ANDREW TROVATO
Randolph,New Jersey
Summary
Dynamic Clinical Scientist with extensive experience at Bristol Myers Squibb, Novartis, and Merck leading innovative CAR T programs, and other small molecule programs to regulatory submissions. Proven track record in strategic planning and team leadership, driving high-quality clinical trial designs. Adept at authoring regulatory documents and mentoring teams, ensuring successful project outcomes and compliance with health authority standards.
Overview
25
25
years of professional experience
Work History
Clinical Scientist Program Lead (Senior Director)
Bristol Myers Squibb
01.2022 - Current
- Lead clinical development of BCMAxGPRC5D dual targeting CAR T. Primary accountability for the asset transition from PoC to Registration phase trials. Developed content and led discussions to gather key strategic insights to inform late development strategy in an Advisory Board as well as one-to-one encounters. Functioned as the primary lead for the build of the Clinical Development Plan. Provided key inputs to inform registrational design strategy and protocol concept. Functioned as a contributing author to FDA/CHMP/PMDA briefing book.
- Lead clinical development of Abecma program to ensure high quality delivery of new protocols, and data packages for regulatory filings.
- Served as Safety subteam lead and bullpen slide caller for KarMMa-3 ODAC which earned an 8-3 favorable vote.
- Developed concept sheet and provided authoring and oversight for protocol development for study in newly diagnosed multiple myeloma (KarMMa-9).
- Contributed to authoring and review of SCS, SCE, CO for sBLA filings to multiple health authorities. (KarMMa-3 submission)
- Member of the rapid response team representing clinical science function for all information requests from health authorities for ongoing filings, annual updates.
- Provided scientific and clinical leadership to support the team; provide program/ therapeutic area/skills training to team members
- Held accountability for the performance and professional development of Clinical Scientist team.
- Provides key input to the scientific publications plan.
- Reviews and approves clinical contributions to all trial documents / abstracts / publications.
- Core member of the Global Program Team to maintain an advanced understanding of the status of all trial activities with the program to facilitate proactive risk identification and mitigation plans; provides progress reports and risk assessment updates to Sr. Leadership.
- Served as the Clinical Development Team co-chair as an intermediary decision-making body between study teams and GPT maintaining clear lines of communication.
- Developed Study Team, Clinical Development Team, Global Program Team escalation guidance for Cell Therapy organization.
- edRepresent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities. Notably 1) DRP optimization 2) Fast-track protocol development 3) CDT Operating Model 4) MyGrowth Change Champion 5) Clinical Protocol Community of Practice.
- Member of Data Standards Review Committee for Cell Therapy and Hem-Onc.
- Responsible for objective setting, development plans, and people management of up to 3 team lead managers. Skip level management of up to 18 clinical scientists.
- Supports resource forecasting, talent development, succession planning and retention strategies.
- Oversight of all cell therapy process improvement initiatives related to AI usage, data standard and review improvements, and competitive intelligence benchmarks.
Clinical Scientist Team Lead (Director)
Bristol Myers Squibb
02.2021 - 01.2022
- Facilitated cross-asset data standards and ensured clarity in protocol amendment strategy as key liaison to Clinical Center of Excellence for cell therapy programs.
- Advocated for BMS integration by coordinating communication among stakeholders to align project goals.
- Lead Development of orva-cel Program and Cell Therapy Long-Term Follow-up study.
- Member of Data Standards Review Committee for Cell Therapy and Hem-Onc.
- Defined objectives and development plans while supervising a team of 3 direct reports to achieve project milestones.
Global Trial Director (Director)
Novartis
07.2017 - 02.2021
- Lead development of Kymriah DLBCL program.
- Chaired Clinical Trial Team for second line lymphoma study, led start-up activities including literature review, protocol development, and budget forecasting.
- Oversaw trial management activities to ensure timely execution of global clinical studies, enhancing overall project delivery.
- Chaired CTT for 3rd line lymphoma study in maintenance phase, ensuring timely delivery of RMP commitments through follow-up on CSRs and HA responses.
- Provided key oversight and input on protocol development for BCMA CART study in Multiple Myeloma to ensure aligned transition from Phase 1 to Phase 2.
