2023 Intercept Medical Affairs Fellowship Program

Transcription

2023 InterceptMedical AffairsFellowshipProgramA Unique Opportunity to HelpPatients with ProgressiveNon-viral Liver Disease

Table of ContentsWhy Intercept? A Message from our Chief Medical Officer Our Company Mission Company Overview Our Values BioPharma in MorristownAbout the InterceptMedical Affairs Fellowship Introduction to the Intercept Fellowship Fellowship Overview Fellowship Year 1: Key Responsibilities Fellowship Year 2: Key Responsibilities Deliverables & Opportunities Fellowship LogisticsRutgers Pharmaceutical IndustryFellowship ProgramReal patients,living with PBC/NASH2023 Intercept Pharmaceuticals Fellowship Program

Why Intercept?2023 Intercept Pharmaceuticals Fellowship Program

A Message from Our Chief Medical Officer & ExecutiveSponsor“If you are passionate about helping others, are focused onnovel science, are eager to learn in a dynamic and diversebusiness environment and are ready to contribute to thefield of hepatology, we want to meet you!As a mid-sized, US-based commercial biopharmacompany with active global development programs,Intercept offers PharmD fellows an opportunity to make animmediate impact supporting patients who have few or notherapeutic options.”M. Michelle Berrey, MD, MPH (she/her)President of Research & Development;Chief Medical Officer2023 Intercept Pharmaceuticals Fellowship Program

Ourmissionis to build a healthiertomorrow for peoplewith progressive nonviral liver diseasesDebbie,Living with PrimaryBiliary Cholangitis (PBC)2023 Intercept Pharmaceuticals Fellowship Program

Company Overview The Intercept StoryThe company started as a vision in our founder’s small New York City apartment, and we’ve grown into abiotech firm that is approximately 300 people strong, with one approved product and investigational therapiescurrently in development.2023 Intercept Pharmaceuticals Fellowship Program6

Company Overview Key AttributesINNOVATIVE PIPELINELEADERS IN RESEARCH & DEVELOPMENTOur scientific platform is based on validatedand novel scientific targets with thepotential for therapeutic application acrossmultiple liver diseases1st therapy approved for PBC in 20 years1st investigational NASH treatment to receiveBreakthrough Therapy Designation status fromFDA and positive results from a Phase 3 study inNASHOUR FOCUSDEDICATED TO PEOPLEDedicated to building a healthiertomorrow for people with progressive nonviral liver diseases, such as PBC and NASHWe keep people at the center of all we doand deliver hope to people with progressivenon-viral liver diseasesCOMMITTED PARTNER TO THELIVER DISEASE COMMUNITYPIONEERS FOR THERAPIES INPROGRESSIVE NON-VIRAL LIVERDISEASE WITH HIGH UNMET NEEDProud supporter of multi-stakeholder initiativesthat further education and research for theliver disease communityForged new regulatory pathways by pioneeringthe design of Phase 3 studies in PBC andNASH2023 Intercept Pharmaceuticals Fellowship Program7

Our Core ValuesThe Intercept Team is Driven by a Commitment to Patients1ComeTogetherWe are one team,and we will deliver on ourcommitment to patientsthrough true collaborationand partnership,both internally andexternally.2BeYourselfGreat teams are madeof individuals withdifferent perspectives.We welcome, respectand value all our teammembers for who theyare and what theycontribute to ourmission.3Own theSolutionWhen we encounter aproblem, we don't wait forothers to fix it. Smart,practical solutions arerequired for complexchallenges. The solutionbegins with you.4Embrace theChallengeWe meet challengeshead on. We stay agileand resilient, even whenthe path forward iscomplex.2023 Intercept Pharmaceuticals Fellowship Program5KeepExploringOur team is driven bypurposeful curiosity and awillingness to do thingsthat haven’t been donebefore. We will never stopexploring.8

We Are Committed to Diversity, Equity, and Inclusion (DEI)In addition to ongoing partnerships with Healthcare Businesswomen’sAssociation and Out & Equal, Intercept has an active voice in fostering aninclusive environment through our Employee Resource Groups:At Intercept, we recognize the power of adiverse, equitable and inclusive work force,and how it enriches the professional lives ofour team members. Diversity drivesinnovation and connects us to the patientsand communities we serve.As we grow, we want to make every effort toprovide a safe and open environment forprofessionals of every background andprovide knowledge on how to workinclusively and equitably to make Intercept agreat place to work.2023 Intercept Pharmaceuticals Fellowship Program9

