ST. JOHN’S UNIVERSITY/ALLERGAN PHARMACEUTICAL INDUSTRY . PDF

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ST. JOHN’S P2020 - 2021In partnership with

YOUR BOLDCAREERSTARTS HERE.1Fellowship Program 2020 - 2021

ABOUT ALLERGANAllergan PLC (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader ina new industry model – Growth Pharma. We are focused on developing, manufacturing and commercializing brandedpharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.We market a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics,gastroenterology, women’s health, urology and anti-infective therapeutic categories.We are an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developinggame-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines inthe pharmaceutical industry with 60 mid-to-late stage pipeline programs currently in development.Learn more at www.Allergan.com.OUR WORLD-CLASS MANUFACTURING AND R&D chburg, NJCincinnati, OHNorthern CA (Biologics)Irvine, CA (Biologics)Dublin, CAWaco, TXCOSTA RICAHouston, TXSan JoseBridgewater, NJIrvine, CAPleasanton, CASunrise, FLMadison, kyoBRAZILSINGAPORESingaporeGuarulhosSão PauloFellowship Program 2020 - 20212

ABOUT ST. JOHN'S UNIVERSITYSt. John’s University College of Pharmacy and Health Sciences, located in Queens, NY, is affiliated and partners with anumber of elite healthcare organizations throughout the New York metropolitan area. Founded in 1870, the Universityoffers undergraduate and graduate level healthcare-related programs. Undergraduates and graduates are activelyinvolved in basic science, clinical research, and providing patient-centered care to an urban patient population.ABOUT OUR FELLOWSHIPLOCATION:Queens, NYDEAN:Russell J. DiGate, Ph.D.GRADUATE PROGRAMS OFFEREDTHROUGH THE UNIVERSITY: M.S./Ph.D. in Pharmaceutical Sciences; M.S. in Biological and PharmaceuticalBiotechnology, Pharmacy Administration,and Toxicology Masters of Business Administration (MBA) Master of Public Health (MPH) M.S. in Data Mining and Predictive AnalyticsJoshua Rickard, PharmDAssistant ProfessorFellowship Program CoordinatorNow entering its 17th year, the St. John’s University/Allergan FellowshipProgram is one of the most dynamic and challenging developmentprograms in the industry. We offer three 1-year fellowships focused inGlobal Regulatory Strategy, Clinical Development, and Regulatory AffairsAdvertising and Labeling. Fellows may be offered the opportunity torotate to other functional areas during an optional second year of thefellowship. The programs are based in Allergan’s Madison, NJ office andare designed to offer a broad range of hands-on training and professionaldevelopment opportunities.ST. JOHN’S UNIVERSITY COMPONENTFellows are full-time University employees and are provided a competitive stipend andbenefits package, including comprehensive health insurance. Each fellow is requiredto complete a one-semester teaching component at the University and a collaborativeresearch project.Additionally, each Fellow is able to participate in a number of other professional andeducational development opportunities at the University, including precepting pharmacystudents; continuing education courses; resident and fellow seminars; Affiliate Facultyappointments; and a teaching certificate course. Fellows may also enroll, with a tuitionremission benefit, and participate in University courses and graduate degree programs.CERTIFICATE OF COMPLETIONUpon successful completion of the program, Fellows will receive a certificate from St.John’s University College of Pharmacy and Health Sciences and Allergan.WEBSITE: dustryfellowship-programsJoseph M. Brocavich, PharmDSenior Associate Deanfor Pharmacy Programs“For the past 17 years St. John’s University, Collegeof Pharmacy and Health Sciences has partnered withselect Pharmaceutical Industry companies includingour first partner, Allergan, to provide Doctor ofPharmacy graduates with structured postgraduateeducation fellowships that develop leadership,practice, research and teaching skills to succeed inthe industry today and in the future.”3Fellowship Program 2020 - 20212

to scholars and scientists who are unified by“ Homeone intrepid goal—to improve the quality of life forpeople globally.”Fellowship Program 2020 - 20214

GLOBAL REGULATORY STRATEGY FELLOWSHIPCURRENT FELLOWSOur Global Regulatory Strategy team leads our Company’s business-criticalrelationships with the U.S. Food and Drug Administration (FDA) and other globalregulatory agencies throughout the world, ensuring the continued success of ourproduct portfolio and pipeline.ROLES AND RESPONSIBILITIESKendra Croker,BS, PharmD, RPhWilkes University,Nesbitt School of Pharmacy1st Year Fellow Developing a comprehensive understanding of global regulations and guidances relating todrug development Supporting cross-functional product teams by offering expertise and strategic guidance onregulatory requirements for global development and market registrations Filing and maintaining Investigational New Drug Applications (INDs), New Drug Applications (NDAs),Marketing Authorization Applications (MAAs) and Clinical Trial Authorizations (CTAs) Interfacing with internal and external stakeholders to ensure company compliance with allappropriate federal regulations and guidances Gaining a thorough understanding on how to best conduct health authority meetings(including advisory committee meetings) and prepare teams for effective regulatory interactionsLauren Aronin,BS, PharmDTouro College of Pharmacy2nd Year FellowAmjad Iqbal, PharmDEXECUTIVE DIRECTOR, GLOBAL REGULATORY STRATEGY“The St. John’s University/Allergan Industry Fellowship gave me the skill sets necessary to achieve a successful career in the pharmaceuticalindustry. The fast-paced, high-energy environment, paired with a very dedicated group of preceptors, afforded me a customized learningexperience that provided the confidence necessary to seek high-profile challenging, and rewarding positions in the industry.5Fellowship Program 2020 - 2021”