- Experienced in managing large budgets and identifying key savings and cost risks for consideration to executive leadership.
- People management including objective setting and development profiles multiple direct reports.
- Subject Matter Expert on eCTD Clinical Submission deliverables.
- Best Practices Sharing Coordinator for TransCelerate – Clinical Content and Reuse team, developed SOP for execution and follow-up of feedback sessions.
Senior Clinical Trial Head (Associate Director)
Novartis
07.2016 - 06.2017
- Lead development of Kymriah for second line treatment in aggressive NHL.
- Drafted protocol concepts and led discussions with study steering committee and KOLs to refine study design in response to Health Authority feedback on second line NHL protocol.
- Oversaw Kymriah Legacy Trial Program by managing budget forecasting and development, addressing quality issues, aligning data, and leading data safety and monitoring board meetings.
- Managed critical Phase I/IIA pediatric trial in r/r ALL patients, including protocol writing, serving as CTT leader, developing clinical budgets, leading data review teams, providing clinical input on statistical plans, reviewing CSR, and managing clinical operations.
- Managed Long-Term Follow-up (LTFU) protocol as CTT leader, overseeing study budget, guiding statistical analysis plans, managing protocol lifecycle, coordinating vendor management for labs and IRT, and reviewing data with global monitoring operations.
- Clinical Submission Sub-team Lead for initial BLA filing: lead team by chairing regular meetings to track key Module 1, 2, and 5 eCTD deliverables. Worked closely with medical writers and project management to ensure document writing plans are in accordance with overall submission plan. Provided regular feedback to global submission team led by DRA. Coordinated training for administrative deliverables and processes to ensure high on-time high quality eCTD submission.
- Contributed to FDA rapid response team by compiling data and drafting responses to information requests driven by data and process.
- Prepared Statement of Conformity, Financial Disclosure, Synopsis of Clinical Studies, Tabular Listing of Clinical Studies, and BIMO/OSI request modules.
Clinical Trial Head (Manager)
Novartis
01.2013 - 06.2016
- Management of critical Phase I/IIA pediatric trial in r/r ALL patients. Responsibilities include protocol writing, CTT leader, clinical budget development, data review team leader, clinical input on statistical plan development, clinical operations management.
- Coordinated clinical submissions for the initial IND submissions and collaborated with regulatory affairs to deliver key clinical documents, including the General Investigational Plan, Investigator Brochure, Study Protocol, Transfer of Obligations, and detailed responses to FDA CBER on clinical trial operations.
- Coordinated clinical submissions for initial BLA filing, collaborated with regulatory affairs to track summary documents and CSRs, resolved submission issues, and facilitated training for administrative processes, ensuring high-quality and timely eCTD submissions.
- Delivered key program-level outputs for initial IB preparation, DSUR filing, and IND filing; compiled cross-functional input for initial IB using UPenn IND data, developed a registration-quality database for UPenn Phase I data, authored DSUR sections, prepared appendices, performed QC on briefing books, responded to FDA inquiries, and completed IND deliverables.
- Delivered key program-level outputs for initial IB preparation, DSUR filing, and IND filing; compiled cross-functional input for initial IB using UPenn IND data, developed a registration-quality database for UPenn Phase I data, authored DSUR sections, prepared appendices, performed QC on briefing books, responded to FDA inquiries, and completed IND deliverables.
- Mentored a new manager from the team on appropriate staffing of the clinical team, delegation, objective setting, conflict management, and performance reviews.
Clinical Trial Head (Manager)
Novartis
01.2011 - 12.2013
- Managed the Signifor Cushings Disease program, including leading the Clinical Trial Team (CTT), and managing the team for all maintenance, and reporting activities for the pivotal Phase III trial, and the ongoing Phase II extension.
- Managed Sandostatin LAR program, leading Clinical Trial Team (CTT) and overseeing all start-up, maintenance, and reporting activities for registration bioequivalence trial and new formulation PK trial.
- Oversaw the preparation of submission profiles for FDA filing for Signifor, including timeline management and draft profile reviews.
- Coordinated FDA 90-day safety update, clinical deliverables for FDA sponsor-monitor inspection, and wrote responses regarding trial conduct to support Signifor approval.
