Monika has 17 years of experience in Regulatory Affairs and Technical Operations from various biotechnology settings, having specialized in discovery, pre-clinical, clinical, commercial and translational research. She is proficient in all stages of cellular therapeutics and biologics drug development, and manufacturing, providing her with broad knowledge of the product lifecycle from research and discovery through commercialization. Monika has collaborated extensively with the U.S. Food and Drug Administration and the European Medicines Agency during her career. At Halloran, Monika has the capacity to serve as an interim Head of Regulatory or Regulatory Lead for Halloran clients whereby she collaboratively establishes the regulatory strategy through advising on critical development decisions for biologics and advanced therapies evaluated in unique programs to drive forward the development of clients’ assets and platform technologies. Regulatory leadership is provided to effectively execute the strategic plans through oversight, authorship and review of regulatory documents and submissions to health authorities, as well as lead interactions with health authorities.

Prior to Halloran, Monika held various leadership roles of increasing responsibility. Most recently she served as CEO, Founder and Regulatory Advisor at regulatory consulting firm, Swietlicka and Associates. Prior to that she spent seven years in SVP/VP of Regulatory Affairs and Technical Operations role at a Cell and Gene Therapy Company, Immusoft. In this role, Monika spearheaded the development and implementation of regulatory strategy and quality systems, including overseeing regulatory submissions and compliance for first in human genetically engineered, autologous, B-cell product. She built a successful manufacturing platform, Critical Raw Materials Program, Cold Chain Supply Chain, obtained Orphan Drug Designation, Rare Pediatric Designation, an open IND and most recently $8M in CIRM funding for first in Human B cell product (ISP-001). Prior to this, she managed a continuous improvement program for a first in class immunotherapy product, Provenge (Sipuleucel-T). She has authored content for FDA and EMA submissions, led Contract Manufacturing Organization tech transfer activities and compliance audits.

Working on autologous, genetically engineered B-cell product is Monika’s third experience with a biotech startup. Earlier, she worked on in-situ therapeutic antibody rescue technology, T-cell activation platform, and the first autologous antigen-presenting cells vaccine designed to stimulate an immune response to a variety of tumor types. She was part of early collaborative efforts with the International AIDS Vaccine Initiative to develop HIV-neutralizing antibodies and has worked on broadly neutralizing antibodies for treating pandemic influenza and severe seasonal influenza.

Education:
Master of Business Administration, International Business, Seattle Pacific University, Seattle, WA
Bachelor of Science, Biochemistry; Minor: Biology, Seattle Pacific University, Seattle, WA
Bachelor of Fine Arts, Painting, Print and Photography, Cornish College of the Arts, Seattle, WA
Certificate-Drug Development, Office of Technology Development, Harvard University, Cambridge, MA