CLINICAL DEVELOPMENT FELLOWSHIPCURRENT FELLOWSOur Clinical Development team is responsible for the development and executionof our global Phase II - IV clinical trials across our therapeutic categories. The fellowwill be responsible for working in collaboration with other functional areas includingBiostatistics, Data Management, Regulatory Affairs, and Global Drug Safety.ROLES AND RESPONSIBILITIESSimranpreet Waraich,PharmDSt. John's UniversityCollege of Pharmacy and Health Sciences1st Year Fellow Working independently as a clinical scientist contributing to clinical trial team andclinical sub-team decisions Developing an understanding of the drug development process from study start up to study close out Participating in the conceptualization, conduct and management of clinical trials Developing study protocols, informed consent forms (ICFs), investigator’s brochures (IBs), final clinicalstudy reports (CSR) and other clinical trial materials Collaborating with Global Clinical Trial Management (GCTM) and Global Site Management Operations(GSMO) to train, manage and answer clinical queries from investigative sites on study related material Analyzing, interpreting, and reporting clinical trial data Working alongside the Medical Safety Physician (MSP) to ensure the safety of our patientsMostafa Seliem,BS, PharmDUniversity of the SciencesPhiladelphia College of Pharmacy2nd Year FellowAnna Chan, PharmDDIRECTOR, CLINICAL DEVELOPMENT“The purpose of the fellowship is to provide real world and transferable experience for compounds in various stages of clinicaldevelopment. The fellow should be able to see how decisions are made and what factors drive those decisions. One of our top priorities isto ensure the fellow is a contributing member of a clinical trial study team.”Fellowship Program 2020 - 20216

REGULATORY AFFAIRS–ADVERTISING AND LABELING FELLOWSHIPCURRENT FELLOWSOur Regulatory Affairs Advertising and Labeling team is responsible for liaisingwith regulatory agencies (e.g., FDA’s Office of Prescription Drug Promotion)related to advertising, promotion, and labeling.ROLES AND RESPONSIBILITIESAnn Lee, PharmDRutgers University,Ernest Mario School of Pharmacy1st Year Fellow Providing Allergan’s internal stakeholders with strategic regulatory advice on advertising andpromotional materials, in accordance with FDA regulations and business goals Facilitating the creation, revision, and maintenance of product labeling in order to communicateaccurate product information to health care providers and consumers Gaining insight into marketing’s goals and objective and understanding how those measures arereflected in the development of product advertising Developing a comprehensive understanding of FDA regulations regarding drug advertising and labeling Applying regulations to the development of product promotion (including, but not limited to, televisioncommercials, social media advertisements, website design, and print brochures), and drug labeling(physician and consumer directed communications)FELLOWSHIP SCHEDULEAlexandra DiDonato, PharmDSt. John’s University,College of Pharmacy and Health Sciences2nd Year FellowREGULATORY ADVERTISING & PROMOTIONREGULATORYLABELING9 months3 monthsMoulakshi Roychowdhury, PharmD, JDEXECUTIVE DIRECTOR, REGULATORY AFFAIRS ADVERTISING AND LABELING“The optimal way to learn is through hands-on experience. This Advertising & Labeling fellowship program is specifically designed toensure the fellows gain real-life, relevant experience, from the perspective of both sides of the coin (regulatory review and marketing)involved in the development of pharmaceutical promotion, from inception to final execution.7Fellowship Program 2020 - 2021”