Join Our Team in Morristown, New JerseyOur headquarters in Morristown, New Jersey add to the state’s century-long legacy ofadvancement in life sciences – joining over 3,200 companies, world-class research universities,medical schools, and some of the best hospitals in the country2023 Intercept Pharmaceuticals Fellowship Program10

About the Intercept Medical Affairs Fellowship2023 Intercept Pharmaceuticals Fellowship Program

Intercept Fellowship Leadership TeamIntroduction to Intercept Fellowship ProgramExecutiveSponsorM. Michelle Berrey, MD, MPHProgramDirectorLisa Miller, PharmD, MBAPresident of Research & Development;Chief Medical Officer(she/her)Vice President,Medical Affairs(she/her)Amarita Randhawa, PharmDSr. Medical Director, Medical Affairs(she/her)PreceptorsMustafa Kamal, PharmDPost-doctoral Fellow, Medical Affairs(he/his)Colleen Tholen, PharmDDirector, Medical Information(she/her)CoordinatorAnna AltheideAssociate, Medical Affairs(she/they)2023 Intercept Pharmaceuticals Fellowship ProgramInauguralFellow2022-202412

Introduction to Intercept Fellowship ProgramWelcome from Our Fellowship Director“On behalf of Intercept, we are thrilled to partner with Rutgers University andoffer a unique and customizable Medical Affairs Fellowship Program forindividuals wishing to prepare for a career in pharmaceutical industry.With a complete immersion into Medical Affairs, our program provides aflexible two-year experience across scientific communications, medicalscience liaison training and medical research aspects, allowing for a wellrounded first-hand experience. Completion of this program will position thefellow for continued professional success.I invite you to explore our brochure and think you’ll agree that there are greatopportunities here at Intercept. As an added benefit, our new headquarters inMorristown, NJ offers a vibrant and exciting place to work and a wide varietyof year-round access to everything the tristate area has to offer.Thank you for your interest in Intercept. I wish you great success throughoutthe interview process, and I look forward to meeting our future fellowshipcandidates.”Lisa Miller, PharmD, MBA (she/her)Vice President, Medical Affairs;Fellowship Director, Intercept/RPIF Program2023 Intercept Pharmaceuticals Fellowship Program

Introduction to Intercept Fellowship ProgramPerspective from Our Current Fellow“In addition to this program’s unique rotational structure which provides fellowswith a chance to support various areas of the Medical Affairs department,Intercept further attains distinction through its personnel and mission.In my time with the company thus far, I have had the opportunity to speakdirectly with numerous members of the Medical Affairs department fromMedical Directors to Medical Science Liaisons. Every team member has beenfriendly in welcoming me to Intercept, accessible in guiding me through theirroles, and supportive of my capacity as a fellow. As a mid-sized firm, Interceptprovides me unique face time with the Executive Leadership Team and thechance to explore professional responsibilities with more freedom.Coming from a clinical background, it was comforting for me to find the samepatient-centered values in the core mission of Intercept. And the value of'embracing the challenge' demonstrates commitment to pushing boundaries toserve patients suffering from chronic liver diseases such as PBC and NASH.”Mustafa Kamal, PharmD (he/him)Post-doctoral Fellow, Medical AffairsUniversity of Florida College of Pharmacy2023 Intercept Pharmaceuticals Fellowship Program

Intercept Fellowship OverviewFellowship Program HighlightsIntercept is dedicated to shaping thenext generation of pharmacists in theindustry through a partnership with theRPIF program.During the 2-year program inIntercept’s Medical Affairs department,fellows will have the opportunity toexperience a unique yet broad andcomprehensive range ofresponsibilities across Medical Affairsthat will serve as the foundation offuture career growth.Unique, in-depth, 2-year, rotation-based Medical AffairsFellowshipMid-sized biotechnology company with rare disease andnew therapeutic area launch experienceComprehensive learning and broad visibilityacross the organizationDedication to a positive fellowship experience in agrowing companyExperienced fellowship faculty comprised of formerfellows and program leaders in Medical Affairs2023 Intercept Pharmaceuticals Fellowship Program15

Intercept Fellowship OverviewThis fellowship allows for a firm understanding of theresponsibilities of Medical Affairs (Strategy), Field Medical(Medical Science Liaison), and Scientific Communications, withadditional research opportunity with the Medical AffairsResearch team.The fellow will appreciate the diverse and dynamic culture of asmall-to-midsize biotech firm dedicated to building a healthiertomorrow for people with progressive non-viral liver disease.This fellowship program will cultivate knowledge and skills withinMedical Affairs, such as: drug development and lifecycle management, medical strategy and planning, building internal and external partnerships, supporting commercialization of products, demonstrating value of products to various stakeholders, etc.2023 Intercept Pharmaceuticals Fellowship Program16

