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2022-2023PharmaceuticalIndustry FellowshipProgram

About AbbVieOur Mission: Create an innovation-driven, patient-focused specialty biopharmaceuticalcompany capable of achieving sustainable top-tier performance through outstandingexecution and a consistent stream of innovative new medicines which have a remarkableimpact on people’s lives.We are a global, research-based biopharmaceutical company committed to discovering,developing and delivering innovative new medicines with distinct and compelling benefits forpeople. Today, our medicines help 57 million people living in more than 175 countries, andwe are making significant advancements with a robust pipeline of potential new medicines.We are a passionate, diverse and inclusive organization with a culture that supports the bestideas, wherever they originate. We bring people together because we know thatcollaboration is the key to breaking barriers and exploring new frontiers in science. We takesmart risks that lead to transformative breakthroughs and can change lives for people all overthe globe.Our commitment to making a remarkable impact doesn’t end at developing medicines; itbegins there. We provide broader support to our patients and help address the health needsof underserved communities. We strive to protect our environment and to make a positiveimpact in the areas where we live and work.About University of Southern CaliforniaThe USC School of Pharmacy is the only private pharmacy school on a major health sciencescampus, which includes the Keck School of Medicine, Keck Hospital of USC and the USC NorrisComprehensive Cancer Center and is immediately adjacent to the LAC USC Medical Center,one of the largest public hospitals in the country.Ranked by US News and World Report as a top ten pharmacy school nationwide and #1among private schools, the USC School of Pharmacy is recognized for its century-oldreputation for innovation in pharmaceutical education, clinical practice, and research.With a history of “firsts” that includes the nation’s first Pharm.D. program (1950), first clinicalclerkship program (1968), first Ph.D. in pharmaceutical economics (1990), and firstprofessional doctorate in regulatory science (2008), the school holds an essential leadershiprole in the safe, efficient, and optimal use of medication therapy that can save lives andimprove the human condition.2

About Our Fellowship ProgramQuoc Ho, Pharm.D.Fellowship Advisor,Associate Director, Clinical Development,Ophthalmology,AbbVie Inc.William C. Gong,Pharm.D., FASHP, FCSHP,Director, Residency and Fellowship ProgramsAssociate Professor of Clinical PharmacyUSC School of PharmacyThe USC-AbbVie Pharmaceutical Industry Fellowship Program is designed to prepare postdoctoralscholars for rewarding careers in the pharmaceutical industry. Fellows work with mentors to participatein activities that enhance the skills required to excel in their field. Graduate-level coursework andseminars at USC may be included in the program, in addition to hands-on project activities in AbbVieteams.Upon completion of the program, fellows will be prepared for the challenges of a career in thepharmaceutical industry. Past fellows have been placed into rewarding positions in industry, pharmacypractice, and research. USC Pharmacy’s fellowship programs adhere to the guidelines of the AmericanAssociation of Colleges of Pharmacy and the American College of Clinical Pharmacy. The fellowshipsbegin on July 1 and end on June 30 (some positions may vary).Key Highlights⁃⁃⁃⁃⁃⁃⁃Access to USC Regulatory Science courses and tuition remission, up to 4 units per semestertowards a graduate certificateNetworking with USC students and alumniParticipating in professional leadership workshopsFinancial relocation assistance for out-of-state fellowsFinancial support to attend professional conferences and eventsDelivering lectures to pharmacy studentsRecruiting prospective graduate and professional students to the Fellowship Program3

Fellowship MentorsJillian McCumber, M.S.Head of Regulatory AffairsStrategy, Facial AestheticFrancisco J. López, M.D., Ph.D.Executive Medical Director,Chief of Staff,Eye Care DevelopmentJimmie Overton, Pharm.D.Vice President,Global Medical InformationJames Cunningham, Ph.D.Executive Director,Drug DeliveryKathy Held, Ph.D.Associate Director,Eye Care ResearchAniket Badkar, Ph.D.Director, Neurotoxin andBiologics ProductDevelopmentRenee S. GarrettGlobal Head EvidenceSolutions, Global MedicalOperationsWarren Tong, Pharm.D., M.S.Associate Director, ClinicalDevelopment, Aesthetic MedicineJie Shen, Ph.D.Executive Director,Clinical PharmacologyAlexandra Traut, Ph.D.Executive Director, GlobalScientific Publications,Neuroscience4Sara Cabrera-Ghayouri,M.S./M.A.Senior Scientist,Biological Research

