Results-oriented, proactive, excellent organization, communication and relationship-building skills.
Regulatory Review Expertise
Public policy background
Directed OCS to develop the JumpStart service. JumpStart received the "Secretary's Pick" Health and Human Services (HHS) Innovates award for its service to reviewers during the early stages of the regulatory review process.
Directed OCS to support regulatory reviewers by providing access to analytical tools, technology, services, and training. Tools and services include: JumpStart, Janus Clinical Trials Repository (CTR), Nonclinical Information Management System (NIMS), Clinical Reviewer Portal, MedDRA Adverse Events Diagnostics (MAED), JReview, and DataFit as well as Statistical Programming Support.
Directed the development of the Janus Clinical Trials Repository (CTR) in CDER to support loading, management, and integration of clinical trials data.
Directed OCS to develop a comprehensive training program providing an integrated approach based on reviewer needs and priorities.
Directed publication of SDTM and SEND validation rules making plain language validation rules available to the public for the first time.
Office of Computational Science, Office of Translational Sciences, CDER, FDAWhite Oak, MDDirector
Serves as director of the Office of Computational Science (OCS).
Provides timely executive-level input to make strategic and tactical plans affecting the scientific computing direction of CDER.
Formulates policy directives that form the framework for OCS's programs. Sets the agenda for OCS-sponsored projects and staff.
Represents OCS at Center and higher levels on computational science matters of major significance to the Agency as well as scientific and professional groups within and outside the Federal government with regard to regulation, policies, and evaluation of activities.
Supervises and manages interdisciplinary staff on the full range of regulatory review, policy developments and the implementation of activities and projects to support the mission of CDER.
Supervises staff and manages human resource-and personnel matters including recruitment, performance appraisals reward and recognition and staff professional development.
Directly supports data standards development and implementation in close collaboration with the Office of Strategic Programs.
Identifies and assesses emerging, standing, complex or precedent-setting issues impeding the operational procedures, policies, activities, and resources of CDER.
Develops budget formulation and execution process and provides budgetary approval for OCS
Establishes collaborations including research, workshops, working groups, and partnership with other HHS and FDA entities.
Office of Regulatory Science and Innovation, Office of the Commissioner, FDAWhite Oak, MDAssociate Director /Senior Policy Analyst
Served as director for Janus Program and ensured alignment with FDA American Recovery Reinvestment Act Patient Centered Outcomes Research (ARRA PCOR)-funded activities and Office of the Chief Scientists' Office of Regulatory Science and Innovation (ORSI) initiatives.
Directed and provided leadership for strategic program planning, management of all aspects of program, including resources and budget.
Served as business lead and member to the ARRA PCOR Governance Board. Directly contributed and managed the creation of the ARRA PCOR program that allocated $21.12 million to four inter-related projects including 1) the development and implementation of a Janus Clinical Trials Repository (Janus CTR) 2) Standardization of legacy study data from clinical studies relevant to specific questions on comparative effectiveness research (LDC Program) 3) Purchase of servers and firewalls to support scientific computing 4) Creation of a Partnership in Applied Comparative Effectiveness Science (PACES) Center.
Served as executive sponsor/business lead for the ARRA PCOR Legacy Data Conversion Program and ensures alignment with FDA's ARRA funded activities.
Office of Critical Path Programs, Office of the Commissioner, FDARockville, MDAssociate Director NonClinical Data Standards /Senior Policy Analyst
Served as principal adviser to the Janus Executive Sponsor for initiatives related to HL7 study data standards and animal toxicology.
Served as Agency lead in animal toxicology workstream of Janus Program.
Directed and lead the effort to develop and test a study data standard for animal toxicology studies (SEND) as a cross-Center data analysis standard.
Provided strategic product development planning, including nonclinical, clinical, and labeling advice, for sponsors submitting regulatory packages to the US FDA and other worldwide regulatory authorities for new, reformulated, generic, and combination products.
Assisted clients in the development of targeted product planning strategies, focused development schema, and optimized timing of nonclinical studies and clinical trials to promote efficient product development and expedited regulatory timelines.
Lead the development, including scientific and budgetary considerations, and review of regulatory submissions to the US FDA during pre-IND, IND, NDA and post-NDA phases of product development.
Assisted sponsors in focusing communications with regulatory authorities, developing communication plans for meetings and inquiries, develop questions and responses to FDA communications.
Office of New Drugs Immediate Office, CDER, FDASilver Spring, MDTeam Leader Study Endpoints and Labeling Development Team
Served as Team Leader and Center expert for OND's initiatives on labeling development, including Physician Label Rule (PLR) and Structured Product Labeling (SPL) in the Immediate Office, Office of New drugs, Study Endpoints and Labeling Development (SEALD) Team.
Managed a multidisciplinary working team with skills including scientific, clinical, regulatory policy, marketing/advertisement, chemistry/compliance and coding-Structured Product Labeling.
Provided leadership and pharmacology and medical expertise to support the development of the policy around determining pharmacological class.
Developed Guidance for Industry "Labeling for Human Prescription Drug and Biological Products - Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information"
Center for Drug Evaluation and Research, Office of Oncology Drug Products, OND, CDER, FDASilver Springs, MDSenior Pharmacologist
Reviewed non-clinical pharmacology, pharmacokinetics, and toxicology studies submitted with Investigational New Drug Applications (INDs) and New Drug Applications (NDAs).
Area of expertise included the review of oligonucleotide therapeutics, in particular antisense phosphorothioate oligonucleotides.
Developed guidelines and policies to enhance intra-and inter-divisional consistency of review issues and regulatory actions related to oligonucleotide drug product development.
Lead the development of a "Best Practices" document on submitting nonclinical data with a VGDS. Participated in the review of nonclinical data submitted as a Voluntary Genomic Submission (VGDS).
Fox Chase Cancer CenterPhiladelphia, PA, USAPost Doctorate: Resistance to Chemotherapeutic agents
Rutgers University-Center for Molecular and Behavioral Neuroscience Newark, New Jersey, USAPh.D.: Neuroscience
University of Puerto Rico, Rio Piedras CampusRio Piedras, PR, USBachelor's Degree: Chemistry