Intercept Fellowship OverviewThe fellow will rotate throughout the Medical Affairs organization, mentored by leaders who havewide variety of industry experience ranging from small to big pharma as well as prior involvementin fellowship programs.YEAR 1PrimaryRotationLongitudinalExperienceMedical Affairs(Strategy)ScientificCommunications*Field Medical(Medical Science Liaison)YEAR 2Concentration inAreas of InterestMedical AffairsResearch*includes Medical Information, Scientific Resources & Training, and Publications & PlanningWhile the fellowship is structured, there is enough flexibility to allow for the fellow to explore areasof interest as they develop their foundational knowledge and attain real-world, hands-onexperience in Medical Affairs.2023 Intercept Pharmaceuticals Fellowship Program17

Year 1: Key ResponsibilitiesMedical Affairs (Strategy)Scientific CommunicationsLongitudinal Experience:Field Medical (Medical Science Liaison)Medical Affairs Responsibilities Assist with development and execution ofMedical Affairs plans that are aligned withmedical/brand strategies and in support oflaunch in NASH and lifecycle management ofIntercept’s marketed product Understand and interpret emerging scientifictrends, clinical data, customer needs, andevolving competitive landscape Serve as a trusted and reliable partner andknowledge expert for internal and externalstakeholders Collaborate with cross-functional teamsincluding: Commercial Strategy, Marketing,Market Access, Regulatory Affairs, Legal, andClinical Research and DevelopmentScientific CommunicationsResponsibilities Assist with development and execution ofmedical communication/education plans thatencompass comprehensive inclusion ofscientific data to best prepare Field Medical Develop and execute scientific resources insupport of external engagement with thoughtleaders and the scientific community aboutdisease state(s) and product(s) Communicate balanced, scientific, andevidence-based responses to unsolicitedmedical questions from our customers Assist with development and execution of thepublication strategic plan to support thecommunication and dissemination of scientificdata on Intercept products and pipeline2023 Intercept Pharmaceuticals Fellowship ProgramField Medical Responsibilities Build credible relationships and articulaterelevant scientific/clinical information tohealthcare professionals and researchers insupport of disease education and the safe,effective, and appropriate use of product(s) Utilize scientific resources to deliver impactfulpresentations in appropriate healthcaresettings, including Managed Care decisionmakers Gather and share insights from externalstakeholders to help inform current practicetrends, changing medical needs, and scientificgaps Support company-sponsored researchinitiatives across all phases of developmentand provide support to clinical siteinvestigators as needed18

Year 2: Key Responsibilities Deliverables & OpportunitiesFellowship Deliverables & OpportunitiesConcentration in Area of InterestBy the end of year 2, the fellow will have explored areas of interest as they developtheir foundational knowledge and attain real-world, hands-on experience in MedicalAffairs, such as: Strategy Planning and ExecutionLongitudinal Experience:Medical Research Advisory Board Planning and Execution Promotional and Medical Review Field Experience, including Thought Leader and Payer Engagement Congress SupportMedical Affairs Research Responsibilities Publication Planning and Execution Gain hands-on experience by assisting with the designand execution of a longitudinal Medical Affairs Researchproject and understand how such research supports thevalue of a product to key internal and externalstakeholders Handling of Unsolicited Medical Information Requests Scientific Resource Development and Training Support Data Generation and Communication Assist with research project(s) that generate real-worldevidence that aligns with the medical strategyThe fellow will have the opportunity to: Co-author an abstract, poster, and/or manuscript andprepare presentation to communicate the results of thelongitudinal research project Attend national meetings/plan of action (POA) meetings (within and outside ofMedical Affairs), as appropriate Attend at least one major scientific congress Attend and present at leadership team meetings (within and outside of MedicalAffairs), as appropriate Participate in Medical Affairs skill-building workshops and training sessions2023 Intercept Pharmaceuticals Fellowship Program19

Fellowship LogisticsHeadquarters: Morristown, New Jersey The fellow should be able to commute to the headquartersoffice in Morristown, NJ. However, location may vary for Field Medical experience.Recruitment: Yearly In the 2022-2023 fellowship year, there is a single fellow; insubsequent years, there will be two fellows (1st Year and2nd Year fellows). The fellow(s) will play an active role in recruiting andmentoring the incoming fellow.2023 Intercept Pharmaceuticals Fellowship Program20

st Mario School of PharmacyRutgers, The State University ofNew Jersey2022 InterceptIntercept PharmaceuticalsPharmaceuticals FellowshipFellowship ProgramProgram2023