FELLOWSHIP ALUMNIGLOBAL REGULATORY STRATEGY2017 - 20192010 - 2012Valerie Tengco, PharmDShweta Pandya, PharmD2016 - 20182009 - 2011Daanish Ashraf, PharmDNicole L. Bradley, PharmD2015 - 20172008 - 2010Colin Vechery, PharmDJulie Plotnikov, PharmDManager, Regulatory Affairs,Allergan PLC.Rutgers University,Ernest Mario School of PharmacySenior Manager, Global Regulatory Policy,BiogenUniversity of Illinois at Chicago,College of PharmacySenior Manager, Regulatory Affairs,BiogenDuquesne University,Mylan School of Pharmacy2014 - 2016Reena Nadpara, PharmDAssociate Director, Regulatory Affairs,Advertising and Promotion,Allergan PLC.St. John’s University,College of Pharmacy and Health SciencesExecutive Director, Regulatory Affairs,Allergan PLC.The Ohio State UniversityMarketing Launch Consultant,CelgeneTemple University,School of Pharmacy2007 - 2009Hiren D. Patel, PharmD, MS, RAC USPHSAssociate Director, Regulatory Affairs,NovartisRutgers University,Ernest Mario School of PharmacyTeam Leader, Regulatory Project Management Division ofPsychiatry Products Center For Drug Evaluation & Research, FDASt. John’s University,College of Pharmacy and Health Sciences2013 - 20152006 - 2008Betsy Kurian, PharmDHilary Winters Henshaw, PharmD2012 - 20142005 - 2007Amol J. Parekh, PharmDSejal P. Emerson, PharmD2011 - 20132004 - 2006Donato M. Forlenza, PharmD, MBAAmjad Iqbal, PharmDAssociate Director, Regulatory Affairs,NovartisSt. John’s University,College of Pharmacy and Health SciencesSenior Global Program Regulatory Manager,NovartisRutgers University,Ernest Mario School of PharmacyDirector, Regulatory Affairs Advertising and Promotion,Regeneron Pharmaceuticals, Inc.Albany College of Pharmacy and Health SciencesSenior Regulatory Program Director (GRL, Line Manager),GenentechUniversity of Michigan,College of PharmacyDirector, Regulatory Affairs ,AbbVieUniversity of Michigan,College of PharmacyExecutive Director, Regulatory Affairs,Allergan PLC.University of Cincinnati,College of PharmacyFellowship Program 2020 - 20218

FELLOWSHIP ALUMNICLINICAL DEVELOPMENT2017 - 20192010 - 2012Ama Berko, PharmDKerri Z. Kaplan, PharmD2016 - 20182009 - 2011Erika Culotta, PharmDJoseph P. Stalder, PharmDManager, Clinical Development,Allergan PLC.St. John’s University,College of Pharmacy and Health SciencesDirector, Project Management,AstraZenecaUniversity of California, San DiegoSkaggs School of Pharmacy and Pharmaceutical Sciences2015 - 20172008 - 2010Erica L. Gray, PharmDJessica Kachadourian, PharmD2014 - 20162007 - 2009Omar Khalid, PharmD, MBAPeter J. McFarland, PharmDGlobal Program Regulatory Manager,NovartisFarleigh Dickinson University,School of Pharmacy and Health SciencesClinical Pharmacist,Diamond Pharmacy Services,Duquesne University,Mylan School of PharmacyAssociate Director, Global Regulatory Affairs,Bristol-Myers SquibbSt. John’s University,College of Pharmacy and Health SciencesDirector, Medical Affairs,NovartisNortheastern University,School of PharmacyDigital Systems Consultant,IDEXX LaboratoriesMassachusetts College of Pharmacy and Health Sciences2013 - 20152006 - 2008Maxwell Adams, PharmDKaren A. Allen, PharmD2012 - 20142005 - 2007Michael C. Camuso, PharmDRachel Luchini, PharmD2011 - 20132004 - 2006Yunji Kim, PharmDVincent C. Yan, PharmDAssociate Director, Clinical Development,Allergan PLC.Massachusetts College of Pharmacyand Health SciencesClinical Pharmacist, Investigational Pharmacy Service,at Boston Medical Center,Albany College of Pharmacy andHealth SciencesDirector, Regulatory Affairs,Regeneron PharmaceuticalsUniversity of North Carolina at Chapel Hill,Eshelman School of Pharmacy9Executive Director, Regulatory Affairs,Allergan PLC.Long Island University, Arnold & Marie Schwartz,College of Pharmacy and Health SciencesFellowship Program 2020 - 2021Associate Director, PVRM, Quality and Compliance,Regeneron Pharmaceuticals, Inc.St. John’s University,College of Pharmacy and Health SciencesAssociate Director, Clinical Development,Allergan, PLC.Rutgers University,Ernest Mario School of PharmacyAssociate Director, Marketing,PharmacyclicsRutgers University,Ernest Mario School of Pharmacy

FELLOWSHIP ALUMNIREGULATORY AFFAIRS – ADVERTISING AND LABELING2017 - 2019Hasan Siddiqui, PharmDSales Representative, Psychiatry,Allergan PLC.University of Illinois at ChicagoPROGRAM LEADERSHIPJune K. Bray,RPh, MBAAmjad Iqbal,PharmD, RPhAnna Chan,PharmD, RPhAmy Toscano,PharmD, RPhJoseph BrocavichPharmD, RPhJosh RickardPharmD, RPhSenior Vice President,Regulatory Affairs& Medical WritingProgram Executive SponsorDirector,Clinical DevelopmentLead PreceptorSenior Associate Deanof Pharmacy ProgramsExecutive Director,Regulatory AffairsProgram DirectorLead PreceptorDirector,Regulatory Affairs – AdvertisingPromotion & LabelingLead Precep

Philadelphia College of Pharmacy 2nd Year Fellow Simranpreet Waraich, PharmD St. John's University College of Pharmacy and Health Sciences 1st Year Fellow Anna Chan, PharmD DIRECTOR, CLINICAL DEVELOPMENT “ The purpose of the fellowship is to provide real world and transferable experience for compounds in various stages of clinical development.