Alnylam PharmD Fellowship Program

Transcription

Alnylam PharmD Fellowship ProgramI N PA R T N E R S H I P W I T HCHALLENGE ACCEPTEDProgram Guide and Application Information 2021-2023

A Message from Alnylam’sLeadershipWatching the Alnylam Fellowship Programexpand since its inception five years agohas been truly remarkable. It has grown toinvolve multiple unique expertise areas, offeringprospective fellows a diversity of experiences.For the biopharmaceutical industry, thefellowship allows us to develop a pipeline of toptalent capable of tackling the complex challengespatients and their caregivers face every day.For Alnylam’s fellows, the opportunities here arelimitless. The role of the fellow does not stop atthe specific expertise area they are working in. Alnylam’s open-culture allows fellowsto wear many different hats and explore interests in multiple expertise areas acrossthe company.Seeing our past fellows continue to serve the organization in various roles reflects theimmense possibilities and gratifying work we do every day. At Alnylam, it is not onlyyour degree or years of experience that dictate which roles and responsibilities you areable to take on. Rather, your skills, dedication, and commitment to patients are whatallow you to thrive in this culture. My own professional trajectory is an example of this;I recently transitioned from a job I loved, serving as the Vice President of MedicalAffairs, to becoming the General Manager of a late-stage pipeline program for apediatric rare disease. As Alnylam evolves to becoming a global research, clinicaldevelopment, and commercial company, I have no doubt that future fellows in theAlnylam Fellowship Program will continue to have unique, immersive, and unboundedexperiences throughout their tenure.Pritesh Gandhi, PharmDGeneral Manager, LumasiranFounder of the Alnylam/Northeastern Fellowship Program

TABLE OF CONTENTSAbout AlnylamCompany Overview 4Science and RNAi Platform 5The Alnylam Fellowship ProgramFellowship Program Overview 6Current Fellowships Recruiting 7-12Regulatory Affairs 7Global Medical Affairs 8Value & Evidence Strategy (VESt/HEOR) 9Global Medical Information 10Clinical Development 11US Marketing 12Past Fellows 13Northeastern UniversityNortheastern Fellowship 14Fellow Network/Life in Boston 15Application InformationApplication Process 16

Alnylam PharmaceuticalsCompany OverviewFounded in 2002, Alnylam Pharmaceuticals establishedTo those who say impossible,an unwavering commitment to harnessing the power ofimpractical, unrealistic,” we say:RNA interference (RNAi) for treating rare conditions forpatients with high unmet medical needs. Alnylam has leadCHALLENGE ACCEPTEDthe translation of RNAi to an innovative class of approvedWe are relentless in our pursuit of newand investigational medicines used to treat a wide range oftreatments. Because patients shouldn’tdiseases using its powerful, clinically validated approach.have to wait for hope.In the summer of 2018, Alnylam established a new class ofmedicines, pioneering the delivery of RNAi therapeuticsto patients through the FDA and EMA approval of ONPATTRO (patisiran). This is the first of multiplelaunches anticipated in the “Alnylam P5x25” guidance for the advancement and commercialization of RNAitherapeutics. The passionate and dedicated employees at Alnylam look forward to delivering its medicinesto patients who need them around the world.COMPANY TRAJECTORY SNAPSHOT 1kEmployees19Countries11ProgramsCurrently in ClinicalDevelopment4ApprovedProducts* 35 8yrsClinical Studiesto DateLongest Durationof ExposureUpdated as of January 2022WE HAVE BEEN NAMED A TOP PLACE TO WORK 7X IN A ROW2015–2021“ RNAi has been heralded as a major scientificbreakthrough that happens once every decade or so.” Phillip Sharp, Ph.D.Noble Laureate & Founder of Alnylam4Return to TOC