Rutgers Pharmaceutical Industry Fellowship ProgramProgram HistoryIn 1984, at Rutgers, The State University of New Jersey, the ErnestMario School of Pharmacy and two pharmaceutical companiesbegan a first-of-its-kind collaborative pilot program to evaluate thepotential contributions of clinically-trained pharmacists within apharmaceutical industry practice setting. Following the successfulpilot, the Rutgers Pharmaceutical Industry Fellowship (RPIF) Programgrew significantly and expanded to include 19 companies within thepharmaceutical and biopharmaceutical industry and well over 300Fellows.In 2002, Dr. Ernest Mario generously provided an endowment toestablish the Institute for Pharmaceutical Industry Fellowships toenhance and promote the role of pharmacists in industry through theRPIF Program.The Institute staff members: provide leadership and administrative support; promote quality, communication, scholarly activity, andprofessional development; and arrange specialized Fellowship training opportunities within thepharmaceutical and biopharmaceutical industry.The RPIF Programhas thrived under theleadership of thefounder, Dr. JosephA. Barone, Dean andProfessor II of theErnest Mario Schoolof Pharmacy, Dr.Carolyn Seyss, theDirector for theInstitute forPharmaceuticalIndustryFellowships, and Dr.Michael Toscani asthe DirectorEmeritus.In 2018, our Program expanded to offer interdisciplinary Fellows’training by adding select physician Fellowship opportunities to ourwell-established program.2023 Intercept Pharmaceuticals Fellowship ProgramJoseph A. Barone, Pharm.D., F.C.C.P.Dean and Professor IIErnest Mario School of PharmacyRutgers UniversityCarolyn Seyss, Pharm.D.Fellowship DirectorInstitute for Pharmaceutical Industry FellowshipsErnest Mario School of PharmacyRPIF AlumnaMichael Toscani, Pharm.D.Research ProfessorFellowship Director EmeritusInstitute for Pharmaceutical Industry FellowshipsErnest Mario School of Pharmacy22

Rutgers Pharmaceutical Industry Fellowship ProgramProfessional Development SeriesAll Fellows gather once monthly as a group to participate in the Professional Development Day(PDD) series, an important component of their training that complements the hands-onexperience provided at the partner companies. The PDDs are steered by a committee of Fellowsand are designed to enhance the Fellows’ leadership skills such as emotional intelligence,communication, critical decision making, and presentation skills. Fellows develop skill sets underthe guidance of external trainers and accomplished RPIF alumni. PDDs also provide generalknowledge about various aspects of drug development/commercialization and issues facing thepharmaceutical and biopharmaceutical industry, and promote connectivity and a sense ofcommunity among Fellows and alumni from different companies and disciplines.The Fellows can learn from each other through individual and group presentations and debateson topics and issues related to the pharmaceutical and biopharmaceutical industry. The dynamicforum of PDD provides an opportunity for open discussion and debate among Fellows, Rutgersfaculty, and company Preceptors. In addition, outside experts provide training and professionaldevelopment in a variety of areas (e.g., tools for corporate success; professional writing,presentations, meeting facilitation, negotiating, influencing, networking, conflict resolution; givingand receiving feedback; personal branding, and business and dining etiquette).Other PDD guest speakers include senior industry executives, including our successful RPIFProgram alumni, who share their career paths, insights, and experiences. Importantly, PDDsprovide an excellent opportunity for Fellows to interact with each other and develop lastingpersonal friendships and a strong professional network of Fellows, faculty, alumni, and otherindustry executives.2023 Intercept Pharmaceuticals Fellowship ProgramMore than 1,400 Post-Doctoral Fellowshave completed the RPIF Program, mostof whom are experiencing influential andrewarding careers in the pharmaceuticaland biopharmaceutical industrythroughout the US and abroad. The RPIFProgram has Preceptors and Mentorsfrom industry who share their knowledgeand experiences with the Fellowsthrough an intense but closely-guidedtraining program.Assignments and projects arechallenging, meaningful, and designed toenhance understanding of thepharmaceutical and biopharmaceuticalindustry and the Fellow’s functionalarea(s). Our goal is to provide theenvironment for Fellows to build thefoundations to fuel their careers as futureleaders in the industry.23