Medical AffairsThe one-year Medical Affairs Fellowship focuses on providing exposure tothree pillars of functionality: Evidence Solutions, Global Medical Information,or Global Medical Communications. The fellow will then be able to developfirsthand experiences in management of post-marketing clinical research,medical information functional operations, or global strategic publicationplanning. This program will provide the fellows the necessary tools tobecome successful professionals within the pharmaceutical industry, as wellas the opportunity to network with a lasting legacy of Allergan alumnifellows.Objectives⁃⁃⁃⁃Establish and maintain collaborative relationships with MedicalDirectors, Medical Science Liaisons, Key Opinion Leaders (KOLs), HealthEconomics and Outcomes Research, Marketing, and PrincipleInvestigatorsGlobal Scientific Publications: Partner with internal and external globalstakeholders to develop a research-based strategic publication plan tomaximize the reach and impact of AbbVie’s science throughpublications. Manage a cross-functional team and a vendor to executethe scientific communication plan for a therapeutic area. Lead researchprojects that help AbbVie better understand the impact of scientificcommunications.Evidence Solutions: Partner with all AbbVie therapeutic areas andgeographies to strategize on filling evidence gaps and execute new andongoing post marketing clinical research to provide valuableinformation to physicians, patients, and payors on AbbVie productsaround the world. Provide transparency of trial status to keystakeholders, and oversee financial standings for Non-interventional,IIS, Collaboration, and Epidemiology studies.Global Medical Information: Develop scientifically-balanced globalresponse letters to address unsolicited medical inquiries, providescientific support to the global affiliates, and provide insights to theorganization identified from medical inquiries.Brittani Hewitt, Pharm.D.Medical Affairs Fellow,Global Scientific PublicationsAustin Mullins, Pharm.D.Medical Affairs Fellow,Evidence SolutionsApplication Requirements⁃⁃⁃Pharm.D., M.D. or Ph.D. from an accredited university or equivalentAttendance and interviewing at the 2021 ASHP Midyear meeting is highlyrecommendedExcellent oral and written communication skills, ethics, professionalism,leadership, and an interest in the biopharmaceutical industry arerequired for all fellowship positions5Parker Wade, Pharm.D.Medical Affairs Fellow,Global Medical Information

Regulatory AffairsThe one-year Global Regulatory Affairs (GRA)-Strategy Fellowship providesfellows with an overview of Regulatory Affairs (RA) responsibilities, includingapplication of regulations and health authority guidance to help developregulatory strategies. The fellow will have hands-on experience developingthe skills to prepare various global regulatory submission documents forproducts in drug development and life cycle management. The fellow is anactive contributor of the Asset Strategy Team and shares the responsibilityfor facilitating timely submission of these documents to regulatory agenciesworldwide. In addition, the fellow has the unique networking opportunity tomanage several projects inside and outside of GRA as part of acomprehensive training program.Objectives⁃⁃⁃Cynthia Sassenberg, Pharm.D.Global Regulatory Affairs Fellow,Strategy⁃⁃⁃Lead and contribute to projects within GRA including assembly andmanagement of regulatory documents for various FDA and other HealthAuthority (HA) submissions that meet regulatory standardsObtain experience in preparing for FDA or other HA meetings includingdevelopment of meetings requests, briefing packages, and coordinatingFDA rehearsal meetingsCross functional interactions with key development stakeholders such asClinical Development, Project Management, Manufacturing, Research andDevelopment, RA-Chemistry, Manufacturing and Control (CMC), DrugSafety, Toxicology, Clinical Pharmacokinetics, Labeling, Quality Assurance,Publishing, and Marketing to discuss issues specific to drug developmentand enhance the practical application of the information acquiredObtain insight on developing regulatory strategies for drug development,clinical study planning, and project implementation with Asset StrategyTeam and RA leadershipBecome knowledgeable on US regulations, FDA guidance documents andICH guidelines that are relevant to assigned projectsComplete assessments of regulatory landscape to generate regulatoryintelligence relevant to assigned therapeutic areasApplication Requirements⁃⁃⁃Pharm.D., Ph.D., or DRSc from an accredited university or equivalentCompletion of MS in Regulatory Science, pharmacy industry-trackcourses and/or industry internship desirableExcellent oral and written communication skills, ethics,professionalism, leadership, and an interest in the biopharmaceuticalindustry are required for all fellowship positions6

