Julie S Engel
Jacksonville,FL
Summary
Regulatory affairs and clinical development leader with deep experience in drug, diagnostic, and combination-product strategy across biotech, pharmaceutical, and diagnostics programs. Leads global submissions, health authority interactions, and co-development planning for CDx, IVD, SaMD, and precision medicine programs, with hands-on experience across FDA, PMDA, EU, and other markets.
Overview
2028
2028
years of professional experience
Work History
Independent Regulatory Affairs Strategy Consultant
Self Employed Web
Jacksonville, Florida
01.2019 - 12.2027
- Provide co-development (drug and diagnostic) regulatory strategy to the pharmaceutical and diagnostics industries with an emphasis on startup/emerging companies.
- Prepared regulatory strategy and coordinated pre-submission and FDA meeting with CDRH for de novo CDx approval
- Formulated CDx strategy for glioblastoma multiforme therapeutic, focusing on enhancing patient outcomes (Sept. 2020 - 2021)
- CDx strategy (BDD) for minimal residual disease (MRD) for early detection of recurrence post standard of care therapy. (March 2022 July 2022) (de novo)
- Long-acting Growth Hormone biosimilar BLA (Jan 2022- Feb 2023)
- Led combined trial for PD-L1 assay in immune-oncology drug registration. (PD-L1 assay for an immune-oncology drug) for EU registration (February 2024 ongoing)
- Guided co-development projects for de novo application in pathology breast cancer.
Principal Consultant MedTech
Parexel International, Inc.
- SaMD - several projects, including preparing BDD and De Novo applications; interactions with the FDA on presubmissions; preparation/management of several 510(k)s
- Directed CDx/IVD projects, including digital pathology collaborations with major digital AI companies.
- Facilitated eSTAR 510(k) and De Novo submissions for a kidney stone extractor and an at-home OTC self-insemination kit.
- Ensured adherence to CAP and CLIA standards, facilitating successful inspections by NYS DOH.
Principal Consultant
Opus Regulatory
- Crafted combination product strategies for PFS and AI, aligning with market needs
- Streamlined biosimilar submission process in EU, enhancing regulatory compliance
- PIK3CA Ovarian and Breast Cancer trials EU and China
Sr. Director, Biomarkers and Molecular Diagnostics
CYTEIR THERAPEUTICS
01.2018 - 01.2021
- Cyteir, a start-up BioTechnology company with backing in part from Celgene
- Developed companion diagnostic and pharmacodynamic assays for Cyteir's lead compound, CYT-0851, a RAD51 inhibitor, including gene expression profiling, mutational signatures, and IHC foci assays; collaborated with pathologist to identify DNA Damage Response (DDR) biomarkers for patient selection in preclinical models, utilizing digital pathology for slide scoring and analysis.
- Led co-development of companion and pharmacodynamic biomarkers and assays for Cyteir's therapeutics, ensuring compliance with regulatory affairs, quality standards, partner selection, and contract negotiations.
- Managed regulatory affairs for lead compound and companion diagnostics (CDER/CDRH), overseeing clinical trial design and execution, IND submissions, meeting requests, and briefing books.
Translational Development and Companion Diagnostics Regulatory Affairs
CELGENE CORPORATION
01.2017 - 01.2018
- Regulatory lead for all programs covered by Precision Medicine.
- Secured IDIFA/IDH2 approval in the US, streamlining regulatory processes for additional products.
- Lead interactions with global regulatory agencies including PMDA.
- Led software device collaboration with external partner; coordinated FDA meetings and presented strategy to achieve regulatory approval.
- Worked with internal and external partners and KOLs to develop complex assays for Celgene's drugs in development.
- Conducted educational training on diagnostic development and regulatory affairs, which enhanced team knowledge and compliance.
Regulatory Program Manager, Companion Diagnostics PHC
ROCHE DIAGNOSTICS, Inc.
01.2011 - 01.2017
- ROCHE PROFESSIONAL DIAGNOSTICS, INC. INDIANAPOLIS, IN 2011 2014
- ROCHE TISSUE DIAGNOSTICS, TUCSON AZ 2014 - 2017
- Director, Companion Diagnostics Regulatory Affairs
- Head of Regulatory for all Roche Tissue Diagnostics (Ventana) companion diagnostics programs that include interaction with internal and external Pharma partners, whether for companion diagnostics, complementary diagnostics, or IVD/CE assays. Oncology products (PD-L1, ALK, others); Other therapeutic areas CNS products (A, others).
- Global CDx Coordinator for all Roche Business Units (Roche Molecular, Roche Diagnostics Corp., Roche Tissue Diagnostics) for regulatory issues including biomarker subteams, pharma partners, etc. Help define the processes for co-development of drugs and diagnostics across the Roche organization.
