Celgene Pharmaceutical Industry Fellowship Program...Message to Candidates ABOUT CELGENE FELLOWSHIP...
Transcript of Celgene Pharmaceutical Industry Fellowship Program...Message to Candidates ABOUT CELGENE FELLOWSHIP...
Celgene PharmaceuticalIndustry Fellowship Program2020-2022
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ContentsAbout Celgene
Message to Candidates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Our Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Our Pipeline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Our Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Our Fellowship Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Our Fellowship Steering Committee . . . . . . . . . . . . . . . . . . . . . 10
Our Fellowship Components . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Our Current Fellows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Fellowship Programs
GCR&D CAR T-Cell Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Hematology & Oncology Medical Affairs . . . . . . . . . . . . . . . . . 14
U .S . Health Economics & Outcomes Research . . . . . . . . . . . . 15
Rutgers Pharmaceutical Industry Fellowship Alumni . . . . . . . . 16
Rutgers Pharmaceutical Industry Fellowship Program . . . 18-20
ABOUTCELGENE
CURRENTFELLOWS
FELLOWSHIPALUMNI
RPIFFELLOWSHIPPROGRAMS
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Message to Candidates
ABOUTCELGENE
FELLOWSHIPALUMNI
RPIF
Dear Prospective Fellows,
We are honored to be a part of the Rutgers Pharmaceutical Industry Fellowship Program and are pleased you are considering Celgene as part of your professional development . Celgene has an incredible history of scientific and research excellence producing transformative new medicines for patients with cancer and inflammatory disease .
Though we are very proud of our progress toward this mission, millions of people with acute, life-threatening or life-altering diseases are underserved by current treatment options . Our mission is to discover and develop innovative therapies for those patients and we are always seeking to strengthen our organization with individuals who share that dedication .
Celgene’s core purpose is to change the course of human health through bold pursuits in science, and a promise to always put patients first . We do this through a strong culture built on five core values:
• Passion for the patient • Courage to face our challenges and the unknown • Trust in our words and actions • Excellence in delivering exceptional results • Curiosity and continuous learning
The combination of great people, great science and a values-driven culture has defined our past successes . Though the world around us is changing quickly, these same elements are critical for our future . At Celgene, we are advancing innovative therapies and making a meaningful difference in the lives of patients . The opportunity you have to impact patients as a healthcare professional is invaluable – thank you for considering joining Celgene in this pursuit .
Sincerely,Mark J . AllesChairman and Chief Executive OfficerCelgene Corporation
CURRENTFELLOWS
FELLOWSHIPPROGRAMS
Mark J. AllesChairman and CEO, Celgene Corporation
“We continue to be delighted to be part of the RPIF program . Since joining, our fellowship offerings have grown significantly across Celgene; however, in measured fashion to ensure we maintain the highest quality and are able retain the talent after completion . Each of our fellowship positions offers a dynamic experience, through multiple therapeutic areas, functions and/or geographies, allowing flexibility to maximize exposure to key learnings . Our fellows gain meaningful experience and insight into the numerous career possibilities within the pharmaceutical industry . A motivated, passionate “self-starter” certainly will thrive in our entrepreneurial culture and gain the requisite foundation to be well positioned as a future leader within the pharmaceutical industry .”
John P. Berg, Pharm.D., R.Ph.Corporate Vice President,Corporate Medical AffairsExecutive Sponsor andProgram Co-LeadCelgene Fellowship Program
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Celgene Products Celgene Worldwide
Inmunotherapy
Corporate HeadquartersSummit, NJ
Seattle, WA
Epigenetics/SignalingSan Diego, CA
International
Asia PacificHeadquarters (APAC)
HeadquartersBoudry, Switzerland
Indicates Celgene presence
50 · 100 · 150 · 200 mg
Today, Celgene has a portfolio of drugs with unique mechanisms of action including immunomodulatory compounds and epigenetic agents that address a broad range of conditions, carrying on our spirit of discovery.
In addition, our growth is being measured geographically as we expand to new countries and deliver our innovative therapies to many more patients around the world. Celgene is impacting the lives of patients with cancer and other serious diseases in more than 50 countries worldwide.
TranslationalDevelopment
San Francisco, CA
CellularTherapeuticsWarren, NJ
SingaporeAvilomicsTM
ResearchBedford, MA
CITRESeville, Spain..
