Praneeta Nagraj

Promoted within function/department from prior role after 6 months to serve as Medical Monitor and Clinical Scientist on two high-impact Phase 3 programs in Rare Liver Portfolio for odevixibat in Progressive Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS), which includes a newly enrolling ALGS infant study. Clinical role and contribution in organization led to achieving 100% Key Performance Indicator (KPI) for 2024 R&D corporate milestones including leading study start-up with first patient-in (FPI) for ASSERT-EXT, Cohort 2, and data submissions outputs across two Phase III studies for Week 72 data batch narratives and Clinical Study Reports (CSRs) submitted to FDA and Modules (M2s) and Integrated Summaries of Safety and Efficacy submitted to EMA. Further highlights:

• Led cross-functional team in partnership with regulatory for Type C meeting with FDA (video conference), including interactions preparation, written responses, review of statistical analysis plan (SAP), liaising with external expert advisors, and development and review of Briefing Book seeking advice for odevixibat vs external control analysis inclusion into sNDA for Phase III program in PFIC, September 2024
• Led strategy and execution of Study Start-up for infant cohort in Alagille Syndrome (ASSERT-EXT, Cohort 2), coordinating site and patient selection, cross-functional collaboration, MSL training, and presenting at 10+ Pre-Study and Site Initiation Visits (SIVs) globally
• Led rapid response team for ASSERT-EXT, Cohort 2 infant study alongside regulatory for EU CTR Part 1 and Part 2 response to protocol amendment from clinical perspective; based on EU decision, team set mitigation plan for study endorsed by upper management
• As per study conduct for both Phase III odevixibat programs (ALGS, PFIC), reviewed 40-50 monthly queries, quarterly reviews of 60+ listings, protocol deviations, global PI study queries, and FAQ documentation, while addressing asset-related questions from internal teams worldwide
• Significant review and contribution for other key regulatory documents for odevixibat including Investigator Brochure update (IBv12), PSUR, and EU-RMP
• In partnership with ClinOps, led cross-functional task force to enable study close out for program in PFIC for early 2025
• Ensure appropriate review, updates, and documentation of all study files per GCP as part of study conduct including but not limited to, eTMF, DSMB and other Hepatic Safety committee Charters, Medical Monitoring Plans, Medical Data Review Plans, NTFs as needed, and review of Statistical Analysis Plan for one Phase III program (ASSERT-EXT)
• Contribution to program level Scientific Communication Platform (SCP), Integrated Evidence Generation Plan, and Global publications plan for odevixibat
• Created Clinical Development Findings log for odevixibat for consistency in updates across asset program provided multiple ongoing Phase III programs leading to appropriate handovers, transition, and Medical Monitor rationale documented for data outputs
• Oversight of Clinical Development Fellow via Rutgers Pharmaceutical Industry Fellowship with development plan, biweekly meetings, and active mentorship throughout 2024

Provided leadership and strategic direction post-acquisition of Albireo Pharma to operationalize and integrate Rare Disease TA Clinical organization acting as Chief of Staff to SVP Global Head Rare Disease TA, leading and owning within Clinical Development, and conducting Medical/Clinical assessments as part of External Innovation (business development) to round out depth of medical affairs experience and provide expertise into Ipsen's growing rare liver portfolio:

• Chief of Staff, Global Strategic Program: Led operational integration of Albireo Pharma’s Rare Disease Therapeutic Area (TA) Clinical organization with SVP Global Head, ensuring seamless alignment and collaboration across functions; spearheaded first global cross-functional offsite for TA for 25+ stakeholders, setting vision and tone for TA in partnership with Global Head resulting in improving stakeholder satisfaction and fostering long-term collaboration and working relations. Developed key strategic tools, including a cross-asset tracking document for 5 assets across TA and a central Rare Disease SharePoint for company, to streamline integration, enhance cross-functional coordination, and support growth of Ipsen's rare disease portfolio. Develop and review materials in coordination with corporate communications for external presentations. Represented and presented on behalf of Senior and Executive Leadership at major conferences to update external stakeholders on clinical advancements (AASLD Liver Meeting) and with multiple patient advocacy associations including, PSC Partners and Courageous Parents Network.
• Clinical Development: Led and managed clinical development initiatives within Rare Disease TA, advancing a Phase I asset as Clinical Development lead on Asset Team, exploring rare liver indications such as hepatitis delta (HDV), go/no go decisions, and presenting on NIH/NIDDK collaboration recommendations to Executive Leadership Team. While also developing and contributing to Phase II asset (ritivixibat) strategy in new target indications for development plan and lifecycle management in partnership with Asset Lead, leading key R&D ad board with top 8 experts
• External Innovation: Conducted over 8 in-depth medical and clinical screening assessments and evaluations as part of External Innovation (business development), providing strategic expertise in assessing potential partnerships (go/no go decisions) including input into Clinical Development Plans and lifecycle management strategy to enhance Ipsen’s rare disease pipeline across following rare disease therapeutic areas: hematology, liver, liver-cognition, kidney, neuromuscular, endocrinology, lung, and metabolic