Alnylam’s Scienceand RNAi PlatformRNAi was first discovered in the purple petunia flower and later translated into worms by biologists AndrewFire and Craig Mello, marking a major scientific breakthrough while establishing a new frontier in drugdevelopment. Alnylam’s mission is to build a top-tier biopharmaceutical company founded on RNAi. Ratherthan treating symptoms, Alnylam’s approved and pipeline of investigational therapies work upstreamof today’s medicines by silencing the messenger RNA (mRNA) that is transcribed into disease-causing ordisease-contributing proteins. Through RNAi, patients are treated in a fundamentally new way.FROM POSSIBILITIESTO PATIENTSABOUT RNAiNEW CLASS OF MEDICINESALNYLAM CLINICAL DEVELOPMENT PIPELINEFocused in 4 Strategic Therapeutic Areas (STArs):Genetic MedicinesCardio-Metabolic DiseasesHUMANPOC1Infectious DiseasesBREAKTHROUGHDESIGNATIONCNS/Ocular DiseasesEARLY/MID STAGELATE STAGE(IND or CTA Filed-Phase 2)(Phase 2-Phase 3)REGISTRATION/COMMERCIAL2(OLE/Phase 4/IIS/registries)COMMERCIALRIGHTSONPATTRO (patisiran)3hATTR Amyloidosis-PNGlobalGIVLAARI (givosiran)4Acute Hepatic PorphyriaGlobalOXLUMO (lumasiran)5Primary Hyperoxaluria Type 1GlobalLeqvio (inclisiran)HypercholesterolemiaMilestones & up to 20% Royalties76VutrisiranATTR Amyloidosis-PNGlobalPatisiranATTR Amyloidosis Label ExpansionGlobalVutrisiranATTR AmyloidosisGlobalVutrisiran8Stargardt DiseaseFitusiranHemophiliaLumasiranSevere PH1 Recurrent Renal StonesCemdisiran ( /- Pozelimab)9Complement-Mediated Diseases50-50; Milestone/RoyaltyBelcesiran10Alpha-1 Liver DiseaseEx-U.S. option post-Phase 3ALN-HBV02 (VIR-2218)11Hepatitis B Virus Infection50-50 option post-Phase 2Zilebesiran Alzheimer’s Disease;Cerebral Amyloid AngiopathyALN-XDHGoutPOC, proof of concept – defined as having demonstrated target gene knockdown and/or additional evidence of activity in clinical studiesIncludes marketing application submissions Approved in the U.S. and Canada for the polyneuropathy (PN) of hATTR amyloidosis in adults, and in the EU, Japan and other countries for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 PN4Approved in the U.S., Brazil and Canada for the treatment of adults with acute hepatic porphyria (AHP), and in the EU and Japan for the treatment of AHP in adults and adolescents aged 12 years and older5Approved in the U.S., EU and Brazil for the treatment of primary hyperoxaluria type 1 in all age groups6Novartis has obtained global rights to develop, manufacture and commercialize inclisiran750% of inclisiran royalty revenue from Novartis will be payable to Blackstone by Alnylam8Phase 3 study of vutrisiran in Stargardt Disease expected to initiate in late 20229Cemdisiran and pozelimab are each currently in Phase 2 development; Alnylam and Regeneron are evaluating potential combinations of these two investigational therapeutics10Dicerna is leading and funding development of BelcesiranGlobal15-30% RoyaltiesGlobal12311Vir is leading and funding development of ALN-HBV02Return to TOCAs of April 20225