- Coordinated and wrote select responses for Sandostatin LAR country level filings.
- Coordinated and acted as a key author on original filing for Sandostatin LAR posology.
- Managed 3 direct reports including objective setting and development profiles.
- Co-authored remediation response on behalf of the office of Novartis CEO.
- Served as key stakeholder in two high-level operational process improvement initiatives: (1) data validation and cleaning, (2) e-roadmap.
Expert Clinical Manager (Senior Associate)
Novartis
12.2008 - 12.2010
- Managed Sandostatin LAR program, authoring protocols and amendments, leading Clinical Trial Team (CTT), overseeing start-up, maintenance, and reporting for two key Phase I PK registration trials.
- Submission manager for two Sandostatin LAR filings (1) 30 mg vial, (2) 40 mg posology.
- Executed start-up activities for IIT for FDA filing for Signifor (Cushing’s Disease), managing protocol development, drug supply, and cost estimates.
- Conducted site initiation visit for 2 trials under the Sandostatin LAR program.
- Authored Epidemiology Section of Signifor EMEA Risk Management Plan (RMP).
- Mentored 1 new hire, served as an ad interim manager to a second new hire for the Signifor glucose tolerance study.
- Key stakeholder in 2 high level operational process improvement initiatives: (1) Clinical program team re-launch, (2) Start-up roadmap/e-roadmap.
Clinical Research Specialist
Merck and Co., Inc.
08.2008 - 12.2008
- Authored and managed vendor deliverables for CSR of key trial assessing Zocor dosing effects on long-term outcomes in SEARCH.
- Led CRS for Phase II trial of a heart failure compound assessing effects on coronary blood flow using imaging. Managed protocol authoring and key start-up deliverables.
- Authored the manuscript that detailed week 1 results of a longitudinal cohort study on niacin users.
- Cardiovascular Disease Department
Epidemiology Program Coordinator
Merck and Co., Inc.
06.2007 - 08.2008
- Coordinated scientific expert panel meetings, developed protocols, monitored CRO activities, and provided clinical support for high priority vaccine program (V212), ensuring project alignment with regulatory standards.
- Conducted descriptive and hypothesis testing statistical analysis for prospective longitudinal cohort study (OR3) of niacin users, contributing to validation report for Flushing Impact Questionnaire (FIQ) and supporting regulatory responses, early results memos for senior management, and high priority abstract presented at ACC 08.
- Coded and analyzed SAS output to determine incidence rates of heart failure co-morbidities from National Inpatient Sample (NIS) data, providing insights for epidemiological assessments.
- Authored systematic literature review of morbidity and mortality estimates of Renal insufficiency related to heart failure for MK-7418 (rolofyline) program.
- Patient Reported Outcome (PRO) development for key Phase II Neuroscience and Oncology compounds (MK-0249 and MK-8669).
- Authored Epidemiology sections of MK-0524A and Varivax EMEA-Risk Management Plan (RMP).
- Epidemiology Department (CRS Rotation Program)
Associate Medical Program Clinical Specialist/Clinical Research Specialist
Merck and Co., Inc.
06.2004 - 06.2007
- Led Phase III critical path filing trial from study start-up to frozen file for MK-0524A (P023). Managed clinical team of four through data review, drug supply, PRO compliance monitoring, SAE reporting, and site management. Achieved start-up to Protocol Approval in under 6 weeks. Completed study on time and managed CSR writing, including safety and discussion sections, alongside regulatory responses for this study.
- Led Phase II safety extension trial (P015) from start-up to database lock. Managed CTT activities, patient tracking, protocol amendments, drug supply, site management, SAE reporting, and data review. Co-authored CSR integrating this study with two other safety extensions.
- Co-led pivotal 24-week, 3-arm Phase III study in MK-0524A program. As PRO lead, developed compliance monitoring tool for primary endpoint and monitored 10 clinical sites, including data review, SAE reporting, and addressing clinical site inquiries.
- Supported 4 studies in Phase II program for MK-0524A (011, 026, 026-DC, 032). Key responsibilities included authoring IND safety update, drug supply management, SAE reporting, medical data review, clinical decision making, ad-hoc analyses, clinical team management, and vendor management. Authored P026 CSR, and P026-DC aCSR.