On assignment (ex-Pat) in international markets, responsible for leading and executing the Medical Affairs strategy for rare cholestatic liver disease, overseeing in-country UK market launch for Bylvay (odevixibat) responsible for defining strategy and budget, collaborating with cross-functional stakeholders, and aligning launch activities with global and regional goals. While also serving as regional SME, providing ongoing support of enrolment for Phase III trials, training teams, facilitating investigator-initiated research and evidence generation, and represent to advance science and improve patient outcomes:

• Identified new and tripled key physician stakeholders from 20 to 60 in UK with less than 2-month lead time to commercial availability, elevating country-experts from local to global leadership with new evidence generation, and establishing visiting professorships across region as launch best-practice contributing to International Markets surpassing corporate milestones for 2022, recognized in early 2023
• Partnering with UK GM in pre-launch activity, led development of Rare Disease Day Initiative presented on UK Television (ITV) coordination with Genetic Alliance UK, Children’s Liver Disease Foundation, and expert thought leader as educational, pre-launch activity: video
• Identified adult patient population with PFIC and genetic variant-associated cholestasis, driving rare disease business growth, reshaping company strategy to include adult hepatologists, and leading to shift in clinical practice for adult hepatologists in UK within 3 months, expanding globally in 6 months with Bylvay®
• Created and led first multinational real-world case series collections with Bylvay® adult patient populations and case-report in undefined genetic cholestasis resulting in two real-world abstracts presented at two therapeutic area critical global medical congresses in 2023 (ESPGHAN, EASL)
• Led, developed, and executed largest Medical Symposia at major congress setting company record of 200+ attendees during multi-country European launches, utilizing four global experts at EASL 2023
• In partnership with Global Head, led Global Medical Insights for Medical Affairs organization of 25 colleagues for quarterly medical affairs insights dissemination across company to relevant stakeholders to best inform overall business strategy, resulting in “best-in-class” recognition by company senior leadership and commercial stakeholders
• Led, developed, and executed 2 country and regional (UK and Europe) and 3 global (above-country) medical affairs advisory boards resulting in change in medical strategy for proactive inclusion of evidence generation via real world settings post-launch
• Led above-country company critical international and global scientific congresses as Medical lead, including leading three (3) highly visible scientific and promotional symposium at regional-UK congresses (BASL 2022, BSPGHAN 2022 and 2023) and two (2) global meetings at EASL 2023 and ESPGHAN 2022
• Initiated 30+ cross-border key stakeholder meetings and roundtables with global thought leaders across UK, US, and EU at 3 key global liver congresses (ESPGHAN, EASL, and AASLD) including meetings with executive leadership at Albireo and then Ipsen in 2022 and 2023
• In partnership with Marketing, developed new launch branding template for materials for all major congress promotional symposium for global organization
• Partnered with Market Access to lead discussions with local payors and regulators on PFIC, Biliary Atresia, and Alagille Syndrome programs, contributing to country/regional reimbursement scoping (NICE, NCPE HSE), and developing Global Value Dossiers for odevixibat for Biliary Atresia and Alagille Syndrome
• Facilitated expanded access for eligible patients to expert treatment network from King’s College London to coordinate ex-UK and EU markets without commercial availability
• Medical Affairs engagement further led to identification and support of three global data generation projects by UK experts across two therapeutic areas (Biliary Atresia, PFIC) funded by Albireo, transitioned to Ipsen demonstrating novel-approaches in lifecycle management strategy with global implications
• Established and continued strong relationships with local patient Advocacy organizations for region including Children’s Liver disease Foundation (CLDF), Rare Disease Ireland (RDI, and Beacon for Rare Diseases UK
• Led local Biliary Atresia study (BOLD study) trial enrollments assessing site issues in visits resulting in receiving company award as part of achieving corporate objectives in 2022
• Review of all medical and promotional materials for internal and external use within region, including education events and training field sales force