- Collaborated with Pharma partner to develop regulatory strategy and manage health authority interactions, facilitating 4-sided meetings (Pharma/Diagnostics/CDER/CDRH) to align goals and streamline communication.
- Led major submissions (PMAs/sPMAs, 510Ks, multiple Pre-submissions and SRDs etc.); VENTANA ALK (D5F3) CDx Assay for crizotinib approved 12JUN2015. VENTANA PD-L1 (SP142) Assay for TECENTRIQ approved 18MAY2016 for mUC and October 18, 2016, for NSCLC; sPMA for ALK on ULTRA approved October 2016. ALK for ceritinib approved May 2017. Others.
- Responsible for global regulatory including Canada, Australia, Japan, South Korea, EU, UK, Latam, etc. Includes IVD readiness.
- Hired, trained, and managed regulatory staff (6 Sr/Managers including PhDs, 3 Sr/Regulatory Specialists)
- SME representative on AdvaMed for PMMD subteam; presentations at RAPS, others, etc..
- Won Best Project of the Year across all of Roche Diagnostics in 2017 for ALK approval
- Directed projects collaborating with internal and external Pharma partners on companion diagnostics and IVD/CE diagnostic assays for Alzheimer's disease and schizophrenia, enhancing alignment on regulatory pathways and timelines.
- Trained and mentored junior regulatory staff on compliance and submission processes, fostering skill development and ensuring adherence to regulatory standards.
- Led information presentation to FDA on Alzheimer's Disease and the diagnostic assay strategy/development approach
Director, Global Regulatory Affairs, US Autoimmune Platform
ELI LILLY & COMPANY
INDIANAPOLIS, IN
01.2009 - 01.2011
- Developed regulatory strategy for Lilly autoimmune platform, guiding molecules for psoriasis, rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
- Led regulatory liaison with FDA for assigned projects, collaborating across drug divisions including dermatology, pulmonology, and gastroenterology.
- Directed cross-functional programs for Eli Lilly global pharmaceutical teams.
- Led strategy reviews with research, clinical, regulatory, and commercial stakeholders.
- Oversaw planning for pipeline priorities and portfolio governance.
Executive Director, Clinical Development
REGENERON PHARMACEUTICALS, INC.
TARRYTOWN, NY
01.2008 - 01.2009
- Managed Clinical Trial Management and Project Management oversight for Global Phase III clinical programs in inflammation (Rilonacept) and ophthalmology (EYLEA).
- Developed strategies for conducting clinical research in Translational Medicine in the areas of Oncology, Ophthalmology, and Inflammation. Provided clinical leadership and oversaw/managed the direction, design, planning, resourcing, implementation, data collection, analysis and interpretation of clinical studies and programs to support the clinical development of the company's product candidates in all phases of clinical development (I-IV).
- Managed cross-functional teams to drive development of novel therapeutics from concept through clinical trials.
- Oversaw daily operations of 40-member staff, guiding 11 Sr. Directors to achieve clinical development goals.
- Led Therapeutic Area Project Management, Clinical Trial Management, Medical Writing, and Clinical Finance and Logistics.
- Established risk management processes; led teams in identifying, mitigating, and managing risks and opportunities.
VP, Clinical and Global Regulatory Affairs
CYTHERIS INC.
ROCKVILLE, MD
01.2004 - 01.2008
- Provided clinical development and global regulatory affairs leadership, strategy, and process expertise to successfully drive recombinant human IL-7, a biologic/cytokine and immune enhancing agent, through the clinical and regulatory process in the U.S. and Canada.
- Led regulatory and drug development organization in the US and defined regulatory and clinical strategy for ROW.
- Served as FDA liaison for regulatory issues in oncology and HIV programs. (Division of Oncology Drug Products; Division of Anti-Viral Products) for oncology and HIV programs; Health Canada contact for regulatory issues for HIV program
- Oversaw clinical trial operations and project management for 5 new monoclonal antibodies and 4 INDs in translational medicine.
- Prepared and managed 5 INDs in oncology, and INDs for HIV, HCV, BMT conducted studies in US, France, Italy, Canada, Switzerland, China.
- Prepared and managed 5 INDs in oncology, and INDs for HIV, HCV, BMT conducted studies in US, France, Italy, Canada, Switzerland, China.
- Coordinated selection and management of CROs and consultants for clinical trials.
Director, Clinical Affairs
ENDOCYTE INCORPORATED
WEST LAFAYETTE, IN
01.2003 - 01.2004
- Overall responsibility for all products in clinical development (Folate Receptor-targeted Imaging agent as a companion diagnostic for Folate Immunotherapy in renal cell carcinoma and ovarian cancer as well as other solid tumors expressing the folate receptor; Folate chemotherapy).
