Future-Proofing CGT Manufacturing: Integrating Digital Solutions With Regulatory Readiness

Monika Swietlicka is a senior regulatory executive with two decades of experience in Regulatory Affairs and Technical Operations across preclinical, clinical, and commercial development. At Halloran, she serves as an on-demand executive and interim Head of Regulatory for biotech companies developing biologics and advanced therapies. She partners with cross-functional teams to define regulatory strategy, guide critical development decisions, and lead interactions with global health authorities, including oversight and authorship of submissions to the FDA, EMA, and other agencies. 

Previously, Monika founded and led Swietlicka and Associates, advising early- and late-stage biotech companies across the product lifecycle, including first-in-human programs, late-phase development, regulatory due diligence, and assessments supporting investment and acquisition decisions. 

Monika spent seven years as SVP/VP of Regulatory Affairs and Technical Operations at Immusoft, a clinical-stage cell and gene therapy company, where she led regulatory strategy and built the quality infrastructure supporting a first-in-human autologous B-cell gene therapy. She also served as a Board Observer, providing regulatory insight to executive leadership and investors. 

Her experience spans cell and gene therapies, mRNA and LNP platforms, monoclonal antibodies, vaccines, small molecules, and combination products across rare disease, infectious disease, ophthalmology, autoimmune, and oncology indications. She serves on the Board of Directors of ORCA and holds an MBA in International Business, a BS in Biochemistry, and an MS in Regulatory Science. 

Dr. Kaye Spratt is a seasoned regulatory leader and scientific advisor with more than 30 years of experience in gene therapy, rare disease drug development, and global regulatory strategy. She provides strategic guidance on worldwide regulatory pathways, agency engagement, and designation strategies to accelerate the development of transformative therapies. 

Most recently, Dr. Spratt served as Senior Vice President of Regulatory Affairs at Rejuvenate Bio. Previously, she was Chief Regulatory Officer at BridgeBio Gene Therapy and Senior Vice President of Regulatory Affairs at Abeona Therapeutics, where she successfully secured U.S. and ex‑U.S. Orphan Drug, Fast Track, RMAT, and Breakthrough Therapy designations for multiple AAV‑based development programs. 

Earlier in her career, Dr. Spratt spent over 17 years at Sangamo Therapeutics in roles of increasing responsibility across assay development, quality control, and non‑clinical development. Her leadership supported IND‑enabling activities and the advancement of gene delivery and gene editing technologies from preclinical research into clinical development. 

Across her career, Dr. Spratt has directed global regulatory efforts spanning North America, Europe, and Australia, supporting the successful progression of numerous gene therapy and gene editing programs. She has led cross‑functional teams, guided translational strategy, and facilitated productive engagement with U.S. and international regulatory agencies, including the FDA and EMA, across multiple therapeutic areas. 

Dr. Spratt is an invited speaker at regulatory and scientific conferences and is an active contributor to the gene and cell therapy community, including participation in the American Society of Gene and Cell Therapy (ASGCT). 

She holds a PhD in Microbiology and Infectious Disease from Meharry Medical College and completed postdoctoral training in Molecular Biology and Biochemistry at the University of California.