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.

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.

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

• 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.

• 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

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