Judith Steenbergen, Ph.D. Email & Phone Number

Newtown, Pennsylvania, Us

Bringing flexible, data-driven scientific and medical affairs expertise to bridge development and launch providing: o Strategic Scientific and Medical Affairs Consulting to small Biotechnology companies o Focusing on medical affairs function planning and budgeting in alignment with company goals and in collaboration with key internal stakeholderso Specializing in global scientific strategies, including scientific platform development, publication planning, data gap analysis, and lexicon development o A core capability of thought leader identification, engagement, and advisory board planning, content development, and execution o Operational infrastructure support to help build medical affairs organizations, including SOP development and vendor selection and managemento Support small companies in drug development: provide support in data gap analysis and IND/NDA writing, FDA advisory committee preparation, and label negotiations. Leading all strategic and operational activities of the organization, which consists of 8 employees and contractors.

Boston, Ma, Us

As the VP of Medical Strategy and Communications, I define and execute an integrated, long-term, strategic plan to align with the overall corporate strategy and lead all medical affairs activities. I am responsible for providing scientific and medical leadership towards establishing an in-depth understanding of the medical landscape in relation to infectious diseases and Paratek products. In addition, I lead and develop the medical affairs team, and I ensure close cross-functional collaboration to achieve corporate objectives and further the medical affairs mission to maximize patient outcomes by advancing the evidence-based medical standard of care.

Boston, Ma, Us

In this role, I was responsible for the design and implementation of clinical microbiology programs required to support IND submissions and NDA submissions. I provided quality, comprehensive data to support microbiology, including breakpoint for all anti-infective NDA and other regulatory filings. I provided science and microbiology expertise for competitive intelligence and due diligence reviews of new chemical entities and products. In addition, I led the strategic planning and execution of external non-human research, publication planning, competitive research strategy and antimicrobial susceptibility testing platform development, including managing timelines and budgets.Furthermore, I conducted high-level scientific and strategic interactions with employees and KOLs, communicating all concepts, ideas and information.

As president, I provided clinical trial support to small and mid-size pharmaceutical companies and CROs with phase II and III antibiotics in development. Specifically, my work involved clinical trial design, central laboratory coordination and data monitoring, real-time review of microbiology data, monitoring trial trends for compliance and pathogen indication labels, providing interpretive criteria for AST and conducting special studies as mandated by regulatory guidance. Additionally, I provided product differentiation strategies to those companies with antibiotics in Phase II and beyond. This involved establishing microbiology attributes, understanding primary pharmacology, consideration of special populations and specialty microbiology studies and Target Product Profile (TPP). With respect to regulatory support, I conducted IND, NDA and ROW document preparation and review, oversaw product labeling for microbiology and prepared AST committee presentations and associated documents.

Lexington, Ma, Us

As Director, I was the microbiology leader on the Zerbaxa project team responsible for preparation of microbiology sections for the new drug application, the marketing authorization application, regulatory defense documentation and final label negotiations. I served as the core development team member who identified, designed and coordinated eternal microbiology and in vivo animal studies. I was the clinical development team member who designed and managed microbiology in Phase II and III cUTI and cIAI studies and also served as the commercial launch team member. I was responsible for preparation of the microbiology sections of rest of world submissions, periodic safety update reports of surveillance and resistance data, and presentations to regulatory agencies and advisory boards. In addition, I led external research collaboration. I designed and implemented an integrated, expandable system for external study evaluation and tracking, managed KOL relationships and coordinated internal/external studies as the discovery and non-clinical development team lead.Furthermore, I was responsible for presentations and negotiations with antimicrobial susceptibility testing (AST) committees. I established an AST strategy, identified key AST devices, evaluated market share and established necessary development contracts with manufacturers. I also presented Clinical and Laboratory Standards Institute break point data for daptomycin. I contributed to abstracts and manuscripts in strategic publication planning, drafting, execution and review.

Lexington, Ma, Us

In this position, I was the core development team member for drug development. I identified, designed and coordinated external microbiology and in vivo animal studies and supported all phases of development for daptomycin, CB-182,804, surotomycin, and ceftolozane/tazobactam programs. I authored clinical microbiology sections of CB-182,804 and Surotomycin INDs. I managed KOL relationships, coordinated central laboratory efforts, created strategic advisory boards and was the troubleshooter for antimicrobial susceptibility testing manufacturer issues. I was the project team lead for an inter-departmental project team charged with developing and initiating a comprehensive strategy to include a retrospective clinical/microbiology joint study, responses to specific commercial initiatives and additional scientific investigations.I was the core team member involved with the life cycle management of the strategic daptomycin development plan. I contributed to abstracts and manuscripts in strategic publication planning, drafting, execution and review.

Lexington, Ma, Us

As a Research Scientist, I managed the microbiology aspects of phase II clinical trials, including protocol development, case report form design, investigator meeting presentations, central laboratory selection and oversight, statistical analysis plan development and execution, data quality processes implementation, manual microbiology sponsor reviews and study report preparation. Responsible for external research collaboration, I managed a portfolio of more than 80 external investigators, liaised with all external collaborators regarding study designs, data analysis, scientific meeting presentations, peer-reviewed publication and managed KOL relationships. Additionally, I assisted with microbiology strategy and developed microbiology slide decks on the FDA Anti-Infective Drugs Advisory Committee. I authored multiple protocols, designed studies and authored final reports for FDA Phase IV microbiology commitments. Furthermore, I provided international regulatory support and reviewed regulatory documents for international filings.

Lexington, Ma, Us

I began my career at Cubist as a research scientist. I was responsible for non-human external research collaborations, managed a portfolio of external investigators and liaised with external collaborators regarding study designs, data analysis, scientific meeting presentations and peer-reviewed publications. In addition, I authored microbiology sections of FDA reports and investigator brochures. I participated in developing microbiology commercial launch plans including the development of daptomycin monograph, marketing pieces, sales presentations, speaker slide preparation and the Web. Furthermore, I participated on advisory boards, presenting microbiology data from the pivotal cSSSI studies, and I contributed to authoring abstracts/manuscripts as needed and assisted with business development.

Doctorate, Microbiology And Immunology

Master Of Science - Ms, Microbiology And Immunology

Bachelor'S Degree, Microbiology And Chemistry