First hire to build out larger Global Medical Affairs team in partnership with SVP Head of Global Medical Affairs within Albireo Pharma championing the development and advancement of IBAT inhibitors across various cholestatic rare liver diseases including but not limited to progressive familial intrahepatic cholestatic (PFIC), Alagille Syndrome, and Biliary Atresia as well as support ongoing pipeline development programs across other viral and cholestatic liver diseases. Additionally, to support Albireo’s corporate, medical/clinical, and scientific objectives, including but not limited to identifying, developing, and managing a variety of key stakeholders, educate clinical community, obtain and inform strategic insights, assist in enrollment of clinical trial sites, identify emerging science, and help advance clinical care for patients with these rare liver diseases. Notable achievements:

• Created and led the first-in-company digital platform for Bylvay®, driving early insights and real-time scientific exchange with 25+ HCPs across theUS. Led cross-functional team, including IT and external agencies, to develop high-value platform that strengthened company credibility, redefined US strategy, and remained active from 2021 to 2023.
• Led and executed multiple regional (US, 10) and global advisory (4) boards pre-launch and post-launch across variety of key stakeholders (Bylvay®)
• Built and fostered key business critical global relationships while covering half of North America prior to rest of world/global team build out, leading to 17+ previously ‘no-see’ relationships increased advocacy and engagement
• Set and established roles and responsibilities charter and execution for regional/local and major global congresses for Medical Affairs Team with cross-functional endorsement resulting in pre-congress briefing meetings and report plus post-congress report by designated leads
• Advanced and provided support to key clinical program milestones and enrollment (ASSERT, BOLD)
• Strategic and consistent partnership with US Market Access and direct presentation resulting in largest payor in United States (UHC) providing favorable access for 26 million patient lives to Bylvay®
• Led four company critical international/global and national congresses, presenting to entire company, senior and executive leadership including organizing relevant stakeholder meetings, 2020-2021
• Led company-wide trainings for all New Hires for onboarding including arranging initial new hire framework; further developing both medical and field sales trainings
• Developed multiple company SOPs for Medical Affairs (e.g. interactions, etc.) in coordination with SVP Medical Affairs and multiple cross-functional stakeholders
• Developed and led company-wide congress charter and process across all relevant internal stakeholders commercial, medical/clinical, regulatory, legal/compliance, corporate communications with continual process improvement.
• Co-developed initial training and framework for new hire onboarding onto Medical Affairs and developed MSL deck
• Led and established rotational monthly Global Medical Affairs Journal Club, for ongoing medical team education and discussion becoming driver for strategic pillars

Acting as an extension of leading medical science and expertise in obstetrics, gynecology, and women’s health, serve in a customer-facing role as a key clinical and scientific resource, identifying and developing key opinion leaders, foster and champion new ideas and paradigms in clinical practice, foster relationships with key customers, inform key medical and business strategy, identify and support opportunities for new research and publications, attend key relevant congresses provide support for advisory boards, and engagements across multiple platforms to advance women’s health:

• Selected as Top Performing MSL of the Year and promoted from MSL to Sr MSL within 6 months of hire, selected as Ambassador for company’s Women’s Network, representing Field Medical at HBA’s Annual Meeting and Women of the Year and supporting growth-initiatives for Women’s Network within the company
• Built a network of expert clinicians across U.S., engaging over 500,000 women through two expert clinician-led sessions on SiriusXM Doctor Radio discussions on post-menopausal (Intrarosa) and women’s sexual health (Vyleesi) products and coordinated Yale University Women’s Health conference session digitally streamed across nation at no charge to patients discussing pertinent education topics
• Worked with alongside clinical development to educate and enroll potential Phase III clinical trial sites and generate independent research interest
• Led Field Insights for MSL Team of 12+, creating a streamlined resource for internal medical affairs (clinical development, real-world evidence, scientific communications) for one-stop shop to see insights on a real-world, timely and monthly interval to inform and direct key Medical Strategy, clinical development, and pre-launch and launch strategy
• Co-created a Voice of Customer (VoC) initiative to be disseminated to broader commercial organization and better inform key business strategy
• Determined Key Intelligence Topics for Field Medical in coordination with Senior Leadership Maternal and Women’s Health portfolio (AMAG-423, Makena, Intrarosa, and Vyleesi)
• Presented and established MSL-led Grand Rounds presentation at University Institution in Buffalo (Intrarosa) and invited by expert thought leader as standing member at NYU Interdisciplinary Gynecology Rounds meeting
• Conducted sales training for maternal and women’s health portfolio launch products (Intrarosa, Vyleesi)

Serve in a customer-facing role as a key clinical/scientific resource, foster and champion new ideas and paradigms in clinical practice, develop relationships with key stakeholders, attend key relevant congresses, identify, and support opportunities for new search and publications in the immunology and neurology space. Additionally, identifying key clinical and research experts for advisory boards and informing key business strategy via key medical insights while engaging across multiple platforms to advance the science, clinical and patient outcomes in the disease state of Multiple Sclerosis while also supporting Betaseron and Betaconnect:

• Built and developed entire stakeholder network in U.S. northeast territory from the ground up as first-time MSL across eight states: New York, New Jersey, Massachusetts, Rhode Island, Connecticut, Vermont, New Hampshire, and Maine for 80+ thought leaders
• Evaluated and enrolled metabolomics investigator-initiated research with Global stakeholder and Multiple Sclerosis-expert for $500K, Brigham Women’s Center in Boston, MA

• First fellow in Medical Affairs within Business Unit with reporting line structures into SVP and Head of Medical of US and Global Medical Affairs Business Unit, responsible for owning development, managing multiple projects and cross-functional work across various disease states and product lifecycles ranging from pre-approval to after loss of exclusivity across following therapeutics areas: pediatric psychiatry (Pristiq), neuroscience / pain (Quillivant XR, Quillichew ER launch, and Relpax), cardiovascular (Lipitor), hematology (Fragmin), oncology (Ibrance launch), and injectable / surgical
• Key focus: Responsible for launch readiness digitally and for field teams for neuroscience division (Quillichew ER)
• Precepted five rotational pharmacy students over the course of the year resulting in 3/5 choosing to pursue fellowships while overseeing an additional two students for manuscript co- authorship and publication in Therapeutic Innovation & Regulatory Science
• Contribution to clinical study protocol and authorship for pediatric pharmacology protocols for FDA Post-Marketing agreement on pre- school study for QuilliChew ER
• Active participation in American Academy of Child and Adolescent Psychiatry (AACAP) Corporate Roundtable in conjunction with Independent Grant Learning Committee to better understand AACAP’s current and future initiatives and build on key collaborations (QuilliChew ER/ Quillivant XR)
• Responsible for setting tone of Fellowship program and successfully recruiting following year Fellow, resulting in two successful candidates for continuation of program

• Participated in bi-Monthly Professional Development Series seminars Rutgers PharmD Fellows from 17 other pharmaceutical companies across the nation to further enhance learnings of the pharmaceutical industry, greater healthcare space, build on healthcare and business acumen, strategic skill sets, and soft-skills
• Precepted five Advanced Practice Pharmacy Students for 6 week rotations at Pfizer Inc., developing monthly rotation outline in coordination with supervisor including 3 presentations and impactful projects for student development resulting in 3 of 5 students receiving highly coveted Pharmaceutical Industry Fellowships upon graduation
• Oversight of two entry Pharmacy students for duration of fellowship, resulting in submitted publication
• Organized and built first-in-Pfizer, Inc. on-site Pharmacy Student site visit to Global Headquarters (NY) with the Pfizer Pharmacist Association to serve as a platform to mentor and develop future Pharmacy students interested in Industry, March 2016