Fellowship ProgramOverviewIn 2015, Alnylam Pharmaceuticals partnered with Northeastern University to offer a unique fellowshipopportunity in the heart of Boston. The program set out to equip postdoctoral PharmDs with the skillsnecessary to develop the advanced medicines of the future, like RNAi. The goal was and remains the same:to cultivate the future leaders of biotechnology and allow fellows to pioneer new therapies for patients.Alnylam fellows are grounded in their core expertise area but utilize the fellowship’s flexibility to branchout and discover other opportunities throughout the organization. Part of the backbone of the fellowshipprogram is the Northeastern University teaching opportunities which allow fellows to share their knowledgein an educational setting.WHAT SETS THE ALNYLAM/NORTHEASTERN FELLOWSHIP APART?1. Ability to work in multiple therapeutic areas across pre-commercial, launch, and post-approval activities2. Vested interest and individualized mentoring from leading professionals in their field3. Opportunities to engage in immersive, personalized experiences inside and out of one’s expertise area4. A bility to conduct academic research aligned with your interests under the mentorship of engagedNortheastern faculty members5. Located in the heart of the world’s biotech hub, Cambridge, MAHeather Sun, PharmDAlnylam Fellowship Program Director & Sr. Director, Medical InformationAmy Monpara, PharmDAlnylam Fellowship Advisor & Medical Science LiaisonMark Douglass, PharmD, RPhNortheastern Faculty Fellowship ManagerMichael Gonyeau, PharmDNortheastern Faculty Fellowship Manager6Return to TOC

Regulatory AffairsACTIVELY RECRUITING: 1 FELLOWROTATIONAL EXPERIENCES International RegulatoryAffairs StrategyAdvertising and PromotionalReviewGlobal Labeling StrategyChemistry, Manufacturing,and ControlsFiling ExcellenceRegulatory Affairs at Alnylam is a group with diverse scientific, technical, andclinical expertise. The team is responsible for creating and implementinginnovative global strategies for expedited drug development and approvalof Alnylam’s products. All stages of drug development are dependent oneffective regulatory support and management, including the generation and filing of investigational new drugapplications, clinical trial applications, and marketing applications, continuing throughout Alnylam’s productlife-cycle. Unique experiences in the rare disease space include orphan drug applications, breakthrough therapy,and PRIME designation requests, and other novel regulatory pathways and approaches.ROLES AND RESPONSIBILITIES Working cross-functionally to support successful global regulatory submissions and filingsSupporting, preparing and submitting international marketing authorization applications (e.g., MAAs, NDAs)Supporting the development and maintenance of regional labeling across programsCoordination and management activities with internal team and external consultantsRegulatory annual report generation, management, and submissionCritical analysis and presentation of regulatory intelligence and industry surveillanceHow is the Alnylam fellowship unique from your perspective?“To work with the teams that achieved approval for the first ever RNAi therapy - and that arecontinuing to bring this technology to patients with unmet needs - affords fellows the opportunityto gain hands-on regulatory experience in areas many do not encounter over the course of acareer. This exciting time at Alnylam has already exposed me to products across all phases ofdevelopment. I am confident the unparalleled experiences provided at Alnylam will serve as anincredible launch pad for a fulfilling career.”Caitlin Albrecht, PharmD, 1st Year Regulatory Affairs FellowWhat did you learn in your first year on the job?“I knew I liked regulatory affairs but didn’t realize how much I would genuinely enjoy the work I do everyday. No day is the same, and there is always something new to stimulate my curiosity. I have been througha product launch, FDA and EMA filing, and new label development within the first year of my career.”Farida Azizova-Such, PharmD, RPh, 2nd Year Regulatory Affairs FellowWhat characteristics do you believe define an Alnylam fellow?“One is ‘insatiable curiosity’. This characteristic emanates throughout Alnylam and has helpedthe company make many scientific breakthroughs for patients. An Alnylam fellow should beinsatiably curious about drug development, innovative science, and how all of this comestogether in our submissions and interactions with Health Agencies. Another is being ‘teamoriented’. One of our core values is Commitment to People, including the diverse set of teammembers we work with daily from across different expertise areas. Drug development is a highlycollaborative endeavor, and an Alnylam fellow will need to engage globally. This will provideskills and experiences to help in any career path they choose.”Andrew Slugg, MS, MBA, Regulatory Affairs Preceptor & Senior Vice President of Regulatory AffairsReturn to TOC7

