Archives: Speakers

Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

Michael is a strategic pharmaceutical professional currently holding a role as a Senior Manager, Clinical Research Souring Strategist at Pfizer. In this role, he develops innovative strategic sourcing strategies for open-label commercial products across diverse therapeutic areas while overseeing vendor operations and relationships. Michael’s background includes experience in category management and full-service outsourcing in Global R&D Procurement at Organon, both before and after the spin-off from Merck & Co. Michael entered the pharmaceutical industry during his time at Almac Group where he held multiple roles within the Business Development team. He holds an MBA and a Bachelor’s degree in Business Management and Marketing from Penn State University and multiple certificates and certifications.

Windell McGill is a packaging industry veteran who leads the digital printing product strategy at Paper Converting Machine Co. (PCMC), a BW Converting Solutions company. During his three-decade career, Windell has held various leadership positions at prominent print and packaging companies including AVT Americas, HP Indigo, and ePac Atlanta. With his extensive experience in this dynamic field, Windell is committed to growing the industry through technological advancements, fostering a culture of innovation, and driving continuous improvement.

Sharon Taylor is a Biological Threat Operations Specialist (BTOS) with U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO) in the Area Port of Philadelphia.  Ms. Taylor began her career in October 2006 at JFK International Airport, NY before transferring to her hometown of Philadelphia, PA in 2009.  Ms. Taylor has 17 years of public service with CBP working in a variety of environments such air passenger, maritime and express carrier locations. During that time, she has worked as an Agriculture Specialist, K9 Handler and with several specialized units/teams within CBP.

With an extensive background in pharmaceutical chemistry, Kristi brings a vast knowledge of product quality to the table. Utilizing her innovative strategic thinking and patient centricity, she focuses on delivering projects with emphasis on improving quality within the Clinical Supply Chain. Kristi holds a BS in Chemistry from Delaware Valley University, a Masters in Analytical Pharmaceutical Chemistry from The Illinois Institute of Technology, and several industry certifications.

Ellyn Ensby is a self-proclaimed generalist, with roles and experiences across plan, source, make, and deliver functions, and through the varied lenses of commercial, R&D, pharmaceuticals and consumer products.  She is a passionate people leader and is focused on evolving temperature management into a key capability and advantage for the Clinical Supply Chain.  Ellyn holds a B.S. in Interdisciplinary Engineering & Management from Clarkson University, and an MBA from DeSales University.  

Naoya Matsuzaki is a CMC specialist in the pharmaceutical industry with over 14 years of experience in researching and developing innovative medical products. During his engagement in new drug development as an analytical chemist in Astellas Pharma in his early career, he collaborated with many CMOs, CTOs, and business partners globally. He experienced global regulatory submission and commercial product launch. Naoya moved to NS Pharma (a US subsidiary of Nippon Shinyaku) in 2022 and began to work as a CMC US lead for multiple global development projects with various CMC responsibilities, such as a lead of CMC members, CMC RA strategy and clinical trial supply. Naoya has a Ph.D. (Pharmaceutical Science) from the University of Shizuoka and is a 2024 MBA candidate at the University of Massachusetts Lowell.

Courtney Bortz, Principal Client Services Lead at 4G Clinical, has vast experience in RTSM system implementation, configuration, and project management. She’s worked on various software platforms and infrastructures including IRT and Accounting & Property Management Software.  Courtney graduated from the University of Cincinnati with a BBA in Accounting & Information Systems

David Bacskai is currently an RTSM Design Lead within Clinical Supply Chain at Janssen. In his current role of RTSM Design Lead,  David leads the development and design for IRT studies in the Oncology and CAR-T therapeutic areas.  David also ensures current CAR-T and Oncology IRT Best Practices are implemented to promote consistency across all trials. David has been in the IRT industry for over 20 years. During his career, David has worked at an IRT vendor and sponsor where he has had the opportunity to lead process improvement initiatives, lead User Acceptance Testing efforts at both platform and protocol level, and support standards implementation/change control