ABOUTCELGENE
FELLOWSHIPALUMNI
RPIFCURRENTFELLOWS
FELLOWSHIPPROGRAMS
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ABOUTCELGENE
FELLOWSHIPALUMNI
RPIF
Phase 1 Phase 2 Phase 3 Post-Approval ResearchArea of Research
© 2019 Celgene Corporation 11/19
For information on approved uses, please refer to approved product labeling. Post-approval research includes Celgene-sponsored and Celgene-supported studies.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established. There is no guarantee that investigational agents or investigational uses will receive health authority approval or become commercially available in any country.
MULTIPLE MYELOMA (MM)POMALYST®/IMNOVID® (US/EU) (pomalidomide) Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ide-cel (BCMA CAR T)a Relapsed/refractoryb . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Second-line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Third-line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
bb21217 (BCMA CAR T)a Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
orva-cel (BCMA CAR T)c Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Iberdomide (CC-220)(CELMoD) Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-92480 (CELMoD) Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-93269 (BCMA TCE) Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-99712 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MYELODYSPLASTIC SYNDROMES (MDS)CC-486 (DNMT inhibitor) Lower-risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Post hypomethylating agent (HMA) failure . . . . . . . . . . . . .
Luspatercept (ACE-536)d Previously treated with ESAe . . . . . . . . . . . . . . . . . . . . . . .
ESA naïve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACUTE MYELOID LEUKEMIA (AML)CC-486 (DNMT inhibitor) Post-induction AML maintenance . . . . . . . . . . . . . . . . . . . .
IDHIFA® (enasidenib)f Relapsed/refractory IDH2 mutation (US) . . . . . . . . . . . . . .
Newly diagnosed AML with an IDH2 mutation . . . . . . . . . .
CC-90009 (CELMoD) Relapsed/refractory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GEM333 (CD3XCD33 Bispecific Antibody)g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-95775 (BET inhibitor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
aIn collaboration with bluebird bio, Inc . bPivotal trial for support of regulatory submission(s) . cBeing developed by Juno Therapeutics, Inc ., a Celgene Company . dIn collaboration with Acceleron Pharma, Inc . eSubmission(s) pending regulatory agency review . fIn collaboration with Agios Pharmaceuticals, Inc . gIn collaboration with GEMoaB Monoclonals GmbH .
ide-cel, idecabtagene vicleucel
orva-cel, orvacabtagene autoleucel
POMALYST®, IMNOVID®, and IDHIFA® are registered trademarks of Celgene Corporation .
Discover the Potential of our Pipeline
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ABOUTCELGENE
FELLOWSHIPALUMNI
RPIF
Area of Research Phase 1 Phase 2 Phase 3 Post-Approval Research
© 2019 Celgene Corporation 11/19
For information on approved uses, please refer to approved product labeling. Post-approval research includes Celgene-sponsored and Celgene-supported studies.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established. There is no guarantee that investigational agents or investigational uses will receive health authority approval or become commercially available in any country.
LYMPHOMAISTODAX® (romidepsin) for injection Peripheral T-cell lymphoma: First-line . . . . . . . . . . . . . . .
liso-cel (CD-19 CAR T) Diffuse large B-cell lymphoma: Third-linea . . . . . . . . . . .
Aggressive large B-cell lymphoma: Relapsed/refractory .
Diffuse large B-cell lymphoma: Second-line . . . . . . . . . .
Mantle-cell lymphoma: Third-line . . . . . . . . . . . . . . . . . .
CC-486 (DNMT inhibitor) Angioimmunoblastic T-cell lymphoma . . . . . . . . . . . . . . .
CC-90002 (Anti-CD47) Non-Hodgkin lymphoma . . . . . . . . . . . . . . . . . . . . . . . .
CC-90010 (BET inhibitor) Non-Hodgkin lymphoma . . . . . . . . . . . . . . . . . . . . . . . .
CC-95775 (BET inhibitor) Non-Hodgkin lymphoma . . . . . . . . . . . . . . . . . . . . . . . .
CC-99282 (CELMoD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-95251 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-90011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)liso-cel (CD-19 CAR T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BETA-THALASSEMIALuspatercept (ACE-536)b Transfusion-dependent . . . . . . . . . . . . . . . . . . . . . . . . .
Non-transfusion-dependent . . . . . . . . . . . . . . . . . . . . . .
MYELOFIBROSIS (MF)Fedratinib . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Luspatercept (ACE-536)b MF anemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
aPivotal trial for support of regulatory submission(s) . bIn collaboration with Acceleron Pharma, Inc .
liso-cel, lisocabtagene maraleucel
ISTODAX® is a registered trademark of Celgene Corporation .