Global Medical AffairsACTIVELY RECRUITING: 1 FELLOWROTATIONAL EXPERIENCES Medical Communicationsand PublicationsField Medical (e.g. MedicalScience Liaison)Patient AdvocacyValue & Evidence Strategy/HEORMedical OperationsThe core responsibility of Medical Affairs at Alnylam is to advancemedicines for patients with rare diseases. Medical Affairs achievesthis through stakeholder engagement, dissemination of data, andproviding education and support to healthcare professionals toenable diagnosis and improve the care of patients. Fellows canexpect to drive Medical Affairs strategy through engaging cross-functional collaborations to advance RNAitherapeutics. This position is ideal for determined and adaptable individuals seeking unique experiencesand professional growth within Global Medical Affairs.ROLES AND RESPONSIBILITIES Creation of medical congress materials, including abstracts, presentations, and scientific symposiaSupport the development of comprehensive global publicationsExecution of scientific communication strategy from development to commercializationEngage with key opinion leaders to develop various medical communication and publication deliverablesCollaboration with Commercial, Regulatory, and Clinical expertise areasOpportunities to expand to additional experiences tailored to your career goalsWhy did you choose Alnylam?“Alnylam drew me in with a powerful mission, dedicated core values, and really interestingscience, but that was just the beginning for me. The more I learned about this organization, themore I realized how instrumental these components have been in the growth of the companyand intriguing pipeline. It’s an honor to be a part of a company that is working day in and dayout to make sure that revolutionary life-changing medications are brought to patients.”Lauren Dodd, PharmD, 1st Year Medical Affairs FellowWhat excites you about Alnylam’s pipeline?“Not only do I get to learn from and work with a new therapeutic class of medications, but thedepth of Alnylam’s RNAi platform technology also provides me with opportunities to interactwith products in different phases of the regulatory approval process. Understanding the intricaterole Medical Affairs plays in these different instances is essential to growing my foundationalknowledge that will set me up for a successful career.”Katie Alfond, PharmD, RPh, 2nd Year Medical Affairs FellowWhat is most rewarding about the fellowship and your role as a preceptor?“At Alnylam, fellows are not just an extension of our team; they are an integral part of ourteam. Fellows will have the unique opportunity to explore different career paths in depthto determine what they want to pursue following this two-year fellowship. While no twofellowship experiences are alike, I am here to guide the fellow in navigating opportunities toensure they are on a path to success.”Ilia Antonino, PharmD, MBA, Medical Affairs Preceptor & Director, Medical Communications and Publications8Return to TOC