- Authored Periodic Safety Update Report (PSUR) for Zocor.
- Cardiovascular Disease Department
Clinical Research Coordinator/Junior Statistician
Mount Sinai School of Medicine
09.2002 - 06.2004
- Supervised data collection efforts for a large biorepository for use in future cancer research, in coordination with Exact Sciences.
- Managed large multi-centered case-control breast cancer study database.
- Provided statistical analysis for several projects assessing the breast cancer genetic polymorphisms in combination with treatment and their effect on survival.
- Performed statistical analysis and background research for development of a new biomarker for breast cancer.
- Monitored NIH-funded project for GCP compliance, preparing and reviewing case-reports and SAE reports to ensure human subject protection.
- Built biorepository tracking database, and biostatistics core database.
- Prepared documentation for IRB, NIH, and Exact Sciences grant progress reports, ensuring adherence to regulatory requirements.
- Derald H. Ruttenberg Cancer Center, Prevention and Control Program
Research Scientist
New Jersey Department of Health and Senior Services
09.2001 - 09.2002
- Developed SAS code, analyzed output, and authored reports for process monitoring data, ensuring compliance with CDC Evaluation Guidance.
- Oversaw vendor (Eagleton) and coordinated data collection, analysis, and resolution of project issues for a large multi-centered Outcomes Research study.
- Conducted analyses and delivered presentations to support additional AIDS prevention initiatives.
- Division of AIDS Prevention and Control, Prevention and Education Unit
Education
M.P.H. - Epidemiology
The George Washington University
Washington, DCB.S. - Public Health
Rutgers University – Rutgers College
New Brunswick, New JerseySkills
- Skilled leader of teams within a matrix organization
- Regulatory document authoring
- Publication authoring
- Media trained for abstract/poster presentations
- Clinical speaking engagements
- Proficient in MS Office
- Proficient in intermediate techniques of data management and analysis with SAS
- Working knowledge of SPSS
- Regulatory submissions
- Clinical trial design
- Protocol development
- Team leadership
- Program management
- Risk assessment
- Mentoring and coaching
- Strategic planning
- Adverse event reporting
- Clinical trial oversight
- Informed consent
- Clinical data interpretation
Affiliations
- Rutgers Alumni Association
- George Washington Alumni Association
Accomplishments
- Chief Medical Office Acceleration - Execution award recipient 2024 (KarMMa-3 Team ODAC and SAGO)
- 4 Time Novartis Vision/Star Award Recipient 2010 (Eroadmap Development), 2012 (Signifor Inspection Team), 2014 (CTL IND Start-up team), 2017 (CTL pediatric ALL Clinical Submission Subteam)
- CGTU Special Achievement Award (Kymriah Submission Milestone)
- Cardiovascular Department Special Achievement Award (Merck & Co., Inc.)
