed a PGY1
Pharmacy Practice Residency. She continued with the Indian Health Service for over five years in both inpatient and outpatient
pharmacy settings. In 2009, she transferred to FDA, where she currently serves as the Deputy Director in the Division of
Medication Error Prevention and Analysis. In her current role, she leverages her knowledge of regulatory science, human
factors, and risk management to provide oversight of safety recommendations regarding drug nomenclature, labels, labeling,
packaging, and product design.
Mishale Mistry, PharmD, MPH | FDA [email protected]
Mishale received her Doctor of Pharmacy from Northeastern University in 2011 and Master in Public Health from University of
Maryland School of Medicine in 2012. Mishale joined the Division of Medication Errors and Prevention Analysis (DMEPA) in the
FDA in 2014. She currently serves as an Associate Director for Nomenclature and Labeling within DMEPA where she oversees
safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design. Prior to joining the
FDA/DMEPA in 2014, she was a fellow with the Office of Disease Prevention and Health Promotion in the Office of the Assistant
Secretary for Health working on adverse drug event prevention.
Adrienne M. Rothstein, PharmD | AbbVie [email protected]
Adrienne received her BS in Pharmacy from St. John’s University and her PharmD from the University of Cincinnati. After
graduation, she pursued a pharmacy practice residency at Stanford University Hospital. She then worked in drug information &
pharmacovigilance at Elan Pharmaceuticals. Adrienne later worked at the FDA in OSE, Division of Pharmacovigilance and OND,
Division of Reproductive, Urology and Bone Products. Today, she is the director of a team that is responsible for safety
surveillance of investigational and approved oncology and immunology products and she contributes to a variety of regulatory
submissions for investigational oncology and immunology products.
Alexandra Terry, PharmD, BCPS | AbbVie [email protected]
Alexandra is an Associate Director in Safety Data Sciences at AbbVie. Her current role within Pharmacovigilance and Patient
Safety involves development of surveillance strategy, signal evaluation, and authoring global safety reports. She supports a
variety of investigational and marketed products in the oncology and general medicine therapeutic areas. Alexandra received
her Doctor of Pharmacy degree from University of Illinois at Chicago and joined AbbVie after completing the Eli Lilly Visiting
Scientist Fellowship in regulatory affairs and a PGY1 pharmacy practice residency at OSF Saint Francis Medical Center.
Jane Y. Chia, PharmD, BCPS | [email protected]
Jane is a Senior Safety Data Scientist in Pharmacovigilance and Patient Safety at AbbVie. She contributes to signal strategy and
assessments, in addition to authoring global safety documents. Her work supports products at all levels of development, focusing
on therapies in infectious diseases and immunology. She holds a Doctor of Pharmacy degree from Midwestern University,
Chicago College of Pharmacy, and completed a PGY1 pharmacy practice residency at Loma Linda University Medical Center
prior to joining the team at AbbVie.
ADVERTISING AND PROMOTION
PROGRAM OVERVIEW
ELI LILLY AND COMPANY FDA PURDUE UNIVERSITY
Regulatory
Advertising & Promotion
Office of Prescription Drug
PromotionCollege of Pharmacy
9 months:
07/2021 – 03/2022
9 months:
04/2022 – 12/2022
6 months:
01/2023 – 06/2023
IND
US
TR
Y
FDA
AC
AD
EM
IAFELLOWSHIP SCHEDULE: 1 TRACK, 1 FELLOW
The fellow will gain exposure to upper level academia and the different 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 the experiential training of pharmacy students.
West Lafayette & Indianapolis, IN
The fellow will gain experience in the FDA promotional review process and provide overviews of relevant laws and FDA guidance documents. The fellow will assist in reviewing promotional materials, evaluating draft product labeling, researching and evaluating industry complaints, and working with other functions in the Office of Prescription Drug Promotion (OPDP).
Silver Spring, MD
The fellow will develop an understanding of FDA regulations and guidance, industry codes, and more, as related to prescription drug advertising and promotional activities. The fellow will work directly with internal business partners such as marketing, legal, medical, and others to ensure that a broad range of promotional materials are in compliance with regulations and internal policies.