Value and EvidenceStrategy (VESt)Health Economics & Outcomes Research (HEOR)ROTATIONAL EXPERIENCES Market AccessCommercialField Medical/PayerField MedicalPatient AdvocacyACTIVELY RECRUITING: 1 FELLOWThe purpose of the Value and Evidence Strategy team at Alnylam is to lead evidence generation and valuedemonstration activities through cross-functional collaboration with Clinical Development, Market Access,Market Insights, Field Medical, and other expertise areas. VESt’s goal is to ensure excellence in evidencegeneration to allow Alnylam’s innovative medicines to reach patients and healthcare systems. The fellowwill develop a thorough understanding of and hands on experience in health economics and outcomesresearch methodologies through various research initiatives and recommended Master of Sciencecoursework. The experience gained throughout this fellowship will allow the VESt Fellow to scientificallyevaluate a therapeutic’s clinical, humanistic, and economic impact.ROLES AND RESPONSIBILITIES Conducting evidence gap analysis and data generation strategy to communicate the value of Alnylam’s productsContributing to prospective and retrospective observational studies, cost-effectiveness analyses, comparativeeffectiveness research, chart review studies, claims analyses, patient-reported outcomes research, and other studieswith potential for publicationConducting burden of illness studies, epidemiologic research, and pharmacoeconomic analyses, as well asdeveloping evidence dossiers for use by key healthcare decision makersCollaboration with peers/KOLs to obtain clinical input into evidence generation activitiesLeading a Medical Affairs product sub-team and participating in cross-functional working groupsHow does the work of the fellow impact department-wide and company-wide goals?“Fellows are key members responsible for projects that drive the company forward. From workingon product launches and leading studies to presentations for key internal stakeholders, fellowsget a breadth and depth of experience that not only supports their department and companygoals, but also provides them with the experience to excel after their fellowship. Alnylam isgrowing exponentially; it’s a very exciting time to be a part of the company’s life.”Siddharth Jain, PharmD, 1st Year Value and Evidence Strategy FellowWhat makes Alnylam stand out to you?“Alnylam stands out for its deep pipeline, innovation, positive work culture, and location inKendall Square (dubbed ‘the most innovative square mile on the planet’). Working to bringRNAi therapeutics, a new class of medicines, to patients with high unmet needs is both fastpaced and incredibly rewarding.”John Ko, PharmD, MS, Director, Value & Evidence Strategy and Interim Global Medical DirectorWhat are the learning opportunities in the VESt fellowship?“VESt Fellows will take away far more than technical HEOR skills from this fellowship. Above all,my objective is to mentor the fellow to think critically to solve problems to meet patient needs.This skill will be crucial to one’s success in any future role.”Sonalee Agarwal, BPharm, PhD, Vice President, Value and Evidence StrategyReturn to TOC9

Global MedicalInformationACTIVELY RECRUITING: 1 FELLOWROTATIONAL EXPERIENCES Medical Communicationsand PublicationsField Medical (e.g. MedicalScience Liaisons)Medical OperationsCommercialPharmacovigilance and SafetyRegulatory AffairsThe Global Medical Information team serves to provide healthcareprofessionals, patients, and caregivers with balanced, accurate, and current medical information aboutAlnylam’s products. Medical Information engages cross functionally with other expertise areas such asPharmacovigilance/Safety, Quality, Legal, Regulatory Affairs, Commercial, Clinical Operations, ClinicalDevelopment, and Information Technology, to ensure the safe, effective, and appropriate use of our therapies.Fellows in this program will partake in the development and launch of Medical Information services across theglobe supporting multiple products. Furthermore, fellows sharpen their ability to read, interpret, and developmedical content accurately and fairly. While helping build the global medical information infrastructure tosupport Alnylam’s robust pipeline, the fellow will learn key project management skills as well.ROLES AND RESPONSIBILITIES Global management of requests for medical informationMedical Information content development, including standard response letters, custom response letters, and FAQsAdverse event and product quality complaint reportingData analytics and insights collection and reportingGlobal product launch preparation and execution pertaining to medical information activitiesSupport of medical congress and information boothWhat is something that has surprised you about working at Alnylam?“The authenticity and open culture of everyone I have interacted with has continuously blownme away. Team members consistently push me to ask questions, which helps solidify knowledgeand growth as a fellow.”Basia Zawadzki, PharmD, 1st Year Global Medical Information FellowWhat inspires you about Alnylam?“Every single person at Alnylam works relentlessly to educate the community about the rarediseases we aim to treat and advocate for patients who otherwise have few or no treatment options.Their tremendous effort does not go unnoticed, and it inspires me every day.”May Le, PharmD, 2nd Year Global Medical Information FellowWhy should a fellowship candidate consider the medical information fellowship at Alnylam?“The Alnylam Medical Information Fellowship is an unique experience in Medical Information andMedical Affairs. The Global Medical Information Fellow will have the opportunity to develop crucialskills and proficiencies for global medical information while learning in the dynamic and growingenvironment at Alnylam; a great combination for future success in the biotech and pharmaceuticalindustries.”Rob Deering, PharmD, PhD, Global Medical Information Fellowship Preceptor & Sr. Manager, Medical Information10Return to TOC