References
Available upon request
Publications
- Ide-Cel Real-World (RW) and Clinical Trial Long-Term Safety Experience: A Special Focus on Movement and Neurocognitive Treatment Adverse Events (MNT AEs) and Second Primary Malignancies (SPMs)., Abonour, R, Kitali A, Gipson A, Trovato A, Shanker M, Chiang M, Gunda A, Park S, Truppel-Hartmann A, Schuberth P, Rodriguez-Otero P., Clinical Lymphoma and Myeloma, 2024, 24S2, PS40
- Long-term pasireotide use leads to improvements in the biochemical parameters of Cushing’s disease: 24-month results form a randomized phase III study., Schopohl J, Bertherat J, Ludlam W, Maldonado M, Trovato A, Hughes G, Gu F, Salgado L, Pivonello R., Endocrine Abstracts, 2012, 29, P1410
- Long-term use of pasireotide in Cushing’s disease: 24-month safety results from a randomized phase III study., Bertherat J, Ludlam W, Pivonello R, Maldonado M, Trovato A, Hughes G, Gu F, Schopohl J, Salgado L., Endocrine Abstracts, 2012, 29, P1405
- Pasireotide treatment is associated with improvements in hypertension: 12-month results from a large phase III study in Cushing’s disease., Pivonello R, Petersenn S, Newell-Price J, Gu F, Maldonado M, Trovato A, Hughes G, Salgado L, Lacroix A, Schopohl J, Biller B., Endocrine Abstracts, 2012, 29, P1406
- Pasireotide treatment is associated with clinically meaningful improvements in health-related quality of life in Cushing’s disease: results from a large, randomized, double-blind phase III trial., Webb S, Badia X, Zgliczynski W, Portocarrero-Ortiz L, Maldonado M, Trovato A, Forsythe A, Nelson L, McLeod L, De Block C, Gadelha M., Endocrine Abstracts, 2012, 29, P1408
- The Impact of Niacin-Induced Flushing during the First Week of Therapy in a Real World Setting., Trovato AT, Norquist JM, Rhodes T, McQuarrie, K, Miller TB, Paolini, JF, Watson DJ., JACC, 2008, 51, 10 Supplement A, 11 March 2008, A255
- Polymorphisms in Genes Related to Oxidative Stress (MPO MnSOD, CAT) and survival after treatment for breast cancer., Ambrosone C, Ahn J, Singh KK, Rezaishiraz H, Furberg AH, Sweeney C, Trovato A., Cancer Research, 2005, 65, 3, 1 Feb 2005, 1105-11
- Association of genetic variation in tamoxifen-metabolizing enzymes with overall survival and recurrence of disease in breast cancer patients., Nowell SA., Ahn J, Rae JM, Scheys JO, Trovato A, Sweeney C, MacLeod SL, Kadlubar, Ambrosone CB., Breast Cancer Research and Treatment, 2005, 91, 3, June 2005, 249-258
- The Arg399Gln polymorphism in the X-ray Repair Cross-Complementing Group 1 (XRCC1) and breast cancer survival among women treated with chemotherapy and radiation., Furberg AH, Trovato A, Sweeney C, Stone A, Ambrosone CB., American Association of Cancer Research 34th Annual Meeting, Toronto, Canada, April 2003/July 2003
- Endorectal Magnetic Resonance Imaging: Impact On Prostate Cancer Detection And Prostate Cancer Risk Stratification In Men With Prior Negative Prostatic Biopsy., Perrotti M, Shurtleff B, Rabhani F, Trovato A, Kennedy E, Epstein R, Thomas K, Kolessa A, Weiss R, Cummings K., Journal of Urology Annual Meeting, Atlanta, Georgia, June 2000
- Brownfields Redevelopment as a Tool for Smart Growth: Analysis of Nine New Jersey Municipalities., Miller T., Greenberg M., Lowrie K., Mayer H., with the assistance of Lambaise A., CCIM, Novis R., Ioannides, D., Meideros, S., and Trovato A., Office of State Planning, March 16, 2000, http://www.state.nj.us/osp/brownfld/rc030800.htm
Timeline
Clinical Scientist Program Lead (Senior Director)
Bristol Myers Squibb
01.2022 - Current
Clinical Scientist Team Lead (Director)
Bristol Myers Squibb
02.2021 - 01.2022
Global Trial Director (Director)
Novartis
07.2017 - 02.2021
Senior Clinical Trial Head (Associate Director)
Novartis
07.2016 - 06.2017
Clinical Trial Head (Manager)
Novartis
01.2013 - 06.2016
Clinical Trial Head (Manager)
Novartis
01.2011 - 12.2013
Expert Clinical Manager (Senior Associate)
Novartis
12.2008 - 12.2010
Clinical Research Specialist
Merck and Co., Inc.
08.2008 - 12.2008
Epidemiology Program Coordinator
Merck and Co., Inc.
06.2007 - 08.2008
Associate Medical Program Clinical Specialist/Clinical Research Specialist
Merck and Co., Inc.
06.2004 - 06.2007
Clinical Research Coordinator/Junior Statistician
Mount Sinai School of Medicine
09.2002 - 06.2004
Research Scientist
New Jersey Department of Health and Senior Services
09.2001 - 09.2002
M.P.H. - Epidemiology
The George Washington University
B.S. - Public Health
Rutgers University – Rutgers College