Ms. Barsky has almost thirty (30) years of broad pharmaceutical experience in various areas of clinical and commercialQA/QC, outsourcing, project management and technical Chemistry, Manufacturing and Controls (CMC)-related operations. This forms the basis for her vast knowledge of the regulations and regulatory compliance for life science companies. Ms. Barsky has traveled the world extensively, helping life science companies overcome potential business and regulatory compliance risks, improving overall operational quality and maximizing profits. She excels at handling multiple, complex, and time-driven global projects, with the main objective being to provide a quick and practical resolution to complicated technical and compliance issues. Ms. Barsky also provided mentoring services to early stage biotechnology and medical device companies as part of the BioStrategy Partners/BioLaunch 611+ Keystone Innovation Zone network and currently provides consultation to potential investors in life science companies to help them to negotiate better prices on their deals.
Since the launching of PSG, Ms. Barsky has leveraged her expertise to 1) conduct due diligence audits, 2) perform multiple operational, quality and computer system validation assessments, 3) develop and implement regulatory compliance and operational strategies, 4) conduct field and fraud investigations, 5) help companies to either build or enhance their quality infrastructure in order to successfully pass customer audits and regulatory authority inspections, 6) host customer and regulatory agency inspections and 7) manage multiple projects that required the assistance of subcontractors. After much research on the businesses in the area, Ms. Barsky has also become a private investor in start-up companies, one of which is a biotech company.
Prior to forming PSG, Ms. Barsky was Associate Director of QA and then of Process Development/Product Formulation at Sankyo (now Daiichi Sankyo). There she 1) was responsible for the outsourcing of the company’s testing activities, 2) helped facilitate and manage the development and commercialization of the company’s drug products, 3) oversaw generation, compilation and coordination of all CMC technical documents required to support US regulatory submissions and 4) performed audits of company vendors as needed. Furthermore, she provided continuous QA/regulatory compliance, technical CMC and strategic input to various project teams with a focus on timelines and budgets.
While at Sankyo, Ms. Barsky was directly involved with numerous global project and outsourcing management efforts. Effective and successful implementation of these efforts required 1) an ability to address cross-cultural differences and sensitivities, 2) a skill to properly position the company with the outsourcing vendors, 3) strategic flexibility and “out-of-the-box” thinking, 4) exceptional communication and negotiation skills, 5) technical competence and 6) strong project management abilities.
Using unconventional, out-of-the box thinking and streamlining the pertinent processes and communication paths, Ms. Barsky implemented nineteen (19) modules of TrackWise (a GMP-based tracking software application) at Sankyo sites in the US in a period of nine (9) months. The prior standard for the vendor was implementation of, at most, five (5) modules in the course of twelve (12) to eighteen (18) months. Throughout the course of this cross-functional project, Ms. Barsky coordinated and monitored activities of twenty-three (23) to twenty-five (25) individuals from the internal Regulatory, Quality Assurance, Supply Chain Management and IT departments, as well as consulting and vendor staff.
Ms. Barsky also worked in the Quality Assurance Department at Bristol-Myers Squibb, where she was responsible for ensuring compliance of the internal and domestic vendor operations with relevant regulations, including Drug Enforcement Administration (DEA), and corporate policies. Additionally, in the capacity of QA/QC at Jacobus Pharmaceuticals, Ms. Barsky was intimately involved with overseeing and enhancing regulatory compliance of multiple aspects: R&D; manufacturing; testing; packaging/labeling; and, distribution operations. She has also conducted multiple investigations related to field complaints, out-of-specification test results, manufacturing, packaging, labeling, distribution and computer system-related operations. Ms. Barsky also hosted multiple FDA inspections.
Ms. Barsky received a Bachelor of Science Degree from Rutgers University, earning Phi Beta Kappa honors. She also served as program co-chair for BioStrategy Partners and provided enforcement training to FDA field inspectors, by invitation only, as part of FDA’s annual training initiative.