Clinical DevelopmentACTIVELY RECRUITING: 1 FELLOWROTATIONAL EXPERIENCES Regulatory AffairsPatient Recruitment & RetentionClinical Oversight and SystemsData Science & StatisticsPharmacovigilance/Patient SafetyPharmacokinetics/PharmacodynamicsClinical Development is the cornerstone of data generation in deliveringnovel medicines to patients. The Clinical Development fellowship at Alnylamwill engage the fellow in work that is a fusion of scientific knowledge andoperations of trial management to support clinical trial excellence. The fellow will start the fellowship inClinical Operations, rotate through Clinical Research, and then have the option to select other expertise areasdepending on the interests of the fellow. The intent of this program is to train fellows in comprehensive ClinicalDevelopment activities to build a foundation for roles as a clinical drug developer.ROLES AND RESPONSIBILITIES Operational, technical, and scientific aspects of generating clinical development plans and clinical trial executionfrom startup through closeout, including management of contract research organizations (CROs) and vendorsDevelopment of key study documents, including protocol concepts and protocols (Phase I-III, natural history),data capture tools such as case report forms, procedure manuals, study operation plans, informed consent forms,clinical study reports, and IND/NDA submission documentsEngagement in ongoing medical data review, analysis, and reporting of clinical information in materials for sites,investigators, and other stakeholdersPlanning and execution of investigator meetings and congresses to provide key messages about clinical trial dataand study executionParticipate in the development of effective working relationships with key investigators to optimize scientificquality/innovation of clinical study design, execution, reporting, and publicationProcess evaluation to ensure that all studies are conducted with the highest level of ethical and safety standardsand in compliance with ICH/GCP guidelines and all applicable regulatory policiesWhat does Sense of Urgency mean to you and how do you live it at work?“Sense of Urgency motivates the Alnylam Clinical Development team to improve the lives of patients withdebilitating conditions. At Alnylam, we live a Sense of Urgency daily because our work contributes to thetreatment of patients with unmet medical needs. I am motivated to work towards innovative solutionsto challenges in clinical trials and contribute to the delivery of highly effective therapies for patients thatwould otherwise have limited treatment options.”Thomas Solomon, PharmD, RPh, 1st Year Clinical Development FellowHow does the work of the fellow impact department-wide and company-wide goals?“Clinical Development Fellows at Alnylam hold positions of key responsibility. I am responsible forensuring all aspects of the trial are executed including patient dosing, safety reporting, primary endpointcollection, and compliance with good clinical practice. Exceeding goals means potentially getting newdrugs to market and expanding our treatment indications, which holds us accountable to the mostimportant stakeholder: the patient.”Joshua A. Emerson, PharmD, RPh, 2nd Year Clinical Development FellowWhy is now the right time for a fellow to join Alnylam as the Clinical Development fellow?“It is an incredible time in Alnylam Clinical Development. Your fellowship will allow experiences contributingto the first studies in uncharacterized diseases to global pivotal efficacy trials for registration. The ClinicalDevelopment Fellowship will uniquely provide a Fellow multi-faceted vision and vertical access on whatit truly takes to bring a novel therapy from first-in-man through to regulatory approval at this innovativebiopharmaceutical company. Are you ready to roll up your sleeves and dive in with us at Alnylam?”Raina Gay Leahy, PhD, Clinical Development Fellowship Preceptor and Associate Director, Clinical OperationsReturn to TOC11