Indianapolis, IN
RECRUITING 1 FELLOW
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Jennifer Chen
Second Year Advertising and Promotion Fellow
"I love how Regulatory Advertising and Promotion is a field in which I can
utilize my pharmacy knowledge and exercise my interpersonal skills to
lead discussions among cross-functional groups. I am grateful that this
fellowship provides unique and invaluable opportunities to learn from
respected mentors and gain significant work experience in the FDA,
academia, and the pharmaceutical industry.“
Steven Abel, PharmD, FASHP | Purdue [email protected]
Prior to his appointment as associate provost for engagement in 2016, Steve served as associate vice president for engagement,
associate vice provost for faculty affairs and held various positions within the Purdue University College of Pharmacy. He has 18
years of prior practice experience, primarily in a health-system setting. Steve received his B.S. (Pharmacy) and PharmD degrees
from Purdue University and completed residency at Mayo Medical Center. Steve is passionate about student education,
faculty/leadership development, mentorship and community engagement. Steve developed the only fully immersive USP 797
compliant virtual cleanroom used for student education, commercially marketed through his company, Penguin Innovations.
Carrie Newcomer, PharmD | [email protected]
Carrie graduated from the University of Pittsburgh School of Pharmacy where she received her PharmD. She has been a
regulatory review officer for the Office of Prescription Drug Promotion (OPDP) since 2005, and currently reviews promotional
materials for ophthalmology and transplant products. She also coordinates the new reviewer training program and the FDA
Pharmacy Student Experiential Program for OPDP. During her time at OPDP, Carrie has been responsible for working in various
therapeutic areas including reproductive, medical imaging, hematology, and urologic products.
Sam Skariah, PharmD | CDR, USPHS | FDAPast Fellow 2005 - 2007 Cycle
CDR Skariah graduated from the University of Illinois at Chicago College of Pharmacy where he received his PharmD. He then
went on to complete this same track of the regulatory fellowship that was in conjunction with Purdue University, Eli Lilly and
Company, and the FDA. He is a Commander in the United States Public Health Service and has served as Team Leader within
FDA’s Office of Prescription Drug Promotion (OPDP) since 2013. Previous to that role, he served as an FDA-OPDP reviewer for
various therapeutic areas.
Mike Sauers | Eli Lilly and [email protected]
Mike Sauers, Director in Eli Lilly’s Global Regulatory Affairs, US Advertising and Promotion group, advises on promotional
compliance across the range of Lilly’s Oncology, Diabetes, and Biomedicines US marketed products. Prior to joining Lilly in 2017,
Mike served for 10 years in the FDA Office of Prescription Drug Promotion (OPDP). Mike held multiple posts within OPDP, most
recently as the Supervisor of the Advertising and Promotion Policy Staff leading OPDP’s guidance, regulatory, and policy
development, as well as the social science research, legal, and project management teams.
PROGRAM PRECEPTORS
Jennifer Chen, PharmD
Industry Sponsor:
Eli Lilly and Company
Second Year Fellow: 2019-2021 Cycle
Purdue University
CURRENT FELLOW
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2018-2020: Megan Cuomo, PharmD
Pharmacist, Division of Drug Information
U.S. Food and Drug Administration
2018-2020: Kaitlin Montagano, PharmD
Manager, Medical Information
Astellas Pharma US
2017-2019: Kiersten Rybakov, PharmD
Associate Consultant, Global Medical Information
Eli Lilly and Company
2017-2019 Jacqueline Wasynczuk, PharmD
Assistant Professor, Department of Pharmacy Practice
Thomas Jefferson University
2016-2018: Sandra Bai, PharmD
Pharmacist, Division of Drug Information
Food and Drug Administration
2015-2016: Megan N. Freeland, PharmD
Owner, Healthcare Digital Marketing Consultant
StockRose Creative, LLC
2014-2016: Jay R. Fajiculay, PharmD
Regulatory Health Project Manager, Gastroenterology
Division of Regulatory Operations for Immunology and Inflammation
Food and Drug Administration
2013-2015: Bhavani T. Parikh, PharmD
Leader, Global Medical Affairs
AstraZeneca
2012-2014: Andrea M. TenBarge, PharmD
Advisor, Next Generation Customer Engagement Planning &
Operations, Eli Lilly and Company
2011-2013: Genevieve Lynn (Ness) Engle, 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
Science Policy Analyst
Division of Clinical Outcome Assessment
Office of New Drugs- Immediate Office
Food and Drug Administration
2009-2011: Lindsay E. Wagner, PharmD, BCPS
Commander, U.S Public Health Service
Branch Chief, Division of Drug Information
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 Aesthetics Inc.