Discover the Potential of our Pipeline
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ABOUTCELGENE
FELLOWSHIPALUMNI
RPIF
Area of Research Phase 1 Phase 2 Phase 3 Post-Approval Research
© 2019 Celgene Corporation 11/19
For information on approved uses, please refer to approved product labeling. Post-approval research includes Celgene-sponsored and Celgene-supported studies.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established. There is no guarantee that investigational agents or investigational uses will receive health authority approval or become commercially available in any country.
SOLID TUMORSMarizomib Glioblastoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Motolimod/PD-1 Head and Neck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-90011 Extensive stage small cell lung cancer . . . . . . . . . . . . . .
CC-90010 (BET inhibitor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-95251 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
POMALYST®/IMNOVID® (US/EU) (pomalidomide) GBM pediatric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GEMoab CD3xPSCAa Solid tumor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INFLAMMATION & IMMUNOLOGYOzanimod Relapsing multiple sclerosisb . . . . . . . . . . . . . . . . . . . . .
Ulcerative colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Crohn’s disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-93538 Eosinophilic esophagitis . . . . . . . . . . . . . . . . . . . . . . . .
Iberdomide (CC-220)(CELMoD) Systemic lupus erythematosus . . . . . . . . . . . . . . . . . . .
CC-90001 Idiopathic pulmonary fibrosis . . . . . . . . . . . . . . . . . . . . .
NASH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-90006 Psoriasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CC-92252 Autoimmune . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
aIn collaboration with GEMoaB Monoclonals GmbH . bSubmission(s) pending regulatory agency review .
POMALYST® and IMNOVID® are registered trademarks of Celgene Corporation .
Discover the Potential of our Pipeline
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ABOUTCELGENE
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ABOUTCELGENE
FELLOWSHIPALUMNI
RPIFFELLOWSHIPPROGRAMS
CURRENTFELLOWS
• Attract highly qualified and motivated individuals, develop leaders, and retain talent .
• Deliver on a best-in-class post-doctoral training program .
• Partner in the development of high-performing program stakeholders by providing opportunities for leadership, coaching, mentoring, and managerial training .
• Foster a culture that aligns fellow contributions with Celgene business needs .
• Advocate the value of healthcare professionals within the pharmaceutical industry .
Our Fellowship Objectives1
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• Consists of: Program Leads, C3 Champions and Preceptors, Celgene Chief Fellow, and HR Program Manager .
• Focuses on 3 main objectives: Consistency, Connectivity, and Challenge the Status Quo (C3) .
• Consistency: Ensure uniform approach with respect to program standards and in the governance and administration of the RPIF program at Celgene .
• Connectivity: Foster the sharing of best practices and identification of development opportunities among program stakeholders .
• Challenge: Continually evolve the RPIF program to differentiate Celgene as a sponsor company of choice .
• Chief Fellow: Serves as point of contact for all fellowship related communication with relevant Celgene stakeholders and the Steering Committee . Leads the coordination of fellowship onboarding including development of core Fellow training, with the support from the rest of the committee .
• HR Program Manager: Leads the creation of a consistent communication platform for Celgene recruitment activities across all academic institutions . Also facilitates the identification of job opportunity and placement .
Our Fellowship Steering Committee
John BergCorporate Vice PresidentCorporate Medical AffairsExecutive Sponsor and Program Co-LeadCelgene Fellowship Program
Adam del CorralSenior DirectorGlobal Project LeadershipProgram Co-LeadCelgene Fellowship Program
Antonia MillerAssociate DirectorProgram ManagerHR Talent Acquisition
Amandeep RiarGlobal Regulatory AffairsChief Fellow
Jully KimDirectorMedical Information
Vrunda PatelAssociate DirectorSenior ManagerRegulatory Affairs
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ABOUTCELGENE
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Celgene provides a robust program grounded in key core competencies to deliver the most viable candidate at the conclusion of the program . In addition to becoming an integral part of their respective function, each fellow will be trained to manage a broad range of responsibilities to enhance their professional development .
Key Fellowship Activities Within Celgene Include:
Celgene Pharmacists Network:Through the collaborative efforts of current employees and the RPIF fellows, the Celgene Pharmacists Network was established in order to:
• Develop and sustain a culture that promotes the increased understanding of the value that pharmacists have within the pharmaceutical industry, as well as;
• Enable an environment that continues to provide continued professional development that aligns with Celgene’s core values .
Through the organization’s objectives, we have hosted several different events since our inception in January 2017, ranging from conducting CE classes for interested members to participating in various philanthropic events . As our group continues to grow and collaborate with both internal and external organizations, we aim to position Celgene as a leader within the pharmacy profession .