- Championed acceptance of Folate Scan imaging agent over tissue biopsy IHC, enhancing patient identification for Folate Immunotherapy in renal cell carcinoma.
- Designed, implemented, and managed all Endocyte's clinical programs.
- Supervised clinical department personnel, fostering team development and ensuring project alignment with clinical objectives.
Director, Clinical Projects
IMCLONE SYSTEMS INCORPORATED
BRANCHBURG, NJ
01.2000 - 01.2003
- Directed gp75 DNA vaccine clinical project for melanoma; achieved IND approval and completed Phase I FIH proof of concept study.
- Led clinical project for anti-angiogenesis program; collaborated with multidisciplinary team to develop clinical program for anti-angiogenesis compounds.
- Supported Core Team for Erbitux eBLA, concentrating on labeling strategy to ensure compliance and accuracy.
Sr. Therapeutic Area Associate/Sr. Clinical Project Manager
ELI LILLY and COMPANY
INDIANAPOLIS, IN
01.1998 - 01.2000
- Facilitated GEMZAR bladder sNDA submission to FDA, contributing to timely regulatory approval..
- Managed global, multicenter randomized GERMZAR clinical trials for registration in US and OUS, ensuring compliance with regulatory standards.
- Received commendation from company for work completed on a safety analysis for Zyprexa that was urgently requested by the FDA
- Prepared monograph on Combined Modality Radiation and GEMZAR Therapy in NSCLC, supporting US Marketing Team's strategic initiatives.
Sr. Manager, Clinical Research
PHARMACYCLICS, INC.
SUNNYVALE, CA
01.1993 - 01.1998
- Led clinical ops department, planning and executing preclinical and clinical studies for Xcytrin, GADOLITE, and lutetium texaphyrin while ensuring compliance with regulatory standards.
- Led cross-functional oncology development plans within biopharmaceutical programs.
- Managed clinical operations support for investigational drug studies.
- Coordinated regulatory document preparation for FDA submissions.
Education
NIH Post Doctoral Fellow - Department of Microbiology and Cell Science
University of Florida
Gainesville, FloridaDoctor of Philosophy - Basic Medical Sciences
New York University School of Medicine
New York, New YorkMaster of Science - Basic Medical Sciences
New York University School of Medicine
New York, New YorkBachelor of Arts - Biology
Hofstra University
Hempstead, New YorkSkills
- Regulatory planning
- FDA applications
- Companion diagnostics development
- Clinical development strategy
- Clinical trial planning
- Combination product development
- Cross-functional collaboration
Affiliations
American Society for Clinical Oncology; Drug Information Association; Regulatory Affairs Professional Society; American Public Health Association
Other
- Regulatory Affairs Certification (RAC) - 2011
- RAPS eCTD and Advanced eCTD courses 2011
- Courses towards Masters in Public Health at George Washington University - degree pending
- Purdue University Lecturer for courses in Biotechnology and Regulatory Affairs
Timeline
Independent Regulatory Affairs Strategy Consultant
Self Employed Web
01.2019 - 12.2027
Sr. Director, Biomarkers and Molecular Diagnostics
CYTEIR THERAPEUTICS
01.2018 - 01.2021
Translational Development and Companion Diagnostics Regulatory Affairs
CELGENE CORPORATION
01.2017 - 01.2018
Regulatory Program Manager, Companion Diagnostics PHC
ROCHE DIAGNOSTICS, Inc.
01.2011 - 01.2017
Director, Global Regulatory Affairs, US Autoimmune Platform
ELI LILLY & COMPANY
01.2009 - 01.2011
Executive Director, Clinical Development
REGENERON PHARMACEUTICALS, INC.
01.2008 - 01.2009
VP, Clinical and Global Regulatory Affairs
CYTHERIS INC.
01.2004 - 01.2008
Director, Clinical Affairs
ENDOCYTE INCORPORATED
01.2003 - 01.2004
Director, Clinical Projects
IMCLONE SYSTEMS INCORPORATED
01.2000 - 01.2003
Sr. Therapeutic Area Associate/Sr. Clinical Project Manager
ELI LILLY and COMPANY
01.1998 - 01.2000
Sr. Manager, Clinical Research
PHARMACYCLICS, INC.
01.1993 - 01.1998
Principal Consultant MedTech
Parexel International, Inc.
Principal Consultant
Opus Regulatory
NIH Post Doctoral Fellow - Department of Microbiology and Cell Science
University of Florida
Doctor of Philosophy - Basic Medical Sciences
New York University School of Medicine
Master of Science - Basic Medical Sciences
New York University School of Medicine
Bachelor of Arts - Biology
Hofstra University