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
Food and Drug Administration
DRUG INFORMATION
FELLOWSHIP ALUMNI
13
ALUMNI SPOTLIGHT
“The three rotations provided in this fellowship build on each
other, which allowed me to continue to refine my drug
information and teaching skills over the course of the two
years. I am also thankful for the excellent professional
connections and mentors that I gained from this program.”
“The Regulatory Pharmaceutical Fellowship provided remarkable
opportunities for professional and personal growth while integrating
me into three distinct areas of drug information practice. I will be
forever grateful to have participated in this program for its rich learning
experiences, rewarding challenges, and truly amazing mentors.”
Megan Cuomo, PharmD
2018-2020
Drug Information Fellow
Kaitlin Montagano, PharmD
2018-2020
Drug Information Fellow
2017-2019: Nikki Pedersen, PharmD
Manager, Regulatory Affairs Advertising & Promotion
Horizon Therapeutics
2015-2017: John Riehl, PharmD
Associate Director
Regulatory Affairs, Advertising and Promotion
Allergan Aesthetics, an AbbVie Company
2013-2015: Sam Davis, PharmD
Consultant, Global Regulatory Affairs
US Advertising & Promotion
Eli Lilly & Company, Lilly USA, LLC
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, East Team Lead
Relypsa
2007-2009: Sheetal Patel, PharmD
Head, Regulatory Advertising and Promotion
Johnson & Johnson Health Care Compliance
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
Sr. Director, Regulatory Affairs Advertising and Promotion
Acadia Pharmaceuticals Inc.
ADVERTISING AND PROMOTION
Danya Faruqi, PharmD
2018-2020
Medication Safety Fellow
Nikki Pedersen, PharmD
2017-2019
Advertising and Promotion Fellow
“The Regulatory Fellowship in Drug Advertising and Promotion
provided me the unique opportunity to deeply understand the
regulatory landscape as it pertains to prescription drug advertising. Not
only did I gain the necessary skills to excel as a regulatory ad/promo
professional, but I also grew personally and professionally alongside
experts and some of the greatest mentors in the industry.”
“The medication safety fellowship helped me to establish a
strong foundation in safety that I can build upon throughout
my career. My mentors and diverse experiences taught me
how to be an effective advocate for patient safety striving to
improve care and ensure positive outcomes.”
2018-2020: Danya Faruqi, PharmD
Senior Safety Data Scientist
AbbVie
2017-2019: Kathryn Marwitz, PharmD, MPH
Assistant Professor of Pharmaceutical Sciences
(Social and Administrative Sciences)
Manchester University College of Pharmacy, Natural & Health Sciences
2016-2018: Kaitlyn Dana, PharmD
Associate Director, Project Planner
Pfizer, Groton, CT
2015-2016: Janelle R. Lenz, PharmD
Medical Science Liaison - Oncology
Lilly USA, LLC
2014-2015: Trang Truong
Director, Global Pharmacovigilance Scientist Lead
Amgen
2013-2015: Katelyn Brown, PharmD
Principal Research Scientist for Clinical Development
Eli Lilly and Company; Indianapolis, IN
2012-2013: Jaclyn A. Jeffries, PharmD, CPh, CPPS
Medication Safety Officer
AdventHealth Central Florida Division-South
MEDICATION SAFETY
ALUMNI SPOTLIGHT
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Jointly sponsored by:
To reach our current fellows and ask questions, write to:
Drug Information Track:
Medication Safety Track:
Regulatory Advertising and Promotion Track:
Jointly sponsored by:
REGULATORY PHARMACEUTICAL FELLOWSHIP
Government Industry Academia
2021-2023