Clinical DevelopmentThis one-year Clinical Development fellowship provides an immersiveintroduction to clinical research in global drug development. As an activemember of multiple clinical teams, the fellow will develop anunderstanding of the principles and challenges in developing noveltherapeutics, while operating within GCP, ICH, and other agencyguidelines. Under mentored guidance, the fellow will gain broad exposureto many interdisciplinary functional areas, while individualized objectiveswill tailor their involvement to projects of particular interest.Objectives⁃⁃⁃⁃⁃⁃Develop expertise in novel therapeutics and their clinical applicationsSupport the execution of the clinical development plan, regulatorysubmissions and development of associated clinical trial documents(e.g., protocols, investigator brochures, procedure manuals,informed consent forms, and clinical study reports)Learn operational aspects of clinical trial design from startup,through execution, and closeoutParticipate in processes of ongoing data review, analysis, and reportPrepare and present clinical data at internal team meetings asneededContribute to the timely performance of clinical trials bycollaborating in a cross-functional team settingMasara Issa, Pharm.D.Clinical Development FellowEye CareApplication Requirements⁃⁃⁃Pharm.D., Ph.D., or M.D. degree from an accredited university orequivalentCompletion of pharmaceutical industry rotation, internship, orprevious exposure to clinical research is desirableExcellent oral and written communication skills, ethics,professionalism, leadership, and an interest in the biopharmaceuticalindustry7Tam Nguyen, Pharm.D.Clinical Development FellowAesthetic Medicine

Clinical PharmacologyThis non-laboratory based one-year Clinical Pharmacology Fellowship focuseson developing skills of a modern clinical pharmacology scientist. The fellowwill be provided opportunities to gain expertise in nonclinical and clinicaldevelopment through honing skills in areas such as nonclinicalpharmacokinetics/toxicokinetics, clinical pharmacology, translationalstrategies, modeling and simulation/pharmacometrics. As part of thetraining, the fellow will be provided with opportunities to engage in variousactivities such as: design and execution of nonclinicalpharmacokinetic/toxicokinetic studies, design and execution of clinicalpharmacology studies, development of translational strategies in support oftarget engagement and biomarker/ dose/regimen selection, preparation ofregulatory documents, and PK/PD and pop-PK modeling. The candidate willalso participate in cross-functional team interactions spanning all of AbbVie’stherapeutic areas. This advanced hands-on training program can be tailoredtowards the specific needs and background of the candidate.Objectives⁃⁃⁃Irene Sunwoo, Pharm.D.Clinical Pharmacology Fellow⁃⁃⁃⁃Collaboratively design and oversee execution of nonclinicalpharmacokinetic/toxicokinetic studies and/or clinical pharmacologystudiesAnalyze, interpret, and present data derived from nonclinical andclinical studiesServe (alongside a senior mentor) as a representative on nonclinicaland clinical project teams to guideclinical pharmacology and translational effortsContribute towards drafting regulatory documentsExecute, interpret, and present results from PK/PD and/or pop-PKanalyses at internal meetingsIf applicable, present work at professional meetings and/or author ascientific publicationApplication Requirements⁃⁃⁃⁃Pharm.D. or Ph.D. from an accredited university or equivalentExperience and coursework in pharmacology, pharmacokinetics,toxicology, or similarExcellent oral and written communication skills, ethics,professionalism, leadershipAn interest in the biopharmaceutical industry8

Research PharmacologyThis one-year Research Pharmacology Fellowship focuses on developingthe pre-clinical translational skills required of a pharmacology scientist. Aspart of the training program, the fellow will participate in pre-clinical studyactivities including study conceptualization through study design, protocoldevelopment, study execution, and cross functional team interactionsacross multiple therapeutic areas within AbbVie. Additionally, interestedfellows can gain expertise in pharmacology sections of regulatorysubmissions, and interact with scientists from other functions such asformulation development, clinical pharmacology and clinical development.The fellowship is intended to enhance the postdoctoral research training ofthe applicant with hands-on application of core biological principles andtechniques to move programs from preclinical stages to clinicaldevelopment for key AbbVie programs.Brianna Hoover, Ph.D.Research Pharmacology Fellow,Eye Care ResearchObjectives⁃⁃⁃⁃Independently design and conduct pharmacology studies to supportprogram projectsResearch, design and validate novel platforms or targetsBe able to execute, interpret, and deliver data analysesIf applicable, present work at internal AbbVie meetings, aprofessional meeting and/or author a scientific publicationApplication Requirements⁃⁃⁃Ph.D. from an accredited university or equivalentExperience and coursework in pharmacology, biochemistry,molecular biology, cell biology, neuroscience, a plusGood oral and written communication skills, teamwork,professionalism, and an interest in biopharmaceutical industry arerequired for all fellowship positions9Myan Do, Ph.D.Research Pharmacology Fellow,Eye Care Research