Our Fellowship Components
Fellowship Speaker SeriesThis series brings in guest speakers from senior leadership, to share their professional development experiences, insights, and successes with our current fellows . The series will help foster visibility of our fellows as they engage with senior leadership in an intimate setting .
Celgene Fellowship Committees
• Recruitment
• Brochure
• Alumni
• Social/Engagement Committee
Mentorship ProgramThe mentorship program pairs current fellows (mentee) with an experienced fellowship alumnus (mentor) within Celgene . The purpose of this program is to provide the fellow with additional support for career guidance, goal development and any other guidance the fellow may need .
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Our Current Fellows
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Amandeep Riar, Pharm.D.Global Regulatory AffairsTemple University School of PharmacyMy fellowship has afforded me the opportunity to customize my program based upon my interests, and learn about different aspects of regulatory and drug development, to provide a well-rounded experience. I have become an integral member of our cross-functional teams while working alongside individuals who are leaders in this industry.
RPIF
Chuka Udeze, Pharm.D.U.S. Health Economics & Outcomes ResearchUniversity of MarylandMy time on the U.S. HEOR team at Celgene has allowed me to work on a variety of disease states across different parts of the drug lifecycle. I have enjoyed the flexibility to make my fellowship experience my own.
Dorothy Zissler, Pharm.D.Global Medical Information & Scientific CommunicationsUniversity of the Sciences Philadelphia College of PharmacyMy fellowship in Corporate Medical Affairs has given me the opportunity to gain experience in both Medical Information and Scientific Communications. I feel extremely lucky because my role has allowed me to get a real feel for industry by working with different teams and on different drugs. It is the greatest feeling in the world to come to work every day and love what you do.
Landon Shupe, Pharm.D.Global Project LeadershipUniversity of Kansas College of PharmacyBeing at the center of the development of a potential first in class CAR T therapy has provided me with an amazing fellowship experience that will be valuable for the rest of my career.
Trevor Homan, Pharm.D.Clinical Research & DevelopmentUniversity of Findlay College of PharmacyMy fellowship has allowed me the opportunity to learn about the many intricacies of drug development and has given me the chance to benefit patients on a global scale.
Hannah Gardocki, Pharm.D.Global Project LeadershipUniversity of Connecticul School of PharmacyI have been fortunate to gain high-level, cross-functional experiences across numerous different products and disease states. Working alongside drug development experts and collaborating with various functions to execute strategy has been a challenging and rewarding experience that will undoubtedly shape my career.
Karan Verma, Pharm.D.Global Knowledge Managerment and Strategic IntelligenceCreighton University School of PharmacyThe cross-functional nature of my fellowship is what makes it a unique one, as it allows me to work on multiple projects and gain exposure to different therapeutic areas. I am able to collaborate with multiple stakeholders for business purposes which is rewarding for me both personally and professionally.
Krystal Huey, Pharm.D.Global Pricing & Market Access/Health Economics & Outcomes ResearchNortheastern University School of PharmacyHaving the opportunity to work in both market access and health economics outcomes research has been unbelievably challenging and rewarding. Learning both allows me to get a comprehensive picture of not only how the research is done, but also relate it to the overall global and market-specific strategy.
Omar Nurilov, Pharm.D.Global Regulatory AffairsSt. John’s University College of PharmacyThe RPIF/Celgene program has given me the opportunity to be exposed to various aspects of the Regulatory Affairs function such as strategy, advertising & promotion, labeling, as well as regulatory intelligence. I receive close guidance and support from experienced professionals within the company and have the opportunity to work on both late stage and early stage assets.
Sean Ahern, Pharm.D.Clinical Research & DevelopmentUniversity of the Sciences Philadelphia College of PharmacyMy fellowship experience at Celgene has been nothing short of incredible. I have gained invaluable skills that will propel my career within the pharmaceutical industry, as well as gained lifelong friends along the way.
Vincent Tran, Pharm.D.Global Medical Communications & LearningTouro College of PharmacyI am truly grateful for all the opportunities, mentorship, and guidance afforded to me through this fellowship. I look forward to seeing how much I will have grown both professionally and personally at the conclusion of this 2-year fellowship. I am confident that these experiences will build the foundation for my career and allow me to make meaningful contributions back to patients.