US MarketingACTIVELY RECRUITING: 1 FELLOWROTATIONAL EXPERIENCES Commercial OperationsMarket InsightsMarket AccessNew Product PlanningLaunch ExcellenceThe US Marketing team is responsible for defining and executingthe US marketing strategy of Alnylam’s RNAi therapeutics.Marketing achieves this through cross-functional collaborationwith Medical Affairs, Regulatory Affairs, Clinical Development, andothers. The US Marketing Fellow will engage in the execution of strategic brand plans and key marketinginitiatives, launch of new RNAi therapeutics, and the generation of commercial insights. This fellowshipis for individuals who are entrepreneurial, biased for action, and enjoy working in a dynamic businessenvironment. The fellow will gain key experiences and skills in communication, commercial execution,marketing and strategic planning.ROLES AND RESPONSIBILITIES Execution of personal promotion and targeted non-personal promotion tacticsCreation of product value messaging and disease awareness materials to support field personnelDevelopment of brand plan and brand positioningCross-functional collaboration with Patient Services, Commercial Analytics, and US field teams to supportlaunch activitiesCommercial activities at key conferences, including booth development, product theaters, and sponsorshipsAssessment of commercial opportunity and strategic fit of early pipeline assets including market sizing,competitive landscape scanning, target product concept development, and revenue forecastsHow have you been able to apply your PharmD training to a marketing role withinthe industry?“In order to become a strong marketer, it’s crucial for me to understand the scientific backgroundrelating to the product and the target disease state. A PharmD graduate is prepared to take thatscientific knowledge and translate it into key messages intended to raise disease state awarenessand promote product education. It is up to us as marketers to communicate the value of our productso that patients get the proper treatment they need.”Andrew Karaki, PharmD, 1st Year US Marketing FellowWhat initiatives have you been able to lead as a fellow?“Christina and the US Marketing team care deeply about the fellows’ growth and development. Overthe past year, I was able to pilot and lead social media efforts for ONPATTRO (patisiran), be thecommercial lead for several US conferences, and be project owner of a variety of materials for bothpatients and healthcare providers. I am excited for what’s to come in my 2nd year!”David Iong, PharmD, 2nd Year US Marketing FellowPrior to coming to Alnylam, you completed a fellowship program yourself. How does thisperspective play into your role as the US Marketing preceptor?“I’m very grateful for my fellowship experience, and I try to emulate my previous preceptors whenmentoring the US Marketing Fellows. I remember what it’s like to move to a new city and join a newcompany right after graduation, and I want every US Marketing Fellow to feel welcomed and integralto the team right from day 1. That means that our US Marketing Fellows are asked to own projectsand contribute to our strategy from the very beginning. After all, the best way to learn is by doing!”Christina Zhao, PharmD, US Marketing Fellowship Preceptor & Associate Director, US Marketing, TTR12Return to TOC

Past FellowsThe Alnylam Fellowship Program is proud to be able to watch our fellowship alumni continue theirprofessional development in key roles within the industry. The experiences and skills they gained duringtheir fellowship tenure have become a launching pad for continued success and learning.Alex Wei, PharmD2015-2017 Medical Affairs FellowCurrent Role: Medical Director at SpoonfulOneDayna LeSueur, PharmD2016-2018 Regulatory Affairs FellowCurrent Role: Clinical Research ScientistAnastasia McManus, PharmD2016-2018 Medical Affairs FellowCurrent Role: Senior Manager, Medical CommunicationsRuthvik Malladi, PharmD2017-2019 Medical Affairs FellowCurrent Role: Senior Manager, Medical DiagnosisMadeline Merkel, PharmD2017-2019 Value & Evidence Strategy FellowCurrent Role: Senior Manager, Value and Evidence StrategySarah Scott, PharmD2017-2019 Regulatory Affairs FellowCurrent Role: Manager, Regulatory AffairsCaitlin Skenyon, PharmD, RPh2018-2020 Regulatory Affairs FellowCurrent Role: Senior Regulatory Specialist,

Andrew Slugg, MS, MBA, Regulatory Affairs Preceptor & Senior Vice President of Regulatory Affairs ROLES AND RESPONSIBILITIES Working cross-functionally to support successful global regulatory submissions and filings Supporting, preparing and submitting international marketing authorization applications (e.g., MAAs, NDAs)