Rutgers Pharmaceutical Industry Fellowship ProgramKey Program FeaturesThe Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growthand development of future pharmaceutical and biopharmaceutical industryprofessionals and leaders through the following key program features:FOSTamily of Leading Companies – Partners include several of the top globalpharmaceutical and biopharmaceutical companies and offer large to small companyenvironments.Enhanced Career Development – Breadth of experiences informs career pathchoices, increasingly challenging assignments build depth of experience, andvisibility creates opportunities - enhancing the potential for accelerated careerpaths.Rigorous Academic Component – Rutgers affiliation provides academic andprofessional development opportunities.utstanding Alumni Track Record – Over 1,400 alumni hold prominent positions atmany leading companies, including VP and C-suite levels.trong Network – Fellows develop valuable, lasting connections with each other,alumni, Preceptors, and Rutgers EMSOP faculty.rusted and Proven Since 1984 – The Rutgers Fellowship Program is nationallyrecognized, trusted, and proven as the key pathway to industry for pharmacists asfuture leaders.Rutgers, The State University of New Jersey, with over 69,000students in its three campuses, is one of the major state universitysystems in the United States. The New Jersey College ofPharmacy was founded in 1892 and was incorporated into theUniversity in 1927.The Ernest Mario School of Pharmacy (EMSOP) is part of RutgersBiomedical and Health Sciences (RBHS), the only state school ofpharmacy in New Jersey, with approximately 1,287 students in itsDoctor of Pharmacy degree program. The Rutgers Ernest MarioSchool of Pharmacy is located on the University’s main science andtechnology campus in Piscataway, New Jersey.Because of its relationship with and close proximity to most of thenation's leading pharmaceutical and biopharmaceutical companies,the Ernest Mario School of Pharmacy and the RPIF Program areuniquely capable of providing Fellows with advanced training in thepharmaceutical and biopharmaceutical industry.2023 Intercept Pharmaceuticals Fellowship Program24

Rutgers Pharmaceutical Industry Fellowship ProgramApplication Process and Eligibility Requirements:Pharmacy Fellows for the Rutgers Pharmaceutical Industry Fellowship Program areselected on a nationally competitive basis. Candidates must have completed a Doctorof Pharmacy degree from an ACPE-accredited institution before July 1 of thefellowship term.All application materials must be submitted electronically tothe RPIF Website per instructions on the site.REQUIRED ITEMSSUBMIT BY*Letter of Intent (LOI)October 5thCurriculum Vitae (CV)October 5thLetters of Recommendation (LORs)November 10thHow to Apply:Interviewing is conducted on a rolling basis. Interested candidates may submittheir application and supporting materials (letter of intent, curriculum vitae, and threeletters of recommendation) starting September 2022 by visiting our website at:pharmafellows.rutgers.edu.Recognizing that the choice of a Post-Doctoral Industry Fellowship is an importantdecision, Rutgers Institute for Pharmaceutical Industry Fellowships, in conjunctionwith the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offersfor Fellowships no earlier than December 7, 2022.*Candidates are considered on a rolling basis. Submission ofmaterials prior to dates noted is strongly encouraged.The AIFA is comprised of Keck Graduate Institute (KGI), Massachusetts Collegeof Pharmacy and Health Sciences (MCPHS), Northeastern UniversityPharmaceutical Industry Fellowships, Purdue University College of Pharmacy,Rutgers Institute for Pharmaceutical Industry Fellowships (RPIF), Saint Joseph’sUniversity, University of North Carolina Division of Pharmacotherapy andExperimental Therapeutics (UNC, DPET), and University of Southern CaliforniaSchool of Pharmacy (USC School of Pharmacy).We see this respect for candidate choice as a common aspect of each of ourProgram’s cultures. We hope that other academic and non-academic FellowshipPrograms will respect this timeline.2023 Intercept Pharmaceuticals Fellowship ProgramYour Letter of Intent & Letters of Recommendationshould be addressed to:Joseph A. Barone, Pharm.D., F.C.C.P.Dean and Professor IIErnest Mario School of PharmacyRutgers, The State University of New Jersey160 Frelinghuysen RoadPiscataway, NJ 08854-802025

www.interceptpharma.com2023 Intercept Pharmaceuticals Fellowship Program

RPIF program. During the 2-year program in Intercept's Medical Affairs department, fellows will have the opportunity to . experience a unique yet broad and comprehensive range of responsibilities. across Medical Affairs that will . serve as the foundation of future career growth. 15. Intercept Fellowship Overview. Fellowship Program Highlights