Second Year Fellows
First Year Fellows
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Global Clinical Research& Development Fellowship(1) Two-Year Position 2020-2022
Summary
The Clinical Research and Development PharmD Fellowship is a 2-year program primarily focused on developing Cellular Therapies in hematology/oncology within the CAR T-Cell Therapy Center of Excellence. For years, the foundations of cancer treatment were standard chemotherapy regimens. More recently, cellular therapies have evolved utilizing a novel modality that enlists and strengthens the power of a patient’s immune system to attach cancer cells. This fellowship opportunity will allow the fellow to work on novel and innovative therapies that are transforming the cancer treatment landscape.
Global Clinical Research & Development Fellowship Objectives:The Global Clinical Research & Development (GCR&D) organization is responsible for developing compounds for the treatment of hematologic and solid tumor malignancies worldwide . GCR&D will offer a two-year post-doctoral Pharm .D fellowship in hematology/ oncology . The GCR&D fellow will function as an Associate Clinical Research Scientist (CRS) and focus on the science and strategy of drug development . The fellow will learn various aspects of global clinical studies (Phases I-III) including start-up, maintenance and close-out activities in collaboration with the Clinical Research Physician (CRP) and the cross-functional study team .
• Understand the principles and key foundations of clinical trial development and how they relate to the overall drug development process (i .e . study endpoints, randomization/stratification, control, blinding, selection of population, and study assessments) .
• Attain a working knowledge of Good Clinical Practices (GCP) and International Council on Harmonisation (ICH) guidelines in relation to clinical trial conduct and sound patient-focused practices .
• Gain extensive hematology/oncology therapeutic area and product-related expertise as well as engage in scientific/strategic discussions with internal and external thought leaders .
• Become a proficient CRS and effective cross-functional study team contributor throughout the clinical trial process by learning to develop protocol concept sheets clinical protocols, informed consent documents, clinical databases, patient narratives, clinical study reports (CSR), Investigator Brochures (IB), Investigational New Drug (IND) safety updates, Development Safety Update Report (DSUR), case report forms (CRFs) and other regulatory submission documents .
• Work closely with the CRP and study team in making study-specific recommendations, providing clinical research expertise, presenting protocol specific topics, responding to health authority requests and supporting the team at various therapeutic area conferences .
• Lead the study team in comprehensive clinical data review and analysis in conjunction with the CRP via available data review tools such as patient profiles and exception listings .
• Partner with the Clinical Operations team to ensure scientific alignment with operational study objectives .
• Interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Early Development, Translational Development, Clinical Pharmacology, Medical Writing, Marketing and Project Leadership .
• Attend and develop materials for presentation at various internal and external meetings including study site initiation visits (SIV) and investigator meetings .
• Engage in departmental initiatives within GCR&D .
Fellowship Preceptor
Marina Youssef, Pharm.D.Senior Manager,Clinical Research Scientist
First Year Fellow
Sean Ahern, Pharm.D.Clinical Research & DevelopmentUniversity of the Sciences Philadelphia College of Pharmacy
ABOUTCELGENE
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RPIF
Second Year Fellow
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Trevor Homan, Pharm.D.Clinical Research & DevelopmentUniversity of Findlay College of Pharmacy
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Hematology & OncologyMedical Affairs Fellowship(1) Two-Year Position 2020-2022
Summary
Celgene Hematology and Oncology Medical Affairs is committed to answering critical open research questions for unmet medical needs by conducting various types of clinical research in the area of hematologic and solid tumor malignancies.
This Medical Affairs Fellowship is a 2-year program which allows the fellow to gain industry experience and knowledge within Medical Affairs, while functioning as a developing scientific manager.
The Celgene Medical Affairs Fellowship is designed to provide a broad exposure to various roles within the Hematology and Oncology Medical Affairs organization. The fellow will learn various aspects of clinical research (company sponsored trials, investigator-initiated trials, cooperative group trials, and registries) while working collaboratively with medical disease teams and cross-functional partners.
Hematology & Oncology Medical Affairs Fellowship Objectives:
• Gain a broad knowledge and understanding of assigned disease areas including, but not limited to: disease biology, currently available therapeutic options, agents in development, and unmet medical needs for specific patient segments .
• Gain product-related expertise in each assigned disease area and engage in scientific and strategic discussions with key internal and external stakeholders .
• Participate in the development, monitoring and close-out of ongoing clinical research trials and activities on respective disease teams, including company sponsored research studies and registries (based upon the life-cycle of projects) .
• Contribute to the evaluation of investigator-initiated trial concepts and how each concept strategically relates to open research questions that have been prioritized within the department and disease team .