Drug Delivery SciencesCore AbbVie therapeutic areas, such as Eye Care and Aesthetic Medicine, arehighly reliant on local delivery of drugs to enable the desired therapeuticeffect. AbbVie’s Drug Delivery Sciences Department, part of DevelopmentSciences, has established industry-leading drug delivery capabilities (e.g., bioerodible sustained release, delivery devices) to support a diverse portfolio ofsmall molecules and biologics. The one-year Drug Delivery Sciencesfellowship focuses on the design and development of new drug deliverysystems and related capabilities including new technologies and noveladaptations of existing systems. This fellowship is intended to givepostdoctoral researchers exposure to conducting R&D in the pharmaceuticalindustry, while advancing the fellow’s own scientific and professional growth.The fellow will also have the opportunity to collaborate with colleagues inother departments and disciplines within R&D.Objectives⁃⁃Contribute to the advancement of AbbVie’s science and capabilities inone or more areas of drug delivery.Collaborate with other scientists, both within and outside thedepartment, to design and evaluate drug delivery systems and enablenew products that address unmet medical need.Ammar Al Khafaji, Ph.D.Drug Delivery Sciences FellowApplication Requirements⁃⁃⁃Ph.D. in chemical engineering, biomedical engineering, mechanicalengineering, materials science, polymer chemistry, colloidal chemistry,physical chemistry, pharmaceutical chemistry or a similar field.Subject matter expertise in areas relevant to drug delivery such as,formulation, physical and chemical characterization, drug targeting andassociated biology, or medical devices is also desirable.Excellent oral and written communication skills, ethics,professionalism, and an interest in the biopharmaceutical industry.10

Pharmaceutical SciencesThe one-year Pharmaceutical Sciences Fellowship focuses on the designand evaluation of novel oral, ophthalmic, and dermal formulations. As partof the training program, the fellow will be provided opportunities to gainfirst-hand experience with the different functional areas of thePharmaceutical Sciences organization. This fellowship program is intendedto give postdoctoral research training to support the fellow’s professionaland career growth.Objectives⁃⁃⁃⁃Design and evaluate novel oral, ophthalmic, and dermal formulationsEvaluate the effect of excipients and processing parameters onquality and performanceInvestigate new formulation platform technologiesExpand technical writing skills by developing, reviewing, and writingprotocols and technical reportsAndrella King, Ph.D.Pharmaceutical Sciences FellowApplication Requirements⁃⁃⁃PhD in pharmaceutical chemistry, pharmaceutical sciences,biomedical engineering, chemical engineering, materials science,polymer science and engineering, physical chemistry or a similar fieldIn-depth understanding of basic science principles, physical chemistryand material propertiesExcellent oral and written communication skills, teamwork,professionalism, and an interest in biopharmaceutical industry arerequired for all fellowship positions11

ImmunologyThe one-year Immunology Fellowship mainly focuses on immunogenicity studies againstbiologics and toxins to support drug development programs. As part of the training, thefellow will be provided with opportunities to participate in various activities like designingexperiments, executing experiments and data analysis. It also involves cross functionalteam interactions across multiple therapeutic areas within AbbVie. Additionally, interestedfellows can gain expertise in flowcytometry, Luminex, ex vivo/in vivo assays. The fellowshipis intended to enhance the postdoctoral research training of the applicant and develop theskills required to excel in their field.Objectives⁃⁃⁃⁃Collaborate and conduct a thorough review and build a knowledge base(ARCH/Convergence collaboration) of the immunogenicity data across all internalophthalmology, Toxin and device programsBuild knowledge base (collect, analyze data) for immunogenicity data and potentialrisks from publications on commercial biologics across all ophthalmology, Toxin anddevice areas.Building knowledge base from literatures around in silico and in vitro assays andidentify the most promising ones for immunogenicity prediction specific for differentmodalitiesProposing fit-for-purpose in vitro/ex vivo/in vivo assays to investigate potential riskevaluation and relevant outcome measures for devicesApplication Requirements⁃⁃⁃⁃PhD from an accredited university or equivalentExperience and coursework in immunology and BiochemistryGood oral and written communication skills, ethics, professionalism and an interestin the biopharmaceutical industryNote: off-cycle fellowship, start date may vary12

