Alex Borrelli Email & Phone Number

Cambridge, Massachusetts, Us

- Provided regulatory and quality guidance for cell transfection technology under an ISO 13485 oriented QMS - Led regulatory affairs activities, including the preparation of regulatory submissions focused on drug master file (DMF) development and maintenance - Interpret and apply applicable regulatory guidelines and directives (21 CFR 211, USP, ICH) to product quality, staying abreast of changes and advising stakeholders appropriately - Managed internal quality and regulatory records through the quality document system, Greenlight Guru - Coordinate with cross-functional teams to resolve quality and regulatory issues

Watertown, Massachusetts, Us

- Provided regulatory guidance with a CMC focus for a single entity combination product regulated under CDER- Knowledge of current FDA regulations and guidance with respect to drug development and GMP practices- Responsible for managing the preparation of US regulatory submissions including timeline development and management, writing, reviewing, editing sections and electronic publishing - Supported routine and non-routine regulatory submissions per established timelines and in compliance with all government regulations (e.g., clinical/CMC information amendments, Annual Reports/DSURs, meeting requests/packages, IMPD)- Interacted with other departments and SMEs to ensure timely and accurate regulatory submissions. Able to interact effectively with departments to ensure departmental goals are met- Responsible for ongoing review and impact assessment of key guidance documents and regulations - Served as regulatory representative on cross functional project teams including the change control review board, providing input and impact assessments - Maintenance of regulatory documentation including submissions history and documentation/tracking of correspondence with FDA- Tracked and coordinated projects related to fulfillment of FDA requests and commitments-

Watertown, Massachusetts, Us

• Responsible for supporting regulatory in all IND and NDA activities for a combination drug/device product regulated under CDER• Provided regulatory input on CMC related issues including method validation/verification, process validation, and stability programs • Directly responsible for authoring, editing, finalizing and submitting routine IND and NDA submissions (e.g. Annual Reports, New Investigators) per established timelines and in compliance with all government regulations.• Responsible for supporting non-routine submissions including prior approval supplements (PAS) and changes being effected (CBE)• Responsible for publishing activities (paper and/or electronic) including the transmittal and review of regulatory submissions in eCTD format to ensure compliance to electronic standards and requirements• Interacted with other departments and SMEs to assure timely and accurate regulatory submissions. Able to interact effectively with departments to ensure departmental goals are met• Represented the regulatory group on cross-functional project teams• Identify and assess regulatory risks for assigned projects or programs.• Maintenance of regulatory documentation including submissions history and documentation/tracking of correspondence with FDA in both electronic and hard copy

• Assisted with the preparation of regulatory documents for FDA/IRB submissions including but not limited to: pre-IND, IND, and SOPs. • Maintained documentation and binders associated with GLP compliant, regulatory enabling studies• Designed, conducted, and reported on experiments in response to initial FDA and IRB response regarding potential product safety concerns. These experiments successfully addressed the concerns of these agencies. • Coordinated with CROs regarding logistics and tech transfer of proprietary characterization assays for a Phase 1 escalating dose clinical trial• General QC and stability analysis for the 3 main components of the tkRNAi system from time point of manufacturing to present (36 months) including but not limited to: storage conditions; system components include surface invasion protein detection, endosomal lysis mechanism detection, and shRNA detection

• Screening of siRNAs to find target gene sequences• Developed or performed Invasion assays to evaluate candidates in the proprietary tkRNAi platform• Evaluation of samples from preclinical studies for gene expression, cytokine expression, and product excretion. Data used for regulatory enabling submissions • Development and conduct of experiments based on FDA guidance documents• Conducted bacterial invasion assays and other experiments utilizing QPCR, ELISA, flow cytometry • Promoted to Quality Manager 3/2009• In August of 2010 Cequent was acquired and renamed as Marina Biotech.

Martinsried, De

• Constructed and pharmacologically verified through growth inhibition studies several oncogene driven cell lines.• Successfully developed medium throughput dot-blot phosphorylation assay to screen the company library of 12,000 compounds for inhibitors of a cancer relevant kinase.• Conducted dose response studies for drug discovery to determine efficacy of various compounds in vitro

• Development of BCG based cancer vaccines targeted to the proteins MUC1 and CD155• Constructed and validated a stable cell line using shRNA to elucidate MUC1’s function in pancreatic cancer• Managed project to ascertain BCG vaccine effectiveness in rats and obtained preliminary data suggesting vaccine protects rats against tumor growth, which went toward grants and posters.• Analyzed expression of CD155 in various patient tissue samples using laser capture microdissection.

Certificate, Domestic Regulatory Affairs

Ms, Biotechnology

Bs, Biology