• Support the medical disease teams with content preparation and planning for medical congresses (e .g . ASCO, ASH) and other key external meetings, including advisory boards, scientific steering committee meetings, and clinical study data monitoring meetings .
• Collaborate with cross functional team members, including Medical Science Liaisons (MSLs), Scientific Communications, Scientific Education, Medical Information, and Learning & Development teams, to create and execute on medical tactical plans .
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Fellowship Preceptor
Michael Ondovik, Pharm.D., MBASenior Director, U.S. Medical Affairs
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U .S . Health Economics &Outcomes Research Fellowship(1) Two-Year Position 2020-2022
Summary
The U.S. Health Economics and Outcomes Research (HEOR) organization at Celgene is responsible for developing, executing and communicating strategies to help define the real-world value of our hematology and oncology (HemOnc) and Inflammation and Immunology (I&I) products. The real-world evidence generated by HEOR aims to limit barriers to access, optimize utilization, and expand the clinical and economic body of evidence for Celgene products and associated disease states.
The objective of the program is to fully prepare the fellow for a career as a HEOR professional through practical training at Celgene with possible supplemental coursework from Rutgers University towards completion of a related masters degree. The fellow will have the opportunity to understand the role of HEOR throughout the lifecycle of a product and will be involved with various HEOR studies, including comparative effectiveness, real-world evidence generation, health economic modeling, and patient-reported outcomes.
U .S . Health Economics & Outcomes ResearchFellowship Objectives: • Understand the principals of health economics and outcomes research as they relate to the evaluation of healthcare interventions . • Enroll in didactic courses towards an optional Masters degree (e .g . MS-HOPE, MPH) at Rutgers University • Develop a deep understanding of the US healthcare system • Attend major conferences related to HEOR methods (e .g . ISPOR, ICPE)
• Gain experience within the pharmaceutical industry in designing and conducting outcomes research studies that examine clinical, economic, and humanistic outcomes . • Contribute to all aspects of the research including but not limited to: • Study design and methodology • Data collection and analysis • Publication of results • Participate and eventually lead a variety of HEOR projects such as: • Retrospective studies (e .g . EMR, claims, PRO surveys) • Economic models • Literature reviews • AMCP dossiers • Develop a knowledge of internal and external stakeholders and partners involved with HEOR
• Understand the application and use of health economics and outcomes research within the pharmaceutical industry, consultancy, and managed care to prepare the fellow for a career in various settings . • Co-author and present abstracts, posters and manuscripts to internal and external audiences • Gain experience in emerging market access dissemination channels for HEOR including: • Field HEOR and FDAMA 114 tool development and/or update • Attend and participate in cross-functional meetings (e .g . Medical Affairs, Market Access), payer-customer meetings and conferences related to managed care, academia, and disease congresses (e .g . AMCP, Academy Health, ASCO) • Gain an understanding of the application of HEOR outside the US
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Fellowship Preceptor
Annette Powers, Pharm.D., MBAExecutive Director,Health Economics &Outcomes Research
Second Year Fellow
Chuka Udeze, Pharm.D.Health Economics & Outcomes ResearchUniversity of Maryland
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Rutgers Pharmaceutical Industry Fellowship Alumni currently employed at Celgene:
Safiya Abouzaid Senior Director, Global Pricing & Market Access Fellowship: Janssen 2008-2010
Narin Ahmed Senior Director, Regulatory Affairs Fellowship: Novartis 2010-2012
Monica Azer Anis Senior Manager, Global Medical Affairs, Myeloid Fellowship: Celgene 2016-2018
Lynn Anyaele Senior Manager, Scientific Education Fellowship: BMS 2011-2013
Kaleen Barbary Director, Global Medical Information Fellowship: Bristol-Myers Squibb 2009-2010
Elbert Chang Senior Regional Medical Liaison, Clinical Sciences Research Fellowship: Bayer Healthcare Pharmaceuticals 2009-2011
Mindy Chen Senior Manager, US Medical Affairs Fellowship: Celgene 2014-2016
