To successfully increase speed-to-market for gene therapies, having a defined CQV (Commissioning, Qualification, and Validation) strategy is critical to project success. In this webinar co-sponsored by Precision ADVANCE and Project Farma, our panel of industry experts discuss tips for delivering efficient, reliable, GMP-compliant facilities and processes specific to gene therapy.
As a leader in the biotech industry, James utilizes his leadership skills, technical knowledge, and project management mindset to support the production of therapeutic products for human consumption. James supports the execution of manufacturing/quality systems such as non-conformances, process validation, training, new product introductions and tech transfers. James believes that a good team consists of many individuals with varying capabilities, each person being as pivotal to the overall goal as the other.
Joe Neroni is a Director at Project Farma. He is a 10+ year leader in the biologics and advanced therapies industry leading and supporting cross-functional teams in Capital Projects, Medical Device, Engineering, and Validation in the Pharmaceutical, Biotechnology and Gene & Cell Therapy Industry, and Aerospace industries. As a member of the Project Farma Team, Joe has helped Project Farma’s growth in the gene and cell therapy space including building gene therapy facilities for some of the first ever commercially approved therapies.
He has worked with small and large biotech companies including gene and cell therapy startups and CMOs/CROs, holding multiple roles ranging in a wide variety of scope and responsibilities from Project Management, Engineering Technical Lead, and Commissioning and Qualification Lead for Gene and Cell Therapy Facility Builds, Medical Device, Business Strategy, Technical Operations advisement and Facility Remediation. He brings a strong technical background in Upstream, Downstream and Fill and Finish processes through the project life cycle from conceptual design through implementation with a proven adaptability to new situations demonstrated by successful projects in a variety of companies and industries involving new or improved facilities, infrastructure, utilities and process equipment.
Kirsten Pier, BS, MBA, serves as Sio Gene Therapy’s Vice President Process Development & Manufacturing, CMC, where she manages the Process Development, Manufacturing, QC, Analytical Development and Supply Chain functions. In her career, she has overseen the commercialization of multiple programs including biologics and cell & gene therapy programs. She has held process development, manufacturing and MSAT positions at Amgen, Shire, bluebird bio and has served as a Senior CMC consultant at Biotech Logic.
She holds a B.S. in Veterinary and Biomedical Sciences from Colorado State University and a Master’s in Business Administration, Operations Management, from Regis University.
Terrell L. Smith is a Director at Project Farma. In his role, Terrell lead project teams, provides direction throughout project delivery life cycle, provides high-level technical direction, and engages with design teams early in the cycle to fully comprehend design scope. He creates project schedules for project tasks and drives alignment back into the overall program schedule, which includes resource planning and account management for both Project Farma and its global life science partners.
Tina Parikh serves as the Head of Quality Assurance for Neurogene Inc., a company focused on gene therapy for rare neurological disorders. Ms. Parikh has spent more than 16 years in the biotechnology industry, focused on gene therapy.
Prior to Neurogene, Ms. Parikh was the Head of Quality and Regulatory Affairs at the Lonza Houston manufacturing facility and played a leadership role in establishing Lonza as a major contract cellular and gene therapy manufacturer. Her experience in gene therapy covers plasmid DNA, viral vector, and cell therapy products, holding positions in Quality Control, Quality Assurance and Regulatory.
Ms. Parikh holds B.S. degrees in Physics and Biomedical Engineering and a M.S. in Quality Assurance and Regulatory Affairs from Temple University.
Michelle Sinsel is a Director at Project Farma. In her role, Michelle leads high-performing CQV teams, mentors and develops peers, creates validation strategies for projects, is an SME for data integrity initiatives, and manages project accounts for Project Farma.
With over 20+ years of extensive validation experience, Michelle brings significant validation and project knowledge to Project Farma. She has worked across the industry as a data integrity SME and validation manager with two startups, numerous process validation and data integrity remediations, and site expansions. Michelle specializes in computer system validations, QC instrument qualification, data integrity solutions, and equipment qualification.