ToxicologyThe one-year Toxicology Fellowship focuses on developing the skills needed to identify thetoxicology and safety pharmacology studies required to support drug developmentprograms, to independently design toxicology studies and to be able to interpret andintegrate data from toxicology studies into risk assessments in support of product safetyand dose selection for initiating clinical investigations or regulatory submissions. As part ofthe training, the fellow will engage as Toxicology Representative on project teams, prepareregulatory documents, learn about the assessment of testing facilities and participate incross-functional team interactions.Objectives⁃⁃⁃⁃⁃⁃Learn about requirements for nonclinical safety testing of pharmaceutical drugs tosupport conduct of clinical trials and marketing authorizationLearn how to independently design and conduct toxicology studiesAcquire experience as Toxicology Representative on projects teams to guide thenonclinical safety strategyBe able to interpret data from toxicology studiesBecome familiar with global regulatory agency interactions and regulatory documentsubmissionsParticipate in/observe nonclinical safety study activitiesApplication Requirements⁃⁃⁃⁃PhD from an accredited university or equivalentExperience and coursework in biological sciences, biochemistry and/or toxicologyGood oral and written communication skills, ethics, professionalism and an interestin the biopharmaceutical industryNote: off-cycle fellowship, start date may vary13

Fellowship Alumni Alma MaterCurrent FellowsAustin Mullins, Pharm.D.Medical Affairs, Evidence Solutions FellowThe Ohio State UniversityTam Nguyen, Pharm.D.Aesthetic Medicine DevelopmentUniversity of Minnesota, Twin CitiesBrittani Hewitt, Pharm.D.Medical Affairs, Global Scientific PublicationsHampton UniversityIrene Sunwoo, Pharm.D.Clinical PharmacologyUniversity of California, San FranciscoParker Wade, Pharm.D.Medical Affairs, Global Medical InformationEast Tennessee State UniversityBrianna Hoover, Ph.D.Research Pharmacology, Eye Care ResearchUniversity of California, IrvineCynthia Sassenberg, Pharm.D.Global Regulatory Affairs, StrategyMarshall B. Ketchum UniversityMyan Do, Ph.D.Research Pharmacology, Eye Care ResearchUniversity of California, San DiegoMasara Issa, Pharm.D.Eye Care DevelopmentUniversity of California, San DiegoAmmar Al Khafaji, Ph.D.Drug Delivery Sciences, Small Molecule Product DevelopmentUniversity of IowaAndrella King, Ph.D.Pharmaceutical SciencesMCPHS University14

Application ProcessThe USC-AbbVie Pharmaceutical Industry Fellowship program provides exceptional preparation and education forpostdoctoral graduates entering the pharmaceutical industry. Entry into the program is competitive and applicantsare encouraged to review all admission requirements and deadlines prior to beginning the application process.The University of Southern California is an Equal Opportunity/Affirmative Action employer. USC-AbbVie Fellowsare classified as students and are affiliated with AbbVie for the purpose of training and career development.REQUIREMENTSTo be admitted to the USC-AbbVie Pharmaceutical IndustryFellowship program, you must have obtained: A Pharm.D., Ph.D., M.D. or equivalent doctorate degree from anaccredited college or university within five years of the initialappointmentADMISSIONDEADLINECandidates must submit theonline application byTo apply, go to https://provost.sma.usc.edu/prog/fellowship/ (openson Oct 1st, 2021) where you will be asked to provide: The email addresses of three references Curriculum Vitae (CV) Letter of intent Official pharmacy school, medical school, or graduate schooltranscriptCONTACT INFORMATIONDecember 11th,2021William C. Gong, Pharm.D., FASHP, FCSHPDirector, Residency and Fellowship ProgramsUniversity of Southern California, School of Pharmacy1985 Zonal AvenueLos Angeles, California 90089-9121Telephone: (323) 442-2625Email: [email protected] [email protected] official transcripts to:Pharmacy Residency & Fellowship Programs,1985 Zonal Avenue, PSC B-15Los Angeles, CA 90033Additional information available ip/15

scholars for rewarding careers in the pharmaceutical industry. Fellows work with mentors to participate . introduction to clinical research in global drug development. As an active member of multiple clinical teams, the fellow will develop an . part of the training program, the fello