Tina (Huang) Conner Associate Director, Project Management Fellowship: Sanofi-Aventis 2008-2009
Daniel Dilanji Regional Medical Liaison, Neurology Fellowship: Celgene 2018-2019
Jennifer Dudinak Senior Vice President, Global Regulatory Affairs Fellowship: Hoffmann-La Roche
Peter Fendt Senior Manager, Global Market Insights Fellowship: Celgene 2016-2018
Unicel-Anne Flores Senior Manager, Global Medical Information Fellowship: Pfizer 2014-2016
Joseph Fulginiti Regional Medical Liaison, Clinical Sciences Research Fellowship: Accorda 2015-2017
Jessica Garzon Clinical Research Scientist, Clinical R&D Management Fellowship: Roche 2016 - 2018
Krista Hudak Principal Clinical Resarch Scientist Fellowship: TKL Research 2009-2011
Michelle Hudson Senior Director, Lead Clinical Research Scientist Fellowship: Novartis 2004-2006
Julie Jeanes Senior Director, Global Medical Affairs, Strategic Planning Fellowship: TKL Research 2008-2010
Hiren Kachhia Senior Regional Medical Liaison, Clinical Sciences Research Fellowship: Sanofi 2012-2013
Janet Kang Principal Clinical Research Scientist, Clinical R&D Management Fellowship: Roche 2005-2007
Jully Kim Director, Medical Information Fellowship: Bristol-Myers Squibb 2008-2009
Will Kim Director, I&I - Access & Value Marketing Fellowship: Sanofi 2011-2013
Stephen Lee Regional Medical Liaison, Rheumatology Dermatology Fellowship: Celgene 2016-2018
Emily Mantovani Manager, Global Clinical Research & Development Fellowship: Celgene 2016-2018
Rubin Modi Senior Manager, Regulatory Affairs Fellowship: Novartis 2015-2017
Dalal Nesheiwat Senior Director, Global Medical Affairs, Lymphoma Fellowship: Novartis 2008-2010
Duong Nguyen Associate Director, Clinical Operations Fellowship: Hoffmann-La Roche 2008-2010
Vi (Tuong) Nguyen Senior Clinical Research Scientist Fellowship: Novartis 2013-2015
Adeleye Ogunkanmi Senior Clinical Research Scientist Fellowship: Schering 2007-2009
Joseph Pariseau Clinical Research Scientist, Clinical R&D Management Fellowship: Celgene 2015-2017
Manish Patel HEOR Field Executive Fellowship: Sanofi 2013-2015
Mona Patel Associate Director, Medical Information Fellowship: Bayer HealthCare 2011-2013
Vrunda Patel Associate Director, Regulatory Affairs Fellowship: Bayer Healthcare 2009-2011
Jennifer Pocoski Director, Global Pricing & Market Access Fellowship: Bayer 2007-2009
Jennifer Poon Principal Clinical Research Scientist Fellowship: Merck 2009-2011
Venkatesh Satram Manager, Project Management Fellowship: Celgene 2017-2019
Arpita Shah Associate Director, Global Knowledge Management Fellowship: Hoffmann-La Roche 2004-2006
Brian Ung Manager, Field US HEOR I&I Fellowship: Celgene 2016-2018
Krishnan Viswanadhan Cell Therapy Franchise Lead Fellowship: Hoffmann-La Roche 2001-2002
Jenny Wong Associate Director, Clinical Trial Planning & Analytics Fellowship: Hoffmann-La Roche 2004-2006
Matthew Wong Chief of Staff, Global Regulatory Affairs Fellowship: Daiichi-Sankyo 2008-2009
Marina Youssef Senior Manager, Clinical Research Scientist Fellowship: Celgene 2017-2019
Sue Yueh Director, Global Medical Information Fellowship: Bristol-Myers Squibb 2008-2009
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Ernest Mario School of PharmacyRutgers, The State Universityof New Jersey
Joseph A Barone, Pharm.D., F.C.C.P.Dean and Professor IIErnest Mario School of Pharmacy
Program HistoryIn 1984, at Rutgers, The State University of New Jersey, the Ernest Mario School of Pharmacy and two pharmaceutical companies began a collaborative pilot program to evaluate the potential contributions of clinically-trained pharmacists within a pharmaceutical industry practice setting . Following the successful pilot, the Rutgers Pharmaceutical Industry Fellowship (RPIF) Program grew significantly and expanded to include 21 companies within the pharmaceutical and biopharmaceutical industries and over 200 fellows annually .
In 2002, Dr . Ernest Mario generously provided an endowment to establish the Institute for Pharmaceutical Industry Fellowships to enhance and promote the role of pharmacists in industry through the RPIF Program . The Institute staff members:
• provide leadership and administrative support;
• promote quality, communication, and scholarly activity; and
• arrange specialized fellowship training opportunities within the pharmaceutical and biopharmaceutical industries .
Recently in 2018, our program has expanded to offer interdisciplinary fellows’ training by adding select physician fellowship opportunities to our well-established program .
The RPIF Program has thrived under the leadership of the founder, Dr . Joseph A . Barone, Dean and Professor II of the Ernest Mario School of Pharmacy and Dr . Michael Toscani, Research Professor and the Director for the Institute for Pharmaceutical Industry Fellowships .
2019 RPIF Program Certificate
More than 1000 post-doctoral fellows have completed the RPIF Program, most of whom are pursuing influential and rewarding careers in the pharmaceutical and biopharmaceutical industries throughout the US and abroad . The RPIF Program has preceptors/mentors from industry who share their knowledge and experiences with the fellows through an intense but closely-guided training program . Assignments and projects are challenging, meaningful, and designed to enhance understanding of the pharmaceutical and biophar-maceutical industries and the fellow’s functional area .
Michael Toscani, Pharm.D.Research Professor, Fellowship DirectorInstitute for PharmaceuticalIndustry Fellowships
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amily of Leading CompaniesPartners include several of the top 21 global pharmaceutical and biopharmaceutical companies .
utstanding Alumni Track RecordOver 1000 alumni hold prominent positions at many leading companies .
trong NetworkOver 200 fellows each year develop valuable, lasting connections with each other, alumni, preceptors and faculty .
he Pathway to IndustrySince 1984, the Rutgers program has been nationally recognized, trusted, and proven as the pathway to industry for pharmacists .
nhanced Career PathIncreasingly challenging assignments build depth of experience and enhance the potential for an accelerated career path .
igorous Academic ComponentRutgers affiliation provides academic and professional development opportunities .
2019 RPIF Program Certificate Dinner
Professional Development SeriesAll fellows gather at Rutgers once or twice monthly as a group to participate in the Professional Development Day (PDD) Series, an important component of their training that complements the hands-on experience provided at the partner companies . The PDDs are steered by a committee of fellows and are designed to enhance the fellows’ presentation skills, emotional intelligence, promote connectivity and a sense of community among fellows from different companies and disciplines, develop new skill sets under the guidance of external trainers, and provide general knowledge about various aspects of drug development and issues facing the pharmaceutical and biopharmaceutical industries .
The fellows learn from each other through individual and group presentations and debates on topics and issues related to the pharmaceutical and biopharmaceutical industries . This dynamic forum provides an opportunity for open discussion and debate among fellows, Rutgers faculty, and company preceptors . In addition, outside experts provide training and professional development in a variety of areas (e .g ., tools for corporate success; professional writing, presentations, meeting facilitation, negotiating, influencing, networking, and conflict resolution skills; giving and receiving feedback; and business and dining etiquette) . Other PDD guest speakers include senior industry executives, patient advocacy groups, and successful RPIF Program alumni who share their insights and experiences . Importantly, PDDs provide an excellent opportunity for fellows to interact with each other and develop lasting personal friendships and a strong professional network of fellows, faculty, alumni, and other industry executives .
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Key Program FeaturesThe Rutgers Pharmaceutical Industry Fellowship Program FOSTERs the growth and development of future pharmaceutical and biopharmaceutical industry professionals through the following key program features:
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Application Process and Eligibility Requirements:Fellows for the Rutgers Pharmaceutical Industry Fellowship Program are selected on a nationally-competitive basis . Candidates must have completed a Doctor of Pharmacy degree from an ACPE accredited institution before July 1 of the fellowship term .
Participation in the ASHP Midyear Clinical Meeting/PPS is strongly encouraged . Interested individuals may submit their application materials (curriculum vitae, three letters of recommendation and a letter of intent) beginning November 23, 2019 and complete a program interest form online by visiting our website: pharmafellows.rutgers.edu
All application materials must be submitted electronically and applicants are strongly encouraged to submit the above documents by December 1st .
Please address your Letter of Intent & Letters of Recommendation 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 08854-8020
Rutgers, The State University of New Jersey, with approximately 70,875 students in its three campuses, is one of the major state university systems in the United States. The New Jersey College of Pharmacy was founded in 1892 and was incorporated into the University in 1927. The Ernest Mario School of Pharmacy is part of Rutgers Biomedical and Health Sciences, the only state school of pharmacy in New Jersey, with approximately 1,300 students in its Doctor of Pharmacy program.
The Rutgers Ernest Mario School of Pharmacy is located on the University’s main science and technology campus in Piscataway, New Jersey. Because of its close proximity to the nation’s leading pharmaceutical and biopharmaceutical companies, the Ernest Mario School of Pharmacy and the RPIF Program are uniquely capable of providing fellows with exposure to the pharmaceutical and biopharmaceutical industries.
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